User login
What COVID-19 has taught us about senior care
Across the globe, there are marked differences in how countries responded to the COVID-19 outbreak, with varying degrees of success in limiting the spread of the virus. Some countries learned important lessons from previous outbreaks, including SARS and MERS, and put policies in place that contributed to lower infection and death rates from COVID-19 in these countries. Others struggled to respond appropriately to the outbreak.
The United States and most of the world was not affected significantly by SARS and MERS. Hence there is a need for different perspectives and observations on lessons that can be learned from this outbreak to help develop effective strategies and policies for the future. It also makes sense to focus intently on the demographic most affected by COVID-19 – the elderly.
Medical care, for the most part, is governed by protocols that clearly detail processes to be followed for the prevention and treatment of disease. Caring for older patients requires going above and beyond the protocols. That is one of the lessons learned from the COVID-19 pandemic – a wake-up call for a more proactive approach for at-risk patients, in this case everyone over the age of 60 years.
In this context, it is important for medical outreach to continue with the senior population long after the pandemic has run its course. Many seniors, particularly those susceptible to other illnesses or exhibiting ongoing issues, would benefit from a consistent and preplanned pattern of contacts by medical professionals and agencies that work with the aging population. These proactive follow-ups can facilitate prevention and treatment and, at the same time, reduce costs that would otherwise increase when health care is reactive.
Lessons in infectious disease containment
As COVID-19 spread globally, there were contrasting responses from individual countries in their efforts to contain the disease. Unfortunately, Italy suffered from its decision to lock down only specific regions of the country initially. The leadership in Italy may have ignored the advice of medical experts and been caught off guard by the intensity of the spread of COVID-19. In fact, they might not have taken strict actions right away because they did not want their responses to be viewed as an overreaction to the disease.
The government decided to shut down areas where the infection rates were high (“red zones”) rather than implement restrictions nationally. This may have inadvertently increased the spread as Italians vacated those “red zones” for other areas of the country not yet affected by COVID-19. Italy’s decentralized health care system also played a part in the effects of the disease, with some regions demonstrating more success in slowing the reach of the disease. According to an article in the Harvard Business Review, the neighboring regions of Lombardy and Veneto applied similar approaches to social distancing and retail closures. Veneto was more proactive, and its response to the outbreak was multipronged, including putting a “strong emphasis on home diagnosis and care” and “specific efforts to monitor and protect health care and other essential workers.” These measures most likely contributed to a slowdown of the spread of the disease in Veneto’s health care facilities, which lessened the load on medical providers.1
Conversely, Taiwan implemented proactive measures swiftly after learning about COVID-19. Taiwan was impacted adversely by the SARS outbreak in 2003 and, afterward, revised their medical policies and procedures to respond quickly to future infectious disease crises. In the beginning, little was known about COVID-19 or how it spread. However, Taiwan’s swift public health response to COVID-19 included early travel restrictions, patient screening, and quarantining of symptomatic patients. The government emphasized education and created real-time digital updates and alerts sent to their citizens, as well as partnering with media to broadcast crucial proactive health information and quickly disproving false information related to COVID-19. They coordinated with organizations throughout the country to increase supplies of personal protective equipment (PPE).2
Although countries and even cities within a country differ in terms of population demographics, health resources, government policies, and cultural practices, initial success stories have some similarities, including the following:
- Early travel restrictions from countries with positive cases, with some circumstances requiring compulsory quarantine periods and testing before entry.
- Extensive testing and proactive tracing of symptomatic cases early. Contacts of people testing positive were also tested, irrespective of being symptomatic or asymptomatic. If testing kits were unavailable, the contacts were self-quarantined.
- Emphasis on avoiding overburdening hospitals by having the public health infrastructure to divert people exhibiting symptoms, including using public health hotlines to send patients to dedicated testing sites and drive-through testing, rather than have patients presenting to emergency rooms and hospitals. This approach protected medical staff from exposure and allowed the focus to remain on treating severe symptomatic patients.
The vastly different response to the COVID-19 outbreak in these two countries illuminates the need for better preparation in the United States. At the onset of this outbreak, emergency room medical professionals, hospitalists, and outpatient primary care providers did not know how to screen for or treat this virus. Additionally, there was limited information on the most effective contact protocols for medical professionals, patients, and visitors. Finally, the lack of PPE and COVID-19 test kits hindered the U.S. response. Once the country is on the road to recovery from COVID-19, it is imperative to set the groundwork to prepare for future outbreaks and create mechanisms to quickly identify vulnerable populations when outbreaks occur.
Senior care in future infectious disease outbreaks
How can medical providers translate lessons learned from this outbreak into improving the quality of care for seniors? The National Institute on Aging (NIA) maintains a website with information about healthy aging. Seniors and their caregivers can use this website to learn more about chronic diseases, lifestyle modifications, disease prevention, and mental health.
In times of a pandemic, this website provides consistent and accurate information and education. One recommendation for reaching the elderly population during future outbreaks is for NIA to develop and implement strategies to increase the use of the website, including adding more audio and visual interfaces and developing a mobile app. Other recommendations for improving the quality of care for seniors include the following:
1. Identify which populations may be most affected when future outbreaks occur.
2. Consider nontraditional platforms, including social media, for communicating with the general population and for medical providers worldwide to learn from each other about new diseases, including the signs, symptoms, and treatment plans. Some medical professionals created specific WhatsApp groups to communicate, and the World Health Organization sent updated information about COVID-19 to anyone who texted them via WhatsApp.3
3. Create a checklist of signs and symptoms related to current infectious diseases and assess every vulnerable patient.
4. Share these guidelines with medical facilities that treat these populations, such as senior care, assisted living and rehabilitation facilities, hospitals, and outpatient treatment centers. Teach the staff at these medical facilities how to screen patients for signs and symptoms of the disease.
5. Implement social isolation strategies, travel and visitor restrictions, and testing and screening as soon as possible at these medical facilities.
6. Recognize that these strategies may affect the psychological and emotional well-being of seniors, increasing their risk for depression and anxiety and negatively affecting their immunity and mental health. Additionally, the use of PPE, either by the medical providers or the patient, may cause anxiety in seniors and those with mild cognitive impairment.
7. Encourage these medical facilities to improve coping strategies with older patients, such as incorporating communication technology that helps seniors stay connected with their families, and participating in physical and mental exercise, as well as religious activities.
8. Ask these medical facilities to create isolation or quarantine rooms for infected seniors.
9. Work with family members to proactively report to medical professionals any symptoms noticed in their senior relatives. Educate seniors to report symptoms earlier.
10. Offer incentives for medical professionals to conduct on-site testing in primary care offices or senior care facilities instead of sending patients to hospital emergency rooms for evaluation. This will only be effective if there are enough test kits available.
11. Urge insurance companies and Medicare to allow additional medical visits for screening vulnerable populations. Encourage the use of telemedicine in place of in-office visits (preferably billed at the same rate as an in-office visit) where appropriate, especially with nonambulatory patients or those with transportation issues. Many insurance companies, including Medicare, approved COVID-19–related coverage of telemedicine in place of office visits to limit the spread of the disease.
12. Provide community health care and integration and better coordination of local, state, and national health care.
13. Hold regular epidemic and pandemic preparedness exercises in every hospital, nursing home, and assisted living facility.
Proactive health care outreach
It is easier to identify the signs and symptoms of already identified infectious diseases as opposed to a novel one like COVID-19. The United States faced a steep learning curve with COVID-19. Hospitalists and other medical professionals were not able to learn about COVID-19 in a journal. At first, they did not know how to screen patients coming into the ER, how to protect staff, or what the treatment plan was for this new disease. As a result, the medical system experienced disorder and confusion. Investing in community health care and better coordination of local, state, and national health care resources is a priority.
The senior citizen population appears to be most vulnerable to this virus and may be just as vulnerable in future outbreaks. Yet the insights gained from this pandemic can lead to a more comprehensive outreach to senior patients and increased screenings for comorbidities and future contagious diseases. An emphasis on proactive health care and outreach for seniors, with a focus on identifying and treating comorbid conditions, improves the medical care system overall and may prevent or slow future community outbreaks.
Dr. Kasarla is a hospitalist with APOGEE Physicians at Wise Surgical at Parkway in Fort Worth, Tex. He did his internal medicine residency at Mercy Hospital & Medical Center, Chicago. Readers can contact him at madhukarreddy.kasarla@apogeephysicians.com. Dr. Devireddy is a family physician at Positive Health Medical Center, Kingston, Jamaica. Contact him at drjaisheel@gmail.com.
References
1. Pisano GP et al. Lessons from Italy’s response to coronavirus. Harvard Business Review. 2020 Mar 27. https://hbr.org/2020/03/lessons-from-italys-response-to-coronavirus.
2. Tu C. Lessons from Taiwan’s experience with COVID-19. New Atlanticist. 2020 Apr 7. https://atlanticcouncil.org/blogs/new-atlanticist/lessons-from-taiwans-experience-with-covid-19/.
3. Newman LH. WhatsApp is at the center of coronavirus response. WIRED. 2020 Mar 20. https://www.wired.com/story/whatsapp-coronavirus-who-information-app/.
Across the globe, there are marked differences in how countries responded to the COVID-19 outbreak, with varying degrees of success in limiting the spread of the virus. Some countries learned important lessons from previous outbreaks, including SARS and MERS, and put policies in place that contributed to lower infection and death rates from COVID-19 in these countries. Others struggled to respond appropriately to the outbreak.
The United States and most of the world was not affected significantly by SARS and MERS. Hence there is a need for different perspectives and observations on lessons that can be learned from this outbreak to help develop effective strategies and policies for the future. It also makes sense to focus intently on the demographic most affected by COVID-19 – the elderly.
Medical care, for the most part, is governed by protocols that clearly detail processes to be followed for the prevention and treatment of disease. Caring for older patients requires going above and beyond the protocols. That is one of the lessons learned from the COVID-19 pandemic – a wake-up call for a more proactive approach for at-risk patients, in this case everyone over the age of 60 years.
In this context, it is important for medical outreach to continue with the senior population long after the pandemic has run its course. Many seniors, particularly those susceptible to other illnesses or exhibiting ongoing issues, would benefit from a consistent and preplanned pattern of contacts by medical professionals and agencies that work with the aging population. These proactive follow-ups can facilitate prevention and treatment and, at the same time, reduce costs that would otherwise increase when health care is reactive.
Lessons in infectious disease containment
As COVID-19 spread globally, there were contrasting responses from individual countries in their efforts to contain the disease. Unfortunately, Italy suffered from its decision to lock down only specific regions of the country initially. The leadership in Italy may have ignored the advice of medical experts and been caught off guard by the intensity of the spread of COVID-19. In fact, they might not have taken strict actions right away because they did not want their responses to be viewed as an overreaction to the disease.
The government decided to shut down areas where the infection rates were high (“red zones”) rather than implement restrictions nationally. This may have inadvertently increased the spread as Italians vacated those “red zones” for other areas of the country not yet affected by COVID-19. Italy’s decentralized health care system also played a part in the effects of the disease, with some regions demonstrating more success in slowing the reach of the disease. According to an article in the Harvard Business Review, the neighboring regions of Lombardy and Veneto applied similar approaches to social distancing and retail closures. Veneto was more proactive, and its response to the outbreak was multipronged, including putting a “strong emphasis on home diagnosis and care” and “specific efforts to monitor and protect health care and other essential workers.” These measures most likely contributed to a slowdown of the spread of the disease in Veneto’s health care facilities, which lessened the load on medical providers.1
Conversely, Taiwan implemented proactive measures swiftly after learning about COVID-19. Taiwan was impacted adversely by the SARS outbreak in 2003 and, afterward, revised their medical policies and procedures to respond quickly to future infectious disease crises. In the beginning, little was known about COVID-19 or how it spread. However, Taiwan’s swift public health response to COVID-19 included early travel restrictions, patient screening, and quarantining of symptomatic patients. The government emphasized education and created real-time digital updates and alerts sent to their citizens, as well as partnering with media to broadcast crucial proactive health information and quickly disproving false information related to COVID-19. They coordinated with organizations throughout the country to increase supplies of personal protective equipment (PPE).2
Although countries and even cities within a country differ in terms of population demographics, health resources, government policies, and cultural practices, initial success stories have some similarities, including the following:
- Early travel restrictions from countries with positive cases, with some circumstances requiring compulsory quarantine periods and testing before entry.
- Extensive testing and proactive tracing of symptomatic cases early. Contacts of people testing positive were also tested, irrespective of being symptomatic or asymptomatic. If testing kits were unavailable, the contacts were self-quarantined.
- Emphasis on avoiding overburdening hospitals by having the public health infrastructure to divert people exhibiting symptoms, including using public health hotlines to send patients to dedicated testing sites and drive-through testing, rather than have patients presenting to emergency rooms and hospitals. This approach protected medical staff from exposure and allowed the focus to remain on treating severe symptomatic patients.
The vastly different response to the COVID-19 outbreak in these two countries illuminates the need for better preparation in the United States. At the onset of this outbreak, emergency room medical professionals, hospitalists, and outpatient primary care providers did not know how to screen for or treat this virus. Additionally, there was limited information on the most effective contact protocols for medical professionals, patients, and visitors. Finally, the lack of PPE and COVID-19 test kits hindered the U.S. response. Once the country is on the road to recovery from COVID-19, it is imperative to set the groundwork to prepare for future outbreaks and create mechanisms to quickly identify vulnerable populations when outbreaks occur.
Senior care in future infectious disease outbreaks
How can medical providers translate lessons learned from this outbreak into improving the quality of care for seniors? The National Institute on Aging (NIA) maintains a website with information about healthy aging. Seniors and their caregivers can use this website to learn more about chronic diseases, lifestyle modifications, disease prevention, and mental health.
In times of a pandemic, this website provides consistent and accurate information and education. One recommendation for reaching the elderly population during future outbreaks is for NIA to develop and implement strategies to increase the use of the website, including adding more audio and visual interfaces and developing a mobile app. Other recommendations for improving the quality of care for seniors include the following:
1. Identify which populations may be most affected when future outbreaks occur.
2. Consider nontraditional platforms, including social media, for communicating with the general population and for medical providers worldwide to learn from each other about new diseases, including the signs, symptoms, and treatment plans. Some medical professionals created specific WhatsApp groups to communicate, and the World Health Organization sent updated information about COVID-19 to anyone who texted them via WhatsApp.3
3. Create a checklist of signs and symptoms related to current infectious diseases and assess every vulnerable patient.
4. Share these guidelines with medical facilities that treat these populations, such as senior care, assisted living and rehabilitation facilities, hospitals, and outpatient treatment centers. Teach the staff at these medical facilities how to screen patients for signs and symptoms of the disease.
5. Implement social isolation strategies, travel and visitor restrictions, and testing and screening as soon as possible at these medical facilities.
6. Recognize that these strategies may affect the psychological and emotional well-being of seniors, increasing their risk for depression and anxiety and negatively affecting their immunity and mental health. Additionally, the use of PPE, either by the medical providers or the patient, may cause anxiety in seniors and those with mild cognitive impairment.
7. Encourage these medical facilities to improve coping strategies with older patients, such as incorporating communication technology that helps seniors stay connected with their families, and participating in physical and mental exercise, as well as religious activities.
8. Ask these medical facilities to create isolation or quarantine rooms for infected seniors.
9. Work with family members to proactively report to medical professionals any symptoms noticed in their senior relatives. Educate seniors to report symptoms earlier.
10. Offer incentives for medical professionals to conduct on-site testing in primary care offices or senior care facilities instead of sending patients to hospital emergency rooms for evaluation. This will only be effective if there are enough test kits available.
11. Urge insurance companies and Medicare to allow additional medical visits for screening vulnerable populations. Encourage the use of telemedicine in place of in-office visits (preferably billed at the same rate as an in-office visit) where appropriate, especially with nonambulatory patients or those with transportation issues. Many insurance companies, including Medicare, approved COVID-19–related coverage of telemedicine in place of office visits to limit the spread of the disease.
12. Provide community health care and integration and better coordination of local, state, and national health care.
13. Hold regular epidemic and pandemic preparedness exercises in every hospital, nursing home, and assisted living facility.
Proactive health care outreach
It is easier to identify the signs and symptoms of already identified infectious diseases as opposed to a novel one like COVID-19. The United States faced a steep learning curve with COVID-19. Hospitalists and other medical professionals were not able to learn about COVID-19 in a journal. At first, they did not know how to screen patients coming into the ER, how to protect staff, or what the treatment plan was for this new disease. As a result, the medical system experienced disorder and confusion. Investing in community health care and better coordination of local, state, and national health care resources is a priority.
The senior citizen population appears to be most vulnerable to this virus and may be just as vulnerable in future outbreaks. Yet the insights gained from this pandemic can lead to a more comprehensive outreach to senior patients and increased screenings for comorbidities and future contagious diseases. An emphasis on proactive health care and outreach for seniors, with a focus on identifying and treating comorbid conditions, improves the medical care system overall and may prevent or slow future community outbreaks.
Dr. Kasarla is a hospitalist with APOGEE Physicians at Wise Surgical at Parkway in Fort Worth, Tex. He did his internal medicine residency at Mercy Hospital & Medical Center, Chicago. Readers can contact him at madhukarreddy.kasarla@apogeephysicians.com. Dr. Devireddy is a family physician at Positive Health Medical Center, Kingston, Jamaica. Contact him at drjaisheel@gmail.com.
References
1. Pisano GP et al. Lessons from Italy’s response to coronavirus. Harvard Business Review. 2020 Mar 27. https://hbr.org/2020/03/lessons-from-italys-response-to-coronavirus.
2. Tu C. Lessons from Taiwan’s experience with COVID-19. New Atlanticist. 2020 Apr 7. https://atlanticcouncil.org/blogs/new-atlanticist/lessons-from-taiwans-experience-with-covid-19/.
3. Newman LH. WhatsApp is at the center of coronavirus response. WIRED. 2020 Mar 20. https://www.wired.com/story/whatsapp-coronavirus-who-information-app/.
Across the globe, there are marked differences in how countries responded to the COVID-19 outbreak, with varying degrees of success in limiting the spread of the virus. Some countries learned important lessons from previous outbreaks, including SARS and MERS, and put policies in place that contributed to lower infection and death rates from COVID-19 in these countries. Others struggled to respond appropriately to the outbreak.
The United States and most of the world was not affected significantly by SARS and MERS. Hence there is a need for different perspectives and observations on lessons that can be learned from this outbreak to help develop effective strategies and policies for the future. It also makes sense to focus intently on the demographic most affected by COVID-19 – the elderly.
Medical care, for the most part, is governed by protocols that clearly detail processes to be followed for the prevention and treatment of disease. Caring for older patients requires going above and beyond the protocols. That is one of the lessons learned from the COVID-19 pandemic – a wake-up call for a more proactive approach for at-risk patients, in this case everyone over the age of 60 years.
In this context, it is important for medical outreach to continue with the senior population long after the pandemic has run its course. Many seniors, particularly those susceptible to other illnesses or exhibiting ongoing issues, would benefit from a consistent and preplanned pattern of contacts by medical professionals and agencies that work with the aging population. These proactive follow-ups can facilitate prevention and treatment and, at the same time, reduce costs that would otherwise increase when health care is reactive.
Lessons in infectious disease containment
As COVID-19 spread globally, there were contrasting responses from individual countries in their efforts to contain the disease. Unfortunately, Italy suffered from its decision to lock down only specific regions of the country initially. The leadership in Italy may have ignored the advice of medical experts and been caught off guard by the intensity of the spread of COVID-19. In fact, they might not have taken strict actions right away because they did not want their responses to be viewed as an overreaction to the disease.
The government decided to shut down areas where the infection rates were high (“red zones”) rather than implement restrictions nationally. This may have inadvertently increased the spread as Italians vacated those “red zones” for other areas of the country not yet affected by COVID-19. Italy’s decentralized health care system also played a part in the effects of the disease, with some regions demonstrating more success in slowing the reach of the disease. According to an article in the Harvard Business Review, the neighboring regions of Lombardy and Veneto applied similar approaches to social distancing and retail closures. Veneto was more proactive, and its response to the outbreak was multipronged, including putting a “strong emphasis on home diagnosis and care” and “specific efforts to monitor and protect health care and other essential workers.” These measures most likely contributed to a slowdown of the spread of the disease in Veneto’s health care facilities, which lessened the load on medical providers.1
Conversely, Taiwan implemented proactive measures swiftly after learning about COVID-19. Taiwan was impacted adversely by the SARS outbreak in 2003 and, afterward, revised their medical policies and procedures to respond quickly to future infectious disease crises. In the beginning, little was known about COVID-19 or how it spread. However, Taiwan’s swift public health response to COVID-19 included early travel restrictions, patient screening, and quarantining of symptomatic patients. The government emphasized education and created real-time digital updates and alerts sent to their citizens, as well as partnering with media to broadcast crucial proactive health information and quickly disproving false information related to COVID-19. They coordinated with organizations throughout the country to increase supplies of personal protective equipment (PPE).2
Although countries and even cities within a country differ in terms of population demographics, health resources, government policies, and cultural practices, initial success stories have some similarities, including the following:
- Early travel restrictions from countries with positive cases, with some circumstances requiring compulsory quarantine periods and testing before entry.
- Extensive testing and proactive tracing of symptomatic cases early. Contacts of people testing positive were also tested, irrespective of being symptomatic or asymptomatic. If testing kits were unavailable, the contacts were self-quarantined.
- Emphasis on avoiding overburdening hospitals by having the public health infrastructure to divert people exhibiting symptoms, including using public health hotlines to send patients to dedicated testing sites and drive-through testing, rather than have patients presenting to emergency rooms and hospitals. This approach protected medical staff from exposure and allowed the focus to remain on treating severe symptomatic patients.
The vastly different response to the COVID-19 outbreak in these two countries illuminates the need for better preparation in the United States. At the onset of this outbreak, emergency room medical professionals, hospitalists, and outpatient primary care providers did not know how to screen for or treat this virus. Additionally, there was limited information on the most effective contact protocols for medical professionals, patients, and visitors. Finally, the lack of PPE and COVID-19 test kits hindered the U.S. response. Once the country is on the road to recovery from COVID-19, it is imperative to set the groundwork to prepare for future outbreaks and create mechanisms to quickly identify vulnerable populations when outbreaks occur.
Senior care in future infectious disease outbreaks
How can medical providers translate lessons learned from this outbreak into improving the quality of care for seniors? The National Institute on Aging (NIA) maintains a website with information about healthy aging. Seniors and their caregivers can use this website to learn more about chronic diseases, lifestyle modifications, disease prevention, and mental health.
In times of a pandemic, this website provides consistent and accurate information and education. One recommendation for reaching the elderly population during future outbreaks is for NIA to develop and implement strategies to increase the use of the website, including adding more audio and visual interfaces and developing a mobile app. Other recommendations for improving the quality of care for seniors include the following:
1. Identify which populations may be most affected when future outbreaks occur.
2. Consider nontraditional platforms, including social media, for communicating with the general population and for medical providers worldwide to learn from each other about new diseases, including the signs, symptoms, and treatment plans. Some medical professionals created specific WhatsApp groups to communicate, and the World Health Organization sent updated information about COVID-19 to anyone who texted them via WhatsApp.3
3. Create a checklist of signs and symptoms related to current infectious diseases and assess every vulnerable patient.
4. Share these guidelines with medical facilities that treat these populations, such as senior care, assisted living and rehabilitation facilities, hospitals, and outpatient treatment centers. Teach the staff at these medical facilities how to screen patients for signs and symptoms of the disease.
5. Implement social isolation strategies, travel and visitor restrictions, and testing and screening as soon as possible at these medical facilities.
6. Recognize that these strategies may affect the psychological and emotional well-being of seniors, increasing their risk for depression and anxiety and negatively affecting their immunity and mental health. Additionally, the use of PPE, either by the medical providers or the patient, may cause anxiety in seniors and those with mild cognitive impairment.
7. Encourage these medical facilities to improve coping strategies with older patients, such as incorporating communication technology that helps seniors stay connected with their families, and participating in physical and mental exercise, as well as religious activities.
8. Ask these medical facilities to create isolation or quarantine rooms for infected seniors.
9. Work with family members to proactively report to medical professionals any symptoms noticed in their senior relatives. Educate seniors to report symptoms earlier.
10. Offer incentives for medical professionals to conduct on-site testing in primary care offices or senior care facilities instead of sending patients to hospital emergency rooms for evaluation. This will only be effective if there are enough test kits available.
11. Urge insurance companies and Medicare to allow additional medical visits for screening vulnerable populations. Encourage the use of telemedicine in place of in-office visits (preferably billed at the same rate as an in-office visit) where appropriate, especially with nonambulatory patients or those with transportation issues. Many insurance companies, including Medicare, approved COVID-19–related coverage of telemedicine in place of office visits to limit the spread of the disease.
12. Provide community health care and integration and better coordination of local, state, and national health care.
13. Hold regular epidemic and pandemic preparedness exercises in every hospital, nursing home, and assisted living facility.
Proactive health care outreach
It is easier to identify the signs and symptoms of already identified infectious diseases as opposed to a novel one like COVID-19. The United States faced a steep learning curve with COVID-19. Hospitalists and other medical professionals were not able to learn about COVID-19 in a journal. At first, they did not know how to screen patients coming into the ER, how to protect staff, or what the treatment plan was for this new disease. As a result, the medical system experienced disorder and confusion. Investing in community health care and better coordination of local, state, and national health care resources is a priority.
The senior citizen population appears to be most vulnerable to this virus and may be just as vulnerable in future outbreaks. Yet the insights gained from this pandemic can lead to a more comprehensive outreach to senior patients and increased screenings for comorbidities and future contagious diseases. An emphasis on proactive health care and outreach for seniors, with a focus on identifying and treating comorbid conditions, improves the medical care system overall and may prevent or slow future community outbreaks.
Dr. Kasarla is a hospitalist with APOGEE Physicians at Wise Surgical at Parkway in Fort Worth, Tex. He did his internal medicine residency at Mercy Hospital & Medical Center, Chicago. Readers can contact him at madhukarreddy.kasarla@apogeephysicians.com. Dr. Devireddy is a family physician at Positive Health Medical Center, Kingston, Jamaica. Contact him at drjaisheel@gmail.com.
References
1. Pisano GP et al. Lessons from Italy’s response to coronavirus. Harvard Business Review. 2020 Mar 27. https://hbr.org/2020/03/lessons-from-italys-response-to-coronavirus.
2. Tu C. Lessons from Taiwan’s experience with COVID-19. New Atlanticist. 2020 Apr 7. https://atlanticcouncil.org/blogs/new-atlanticist/lessons-from-taiwans-experience-with-covid-19/.
3. Newman LH. WhatsApp is at the center of coronavirus response. WIRED. 2020 Mar 20. https://www.wired.com/story/whatsapp-coronavirus-who-information-app/.
Marijuana for migraine? Some tentative evidence
according to results from a small study conducted at the Jefferson Headache Center at Thomas Jefferson University. The researchers found general satisfaction with medical marijuana, more frequent use as an abortive medication rather than a preventative, and more than two-thirds using the inhaled form rather than oral.
Many patients ask about medical marijuana, but there is relatively little data on its effects on headache. Studies are generally retrospective, and often focus on marijuana use for general pain, with subset analyses looking at headache, according to coauthor Claire Ceriani, MD, who is a headache fellow at Jefferson. “A lot of patients are interested in medical marijuana but don’t know how to integrate it into the therapy plan they already have – whether it should be just to treat bad headaches when they happen, or is it meant to be a preventive medicine they use every day? We have some data out there that it can be helpful, but not a lot of specific information to guide your recommendations,” said Dr. Ceriani in an interview.
Although the research is far from a final word on the subject, it did have some take-home messages, said Dr. Ceriani. “Most people seem to find it effective as an abortive medication that might be able to take the place of some of the prescription medications that they were previously using,” she said.
The study was part of the virtual annual meeting of the American Headache Society.
An effective abortive therapy?
The study began shortly after the Jefferson Headache Center became certified to offer medical marijuana around the beginning of 2019. “We wanted to start keeping track of these patients from the get-go so we’d be able to learn as much as possible from them and help guide the recommendations we give to patients in the future,” said Dr. Ceriani.
The study included 48 patients with migraine or other types of chronic headache who received medical marijuana treatment between January and September 2019. After collecting baseline information from medical records and questionnaires filled out at marijuana treatment initiation, the researchers followed up periodically with telephone questionnaires to assess treatment response and side effects. About half of the participants (56.3%) reported daily headache. 14.6% had posttraumatic headache, 10.4% new daily persistent headache, and 4.2% tension-type headache. Additional symptoms were common, including anxiety (72.9%) and insomnia (62.5%).
A total of 28 subjects completed a follow-up questionnaire over the phone. Out of the 28 participants , 3 had stopped using marijuana. Of 25 subjects who continued use, 71.4% used it two or more times per week, and 25.0% used it every day. Among participants, 50% used a THC-dominant strain of marijuana. Overall, 71.4% used an inhaled form.
Side effects included dry mouth/throat (46.4%), dry/red eyes (35.7%), fatigue/lethargy (35.7%), and increased appetite (35.7%).
Before starting on marijuana, 46.4% of the subjects used abortive medications at least 10 days per month. After starting marijuana treatment, the rate dropped to 25.0%. Marijuana use was associated with improvements in anxiety: 57.1% who had anxiety reported improvement with marijuana use, as did 78.6% with insomnia. On a scale of 10, the average rating of marijuana’s usefulness was 5.9, and 17.9% rated it as 10.
Several concerns
The study has numerous limitations. It has a small sample size, it is from a single center, and the patient population had relatively severe symptoms. Such studies are “fraught with possible bias,” said Andrew Charles, MD, professor of neurology and director of the UCLA Goldberg Migraine Program, when asked to comment.
He pointed out that one key concern for marijuana is concerns over worsening of the condition or refractoriness caused by medication overuse. The cannabinoid receptors it acts on bear some similarity to opioid receptors, and opioid overuse headache is well known. The recent changes in marijuana laws makes it an important issue, one that patients often asked about. But prospective clinical trials face a range of roadblocks: Marijuana remains a controlled substance, it would be difficult to create a placebo control, and no large companies are likely to sponsor such a trial.
“But I think it’s important to keep talking about and developing evidence as much as we can and addressing not just the benefits but also being keenly aware of the possible adverse effects, especially medication overuse,” said Dr. Charles.
The authors also acknowledged the study’s limitations, “but I think there is value, because there are definitely specific patterns we were able to find in terms of what’s helpful for patients, and we also found that a lot of patients also have other disorders in addition to headache, like anxiety and insomnia. And we found that those patients in particular seemed to have more benefit than most with medical marijuana,” said coauthor Angela Hou, MD, who is also a headache fellow at Jefferson.
Dr. Hou and Dr. Ceriani cautioned against use of marijuana in any patient with a substance use disorder, as well as the inhaled form in patients with chronic lung conditions.
The study received no funding. Dr. Ceriani and Dr. Hou had no relevant financial disclosures. Dr. Charles has consulted for Amgen, Biohaven, Eli Lilly, Novartis, and Lundbeck.
SOURCE: Marmura MJ et al. AHS 2020, Abstract 842679.
according to results from a small study conducted at the Jefferson Headache Center at Thomas Jefferson University. The researchers found general satisfaction with medical marijuana, more frequent use as an abortive medication rather than a preventative, and more than two-thirds using the inhaled form rather than oral.
Many patients ask about medical marijuana, but there is relatively little data on its effects on headache. Studies are generally retrospective, and often focus on marijuana use for general pain, with subset analyses looking at headache, according to coauthor Claire Ceriani, MD, who is a headache fellow at Jefferson. “A lot of patients are interested in medical marijuana but don’t know how to integrate it into the therapy plan they already have – whether it should be just to treat bad headaches when they happen, or is it meant to be a preventive medicine they use every day? We have some data out there that it can be helpful, but not a lot of specific information to guide your recommendations,” said Dr. Ceriani in an interview.
Although the research is far from a final word on the subject, it did have some take-home messages, said Dr. Ceriani. “Most people seem to find it effective as an abortive medication that might be able to take the place of some of the prescription medications that they were previously using,” she said.
The study was part of the virtual annual meeting of the American Headache Society.
An effective abortive therapy?
The study began shortly after the Jefferson Headache Center became certified to offer medical marijuana around the beginning of 2019. “We wanted to start keeping track of these patients from the get-go so we’d be able to learn as much as possible from them and help guide the recommendations we give to patients in the future,” said Dr. Ceriani.
The study included 48 patients with migraine or other types of chronic headache who received medical marijuana treatment between January and September 2019. After collecting baseline information from medical records and questionnaires filled out at marijuana treatment initiation, the researchers followed up periodically with telephone questionnaires to assess treatment response and side effects. About half of the participants (56.3%) reported daily headache. 14.6% had posttraumatic headache, 10.4% new daily persistent headache, and 4.2% tension-type headache. Additional symptoms were common, including anxiety (72.9%) and insomnia (62.5%).
A total of 28 subjects completed a follow-up questionnaire over the phone. Out of the 28 participants , 3 had stopped using marijuana. Of 25 subjects who continued use, 71.4% used it two or more times per week, and 25.0% used it every day. Among participants, 50% used a THC-dominant strain of marijuana. Overall, 71.4% used an inhaled form.
Side effects included dry mouth/throat (46.4%), dry/red eyes (35.7%), fatigue/lethargy (35.7%), and increased appetite (35.7%).
Before starting on marijuana, 46.4% of the subjects used abortive medications at least 10 days per month. After starting marijuana treatment, the rate dropped to 25.0%. Marijuana use was associated with improvements in anxiety: 57.1% who had anxiety reported improvement with marijuana use, as did 78.6% with insomnia. On a scale of 10, the average rating of marijuana’s usefulness was 5.9, and 17.9% rated it as 10.
Several concerns
The study has numerous limitations. It has a small sample size, it is from a single center, and the patient population had relatively severe symptoms. Such studies are “fraught with possible bias,” said Andrew Charles, MD, professor of neurology and director of the UCLA Goldberg Migraine Program, when asked to comment.
He pointed out that one key concern for marijuana is concerns over worsening of the condition or refractoriness caused by medication overuse. The cannabinoid receptors it acts on bear some similarity to opioid receptors, and opioid overuse headache is well known. The recent changes in marijuana laws makes it an important issue, one that patients often asked about. But prospective clinical trials face a range of roadblocks: Marijuana remains a controlled substance, it would be difficult to create a placebo control, and no large companies are likely to sponsor such a trial.
“But I think it’s important to keep talking about and developing evidence as much as we can and addressing not just the benefits but also being keenly aware of the possible adverse effects, especially medication overuse,” said Dr. Charles.
The authors also acknowledged the study’s limitations, “but I think there is value, because there are definitely specific patterns we were able to find in terms of what’s helpful for patients, and we also found that a lot of patients also have other disorders in addition to headache, like anxiety and insomnia. And we found that those patients in particular seemed to have more benefit than most with medical marijuana,” said coauthor Angela Hou, MD, who is also a headache fellow at Jefferson.
Dr. Hou and Dr. Ceriani cautioned against use of marijuana in any patient with a substance use disorder, as well as the inhaled form in patients with chronic lung conditions.
The study received no funding. Dr. Ceriani and Dr. Hou had no relevant financial disclosures. Dr. Charles has consulted for Amgen, Biohaven, Eli Lilly, Novartis, and Lundbeck.
SOURCE: Marmura MJ et al. AHS 2020, Abstract 842679.
according to results from a small study conducted at the Jefferson Headache Center at Thomas Jefferson University. The researchers found general satisfaction with medical marijuana, more frequent use as an abortive medication rather than a preventative, and more than two-thirds using the inhaled form rather than oral.
Many patients ask about medical marijuana, but there is relatively little data on its effects on headache. Studies are generally retrospective, and often focus on marijuana use for general pain, with subset analyses looking at headache, according to coauthor Claire Ceriani, MD, who is a headache fellow at Jefferson. “A lot of patients are interested in medical marijuana but don’t know how to integrate it into the therapy plan they already have – whether it should be just to treat bad headaches when they happen, or is it meant to be a preventive medicine they use every day? We have some data out there that it can be helpful, but not a lot of specific information to guide your recommendations,” said Dr. Ceriani in an interview.
Although the research is far from a final word on the subject, it did have some take-home messages, said Dr. Ceriani. “Most people seem to find it effective as an abortive medication that might be able to take the place of some of the prescription medications that they were previously using,” she said.
The study was part of the virtual annual meeting of the American Headache Society.
An effective abortive therapy?
The study began shortly after the Jefferson Headache Center became certified to offer medical marijuana around the beginning of 2019. “We wanted to start keeping track of these patients from the get-go so we’d be able to learn as much as possible from them and help guide the recommendations we give to patients in the future,” said Dr. Ceriani.
The study included 48 patients with migraine or other types of chronic headache who received medical marijuana treatment between January and September 2019. After collecting baseline information from medical records and questionnaires filled out at marijuana treatment initiation, the researchers followed up periodically with telephone questionnaires to assess treatment response and side effects. About half of the participants (56.3%) reported daily headache. 14.6% had posttraumatic headache, 10.4% new daily persistent headache, and 4.2% tension-type headache. Additional symptoms were common, including anxiety (72.9%) and insomnia (62.5%).
A total of 28 subjects completed a follow-up questionnaire over the phone. Out of the 28 participants , 3 had stopped using marijuana. Of 25 subjects who continued use, 71.4% used it two or more times per week, and 25.0% used it every day. Among participants, 50% used a THC-dominant strain of marijuana. Overall, 71.4% used an inhaled form.
Side effects included dry mouth/throat (46.4%), dry/red eyes (35.7%), fatigue/lethargy (35.7%), and increased appetite (35.7%).
Before starting on marijuana, 46.4% of the subjects used abortive medications at least 10 days per month. After starting marijuana treatment, the rate dropped to 25.0%. Marijuana use was associated with improvements in anxiety: 57.1% who had anxiety reported improvement with marijuana use, as did 78.6% with insomnia. On a scale of 10, the average rating of marijuana’s usefulness was 5.9, and 17.9% rated it as 10.
Several concerns
The study has numerous limitations. It has a small sample size, it is from a single center, and the patient population had relatively severe symptoms. Such studies are “fraught with possible bias,” said Andrew Charles, MD, professor of neurology and director of the UCLA Goldberg Migraine Program, when asked to comment.
He pointed out that one key concern for marijuana is concerns over worsening of the condition or refractoriness caused by medication overuse. The cannabinoid receptors it acts on bear some similarity to opioid receptors, and opioid overuse headache is well known. The recent changes in marijuana laws makes it an important issue, one that patients often asked about. But prospective clinical trials face a range of roadblocks: Marijuana remains a controlled substance, it would be difficult to create a placebo control, and no large companies are likely to sponsor such a trial.
“But I think it’s important to keep talking about and developing evidence as much as we can and addressing not just the benefits but also being keenly aware of the possible adverse effects, especially medication overuse,” said Dr. Charles.
The authors also acknowledged the study’s limitations, “but I think there is value, because there are definitely specific patterns we were able to find in terms of what’s helpful for patients, and we also found that a lot of patients also have other disorders in addition to headache, like anxiety and insomnia. And we found that those patients in particular seemed to have more benefit than most with medical marijuana,” said coauthor Angela Hou, MD, who is also a headache fellow at Jefferson.
Dr. Hou and Dr. Ceriani cautioned against use of marijuana in any patient with a substance use disorder, as well as the inhaled form in patients with chronic lung conditions.
The study received no funding. Dr. Ceriani and Dr. Hou had no relevant financial disclosures. Dr. Charles has consulted for Amgen, Biohaven, Eli Lilly, Novartis, and Lundbeck.
SOURCE: Marmura MJ et al. AHS 2020, Abstract 842679.
FROM AHS 2020
Surge in colonoscopies postponed by COVID-19 expected
An expected surge in the number of people seeking colonoscopy after the peak of the COVID-19 pandemic passes could cause physicians to rethink patient prioritization, could create a strain on endoscopy capacity, and might raise the specter of detecting colorectal cancer in more patients at a later stage of disease.
Furthermore, months of delay in diagnosis of colorectal cancer (CRC) could shorten survival, although more data is needed, according to expert analysis from a gastroenterologist, a medical oncologist, and a colorectal surgeon.
“It has been a big decrease in the number of colonoscopies performed at our hospital in Alicante, Spain,” Rodrigo Jover Martinez, MD, PhD, said during a COVID-19 and Digestive Health webinar presented by United European Gastroenterology (UEG). He estimated colonoscopy procedures are down 60%-90%, and the number of CRC surgeries has dropped by 60%. “As you know, the COVID-19 pandemic is hitting Europe hard.”
When patients do return, “the backlog will be huge ... in already exhausted endoscopy units,” predicted Dr. Martinez, a gastroenterologist at Hospital General Universitario in Alicante.
Multiple risks
Not knowing which patients with CRC will develop severe COVID-19 infection is another challenge, Bartomeu Massuti, MD, of the medical oncology service at the Hospital General Universitario de Alicante, said during the webinar.
Caution is warranted because “we know cancer patients have an increased risk of infection.” However, he added, most evidence supports an elevated risk for bacterial infections, not viral infections.
Therefore, physicians must continue to balance the risks associated with potential COVID-19 exposure against the risks associated with postponed treatment, Dr. Massuti said. “The goal of oncology care is to try to maintain the preplanned treatment and follow-up. We need mainly to avoid stopping or delaying treatment ... because we will lose efficacy in oncology disease outcomes.”
Imran Aslam, MD, PhD, a colorectal surgeon who moderated and presented during the webinar, agreed: “By delaying the treatment, we might do harm to our patients.”
Dr. Aslam cited data about clinical costs of delaying CRC surgery. A 2019 population-based study in PLOS ONE evaluated different times from diagnosis to treatment. The researchers found a delay of more than 150 days “significantly reduced survival, even during stage I, II, and III disease,” he said. The stage I hazard ratio was 2.66, compared with a reference HR of 1.00 for 90 days or fewer. They also reported elevated risk for people with stage II CRC (HR, 2.80), stage III CRC (HR, 2.70), and stage IV CRC (HR, 1.36).
“This could become more and more abysmal if the pandemic continues,” added Dr. Aslam, consultant colorectal surgeon at University Hospitals of Coventry and Warwickshire, England.
Prioritizing patients
Restarting endoscopy with prioritization strategies and increasing patient capacity are possible solutions. Dr. Martinez suggested a four-quadrant matrix in which physicians place patients into “now,” “next,” “delayed,” or “never” categories based on clinical indicators. The priority 1 “now” patients, for example, will be those with suspected CRC based on physical examination, imaging results, and/or an abnormal fecal immunochemical test result.
He suggested, furthermore, that more widespread CRC screening can resume once “endoscopy units have been alleviated of priority 1, symptomatic patients.”
Dr. Massuti concurred with Dr. Martinez’s call to prioritize patients carefully. He suggested a green, yellow, and red classification system based on treatment priority recommendations from the European Society for Medical Oncology. The green group, for example, should receive priority for intervention based on a condition that is immediately clinically unstable or life threatening.
“The main goal is to preserve the continuum of care,” he added.
Another concern – although data are limited – is that treatment might also increase risk of mortality among cancer patients with COVID-19, according to a cohort study of nearly 1,000 such patients reported May 2020 in The Lancet. Dr. Massuti, who was not affiliated with the research, noted that 12% of the patients had GI tumors. In addition to increased risk associated with male sex (odds ratio, 1.63), cytotoxic cancer treatment in the prior 4 weeks increased risk (OR, 1.47), as did surgery in the same time frame (OR, 1.52).
“This means patients on treatment have an increased risk of mortality,” Dr. Massuti said.
Moving forward
Implementing telehealth information and communication technologies will continue to grow in importance, Dr. Massuti said. Dr. Aslam noted that video consultation with patients before surgery is already replacing face-to-face interaction, and most follow-up care at his hospital is now done by telephone.
Postoperative care is just as essential in the COVID-19 era, if not more so. “We need to be very vigilant to manage postoperative complications – any symptoms of pyrexia or sepsis, or any sign of COVID,” Dr. Aslam said, including postoperative fever. “If there is any doubt, do a chest CT scan.”
Dr. Aslam predicted the time to perform endoscopy or surgery for each patient will be longer, “so the number of patients done in 1 day will be less than 4 months ago.” In addition, elective surgery patients at his institution undergo COVID-19 testing twice, 3 days apart, prior to intervention.
“This disease will continue in the community for a while, so we have to continue what we’ve done well, like social distancing,” Dr. Aslam said. “We’ve gone through a storm and we are awaiting a tsunami. That tsunami of patients will overwhelm us in the coming months.”
Dr. Martinez, Dr. Massuti, and Dr. Aslam had no relevant disclosures.
Medical issues, deferred or neglected during the pandemic, can result in adverse outcomes, and this applies to colorectal cancer (CRC) screening and surveillance. There is a real risk of increased rates of CRC and discovery of CRC at an advanced stage if individuals go unscreened. While colonoscopy remains an important screening option, capacity has been limited during the pandemic. I believe it is important to offer patients screening choices like fecal immunochemical test, and then prioritize patients with positive fecal immunochemical test results for colonoscopy since these patients have a higher risk of CRC, compared with those with negative tests. Patients with a prior history of high-risk adenomas should be prioritized for surveillance colonoscopy.
David Lieberman, MD, past president of the American Gastroenterological Association, professor of medicine and chief of division of gastroenterology and hepatology at Oregon Health and Science University, Portland. He has no conflicts.
Medical issues, deferred or neglected during the pandemic, can result in adverse outcomes, and this applies to colorectal cancer (CRC) screening and surveillance. There is a real risk of increased rates of CRC and discovery of CRC at an advanced stage if individuals go unscreened. While colonoscopy remains an important screening option, capacity has been limited during the pandemic. I believe it is important to offer patients screening choices like fecal immunochemical test, and then prioritize patients with positive fecal immunochemical test results for colonoscopy since these patients have a higher risk of CRC, compared with those with negative tests. Patients with a prior history of high-risk adenomas should be prioritized for surveillance colonoscopy.
David Lieberman, MD, past president of the American Gastroenterological Association, professor of medicine and chief of division of gastroenterology and hepatology at Oregon Health and Science University, Portland. He has no conflicts.
Medical issues, deferred or neglected during the pandemic, can result in adverse outcomes, and this applies to colorectal cancer (CRC) screening and surveillance. There is a real risk of increased rates of CRC and discovery of CRC at an advanced stage if individuals go unscreened. While colonoscopy remains an important screening option, capacity has been limited during the pandemic. I believe it is important to offer patients screening choices like fecal immunochemical test, and then prioritize patients with positive fecal immunochemical test results for colonoscopy since these patients have a higher risk of CRC, compared with those with negative tests. Patients with a prior history of high-risk adenomas should be prioritized for surveillance colonoscopy.
David Lieberman, MD, past president of the American Gastroenterological Association, professor of medicine and chief of division of gastroenterology and hepatology at Oregon Health and Science University, Portland. He has no conflicts.
An expected surge in the number of people seeking colonoscopy after the peak of the COVID-19 pandemic passes could cause physicians to rethink patient prioritization, could create a strain on endoscopy capacity, and might raise the specter of detecting colorectal cancer in more patients at a later stage of disease.
Furthermore, months of delay in diagnosis of colorectal cancer (CRC) could shorten survival, although more data is needed, according to expert analysis from a gastroenterologist, a medical oncologist, and a colorectal surgeon.
“It has been a big decrease in the number of colonoscopies performed at our hospital in Alicante, Spain,” Rodrigo Jover Martinez, MD, PhD, said during a COVID-19 and Digestive Health webinar presented by United European Gastroenterology (UEG). He estimated colonoscopy procedures are down 60%-90%, and the number of CRC surgeries has dropped by 60%. “As you know, the COVID-19 pandemic is hitting Europe hard.”
When patients do return, “the backlog will be huge ... in already exhausted endoscopy units,” predicted Dr. Martinez, a gastroenterologist at Hospital General Universitario in Alicante.
Multiple risks
Not knowing which patients with CRC will develop severe COVID-19 infection is another challenge, Bartomeu Massuti, MD, of the medical oncology service at the Hospital General Universitario de Alicante, said during the webinar.
Caution is warranted because “we know cancer patients have an increased risk of infection.” However, he added, most evidence supports an elevated risk for bacterial infections, not viral infections.
Therefore, physicians must continue to balance the risks associated with potential COVID-19 exposure against the risks associated with postponed treatment, Dr. Massuti said. “The goal of oncology care is to try to maintain the preplanned treatment and follow-up. We need mainly to avoid stopping or delaying treatment ... because we will lose efficacy in oncology disease outcomes.”
Imran Aslam, MD, PhD, a colorectal surgeon who moderated and presented during the webinar, agreed: “By delaying the treatment, we might do harm to our patients.”
Dr. Aslam cited data about clinical costs of delaying CRC surgery. A 2019 population-based study in PLOS ONE evaluated different times from diagnosis to treatment. The researchers found a delay of more than 150 days “significantly reduced survival, even during stage I, II, and III disease,” he said. The stage I hazard ratio was 2.66, compared with a reference HR of 1.00 for 90 days or fewer. They also reported elevated risk for people with stage II CRC (HR, 2.80), stage III CRC (HR, 2.70), and stage IV CRC (HR, 1.36).
“This could become more and more abysmal if the pandemic continues,” added Dr. Aslam, consultant colorectal surgeon at University Hospitals of Coventry and Warwickshire, England.
Prioritizing patients
Restarting endoscopy with prioritization strategies and increasing patient capacity are possible solutions. Dr. Martinez suggested a four-quadrant matrix in which physicians place patients into “now,” “next,” “delayed,” or “never” categories based on clinical indicators. The priority 1 “now” patients, for example, will be those with suspected CRC based on physical examination, imaging results, and/or an abnormal fecal immunochemical test result.
He suggested, furthermore, that more widespread CRC screening can resume once “endoscopy units have been alleviated of priority 1, symptomatic patients.”
Dr. Massuti concurred with Dr. Martinez’s call to prioritize patients carefully. He suggested a green, yellow, and red classification system based on treatment priority recommendations from the European Society for Medical Oncology. The green group, for example, should receive priority for intervention based on a condition that is immediately clinically unstable or life threatening.
“The main goal is to preserve the continuum of care,” he added.
Another concern – although data are limited – is that treatment might also increase risk of mortality among cancer patients with COVID-19, according to a cohort study of nearly 1,000 such patients reported May 2020 in The Lancet. Dr. Massuti, who was not affiliated with the research, noted that 12% of the patients had GI tumors. In addition to increased risk associated with male sex (odds ratio, 1.63), cytotoxic cancer treatment in the prior 4 weeks increased risk (OR, 1.47), as did surgery in the same time frame (OR, 1.52).
“This means patients on treatment have an increased risk of mortality,” Dr. Massuti said.
Moving forward
Implementing telehealth information and communication technologies will continue to grow in importance, Dr. Massuti said. Dr. Aslam noted that video consultation with patients before surgery is already replacing face-to-face interaction, and most follow-up care at his hospital is now done by telephone.
Postoperative care is just as essential in the COVID-19 era, if not more so. “We need to be very vigilant to manage postoperative complications – any symptoms of pyrexia or sepsis, or any sign of COVID,” Dr. Aslam said, including postoperative fever. “If there is any doubt, do a chest CT scan.”
Dr. Aslam predicted the time to perform endoscopy or surgery for each patient will be longer, “so the number of patients done in 1 day will be less than 4 months ago.” In addition, elective surgery patients at his institution undergo COVID-19 testing twice, 3 days apart, prior to intervention.
“This disease will continue in the community for a while, so we have to continue what we’ve done well, like social distancing,” Dr. Aslam said. “We’ve gone through a storm and we are awaiting a tsunami. That tsunami of patients will overwhelm us in the coming months.”
Dr. Martinez, Dr. Massuti, and Dr. Aslam had no relevant disclosures.
An expected surge in the number of people seeking colonoscopy after the peak of the COVID-19 pandemic passes could cause physicians to rethink patient prioritization, could create a strain on endoscopy capacity, and might raise the specter of detecting colorectal cancer in more patients at a later stage of disease.
Furthermore, months of delay in diagnosis of colorectal cancer (CRC) could shorten survival, although more data is needed, according to expert analysis from a gastroenterologist, a medical oncologist, and a colorectal surgeon.
“It has been a big decrease in the number of colonoscopies performed at our hospital in Alicante, Spain,” Rodrigo Jover Martinez, MD, PhD, said during a COVID-19 and Digestive Health webinar presented by United European Gastroenterology (UEG). He estimated colonoscopy procedures are down 60%-90%, and the number of CRC surgeries has dropped by 60%. “As you know, the COVID-19 pandemic is hitting Europe hard.”
When patients do return, “the backlog will be huge ... in already exhausted endoscopy units,” predicted Dr. Martinez, a gastroenterologist at Hospital General Universitario in Alicante.
Multiple risks
Not knowing which patients with CRC will develop severe COVID-19 infection is another challenge, Bartomeu Massuti, MD, of the medical oncology service at the Hospital General Universitario de Alicante, said during the webinar.
Caution is warranted because “we know cancer patients have an increased risk of infection.” However, he added, most evidence supports an elevated risk for bacterial infections, not viral infections.
Therefore, physicians must continue to balance the risks associated with potential COVID-19 exposure against the risks associated with postponed treatment, Dr. Massuti said. “The goal of oncology care is to try to maintain the preplanned treatment and follow-up. We need mainly to avoid stopping or delaying treatment ... because we will lose efficacy in oncology disease outcomes.”
Imran Aslam, MD, PhD, a colorectal surgeon who moderated and presented during the webinar, agreed: “By delaying the treatment, we might do harm to our patients.”
Dr. Aslam cited data about clinical costs of delaying CRC surgery. A 2019 population-based study in PLOS ONE evaluated different times from diagnosis to treatment. The researchers found a delay of more than 150 days “significantly reduced survival, even during stage I, II, and III disease,” he said. The stage I hazard ratio was 2.66, compared with a reference HR of 1.00 for 90 days or fewer. They also reported elevated risk for people with stage II CRC (HR, 2.80), stage III CRC (HR, 2.70), and stage IV CRC (HR, 1.36).
“This could become more and more abysmal if the pandemic continues,” added Dr. Aslam, consultant colorectal surgeon at University Hospitals of Coventry and Warwickshire, England.
Prioritizing patients
Restarting endoscopy with prioritization strategies and increasing patient capacity are possible solutions. Dr. Martinez suggested a four-quadrant matrix in which physicians place patients into “now,” “next,” “delayed,” or “never” categories based on clinical indicators. The priority 1 “now” patients, for example, will be those with suspected CRC based on physical examination, imaging results, and/or an abnormal fecal immunochemical test result.
He suggested, furthermore, that more widespread CRC screening can resume once “endoscopy units have been alleviated of priority 1, symptomatic patients.”
Dr. Massuti concurred with Dr. Martinez’s call to prioritize patients carefully. He suggested a green, yellow, and red classification system based on treatment priority recommendations from the European Society for Medical Oncology. The green group, for example, should receive priority for intervention based on a condition that is immediately clinically unstable or life threatening.
“The main goal is to preserve the continuum of care,” he added.
Another concern – although data are limited – is that treatment might also increase risk of mortality among cancer patients with COVID-19, according to a cohort study of nearly 1,000 such patients reported May 2020 in The Lancet. Dr. Massuti, who was not affiliated with the research, noted that 12% of the patients had GI tumors. In addition to increased risk associated with male sex (odds ratio, 1.63), cytotoxic cancer treatment in the prior 4 weeks increased risk (OR, 1.47), as did surgery in the same time frame (OR, 1.52).
“This means patients on treatment have an increased risk of mortality,” Dr. Massuti said.
Moving forward
Implementing telehealth information and communication technologies will continue to grow in importance, Dr. Massuti said. Dr. Aslam noted that video consultation with patients before surgery is already replacing face-to-face interaction, and most follow-up care at his hospital is now done by telephone.
Postoperative care is just as essential in the COVID-19 era, if not more so. “We need to be very vigilant to manage postoperative complications – any symptoms of pyrexia or sepsis, or any sign of COVID,” Dr. Aslam said, including postoperative fever. “If there is any doubt, do a chest CT scan.”
Dr. Aslam predicted the time to perform endoscopy or surgery for each patient will be longer, “so the number of patients done in 1 day will be less than 4 months ago.” In addition, elective surgery patients at his institution undergo COVID-19 testing twice, 3 days apart, prior to intervention.
“This disease will continue in the community for a while, so we have to continue what we’ve done well, like social distancing,” Dr. Aslam said. “We’ve gone through a storm and we are awaiting a tsunami. That tsunami of patients will overwhelm us in the coming months.”
Dr. Martinez, Dr. Massuti, and Dr. Aslam had no relevant disclosures.
Endoscopic myotomy for achalasia
Dear colleagues and friends,
In this edition of Perspectives, Dr. Mouen Khashab and Dr. Robert Siwiec tackle an exciting and constantly evolving topic, which is the optimal approach to myotomy for patients with achalasia. Dr. Khashab makes the case for endoscopic myotomy, while Dr. Siwiec argues that surgical myotomy remains the gold standard. I hope that you will find this debate as useful and thought provoking as I did. As always, I welcome your comments and suggestions for future topics at ginews@gastro.org.
Charles Kahi, MD, MS, AGAF, is a professor of medicine at Indiana University, Indianapolis. He is also an associate editor for GI & Hepatology News.
Endoscopic myotomy for achalasia is ready for prime time
BY MOUEN A. KHASHAB, MD
When I encounter a symptomatic patient with manometrically confirmed achalasia, I discuss three effective treatment modalities: pneumatic dilation (PD), peroral endoscopic myotomy (POEM), and laparoscopic Heller myotomy (LHM). I recommend against botulinum toxin injection and reserve it for patients who are not candidates for the aforementioned definitive therapies. I also present to the patient the current level I evidence from randomized, controlled trials (RCTs) comparing achalasia treatment modalities.
One landmark RCT reported comparative outcomes at 2 years following POEM and PD and found higher treatment success at the 2-year follow-up in the POEM group (92% vs. 54%; P < .001).1 Reflux esophagitis was observed significantly more frequently in patients treated with POEM (41% in the POEM group, of whom 35% were assigned Los Angeles grade A-B and 6% were assigned LA grade C versus 7% in the PD group, all of whom were assigned LA grade A; P = .002).1
Another milestone RCT included 221 patients and compared outcomes of POEM and LHM plus Dor fundoplication.2 Clinical success at the 2-year follow-up was observed in 83.0% of patients in the POEM group, and was noninferior to the LHM group (81.7%). Serious adverse events occurred in 2.7% of patients in the POEM group and in 7.3% of patients in the LHM group. Although 57% of patients in the POEM group and 20% of patients in the LHM group had reflux esophagitis as assessed by endoscopy at 3 months, the corresponding proportions were 44% and 29% at 24 months. Importantly, the rate of severe esophagitis was not different between both groups (6% vs. 3% at 3 months, and 5% vs. 6% at 24 months).2
I summarize these results by stating that POEM seems to be superior to PD and equivalent to LHM in terms of clinical success. Nonetheless, POEM also seems to be associated with increased risk of early gastroesophageal reflux disease.
POEM is now a ubiquitous procedure performed worldwide and is endorsed as a primary achalasia treatment by multiple society guidelines.3 It is a minimally invasive, effective, and safe therapeutic option for patients with all types of achalasia and is considered the treatment of choice for achalasia type III. POEM has also been shown to be effective in the treatment of spastic esophageal disorders (e.g. Jackhammer esophagus, diffuse esophageal spasm) and esophagogastric junction outflow obstruction. It can be performed in the endoscopy unit or operating theater either by experienced therapeutic endoscopists or surgical endoscopists in less than an hour. The procedure can be performed on an outpatient basis in appropriate individuals and allows tailoring the myotomy length to specific clinical scenarios. For example, patients with type III achalasia (and those with spastic esophageal disorders) typically require a long myotomy and that can be readily accomplished during POEM as opposed to LHM. POEM has also proven effective in children; octogenarians; and patients with sigmoid esophagus, epiphrenic diverticula, and those who had undergone prior interventions for achalasia, including LHM and PD. In experienced hands, the rate of adverse events is low and serious events are rare and occur in 0.5% of cases. Perforations/leakage are also uncommon and occur in 0.7% of patients. It is an incisionless procedure that eliminates the risk of wound infection and shortens postprocedural recovery. Patients are typically admitted for an overnight observation postprocedure, discharged home the following day, and back to activities of daily living (including work) within a few days. Postprocedural pain is minimal in most patients and narcotics are rarely needed. Resumption of a soft diet is carried out on the first postoperative day and normal diet 1 week later.
LHM is an established procedure with proven long-term efficacy in the treatment of achalasia. Nonetheless, it is invasive and requires placement of multiple trocars. The procedure is more time consuming than POEM and length of hospital stay can also be longer. This results in possibly higher cost than POEM. Importantly, recovery of dysphagia and resumption of normal diet is significantly delayed and is likely the result of the partial concomitant fundoplication procedure. Finally, LHM is not appropriate for the treatment of spastic esophageal disorders, including type III achalasia.
A major advantage of LHM plus partial fundoplication over POEM is the diminished risk of gastroesophageal reflux disease (GERD). However, this advantage seems short lived as the risk of GERD increases over time after surgery, likely because of the loosening of the wrap over time. From the New England Journal of Medicine paper mentioned earlier, it seems that the increased risk of GERD after POEM as compared with LHM diminishes over time.2 Importantly, it also appears that the rate of significant esophagitis (LA grade C-D) is similar between both procedures.2
In an effort to assess the long-term antireflux efficacy of surgical partial fundoplication, one study noted that 12% of 182 patients who had surgical myotomy with partial fundoplication continued to have occasional or continuous heartburn symptoms at a median of 18 years after surgery. Esophagitis and Barrett’s esophagus were found in 14.5% and 0.8% of patients, respectively. De novo esophageal adenocarcinoma has been reported after both POEM and LHM.4
Therefore, GERD and its complications can occur after any procedure that disrupts the lower esophageal sphincter (POEM, LHM, and PD) and postprocedural management of patients should include long-term testing and management of possible GERD. Different strategies have been proposed and include objective periodic testing for esophageal acid exposure, long-term and possible lifelong proton pump inhibitor use, and surveillance for long-term consequences of GER via periodic upper endoscopy.3
It is important to acknowledge that the lack of symptoms or the absence of endoscopic evidence of GER on initial endoscopy does not necessarily rule out GER. Approximately a third of post-POEM patients with clinically successful outcome and absence of reflux esophagitis on their first surveillance endoscopy eventually develop esophagitis at subsequent surveillance endoscopy.5
In summary, POEM has deservingly taken a prime time spot in the management of patients with achalasia. It is an efficient, efficacious and safe treatment modality that results in rapid resolution of achalasia symptoms in the majority of patients. Research should focus on technical modifications (e.g., short gastric myotomy; addition of endoscopic fundoplication) that reduce the incidence of postprocedural GERD.
References
1. Ponds FA et al. Effect of peroral endoscopic myotomy versus pneumatic dilation on symptom severity and treatment outcomes among treatment-naive patients with achalasia: A randomized clinical trial. JAMA. 2019;322:134-44.
2. Werner YB et al. Endoscopic or surgical myotomy in patients with idiopathic achalasia. N Engl J Med. 2019;381:2219-29.
3. Khashab MA et al. ASGE guideline on the management of achalasia. Gastrointest Endosc. 2020;91:213-27 e6.
4. Ichkhanian Y et al. Case of early Barrett cancer following peroral endoscopic myotomy. Gut. 2019;68:2107-110.
5. Werner YB et al. Clinical response to peroral endoscopic myotomy in patients with idiopathic achalasia at a minimum follow-up of 2 years. Gut. 2016;65:899-906.
Dr. Khashab is associate professor of medicine, director of therapeutic endoscopy, division of gastroenterology and hepatology, Johns Hopkins Hospital, Baltimore. He is a consultant for BSCI, Olympus, and Medtronic.
Heller myotomy is still the gold standard
BY ROBERT M. SIWIEC, MD
Achalasia is a rare, primary esophageal motor disorder characterized by ineffective relaxation of the lower esophageal sphincter (LES) and concomitant loss of esophageal peristalsis. High-resolution esophageal manometry has allowed for the diagnosis and classification of achalasia into relevant clinical subtypes which become important when discussing and considering treatment options. Confirmatory studies (e.g., timed barium esophagram) and provocative manometric maneuvers (e.g., upright swallows, rapid swallow sequence, and/or rapid drink challenge) can be helpful when distinguishing between true achalasia versus achalasia variants and esophagogastric junction outflow obstruction.
Treatment options only provide palliation by eliminating outflow obstruction caused by a nonrelaxing and often times hypertensive LES. Pharmacotherapy (e.g., oral nitrates, 5-phosphodiesterase inhibitors, anticholinergics) is the least effective option because of medication side effects and short-acting duration. I only consider it for patients who are either unwilling or unable to tolerate invasive therapies. Botulinum toxin injection into the LES can be considered in patients who are not good candidates for more definitive therapy with PD or myotomy (endoscopic or surgical). Although the success rates with botulinum toxin are comparable with PD and surgical myotomy, patients treated with botulinum toxin require retreatment. Furthermore, continued botulinum toxin injections can compromise tissue planes making myotomy complex and challenging.
During the 1970s and 1980s, PD was the primary treatment modality for achalasia. Surgical myotomy was reserved for patients who suffered a perforation during PD or developed recurrent symptoms after multiple dilations. Minimally invasive surgery (left thoracoscopic approach) for achalasia was first introduced in the early 1990s and was shown to be a feasible, safe, and effective procedure, becoming the primary treatment approach in most centers. Patients fared well; however, it was soon discovered that >50% had pathological reflux based on pH monitoring. A few centers then began to perform a Heller myotomy through a laparoscopic approach with the addition of a fundoplication resulting in significant reductions in pathological reflux by pH monitoring. Eventually, a seminal RCT confirmed the importance of fundoplication with laparoscopic Heller myotomy (LHM) – resolution of dysphagia was unaffected and pathological reflux was avoided in most patients.1 Overall, clinical success rates for LHM with fundoplication are typically >90% and reflux incidence rates <10% with the overall complication rate being about 5% with reported mortality <0.1%.
PD remains appealing in that it is cost effective and less invasive, compared with POEM and LHM. Initial success rates and short-term efficacy are comparable with LHM but unfortunately PD’s efficacy significantly wanes over time. POEM, introduced by Inoue et al. in 2010, is a novel endoscopic technique with an excellent safety profile that provides good symptom relief while avoiding abdominal wall scars for patients. It has been shown to have a distinct advantage in patients with type III achalasia by nature of the longer myotomy not achievable by LHM.2 POEM has seen increasing enthusiasm and acceptance as a standard treatment option for achalasia largely because of the fact that its safety and efficacy have been shown to be comparable and in most cases equal with LHM. However, in 2020, direct comparison with LHM is challenging given that the follow-up in the majority of studies is either short or incomplete. The most recent multicenter, randomized trial comparing POEM with LHM plus Dor fundoplication showed POEM’s noninferiority in controlling symptoms of achalasia, but only after a 24 month follow-up.3 A recent report included one of the largest cohorts of post-POEM patients (500), but the 36-month data were based on the follow-up of only 61 patients (about 12%).4
Once the muscle fibers of the LES are disrupted, reflux will occur in the majority of patients. Unlike LHM, no concomitant fundoplication is performed during POEM and this increases the incidence of GERD and its long-term sequelae including peptic strictures, Barrett’s esophagus, and adenocarcinoma. A meta-analysis from 2018 looked at published series of POEM and LHM with fundoplication and found that GERD symptoms were present in 19% of POEM patients, compared with 8.8% of LHM patients. Worse yet, esophagitis was seen in 29.4% of the POEM group and 7.6% of the LHM group, with more individuals in the POEM group also having abnormal acid exposure based on ambulatory pH monitoring (39.0% vs. 16.8%).5
Proponents of POEM will argue that proton pump inhibitors (PPIs) are the panacea for post-POEM GERD. Unfortunately, this approach has its own problems. PPIs are very effective at reducing acid secretion by parietal cells, but do not block reflux through an iatrogenically incompetent LES. The drumbeat of publications on potential complications from chronic PPI use has greatly contributed to patients’ reluctance to commit to long-term PPI use. Lastly, the first case of early Barrett’s cancer was recently reported in a patient 4 years post-POEM despite adherence to an aggressive antisecretory regimen (b.i.d. PPI and H2 blocker at bedtime).6 LHM with fundoplication significantly reduces the risk of pathological GERD and spares patients from committing to lifelong PPI therapy and routine endoscopic surveillance (appropriate interval yet to be determined) and needing to consider additional procedures (i.e., endoscopic or surgical fundoplication).
Despite POEM’s well established efficacy and safety, the development of post-POEM GERD is a major concern that has yet to be adequately addressed. A significant number of post-POEM patients with pathological reflux have asymptomatic and unrecognized GERD and current management and monitoring strategies for post-POEM GERD are anemic and poorly established. Without question, there are individual patients who are clearly better served with POEM (type III achalasia and other spastic esophageal disorders). However, as we continue to learn more about post-POEM GERD and how to better prevent, manage, and monitor it, LHM with fundoplication for the time being remains the tried-and-tested treatment option for patients with non–type III achalasia.
References
1. Richards WO et al. Heller myotomy versus Heller myotomy with Dor fundoplication for achalasia: A prospective randomized double-blind clinical trial. Ann Surg. 2004;240:405-12.
2. Podboy AJ et al. Long-term outcomes of peroral endoscopic myotomy compared to laparoscopic Heller myotomy for achalasia: A single-center experience. Surg Endosc. 2020. doi: 10.1007/s00464-020-07450-6.
3. Werner YB et al. Endoscopic or surgical myotomy in patients with idiopathic achalasia. N Engl J Med. 2019;381(23):2219-29.
4. Inoue H et al. Peroral endoscopic myotomy: A series of 500 patients. J Am Coll Surg. 2015;221:256-64.
5. Repici A et al. GERD after peroral endoscopic myotomy as compared with Heller’s myotomy with fundoplication: A systematic review with meta-analysis. Gastrointest Endosc. 2018;87(4):934-43.
6. Ichkhanian Y et al. Case of early Barrett cancer following peroral endoscopic myotomy. Gut. 2019;68:2107-10.
Dr. Siwiec is assistant professor of clinical medicine, division of gastroenterology and hepatology, GI motility and neurogastroenterology unit, Indiana University, Indianapolis. He has no conflicts of interest.
Dear colleagues and friends,
In this edition of Perspectives, Dr. Mouen Khashab and Dr. Robert Siwiec tackle an exciting and constantly evolving topic, which is the optimal approach to myotomy for patients with achalasia. Dr. Khashab makes the case for endoscopic myotomy, while Dr. Siwiec argues that surgical myotomy remains the gold standard. I hope that you will find this debate as useful and thought provoking as I did. As always, I welcome your comments and suggestions for future topics at ginews@gastro.org.
Charles Kahi, MD, MS, AGAF, is a professor of medicine at Indiana University, Indianapolis. He is also an associate editor for GI & Hepatology News.
Endoscopic myotomy for achalasia is ready for prime time
BY MOUEN A. KHASHAB, MD
When I encounter a symptomatic patient with manometrically confirmed achalasia, I discuss three effective treatment modalities: pneumatic dilation (PD), peroral endoscopic myotomy (POEM), and laparoscopic Heller myotomy (LHM). I recommend against botulinum toxin injection and reserve it for patients who are not candidates for the aforementioned definitive therapies. I also present to the patient the current level I evidence from randomized, controlled trials (RCTs) comparing achalasia treatment modalities.
One landmark RCT reported comparative outcomes at 2 years following POEM and PD and found higher treatment success at the 2-year follow-up in the POEM group (92% vs. 54%; P < .001).1 Reflux esophagitis was observed significantly more frequently in patients treated with POEM (41% in the POEM group, of whom 35% were assigned Los Angeles grade A-B and 6% were assigned LA grade C versus 7% in the PD group, all of whom were assigned LA grade A; P = .002).1
Another milestone RCT included 221 patients and compared outcomes of POEM and LHM plus Dor fundoplication.2 Clinical success at the 2-year follow-up was observed in 83.0% of patients in the POEM group, and was noninferior to the LHM group (81.7%). Serious adverse events occurred in 2.7% of patients in the POEM group and in 7.3% of patients in the LHM group. Although 57% of patients in the POEM group and 20% of patients in the LHM group had reflux esophagitis as assessed by endoscopy at 3 months, the corresponding proportions were 44% and 29% at 24 months. Importantly, the rate of severe esophagitis was not different between both groups (6% vs. 3% at 3 months, and 5% vs. 6% at 24 months).2
I summarize these results by stating that POEM seems to be superior to PD and equivalent to LHM in terms of clinical success. Nonetheless, POEM also seems to be associated with increased risk of early gastroesophageal reflux disease.
POEM is now a ubiquitous procedure performed worldwide and is endorsed as a primary achalasia treatment by multiple society guidelines.3 It is a minimally invasive, effective, and safe therapeutic option for patients with all types of achalasia and is considered the treatment of choice for achalasia type III. POEM has also been shown to be effective in the treatment of spastic esophageal disorders (e.g. Jackhammer esophagus, diffuse esophageal spasm) and esophagogastric junction outflow obstruction. It can be performed in the endoscopy unit or operating theater either by experienced therapeutic endoscopists or surgical endoscopists in less than an hour. The procedure can be performed on an outpatient basis in appropriate individuals and allows tailoring the myotomy length to specific clinical scenarios. For example, patients with type III achalasia (and those with spastic esophageal disorders) typically require a long myotomy and that can be readily accomplished during POEM as opposed to LHM. POEM has also proven effective in children; octogenarians; and patients with sigmoid esophagus, epiphrenic diverticula, and those who had undergone prior interventions for achalasia, including LHM and PD. In experienced hands, the rate of adverse events is low and serious events are rare and occur in 0.5% of cases. Perforations/leakage are also uncommon and occur in 0.7% of patients. It is an incisionless procedure that eliminates the risk of wound infection and shortens postprocedural recovery. Patients are typically admitted for an overnight observation postprocedure, discharged home the following day, and back to activities of daily living (including work) within a few days. Postprocedural pain is minimal in most patients and narcotics are rarely needed. Resumption of a soft diet is carried out on the first postoperative day and normal diet 1 week later.
LHM is an established procedure with proven long-term efficacy in the treatment of achalasia. Nonetheless, it is invasive and requires placement of multiple trocars. The procedure is more time consuming than POEM and length of hospital stay can also be longer. This results in possibly higher cost than POEM. Importantly, recovery of dysphagia and resumption of normal diet is significantly delayed and is likely the result of the partial concomitant fundoplication procedure. Finally, LHM is not appropriate for the treatment of spastic esophageal disorders, including type III achalasia.
A major advantage of LHM plus partial fundoplication over POEM is the diminished risk of gastroesophageal reflux disease (GERD). However, this advantage seems short lived as the risk of GERD increases over time after surgery, likely because of the loosening of the wrap over time. From the New England Journal of Medicine paper mentioned earlier, it seems that the increased risk of GERD after POEM as compared with LHM diminishes over time.2 Importantly, it also appears that the rate of significant esophagitis (LA grade C-D) is similar between both procedures.2
In an effort to assess the long-term antireflux efficacy of surgical partial fundoplication, one study noted that 12% of 182 patients who had surgical myotomy with partial fundoplication continued to have occasional or continuous heartburn symptoms at a median of 18 years after surgery. Esophagitis and Barrett’s esophagus were found in 14.5% and 0.8% of patients, respectively. De novo esophageal adenocarcinoma has been reported after both POEM and LHM.4
Therefore, GERD and its complications can occur after any procedure that disrupts the lower esophageal sphincter (POEM, LHM, and PD) and postprocedural management of patients should include long-term testing and management of possible GERD. Different strategies have been proposed and include objective periodic testing for esophageal acid exposure, long-term and possible lifelong proton pump inhibitor use, and surveillance for long-term consequences of GER via periodic upper endoscopy.3
It is important to acknowledge that the lack of symptoms or the absence of endoscopic evidence of GER on initial endoscopy does not necessarily rule out GER. Approximately a third of post-POEM patients with clinically successful outcome and absence of reflux esophagitis on their first surveillance endoscopy eventually develop esophagitis at subsequent surveillance endoscopy.5
In summary, POEM has deservingly taken a prime time spot in the management of patients with achalasia. It is an efficient, efficacious and safe treatment modality that results in rapid resolution of achalasia symptoms in the majority of patients. Research should focus on technical modifications (e.g., short gastric myotomy; addition of endoscopic fundoplication) that reduce the incidence of postprocedural GERD.
References
1. Ponds FA et al. Effect of peroral endoscopic myotomy versus pneumatic dilation on symptom severity and treatment outcomes among treatment-naive patients with achalasia: A randomized clinical trial. JAMA. 2019;322:134-44.
2. Werner YB et al. Endoscopic or surgical myotomy in patients with idiopathic achalasia. N Engl J Med. 2019;381:2219-29.
3. Khashab MA et al. ASGE guideline on the management of achalasia. Gastrointest Endosc. 2020;91:213-27 e6.
4. Ichkhanian Y et al. Case of early Barrett cancer following peroral endoscopic myotomy. Gut. 2019;68:2107-110.
5. Werner YB et al. Clinical response to peroral endoscopic myotomy in patients with idiopathic achalasia at a minimum follow-up of 2 years. Gut. 2016;65:899-906.
Dr. Khashab is associate professor of medicine, director of therapeutic endoscopy, division of gastroenterology and hepatology, Johns Hopkins Hospital, Baltimore. He is a consultant for BSCI, Olympus, and Medtronic.
Heller myotomy is still the gold standard
BY ROBERT M. SIWIEC, MD
Achalasia is a rare, primary esophageal motor disorder characterized by ineffective relaxation of the lower esophageal sphincter (LES) and concomitant loss of esophageal peristalsis. High-resolution esophageal manometry has allowed for the diagnosis and classification of achalasia into relevant clinical subtypes which become important when discussing and considering treatment options. Confirmatory studies (e.g., timed barium esophagram) and provocative manometric maneuvers (e.g., upright swallows, rapid swallow sequence, and/or rapid drink challenge) can be helpful when distinguishing between true achalasia versus achalasia variants and esophagogastric junction outflow obstruction.
Treatment options only provide palliation by eliminating outflow obstruction caused by a nonrelaxing and often times hypertensive LES. Pharmacotherapy (e.g., oral nitrates, 5-phosphodiesterase inhibitors, anticholinergics) is the least effective option because of medication side effects and short-acting duration. I only consider it for patients who are either unwilling or unable to tolerate invasive therapies. Botulinum toxin injection into the LES can be considered in patients who are not good candidates for more definitive therapy with PD or myotomy (endoscopic or surgical). Although the success rates with botulinum toxin are comparable with PD and surgical myotomy, patients treated with botulinum toxin require retreatment. Furthermore, continued botulinum toxin injections can compromise tissue planes making myotomy complex and challenging.
During the 1970s and 1980s, PD was the primary treatment modality for achalasia. Surgical myotomy was reserved for patients who suffered a perforation during PD or developed recurrent symptoms after multiple dilations. Minimally invasive surgery (left thoracoscopic approach) for achalasia was first introduced in the early 1990s and was shown to be a feasible, safe, and effective procedure, becoming the primary treatment approach in most centers. Patients fared well; however, it was soon discovered that >50% had pathological reflux based on pH monitoring. A few centers then began to perform a Heller myotomy through a laparoscopic approach with the addition of a fundoplication resulting in significant reductions in pathological reflux by pH monitoring. Eventually, a seminal RCT confirmed the importance of fundoplication with laparoscopic Heller myotomy (LHM) – resolution of dysphagia was unaffected and pathological reflux was avoided in most patients.1 Overall, clinical success rates for LHM with fundoplication are typically >90% and reflux incidence rates <10% with the overall complication rate being about 5% with reported mortality <0.1%.
PD remains appealing in that it is cost effective and less invasive, compared with POEM and LHM. Initial success rates and short-term efficacy are comparable with LHM but unfortunately PD’s efficacy significantly wanes over time. POEM, introduced by Inoue et al. in 2010, is a novel endoscopic technique with an excellent safety profile that provides good symptom relief while avoiding abdominal wall scars for patients. It has been shown to have a distinct advantage in patients with type III achalasia by nature of the longer myotomy not achievable by LHM.2 POEM has seen increasing enthusiasm and acceptance as a standard treatment option for achalasia largely because of the fact that its safety and efficacy have been shown to be comparable and in most cases equal with LHM. However, in 2020, direct comparison with LHM is challenging given that the follow-up in the majority of studies is either short or incomplete. The most recent multicenter, randomized trial comparing POEM with LHM plus Dor fundoplication showed POEM’s noninferiority in controlling symptoms of achalasia, but only after a 24 month follow-up.3 A recent report included one of the largest cohorts of post-POEM patients (500), but the 36-month data were based on the follow-up of only 61 patients (about 12%).4
Once the muscle fibers of the LES are disrupted, reflux will occur in the majority of patients. Unlike LHM, no concomitant fundoplication is performed during POEM and this increases the incidence of GERD and its long-term sequelae including peptic strictures, Barrett’s esophagus, and adenocarcinoma. A meta-analysis from 2018 looked at published series of POEM and LHM with fundoplication and found that GERD symptoms were present in 19% of POEM patients, compared with 8.8% of LHM patients. Worse yet, esophagitis was seen in 29.4% of the POEM group and 7.6% of the LHM group, with more individuals in the POEM group also having abnormal acid exposure based on ambulatory pH monitoring (39.0% vs. 16.8%).5
Proponents of POEM will argue that proton pump inhibitors (PPIs) are the panacea for post-POEM GERD. Unfortunately, this approach has its own problems. PPIs are very effective at reducing acid secretion by parietal cells, but do not block reflux through an iatrogenically incompetent LES. The drumbeat of publications on potential complications from chronic PPI use has greatly contributed to patients’ reluctance to commit to long-term PPI use. Lastly, the first case of early Barrett’s cancer was recently reported in a patient 4 years post-POEM despite adherence to an aggressive antisecretory regimen (b.i.d. PPI and H2 blocker at bedtime).6 LHM with fundoplication significantly reduces the risk of pathological GERD and spares patients from committing to lifelong PPI therapy and routine endoscopic surveillance (appropriate interval yet to be determined) and needing to consider additional procedures (i.e., endoscopic or surgical fundoplication).
Despite POEM’s well established efficacy and safety, the development of post-POEM GERD is a major concern that has yet to be adequately addressed. A significant number of post-POEM patients with pathological reflux have asymptomatic and unrecognized GERD and current management and monitoring strategies for post-POEM GERD are anemic and poorly established. Without question, there are individual patients who are clearly better served with POEM (type III achalasia and other spastic esophageal disorders). However, as we continue to learn more about post-POEM GERD and how to better prevent, manage, and monitor it, LHM with fundoplication for the time being remains the tried-and-tested treatment option for patients with non–type III achalasia.
References
1. Richards WO et al. Heller myotomy versus Heller myotomy with Dor fundoplication for achalasia: A prospective randomized double-blind clinical trial. Ann Surg. 2004;240:405-12.
2. Podboy AJ et al. Long-term outcomes of peroral endoscopic myotomy compared to laparoscopic Heller myotomy for achalasia: A single-center experience. Surg Endosc. 2020. doi: 10.1007/s00464-020-07450-6.
3. Werner YB et al. Endoscopic or surgical myotomy in patients with idiopathic achalasia. N Engl J Med. 2019;381(23):2219-29.
4. Inoue H et al. Peroral endoscopic myotomy: A series of 500 patients. J Am Coll Surg. 2015;221:256-64.
5. Repici A et al. GERD after peroral endoscopic myotomy as compared with Heller’s myotomy with fundoplication: A systematic review with meta-analysis. Gastrointest Endosc. 2018;87(4):934-43.
6. Ichkhanian Y et al. Case of early Barrett cancer following peroral endoscopic myotomy. Gut. 2019;68:2107-10.
Dr. Siwiec is assistant professor of clinical medicine, division of gastroenterology and hepatology, GI motility and neurogastroenterology unit, Indiana University, Indianapolis. He has no conflicts of interest.
Dear colleagues and friends,
In this edition of Perspectives, Dr. Mouen Khashab and Dr. Robert Siwiec tackle an exciting and constantly evolving topic, which is the optimal approach to myotomy for patients with achalasia. Dr. Khashab makes the case for endoscopic myotomy, while Dr. Siwiec argues that surgical myotomy remains the gold standard. I hope that you will find this debate as useful and thought provoking as I did. As always, I welcome your comments and suggestions for future topics at ginews@gastro.org.
Charles Kahi, MD, MS, AGAF, is a professor of medicine at Indiana University, Indianapolis. He is also an associate editor for GI & Hepatology News.
Endoscopic myotomy for achalasia is ready for prime time
BY MOUEN A. KHASHAB, MD
When I encounter a symptomatic patient with manometrically confirmed achalasia, I discuss three effective treatment modalities: pneumatic dilation (PD), peroral endoscopic myotomy (POEM), and laparoscopic Heller myotomy (LHM). I recommend against botulinum toxin injection and reserve it for patients who are not candidates for the aforementioned definitive therapies. I also present to the patient the current level I evidence from randomized, controlled trials (RCTs) comparing achalasia treatment modalities.
One landmark RCT reported comparative outcomes at 2 years following POEM and PD and found higher treatment success at the 2-year follow-up in the POEM group (92% vs. 54%; P < .001).1 Reflux esophagitis was observed significantly more frequently in patients treated with POEM (41% in the POEM group, of whom 35% were assigned Los Angeles grade A-B and 6% were assigned LA grade C versus 7% in the PD group, all of whom were assigned LA grade A; P = .002).1
Another milestone RCT included 221 patients and compared outcomes of POEM and LHM plus Dor fundoplication.2 Clinical success at the 2-year follow-up was observed in 83.0% of patients in the POEM group, and was noninferior to the LHM group (81.7%). Serious adverse events occurred in 2.7% of patients in the POEM group and in 7.3% of patients in the LHM group. Although 57% of patients in the POEM group and 20% of patients in the LHM group had reflux esophagitis as assessed by endoscopy at 3 months, the corresponding proportions were 44% and 29% at 24 months. Importantly, the rate of severe esophagitis was not different between both groups (6% vs. 3% at 3 months, and 5% vs. 6% at 24 months).2
I summarize these results by stating that POEM seems to be superior to PD and equivalent to LHM in terms of clinical success. Nonetheless, POEM also seems to be associated with increased risk of early gastroesophageal reflux disease.
POEM is now a ubiquitous procedure performed worldwide and is endorsed as a primary achalasia treatment by multiple society guidelines.3 It is a minimally invasive, effective, and safe therapeutic option for patients with all types of achalasia and is considered the treatment of choice for achalasia type III. POEM has also been shown to be effective in the treatment of spastic esophageal disorders (e.g. Jackhammer esophagus, diffuse esophageal spasm) and esophagogastric junction outflow obstruction. It can be performed in the endoscopy unit or operating theater either by experienced therapeutic endoscopists or surgical endoscopists in less than an hour. The procedure can be performed on an outpatient basis in appropriate individuals and allows tailoring the myotomy length to specific clinical scenarios. For example, patients with type III achalasia (and those with spastic esophageal disorders) typically require a long myotomy and that can be readily accomplished during POEM as opposed to LHM. POEM has also proven effective in children; octogenarians; and patients with sigmoid esophagus, epiphrenic diverticula, and those who had undergone prior interventions for achalasia, including LHM and PD. In experienced hands, the rate of adverse events is low and serious events are rare and occur in 0.5% of cases. Perforations/leakage are also uncommon and occur in 0.7% of patients. It is an incisionless procedure that eliminates the risk of wound infection and shortens postprocedural recovery. Patients are typically admitted for an overnight observation postprocedure, discharged home the following day, and back to activities of daily living (including work) within a few days. Postprocedural pain is minimal in most patients and narcotics are rarely needed. Resumption of a soft diet is carried out on the first postoperative day and normal diet 1 week later.
LHM is an established procedure with proven long-term efficacy in the treatment of achalasia. Nonetheless, it is invasive and requires placement of multiple trocars. The procedure is more time consuming than POEM and length of hospital stay can also be longer. This results in possibly higher cost than POEM. Importantly, recovery of dysphagia and resumption of normal diet is significantly delayed and is likely the result of the partial concomitant fundoplication procedure. Finally, LHM is not appropriate for the treatment of spastic esophageal disorders, including type III achalasia.
A major advantage of LHM plus partial fundoplication over POEM is the diminished risk of gastroesophageal reflux disease (GERD). However, this advantage seems short lived as the risk of GERD increases over time after surgery, likely because of the loosening of the wrap over time. From the New England Journal of Medicine paper mentioned earlier, it seems that the increased risk of GERD after POEM as compared with LHM diminishes over time.2 Importantly, it also appears that the rate of significant esophagitis (LA grade C-D) is similar between both procedures.2
In an effort to assess the long-term antireflux efficacy of surgical partial fundoplication, one study noted that 12% of 182 patients who had surgical myotomy with partial fundoplication continued to have occasional or continuous heartburn symptoms at a median of 18 years after surgery. Esophagitis and Barrett’s esophagus were found in 14.5% and 0.8% of patients, respectively. De novo esophageal adenocarcinoma has been reported after both POEM and LHM.4
Therefore, GERD and its complications can occur after any procedure that disrupts the lower esophageal sphincter (POEM, LHM, and PD) and postprocedural management of patients should include long-term testing and management of possible GERD. Different strategies have been proposed and include objective periodic testing for esophageal acid exposure, long-term and possible lifelong proton pump inhibitor use, and surveillance for long-term consequences of GER via periodic upper endoscopy.3
It is important to acknowledge that the lack of symptoms or the absence of endoscopic evidence of GER on initial endoscopy does not necessarily rule out GER. Approximately a third of post-POEM patients with clinically successful outcome and absence of reflux esophagitis on their first surveillance endoscopy eventually develop esophagitis at subsequent surveillance endoscopy.5
In summary, POEM has deservingly taken a prime time spot in the management of patients with achalasia. It is an efficient, efficacious and safe treatment modality that results in rapid resolution of achalasia symptoms in the majority of patients. Research should focus on technical modifications (e.g., short gastric myotomy; addition of endoscopic fundoplication) that reduce the incidence of postprocedural GERD.
References
1. Ponds FA et al. Effect of peroral endoscopic myotomy versus pneumatic dilation on symptom severity and treatment outcomes among treatment-naive patients with achalasia: A randomized clinical trial. JAMA. 2019;322:134-44.
2. Werner YB et al. Endoscopic or surgical myotomy in patients with idiopathic achalasia. N Engl J Med. 2019;381:2219-29.
3. Khashab MA et al. ASGE guideline on the management of achalasia. Gastrointest Endosc. 2020;91:213-27 e6.
4. Ichkhanian Y et al. Case of early Barrett cancer following peroral endoscopic myotomy. Gut. 2019;68:2107-110.
5. Werner YB et al. Clinical response to peroral endoscopic myotomy in patients with idiopathic achalasia at a minimum follow-up of 2 years. Gut. 2016;65:899-906.
Dr. Khashab is associate professor of medicine, director of therapeutic endoscopy, division of gastroenterology and hepatology, Johns Hopkins Hospital, Baltimore. He is a consultant for BSCI, Olympus, and Medtronic.
Heller myotomy is still the gold standard
BY ROBERT M. SIWIEC, MD
Achalasia is a rare, primary esophageal motor disorder characterized by ineffective relaxation of the lower esophageal sphincter (LES) and concomitant loss of esophageal peristalsis. High-resolution esophageal manometry has allowed for the diagnosis and classification of achalasia into relevant clinical subtypes which become important when discussing and considering treatment options. Confirmatory studies (e.g., timed barium esophagram) and provocative manometric maneuvers (e.g., upright swallows, rapid swallow sequence, and/or rapid drink challenge) can be helpful when distinguishing between true achalasia versus achalasia variants and esophagogastric junction outflow obstruction.
Treatment options only provide palliation by eliminating outflow obstruction caused by a nonrelaxing and often times hypertensive LES. Pharmacotherapy (e.g., oral nitrates, 5-phosphodiesterase inhibitors, anticholinergics) is the least effective option because of medication side effects and short-acting duration. I only consider it for patients who are either unwilling or unable to tolerate invasive therapies. Botulinum toxin injection into the LES can be considered in patients who are not good candidates for more definitive therapy with PD or myotomy (endoscopic or surgical). Although the success rates with botulinum toxin are comparable with PD and surgical myotomy, patients treated with botulinum toxin require retreatment. Furthermore, continued botulinum toxin injections can compromise tissue planes making myotomy complex and challenging.
During the 1970s and 1980s, PD was the primary treatment modality for achalasia. Surgical myotomy was reserved for patients who suffered a perforation during PD or developed recurrent symptoms after multiple dilations. Minimally invasive surgery (left thoracoscopic approach) for achalasia was first introduced in the early 1990s and was shown to be a feasible, safe, and effective procedure, becoming the primary treatment approach in most centers. Patients fared well; however, it was soon discovered that >50% had pathological reflux based on pH monitoring. A few centers then began to perform a Heller myotomy through a laparoscopic approach with the addition of a fundoplication resulting in significant reductions in pathological reflux by pH monitoring. Eventually, a seminal RCT confirmed the importance of fundoplication with laparoscopic Heller myotomy (LHM) – resolution of dysphagia was unaffected and pathological reflux was avoided in most patients.1 Overall, clinical success rates for LHM with fundoplication are typically >90% and reflux incidence rates <10% with the overall complication rate being about 5% with reported mortality <0.1%.
PD remains appealing in that it is cost effective and less invasive, compared with POEM and LHM. Initial success rates and short-term efficacy are comparable with LHM but unfortunately PD’s efficacy significantly wanes over time. POEM, introduced by Inoue et al. in 2010, is a novel endoscopic technique with an excellent safety profile that provides good symptom relief while avoiding abdominal wall scars for patients. It has been shown to have a distinct advantage in patients with type III achalasia by nature of the longer myotomy not achievable by LHM.2 POEM has seen increasing enthusiasm and acceptance as a standard treatment option for achalasia largely because of the fact that its safety and efficacy have been shown to be comparable and in most cases equal with LHM. However, in 2020, direct comparison with LHM is challenging given that the follow-up in the majority of studies is either short or incomplete. The most recent multicenter, randomized trial comparing POEM with LHM plus Dor fundoplication showed POEM’s noninferiority in controlling symptoms of achalasia, but only after a 24 month follow-up.3 A recent report included one of the largest cohorts of post-POEM patients (500), but the 36-month data were based on the follow-up of only 61 patients (about 12%).4
Once the muscle fibers of the LES are disrupted, reflux will occur in the majority of patients. Unlike LHM, no concomitant fundoplication is performed during POEM and this increases the incidence of GERD and its long-term sequelae including peptic strictures, Barrett’s esophagus, and adenocarcinoma. A meta-analysis from 2018 looked at published series of POEM and LHM with fundoplication and found that GERD symptoms were present in 19% of POEM patients, compared with 8.8% of LHM patients. Worse yet, esophagitis was seen in 29.4% of the POEM group and 7.6% of the LHM group, with more individuals in the POEM group also having abnormal acid exposure based on ambulatory pH monitoring (39.0% vs. 16.8%).5
Proponents of POEM will argue that proton pump inhibitors (PPIs) are the panacea for post-POEM GERD. Unfortunately, this approach has its own problems. PPIs are very effective at reducing acid secretion by parietal cells, but do not block reflux through an iatrogenically incompetent LES. The drumbeat of publications on potential complications from chronic PPI use has greatly contributed to patients’ reluctance to commit to long-term PPI use. Lastly, the first case of early Barrett’s cancer was recently reported in a patient 4 years post-POEM despite adherence to an aggressive antisecretory regimen (b.i.d. PPI and H2 blocker at bedtime).6 LHM with fundoplication significantly reduces the risk of pathological GERD and spares patients from committing to lifelong PPI therapy and routine endoscopic surveillance (appropriate interval yet to be determined) and needing to consider additional procedures (i.e., endoscopic or surgical fundoplication).
Despite POEM’s well established efficacy and safety, the development of post-POEM GERD is a major concern that has yet to be adequately addressed. A significant number of post-POEM patients with pathological reflux have asymptomatic and unrecognized GERD and current management and monitoring strategies for post-POEM GERD are anemic and poorly established. Without question, there are individual patients who are clearly better served with POEM (type III achalasia and other spastic esophageal disorders). However, as we continue to learn more about post-POEM GERD and how to better prevent, manage, and monitor it, LHM with fundoplication for the time being remains the tried-and-tested treatment option for patients with non–type III achalasia.
References
1. Richards WO et al. Heller myotomy versus Heller myotomy with Dor fundoplication for achalasia: A prospective randomized double-blind clinical trial. Ann Surg. 2004;240:405-12.
2. Podboy AJ et al. Long-term outcomes of peroral endoscopic myotomy compared to laparoscopic Heller myotomy for achalasia: A single-center experience. Surg Endosc. 2020. doi: 10.1007/s00464-020-07450-6.
3. Werner YB et al. Endoscopic or surgical myotomy in patients with idiopathic achalasia. N Engl J Med. 2019;381(23):2219-29.
4. Inoue H et al. Peroral endoscopic myotomy: A series of 500 patients. J Am Coll Surg. 2015;221:256-64.
5. Repici A et al. GERD after peroral endoscopic myotomy as compared with Heller’s myotomy with fundoplication: A systematic review with meta-analysis. Gastrointest Endosc. 2018;87(4):934-43.
6. Ichkhanian Y et al. Case of early Barrett cancer following peroral endoscopic myotomy. Gut. 2019;68:2107-10.
Dr. Siwiec is assistant professor of clinical medicine, division of gastroenterology and hepatology, GI motility and neurogastroenterology unit, Indiana University, Indianapolis. He has no conflicts of interest.
A tribute to Edward Ross Ritvo, MD, 1930-2020
Reflections on loss amid COVID-19
I sit here on Father’s Day during a global pandemic and can’t help but think of Mark Twain’s quote, “Truth is stranger than fiction.” Isn’t that what calls us to our profession? When friends ask if I have watched a particular movie or TV show, I almost always say no. Why would I? Day after day at “work” I am hearing the most remarkable stories – many unfolding right before my eyes.
My Dad’s story is no less remarkable. As he was a pioneer in our field, I hope you will allow me to share a few recollections.
June 10, just 10 days after turning 90, Dad died peacefully in his home. His obituary, written by James McCracken, MD, says: “He was an internationally known child psychiatrist who, with colleagues, formed the vanguard of UCLA researchers establishing the biomedical basis of autism in the 1960s despite the prevailing psychological theories of the day ... who would later break new ground in identifying the role of genetics, sleep, and neurophysiological differences, perinatal risk factors, and biomarkers relating to autism and autism risk.”
Dad had extensive training in psychoanalysis and worked hard to maintain expertise in both the psychological and biological arenas. While he helped established autism as a neurologic disease and advocated for DSM criteria changes, he continued teaching Psychodynamic Theory of Personality to the UCLA medical students and maintained a clinical practice based in psychotherapeutic techniques. He was practicing biopsychosocial medicine long before the concept was articulated.
He conducted the first epidemiologic survey of autism in the state of Utah. He chose Utah because the Mormons keep perfect genealogical records. He identified multiple families with more than one child affected as well as examining, pre-, peri-, and postnatal factors affecting these families. Being a maverick has its challenges. One paper about parents with mild autism was rejected from publication seven times before a watered-down version of clinical vignettes finally got accepted. In collaboration with his wife, Riva Ariella Ritvo, he developed the Ritvo Autism Asperger Diagnostic Scale–Revised, (RAADS-R) still in use today.
Dad’s career was complicated by medical issues beginning in his 40s when he had a near-fatal heart attack at the top of Mammoth Mountain while skiing. After struggling for 20 years, he ultimately had a heart transplant at Cedars-Sinai Medical Center at 69 years old. Months after the transplant, he was back at work. He was unstoppable and maintained his optimism and great sense of humor throughout this complicated ordeal. He always remembered his commitment to his donor and his new heart, and worked out every day. Living to 90 was against all the odds.
Dad also persevered throughout his youngest son’s 10-year battle with Ewing’s sarcoma. Despite losing Max in 2016, Dad was active in research and clinical practice until the very end. He was doing telepsychiatry with patients in prisons and rehabilitation hospitals the last few years because he was too weak to travel to an office. He continued his research, and his last paper on eye movement responses as a possible biological marker of autism was published in February 2020.
Although Dad did not have COVID-19, the social isolation and stress of the last few months hastened his decline. The last week in the hospital with no visitors was too much for such a social man, and he died days after he was discharged. Always a trailblazer, Dad’s Zoom funeral was watched across the country by his children, grandchildren, extended family, and friends. Choosing to honor his wish to be cautious in this pandemic, we remained sheltering in place.
As Dad was the ultimate professor, I know he would want us to learn from his life and his passing. We are in an accelerated growth phase now as our lives and the lives of our patients are radically altered.
I hope, like Dad, we can choose to feel nourished by our meaningful work as we travel through life’s ups and downs. We must learn new ways to care for ourselves, our families, and our patients during these challenging times. We must find ways to mourn and celebrate those lost during the pandemic.
I know Dad would love synchronicity that I spent Father’s Day writing about him for Clinical Psychiatry News! Thank you for giving me this gift of reflection on this special day.
Dr. Ritvo, a psychiatrist with more than 25 years’ experience, practices in Miami Beach. She is the author of “Bekindr – The Transformative Power of Kindness” (Hellertown, Pa.: Momosa Publishing, 2018) and is the founder of the Bekindr Global Initiative, a movement aimed at cultivating kindness in the world. Dr. Ritvo also is the cofounder of the Bold Beauty Project, a nonprofit group that pairs women with disabilities with photographers who create art exhibitions to raise awareness.
Reflections on loss amid COVID-19
Reflections on loss amid COVID-19
I sit here on Father’s Day during a global pandemic and can’t help but think of Mark Twain’s quote, “Truth is stranger than fiction.” Isn’t that what calls us to our profession? When friends ask if I have watched a particular movie or TV show, I almost always say no. Why would I? Day after day at “work” I am hearing the most remarkable stories – many unfolding right before my eyes.
My Dad’s story is no less remarkable. As he was a pioneer in our field, I hope you will allow me to share a few recollections.
June 10, just 10 days after turning 90, Dad died peacefully in his home. His obituary, written by James McCracken, MD, says: “He was an internationally known child psychiatrist who, with colleagues, formed the vanguard of UCLA researchers establishing the biomedical basis of autism in the 1960s despite the prevailing psychological theories of the day ... who would later break new ground in identifying the role of genetics, sleep, and neurophysiological differences, perinatal risk factors, and biomarkers relating to autism and autism risk.”
Dad had extensive training in psychoanalysis and worked hard to maintain expertise in both the psychological and biological arenas. While he helped established autism as a neurologic disease and advocated for DSM criteria changes, he continued teaching Psychodynamic Theory of Personality to the UCLA medical students and maintained a clinical practice based in psychotherapeutic techniques. He was practicing biopsychosocial medicine long before the concept was articulated.
He conducted the first epidemiologic survey of autism in the state of Utah. He chose Utah because the Mormons keep perfect genealogical records. He identified multiple families with more than one child affected as well as examining, pre-, peri-, and postnatal factors affecting these families. Being a maverick has its challenges. One paper about parents with mild autism was rejected from publication seven times before a watered-down version of clinical vignettes finally got accepted. In collaboration with his wife, Riva Ariella Ritvo, he developed the Ritvo Autism Asperger Diagnostic Scale–Revised, (RAADS-R) still in use today.
Dad’s career was complicated by medical issues beginning in his 40s when he had a near-fatal heart attack at the top of Mammoth Mountain while skiing. After struggling for 20 years, he ultimately had a heart transplant at Cedars-Sinai Medical Center at 69 years old. Months after the transplant, he was back at work. He was unstoppable and maintained his optimism and great sense of humor throughout this complicated ordeal. He always remembered his commitment to his donor and his new heart, and worked out every day. Living to 90 was against all the odds.
Dad also persevered throughout his youngest son’s 10-year battle with Ewing’s sarcoma. Despite losing Max in 2016, Dad was active in research and clinical practice until the very end. He was doing telepsychiatry with patients in prisons and rehabilitation hospitals the last few years because he was too weak to travel to an office. He continued his research, and his last paper on eye movement responses as a possible biological marker of autism was published in February 2020.
Although Dad did not have COVID-19, the social isolation and stress of the last few months hastened his decline. The last week in the hospital with no visitors was too much for such a social man, and he died days after he was discharged. Always a trailblazer, Dad’s Zoom funeral was watched across the country by his children, grandchildren, extended family, and friends. Choosing to honor his wish to be cautious in this pandemic, we remained sheltering in place.
As Dad was the ultimate professor, I know he would want us to learn from his life and his passing. We are in an accelerated growth phase now as our lives and the lives of our patients are radically altered.
I hope, like Dad, we can choose to feel nourished by our meaningful work as we travel through life’s ups and downs. We must learn new ways to care for ourselves, our families, and our patients during these challenging times. We must find ways to mourn and celebrate those lost during the pandemic.
I know Dad would love synchronicity that I spent Father’s Day writing about him for Clinical Psychiatry News! Thank you for giving me this gift of reflection on this special day.
Dr. Ritvo, a psychiatrist with more than 25 years’ experience, practices in Miami Beach. She is the author of “Bekindr – The Transformative Power of Kindness” (Hellertown, Pa.: Momosa Publishing, 2018) and is the founder of the Bekindr Global Initiative, a movement aimed at cultivating kindness in the world. Dr. Ritvo also is the cofounder of the Bold Beauty Project, a nonprofit group that pairs women with disabilities with photographers who create art exhibitions to raise awareness.
I sit here on Father’s Day during a global pandemic and can’t help but think of Mark Twain’s quote, “Truth is stranger than fiction.” Isn’t that what calls us to our profession? When friends ask if I have watched a particular movie or TV show, I almost always say no. Why would I? Day after day at “work” I am hearing the most remarkable stories – many unfolding right before my eyes.
My Dad’s story is no less remarkable. As he was a pioneer in our field, I hope you will allow me to share a few recollections.
June 10, just 10 days after turning 90, Dad died peacefully in his home. His obituary, written by James McCracken, MD, says: “He was an internationally known child psychiatrist who, with colleagues, formed the vanguard of UCLA researchers establishing the biomedical basis of autism in the 1960s despite the prevailing psychological theories of the day ... who would later break new ground in identifying the role of genetics, sleep, and neurophysiological differences, perinatal risk factors, and biomarkers relating to autism and autism risk.”
Dad had extensive training in psychoanalysis and worked hard to maintain expertise in both the psychological and biological arenas. While he helped established autism as a neurologic disease and advocated for DSM criteria changes, he continued teaching Psychodynamic Theory of Personality to the UCLA medical students and maintained a clinical practice based in psychotherapeutic techniques. He was practicing biopsychosocial medicine long before the concept was articulated.
He conducted the first epidemiologic survey of autism in the state of Utah. He chose Utah because the Mormons keep perfect genealogical records. He identified multiple families with more than one child affected as well as examining, pre-, peri-, and postnatal factors affecting these families. Being a maverick has its challenges. One paper about parents with mild autism was rejected from publication seven times before a watered-down version of clinical vignettes finally got accepted. In collaboration with his wife, Riva Ariella Ritvo, he developed the Ritvo Autism Asperger Diagnostic Scale–Revised, (RAADS-R) still in use today.
Dad’s career was complicated by medical issues beginning in his 40s when he had a near-fatal heart attack at the top of Mammoth Mountain while skiing. After struggling for 20 years, he ultimately had a heart transplant at Cedars-Sinai Medical Center at 69 years old. Months after the transplant, he was back at work. He was unstoppable and maintained his optimism and great sense of humor throughout this complicated ordeal. He always remembered his commitment to his donor and his new heart, and worked out every day. Living to 90 was against all the odds.
Dad also persevered throughout his youngest son’s 10-year battle with Ewing’s sarcoma. Despite losing Max in 2016, Dad was active in research and clinical practice until the very end. He was doing telepsychiatry with patients in prisons and rehabilitation hospitals the last few years because he was too weak to travel to an office. He continued his research, and his last paper on eye movement responses as a possible biological marker of autism was published in February 2020.
Although Dad did not have COVID-19, the social isolation and stress of the last few months hastened his decline. The last week in the hospital with no visitors was too much for such a social man, and he died days after he was discharged. Always a trailblazer, Dad’s Zoom funeral was watched across the country by his children, grandchildren, extended family, and friends. Choosing to honor his wish to be cautious in this pandemic, we remained sheltering in place.
As Dad was the ultimate professor, I know he would want us to learn from his life and his passing. We are in an accelerated growth phase now as our lives and the lives of our patients are radically altered.
I hope, like Dad, we can choose to feel nourished by our meaningful work as we travel through life’s ups and downs. We must learn new ways to care for ourselves, our families, and our patients during these challenging times. We must find ways to mourn and celebrate those lost during the pandemic.
I know Dad would love synchronicity that I spent Father’s Day writing about him for Clinical Psychiatry News! Thank you for giving me this gift of reflection on this special day.
Dr. Ritvo, a psychiatrist with more than 25 years’ experience, practices in Miami Beach. She is the author of “Bekindr – The Transformative Power of Kindness” (Hellertown, Pa.: Momosa Publishing, 2018) and is the founder of the Bekindr Global Initiative, a movement aimed at cultivating kindness in the world. Dr. Ritvo also is the cofounder of the Bold Beauty Project, a nonprofit group that pairs women with disabilities with photographers who create art exhibitions to raise awareness.
Isa-Kd improves PFS in relapsed/refractory multiple myeloma
The risk of progression or death for patients with relapsed or refractory multiple myeloma was nearly halved with the addition of isatuximab to carfilzomib and dexamethasone, according to an interim analysis of the phase 3 IKEMA trial (NCT03275285).
After a median follow-up of 20.7 months, the median progression-free survival had not been reached for 179 patients treated with isatuximab (Sarclisa), carfilzomib (Kyprolis), and dexamethasone (together, known as Isa-Kd), compared with 19.5 months for 123 patients treated with carfilzomib and dexamethasone alone (Kd). The hazard ratio for progression free survival with the triple combination was 0.531 (P = .0007), reported coprincipal investigator Phillipe Moreau, MD, from the University Hospital Hôtel-Dieu in Nantes, France.
“The benefit of the triplet combination was observed across subgroups, including patients difficult to treat, such as [those with] high-risk cytogenetics or elderly patients,” he said in a late-breaking abstract presentation during the virtual annual congress of the European Hematology Association.
Isatuximab is an immunoglobulin G1 monoclonal antibody targeting a CD38 transmembrane glycoprotein on multiple myeloma cells, with a mechanism of action similar to that of another anti-CD38 antibody, daratumumab (Darzalex). Isatuximab is approved in the United States and Europe in combination with pomalidomide and dexamethasone for patients with relapsed/refractory multiple myeloma after at least two prior lines of therapy.
A ‘me too’ agent?
It’s unclear, however, whether isatuximab offers any additional benefit over daratumumab, an agent approved for use both in front line therapy combinations and for patients with relapsed/refractory disease, said Brea C. Lipe, MD, a multiple myeloma specialist at the University of Rochester (N.Y.) Wilmot Cancer Institute, who was not involved in the study.
“Every time we get a new drug it’s nice to have another option, but it doesn’t really add anything different from daratumumab at this point,” she said in an interview.
Dr. Lipe noted the IKEMA results are similar to those seen in the phase 3 CANDOR trial, comparing carfilzomib, dexamethasone, and daratumumab to carfilzomib/dexamethasone alone in patients with relapsed/refractory myeloma. In addition, it’s unknown whether patients with disease that is refractory to daratumumab could benefit from isatuximab, she said.
Although isatuximab has been touted as offering more rapid and more convenient dosing than daratumumab, the introduction of rapid infusion and subcutaneous administration of daratumumab has negated any theoretical advantage of the newcomer, Dr. Lipe added.
Study details
In the IKEMA trial, 302 patients with relapsed/refractory multiple myeloma who’d received one to three prior lines of therapy were stratified by the number of prior lines and by revised Multiple Myeloma International Staging System (R-ISS) and were then randomized on a 3:2 basis to treatment with carfilzomib 20 mg/m2 on days 1, 2, 8, 9, 15, and 16 of cycle 1 and 56 mg/m2 on the corresponding days of each subsequent cycle plus dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each cycle, with or without isatuximab. The antibody was dosed 10 mg/kg on days 1, 8, 15, and 22 in cycle 1 then every 2 weeks thereafter.
Treatments were continued until disease progression, unacceptable toxicity, or patient choice intervened.
At a prespecified interim analysis, the trial met its primary endpoint of a minimum 41% risk reduction in the hazard rate for progression free survival (PFS), with an actual risk reduction of 47%.
An analysis of PFS by subgroup showed significant benefits with the triple combination for patients aged 65 years and older, those with baseline estimated glomerular filtration rates below 60 mL/min per 1.73 m2, those with more than one prior line of therapy, those who had not previously received a proteasome inhibitor (e.g., bortezomib) or immunomodulatory agent (e.g., lenalidomide), those with high-risk cytogenetic status, and those with R-ISS stage II at study entry.
Overall response rates were similar between the study arms, at 86.6% with Isa-Kd and 82.9% with Kd, but the rate of very good partial responses or better was significantly higher with the triplet, at 72.6% versus 56.1% (P = .0011). The rate of minimal residual disease negativity was also significantly lower with Isa-Kd in the intent-to-treat population, at 29.6% versus 13%, respectively (P = .0004).
Overall survival data were not mature at the time of data cutoff and will be reported later, Dr. Moreau said.
Grade 3 or greater treatment-emergent adverse events (TEAEs) occurred in 76.8% of patients on the triplet and 67.2% of those on Kd. The incidences of death, serious TEAEs, or adverse events leading to discontinuation of therapy did not differ markedly between the treatment arms, however. Grade 3 or greater cardiac failure occurred in seven patients treated with the triplet (4%) and five treated with Kd (4.1%); respective rates of grade 3 or greater hematologic abnormalities included anemia in 22% and 19.7%, neutropenia in 19.2% and 7.4%, and thrombocytopenia in 29.9% and 23.8%.
The primary completion date for the trial is estimated to occur in November 2020, with final results in November 2023.
The study was sponsored by Sanofi. Dr. Moreau disclosed honoraria and a consulting or advisory role with several companies, not including Sanofi. Dr. Lipe disclosed impending advisory board activity for Janssen.
SOURCE: Moreau P et al. EHA Congress, Abstract LB2603.
The risk of progression or death for patients with relapsed or refractory multiple myeloma was nearly halved with the addition of isatuximab to carfilzomib and dexamethasone, according to an interim analysis of the phase 3 IKEMA trial (NCT03275285).
After a median follow-up of 20.7 months, the median progression-free survival had not been reached for 179 patients treated with isatuximab (Sarclisa), carfilzomib (Kyprolis), and dexamethasone (together, known as Isa-Kd), compared with 19.5 months for 123 patients treated with carfilzomib and dexamethasone alone (Kd). The hazard ratio for progression free survival with the triple combination was 0.531 (P = .0007), reported coprincipal investigator Phillipe Moreau, MD, from the University Hospital Hôtel-Dieu in Nantes, France.
“The benefit of the triplet combination was observed across subgroups, including patients difficult to treat, such as [those with] high-risk cytogenetics or elderly patients,” he said in a late-breaking abstract presentation during the virtual annual congress of the European Hematology Association.
Isatuximab is an immunoglobulin G1 monoclonal antibody targeting a CD38 transmembrane glycoprotein on multiple myeloma cells, with a mechanism of action similar to that of another anti-CD38 antibody, daratumumab (Darzalex). Isatuximab is approved in the United States and Europe in combination with pomalidomide and dexamethasone for patients with relapsed/refractory multiple myeloma after at least two prior lines of therapy.
A ‘me too’ agent?
It’s unclear, however, whether isatuximab offers any additional benefit over daratumumab, an agent approved for use both in front line therapy combinations and for patients with relapsed/refractory disease, said Brea C. Lipe, MD, a multiple myeloma specialist at the University of Rochester (N.Y.) Wilmot Cancer Institute, who was not involved in the study.
“Every time we get a new drug it’s nice to have another option, but it doesn’t really add anything different from daratumumab at this point,” she said in an interview.
Dr. Lipe noted the IKEMA results are similar to those seen in the phase 3 CANDOR trial, comparing carfilzomib, dexamethasone, and daratumumab to carfilzomib/dexamethasone alone in patients with relapsed/refractory myeloma. In addition, it’s unknown whether patients with disease that is refractory to daratumumab could benefit from isatuximab, she said.
Although isatuximab has been touted as offering more rapid and more convenient dosing than daratumumab, the introduction of rapid infusion and subcutaneous administration of daratumumab has negated any theoretical advantage of the newcomer, Dr. Lipe added.
Study details
In the IKEMA trial, 302 patients with relapsed/refractory multiple myeloma who’d received one to three prior lines of therapy were stratified by the number of prior lines and by revised Multiple Myeloma International Staging System (R-ISS) and were then randomized on a 3:2 basis to treatment with carfilzomib 20 mg/m2 on days 1, 2, 8, 9, 15, and 16 of cycle 1 and 56 mg/m2 on the corresponding days of each subsequent cycle plus dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each cycle, with or without isatuximab. The antibody was dosed 10 mg/kg on days 1, 8, 15, and 22 in cycle 1 then every 2 weeks thereafter.
Treatments were continued until disease progression, unacceptable toxicity, or patient choice intervened.
At a prespecified interim analysis, the trial met its primary endpoint of a minimum 41% risk reduction in the hazard rate for progression free survival (PFS), with an actual risk reduction of 47%.
An analysis of PFS by subgroup showed significant benefits with the triple combination for patients aged 65 years and older, those with baseline estimated glomerular filtration rates below 60 mL/min per 1.73 m2, those with more than one prior line of therapy, those who had not previously received a proteasome inhibitor (e.g., bortezomib) or immunomodulatory agent (e.g., lenalidomide), those with high-risk cytogenetic status, and those with R-ISS stage II at study entry.
Overall response rates were similar between the study arms, at 86.6% with Isa-Kd and 82.9% with Kd, but the rate of very good partial responses or better was significantly higher with the triplet, at 72.6% versus 56.1% (P = .0011). The rate of minimal residual disease negativity was also significantly lower with Isa-Kd in the intent-to-treat population, at 29.6% versus 13%, respectively (P = .0004).
Overall survival data were not mature at the time of data cutoff and will be reported later, Dr. Moreau said.
Grade 3 or greater treatment-emergent adverse events (TEAEs) occurred in 76.8% of patients on the triplet and 67.2% of those on Kd. The incidences of death, serious TEAEs, or adverse events leading to discontinuation of therapy did not differ markedly between the treatment arms, however. Grade 3 or greater cardiac failure occurred in seven patients treated with the triplet (4%) and five treated with Kd (4.1%); respective rates of grade 3 or greater hematologic abnormalities included anemia in 22% and 19.7%, neutropenia in 19.2% and 7.4%, and thrombocytopenia in 29.9% and 23.8%.
The primary completion date for the trial is estimated to occur in November 2020, with final results in November 2023.
The study was sponsored by Sanofi. Dr. Moreau disclosed honoraria and a consulting or advisory role with several companies, not including Sanofi. Dr. Lipe disclosed impending advisory board activity for Janssen.
SOURCE: Moreau P et al. EHA Congress, Abstract LB2603.
The risk of progression or death for patients with relapsed or refractory multiple myeloma was nearly halved with the addition of isatuximab to carfilzomib and dexamethasone, according to an interim analysis of the phase 3 IKEMA trial (NCT03275285).
After a median follow-up of 20.7 months, the median progression-free survival had not been reached for 179 patients treated with isatuximab (Sarclisa), carfilzomib (Kyprolis), and dexamethasone (together, known as Isa-Kd), compared with 19.5 months for 123 patients treated with carfilzomib and dexamethasone alone (Kd). The hazard ratio for progression free survival with the triple combination was 0.531 (P = .0007), reported coprincipal investigator Phillipe Moreau, MD, from the University Hospital Hôtel-Dieu in Nantes, France.
“The benefit of the triplet combination was observed across subgroups, including patients difficult to treat, such as [those with] high-risk cytogenetics or elderly patients,” he said in a late-breaking abstract presentation during the virtual annual congress of the European Hematology Association.
Isatuximab is an immunoglobulin G1 monoclonal antibody targeting a CD38 transmembrane glycoprotein on multiple myeloma cells, with a mechanism of action similar to that of another anti-CD38 antibody, daratumumab (Darzalex). Isatuximab is approved in the United States and Europe in combination with pomalidomide and dexamethasone for patients with relapsed/refractory multiple myeloma after at least two prior lines of therapy.
A ‘me too’ agent?
It’s unclear, however, whether isatuximab offers any additional benefit over daratumumab, an agent approved for use both in front line therapy combinations and for patients with relapsed/refractory disease, said Brea C. Lipe, MD, a multiple myeloma specialist at the University of Rochester (N.Y.) Wilmot Cancer Institute, who was not involved in the study.
“Every time we get a new drug it’s nice to have another option, but it doesn’t really add anything different from daratumumab at this point,” she said in an interview.
Dr. Lipe noted the IKEMA results are similar to those seen in the phase 3 CANDOR trial, comparing carfilzomib, dexamethasone, and daratumumab to carfilzomib/dexamethasone alone in patients with relapsed/refractory myeloma. In addition, it’s unknown whether patients with disease that is refractory to daratumumab could benefit from isatuximab, she said.
Although isatuximab has been touted as offering more rapid and more convenient dosing than daratumumab, the introduction of rapid infusion and subcutaneous administration of daratumumab has negated any theoretical advantage of the newcomer, Dr. Lipe added.
Study details
In the IKEMA trial, 302 patients with relapsed/refractory multiple myeloma who’d received one to three prior lines of therapy were stratified by the number of prior lines and by revised Multiple Myeloma International Staging System (R-ISS) and were then randomized on a 3:2 basis to treatment with carfilzomib 20 mg/m2 on days 1, 2, 8, 9, 15, and 16 of cycle 1 and 56 mg/m2 on the corresponding days of each subsequent cycle plus dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each cycle, with or without isatuximab. The antibody was dosed 10 mg/kg on days 1, 8, 15, and 22 in cycle 1 then every 2 weeks thereafter.
Treatments were continued until disease progression, unacceptable toxicity, or patient choice intervened.
At a prespecified interim analysis, the trial met its primary endpoint of a minimum 41% risk reduction in the hazard rate for progression free survival (PFS), with an actual risk reduction of 47%.
An analysis of PFS by subgroup showed significant benefits with the triple combination for patients aged 65 years and older, those with baseline estimated glomerular filtration rates below 60 mL/min per 1.73 m2, those with more than one prior line of therapy, those who had not previously received a proteasome inhibitor (e.g., bortezomib) or immunomodulatory agent (e.g., lenalidomide), those with high-risk cytogenetic status, and those with R-ISS stage II at study entry.
Overall response rates were similar between the study arms, at 86.6% with Isa-Kd and 82.9% with Kd, but the rate of very good partial responses or better was significantly higher with the triplet, at 72.6% versus 56.1% (P = .0011). The rate of minimal residual disease negativity was also significantly lower with Isa-Kd in the intent-to-treat population, at 29.6% versus 13%, respectively (P = .0004).
Overall survival data were not mature at the time of data cutoff and will be reported later, Dr. Moreau said.
Grade 3 or greater treatment-emergent adverse events (TEAEs) occurred in 76.8% of patients on the triplet and 67.2% of those on Kd. The incidences of death, serious TEAEs, or adverse events leading to discontinuation of therapy did not differ markedly between the treatment arms, however. Grade 3 or greater cardiac failure occurred in seven patients treated with the triplet (4%) and five treated with Kd (4.1%); respective rates of grade 3 or greater hematologic abnormalities included anemia in 22% and 19.7%, neutropenia in 19.2% and 7.4%, and thrombocytopenia in 29.9% and 23.8%.
The primary completion date for the trial is estimated to occur in November 2020, with final results in November 2023.
The study was sponsored by Sanofi. Dr. Moreau disclosed honoraria and a consulting or advisory role with several companies, not including Sanofi. Dr. Lipe disclosed impending advisory board activity for Janssen.
SOURCE: Moreau P et al. EHA Congress, Abstract LB2603.
FROM EHA CONGRESS
Microneedling plus 10% TCA peels bests CO2 laser alone for infraorbital dark circles
In a study of patients with mild to moderate infraorbital dark circles, treatment with carbon dioxide laser resurfacing did not produce a significant improvement in infraorbital hyperpigmentation. However, the combination of microneedling and 10% trichloroacetic acid peels did.
The finding comes from what is believed to be the first head-to-head comparison of the two procedures for infraorbital dark circles, which are a common cosmetic concern with increased age.
During a late-breaking abstract session at the virtual annual meeting of the American Academy of Dermatology, lead study author Banu Farabi, MD, said that dark circles seen in the periorbital area are defined as bilateral, round homogeneous pigmented macules whose etiology is thought to be multifactorial. Available treatments include bleaching creams, topical retinoids, chemical peels, lasers, autologous fat transplantation, injectable fillers, and blepharoplasty.
“Microneedling has been recently suggested as an effective and efficient method for reducing infraorbital dark circles,” Dr. Farabi said. “This technique is based on creating microchannels that can stimulate the production of subcutaneous collagen and elastin. It also enhances the revascularization and fibroblast activity, which increases the skin thickness and gives a shiny appearance to the skin. The fractional CO2 has also been introduced as an effective procedure to remove infraorbital dark circles. However, there are some potential complications with that therapy.”
For the current study, Dr. Farabi, of the department of dermatology at Ankara (Turkey) University, and Mohamad Goldust, MD, of University Hospital Basel (Switzerland), They used the handheld Automatic Microneedle Therapy System-Handhold from MCure. After creating microchannels, the investigators topically applied 10% trichloroacetic acid peels to each infraorbital area and waited for 5 minutes.
In the carbon dioxide laser group, a Lutronic CO2 laser was used with a pulse energy of 10 J/cm2, a 100-microsecond pulse rate, 30 W of power, and a pulse width of 4 mm. The treatment outcome was assessed with the patient’s satisfaction and the physician’s judgment, which were no response, partial response, and complete response. Patients in both study groups were followed up for blinded-investigator assessment of infraorbital hyperpigmentation, adverse events, and improvement, compared with baseline.
The mean age of patients was 40 years, with a range between 27 and 58 years. About one-third of patients in each group had Fitzpatrick skin types II, III, and IV, respectively. In the blinded investigator assessment, the laser-resurfacing procedure did not demonstrate a significant improvement in infraorbital hyperpigmentation at day 90 (P = .24). However, the combination of microneedling and 10% trichloroacetic acid peels significantly improved infraorbital hyperpigmentation by day 90, with improvement maintained through day 180 (P = .012 and .002, respectively).
Adverse events were mild and temporary in both groups. In the laser-resurfacing group, 7 of the patients (22.5%) developed transient infraorbital hyperpigmentation postoperatively that lasted 4 weeks. In the combination treatment group, 18 patients (58%) developed transient erythema that lasted for up to 1 week.
“We suggest using microneedling plus 10% [trichloroacetic acid] as a cost-effective and efficient method for reducing infraorbital dark circles,” Dr. Farabi concluded.
The researchers reported having no financial disclosures.
In a study of patients with mild to moderate infraorbital dark circles, treatment with carbon dioxide laser resurfacing did not produce a significant improvement in infraorbital hyperpigmentation. However, the combination of microneedling and 10% trichloroacetic acid peels did.
The finding comes from what is believed to be the first head-to-head comparison of the two procedures for infraorbital dark circles, which are a common cosmetic concern with increased age.
During a late-breaking abstract session at the virtual annual meeting of the American Academy of Dermatology, lead study author Banu Farabi, MD, said that dark circles seen in the periorbital area are defined as bilateral, round homogeneous pigmented macules whose etiology is thought to be multifactorial. Available treatments include bleaching creams, topical retinoids, chemical peels, lasers, autologous fat transplantation, injectable fillers, and blepharoplasty.
“Microneedling has been recently suggested as an effective and efficient method for reducing infraorbital dark circles,” Dr. Farabi said. “This technique is based on creating microchannels that can stimulate the production of subcutaneous collagen and elastin. It also enhances the revascularization and fibroblast activity, which increases the skin thickness and gives a shiny appearance to the skin. The fractional CO2 has also been introduced as an effective procedure to remove infraorbital dark circles. However, there are some potential complications with that therapy.”
For the current study, Dr. Farabi, of the department of dermatology at Ankara (Turkey) University, and Mohamad Goldust, MD, of University Hospital Basel (Switzerland), They used the handheld Automatic Microneedle Therapy System-Handhold from MCure. After creating microchannels, the investigators topically applied 10% trichloroacetic acid peels to each infraorbital area and waited for 5 minutes.
In the carbon dioxide laser group, a Lutronic CO2 laser was used with a pulse energy of 10 J/cm2, a 100-microsecond pulse rate, 30 W of power, and a pulse width of 4 mm. The treatment outcome was assessed with the patient’s satisfaction and the physician’s judgment, which were no response, partial response, and complete response. Patients in both study groups were followed up for blinded-investigator assessment of infraorbital hyperpigmentation, adverse events, and improvement, compared with baseline.
The mean age of patients was 40 years, with a range between 27 and 58 years. About one-third of patients in each group had Fitzpatrick skin types II, III, and IV, respectively. In the blinded investigator assessment, the laser-resurfacing procedure did not demonstrate a significant improvement in infraorbital hyperpigmentation at day 90 (P = .24). However, the combination of microneedling and 10% trichloroacetic acid peels significantly improved infraorbital hyperpigmentation by day 90, with improvement maintained through day 180 (P = .012 and .002, respectively).
Adverse events were mild and temporary in both groups. In the laser-resurfacing group, 7 of the patients (22.5%) developed transient infraorbital hyperpigmentation postoperatively that lasted 4 weeks. In the combination treatment group, 18 patients (58%) developed transient erythema that lasted for up to 1 week.
“We suggest using microneedling plus 10% [trichloroacetic acid] as a cost-effective and efficient method for reducing infraorbital dark circles,” Dr. Farabi concluded.
The researchers reported having no financial disclosures.
In a study of patients with mild to moderate infraorbital dark circles, treatment with carbon dioxide laser resurfacing did not produce a significant improvement in infraorbital hyperpigmentation. However, the combination of microneedling and 10% trichloroacetic acid peels did.
The finding comes from what is believed to be the first head-to-head comparison of the two procedures for infraorbital dark circles, which are a common cosmetic concern with increased age.
During a late-breaking abstract session at the virtual annual meeting of the American Academy of Dermatology, lead study author Banu Farabi, MD, said that dark circles seen in the periorbital area are defined as bilateral, round homogeneous pigmented macules whose etiology is thought to be multifactorial. Available treatments include bleaching creams, topical retinoids, chemical peels, lasers, autologous fat transplantation, injectable fillers, and blepharoplasty.
“Microneedling has been recently suggested as an effective and efficient method for reducing infraorbital dark circles,” Dr. Farabi said. “This technique is based on creating microchannels that can stimulate the production of subcutaneous collagen and elastin. It also enhances the revascularization and fibroblast activity, which increases the skin thickness and gives a shiny appearance to the skin. The fractional CO2 has also been introduced as an effective procedure to remove infraorbital dark circles. However, there are some potential complications with that therapy.”
For the current study, Dr. Farabi, of the department of dermatology at Ankara (Turkey) University, and Mohamad Goldust, MD, of University Hospital Basel (Switzerland), They used the handheld Automatic Microneedle Therapy System-Handhold from MCure. After creating microchannels, the investigators topically applied 10% trichloroacetic acid peels to each infraorbital area and waited for 5 minutes.
In the carbon dioxide laser group, a Lutronic CO2 laser was used with a pulse energy of 10 J/cm2, a 100-microsecond pulse rate, 30 W of power, and a pulse width of 4 mm. The treatment outcome was assessed with the patient’s satisfaction and the physician’s judgment, which were no response, partial response, and complete response. Patients in both study groups were followed up for blinded-investigator assessment of infraorbital hyperpigmentation, adverse events, and improvement, compared with baseline.
The mean age of patients was 40 years, with a range between 27 and 58 years. About one-third of patients in each group had Fitzpatrick skin types II, III, and IV, respectively. In the blinded investigator assessment, the laser-resurfacing procedure did not demonstrate a significant improvement in infraorbital hyperpigmentation at day 90 (P = .24). However, the combination of microneedling and 10% trichloroacetic acid peels significantly improved infraorbital hyperpigmentation by day 90, with improvement maintained through day 180 (P = .012 and .002, respectively).
Adverse events were mild and temporary in both groups. In the laser-resurfacing group, 7 of the patients (22.5%) developed transient infraorbital hyperpigmentation postoperatively that lasted 4 weeks. In the combination treatment group, 18 patients (58%) developed transient erythema that lasted for up to 1 week.
“We suggest using microneedling plus 10% [trichloroacetic acid] as a cost-effective and efficient method for reducing infraorbital dark circles,” Dr. Farabi concluded.
The researchers reported having no financial disclosures.
FROM AAD 20
Women thrive on baroreflex activation for heart failure
The striking gains in functional capacity and quality of life conferred by baroreflex activation therapy in patients with heart failure, as shown in the pivotal phase 3 clinical trial for this novel intervention, were at least as great in women as in men, JoAnn Lindenfeld, MD, said at the European Society of Cardiology Heart Failure Discoveries virtual meeting.
The results of the multicenter, prospective, randomized BeAT-HF trial led to marketing approval of the BaroStim Neo system for improvement in symptoms of heart failure with reduced ejection fraction (HFrEF) by the Food and Drug Administration in August 2019. Dr. Lindenfeld presented a fresh breakdown of the results by gender which showed, intriguingly, that the improvement in all study endpoints was consistently numerically greater in the women – sometimes startlingly so – although these gender differences in response didn’t achieve statistical significance. The 6-month randomized trial was underpowered for drawing definitive conclusions on that score, with a study population of only 53 women and 211 men. So the investigator remained circumspect.
“We think that what this study shows us is that women have at least equivalent improvement as men in this population. I don’t think we can conclude from this study yet that it’s better, but it’s certainly in all these parameters as least as good. And I think this is a population in which we’ve seen that improving symptoms and functional capacity is very important,” said Dr. Lindenfeld, professor of medicine and director of advanced heart failure/cardiac transplantation at Vanderbilt University, Nashville, Tenn.
The FDA approval was restricted to patients like those enrolled in BeAT-HF: that is, individuals with New York Heart Association functional class III heart failure, a left ventricular ejection fraction of 35% or less while on stable optimal medical therapy, and ineligibility for cardiac resynchronization therapy according to current guidelines. Seventy-eight percent of BeAT-HF participants had an implantable cardioverter-defibrillator.
Participants were randomized to baroreflex activation therapy (BAT) plus optimal medical therapy or to optimal medical therapy alone. The three coprimary endpoints were change from baseline to 6 months in 6-minute hall walk distance (6MHW), scores on the Minnesota Living with Heart Failure Questionnaire (MLHF), and N-terminal pro-B-type natriuretic peptide (NT-proBNP).
In the overall study population, 6MHW increased by 60 m in the BAT group and decreased by 8 m in controls; MLHF scores dropped by 14 and 6 points, respectively; and NT-proBNP fell by an average of 25% with BAT while rising by 3% in controls.
Very often, just a 5-point reduction in MLHF score is considered a clinically meaningful improvement in quality of life, the cardiologist noted.
The gender-based analysis is where things got particularly interesting.
The investigators defined a clinically relevant response as a greater than 10% increase from baseline on the 6MHW, at least a one-class improvement in NYHA class, or a reduction of 5 points or more on the MLHF. Among subjects in the BAT group, 70% of women and 60% of men met the clinically relevant response standard in terms of 6MHW, as did 70% of women and 64% of men for improvement in NYHA class, and 78% of women and 66% of men for MLHF score.
Eighty-seven percent of women and 68% of men on BAT had a clinically relevant response on at least one of these endpoints, as did about 28% of controls. Moreover, 31% of women in the BAT group were clinically relevant responders on at least two endpoints, compared with 19% of BAT men and 4% and 9% of controls.
Women dominate super-responder category
In order to be classified as a super responder, a patient had to demonstrate a greater than 20% increase in 6MHW, improvement in NYHA class I status, or at least a 10-point improvement in MLHF score. Ninety-one percent of women on BAT achieved super-responder status for at least one of these endpoints, compared with 76% of men. Forty-three percent of women and 24% of men in the BAT group were super responders in at least two domains, as were 8% and 11% of female and male controls, Dr. Lindenfeld continued.
Discussant Ewa Anita Jankowska, MD, PhD, deemed the BeAT-HF results on the therapeutic benefits of this autonomic modulation strategy “quite convincing.”
“We need to acknowledge that in recent years we have been spoiled a bit by the huge trials in heart failure where the ultimate goal was a reduction in mortality. But I think this is the time when we should think about the patients who want to live – here, now – with a better life. Patients expect symptomatic benefits. There is a substantial group of patients who are symptomatic even though they receive quite extensive neurohormonal blockage and who are not suitable for CRT. This study demonstrates that, for this group of patients, BAT can bring really significant symptomatic benefits,” she said.
“If you think about a treatment that provides patients who are NYHA class III an increase in 6MHW of 60 meters, that’s really something. And 20% of patients went from NYHA class III to class I – that’s really something, too,” added Dr. Jankowska, professor of medicine and head of the laboratory of applied research on the cardiovascular system at Wroclaw (Poland) University.
How baroreflex activation therapy works
The BaroStim system consists of a 2-mm unipolar electrode on a 7-mm backer that is placed over the carotid sinus. It is supported by a small generator with a 4- to 5-year battery life implanted under the collarbone, along with radiofrequency telemetry capability and programming flexibility.
Stimulation of the carotid baroreceptor promotes an integrated autonomic nervous system response which enhances parasympathetic activity and inhibits sympathetic nervous system activity. The result, as shown in numerous earlier proof-of-concept studies, is a reduced heart rate, decreased ventricular remodeling, enhanced diuresis, increased vasodilation, a drop in elevated blood pressure, and decreased renin secretion – all achieved nonpharmacologically.
The study was sponsored by CVRx. Dr. Lindenfeld reported serving as a consultant to CVRx, Abbott, AstraZeneca, Boehringer Ingelheim, Edwards Lifesciences, Impulse Dynamics, and VWave.
The striking gains in functional capacity and quality of life conferred by baroreflex activation therapy in patients with heart failure, as shown in the pivotal phase 3 clinical trial for this novel intervention, were at least as great in women as in men, JoAnn Lindenfeld, MD, said at the European Society of Cardiology Heart Failure Discoveries virtual meeting.
The results of the multicenter, prospective, randomized BeAT-HF trial led to marketing approval of the BaroStim Neo system for improvement in symptoms of heart failure with reduced ejection fraction (HFrEF) by the Food and Drug Administration in August 2019. Dr. Lindenfeld presented a fresh breakdown of the results by gender which showed, intriguingly, that the improvement in all study endpoints was consistently numerically greater in the women – sometimes startlingly so – although these gender differences in response didn’t achieve statistical significance. The 6-month randomized trial was underpowered for drawing definitive conclusions on that score, with a study population of only 53 women and 211 men. So the investigator remained circumspect.
“We think that what this study shows us is that women have at least equivalent improvement as men in this population. I don’t think we can conclude from this study yet that it’s better, but it’s certainly in all these parameters as least as good. And I think this is a population in which we’ve seen that improving symptoms and functional capacity is very important,” said Dr. Lindenfeld, professor of medicine and director of advanced heart failure/cardiac transplantation at Vanderbilt University, Nashville, Tenn.
The FDA approval was restricted to patients like those enrolled in BeAT-HF: that is, individuals with New York Heart Association functional class III heart failure, a left ventricular ejection fraction of 35% or less while on stable optimal medical therapy, and ineligibility for cardiac resynchronization therapy according to current guidelines. Seventy-eight percent of BeAT-HF participants had an implantable cardioverter-defibrillator.
Participants were randomized to baroreflex activation therapy (BAT) plus optimal medical therapy or to optimal medical therapy alone. The three coprimary endpoints were change from baseline to 6 months in 6-minute hall walk distance (6MHW), scores on the Minnesota Living with Heart Failure Questionnaire (MLHF), and N-terminal pro-B-type natriuretic peptide (NT-proBNP).
In the overall study population, 6MHW increased by 60 m in the BAT group and decreased by 8 m in controls; MLHF scores dropped by 14 and 6 points, respectively; and NT-proBNP fell by an average of 25% with BAT while rising by 3% in controls.
Very often, just a 5-point reduction in MLHF score is considered a clinically meaningful improvement in quality of life, the cardiologist noted.
The gender-based analysis is where things got particularly interesting.
The investigators defined a clinically relevant response as a greater than 10% increase from baseline on the 6MHW, at least a one-class improvement in NYHA class, or a reduction of 5 points or more on the MLHF. Among subjects in the BAT group, 70% of women and 60% of men met the clinically relevant response standard in terms of 6MHW, as did 70% of women and 64% of men for improvement in NYHA class, and 78% of women and 66% of men for MLHF score.
Eighty-seven percent of women and 68% of men on BAT had a clinically relevant response on at least one of these endpoints, as did about 28% of controls. Moreover, 31% of women in the BAT group were clinically relevant responders on at least two endpoints, compared with 19% of BAT men and 4% and 9% of controls.
Women dominate super-responder category
In order to be classified as a super responder, a patient had to demonstrate a greater than 20% increase in 6MHW, improvement in NYHA class I status, or at least a 10-point improvement in MLHF score. Ninety-one percent of women on BAT achieved super-responder status for at least one of these endpoints, compared with 76% of men. Forty-three percent of women and 24% of men in the BAT group were super responders in at least two domains, as were 8% and 11% of female and male controls, Dr. Lindenfeld continued.
Discussant Ewa Anita Jankowska, MD, PhD, deemed the BeAT-HF results on the therapeutic benefits of this autonomic modulation strategy “quite convincing.”
“We need to acknowledge that in recent years we have been spoiled a bit by the huge trials in heart failure where the ultimate goal was a reduction in mortality. But I think this is the time when we should think about the patients who want to live – here, now – with a better life. Patients expect symptomatic benefits. There is a substantial group of patients who are symptomatic even though they receive quite extensive neurohormonal blockage and who are not suitable for CRT. This study demonstrates that, for this group of patients, BAT can bring really significant symptomatic benefits,” she said.
“If you think about a treatment that provides patients who are NYHA class III an increase in 6MHW of 60 meters, that’s really something. And 20% of patients went from NYHA class III to class I – that’s really something, too,” added Dr. Jankowska, professor of medicine and head of the laboratory of applied research on the cardiovascular system at Wroclaw (Poland) University.
How baroreflex activation therapy works
The BaroStim system consists of a 2-mm unipolar electrode on a 7-mm backer that is placed over the carotid sinus. It is supported by a small generator with a 4- to 5-year battery life implanted under the collarbone, along with radiofrequency telemetry capability and programming flexibility.
Stimulation of the carotid baroreceptor promotes an integrated autonomic nervous system response which enhances parasympathetic activity and inhibits sympathetic nervous system activity. The result, as shown in numerous earlier proof-of-concept studies, is a reduced heart rate, decreased ventricular remodeling, enhanced diuresis, increased vasodilation, a drop in elevated blood pressure, and decreased renin secretion – all achieved nonpharmacologically.
The study was sponsored by CVRx. Dr. Lindenfeld reported serving as a consultant to CVRx, Abbott, AstraZeneca, Boehringer Ingelheim, Edwards Lifesciences, Impulse Dynamics, and VWave.
The striking gains in functional capacity and quality of life conferred by baroreflex activation therapy in patients with heart failure, as shown in the pivotal phase 3 clinical trial for this novel intervention, were at least as great in women as in men, JoAnn Lindenfeld, MD, said at the European Society of Cardiology Heart Failure Discoveries virtual meeting.
The results of the multicenter, prospective, randomized BeAT-HF trial led to marketing approval of the BaroStim Neo system for improvement in symptoms of heart failure with reduced ejection fraction (HFrEF) by the Food and Drug Administration in August 2019. Dr. Lindenfeld presented a fresh breakdown of the results by gender which showed, intriguingly, that the improvement in all study endpoints was consistently numerically greater in the women – sometimes startlingly so – although these gender differences in response didn’t achieve statistical significance. The 6-month randomized trial was underpowered for drawing definitive conclusions on that score, with a study population of only 53 women and 211 men. So the investigator remained circumspect.
“We think that what this study shows us is that women have at least equivalent improvement as men in this population. I don’t think we can conclude from this study yet that it’s better, but it’s certainly in all these parameters as least as good. And I think this is a population in which we’ve seen that improving symptoms and functional capacity is very important,” said Dr. Lindenfeld, professor of medicine and director of advanced heart failure/cardiac transplantation at Vanderbilt University, Nashville, Tenn.
The FDA approval was restricted to patients like those enrolled in BeAT-HF: that is, individuals with New York Heart Association functional class III heart failure, a left ventricular ejection fraction of 35% or less while on stable optimal medical therapy, and ineligibility for cardiac resynchronization therapy according to current guidelines. Seventy-eight percent of BeAT-HF participants had an implantable cardioverter-defibrillator.
Participants were randomized to baroreflex activation therapy (BAT) plus optimal medical therapy or to optimal medical therapy alone. The three coprimary endpoints were change from baseline to 6 months in 6-minute hall walk distance (6MHW), scores on the Minnesota Living with Heart Failure Questionnaire (MLHF), and N-terminal pro-B-type natriuretic peptide (NT-proBNP).
In the overall study population, 6MHW increased by 60 m in the BAT group and decreased by 8 m in controls; MLHF scores dropped by 14 and 6 points, respectively; and NT-proBNP fell by an average of 25% with BAT while rising by 3% in controls.
Very often, just a 5-point reduction in MLHF score is considered a clinically meaningful improvement in quality of life, the cardiologist noted.
The gender-based analysis is where things got particularly interesting.
The investigators defined a clinically relevant response as a greater than 10% increase from baseline on the 6MHW, at least a one-class improvement in NYHA class, or a reduction of 5 points or more on the MLHF. Among subjects in the BAT group, 70% of women and 60% of men met the clinically relevant response standard in terms of 6MHW, as did 70% of women and 64% of men for improvement in NYHA class, and 78% of women and 66% of men for MLHF score.
Eighty-seven percent of women and 68% of men on BAT had a clinically relevant response on at least one of these endpoints, as did about 28% of controls. Moreover, 31% of women in the BAT group were clinically relevant responders on at least two endpoints, compared with 19% of BAT men and 4% and 9% of controls.
Women dominate super-responder category
In order to be classified as a super responder, a patient had to demonstrate a greater than 20% increase in 6MHW, improvement in NYHA class I status, or at least a 10-point improvement in MLHF score. Ninety-one percent of women on BAT achieved super-responder status for at least one of these endpoints, compared with 76% of men. Forty-three percent of women and 24% of men in the BAT group were super responders in at least two domains, as were 8% and 11% of female and male controls, Dr. Lindenfeld continued.
Discussant Ewa Anita Jankowska, MD, PhD, deemed the BeAT-HF results on the therapeutic benefits of this autonomic modulation strategy “quite convincing.”
“We need to acknowledge that in recent years we have been spoiled a bit by the huge trials in heart failure where the ultimate goal was a reduction in mortality. But I think this is the time when we should think about the patients who want to live – here, now – with a better life. Patients expect symptomatic benefits. There is a substantial group of patients who are symptomatic even though they receive quite extensive neurohormonal blockage and who are not suitable for CRT. This study demonstrates that, for this group of patients, BAT can bring really significant symptomatic benefits,” she said.
“If you think about a treatment that provides patients who are NYHA class III an increase in 6MHW of 60 meters, that’s really something. And 20% of patients went from NYHA class III to class I – that’s really something, too,” added Dr. Jankowska, professor of medicine and head of the laboratory of applied research on the cardiovascular system at Wroclaw (Poland) University.
How baroreflex activation therapy works
The BaroStim system consists of a 2-mm unipolar electrode on a 7-mm backer that is placed over the carotid sinus. It is supported by a small generator with a 4- to 5-year battery life implanted under the collarbone, along with radiofrequency telemetry capability and programming flexibility.
Stimulation of the carotid baroreceptor promotes an integrated autonomic nervous system response which enhances parasympathetic activity and inhibits sympathetic nervous system activity. The result, as shown in numerous earlier proof-of-concept studies, is a reduced heart rate, decreased ventricular remodeling, enhanced diuresis, increased vasodilation, a drop in elevated blood pressure, and decreased renin secretion – all achieved nonpharmacologically.
The study was sponsored by CVRx. Dr. Lindenfeld reported serving as a consultant to CVRx, Abbott, AstraZeneca, Boehringer Ingelheim, Edwards Lifesciences, Impulse Dynamics, and VWave.
FROM ESC HEART FAILURE 2020
School daze
A few weeks ago I was asked by the head of our local parks and recreation department for my opinion on whether the town should open its summer recreation camps program. He had been receiving multiple inquiries from parents who in the past had relied on the day camps for day care. The director already had surveyed health care administrators and other providers in the town and his team had crafted a plan based on what guidelines they could glean from state and federal advisory groups. The feedback he had received from town officials and health care representatives was that they felt opening would be a bad decision. One physician observed that there is just “so much we don’t know about the virus at this point.”
I certainly agreed that we still have much to learn about COVID-19, but I told the director that we know enough that I would feel comfortable with opening the day camps, which have traditionally been held outdoors under open-sided tents. If group sizes were kept small, staff personnel were dedicated to just one group, and temperatures were taken at the beginning and at the midpoint of each daily session, I felt that the risk of triggering an outbreak was small. I told him that in my mind the Achilles heel of the plan was whether the camp staff, who are generally high school and college-age young people, could be trusted to follow rigorous social distancing in their off-work hours.
Eventually the decision was made by the traditionally risk-averse town officials to open the camps. I hope that this step forward will spur the process of reopening the schools in the fall by demonstrating that, at least in an open-air environment, some simple common sense measures could create a safe environment for children to congregate in. Unfortunately, the long delay in formulating the plan and a basic hesitancy on the part of some parents has resulted in disappointing enrollment figures so far.
I suspect that many of you have been asked to participate in the planning and decision-making processes for opening the school systems in your community or at least have some thoughts of your own about how best to begin the reopening process.
I suspect you agree that, if the number of new cases detected each day in your state is still rising and/or your state’s ability to test, track, case find, and quarantine is inadequate, reopening schools is probably just asking for trouble. However, a recent study has found that children and young adults under the age of 20 years were almost half as likely to become infected as those over the age of 20 (Nat Med. 2020 Jun 16. doi: 10.1038/s41591-020-0962-9). We already know that, in general, children are presenting with less severe illness. Although the authors observe that we still need to learn more about the transmissibility of subclinical infections, particularly in children, they suggest that “interventions aimed at children might have relatively little impact on reducing SARS-CoV-2 transmission.” It is sounding like reopening schools will place the children at relatively low risk. However, until we know more about transmissibility we have to assume reopening schools may place the community at an increased risk.
If this new information is confirmed by other studies, how would this change the recommendations you would make to the community about reopening its schools? What about masks? We are learning that they make a difference for adults, but is this true for very young children as well? Masks should probably remain part of the hygiene education program as well for at least the foreseeable future.
Do you think your school system can broaden its focus beyond surface cleaning to air handling and ventilation? Here in Maine, keeping the windows open for more than a few weeks a year is going to present problems that may be expensive to remedy.
There are always more questions than answers, but my hope is that here in Maine our apparent success on a state level will allow us to reopen the schools as long as we remain vigilant for the first signs that we need to return to lock down. How do you feel about your community’s situation?
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.
A few weeks ago I was asked by the head of our local parks and recreation department for my opinion on whether the town should open its summer recreation camps program. He had been receiving multiple inquiries from parents who in the past had relied on the day camps for day care. The director already had surveyed health care administrators and other providers in the town and his team had crafted a plan based on what guidelines they could glean from state and federal advisory groups. The feedback he had received from town officials and health care representatives was that they felt opening would be a bad decision. One physician observed that there is just “so much we don’t know about the virus at this point.”
I certainly agreed that we still have much to learn about COVID-19, but I told the director that we know enough that I would feel comfortable with opening the day camps, which have traditionally been held outdoors under open-sided tents. If group sizes were kept small, staff personnel were dedicated to just one group, and temperatures were taken at the beginning and at the midpoint of each daily session, I felt that the risk of triggering an outbreak was small. I told him that in my mind the Achilles heel of the plan was whether the camp staff, who are generally high school and college-age young people, could be trusted to follow rigorous social distancing in their off-work hours.
Eventually the decision was made by the traditionally risk-averse town officials to open the camps. I hope that this step forward will spur the process of reopening the schools in the fall by demonstrating that, at least in an open-air environment, some simple common sense measures could create a safe environment for children to congregate in. Unfortunately, the long delay in formulating the plan and a basic hesitancy on the part of some parents has resulted in disappointing enrollment figures so far.
I suspect that many of you have been asked to participate in the planning and decision-making processes for opening the school systems in your community or at least have some thoughts of your own about how best to begin the reopening process.
I suspect you agree that, if the number of new cases detected each day in your state is still rising and/or your state’s ability to test, track, case find, and quarantine is inadequate, reopening schools is probably just asking for trouble. However, a recent study has found that children and young adults under the age of 20 years were almost half as likely to become infected as those over the age of 20 (Nat Med. 2020 Jun 16. doi: 10.1038/s41591-020-0962-9). We already know that, in general, children are presenting with less severe illness. Although the authors observe that we still need to learn more about the transmissibility of subclinical infections, particularly in children, they suggest that “interventions aimed at children might have relatively little impact on reducing SARS-CoV-2 transmission.” It is sounding like reopening schools will place the children at relatively low risk. However, until we know more about transmissibility we have to assume reopening schools may place the community at an increased risk.
If this new information is confirmed by other studies, how would this change the recommendations you would make to the community about reopening its schools? What about masks? We are learning that they make a difference for adults, but is this true for very young children as well? Masks should probably remain part of the hygiene education program as well for at least the foreseeable future.
Do you think your school system can broaden its focus beyond surface cleaning to air handling and ventilation? Here in Maine, keeping the windows open for more than a few weeks a year is going to present problems that may be expensive to remedy.
There are always more questions than answers, but my hope is that here in Maine our apparent success on a state level will allow us to reopen the schools as long as we remain vigilant for the first signs that we need to return to lock down. How do you feel about your community’s situation?
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.
A few weeks ago I was asked by the head of our local parks and recreation department for my opinion on whether the town should open its summer recreation camps program. He had been receiving multiple inquiries from parents who in the past had relied on the day camps for day care. The director already had surveyed health care administrators and other providers in the town and his team had crafted a plan based on what guidelines they could glean from state and federal advisory groups. The feedback he had received from town officials and health care representatives was that they felt opening would be a bad decision. One physician observed that there is just “so much we don’t know about the virus at this point.”
I certainly agreed that we still have much to learn about COVID-19, but I told the director that we know enough that I would feel comfortable with opening the day camps, which have traditionally been held outdoors under open-sided tents. If group sizes were kept small, staff personnel were dedicated to just one group, and temperatures were taken at the beginning and at the midpoint of each daily session, I felt that the risk of triggering an outbreak was small. I told him that in my mind the Achilles heel of the plan was whether the camp staff, who are generally high school and college-age young people, could be trusted to follow rigorous social distancing in their off-work hours.
Eventually the decision was made by the traditionally risk-averse town officials to open the camps. I hope that this step forward will spur the process of reopening the schools in the fall by demonstrating that, at least in an open-air environment, some simple common sense measures could create a safe environment for children to congregate in. Unfortunately, the long delay in formulating the plan and a basic hesitancy on the part of some parents has resulted in disappointing enrollment figures so far.
I suspect that many of you have been asked to participate in the planning and decision-making processes for opening the school systems in your community or at least have some thoughts of your own about how best to begin the reopening process.
I suspect you agree that, if the number of new cases detected each day in your state is still rising and/or your state’s ability to test, track, case find, and quarantine is inadequate, reopening schools is probably just asking for trouble. However, a recent study has found that children and young adults under the age of 20 years were almost half as likely to become infected as those over the age of 20 (Nat Med. 2020 Jun 16. doi: 10.1038/s41591-020-0962-9). We already know that, in general, children are presenting with less severe illness. Although the authors observe that we still need to learn more about the transmissibility of subclinical infections, particularly in children, they suggest that “interventions aimed at children might have relatively little impact on reducing SARS-CoV-2 transmission.” It is sounding like reopening schools will place the children at relatively low risk. However, until we know more about transmissibility we have to assume reopening schools may place the community at an increased risk.
If this new information is confirmed by other studies, how would this change the recommendations you would make to the community about reopening its schools? What about masks? We are learning that they make a difference for adults, but is this true for very young children as well? Masks should probably remain part of the hygiene education program as well for at least the foreseeable future.
Do you think your school system can broaden its focus beyond surface cleaning to air handling and ventilation? Here in Maine, keeping the windows open for more than a few weeks a year is going to present problems that may be expensive to remedy.
There are always more questions than answers, but my hope is that here in Maine our apparent success on a state level will allow us to reopen the schools as long as we remain vigilant for the first signs that we need to return to lock down. How do you feel about your community’s situation?
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.
Telehealth and medical liability
The COVID-19 pandemic has led to the rapid uptake of telehealth nationwide in primary care and specialty practices. Over the last few months many practices have actually performed more telehealth visits than traditional in-person visits. The use of telehealth, which had been increasing slowly for the last few years, accelerated rapidly during the pandemic. Long term, telehealth has the potential to increase access to primary care and specialists, and make follow-up easier for many patients, changing how health care is delivered to millions of patients throughout the world.
Since telehealth will be a regular part of our practices from now on, it is important for clinicians to recognize how telehealth visits are viewed in a legal arena.
As is often the case with technological advances, the law needs time to adapt. Will a health care provider treating a patient using telemedicine be held to the same standard of care applicable to an in-person encounter? Stated differently, will consideration be given to the obvious limitations imposed by a telemedicine exam?
Standard of care in medical malpractice cases
The central question in most medical malpractice cases is whether the provider complied with the generally accepted standard of care when evaluating, diagnosing, or treating a patient. This standard typically takes into consideration the provider’s particular specialty as well as all the circumstances surrounding the encounter.1 Medical providers, not state legislators, usually define the standard of care for medical professionals. In malpractice cases, medical experts explain the applicable standard of care to the jury and guide its determination of whether, in the particular case, the standard of care was met. In this way, the law has long recognized that the medical profession itself is best suited to establish the appropriate standards of care under any particular set of circumstances. This standard of care is often referred to as the “reasonable professional under the circumstances” standard of care.
Telemedicine standard of care
Despite the fact that the complex and often nebulous concept of standard of care has been traditionally left to the medical experts to define, state legislators and regulators throughout the nation have chosen to weigh in on this issue in the context of telemedicine. Most states with telemedicine regulations have followed the model policy adopted by the Federation of State Medical Boards in April 2014 which states that “[t]reatment and consultation recommendations made in an online setting … will be held to the same standards of appropriate practice as those in traditional (in-person) settings.”2 States that have adopted this model policy have effectively created a “legal fiction” requiring a jury to ignore the fact that the care was provided virtually by telemedicine technologies and instead assume that the physician treated the patient in person, i.e, applying an “in-person” standard of care. Hawaii appears to be the lone notable exception. Its telemedicine law recognizes that an in-person standard of care should not be applied if there was not a face-to-face visit.3
Proponents of the in-person telemedicine standard claim that it is necessary to ensure patient safety, thus justifying the “legal fiction.” Holding the provider to the in-person standard, it is argued, forces the physician to err on the side of caution and require an actual in-person encounter to ensure the advantages of sight, touch, and sense of things are fully available.4 This discourages the use of telemedicine and deprives the population of its many benefits.
Telemedicine can overcome geographical barriers, increase clinical support, improve health outcomes, reduce health care costs, encourage patient input, reduce travel, and foster continuity of care. The pandemic, which has significantly limited the ability of providers to see patients in person, only underscores the benefits of telemedicine.
The legislatively imposed in-person telemedicine standard of care should be replaced with the “reasonable professional under the circumstances” standard in order to fairly judge physicians’ care and promote overall population health. The “reasonable professional under the circumstances” standard has applied to physicians and other health care professionals outside of telemedicine for decades, and it has served the medical community and public well. It is unfortunate that legislators felt the need to weigh in and define a distinctly different standard of care for telemedicine than for the rest of medicine, as this may present unforeseen obstacles to the use of telemedicine.
The in-person telemedicine standard of care remains a significant barrier for long-term telemedicine. Eliminating this legal fiction has the potential to further expand physicians’ use of telemedicine and fulfill its promise of improving access to care and improving population health.
Mr. Horner (partner), Mr. Milewski (partner), and Mr. Gajer (associate) are attorneys with White and Williams. They specialize in defending health care providers in medical malpractice lawsuits and other health care–related matters. Dr. Skolnik is professor of family and community Medicine at the Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Jefferson Health. Follow Dr. Skolnik, and feel free to submit questions to him on Twitter: @neilskolnik. The authors have no financial conflicts related to the content of this piece.
References
1. Cowan v. Doering, 111 N.J. 451-62,.1988.
2. Model Policy For The Appropriate Use Of Telemedicine Technologies In The Practice Of Medicine. State Medical Boards Appropriate Regulation of Telemedicine. April 2014..
3. Haw. Rev. Stat. Ann. § 453-1.3(c).
4. Kaspar BJ. Iowa Law Review. 2014 Jan;99:839-59.
The COVID-19 pandemic has led to the rapid uptake of telehealth nationwide in primary care and specialty practices. Over the last few months many practices have actually performed more telehealth visits than traditional in-person visits. The use of telehealth, which had been increasing slowly for the last few years, accelerated rapidly during the pandemic. Long term, telehealth has the potential to increase access to primary care and specialists, and make follow-up easier for many patients, changing how health care is delivered to millions of patients throughout the world.
Since telehealth will be a regular part of our practices from now on, it is important for clinicians to recognize how telehealth visits are viewed in a legal arena.
As is often the case with technological advances, the law needs time to adapt. Will a health care provider treating a patient using telemedicine be held to the same standard of care applicable to an in-person encounter? Stated differently, will consideration be given to the obvious limitations imposed by a telemedicine exam?
Standard of care in medical malpractice cases
The central question in most medical malpractice cases is whether the provider complied with the generally accepted standard of care when evaluating, diagnosing, or treating a patient. This standard typically takes into consideration the provider’s particular specialty as well as all the circumstances surrounding the encounter.1 Medical providers, not state legislators, usually define the standard of care for medical professionals. In malpractice cases, medical experts explain the applicable standard of care to the jury and guide its determination of whether, in the particular case, the standard of care was met. In this way, the law has long recognized that the medical profession itself is best suited to establish the appropriate standards of care under any particular set of circumstances. This standard of care is often referred to as the “reasonable professional under the circumstances” standard of care.
Telemedicine standard of care
Despite the fact that the complex and often nebulous concept of standard of care has been traditionally left to the medical experts to define, state legislators and regulators throughout the nation have chosen to weigh in on this issue in the context of telemedicine. Most states with telemedicine regulations have followed the model policy adopted by the Federation of State Medical Boards in April 2014 which states that “[t]reatment and consultation recommendations made in an online setting … will be held to the same standards of appropriate practice as those in traditional (in-person) settings.”2 States that have adopted this model policy have effectively created a “legal fiction” requiring a jury to ignore the fact that the care was provided virtually by telemedicine technologies and instead assume that the physician treated the patient in person, i.e, applying an “in-person” standard of care. Hawaii appears to be the lone notable exception. Its telemedicine law recognizes that an in-person standard of care should not be applied if there was not a face-to-face visit.3
Proponents of the in-person telemedicine standard claim that it is necessary to ensure patient safety, thus justifying the “legal fiction.” Holding the provider to the in-person standard, it is argued, forces the physician to err on the side of caution and require an actual in-person encounter to ensure the advantages of sight, touch, and sense of things are fully available.4 This discourages the use of telemedicine and deprives the population of its many benefits.
Telemedicine can overcome geographical barriers, increase clinical support, improve health outcomes, reduce health care costs, encourage patient input, reduce travel, and foster continuity of care. The pandemic, which has significantly limited the ability of providers to see patients in person, only underscores the benefits of telemedicine.
The legislatively imposed in-person telemedicine standard of care should be replaced with the “reasonable professional under the circumstances” standard in order to fairly judge physicians’ care and promote overall population health. The “reasonable professional under the circumstances” standard has applied to physicians and other health care professionals outside of telemedicine for decades, and it has served the medical community and public well. It is unfortunate that legislators felt the need to weigh in and define a distinctly different standard of care for telemedicine than for the rest of medicine, as this may present unforeseen obstacles to the use of telemedicine.
The in-person telemedicine standard of care remains a significant barrier for long-term telemedicine. Eliminating this legal fiction has the potential to further expand physicians’ use of telemedicine and fulfill its promise of improving access to care and improving population health.
Mr. Horner (partner), Mr. Milewski (partner), and Mr. Gajer (associate) are attorneys with White and Williams. They specialize in defending health care providers in medical malpractice lawsuits and other health care–related matters. Dr. Skolnik is professor of family and community Medicine at the Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Jefferson Health. Follow Dr. Skolnik, and feel free to submit questions to him on Twitter: @neilskolnik. The authors have no financial conflicts related to the content of this piece.
References
1. Cowan v. Doering, 111 N.J. 451-62,.1988.
2. Model Policy For The Appropriate Use Of Telemedicine Technologies In The Practice Of Medicine. State Medical Boards Appropriate Regulation of Telemedicine. April 2014..
3. Haw. Rev. Stat. Ann. § 453-1.3(c).
4. Kaspar BJ. Iowa Law Review. 2014 Jan;99:839-59.
The COVID-19 pandemic has led to the rapid uptake of telehealth nationwide in primary care and specialty practices. Over the last few months many practices have actually performed more telehealth visits than traditional in-person visits. The use of telehealth, which had been increasing slowly for the last few years, accelerated rapidly during the pandemic. Long term, telehealth has the potential to increase access to primary care and specialists, and make follow-up easier for many patients, changing how health care is delivered to millions of patients throughout the world.
Since telehealth will be a regular part of our practices from now on, it is important for clinicians to recognize how telehealth visits are viewed in a legal arena.
As is often the case with technological advances, the law needs time to adapt. Will a health care provider treating a patient using telemedicine be held to the same standard of care applicable to an in-person encounter? Stated differently, will consideration be given to the obvious limitations imposed by a telemedicine exam?
Standard of care in medical malpractice cases
The central question in most medical malpractice cases is whether the provider complied with the generally accepted standard of care when evaluating, diagnosing, or treating a patient. This standard typically takes into consideration the provider’s particular specialty as well as all the circumstances surrounding the encounter.1 Medical providers, not state legislators, usually define the standard of care for medical professionals. In malpractice cases, medical experts explain the applicable standard of care to the jury and guide its determination of whether, in the particular case, the standard of care was met. In this way, the law has long recognized that the medical profession itself is best suited to establish the appropriate standards of care under any particular set of circumstances. This standard of care is often referred to as the “reasonable professional under the circumstances” standard of care.
Telemedicine standard of care
Despite the fact that the complex and often nebulous concept of standard of care has been traditionally left to the medical experts to define, state legislators and regulators throughout the nation have chosen to weigh in on this issue in the context of telemedicine. Most states with telemedicine regulations have followed the model policy adopted by the Federation of State Medical Boards in April 2014 which states that “[t]reatment and consultation recommendations made in an online setting … will be held to the same standards of appropriate practice as those in traditional (in-person) settings.”2 States that have adopted this model policy have effectively created a “legal fiction” requiring a jury to ignore the fact that the care was provided virtually by telemedicine technologies and instead assume that the physician treated the patient in person, i.e, applying an “in-person” standard of care. Hawaii appears to be the lone notable exception. Its telemedicine law recognizes that an in-person standard of care should not be applied if there was not a face-to-face visit.3
Proponents of the in-person telemedicine standard claim that it is necessary to ensure patient safety, thus justifying the “legal fiction.” Holding the provider to the in-person standard, it is argued, forces the physician to err on the side of caution and require an actual in-person encounter to ensure the advantages of sight, touch, and sense of things are fully available.4 This discourages the use of telemedicine and deprives the population of its many benefits.
Telemedicine can overcome geographical barriers, increase clinical support, improve health outcomes, reduce health care costs, encourage patient input, reduce travel, and foster continuity of care. The pandemic, which has significantly limited the ability of providers to see patients in person, only underscores the benefits of telemedicine.
The legislatively imposed in-person telemedicine standard of care should be replaced with the “reasonable professional under the circumstances” standard in order to fairly judge physicians’ care and promote overall population health. The “reasonable professional under the circumstances” standard has applied to physicians and other health care professionals outside of telemedicine for decades, and it has served the medical community and public well. It is unfortunate that legislators felt the need to weigh in and define a distinctly different standard of care for telemedicine than for the rest of medicine, as this may present unforeseen obstacles to the use of telemedicine.
The in-person telemedicine standard of care remains a significant barrier for long-term telemedicine. Eliminating this legal fiction has the potential to further expand physicians’ use of telemedicine and fulfill its promise of improving access to care and improving population health.
Mr. Horner (partner), Mr. Milewski (partner), and Mr. Gajer (associate) are attorneys with White and Williams. They specialize in defending health care providers in medical malpractice lawsuits and other health care–related matters. Dr. Skolnik is professor of family and community Medicine at the Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Jefferson Health. Follow Dr. Skolnik, and feel free to submit questions to him on Twitter: @neilskolnik. The authors have no financial conflicts related to the content of this piece.
References
1. Cowan v. Doering, 111 N.J. 451-62,.1988.
2. Model Policy For The Appropriate Use Of Telemedicine Technologies In The Practice Of Medicine. State Medical Boards Appropriate Regulation of Telemedicine. April 2014..
3. Haw. Rev. Stat. Ann. § 453-1.3(c).
4. Kaspar BJ. Iowa Law Review. 2014 Jan;99:839-59.