Ted Bosworth

SAN FRANCISCO – The potential power of machine learning to improve therapeutic choices in inflammatory bowel disease (IBD) is at the threshold of clinical applications, according to data presented at the 2019 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

Joel Austell/MDedge News

This type of work is relevant to many fields of medicine, but studies conducted in IBD have provided particularly compelling evidence that predictive analytics will improve outcomes and lead to more cost-effective delivery of care, according to Akbar K. Waljee, MD, MSc, an associate professor in the division of gastroenterology, University of Michigan, Ann Arbor, and a staff physician and researcher at the VA Ann Arbor Healthcare System.

Having now published several papers on the role of precision analytics and big data to improve treatment choices in IBD as well as other diseases, Dr. Waljee said, “We collect large amounts of clinical data every day in the delivery of health care but we are now only just beginning to leverage [these] data to guide treatment.”

Based on the experience in IBD, these analyses are relevant for selecting who to treat and not to treat with a given drug.

In one study of how this technology can be applied, data from 1,080 IBD patients taking thiopurines were used to develop a machine learning algorithm that analyzed multiple readily available variables, such as a complete blood count with differential and a chemistry panel, to predict if the patient was in remission. The area under the receiver operating characteristics curve (AuROC) was 0.79 or much higher than previous prediction using drug metabolites, according to Dr. Waljee.

The mean yearly rate of clinical events (new steroid prescriptions, hospitalizations, and abdominal surgeries) was then compared between those who did and those who did not have an algorithm-predicted remission. The lower mean rate in those predicted to be in remission (1.08 vs. 3.95 events) provided support for the conclusions that the algorithm is clinically viable.

“The heterogeneity of response to therapies for IBD is well established. If machine learning predicts effective choices, there will be an opportunity to accelerate the time to disease control as well as save costs by avoiding therapies not likely to be effective,” Dr. Waljee explained.

In another example, the focus was on predicting response to vedolizumab, a monoclonal antibody targeted at a gut-specific mediator of inflammation. In this case, machine learning was applied to predicting corticosteroid-free remission at 1 year in patients with Crohn’s disease patients evaluated 6 weeks after initiating therapy. The machine-learning algorithm was based on an analysis of numerous variables, including laboratory data, sex, and race. Based on the model drawn from the analysis of 472 patients, 35.8% of the patients predicted to be in corticosteroid-free biologic remission at 1 year achieved this endpoint, whereas only 6.7% of the patients predicted to fail achieved the endpoint.

“This suggests that we can use an algorithm relatively early in the course of this biologic to predict who is going to respond,” reported Dr. Waljee. Again, patients with a low likelihood of response at 6 weeks can be started on an alternative therapy, potentially accelerating the time to disease control and avoiding the costs of ineffective and expensive treatments.

IBD is a particularly attractive focus of precision analytics with big data. IBD has a relatively unpredictable relapsing-remitting course and a variable heterogeneous response to available therapies. Algorithms predictive of response circumvent the inherent delays from evaluating disease control over an extended period.

“With ever increasing concern about costs of care and access to care, these treatment algorithms promise to use resources more efficiently,” Dr. Waljee said.

SAN FRANCISCO – The potential power of machine learning to improve therapeutic choices in inflammatory bowel disease (IBD) is at the threshold of clinical applications, according to data presented at the 2019 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

Joel Austell/MDedge News

This type of work is relevant to many fields of medicine, but studies conducted in IBD have provided particularly compelling evidence that predictive analytics will improve outcomes and lead to more cost-effective delivery of care, according to Akbar K. Waljee, MD, MSc, an associate professor in the division of gastroenterology, University of Michigan, Ann Arbor, and a staff physician and researcher at the VA Ann Arbor Healthcare System.

Having now published several papers on the role of precision analytics and big data to improve treatment choices in IBD as well as other diseases, Dr. Waljee said, “We collect large amounts of clinical data every day in the delivery of health care but we are now only just beginning to leverage [these] data to guide treatment.”

Based on the experience in IBD, these analyses are relevant for selecting who to treat and not to treat with a given drug.

In one study of how this technology can be applied, data from 1,080 IBD patients taking thiopurines were used to develop a machine learning algorithm that analyzed multiple readily available variables, such as a complete blood count with differential and a chemistry panel, to predict if the patient was in remission. The area under the receiver operating characteristics curve (AuROC) was 0.79 or much higher than previous prediction using drug metabolites, according to Dr. Waljee.

The mean yearly rate of clinical events (new steroid prescriptions, hospitalizations, and abdominal surgeries) was then compared between those who did and those who did not have an algorithm-predicted remission. The lower mean rate in those predicted to be in remission (1.08 vs. 3.95 events) provided support for the conclusions that the algorithm is clinically viable.

“The heterogeneity of response to therapies for IBD is well established. If machine learning predicts effective choices, there will be an opportunity to accelerate the time to disease control as well as save costs by avoiding therapies not likely to be effective,” Dr. Waljee explained.

In another example, the focus was on predicting response to vedolizumab, a monoclonal antibody targeted at a gut-specific mediator of inflammation. In this case, machine learning was applied to predicting corticosteroid-free remission at 1 year in patients with Crohn’s disease patients evaluated 6 weeks after initiating therapy. The machine-learning algorithm was based on an analysis of numerous variables, including laboratory data, sex, and race. Based on the model drawn from the analysis of 472 patients, 35.8% of the patients predicted to be in corticosteroid-free biologic remission at 1 year achieved this endpoint, whereas only 6.7% of the patients predicted to fail achieved the endpoint.

“This suggests that we can use an algorithm relatively early in the course of this biologic to predict who is going to respond,” reported Dr. Waljee. Again, patients with a low likelihood of response at 6 weeks can be started on an alternative therapy, potentially accelerating the time to disease control and avoiding the costs of ineffective and expensive treatments.

IBD is a particularly attractive focus of precision analytics with big data. IBD has a relatively unpredictable relapsing-remitting course and a variable heterogeneous response to available therapies. Algorithms predictive of response circumvent the inherent delays from evaluating disease control over an extended period.

“With ever increasing concern about costs of care and access to care, these treatment algorithms promise to use resources more efficiently,” Dr. Waljee said.

SAN FRANCISCO – The potential power of machine learning to improve therapeutic choices in inflammatory bowel disease (IBD) is at the threshold of clinical applications, according to data presented at the 2019 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

Joel Austell/MDedge News

This type of work is relevant to many fields of medicine, but studies conducted in IBD have provided particularly compelling evidence that predictive analytics will improve outcomes and lead to more cost-effective delivery of care, according to Akbar K. Waljee, MD, MSc, an associate professor in the division of gastroenterology, University of Michigan, Ann Arbor, and a staff physician and researcher at the VA Ann Arbor Healthcare System.

Having now published several papers on the role of precision analytics and big data to improve treatment choices in IBD as well as other diseases, Dr. Waljee said, “We collect large amounts of clinical data every day in the delivery of health care but we are now only just beginning to leverage [these] data to guide treatment.”

Based on the experience in IBD, these analyses are relevant for selecting who to treat and not to treat with a given drug.

In one study of how this technology can be applied, data from 1,080 IBD patients taking thiopurines were used to develop a machine learning algorithm that analyzed multiple readily available variables, such as a complete blood count with differential and a chemistry panel, to predict if the patient was in remission. The area under the receiver operating characteristics curve (AuROC) was 0.79 or much higher than previous prediction using drug metabolites, according to Dr. Waljee.

The mean yearly rate of clinical events (new steroid prescriptions, hospitalizations, and abdominal surgeries) was then compared between those who did and those who did not have an algorithm-predicted remission. The lower mean rate in those predicted to be in remission (1.08 vs. 3.95 events) provided support for the conclusions that the algorithm is clinically viable.

“The heterogeneity of response to therapies for IBD is well established. If machine learning predicts effective choices, there will be an opportunity to accelerate the time to disease control as well as save costs by avoiding therapies not likely to be effective,” Dr. Waljee explained.

In another example, the focus was on predicting response to vedolizumab, a monoclonal antibody targeted at a gut-specific mediator of inflammation. In this case, machine learning was applied to predicting corticosteroid-free remission at 1 year in patients with Crohn’s disease patients evaluated 6 weeks after initiating therapy. The machine-learning algorithm was based on an analysis of numerous variables, including laboratory data, sex, and race. Based on the model drawn from the analysis of 472 patients, 35.8% of the patients predicted to be in corticosteroid-free biologic remission at 1 year achieved this endpoint, whereas only 6.7% of the patients predicted to fail achieved the endpoint.

“This suggests that we can use an algorithm relatively early in the course of this biologic to predict who is going to respond,” reported Dr. Waljee. Again, patients with a low likelihood of response at 6 weeks can be started on an alternative therapy, potentially accelerating the time to disease control and avoiding the costs of ineffective and expensive treatments.

IBD is a particularly attractive focus of precision analytics with big data. IBD has a relatively unpredictable relapsing-remitting course and a variable heterogeneous response to available therapies. Algorithms predictive of response circumvent the inherent delays from evaluating disease control over an extended period.

“With ever increasing concern about costs of care and access to care, these treatment algorithms promise to use resources more efficiently,” Dr. Waljee said.

SAN FRANCISCO – The growing sophistication of simulation technology has the potential to improve training and assessment of skills in gastrointestinal endoscopy, but there are gaps between the promise and evidence, according to an overview of this form of training at the 2019 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

For endoscopy, the term simulator encompasses a broad expanse of tools that can range from a simple physical model with holes used to practice endoscope navigation skills to a complex virtual world that challenges technical skills as well as decision-making processes. In 2012, the American Society of Gastrointestinal Endoscopy (ASGE) issued a statement encouraging endoscopy simulation-based training in the context of other strategies to gain skills, but Catharine Walsh, MD, MEd, PhD, of the University of Toronto, warned of the current limits as well as the advantages of simulation training.

“There are many companies making simulators of varying price and complexity. For early skill acquisition, more expensive devices may not necessarily be better,” Dr. Walsh said. She highlighted that “one’s choice of simulator should be based on the educational goals as opposed to technology, as the effectiveness of simulation depends highly on a close match between the training goals and the simulation tool.” A longstanding issue in the field of simulation relates to cost and access. Simulation will not have widespread impact unless it is accessible. “There is a need for future development of inexpensive, portable simulators targeting specific skills to help facilitate uptake of simulation across endoscopy units and training programs,” said Dr. Walsh. Other strategies to increase uptake include specific learning modules designed to complement simulators.

Although simulators are increasingly being used during training to help endoscopists develop basic endoscopic skills, Dr. Walsh focused on the gap in development of simulator devices targeting practicing endoscopists and research examining their use for training new skills within practice, preventing skills decay, and remediating performance deficits. She explained that “currently, there is a lack of evidence that simulation adoption by practicing endoscopists leads to better patient outcomes. This remains a priority area for simulation education, research, and development.” It also remains to be seen how cost-effective simulators are compared with other reaching modalities, she said. 

“The potential is certainly there, but it is essential to develop simulators targeting training for low-volume, higher stakes therapeutic techniques, emerging procedures, and techniques and advanced endoscopic procedures, and perform well-controlled studies to demonstrate their effectiveness in practice,” Dr. Walsh said. “Embedding assessments within emerging simulation technology is key as it permits identification of skills requiring further practice and can form the basis of virtual coaching employing endoscopic simulation to improve skills and outcomes.”

Simulators offer the very important advantage of giving the physician the chance to acquire skills before participating in a clinical case and allowing errors to occur in a risk-free environment, suggesting that this type of training will only grow. For example, Dr. Walsh described emerging simulation-based team training that allows endoscopy teams to practice both technical skills as well as nontechnical skills, such as communication and decision making, which may be particularly important in the event of a crisis. Gamification is also being pursued as a potential adjunct strategy to help improve engagement and skill acquisition.

Current simulators are limited in their ability to train and assess cognitive and nontechnical skills. Development of simulation-based cognitive training tools for key areas such as lesion recognition, classification, and management decision-making skills is also a promising area to pursue. Such education could be delivered via portable electronic devices and incorporate assessment and feedback to facilitate skills acquisition.

“There remains a substantial gap between the promise of many types of simulation training and objective evidence that these are helping endoscopists gain skills,” Dr. Walsh said. This in no way diminishes the enormous promise of new simulation technology to be an effective and safe approach for clinicians to learn and maintain performance of endoscopic skills, but Dr. Walsh focused on the need for the development of new simulation technologies and controlled studies that will render these approaches evidence based.

SAN FRANCISCO – The growing sophistication of simulation technology has the potential to improve training and assessment of skills in gastrointestinal endoscopy, but there are gaps between the promise and evidence, according to an overview of this form of training at the 2019 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

For endoscopy, the term simulator encompasses a broad expanse of tools that can range from a simple physical model with holes used to practice endoscope navigation skills to a complex virtual world that challenges technical skills as well as decision-making processes. In 2012, the American Society of Gastrointestinal Endoscopy (ASGE) issued a statement encouraging endoscopy simulation-based training in the context of other strategies to gain skills, but Catharine Walsh, MD, MEd, PhD, of the University of Toronto, warned of the current limits as well as the advantages of simulation training.

“There are many companies making simulators of varying price and complexity. For early skill acquisition, more expensive devices may not necessarily be better,” Dr. Walsh said. She highlighted that “one’s choice of simulator should be based on the educational goals as opposed to technology, as the effectiveness of simulation depends highly on a close match between the training goals and the simulation tool.” A longstanding issue in the field of simulation relates to cost and access. Simulation will not have widespread impact unless it is accessible. “There is a need for future development of inexpensive, portable simulators targeting specific skills to help facilitate uptake of simulation across endoscopy units and training programs,” said Dr. Walsh. Other strategies to increase uptake include specific learning modules designed to complement simulators.

Although simulators are increasingly being used during training to help endoscopists develop basic endoscopic skills, Dr. Walsh focused on the gap in development of simulator devices targeting practicing endoscopists and research examining their use for training new skills within practice, preventing skills decay, and remediating performance deficits. She explained that “currently, there is a lack of evidence that simulation adoption by practicing endoscopists leads to better patient outcomes. This remains a priority area for simulation education, research, and development.” It also remains to be seen how cost-effective simulators are compared with other reaching modalities, she said. 

“The potential is certainly there, but it is essential to develop simulators targeting training for low-volume, higher stakes therapeutic techniques, emerging procedures, and techniques and advanced endoscopic procedures, and perform well-controlled studies to demonstrate their effectiveness in practice,” Dr. Walsh said. “Embedding assessments within emerging simulation technology is key as it permits identification of skills requiring further practice and can form the basis of virtual coaching employing endoscopic simulation to improve skills and outcomes.”

Simulators offer the very important advantage of giving the physician the chance to acquire skills before participating in a clinical case and allowing errors to occur in a risk-free environment, suggesting that this type of training will only grow. For example, Dr. Walsh described emerging simulation-based team training that allows endoscopy teams to practice both technical skills as well as nontechnical skills, such as communication and decision making, which may be particularly important in the event of a crisis. Gamification is also being pursued as a potential adjunct strategy to help improve engagement and skill acquisition.

Current simulators are limited in their ability to train and assess cognitive and nontechnical skills. Development of simulation-based cognitive training tools for key areas such as lesion recognition, classification, and management decision-making skills is also a promising area to pursue. Such education could be delivered via portable electronic devices and incorporate assessment and feedback to facilitate skills acquisition.

“There remains a substantial gap between the promise of many types of simulation training and objective evidence that these are helping endoscopists gain skills,” Dr. Walsh said. This in no way diminishes the enormous promise of new simulation technology to be an effective and safe approach for clinicians to learn and maintain performance of endoscopic skills, but Dr. Walsh focused on the need for the development of new simulation technologies and controlled studies that will render these approaches evidence based.

SAN FRANCISCO – The growing sophistication of simulation technology has the potential to improve training and assessment of skills in gastrointestinal endoscopy, but there are gaps between the promise and evidence, according to an overview of this form of training at the 2019 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

For endoscopy, the term simulator encompasses a broad expanse of tools that can range from a simple physical model with holes used to practice endoscope navigation skills to a complex virtual world that challenges technical skills as well as decision-making processes. In 2012, the American Society of Gastrointestinal Endoscopy (ASGE) issued a statement encouraging endoscopy simulation-based training in the context of other strategies to gain skills, but Catharine Walsh, MD, MEd, PhD, of the University of Toronto, warned of the current limits as well as the advantages of simulation training.

“There are many companies making simulators of varying price and complexity. For early skill acquisition, more expensive devices may not necessarily be better,” Dr. Walsh said. She highlighted that “one’s choice of simulator should be based on the educational goals as opposed to technology, as the effectiveness of simulation depends highly on a close match between the training goals and the simulation tool.” A longstanding issue in the field of simulation relates to cost and access. Simulation will not have widespread impact unless it is accessible. “There is a need for future development of inexpensive, portable simulators targeting specific skills to help facilitate uptake of simulation across endoscopy units and training programs,” said Dr. Walsh. Other strategies to increase uptake include specific learning modules designed to complement simulators.

Although simulators are increasingly being used during training to help endoscopists develop basic endoscopic skills, Dr. Walsh focused on the gap in development of simulator devices targeting practicing endoscopists and research examining their use for training new skills within practice, preventing skills decay, and remediating performance deficits. She explained that “currently, there is a lack of evidence that simulation adoption by practicing endoscopists leads to better patient outcomes. This remains a priority area for simulation education, research, and development.” It also remains to be seen how cost-effective simulators are compared with other reaching modalities, she said. 

“The potential is certainly there, but it is essential to develop simulators targeting training for low-volume, higher stakes therapeutic techniques, emerging procedures, and techniques and advanced endoscopic procedures, and perform well-controlled studies to demonstrate their effectiveness in practice,” Dr. Walsh said. “Embedding assessments within emerging simulation technology is key as it permits identification of skills requiring further practice and can form the basis of virtual coaching employing endoscopic simulation to improve skills and outcomes.”

Simulators offer the very important advantage of giving the physician the chance to acquire skills before participating in a clinical case and allowing errors to occur in a risk-free environment, suggesting that this type of training will only grow. For example, Dr. Walsh described emerging simulation-based team training that allows endoscopy teams to practice both technical skills as well as nontechnical skills, such as communication and decision making, which may be particularly important in the event of a crisis. Gamification is also being pursued as a potential adjunct strategy to help improve engagement and skill acquisition.

Current simulators are limited in their ability to train and assess cognitive and nontechnical skills. Development of simulation-based cognitive training tools for key areas such as lesion recognition, classification, and management decision-making skills is also a promising area to pursue. Such education could be delivered via portable electronic devices and incorporate assessment and feedback to facilitate skills acquisition.

“There remains a substantial gap between the promise of many types of simulation training and objective evidence that these are helping endoscopists gain skills,” Dr. Walsh said. This in no way diminishes the enormous promise of new simulation technology to be an effective and safe approach for clinicians to learn and maintain performance of endoscopic skills, but Dr. Walsh focused on the need for the development of new simulation technologies and controlled studies that will render these approaches evidence based.

SAN FRANCISCO – The body of evidence to support virtual reality (VR) as a therapeutic modality will increasingly involve the GI tract, according to evidence summarized at the 2019 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. Evolving from its early use in acute or chronic pain, where its function was to simply divert attention from symptoms, VR computer-generated environments are now being applied to alter patient perceptions and behavior that may involve changes in brain function, according to Brennan Spiegel, MD, AGAF, director of Health Services Research for Cedars-Sinai Medical Center, Los Angeles.

“The field of gastroenterology is a particularly promising area for treatment based on VR because of the well-established brain-gut interaction,” Dr. Spiegel explained. He said this tool has now been shown repeatedly to change how patients experience their symptoms in a variety of clinical contexts.

The field is not entirely new. Already by 2017, 11 randomized controlled trials of VR for therapeutic purposes were identified in a systematic review (Innov Clin Neurosci 2017;14:14-21). These trials, dating back to 2010, have explored this technology in depression, cognitive and motor rehabilitation, and eating disorders. Most showed significant benefit. In eating disorders, for example, response at one year was 44% in those receiving VR as an adjunct to cognitive behavioral therapy versus 10% in the controls.

“VR may not just alter perception. In studies being conducted with functional MRI imaging, changes in brain function similar to those observed in patients taking opioids have been observed,” said Dr. Spiegel, outlining objective evidence that VR has physiological effects.

VR already has an established role as a training tool for physicians in GI and other areas of medicine, but Dr. Spiegel focused on the evidence of its applications in treatment. Earlier this year, an expert panel in which he participated published a methodology for VR clinical trials to help move the field forward by defining how to establish evidence of benefit (JMIR Mental Health 2019;6:e11973). With a growing body of data suggesting VR has measurable clinical benefits, the field is poised to grow quickly.

In gastroenterology specifically, Dr. Spiegel envisions applications in functional diseases, such as irritable bowel syndrome (IBS), in which there is already strong evidence of a mind-gut component to symptom flares. He said, “VR can help patients to engage with their body differently, changing how they react to symptoms and leading to better coping mechanisms.”

In one example, Dr. Spiegel displayed a video depicting a woman with severe pain due to liver ascites testifying to substantial pain relief after a VR experience that included images that took her far from the hospital room in which she was sitting at the time. He reported that gastrointestinal pain relief is so consistent with VR that failure to respond prompts him to reevaluate patients for missed organic pathology.

Implementation of VR as a therapeutic tool is not without obstacles. For example, patients susceptible to motion sickness can react poorly to the three-dimensional environment created by VR, according to Dr. Spiegel. Many patients have expressed reluctance to try VR for any one of a number of reasons, including skepticism. However, there are many potential advantages. In the management of pain, for example, VR circumvents a long list of adverse events related to opioids or other analgesics.

This technology is only being used in a few centers, but there is enough evidence of clinical benefit that Dr. Siegel expects it to be more broadly adopted as indications expand. With more controlled trials being performed to measure and establish benefits, he envisions an evidence-based VR pharmacy that will allow clinicians to prescribe specific VR software suitable not only for the target condition but matched to patient preferences for VR environments.

“We have good evidence that VR is a powerful tool to manage mood disorders and pain perception. Although there is so far a fairly limited about of research specific to GI conditions, this is coming,” Dr. Spiegel said.

SAN FRANCISCO – The body of evidence to support virtual reality (VR) as a therapeutic modality will increasingly involve the GI tract, according to evidence summarized at the 2019 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. Evolving from its early use in acute or chronic pain, where its function was to simply divert attention from symptoms, VR computer-generated environments are now being applied to alter patient perceptions and behavior that may involve changes in brain function, according to Brennan Spiegel, MD, AGAF, director of Health Services Research for Cedars-Sinai Medical Center, Los Angeles.

“The field of gastroenterology is a particularly promising area for treatment based on VR because of the well-established brain-gut interaction,” Dr. Spiegel explained. He said this tool has now been shown repeatedly to change how patients experience their symptoms in a variety of clinical contexts.

The field is not entirely new. Already by 2017, 11 randomized controlled trials of VR for therapeutic purposes were identified in a systematic review (Innov Clin Neurosci 2017;14:14-21). These trials, dating back to 2010, have explored this technology in depression, cognitive and motor rehabilitation, and eating disorders. Most showed significant benefit. In eating disorders, for example, response at one year was 44% in those receiving VR as an adjunct to cognitive behavioral therapy versus 10% in the controls.

“VR may not just alter perception. In studies being conducted with functional MRI imaging, changes in brain function similar to those observed in patients taking opioids have been observed,” said Dr. Spiegel, outlining objective evidence that VR has physiological effects.

VR already has an established role as a training tool for physicians in GI and other areas of medicine, but Dr. Spiegel focused on the evidence of its applications in treatment. Earlier this year, an expert panel in which he participated published a methodology for VR clinical trials to help move the field forward by defining how to establish evidence of benefit (JMIR Mental Health 2019;6:e11973). With a growing body of data suggesting VR has measurable clinical benefits, the field is poised to grow quickly.

In gastroenterology specifically, Dr. Spiegel envisions applications in functional diseases, such as irritable bowel syndrome (IBS), in which there is already strong evidence of a mind-gut component to symptom flares. He said, “VR can help patients to engage with their body differently, changing how they react to symptoms and leading to better coping mechanisms.”

In one example, Dr. Spiegel displayed a video depicting a woman with severe pain due to liver ascites testifying to substantial pain relief after a VR experience that included images that took her far from the hospital room in which she was sitting at the time. He reported that gastrointestinal pain relief is so consistent with VR that failure to respond prompts him to reevaluate patients for missed organic pathology.

Implementation of VR as a therapeutic tool is not without obstacles. For example, patients susceptible to motion sickness can react poorly to the three-dimensional environment created by VR, according to Dr. Spiegel. Many patients have expressed reluctance to try VR for any one of a number of reasons, including skepticism. However, there are many potential advantages. In the management of pain, for example, VR circumvents a long list of adverse events related to opioids or other analgesics.

This technology is only being used in a few centers, but there is enough evidence of clinical benefit that Dr. Siegel expects it to be more broadly adopted as indications expand. With more controlled trials being performed to measure and establish benefits, he envisions an evidence-based VR pharmacy that will allow clinicians to prescribe specific VR software suitable not only for the target condition but matched to patient preferences for VR environments.

“We have good evidence that VR is a powerful tool to manage mood disorders and pain perception. Although there is so far a fairly limited about of research specific to GI conditions, this is coming,” Dr. Spiegel said.

SAN FRANCISCO – The body of evidence to support virtual reality (VR) as a therapeutic modality will increasingly involve the GI tract, according to evidence summarized at the 2019 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. Evolving from its early use in acute or chronic pain, where its function was to simply divert attention from symptoms, VR computer-generated environments are now being applied to alter patient perceptions and behavior that may involve changes in brain function, according to Brennan Spiegel, MD, AGAF, director of Health Services Research for Cedars-Sinai Medical Center, Los Angeles.

“The field of gastroenterology is a particularly promising area for treatment based on VR because of the well-established brain-gut interaction,” Dr. Spiegel explained. He said this tool has now been shown repeatedly to change how patients experience their symptoms in a variety of clinical contexts.

The field is not entirely new. Already by 2017, 11 randomized controlled trials of VR for therapeutic purposes were identified in a systematic review (Innov Clin Neurosci 2017;14:14-21). These trials, dating back to 2010, have explored this technology in depression, cognitive and motor rehabilitation, and eating disorders. Most showed significant benefit. In eating disorders, for example, response at one year was 44% in those receiving VR as an adjunct to cognitive behavioral therapy versus 10% in the controls.

“VR may not just alter perception. In studies being conducted with functional MRI imaging, changes in brain function similar to those observed in patients taking opioids have been observed,” said Dr. Spiegel, outlining objective evidence that VR has physiological effects.

VR already has an established role as a training tool for physicians in GI and other areas of medicine, but Dr. Spiegel focused on the evidence of its applications in treatment. Earlier this year, an expert panel in which he participated published a methodology for VR clinical trials to help move the field forward by defining how to establish evidence of benefit (JMIR Mental Health 2019;6:e11973). With a growing body of data suggesting VR has measurable clinical benefits, the field is poised to grow quickly.

In gastroenterology specifically, Dr. Spiegel envisions applications in functional diseases, such as irritable bowel syndrome (IBS), in which there is already strong evidence of a mind-gut component to symptom flares. He said, “VR can help patients to engage with their body differently, changing how they react to symptoms and leading to better coping mechanisms.”

In one example, Dr. Spiegel displayed a video depicting a woman with severe pain due to liver ascites testifying to substantial pain relief after a VR experience that included images that took her far from the hospital room in which she was sitting at the time. He reported that gastrointestinal pain relief is so consistent with VR that failure to respond prompts him to reevaluate patients for missed organic pathology.

Implementation of VR as a therapeutic tool is not without obstacles. For example, patients susceptible to motion sickness can react poorly to the three-dimensional environment created by VR, according to Dr. Spiegel. Many patients have expressed reluctance to try VR for any one of a number of reasons, including skepticism. However, there are many potential advantages. In the management of pain, for example, VR circumvents a long list of adverse events related to opioids or other analgesics.

This technology is only being used in a few centers, but there is enough evidence of clinical benefit that Dr. Siegel expects it to be more broadly adopted as indications expand. With more controlled trials being performed to measure and establish benefits, he envisions an evidence-based VR pharmacy that will allow clinicians to prescribe specific VR software suitable not only for the target condition but matched to patient preferences for VR environments.

“We have good evidence that VR is a powerful tool to manage mood disorders and pain perception. Although there is so far a fairly limited about of research specific to GI conditions, this is coming,” Dr. Spiegel said.

WASHINGTON –Although an implantable device for detecting myocardial infarction missed the primary composite outcome endpoint in a controlled trial, a newly completed extended analysis associated the device with a higher positive predictive value and a lower false positive rate when compared to sham control, according to data presented at CRT 2019, sponsored by MedStar Heart & Vascular Institute.

Ted Bosworth/MDedge News

“Among high risk patients, this system may be beneficial in the identification of both symptomatic and asymptomatic coronary events,” reported C. Michael Gibson, MD, chief of clinical research in the cardiology division at Beth Israel Deaconess Hospital, Boston.

The implantable device (AngelMed Guardian System), which received Food and Drug Administration approval in April 2018, is designed to identify MI through detection of ST-segment elevations in the absence of an elevated heart rate. When the system detects an event during continuous monitoring, it sends a signal (internal vibration and auditory signal to an external monitor) designed to tell the patient to seek medical care.

The previously published multicenter and randomized ALERTS (AngelMed for Early Recognition and Treatment of STEMI) trial that tested this device was negative for primary composite endpoint of cardiac or unexplained death, new Q-wave MI, or presentation at the emergency department (ED) more than 2 hours after symptom onset (J Am Coll Cardiol. 2019 Feb 25. pii: S0735-1097[19]30237-2). In that trial 907 patients were fitted with the device and then randomized to having the device switched on or left off.

At 7 days, a primary endpoint was reached by 3.8% of those in the device-on group versus 4.9% of those in the device-off group, which was not significantly different.

Although the primary endpoint was not met, there were promising results. For example, in those who did have an occlusive event, patients in the device-on group had better preserved left ventricular function when evaluated after the event, a result consistent with earlier presentation in the ED and earlier treatment. In fact, 85% of patients with an MI in the device-on group presented to a hospital within 2 hours, compared with just 5% of those in the device-off control group during the initial study period.

More evidence of a potential clinical role for the device has now been generated in a new extended analysis. This analysis was made possible because patients in both of the randomized groups continue to wear the device, including those in the device-off group who had their devices activated after 6 months. There are now 3 more years of data of follow-up from those initially in the device-on group and those switched from the device-off group.

“So we started the clock over with a new statistical analysis plan and new endpoints,” Dr. Gibson explained. The FDA was consulted in selecting endpoints, particularly regarding evidence that the device did not increase false-positive ED visits.

There were numerous encouraging findings. One was that 42 silent MIs, which would otherwise have been missed, were detected over the extended follow-up. Another was that the annualized false-positive rate was lower in those with an activated device (0.164/year) when compared to the original device-off group (0.678/year; P less than .001). Lastly, the positive predictive value of an alarm during the extended follow-up was higher than that of symptoms alone among the original device-off group (25.8% vs. 18.2%).

The device was found safe. The rate of system-related complications was under 4%, which Dr. Gibson said is noninferior to that associated with pacemakers.

One of the potential explanations for the failure of the device to achieve the primary endpoint in the original trial was an unexpectedly low event rate, according to Dr. Gibson.

Even before this extended analysis, the FDA had accepted the potential benefits of this device as demonstrated in the approval last year. In the labeling, the device is called “a more accurate predictor of acute coronary syndrome events when compared to patient recognized symptoms alone and demonstrates a reduced rate over time of patient presentations without ACS events.”

“About 50% of patients wait more than 3 hours after the onset of symptoms before reaching an emergency room,” observed Dr. Gibson. Emphasizing the evidence that delay is an important predictor of adverse outcomes, he suggested the alarm device might be useful in accelerating care in some high risk groups.

WASHINGTON –Although an implantable device for detecting myocardial infarction missed the primary composite outcome endpoint in a controlled trial, a newly completed extended analysis associated the device with a higher positive predictive value and a lower false positive rate when compared to sham control, according to data presented at CRT 2019, sponsored by MedStar Heart & Vascular Institute.

Ted Bosworth/MDedge News

“Among high risk patients, this system may be beneficial in the identification of both symptomatic and asymptomatic coronary events,” reported C. Michael Gibson, MD, chief of clinical research in the cardiology division at Beth Israel Deaconess Hospital, Boston.

The implantable device (AngelMed Guardian System), which received Food and Drug Administration approval in April 2018, is designed to identify MI through detection of ST-segment elevations in the absence of an elevated heart rate. When the system detects an event during continuous monitoring, it sends a signal (internal vibration and auditory signal to an external monitor) designed to tell the patient to seek medical care.

The previously published multicenter and randomized ALERTS (AngelMed for Early Recognition and Treatment of STEMI) trial that tested this device was negative for primary composite endpoint of cardiac or unexplained death, new Q-wave MI, or presentation at the emergency department (ED) more than 2 hours after symptom onset (J Am Coll Cardiol. 2019 Feb 25. pii: S0735-1097[19]30237-2). In that trial 907 patients were fitted with the device and then randomized to having the device switched on or left off.

At 7 days, a primary endpoint was reached by 3.8% of those in the device-on group versus 4.9% of those in the device-off group, which was not significantly different.

Although the primary endpoint was not met, there were promising results. For example, in those who did have an occlusive event, patients in the device-on group had better preserved left ventricular function when evaluated after the event, a result consistent with earlier presentation in the ED and earlier treatment. In fact, 85% of patients with an MI in the device-on group presented to a hospital within 2 hours, compared with just 5% of those in the device-off control group during the initial study period.

More evidence of a potential clinical role for the device has now been generated in a new extended analysis. This analysis was made possible because patients in both of the randomized groups continue to wear the device, including those in the device-off group who had their devices activated after 6 months. There are now 3 more years of data of follow-up from those initially in the device-on group and those switched from the device-off group.

“So we started the clock over with a new statistical analysis plan and new endpoints,” Dr. Gibson explained. The FDA was consulted in selecting endpoints, particularly regarding evidence that the device did not increase false-positive ED visits.

There were numerous encouraging findings. One was that 42 silent MIs, which would otherwise have been missed, were detected over the extended follow-up. Another was that the annualized false-positive rate was lower in those with an activated device (0.164/year) when compared to the original device-off group (0.678/year; P less than .001). Lastly, the positive predictive value of an alarm during the extended follow-up was higher than that of symptoms alone among the original device-off group (25.8% vs. 18.2%).

The device was found safe. The rate of system-related complications was under 4%, which Dr. Gibson said is noninferior to that associated with pacemakers.

One of the potential explanations for the failure of the device to achieve the primary endpoint in the original trial was an unexpectedly low event rate, according to Dr. Gibson.

Even before this extended analysis, the FDA had accepted the potential benefits of this device as demonstrated in the approval last year. In the labeling, the device is called “a more accurate predictor of acute coronary syndrome events when compared to patient recognized symptoms alone and demonstrates a reduced rate over time of patient presentations without ACS events.”

“About 50% of patients wait more than 3 hours after the onset of symptoms before reaching an emergency room,” observed Dr. Gibson. Emphasizing the evidence that delay is an important predictor of adverse outcomes, he suggested the alarm device might be useful in accelerating care in some high risk groups.

WASHINGTON –Although an implantable device for detecting myocardial infarction missed the primary composite outcome endpoint in a controlled trial, a newly completed extended analysis associated the device with a higher positive predictive value and a lower false positive rate when compared to sham control, according to data presented at CRT 2019, sponsored by MedStar Heart & Vascular Institute.

Ted Bosworth/MDedge News

“Among high risk patients, this system may be beneficial in the identification of both symptomatic and asymptomatic coronary events,” reported C. Michael Gibson, MD, chief of clinical research in the cardiology division at Beth Israel Deaconess Hospital, Boston.

The implantable device (AngelMed Guardian System), which received Food and Drug Administration approval in April 2018, is designed to identify MI through detection of ST-segment elevations in the absence of an elevated heart rate. When the system detects an event during continuous monitoring, it sends a signal (internal vibration and auditory signal to an external monitor) designed to tell the patient to seek medical care.

The previously published multicenter and randomized ALERTS (AngelMed for Early Recognition and Treatment of STEMI) trial that tested this device was negative for primary composite endpoint of cardiac or unexplained death, new Q-wave MI, or presentation at the emergency department (ED) more than 2 hours after symptom onset (J Am Coll Cardiol. 2019 Feb 25. pii: S0735-1097[19]30237-2). In that trial 907 patients were fitted with the device and then randomized to having the device switched on or left off.

At 7 days, a primary endpoint was reached by 3.8% of those in the device-on group versus 4.9% of those in the device-off group, which was not significantly different.

Although the primary endpoint was not met, there were promising results. For example, in those who did have an occlusive event, patients in the device-on group had better preserved left ventricular function when evaluated after the event, a result consistent with earlier presentation in the ED and earlier treatment. In fact, 85% of patients with an MI in the device-on group presented to a hospital within 2 hours, compared with just 5% of those in the device-off control group during the initial study period.

More evidence of a potential clinical role for the device has now been generated in a new extended analysis. This analysis was made possible because patients in both of the randomized groups continue to wear the device, including those in the device-off group who had their devices activated after 6 months. There are now 3 more years of data of follow-up from those initially in the device-on group and those switched from the device-off group.

“So we started the clock over with a new statistical analysis plan and new endpoints,” Dr. Gibson explained. The FDA was consulted in selecting endpoints, particularly regarding evidence that the device did not increase false-positive ED visits.

There were numerous encouraging findings. One was that 42 silent MIs, which would otherwise have been missed, were detected over the extended follow-up. Another was that the annualized false-positive rate was lower in those with an activated device (0.164/year) when compared to the original device-off group (0.678/year; P less than .001). Lastly, the positive predictive value of an alarm during the extended follow-up was higher than that of symptoms alone among the original device-off group (25.8% vs. 18.2%).

The device was found safe. The rate of system-related complications was under 4%, which Dr. Gibson said is noninferior to that associated with pacemakers.

One of the potential explanations for the failure of the device to achieve the primary endpoint in the original trial was an unexpectedly low event rate, according to Dr. Gibson.

Even before this extended analysis, the FDA had accepted the potential benefits of this device as demonstrated in the approval last year. In the labeling, the device is called “a more accurate predictor of acute coronary syndrome events when compared to patient recognized symptoms alone and demonstrates a reduced rate over time of patient presentations without ACS events.”

“About 50% of patients wait more than 3 hours after the onset of symptoms before reaching an emergency room,” observed Dr. Gibson. Emphasizing the evidence that delay is an important predictor of adverse outcomes, he suggested the alarm device might be useful in accelerating care in some high risk groups.

WASHINGTON – One transcatheter device designed to prevent left ventricular outflow tract (LVOT) obstruction relevant to transcatheter mitral valve replacement (TMVR) and another designed to prevent coronary obstruction relevant to transcatheter aortic valve replacement (TAVR) performed well in feasibility studies, according to data presented in two separate late breaking clinical trial sessions at the CRT 2019, sponsored by MedStar Heart & Vascular Institute.

LVOT obstruction prevention

“The 30-day survival in subjects with an increased risk of LVOT obstruction was significantly better than that previously reported in registries,” said Jaffar M. Khan, BM BCh, of the National Heart, Lung, and Blood Institute, who addressing results with the LAMPOON device prior to TMVR,.

LAMPOON is an acronym for intentional Laceration of the Anterior Mitral valve leaflet to Prevent LVOT ObstructioN. Introduced percutaneously and guided to the valve with wires, it was designed to tear existing mitral valve leaflets to prevent them from causing life-threatening LVOT obstruction. It is used immediately prior to TMVR in patients at risk for this complication.

In a feasibility study, delivery, deployment, and retrieval of the device was achieved in all 30 patients. On the basis of the primary endpoint of LVOT gradients of less than 50 mm Hg and no emergency surgery, the procedural success was 73%. The 30-day survival was 93%.

Citing data from registries, Dr. Khan said that the expected survival in TMVR patients with LVOT obstruction caused by a native mitral valve leaflet has been less than 40%. With few existing options to prevent this complication, none of which are reliable, LAMPOON is poised to permit patients who are poor candidates or are contraindicated for TMVR to undergo this treatment, according to Dr. Khan.

“LAMPOON is feasible in all anatomies and calcium patterns,” said Dr. Khan, who noted that gradients of less than 30 mm Hg was achieved in 29 of the 30 patients. Although Dr. Khan acknowledged that this study was small and uncontrolled, and he further cautioned that current strategies for predicting mitral valve leaflet LVOT obstruction are “imprecise,” he believes larger studies of LAMPOON are warranted based on these results.
 

Coronary artery obstruction prevention

Dr. Khan also presented data on the BASILICA device from a second feasibility study. The device is employed immediately prior to TAVR in order to prevent large aortic valve leaflets, whether native or from an existing bioprosthetic valve, from producing coronary obstruction. BASILICA is an acronym for Bioprosthetic Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction.

This device is also introduced percutaneously and uses radiofrequency ablation to split leaflets that are considered to pose a risk for coronary obstruction. Even though Dr. Khan acknowledged that there is also a lack of precision for predicting which TAVR candidates require an intervention to prevent coronary obstruction, he cited mortality rates exceeding 40% when this complication occurs.

In the feasibility study, 30 patients, of whom 80% were female, were enrolled. In half of the cases, the target for BASILICA was a native valve. The remainder was treated for risk of coronary obstruction posed by a bioprosthetic valve. Multiple comorbidities, including a high proportion with prior stroke, made those selected for enrollment poor candidates for surgery.

The BASILICA intervention was successful in 28 of the 30 participants and in 35 of the 37 leaflets treated. At 30 days, there was one death and one disabling stroke. The overall success rate of the procedure was 93%, according to Dr. Khan.

“One hundred percent of patients were discharged from the cath lab without coronary obstruction despite the high baseline risk,” Dr. Khan said. Again, larger studies are needed to validate the safety and efficacy of this approach, but Dr. Khan believes the outcomes in this study warrant expanded clinical studies.

cardnews@mdedge.com

WASHINGTON – One transcatheter device designed to prevent left ventricular outflow tract (LVOT) obstruction relevant to transcatheter mitral valve replacement (TMVR) and another designed to prevent coronary obstruction relevant to transcatheter aortic valve replacement (TAVR) performed well in feasibility studies, according to data presented in two separate late breaking clinical trial sessions at the CRT 2019, sponsored by MedStar Heart & Vascular Institute.

LVOT obstruction prevention

“The 30-day survival in subjects with an increased risk of LVOT obstruction was significantly better than that previously reported in registries,” said Jaffar M. Khan, BM BCh, of the National Heart, Lung, and Blood Institute, who addressing results with the LAMPOON device prior to TMVR,.

LAMPOON is an acronym for intentional Laceration of the Anterior Mitral valve leaflet to Prevent LVOT ObstructioN. Introduced percutaneously and guided to the valve with wires, it was designed to tear existing mitral valve leaflets to prevent them from causing life-threatening LVOT obstruction. It is used immediately prior to TMVR in patients at risk for this complication.

In a feasibility study, delivery, deployment, and retrieval of the device was achieved in all 30 patients. On the basis of the primary endpoint of LVOT gradients of less than 50 mm Hg and no emergency surgery, the procedural success was 73%. The 30-day survival was 93%.

Citing data from registries, Dr. Khan said that the expected survival in TMVR patients with LVOT obstruction caused by a native mitral valve leaflet has been less than 40%. With few existing options to prevent this complication, none of which are reliable, LAMPOON is poised to permit patients who are poor candidates or are contraindicated for TMVR to undergo this treatment, according to Dr. Khan.

“LAMPOON is feasible in all anatomies and calcium patterns,” said Dr. Khan, who noted that gradients of less than 30 mm Hg was achieved in 29 of the 30 patients. Although Dr. Khan acknowledged that this study was small and uncontrolled, and he further cautioned that current strategies for predicting mitral valve leaflet LVOT obstruction are “imprecise,” he believes larger studies of LAMPOON are warranted based on these results.
 

Coronary artery obstruction prevention

Dr. Khan also presented data on the BASILICA device from a second feasibility study. The device is employed immediately prior to TAVR in order to prevent large aortic valve leaflets, whether native or from an existing bioprosthetic valve, from producing coronary obstruction. BASILICA is an acronym for Bioprosthetic Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction.

This device is also introduced percutaneously and uses radiofrequency ablation to split leaflets that are considered to pose a risk for coronary obstruction. Even though Dr. Khan acknowledged that there is also a lack of precision for predicting which TAVR candidates require an intervention to prevent coronary obstruction, he cited mortality rates exceeding 40% when this complication occurs.

In the feasibility study, 30 patients, of whom 80% were female, were enrolled. In half of the cases, the target for BASILICA was a native valve. The remainder was treated for risk of coronary obstruction posed by a bioprosthetic valve. Multiple comorbidities, including a high proportion with prior stroke, made those selected for enrollment poor candidates for surgery.

The BASILICA intervention was successful in 28 of the 30 participants and in 35 of the 37 leaflets treated. At 30 days, there was one death and one disabling stroke. The overall success rate of the procedure was 93%, according to Dr. Khan.

“One hundred percent of patients were discharged from the cath lab without coronary obstruction despite the high baseline risk,” Dr. Khan said. Again, larger studies are needed to validate the safety and efficacy of this approach, but Dr. Khan believes the outcomes in this study warrant expanded clinical studies.

cardnews@mdedge.com

WASHINGTON – One transcatheter device designed to prevent left ventricular outflow tract (LVOT) obstruction relevant to transcatheter mitral valve replacement (TMVR) and another designed to prevent coronary obstruction relevant to transcatheter aortic valve replacement (TAVR) performed well in feasibility studies, according to data presented in two separate late breaking clinical trial sessions at the CRT 2019, sponsored by MedStar Heart & Vascular Institute.

LVOT obstruction prevention

“The 30-day survival in subjects with an increased risk of LVOT obstruction was significantly better than that previously reported in registries,” said Jaffar M. Khan, BM BCh, of the National Heart, Lung, and Blood Institute, who addressing results with the LAMPOON device prior to TMVR,.

LAMPOON is an acronym for intentional Laceration of the Anterior Mitral valve leaflet to Prevent LVOT ObstructioN. Introduced percutaneously and guided to the valve with wires, it was designed to tear existing mitral valve leaflets to prevent them from causing life-threatening LVOT obstruction. It is used immediately prior to TMVR in patients at risk for this complication.

In a feasibility study, delivery, deployment, and retrieval of the device was achieved in all 30 patients. On the basis of the primary endpoint of LVOT gradients of less than 50 mm Hg and no emergency surgery, the procedural success was 73%. The 30-day survival was 93%.

Citing data from registries, Dr. Khan said that the expected survival in TMVR patients with LVOT obstruction caused by a native mitral valve leaflet has been less than 40%. With few existing options to prevent this complication, none of which are reliable, LAMPOON is poised to permit patients who are poor candidates or are contraindicated for TMVR to undergo this treatment, according to Dr. Khan.

“LAMPOON is feasible in all anatomies and calcium patterns,” said Dr. Khan, who noted that gradients of less than 30 mm Hg was achieved in 29 of the 30 patients. Although Dr. Khan acknowledged that this study was small and uncontrolled, and he further cautioned that current strategies for predicting mitral valve leaflet LVOT obstruction are “imprecise,” he believes larger studies of LAMPOON are warranted based on these results.
 

Coronary artery obstruction prevention

Dr. Khan also presented data on the BASILICA device from a second feasibility study. The device is employed immediately prior to TAVR in order to prevent large aortic valve leaflets, whether native or from an existing bioprosthetic valve, from producing coronary obstruction. BASILICA is an acronym for Bioprosthetic Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction.

This device is also introduced percutaneously and uses radiofrequency ablation to split leaflets that are considered to pose a risk for coronary obstruction. Even though Dr. Khan acknowledged that there is also a lack of precision for predicting which TAVR candidates require an intervention to prevent coronary obstruction, he cited mortality rates exceeding 40% when this complication occurs.

In the feasibility study, 30 patients, of whom 80% were female, were enrolled. In half of the cases, the target for BASILICA was a native valve. The remainder was treated for risk of coronary obstruction posed by a bioprosthetic valve. Multiple comorbidities, including a high proportion with prior stroke, made those selected for enrollment poor candidates for surgery.

The BASILICA intervention was successful in 28 of the 30 participants and in 35 of the 37 leaflets treated. At 30 days, there was one death and one disabling stroke. The overall success rate of the procedure was 93%, according to Dr. Khan.

“One hundred percent of patients were discharged from the cath lab without coronary obstruction despite the high baseline risk,” Dr. Khan said. Again, larger studies are needed to validate the safety and efficacy of this approach, but Dr. Khan believes the outcomes in this study warrant expanded clinical studies.

cardnews@mdedge.com

NEW ORLEANS – In a large community-based study that evaluated sex hormone levels in older men, higher levels of estradiol correlated strongly with longer telomere length, a measure of biologic age, suggesting that sex hormones influence the aging process.

“There was a large effect size, comparable with being 2 or 3 years younger for those with relatively high levels of estradiol, compared with those with lower levels of the hormone,” said Bu Yeap, MBBS, PhD, professor of medicine, University of Western Australia Medical School, Perth, who reported the results at the annual meeting of the Endocrine Society.

In a video interview conducted at the meeting, Dr. Yeap explained the basis of the study, which is the variety of evidence showing that decline in sex hormones correlates with higher rates of age-related disease processes. For example, increasing rates of cardiovascular disease, dementia, and mortality in men all correlate with declining levels of testosterone.

In the study, 2,913 men between the ages of 70 and 89 years and living in the community were recruited. The average age of the men was 77 years. Serum levels of testosterone, dihydrotestosterone, and estradiol were measured. Telomere length was calculated with a polymerase chain reaction test.

Serum levels of testosterone and dihydrotestosterone did not correlate with telomere length, but incremental increases in serum estradiol levels were associated with incremental increases in telomere length.

“Telomeres are both a mediator and a biomarker for biological aging,” according to Dr. Yeap, who added that the telomeres protect chromosomes from degradation. As the telomeres shorten, cell senescence is increased along with an array of age-related diseases.

The next step for researchers is to evaluate whether administering exogenous sex hormones can favorably alter telomere length. If such an effect is demonstrated, then it could provide a step toward understanding how to slow the aging process, he said.

Dr Yeap and his colleagues reported no disclosures or financial conflicts of interest.

Vidyard Video

NEW ORLEANS – In a large community-based study that evaluated sex hormone levels in older men, higher levels of estradiol correlated strongly with longer telomere length, a measure of biologic age, suggesting that sex hormones influence the aging process.

“There was a large effect size, comparable with being 2 or 3 years younger for those with relatively high levels of estradiol, compared with those with lower levels of the hormone,” said Bu Yeap, MBBS, PhD, professor of medicine, University of Western Australia Medical School, Perth, who reported the results at the annual meeting of the Endocrine Society.

In a video interview conducted at the meeting, Dr. Yeap explained the basis of the study, which is the variety of evidence showing that decline in sex hormones correlates with higher rates of age-related disease processes. For example, increasing rates of cardiovascular disease, dementia, and mortality in men all correlate with declining levels of testosterone.

In the study, 2,913 men between the ages of 70 and 89 years and living in the community were recruited. The average age of the men was 77 years. Serum levels of testosterone, dihydrotestosterone, and estradiol were measured. Telomere length was calculated with a polymerase chain reaction test.

Serum levels of testosterone and dihydrotestosterone did not correlate with telomere length, but incremental increases in serum estradiol levels were associated with incremental increases in telomere length.

“Telomeres are both a mediator and a biomarker for biological aging,” according to Dr. Yeap, who added that the telomeres protect chromosomes from degradation. As the telomeres shorten, cell senescence is increased along with an array of age-related diseases.

The next step for researchers is to evaluate whether administering exogenous sex hormones can favorably alter telomere length. If such an effect is demonstrated, then it could provide a step toward understanding how to slow the aging process, he said.

Dr Yeap and his colleagues reported no disclosures or financial conflicts of interest.

Vidyard Video

NEW ORLEANS – In a large community-based study that evaluated sex hormone levels in older men, higher levels of estradiol correlated strongly with longer telomere length, a measure of biologic age, suggesting that sex hormones influence the aging process.

“There was a large effect size, comparable with being 2 or 3 years younger for those with relatively high levels of estradiol, compared with those with lower levels of the hormone,” said Bu Yeap, MBBS, PhD, professor of medicine, University of Western Australia Medical School, Perth, who reported the results at the annual meeting of the Endocrine Society.

In a video interview conducted at the meeting, Dr. Yeap explained the basis of the study, which is the variety of evidence showing that decline in sex hormones correlates with higher rates of age-related disease processes. For example, increasing rates of cardiovascular disease, dementia, and mortality in men all correlate with declining levels of testosterone.

In the study, 2,913 men between the ages of 70 and 89 years and living in the community were recruited. The average age of the men was 77 years. Serum levels of testosterone, dihydrotestosterone, and estradiol were measured. Telomere length was calculated with a polymerase chain reaction test.

Serum levels of testosterone and dihydrotestosterone did not correlate with telomere length, but incremental increases in serum estradiol levels were associated with incremental increases in telomere length.

“Telomeres are both a mediator and a biomarker for biological aging,” according to Dr. Yeap, who added that the telomeres protect chromosomes from degradation. As the telomeres shorten, cell senescence is increased along with an array of age-related diseases.

The next step for researchers is to evaluate whether administering exogenous sex hormones can favorably alter telomere length. If such an effect is demonstrated, then it could provide a step toward understanding how to slow the aging process, he said.

Dr Yeap and his colleagues reported no disclosures or financial conflicts of interest.

Vidyard Video

WASHINGTON – In the latest analysis of data from a randomized trial comparing three different thin polymer-coated drug-eluting stents, the signal at 1 year that the thinnest device might reduce risk of target lesion revascularization has been lost at 3 years, according to an update of results from the BIO-RESORT trial presented at CRT 2019 sponsored by MedStar Heart & Vascular Institute.

Ted Bosworth/MDedge News

“At 3-year follow-up, all three drug-eluting stents were associated with favorable outcomes and both very thin strut polymer-coated devices showed safety and patency similar to the thin-strut durable polymer drug-eluting stent,” reported Clemons von Birgelen, MD, PhD, professor of cardiology, University of Twente, Enschede, the Netherlands.

In order of strut thickness, the stents tested in BIO-RESORT were Orsiro (60 mcm), Synergy (74 mcm), and Resolute Integrity (90 mcm). Although the study had a noninferiority design, the potential for the biodegradable polymer coatings of the two thinner stents to provide faster healing than the durable polymer of the Resolute stent was one of the driving hypotheses of the trial (Lancet. 2016 Nov 26;388[10060]:2607-17).

Some support for this hypothesis was provided by 2-year results presented at EuroPCR 2018 last year. At that time, it was reported that the risk of target lesion revascularization between the end of year 1 and end of year 2 was significantly lower for the Orsiro stent (1.3%) than the Resolute stent (2.3%). Target lesion revascularization also was lower in the Synergy stent group (1.8%), but this rate did not differ significantly from that of the other two stents in the trial.

Now, reassessed at 3 years, the target lesion revascularization rates are 2.9%, 3.3%, and 3.8% for the Orsiro, Synergy, and Resolute stents, respectively. Although the numerical hierarchy is preserved, the differences are no longer significant.

Other outcomes, including the primary outcome of target lesion failure, show the same numerical hierarchy but, again, without differences reaching significance. For target lesion failure, these rates are 8.5%, 8.8%, and 10.0%, respectively.

The difference in the rates of stent thrombosis at 3 years was even smaller with rates of less than 1% for all three stents. A catch-up phenomenon between years 2 and 3 of follow-up largely eliminated a numerical advantage seen earlier for the Orsiro stent.

The BIO-RESORT trial randomized 3,514 patients, of whom 70% had an acute coronary syndrome. Nearly one-third had an ST-elevated myocardial infarction. Dr. von Birgelen emphasized that this was “a very complex study population.” For example, roughly 20% had severely calcified lesions. Follow-up data were available on 97% of the randomized patients at 3 years.

There are differences between these stents other than thickness and the durability of the polymer. In particular, Orsiro is coated with sirolimus, Synergy with everolimus, and Resolute with zotarolimus. While the metals of the frame also differ, the estimated time to resorption of the polymer is faster with the Synergy stent (4 months) than the Orsiro stent (24 months).

Despite the loss of a difference in target vessel revascularization in the most recent follow-up, the potential for the differences in designs and materials to influence risk of late complications, including revascularization and thrombosis, persists.

“Follow-up beyond 3 years is of interest to definitely answer the question of whether one of these drug-eluting stents might improve outcome at a later stage,” Dr. von Birgelen said.

WASHINGTON – In the latest analysis of data from a randomized trial comparing three different thin polymer-coated drug-eluting stents, the signal at 1 year that the thinnest device might reduce risk of target lesion revascularization has been lost at 3 years, according to an update of results from the BIO-RESORT trial presented at CRT 2019 sponsored by MedStar Heart & Vascular Institute.

Ted Bosworth/MDedge News

“At 3-year follow-up, all three drug-eluting stents were associated with favorable outcomes and both very thin strut polymer-coated devices showed safety and patency similar to the thin-strut durable polymer drug-eluting stent,” reported Clemons von Birgelen, MD, PhD, professor of cardiology, University of Twente, Enschede, the Netherlands.

In order of strut thickness, the stents tested in BIO-RESORT were Orsiro (60 mcm), Synergy (74 mcm), and Resolute Integrity (90 mcm). Although the study had a noninferiority design, the potential for the biodegradable polymer coatings of the two thinner stents to provide faster healing than the durable polymer of the Resolute stent was one of the driving hypotheses of the trial (Lancet. 2016 Nov 26;388[10060]:2607-17).

Some support for this hypothesis was provided by 2-year results presented at EuroPCR 2018 last year. At that time, it was reported that the risk of target lesion revascularization between the end of year 1 and end of year 2 was significantly lower for the Orsiro stent (1.3%) than the Resolute stent (2.3%). Target lesion revascularization also was lower in the Synergy stent group (1.8%), but this rate did not differ significantly from that of the other two stents in the trial.

Now, reassessed at 3 years, the target lesion revascularization rates are 2.9%, 3.3%, and 3.8% for the Orsiro, Synergy, and Resolute stents, respectively. Although the numerical hierarchy is preserved, the differences are no longer significant.

Other outcomes, including the primary outcome of target lesion failure, show the same numerical hierarchy but, again, without differences reaching significance. For target lesion failure, these rates are 8.5%, 8.8%, and 10.0%, respectively.

The difference in the rates of stent thrombosis at 3 years was even smaller with rates of less than 1% for all three stents. A catch-up phenomenon between years 2 and 3 of follow-up largely eliminated a numerical advantage seen earlier for the Orsiro stent.

The BIO-RESORT trial randomized 3,514 patients, of whom 70% had an acute coronary syndrome. Nearly one-third had an ST-elevated myocardial infarction. Dr. von Birgelen emphasized that this was “a very complex study population.” For example, roughly 20% had severely calcified lesions. Follow-up data were available on 97% of the randomized patients at 3 years.

There are differences between these stents other than thickness and the durability of the polymer. In particular, Orsiro is coated with sirolimus, Synergy with everolimus, and Resolute with zotarolimus. While the metals of the frame also differ, the estimated time to resorption of the polymer is faster with the Synergy stent (4 months) than the Orsiro stent (24 months).

Despite the loss of a difference in target vessel revascularization in the most recent follow-up, the potential for the differences in designs and materials to influence risk of late complications, including revascularization and thrombosis, persists.

“Follow-up beyond 3 years is of interest to definitely answer the question of whether one of these drug-eluting stents might improve outcome at a later stage,” Dr. von Birgelen said.

WASHINGTON – In the latest analysis of data from a randomized trial comparing three different thin polymer-coated drug-eluting stents, the signal at 1 year that the thinnest device might reduce risk of target lesion revascularization has been lost at 3 years, according to an update of results from the BIO-RESORT trial presented at CRT 2019 sponsored by MedStar Heart & Vascular Institute.

Ted Bosworth/MDedge News

“At 3-year follow-up, all three drug-eluting stents were associated with favorable outcomes and both very thin strut polymer-coated devices showed safety and patency similar to the thin-strut durable polymer drug-eluting stent,” reported Clemons von Birgelen, MD, PhD, professor of cardiology, University of Twente, Enschede, the Netherlands.

In order of strut thickness, the stents tested in BIO-RESORT were Orsiro (60 mcm), Synergy (74 mcm), and Resolute Integrity (90 mcm). Although the study had a noninferiority design, the potential for the biodegradable polymer coatings of the two thinner stents to provide faster healing than the durable polymer of the Resolute stent was one of the driving hypotheses of the trial (Lancet. 2016 Nov 26;388[10060]:2607-17).

Some support for this hypothesis was provided by 2-year results presented at EuroPCR 2018 last year. At that time, it was reported that the risk of target lesion revascularization between the end of year 1 and end of year 2 was significantly lower for the Orsiro stent (1.3%) than the Resolute stent (2.3%). Target lesion revascularization also was lower in the Synergy stent group (1.8%), but this rate did not differ significantly from that of the other two stents in the trial.

Now, reassessed at 3 years, the target lesion revascularization rates are 2.9%, 3.3%, and 3.8% for the Orsiro, Synergy, and Resolute stents, respectively. Although the numerical hierarchy is preserved, the differences are no longer significant.

Other outcomes, including the primary outcome of target lesion failure, show the same numerical hierarchy but, again, without differences reaching significance. For target lesion failure, these rates are 8.5%, 8.8%, and 10.0%, respectively.

The difference in the rates of stent thrombosis at 3 years was even smaller with rates of less than 1% for all three stents. A catch-up phenomenon between years 2 and 3 of follow-up largely eliminated a numerical advantage seen earlier for the Orsiro stent.

The BIO-RESORT trial randomized 3,514 patients, of whom 70% had an acute coronary syndrome. Nearly one-third had an ST-elevated myocardial infarction. Dr. von Birgelen emphasized that this was “a very complex study population.” For example, roughly 20% had severely calcified lesions. Follow-up data were available on 97% of the randomized patients at 3 years.

There are differences between these stents other than thickness and the durability of the polymer. In particular, Orsiro is coated with sirolimus, Synergy with everolimus, and Resolute with zotarolimus. While the metals of the frame also differ, the estimated time to resorption of the polymer is faster with the Synergy stent (4 months) than the Orsiro stent (24 months).

Despite the loss of a difference in target vessel revascularization in the most recent follow-up, the potential for the differences in designs and materials to influence risk of late complications, including revascularization and thrombosis, persists.

“Follow-up beyond 3 years is of interest to definitely answer the question of whether one of these drug-eluting stents might improve outcome at a later stage,” Dr. von Birgelen said.

NEW ORLEANS – When HIV-negative children born to mothers infected with HIV are evaluated in adolescence, they are found to have far higher rates of obesity and reactive airway disease than are those with no such exposure, according to research that provides a compelling link between inflammatory activity in utero and subsequent risk of metabolic disorders.

Most supportive of that link was a near-linear inverse relationship between CD4 counts during the time of pregnancy and risk of both obesity and reactive respiratory disease more than a decade later, according to research presented by Lindsay Fourman, MD, an instructor in medicine at Massachusetts General Hospital, Boston, during the annual meeting of the Endocrine Society.

In this video interview, Dr. Fourman discusses the effort to understand the long-term health consequences of being exposed to HIV and antiretroviral therapies while in utero, a group known by the acronym HIV-exposed uninfected (HEU). With effective therapies now routinely preventing mother-to-child transmission, this population of children is growing quickly.

For this study, 50 HEU individuals were identified from a patient database. They were matched in a 3:1 ratio to a control group for a variety of demographic and socioeconomic variables. At a median age of 18 years, the HEU population was found to have a “strikingly” higher rate of obesity, compared with controls (42% vs. 25%, respectively; P = .04). The rate of reactive airway disease was similarly increased in the HEU group (40% vs. 24%; P = .04).

These data are important for considering health risks in an HEU population, but Dr. Fourman explained that it provides support for looking at metabolic risks from other in utero exposures linked to upregulated inflammation, such as gestational diabetes or obesity.

Dr Fourman and her colleagues reported no disclosures or financial conflicts of interest.

SOURCE: Fourman L et al. ENDO 2019, Session P10 (SAT-256).

NEW ORLEANS – When HIV-negative children born to mothers infected with HIV are evaluated in adolescence, they are found to have far higher rates of obesity and reactive airway disease than are those with no such exposure, according to research that provides a compelling link between inflammatory activity in utero and subsequent risk of metabolic disorders.

Most supportive of that link was a near-linear inverse relationship between CD4 counts during the time of pregnancy and risk of both obesity and reactive respiratory disease more than a decade later, according to research presented by Lindsay Fourman, MD, an instructor in medicine at Massachusetts General Hospital, Boston, during the annual meeting of the Endocrine Society.

In this video interview, Dr. Fourman discusses the effort to understand the long-term health consequences of being exposed to HIV and antiretroviral therapies while in utero, a group known by the acronym HIV-exposed uninfected (HEU). With effective therapies now routinely preventing mother-to-child transmission, this population of children is growing quickly.

For this study, 50 HEU individuals were identified from a patient database. They were matched in a 3:1 ratio to a control group for a variety of demographic and socioeconomic variables. At a median age of 18 years, the HEU population was found to have a “strikingly” higher rate of obesity, compared with controls (42% vs. 25%, respectively; P = .04). The rate of reactive airway disease was similarly increased in the HEU group (40% vs. 24%; P = .04).

These data are important for considering health risks in an HEU population, but Dr. Fourman explained that it provides support for looking at metabolic risks from other in utero exposures linked to upregulated inflammation, such as gestational diabetes or obesity.

Dr Fourman and her colleagues reported no disclosures or financial conflicts of interest.

SOURCE: Fourman L et al. ENDO 2019, Session P10 (SAT-256).

NEW ORLEANS – When HIV-negative children born to mothers infected with HIV are evaluated in adolescence, they are found to have far higher rates of obesity and reactive airway disease than are those with no such exposure, according to research that provides a compelling link between inflammatory activity in utero and subsequent risk of metabolic disorders.

Most supportive of that link was a near-linear inverse relationship between CD4 counts during the time of pregnancy and risk of both obesity and reactive respiratory disease more than a decade later, according to research presented by Lindsay Fourman, MD, an instructor in medicine at Massachusetts General Hospital, Boston, during the annual meeting of the Endocrine Society.

In this video interview, Dr. Fourman discusses the effort to understand the long-term health consequences of being exposed to HIV and antiretroviral therapies while in utero, a group known by the acronym HIV-exposed uninfected (HEU). With effective therapies now routinely preventing mother-to-child transmission, this population of children is growing quickly.

For this study, 50 HEU individuals were identified from a patient database. They were matched in a 3:1 ratio to a control group for a variety of demographic and socioeconomic variables. At a median age of 18 years, the HEU population was found to have a “strikingly” higher rate of obesity, compared with controls (42% vs. 25%, respectively; P = .04). The rate of reactive airway disease was similarly increased in the HEU group (40% vs. 24%; P = .04).

These data are important for considering health risks in an HEU population, but Dr. Fourman explained that it provides support for looking at metabolic risks from other in utero exposures linked to upregulated inflammation, such as gestational diabetes or obesity.

Dr Fourman and her colleagues reported no disclosures or financial conflicts of interest.

SOURCE: Fourman L et al. ENDO 2019, Session P10 (SAT-256).

WASHINGTON – Of patients with ST-elevation MI (STEMI) complicated by cardiogenic shock, 13% are readmitted within 30 days and remain in hospital for an average of 6 days, according to an analysis from the National Readmission Database presented at CRT 2019 sponsored by MedStar Heart & Vascular Institute.

“About one in four of the readmissions was for heart failure,” reported Karan Sud, MD, a cardiology resident at the Mount Sinai St. Luke’s West Hospital, New York.

Despite gains in acute survival among STEMI patients in cardiogenic shock, little attention has been paid to the risk of readmissions, according to Dr. Sud. According to data collected from the National Readmissions Database for 2010-2014, these rates are high enough to deserve attention, he said.
 

“Our goal is now to develop a scoring system based on our predictive model to identify patients at the index admission who are at risk for readmission,” Dr. Sud reported. On the basis of these predictors, it might be possible to implement strategies to optimize management and improve access to care.

In the years studied, there were 94,991 patients with STEMI and cardiogenic shock captured in the National Readmissions Database, of whom 43,205 survived and were followed for readmission. Of the 5,503 readmissions within 30 days, 12% were considered unplanned.

Half of the readmissions were for noncardiovascular causes, including sepsis, respiratory failure, and major bleeding. Of those related to cardiovascular disease, about half, or nearly 25% of the total, were for heart failure.

The predictors of readmission included female sex, age older than 75 years, average length of stay longer than 10 days, and more than three comorbidities, such as diabetes or chronic kidney disease, according to Dr. Sud.

“Those sent home from the index admission were more likely than those discharged to an extended care facility to be readmitted,” he added. He also noted that lower socioeconomic status was a risk factor for readmission, a phenomenon that he attributed to access issues regarding follow-up care.

“We are now conducting a prospective study to look at readmissions at 6 months,” reported Dr. Sud, who believes that efforts to understand the risk of readmission following STEMI complicated by cardiogenic shock might uncover opportunities for better management.

WASHINGTON – Of patients with ST-elevation MI (STEMI) complicated by cardiogenic shock, 13% are readmitted within 30 days and remain in hospital for an average of 6 days, according to an analysis from the National Readmission Database presented at CRT 2019 sponsored by MedStar Heart & Vascular Institute.

“About one in four of the readmissions was for heart failure,” reported Karan Sud, MD, a cardiology resident at the Mount Sinai St. Luke’s West Hospital, New York.

Despite gains in acute survival among STEMI patients in cardiogenic shock, little attention has been paid to the risk of readmissions, according to Dr. Sud. According to data collected from the National Readmissions Database for 2010-2014, these rates are high enough to deserve attention, he said.
 

“Our goal is now to develop a scoring system based on our predictive model to identify patients at the index admission who are at risk for readmission,” Dr. Sud reported. On the basis of these predictors, it might be possible to implement strategies to optimize management and improve access to care.

In the years studied, there were 94,991 patients with STEMI and cardiogenic shock captured in the National Readmissions Database, of whom 43,205 survived and were followed for readmission. Of the 5,503 readmissions within 30 days, 12% were considered unplanned.

Half of the readmissions were for noncardiovascular causes, including sepsis, respiratory failure, and major bleeding. Of those related to cardiovascular disease, about half, or nearly 25% of the total, were for heart failure.

The predictors of readmission included female sex, age older than 75 years, average length of stay longer than 10 days, and more than three comorbidities, such as diabetes or chronic kidney disease, according to Dr. Sud.

“Those sent home from the index admission were more likely than those discharged to an extended care facility to be readmitted,” he added. He also noted that lower socioeconomic status was a risk factor for readmission, a phenomenon that he attributed to access issues regarding follow-up care.

“We are now conducting a prospective study to look at readmissions at 6 months,” reported Dr. Sud, who believes that efforts to understand the risk of readmission following STEMI complicated by cardiogenic shock might uncover opportunities for better management.

WASHINGTON – Of patients with ST-elevation MI (STEMI) complicated by cardiogenic shock, 13% are readmitted within 30 days and remain in hospital for an average of 6 days, according to an analysis from the National Readmission Database presented at CRT 2019 sponsored by MedStar Heart & Vascular Institute.

“About one in four of the readmissions was for heart failure,” reported Karan Sud, MD, a cardiology resident at the Mount Sinai St. Luke’s West Hospital, New York.

Despite gains in acute survival among STEMI patients in cardiogenic shock, little attention has been paid to the risk of readmissions, according to Dr. Sud. According to data collected from the National Readmissions Database for 2010-2014, these rates are high enough to deserve attention, he said.
 

“Our goal is now to develop a scoring system based on our predictive model to identify patients at the index admission who are at risk for readmission,” Dr. Sud reported. On the basis of these predictors, it might be possible to implement strategies to optimize management and improve access to care.

In the years studied, there were 94,991 patients with STEMI and cardiogenic shock captured in the National Readmissions Database, of whom 43,205 survived and were followed for readmission. Of the 5,503 readmissions within 30 days, 12% were considered unplanned.

Half of the readmissions were for noncardiovascular causes, including sepsis, respiratory failure, and major bleeding. Of those related to cardiovascular disease, about half, or nearly 25% of the total, were for heart failure.

The predictors of readmission included female sex, age older than 75 years, average length of stay longer than 10 days, and more than three comorbidities, such as diabetes or chronic kidney disease, according to Dr. Sud.

“Those sent home from the index admission were more likely than those discharged to an extended care facility to be readmitted,” he added. He also noted that lower socioeconomic status was a risk factor for readmission, a phenomenon that he attributed to access issues regarding follow-up care.

“We are now conducting a prospective study to look at readmissions at 6 months,” reported Dr. Sud, who believes that efforts to understand the risk of readmission following STEMI complicated by cardiogenic shock might uncover opportunities for better management.

NEW ORLEANS – Couples with recurrent pregnancy loss (RPL) might benefit from seminal parameter testing, based on results from a study presented at the annual meeting of the Endocrine Society.

Sperm quality was more likely to be impaired in the 50 male partners of women with recurrent pregnancy loss than it was in a control group of 63 similar-age men, reported Anastasia P. Dimakopoulou, MBBS, a clinical research fellow at Imperial College, London.

Recurrent pregnancy loss is defined as three pregnancy losses before 20 weeks of gestation.

The reported prevalence of RPL has been estimated at less than 2% in couples attempting pregnancy. About half of those cases are considered to be idiopathic, she said.

Sperm DNA plays a role in placentation, and previous study findings have shown that men in RPL couples are more likely to have higher rates of DNA fragmentation in their sperm. Male partners are not routinely evaluated when seeking a cause for RPL, however.

In this study, 50 men from RPL couples and 63 control men were screened for factors known to affect sperm quality, such as previous testicular surgery, sexually transmitted diseases, alcohol intake, and smoking. In patients and controls, semen reactive oxidative stress, a novel biomarker of sperm function, was measured with a chemiluminescence luminol assay.

The proportion of men with abnormal sperm morphology, although modest in both groups, was significantly more common in men from RPL couples than in controls (4.5% vs. 3.4%, respectively; P less than .001). In addition, the mean reactive oxidative stress levels were four times greater in the RPL men (9.3 vs. 2.3 relative light units/sec per 10⁶ sperm; P less than .05).

Consistent with the higher median reactive oxidative stress levels, the median DNA fragmentation index, which is likely to be linked to increased reactive oxidative stress, was more than twice as high in the RPL men, compared with the controls (16.3 vs. 7.4; P less than .0001).

In addition, the sperm volume was significantly lower in men from the RPL couples, compared with controls. The levels of morning serum testosterone also were lower in men from RPL couples, but the difference did not reach significance relative to controls.

There has been relatively little attention directed toward the male partner in the evaluation and treatment of RPL, but that should change, according to Dr. Dimakopoulou. She said data encourage a new direction of study, including the effort to look for treatable causes of RPL in the male partner.

“By pursuing drugs that stop sperm DNA damage, it may be possible to identify new therapeutic pathways for couples who experience RPL,” Dr. Dimakopoulou maintained. However, even in advance of targeted therapies, she suggested these data encourage investigation of male partners in couples with RPL. Although evidence of reactive oxidative stress may not define a cause, it broadens the scope of investigation and might have value when counseling patients.

Dr. Dimakopoulou reported no relevant financial relationships to disclose.

SOURCE: Dimakopoulou AP et al. ENDO 2019, Session OR18-5.

NEW ORLEANS – Couples with recurrent pregnancy loss (RPL) might benefit from seminal parameter testing, based on results from a study presented at the annual meeting of the Endocrine Society.

Sperm quality was more likely to be impaired in the 50 male partners of women with recurrent pregnancy loss than it was in a control group of 63 similar-age men, reported Anastasia P. Dimakopoulou, MBBS, a clinical research fellow at Imperial College, London.

Recurrent pregnancy loss is defined as three pregnancy losses before 20 weeks of gestation.

The reported prevalence of RPL has been estimated at less than 2% in couples attempting pregnancy. About half of those cases are considered to be idiopathic, she said.

Sperm DNA plays a role in placentation, and previous study findings have shown that men in RPL couples are more likely to have higher rates of DNA fragmentation in their sperm. Male partners are not routinely evaluated when seeking a cause for RPL, however.

In this study, 50 men from RPL couples and 63 control men were screened for factors known to affect sperm quality, such as previous testicular surgery, sexually transmitted diseases, alcohol intake, and smoking. In patients and controls, semen reactive oxidative stress, a novel biomarker of sperm function, was measured with a chemiluminescence luminol assay.

The proportion of men with abnormal sperm morphology, although modest in both groups, was significantly more common in men from RPL couples than in controls (4.5% vs. 3.4%, respectively; P less than .001). In addition, the mean reactive oxidative stress levels were four times greater in the RPL men (9.3 vs. 2.3 relative light units/sec per 10⁶ sperm; P less than .05).

Consistent with the higher median reactive oxidative stress levels, the median DNA fragmentation index, which is likely to be linked to increased reactive oxidative stress, was more than twice as high in the RPL men, compared with the controls (16.3 vs. 7.4; P less than .0001).

In addition, the sperm volume was significantly lower in men from the RPL couples, compared with controls. The levels of morning serum testosterone also were lower in men from RPL couples, but the difference did not reach significance relative to controls.

There has been relatively little attention directed toward the male partner in the evaluation and treatment of RPL, but that should change, according to Dr. Dimakopoulou. She said data encourage a new direction of study, including the effort to look for treatable causes of RPL in the male partner.

“By pursuing drugs that stop sperm DNA damage, it may be possible to identify new therapeutic pathways for couples who experience RPL,” Dr. Dimakopoulou maintained. However, even in advance of targeted therapies, she suggested these data encourage investigation of male partners in couples with RPL. Although evidence of reactive oxidative stress may not define a cause, it broadens the scope of investigation and might have value when counseling patients.

Dr. Dimakopoulou reported no relevant financial relationships to disclose.

SOURCE: Dimakopoulou AP et al. ENDO 2019, Session OR18-5.

NEW ORLEANS – Couples with recurrent pregnancy loss (RPL) might benefit from seminal parameter testing, based on results from a study presented at the annual meeting of the Endocrine Society.

Sperm quality was more likely to be impaired in the 50 male partners of women with recurrent pregnancy loss than it was in a control group of 63 similar-age men, reported Anastasia P. Dimakopoulou, MBBS, a clinical research fellow at Imperial College, London.

Recurrent pregnancy loss is defined as three pregnancy losses before 20 weeks of gestation.

The reported prevalence of RPL has been estimated at less than 2% in couples attempting pregnancy. About half of those cases are considered to be idiopathic, she said.

Sperm DNA plays a role in placentation, and previous study findings have shown that men in RPL couples are more likely to have higher rates of DNA fragmentation in their sperm. Male partners are not routinely evaluated when seeking a cause for RPL, however.

In this study, 50 men from RPL couples and 63 control men were screened for factors known to affect sperm quality, such as previous testicular surgery, sexually transmitted diseases, alcohol intake, and smoking. In patients and controls, semen reactive oxidative stress, a novel biomarker of sperm function, was measured with a chemiluminescence luminol assay.

The proportion of men with abnormal sperm morphology, although modest in both groups, was significantly more common in men from RPL couples than in controls (4.5% vs. 3.4%, respectively; P less than .001). In addition, the mean reactive oxidative stress levels were four times greater in the RPL men (9.3 vs. 2.3 relative light units/sec per 10⁶ sperm; P less than .05).

Consistent with the higher median reactive oxidative stress levels, the median DNA fragmentation index, which is likely to be linked to increased reactive oxidative stress, was more than twice as high in the RPL men, compared with the controls (16.3 vs. 7.4; P less than .0001).

In addition, the sperm volume was significantly lower in men from the RPL couples, compared with controls. The levels of morning serum testosterone also were lower in men from RPL couples, but the difference did not reach significance relative to controls.

There has been relatively little attention directed toward the male partner in the evaluation and treatment of RPL, but that should change, according to Dr. Dimakopoulou. She said data encourage a new direction of study, including the effort to look for treatable causes of RPL in the male partner.

“By pursuing drugs that stop sperm DNA damage, it may be possible to identify new therapeutic pathways for couples who experience RPL,” Dr. Dimakopoulou maintained. However, even in advance of targeted therapies, she suggested these data encourage investigation of male partners in couples with RPL. Although evidence of reactive oxidative stress may not define a cause, it broadens the scope of investigation and might have value when counseling patients.

Dr. Dimakopoulou reported no relevant financial relationships to disclose.

SOURCE: Dimakopoulou AP et al. ENDO 2019, Session OR18-5.