Mitchel L. Zoler, PhD

NEW ORLEANS – A novel way to manage drug-resistant hypertension using an implanted device to deliver a small, continuous electrical current to both carotid sinuses will need more testing as results from a 265-patient pivotal trial failed to clearly prove efficacy.

The new trial results "justify further development" of baroreflex activation therapy, Dr. John D. Bisognano said April 5 at the meeting.

"This treatment is coming. The data were very encouraging. This is a modality that will work. I anticipate further studies to better define which patients get the greatest benefit," said Dr. Bisognano, director of cardiac rehabilitation and clinical preventive cardiology at the University of Rochester (N.Y.).

Cardiologists who heard the results had a mixed read on the potential role of this approach, which involved implanting a small device below the patient’s clavicle and placing a pair of electrical leads that wrap around the carotid sinus on each side of the patient’s neck. The device delivers a continuous electrical current of 1-6 volts to each carotid sinus, activating the reflex and producing a reduction in blood pressure in most patients.

"When the device becomes available, the greatest benefit will be in patients with end-stage renal failure. No matter what you do, their blood pressure does not go down," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "I just hope that patients tolerate" having leads in their necks, he added in an interview.

In the study results reported by Dr. Bisognano, 25% of the patients who received the device had at least one procedure-related adverse event within 30 days of device placement, including 4% with permanent nerve injury that resulted in numbness, dysphagia, or dysphonia; 5% with a transient nerve injury; 4% with a surgical complication (most of which resolved); and 3% with respiratory complaints (all of which resolved). Overall, 76% of the adverse events resolved, but about 2% of patients required explant of the device.

Dr. Prakash C. Deedwania took a more skeptical view of the approach. "This device would require battery changes and is subject to malfunctions. In my opinion, renal artery denervation is probably better, right now, for patients with treatment-resistant hypertension." The current study’s design also "left many unanswered questions," said Dr. Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

Patients enrolled in the study should have been thoroughly assessed for neuroendocrine hypertension. About a third of patients with treatment-resistant hypertension have a neuroendocrine cause, he noted.

The study’s design also left unclear how many enrolled patients were truly treatment resistant. One month on stable treatment with at least three drugs may not identify patients who are unresponsive to drugs, as some drugs, such as the direct renin inhibitor aliskiren, take longer than 1 month to start having a complete effect, he said.

In addition, current hypertension treatment guidelines from the American Heart Association call for using a mineralocorticoid receptor antagonist such as spironolactone or amiloride in patients with persistent hypertension that remains unresponsive to combinations of other drugs (Hypertension 2008;51:1403-19). The current report gives no information on whether all enrolled patients had first received spironolactone, a very inexpensive drug that often works in otherwise unresponsive patients, Dr. Deedwania said.

The pivotal study for the Rheos baroreflex activation device enrolled patients at 37 U.S. sites and two centers in Europe. All 265 patients who were enrolled received placement of the device. One month after surgery, a 2:1 randomization scheme led to blinded activation of the device in 181 patients and no activation in the other 84. Six months later, the researchers activated all the devices.

The patients averaged 54 years old, about 60% were men, and about three-quarters were white. Participants had failed to have their blood pressure controlled by an average of five drugs, and they had been on a stable regimen for at least a month at the time of entry. During the course of the study their treating physicians could freely change antihypertensive drug dosages and also add or remove drugs. Their systolic and diastolic blood pressure at baseline averaged about 177/103 mm Hg, and their heart rate averaged 74 beats/min. To qualify for the study, patients needed a minimum blood pressure of at least 160/80 mm Hg, a 24-hour average ambulatory pressure of at least 135 mm Hg, and they had to be on at least three antihypertensive medications.

The study included five primary end points, with a prespecified definition of success for each of the end point.

One end point assessed short-term response after 6 months, defining success as at least a 10-mm Hg drop in systolic pressure, compared with baseline. This criteria for success occurred in 54% of patients with an activated device in the study’s first 6 months and in 46% of those with an inactive device, an 8% difference in response rate between the active and control arms that failed to meet the prespecified goal of a 20% difference. Dr. Bisognano speculated that the placebo response may have been so high because of continued drug treatment optimization during this period.

The second end point assessed the 12-month response in all 265 patients, again using a 10-mm Hg drop in systolic pressure relative to baseline as the criterion for a positive response. This reduction occurred in 88% of patients, surpassing the prespecified success threshold of 65%.

The third end point focused on 30-day safety. The 25% of patients with an adverse event exceeded the prespecified threshold of 18%.

The fourth end point looked at safety at 6 months, with an adverse-event threshold in the active-treatment arm of no more than 15% greater than in the control arm. The results showed that patients receiving activation had a 2% reduced rate of adverse events, compared with the inactive, control arm, which meant the results fulfilled this criterion of success.

The fifth end point looked at the overall adverse event rate on active therapy in all 265 patients after 12 months. The 13% actual rate fell within the prespecified goal of less than 28%, meaning the results fulfilled this criterion of success.

The study also assessed efficacy another way, by tallying the percentage of patients whose systolic pressure dropped below 140 mm Hg. At the 6-month mark, this degree of blood pressure reduction occurred in 42% of patients receiving activation and in 24% of patients whose device had not yet been activated, a statistically significant difference. At the 12-month mark, 53% of the patients on continuous active treatment and 51% of those who switched from 6 months off treatment to 6 months on treatment reached this systolic pressure goal.

In addition, the study included an echocardiography substudy designed to assess the impact of baroreflex activation on left ventricular mass and shape. At baseline, these 60 patients had an average left ventricular mass index of 117 kg/m². A year later, the average had dropped to 102 kg/m², a statistically significant difference. Patients also shifted toward having more normalized left ventricular shapes, Dr. Bisognano reported in a separate talk at the meeting.

Dr. Bisognano said that he has received consulting fees or honoraria from CVrx, the company that is developing the carotid baroreflex activation device. Dr. Ram said that he has served on the speakers’ bureau for the Peer Group and for Advanced Health Media. Dr. Deedwania said that he had no disclosures.

NEW ORLEANS – A novel way to manage drug-resistant hypertension using an implanted device to deliver a small, continuous electrical current to both carotid sinuses will need more testing as results from a 265-patient pivotal trial failed to clearly prove efficacy.

The new trial results "justify further development" of baroreflex activation therapy, Dr. John D. Bisognano said April 5 at the meeting.

"This treatment is coming. The data were very encouraging. This is a modality that will work. I anticipate further studies to better define which patients get the greatest benefit," said Dr. Bisognano, director of cardiac rehabilitation and clinical preventive cardiology at the University of Rochester (N.Y.).

Cardiologists who heard the results had a mixed read on the potential role of this approach, which involved implanting a small device below the patient’s clavicle and placing a pair of electrical leads that wrap around the carotid sinus on each side of the patient’s neck. The device delivers a continuous electrical current of 1-6 volts to each carotid sinus, activating the reflex and producing a reduction in blood pressure in most patients.

"When the device becomes available, the greatest benefit will be in patients with end-stage renal failure. No matter what you do, their blood pressure does not go down," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "I just hope that patients tolerate" having leads in their necks, he added in an interview.

In the study results reported by Dr. Bisognano, 25% of the patients who received the device had at least one procedure-related adverse event within 30 days of device placement, including 4% with permanent nerve injury that resulted in numbness, dysphagia, or dysphonia; 5% with a transient nerve injury; 4% with a surgical complication (most of which resolved); and 3% with respiratory complaints (all of which resolved). Overall, 76% of the adverse events resolved, but about 2% of patients required explant of the device.

Dr. Prakash C. Deedwania took a more skeptical view of the approach. "This device would require battery changes and is subject to malfunctions. In my opinion, renal artery denervation is probably better, right now, for patients with treatment-resistant hypertension." The current study’s design also "left many unanswered questions," said Dr. Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

Patients enrolled in the study should have been thoroughly assessed for neuroendocrine hypertension. About a third of patients with treatment-resistant hypertension have a neuroendocrine cause, he noted.

The study’s design also left unclear how many enrolled patients were truly treatment resistant. One month on stable treatment with at least three drugs may not identify patients who are unresponsive to drugs, as some drugs, such as the direct renin inhibitor aliskiren, take longer than 1 month to start having a complete effect, he said.

In addition, current hypertension treatment guidelines from the American Heart Association call for using a mineralocorticoid receptor antagonist such as spironolactone or amiloride in patients with persistent hypertension that remains unresponsive to combinations of other drugs (Hypertension 2008;51:1403-19). The current report gives no information on whether all enrolled patients had first received spironolactone, a very inexpensive drug that often works in otherwise unresponsive patients, Dr. Deedwania said.

The pivotal study for the Rheos baroreflex activation device enrolled patients at 37 U.S. sites and two centers in Europe. All 265 patients who were enrolled received placement of the device. One month after surgery, a 2:1 randomization scheme led to blinded activation of the device in 181 patients and no activation in the other 84. Six months later, the researchers activated all the devices.

The patients averaged 54 years old, about 60% were men, and about three-quarters were white. Participants had failed to have their blood pressure controlled by an average of five drugs, and they had been on a stable regimen for at least a month at the time of entry. During the course of the study their treating physicians could freely change antihypertensive drug dosages and also add or remove drugs. Their systolic and diastolic blood pressure at baseline averaged about 177/103 mm Hg, and their heart rate averaged 74 beats/min. To qualify for the study, patients needed a minimum blood pressure of at least 160/80 mm Hg, a 24-hour average ambulatory pressure of at least 135 mm Hg, and they had to be on at least three antihypertensive medications.

The study included five primary end points, with a prespecified definition of success for each of the end point.

One end point assessed short-term response after 6 months, defining success as at least a 10-mm Hg drop in systolic pressure, compared with baseline. This criteria for success occurred in 54% of patients with an activated device in the study’s first 6 months and in 46% of those with an inactive device, an 8% difference in response rate between the active and control arms that failed to meet the prespecified goal of a 20% difference. Dr. Bisognano speculated that the placebo response may have been so high because of continued drug treatment optimization during this period.

The second end point assessed the 12-month response in all 265 patients, again using a 10-mm Hg drop in systolic pressure relative to baseline as the criterion for a positive response. This reduction occurred in 88% of patients, surpassing the prespecified success threshold of 65%.

The third end point focused on 30-day safety. The 25% of patients with an adverse event exceeded the prespecified threshold of 18%.

The fourth end point looked at safety at 6 months, with an adverse-event threshold in the active-treatment arm of no more than 15% greater than in the control arm. The results showed that patients receiving activation had a 2% reduced rate of adverse events, compared with the inactive, control arm, which meant the results fulfilled this criterion of success.

The fifth end point looked at the overall adverse event rate on active therapy in all 265 patients after 12 months. The 13% actual rate fell within the prespecified goal of less than 28%, meaning the results fulfilled this criterion of success.

The study also assessed efficacy another way, by tallying the percentage of patients whose systolic pressure dropped below 140 mm Hg. At the 6-month mark, this degree of blood pressure reduction occurred in 42% of patients receiving activation and in 24% of patients whose device had not yet been activated, a statistically significant difference. At the 12-month mark, 53% of the patients on continuous active treatment and 51% of those who switched from 6 months off treatment to 6 months on treatment reached this systolic pressure goal.

In addition, the study included an echocardiography substudy designed to assess the impact of baroreflex activation on left ventricular mass and shape. At baseline, these 60 patients had an average left ventricular mass index of 117 kg/m². A year later, the average had dropped to 102 kg/m², a statistically significant difference. Patients also shifted toward having more normalized left ventricular shapes, Dr. Bisognano reported in a separate talk at the meeting.

Dr. Bisognano said that he has received consulting fees or honoraria from CVrx, the company that is developing the carotid baroreflex activation device. Dr. Ram said that he has served on the speakers’ bureau for the Peer Group and for Advanced Health Media. Dr. Deedwania said that he had no disclosures.

NEW ORLEANS – A novel way to manage drug-resistant hypertension using an implanted device to deliver a small, continuous electrical current to both carotid sinuses will need more testing as results from a 265-patient pivotal trial failed to clearly prove efficacy.

The new trial results "justify further development" of baroreflex activation therapy, Dr. John D. Bisognano said April 5 at the meeting.

"This treatment is coming. The data were very encouraging. This is a modality that will work. I anticipate further studies to better define which patients get the greatest benefit," said Dr. Bisognano, director of cardiac rehabilitation and clinical preventive cardiology at the University of Rochester (N.Y.).

Cardiologists who heard the results had a mixed read on the potential role of this approach, which involved implanting a small device below the patient’s clavicle and placing a pair of electrical leads that wrap around the carotid sinus on each side of the patient’s neck. The device delivers a continuous electrical current of 1-6 volts to each carotid sinus, activating the reflex and producing a reduction in blood pressure in most patients.

"When the device becomes available, the greatest benefit will be in patients with end-stage renal failure. No matter what you do, their blood pressure does not go down," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "I just hope that patients tolerate" having leads in their necks, he added in an interview.

In the study results reported by Dr. Bisognano, 25% of the patients who received the device had at least one procedure-related adverse event within 30 days of device placement, including 4% with permanent nerve injury that resulted in numbness, dysphagia, or dysphonia; 5% with a transient nerve injury; 4% with a surgical complication (most of which resolved); and 3% with respiratory complaints (all of which resolved). Overall, 76% of the adverse events resolved, but about 2% of patients required explant of the device.

Dr. Prakash C. Deedwania took a more skeptical view of the approach. "This device would require battery changes and is subject to malfunctions. In my opinion, renal artery denervation is probably better, right now, for patients with treatment-resistant hypertension." The current study’s design also "left many unanswered questions," said Dr. Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

Patients enrolled in the study should have been thoroughly assessed for neuroendocrine hypertension. About a third of patients with treatment-resistant hypertension have a neuroendocrine cause, he noted.

The study’s design also left unclear how many enrolled patients were truly treatment resistant. One month on stable treatment with at least three drugs may not identify patients who are unresponsive to drugs, as some drugs, such as the direct renin inhibitor aliskiren, take longer than 1 month to start having a complete effect, he said.

In addition, current hypertension treatment guidelines from the American Heart Association call for using a mineralocorticoid receptor antagonist such as spironolactone or amiloride in patients with persistent hypertension that remains unresponsive to combinations of other drugs (Hypertension 2008;51:1403-19). The current report gives no information on whether all enrolled patients had first received spironolactone, a very inexpensive drug that often works in otherwise unresponsive patients, Dr. Deedwania said.

The pivotal study for the Rheos baroreflex activation device enrolled patients at 37 U.S. sites and two centers in Europe. All 265 patients who were enrolled received placement of the device. One month after surgery, a 2:1 randomization scheme led to blinded activation of the device in 181 patients and no activation in the other 84. Six months later, the researchers activated all the devices.

The patients averaged 54 years old, about 60% were men, and about three-quarters were white. Participants had failed to have their blood pressure controlled by an average of five drugs, and they had been on a stable regimen for at least a month at the time of entry. During the course of the study their treating physicians could freely change antihypertensive drug dosages and also add or remove drugs. Their systolic and diastolic blood pressure at baseline averaged about 177/103 mm Hg, and their heart rate averaged 74 beats/min. To qualify for the study, patients needed a minimum blood pressure of at least 160/80 mm Hg, a 24-hour average ambulatory pressure of at least 135 mm Hg, and they had to be on at least three antihypertensive medications.

The study included five primary end points, with a prespecified definition of success for each of the end point.

One end point assessed short-term response after 6 months, defining success as at least a 10-mm Hg drop in systolic pressure, compared with baseline. This criteria for success occurred in 54% of patients with an activated device in the study’s first 6 months and in 46% of those with an inactive device, an 8% difference in response rate between the active and control arms that failed to meet the prespecified goal of a 20% difference. Dr. Bisognano speculated that the placebo response may have been so high because of continued drug treatment optimization during this period.

The second end point assessed the 12-month response in all 265 patients, again using a 10-mm Hg drop in systolic pressure relative to baseline as the criterion for a positive response. This reduction occurred in 88% of patients, surpassing the prespecified success threshold of 65%.

The third end point focused on 30-day safety. The 25% of patients with an adverse event exceeded the prespecified threshold of 18%.

The fourth end point looked at safety at 6 months, with an adverse-event threshold in the active-treatment arm of no more than 15% greater than in the control arm. The results showed that patients receiving activation had a 2% reduced rate of adverse events, compared with the inactive, control arm, which meant the results fulfilled this criterion of success.

The fifth end point looked at the overall adverse event rate on active therapy in all 265 patients after 12 months. The 13% actual rate fell within the prespecified goal of less than 28%, meaning the results fulfilled this criterion of success.

The study also assessed efficacy another way, by tallying the percentage of patients whose systolic pressure dropped below 140 mm Hg. At the 6-month mark, this degree of blood pressure reduction occurred in 42% of patients receiving activation and in 24% of patients whose device had not yet been activated, a statistically significant difference. At the 12-month mark, 53% of the patients on continuous active treatment and 51% of those who switched from 6 months off treatment to 6 months on treatment reached this systolic pressure goal.

In addition, the study included an echocardiography substudy designed to assess the impact of baroreflex activation on left ventricular mass and shape. At baseline, these 60 patients had an average left ventricular mass index of 117 kg/m². A year later, the average had dropped to 102 kg/m², a statistically significant difference. Patients also shifted toward having more normalized left ventricular shapes, Dr. Bisognano reported in a separate talk at the meeting.

Dr. Bisognano said that he has received consulting fees or honoraria from CVrx, the company that is developing the carotid baroreflex activation device. Dr. Ram said that he has served on the speakers’ bureau for the Peer Group and for Advanced Health Media. Dr. Deedwania said that he had no disclosures.

NEW ORLEANS – With broader use of radial-artery access for percutaneous coronary interventions already gaining momentum in the United States, results from the largest study by far to compare radial- and femoral-artery approaches may give an extra boost to the radial camp.

While results from the Radial vs Femoral Access for Coronary Intervention (RIVAL) trial showed primary end point equivalence for the two arterial access strategies in a 7,000-patient randomized trial, radial access may have won by not losing.

"The similar efficacy helps the radial approach, because there was a persistent uncertainty whether it really was as good as femoral, Dr. Sanjit S. Jolly, lead investigator of the trial, said at the annual meeting of the American College of Cardiology.

In addition, the study’s findings "in high-volume centers and in patients with ST elevation myocardial infarctions will produce more momentum for a shift," he predicted.

Interventional cardiologists in some countries have embraced radial-artery access for placing catheters aimed at the coronaries into patients. Dr. Jolly, a cardiologist at McMaster University in Hamilton, Canada, cited a greater than 90% rate among French interventionalists and a greater than 95% rate in Canada. But as recently as last summer, U.S. cardiologists used radial access for a mere 4% of their coronary catheterizations, based on data collected by the National Cardiovascular Data Registry, said Dr. Edward J. McNulty, an interventional cardiologist at Kaiser Permanente San Francisco.

The U.S. numbers clearly have a long way to go before they start to resemble what is now routine in many other places, but some clues at the meeting suggest they began trending up even before Dr. Jolly delivered the RIVAL results. For example, in a separate talk earlier in the meeting, Detroit interventionalist Dr. Akshay Khandelwal recounted his personal experience introducing radial access into his practice starting about 18 months ago. His cases gradually shifted, and by March roughly 75% of his coronary procedures used radial access. Following his lead, his colleagues at Henry Ford Hospital, Detroit, began to become radialists, too, and as of March 2011 a quarter of his cath lab’s coronary work occurred via the patient’s wrist, said Dr. Khandelwal, director of outpatient cardiovascular services at Henry Ford.

"At Columbia [University’s Center for Interventional Vascular Therapy] the frequency of radial access has increased," agreed Dr. Martin B. Leon, who directs the center in New York. "It was in single digits in 2010, but now, for the first time, it’s more than 20%. It’s climbing quickly. Many operators are becoming more interested in gaining expertise, particularly younger operators," he said.

Part of this shift is driven by physicians who believe they might achieve better results, with less bleeding and access site complications, and part comes from patient demand because most patients find the radial approach more comfortable. "Patients like it, and I think that will drive the option," Dr. McNulty said. Another important factor is cost.

"There is a recent trend in the U.S. to do more outpatient angioplasty in low-risk and stable patients," Dr. Leon said, and radial access makes same-day discharge feasible much more often than does femoral access. "If that trend continues, and the predictions are it will, you can imagine that the radial approach will be attractive."

Until RIVAL, prior comparisons of radial and femoral entry had been too small for a definitive comparison. Dr. Jolly and his associates designed their study to test their hunch that radial entry might actually produce better outcomes. (Dr. Jolly admitted that in his own interventional practice he performs about 80% of his cases by radial entry.) "Our hypothesis was a paradigm shift" that radial would result in a significantly reduced rate of a primary outcome of death, myocardial infarction, stroke, and bleeding not related to coronary bypass during the 30 days following percutaneous coronary intervention in patients with acute coronary syndrome.

The ambitious study enrolled 7,021 patients at 158 sites in 32 countries, piggybacked onto an acute coronary syndrome trial that tested clopidogrel and aspirin treatment (CURRENT–OASIS 7). The patient’s average age was 62 years, nearly three-quarters were men, and 45% had unstable angina, with the remaining patients split evenly between ST elevation myocardial infarction (MI) and non–ST-elevation MI.

The combined end point occurred in roughly 4% of patients in both groups. The rate of major bleeds not associated with coronary artery bypass surgery also occurred at roughly similar rates, just under 1%, in both the radial and femoral groups, an unexpected failure for the radial approach. "We expected to see a large decrease in major bleeds" in the radial access patients, Dr. Jolly said. "A take-home message is that in acute coronary syndrome both access site and non–access site bleeds are important." Concurrently with Dr. Jolly’s report, an article with the results was published online in The Lancet (Lancet 2011 April 4 [doi:10.1016/S0140-6736(11)60404-2]).

The only prespecified end point where radial access outperformed femoral access was in the secondary measure of major vascular access site complications: large hematomas, pseudoaneurysms requiring closure, arteriovenous fistula, and other vascular surgery related to the access site. In the radial group, this occurred in 1.4% of patients and in 3.7% of those in the femoral group, a statistically significant 63% relative risk reduction.

"By going radial you prevent complications at the access site," explained Dr. Jolly. These complications "don’t cause deaths," he admitted, "but they are important to patients. They can cause significant discomfort."

But others minimized the importance of access site complications.

"Access-site hematomas don’t impact mortality. Large bleeds are associated with mortality. Gastrointestinal bleeds, genitourinary bleeds, and intracranial bleeds really impact mortality," commented Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research and education at Columbia. Dr. Stone noted that he performs 99% of his coronary interventions via the femoral route.

Aside from the basic findings, perhaps the most notable results focused on the importance of operator and center experience in performing radial catheterizations. One prespecified subgroup analysis split the participating centers into tertiles based on their annual volume of radial-access procedures: those that did at least 146 a year (the highest tertile), those that did 61-145 radial procedures annually (middle tertile), and those performing 60 or fewer annually. The highest tertile centers showed a statistically significant reduction in the study’s primary end point when using radial access.

Also, focusing on outcomes in patients with an ST elevation MI showed that in this subgroup radial access produced a statistically significant reduction in the primary end point, an effect that Dr. Jolly speculated related to individual operator experience. "Radial access in the ST elevation MI patients primarily was done by the high-volume operators because of the time pressure." Only the most experienced operators were comfortable treating these patients radially, he said. Another issue was that these patients are more heavily treated with antiplatelet drugs, which magnified the benefit from radial access in cutting bleeding complications.

The subgroup findings convinced some cardiologists that RIVAL, in sum, scored a triumph for radial access.

"At the least, radial access reduced bleeding, and at best it improved the hard outcomes of death and MI" at the high volume centers, noted Dr. Khandelwal. "Perhaps our goal should be to emulate the operators in the top tertile," he said in an interview.

But Dr. Stone had the take of a femoral-artery enthusiast. "I don’t think in and of itself these data will change practice. What might change practice," he conceded, "is patient comfort."

Dr. Jolly said that he has received consultant fees or honoraria from Boehringer-Ingelheim, GlaxoSmithKline, and Sanofi-Aventis, and research grants from Merck. Dr. McNulty said he had no disclosures. Dr. Leon said he has been an unpaid consultant to Abbott, Boston Scientific, and Medtronic. Dr. Stone said that he has been a consultant to Inspire MD, Reva, Osprey, Lilly, BMS/Sanofi, Medtronic, AstraZeneca, Vascular Solutions, Gilead, The Medicines Company, Abbott Vascular, Boston Scientific, Ortho-McNeil, Edwards, and Merck; he has an ownership or partnership role in MiCardia, Biostar I and II, FlowCardia, Embrella, Caliber, Medfocus I and II, Accelerator, and Access Closure; and he has received research funds from InfraReDx, TherOx, Atrium, and Volcano. Dr. Khandelwal said he had no disclosures.

NEW ORLEANS – With broader use of radial-artery access for percutaneous coronary interventions already gaining momentum in the United States, results from the largest study by far to compare radial- and femoral-artery approaches may give an extra boost to the radial camp.

While results from the Radial vs Femoral Access for Coronary Intervention (RIVAL) trial showed primary end point equivalence for the two arterial access strategies in a 7,000-patient randomized trial, radial access may have won by not losing.

"The similar efficacy helps the radial approach, because there was a persistent uncertainty whether it really was as good as femoral, Dr. Sanjit S. Jolly, lead investigator of the trial, said at the annual meeting of the American College of Cardiology.

In addition, the study’s findings "in high-volume centers and in patients with ST elevation myocardial infarctions will produce more momentum for a shift," he predicted.

Interventional cardiologists in some countries have embraced radial-artery access for placing catheters aimed at the coronaries into patients. Dr. Jolly, a cardiologist at McMaster University in Hamilton, Canada, cited a greater than 90% rate among French interventionalists and a greater than 95% rate in Canada. But as recently as last summer, U.S. cardiologists used radial access for a mere 4% of their coronary catheterizations, based on data collected by the National Cardiovascular Data Registry, said Dr. Edward J. McNulty, an interventional cardiologist at Kaiser Permanente San Francisco.

The U.S. numbers clearly have a long way to go before they start to resemble what is now routine in many other places, but some clues at the meeting suggest they began trending up even before Dr. Jolly delivered the RIVAL results. For example, in a separate talk earlier in the meeting, Detroit interventionalist Dr. Akshay Khandelwal recounted his personal experience introducing radial access into his practice starting about 18 months ago. His cases gradually shifted, and by March roughly 75% of his coronary procedures used radial access. Following his lead, his colleagues at Henry Ford Hospital, Detroit, began to become radialists, too, and as of March 2011 a quarter of his cath lab’s coronary work occurred via the patient’s wrist, said Dr. Khandelwal, director of outpatient cardiovascular services at Henry Ford.

"At Columbia [University’s Center for Interventional Vascular Therapy] the frequency of radial access has increased," agreed Dr. Martin B. Leon, who directs the center in New York. "It was in single digits in 2010, but now, for the first time, it’s more than 20%. It’s climbing quickly. Many operators are becoming more interested in gaining expertise, particularly younger operators," he said.

Part of this shift is driven by physicians who believe they might achieve better results, with less bleeding and access site complications, and part comes from patient demand because most patients find the radial approach more comfortable. "Patients like it, and I think that will drive the option," Dr. McNulty said. Another important factor is cost.

"There is a recent trend in the U.S. to do more outpatient angioplasty in low-risk and stable patients," Dr. Leon said, and radial access makes same-day discharge feasible much more often than does femoral access. "If that trend continues, and the predictions are it will, you can imagine that the radial approach will be attractive."

Until RIVAL, prior comparisons of radial and femoral entry had been too small for a definitive comparison. Dr. Jolly and his associates designed their study to test their hunch that radial entry might actually produce better outcomes. (Dr. Jolly admitted that in his own interventional practice he performs about 80% of his cases by radial entry.) "Our hypothesis was a paradigm shift" that radial would result in a significantly reduced rate of a primary outcome of death, myocardial infarction, stroke, and bleeding not related to coronary bypass during the 30 days following percutaneous coronary intervention in patients with acute coronary syndrome.

The ambitious study enrolled 7,021 patients at 158 sites in 32 countries, piggybacked onto an acute coronary syndrome trial that tested clopidogrel and aspirin treatment (CURRENT–OASIS 7). The patient’s average age was 62 years, nearly three-quarters were men, and 45% had unstable angina, with the remaining patients split evenly between ST elevation myocardial infarction (MI) and non–ST-elevation MI.

The combined end point occurred in roughly 4% of patients in both groups. The rate of major bleeds not associated with coronary artery bypass surgery also occurred at roughly similar rates, just under 1%, in both the radial and femoral groups, an unexpected failure for the radial approach. "We expected to see a large decrease in major bleeds" in the radial access patients, Dr. Jolly said. "A take-home message is that in acute coronary syndrome both access site and non–access site bleeds are important." Concurrently with Dr. Jolly’s report, an article with the results was published online in The Lancet (Lancet 2011 April 4 [doi:10.1016/S0140-6736(11)60404-2]).

The only prespecified end point where radial access outperformed femoral access was in the secondary measure of major vascular access site complications: large hematomas, pseudoaneurysms requiring closure, arteriovenous fistula, and other vascular surgery related to the access site. In the radial group, this occurred in 1.4% of patients and in 3.7% of those in the femoral group, a statistically significant 63% relative risk reduction.

"By going radial you prevent complications at the access site," explained Dr. Jolly. These complications "don’t cause deaths," he admitted, "but they are important to patients. They can cause significant discomfort."

But others minimized the importance of access site complications.

"Access-site hematomas don’t impact mortality. Large bleeds are associated with mortality. Gastrointestinal bleeds, genitourinary bleeds, and intracranial bleeds really impact mortality," commented Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research and education at Columbia. Dr. Stone noted that he performs 99% of his coronary interventions via the femoral route.

Aside from the basic findings, perhaps the most notable results focused on the importance of operator and center experience in performing radial catheterizations. One prespecified subgroup analysis split the participating centers into tertiles based on their annual volume of radial-access procedures: those that did at least 146 a year (the highest tertile), those that did 61-145 radial procedures annually (middle tertile), and those performing 60 or fewer annually. The highest tertile centers showed a statistically significant reduction in the study’s primary end point when using radial access.

Also, focusing on outcomes in patients with an ST elevation MI showed that in this subgroup radial access produced a statistically significant reduction in the primary end point, an effect that Dr. Jolly speculated related to individual operator experience. "Radial access in the ST elevation MI patients primarily was done by the high-volume operators because of the time pressure." Only the most experienced operators were comfortable treating these patients radially, he said. Another issue was that these patients are more heavily treated with antiplatelet drugs, which magnified the benefit from radial access in cutting bleeding complications.

The subgroup findings convinced some cardiologists that RIVAL, in sum, scored a triumph for radial access.

"At the least, radial access reduced bleeding, and at best it improved the hard outcomes of death and MI" at the high volume centers, noted Dr. Khandelwal. "Perhaps our goal should be to emulate the operators in the top tertile," he said in an interview.

But Dr. Stone had the take of a femoral-artery enthusiast. "I don’t think in and of itself these data will change practice. What might change practice," he conceded, "is patient comfort."

Dr. Jolly said that he has received consultant fees or honoraria from Boehringer-Ingelheim, GlaxoSmithKline, and Sanofi-Aventis, and research grants from Merck. Dr. McNulty said he had no disclosures. Dr. Leon said he has been an unpaid consultant to Abbott, Boston Scientific, and Medtronic. Dr. Stone said that he has been a consultant to Inspire MD, Reva, Osprey, Lilly, BMS/Sanofi, Medtronic, AstraZeneca, Vascular Solutions, Gilead, The Medicines Company, Abbott Vascular, Boston Scientific, Ortho-McNeil, Edwards, and Merck; he has an ownership or partnership role in MiCardia, Biostar I and II, FlowCardia, Embrella, Caliber, Medfocus I and II, Accelerator, and Access Closure; and he has received research funds from InfraReDx, TherOx, Atrium, and Volcano. Dr. Khandelwal said he had no disclosures.

NEW ORLEANS – With broader use of radial-artery access for percutaneous coronary interventions already gaining momentum in the United States, results from the largest study by far to compare radial- and femoral-artery approaches may give an extra boost to the radial camp.

While results from the Radial vs Femoral Access for Coronary Intervention (RIVAL) trial showed primary end point equivalence for the two arterial access strategies in a 7,000-patient randomized trial, radial access may have won by not losing.

"The similar efficacy helps the radial approach, because there was a persistent uncertainty whether it really was as good as femoral, Dr. Sanjit S. Jolly, lead investigator of the trial, said at the annual meeting of the American College of Cardiology.

In addition, the study’s findings "in high-volume centers and in patients with ST elevation myocardial infarctions will produce more momentum for a shift," he predicted.

Interventional cardiologists in some countries have embraced radial-artery access for placing catheters aimed at the coronaries into patients. Dr. Jolly, a cardiologist at McMaster University in Hamilton, Canada, cited a greater than 90% rate among French interventionalists and a greater than 95% rate in Canada. But as recently as last summer, U.S. cardiologists used radial access for a mere 4% of their coronary catheterizations, based on data collected by the National Cardiovascular Data Registry, said Dr. Edward J. McNulty, an interventional cardiologist at Kaiser Permanente San Francisco.

The U.S. numbers clearly have a long way to go before they start to resemble what is now routine in many other places, but some clues at the meeting suggest they began trending up even before Dr. Jolly delivered the RIVAL results. For example, in a separate talk earlier in the meeting, Detroit interventionalist Dr. Akshay Khandelwal recounted his personal experience introducing radial access into his practice starting about 18 months ago. His cases gradually shifted, and by March roughly 75% of his coronary procedures used radial access. Following his lead, his colleagues at Henry Ford Hospital, Detroit, began to become radialists, too, and as of March 2011 a quarter of his cath lab’s coronary work occurred via the patient’s wrist, said Dr. Khandelwal, director of outpatient cardiovascular services at Henry Ford.

"At Columbia [University’s Center for Interventional Vascular Therapy] the frequency of radial access has increased," agreed Dr. Martin B. Leon, who directs the center in New York. "It was in single digits in 2010, but now, for the first time, it’s more than 20%. It’s climbing quickly. Many operators are becoming more interested in gaining expertise, particularly younger operators," he said.

Part of this shift is driven by physicians who believe they might achieve better results, with less bleeding and access site complications, and part comes from patient demand because most patients find the radial approach more comfortable. "Patients like it, and I think that will drive the option," Dr. McNulty said. Another important factor is cost.

"There is a recent trend in the U.S. to do more outpatient angioplasty in low-risk and stable patients," Dr. Leon said, and radial access makes same-day discharge feasible much more often than does femoral access. "If that trend continues, and the predictions are it will, you can imagine that the radial approach will be attractive."

Until RIVAL, prior comparisons of radial and femoral entry had been too small for a definitive comparison. Dr. Jolly and his associates designed their study to test their hunch that radial entry might actually produce better outcomes. (Dr. Jolly admitted that in his own interventional practice he performs about 80% of his cases by radial entry.) "Our hypothesis was a paradigm shift" that radial would result in a significantly reduced rate of a primary outcome of death, myocardial infarction, stroke, and bleeding not related to coronary bypass during the 30 days following percutaneous coronary intervention in patients with acute coronary syndrome.

The ambitious study enrolled 7,021 patients at 158 sites in 32 countries, piggybacked onto an acute coronary syndrome trial that tested clopidogrel and aspirin treatment (CURRENT–OASIS 7). The patient’s average age was 62 years, nearly three-quarters were men, and 45% had unstable angina, with the remaining patients split evenly between ST elevation myocardial infarction (MI) and non–ST-elevation MI.

The combined end point occurred in roughly 4% of patients in both groups. The rate of major bleeds not associated with coronary artery bypass surgery also occurred at roughly similar rates, just under 1%, in both the radial and femoral groups, an unexpected failure for the radial approach. "We expected to see a large decrease in major bleeds" in the radial access patients, Dr. Jolly said. "A take-home message is that in acute coronary syndrome both access site and non–access site bleeds are important." Concurrently with Dr. Jolly’s report, an article with the results was published online in The Lancet (Lancet 2011 April 4 [doi:10.1016/S0140-6736(11)60404-2]).

The only prespecified end point where radial access outperformed femoral access was in the secondary measure of major vascular access site complications: large hematomas, pseudoaneurysms requiring closure, arteriovenous fistula, and other vascular surgery related to the access site. In the radial group, this occurred in 1.4% of patients and in 3.7% of those in the femoral group, a statistically significant 63% relative risk reduction.

"By going radial you prevent complications at the access site," explained Dr. Jolly. These complications "don’t cause deaths," he admitted, "but they are important to patients. They can cause significant discomfort."

But others minimized the importance of access site complications.

"Access-site hematomas don’t impact mortality. Large bleeds are associated with mortality. Gastrointestinal bleeds, genitourinary bleeds, and intracranial bleeds really impact mortality," commented Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research and education at Columbia. Dr. Stone noted that he performs 99% of his coronary interventions via the femoral route.

Aside from the basic findings, perhaps the most notable results focused on the importance of operator and center experience in performing radial catheterizations. One prespecified subgroup analysis split the participating centers into tertiles based on their annual volume of radial-access procedures: those that did at least 146 a year (the highest tertile), those that did 61-145 radial procedures annually (middle tertile), and those performing 60 or fewer annually. The highest tertile centers showed a statistically significant reduction in the study’s primary end point when using radial access.

Also, focusing on outcomes in patients with an ST elevation MI showed that in this subgroup radial access produced a statistically significant reduction in the primary end point, an effect that Dr. Jolly speculated related to individual operator experience. "Radial access in the ST elevation MI patients primarily was done by the high-volume operators because of the time pressure." Only the most experienced operators were comfortable treating these patients radially, he said. Another issue was that these patients are more heavily treated with antiplatelet drugs, which magnified the benefit from radial access in cutting bleeding complications.

The subgroup findings convinced some cardiologists that RIVAL, in sum, scored a triumph for radial access.

"At the least, radial access reduced bleeding, and at best it improved the hard outcomes of death and MI" at the high volume centers, noted Dr. Khandelwal. "Perhaps our goal should be to emulate the operators in the top tertile," he said in an interview.

But Dr. Stone had the take of a femoral-artery enthusiast. "I don’t think in and of itself these data will change practice. What might change practice," he conceded, "is patient comfort."

Dr. Jolly said that he has received consultant fees or honoraria from Boehringer-Ingelheim, GlaxoSmithKline, and Sanofi-Aventis, and research grants from Merck. Dr. McNulty said he had no disclosures. Dr. Leon said he has been an unpaid consultant to Abbott, Boston Scientific, and Medtronic. Dr. Stone said that he has been a consultant to Inspire MD, Reva, Osprey, Lilly, BMS/Sanofi, Medtronic, AstraZeneca, Vascular Solutions, Gilead, The Medicines Company, Abbott Vascular, Boston Scientific, Ortho-McNeil, Edwards, and Merck; he has an ownership or partnership role in MiCardia, Biostar I and II, FlowCardia, Embrella, Caliber, Medfocus I and II, Accelerator, and Access Closure; and he has received research funds from InfraReDx, TherOx, Atrium, and Volcano. Dr. Khandelwal said he had no disclosures.

NEW ORLEANS – With broader use of radial-artery access for percutaneous coronary interventions already gaining momentum in the United States, results from the largest study by far to compare radial- and femoral-artery approaches may give an extra boost to the radial camp.

While results from the Radial vs Femoral Access for Coronary Intervention (RIVAL) trial showed primary end point equivalence for the two arterial access strategies in a 7,000-patient randomized trial, radial access may have won by not losing.

"The similar efficacy helps the radial approach, because there was a persistent uncertainty whether it really was as good as femoral, Dr. Sanjit S. Jolly, lead investigator of the trial, said at the annual meeting of the American College of Cardiology.

In addition, the study’s findings "in high-volume centers and in patients with ST elevation myocardial infarctions will produce more momentum for a shift," he predicted.

Interventional cardiologists in some countries have embraced radial-artery access for placing catheters aimed at the coronaries into patients. Dr. Jolly, a cardiologist at McMaster University in Hamilton, Canada, cited a greater than 90% rate among French interventionalists and a greater than 95% rate in Canada. But as recently as last summer, U.S. cardiologists used radial access for a mere 4% of their coronary catheterizations, based on data collected by the National Cardiovascular Data Registry, said Dr. Edward J. McNulty, an interventional cardiologist at Kaiser Permanente San Francisco.

The U.S. numbers clearly have a long way to go before they start to resemble what is now routine in many other places, but some clues at the meeting suggest they began trending up even before Dr. Jolly delivered the RIVAL results. For example, in a separate talk earlier in the meeting, Detroit interventionalist Dr. Akshay Khandelwal recounted his personal experience introducing radial access into his practice starting about 18 months ago. His cases gradually shifted, and by March roughly 75% of his coronary procedures used radial access. Following his lead, his colleagues at Henry Ford Hospital, Detroit, began to become radialists, too, and as of March 2011 a quarter of his cath lab’s coronary work occurred via the patient’s wrist, said Dr. Khandelwal, director of outpatient cardiovascular services at Henry Ford.

"At Columbia [University’s Center for Interventional Vascular Therapy] the frequency of radial access has increased," agreed Dr. Martin B. Leon, who directs the center in New York. "It was in single digits in 2010, but now, for the first time, it’s more than 20%. It’s climbing quickly. Many operators are becoming more interested in gaining expertise, particularly younger operators," he said.

Part of this shift is driven by physicians who believe they might achieve better results, with less bleeding and access site complications, and part comes from patient demand because most patients find the radial approach more comfortable. "Patients like it, and I think that will drive the option," Dr. McNulty said. Another important factor is cost.

"There is a recent trend in the U.S. to do more outpatient angioplasty in low-risk and stable patients," Dr. Leon said, and radial access makes same-day discharge feasible much more often than does femoral access. "If that trend continues, and the predictions are it will, you can imagine that the radial approach will be attractive."

Until RIVAL, prior comparisons of radial and femoral entry had been too small for a definitive comparison. Dr. Jolly and his associates designed their study to test their hunch that radial entry might actually produce better outcomes. (Dr. Jolly admitted that in his own interventional practice he performs about 80% of his cases by radial entry.) "Our hypothesis was a paradigm shift" that radial would result in a significantly reduced rate of a primary outcome of death, myocardial infarction, stroke, and bleeding not related to coronary bypass during the 30 days following percutaneous coronary intervention in patients with acute coronary syndrome.

The ambitious study enrolled 7,021 patients at 158 sites in 32 countries, piggybacked onto an acute coronary syndrome trial that tested clopidogrel and aspirin treatment (CURRENT–OASIS 7). The patient’s average age was 62 years, nearly three-quarters were men, and 45% had unstable angina, with the remaining patients split evenly between ST elevation myocardial infarction (MI) and non–ST-elevation MI.

The combined end point occurred in roughly 4% of patients in both groups. The rate of major bleeds not associated with coronary artery bypass surgery also occurred at roughly similar rates, just under 1%, in both the radial and femoral groups, an unexpected failure for the radial approach. "We expected to see a large decrease in major bleeds" in the radial access patients, Dr. Jolly said. "A take-home message is that in acute coronary syndrome both access site and non–access site bleeds are important." Concurrently with Dr. Jolly’s report, an article with the results was published online in The Lancet (Lancet 2011 April 4 [doi:10.1016/S0140-6736(11)60404-2]).

The only prespecified end point where radial access outperformed femoral access was in the secondary measure of major vascular access site complications: large hematomas, pseudoaneurysms requiring closure, arteriovenous fistula, and other vascular surgery related to the access site. In the radial group, this occurred in 1.4% of patients and in 3.7% of those in the femoral group, a statistically significant 63% relative risk reduction.

"By going radial you prevent complications at the access site," explained Dr. Jolly. These complications "don’t cause deaths," he admitted, "but they are important to patients. They can cause significant discomfort."

But others minimized the importance of access site complications.

"Access-site hematomas don’t impact mortality. Large bleeds are associated with mortality. Gastrointestinal bleeds, genitourinary bleeds, and intracranial bleeds really impact mortality," commented Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research and education at Columbia. Dr. Stone noted that he performs 99% of his coronary interventions via the femoral route.

Aside from the basic findings, perhaps the most notable results focused on the importance of operator and center experience in performing radial catheterizations. One prespecified subgroup analysis split the participating centers into tertiles based on their annual volume of radial-access procedures: those that did at least 146 a year (the highest tertile), those that did 61-145 radial procedures annually (middle tertile), and those performing 60 or fewer annually. The highest tertile centers showed a statistically significant reduction in the study’s primary end point when using radial access.

Also, focusing on outcomes in patients with an ST elevation MI showed that in this subgroup radial access produced a statistically significant reduction in the primary end point, an effect that Dr. Jolly speculated related to individual operator experience. "Radial access in the ST elevation MI patients primarily was done by the high-volume operators because of the time pressure." Only the most experienced operators were comfortable treating these patients radially, he said. Another issue was that these patients are more heavily treated with antiplatelet drugs, which magnified the benefit from radial access in cutting bleeding complications.

The subgroup findings convinced some cardiologists that RIVAL, in sum, scored a triumph for radial access.

"At the least, radial access reduced bleeding, and at best it improved the hard outcomes of death and MI" at the high volume centers, noted Dr. Khandelwal. "Perhaps our goal should be to emulate the operators in the top tertile," he said in an interview.

But Dr. Stone had the take of a femoral-artery enthusiast. "I don’t think in and of itself these data will change practice. What might change practice," he conceded, "is patient comfort."

Dr. Jolly said that he has received consultant fees or honoraria from Boehringer-Ingelheim, GlaxoSmithKline, and Sanofi-Aventis, and research grants from Merck. Dr. McNulty said he had no disclosures. Dr. Leon said he has been an unpaid consultant to Abbott, Boston Scientific, and Medtronic. Dr. Stone said that he has been a consultant to Inspire MD, Reva, Osprey, Lilly, BMS/Sanofi, Medtronic, AstraZeneca, Vascular Solutions, Gilead, The Medicines Company, Abbott Vascular, Boston Scientific, Ortho-McNeil, Edwards, and Merck; he has an ownership or partnership role in MiCardia, Biostar I and II, FlowCardia, Embrella, Caliber, Medfocus I and II, Accelerator, and Access Closure; and he has received research funds from InfraReDx, TherOx, Atrium, and Volcano. Dr. Khandelwal said he had no disclosures.

NEW ORLEANS – With broader use of radial-artery access for percutaneous coronary interventions already gaining momentum in the United States, results from the largest study by far to compare radial- and femoral-artery approaches may give an extra boost to the radial camp.

While results from the Radial vs Femoral Access for Coronary Intervention (RIVAL) trial showed primary end point equivalence for the two arterial access strategies in a 7,000-patient randomized trial, radial access may have won by not losing.

"The similar efficacy helps the radial approach, because there was a persistent uncertainty whether it really was as good as femoral, Dr. Sanjit S. Jolly, lead investigator of the trial, said at the annual meeting of the American College of Cardiology.

In addition, the study’s findings "in high-volume centers and in patients with ST elevation myocardial infarctions will produce more momentum for a shift," he predicted.

Interventional cardiologists in some countries have embraced radial-artery access for placing catheters aimed at the coronaries into patients. Dr. Jolly, a cardiologist at McMaster University in Hamilton, Canada, cited a greater than 90% rate among French interventionalists and a greater than 95% rate in Canada. But as recently as last summer, U.S. cardiologists used radial access for a mere 4% of their coronary catheterizations, based on data collected by the National Cardiovascular Data Registry, said Dr. Edward J. McNulty, an interventional cardiologist at Kaiser Permanente San Francisco.

The U.S. numbers clearly have a long way to go before they start to resemble what is now routine in many other places, but some clues at the meeting suggest they began trending up even before Dr. Jolly delivered the RIVAL results. For example, in a separate talk earlier in the meeting, Detroit interventionalist Dr. Akshay Khandelwal recounted his personal experience introducing radial access into his practice starting about 18 months ago. His cases gradually shifted, and by March roughly 75% of his coronary procedures used radial access. Following his lead, his colleagues at Henry Ford Hospital, Detroit, began to become radialists, too, and as of March 2011 a quarter of his cath lab’s coronary work occurred via the patient’s wrist, said Dr. Khandelwal, director of outpatient cardiovascular services at Henry Ford.

"At Columbia [University’s Center for Interventional Vascular Therapy] the frequency of radial access has increased," agreed Dr. Martin B. Leon, who directs the center in New York. "It was in single digits in 2010, but now, for the first time, it’s more than 20%. It’s climbing quickly. Many operators are becoming more interested in gaining expertise, particularly younger operators," he said.

Part of this shift is driven by physicians who believe they might achieve better results, with less bleeding and access site complications, and part comes from patient demand because most patients find the radial approach more comfortable. "Patients like it, and I think that will drive the option," Dr. McNulty said. Another important factor is cost.

"There is a recent trend in the U.S. to do more outpatient angioplasty in low-risk and stable patients," Dr. Leon said, and radial access makes same-day discharge feasible much more often than does femoral access. "If that trend continues, and the predictions are it will, you can imagine that the radial approach will be attractive."

Until RIVAL, prior comparisons of radial and femoral entry had been too small for a definitive comparison. Dr. Jolly and his associates designed their study to test their hunch that radial entry might actually produce better outcomes. (Dr. Jolly admitted that in his own interventional practice he performs about 80% of his cases by radial entry.) "Our hypothesis was a paradigm shift" that radial would result in a significantly reduced rate of a primary outcome of death, myocardial infarction, stroke, and bleeding not related to coronary bypass during the 30 days following percutaneous coronary intervention in patients with acute coronary syndrome.

The ambitious study enrolled 7,021 patients at 158 sites in 32 countries, piggybacked onto an acute coronary syndrome trial that tested clopidogrel and aspirin treatment (CURRENT–OASIS 7). The patient’s average age was 62 years, nearly three-quarters were men, and 45% had unstable angina, with the remaining patients split evenly between ST elevation myocardial infarction (MI) and non–ST-elevation MI.

The combined end point occurred in roughly 4% of patients in both groups. The rate of major bleeds not associated with coronary artery bypass surgery also occurred at roughly similar rates, just under 1%, in both the radial and femoral groups, an unexpected failure for the radial approach. "We expected to see a large decrease in major bleeds" in the radial access patients, Dr. Jolly said. "A take-home message is that in acute coronary syndrome both access site and non–access site bleeds are important." Concurrently with Dr. Jolly’s report, an article with the results was published online in The Lancet (Lancet 2011 April 4 [doi:10.1016/S0140-6736(11)60404-2]).

The only prespecified end point where radial access outperformed femoral access was in the secondary measure of major vascular access site complications: large hematomas, pseudoaneurysms requiring closure, arteriovenous fistula, and other vascular surgery related to the access site. In the radial group, this occurred in 1.4% of patients and in 3.7% of those in the femoral group, a statistically significant 63% relative risk reduction.

"By going radial you prevent complications at the access site," explained Dr. Jolly. These complications "don’t cause deaths," he admitted, "but they are important to patients. They can cause significant discomfort."

But others minimized the importance of access site complications.

"Access-site hematomas don’t impact mortality. Large bleeds are associated with mortality. Gastrointestinal bleeds, genitourinary bleeds, and intracranial bleeds really impact mortality," commented Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research and education at Columbia. Dr. Stone noted that he performs 99% of his coronary interventions via the femoral route.

Aside from the basic findings, perhaps the most notable results focused on the importance of operator and center experience in performing radial catheterizations. One prespecified subgroup analysis split the participating centers into tertiles based on their annual volume of radial-access procedures: those that did at least 146 a year (the highest tertile), those that did 61-145 radial procedures annually (middle tertile), and those performing 60 or fewer annually. The highest tertile centers showed a statistically significant reduction in the study’s primary end point when using radial access.

Also, focusing on outcomes in patients with an ST elevation MI showed that in this subgroup radial access produced a statistically significant reduction in the primary end point, an effect that Dr. Jolly speculated related to individual operator experience. "Radial access in the ST elevation MI patients primarily was done by the high-volume operators because of the time pressure." Only the most experienced operators were comfortable treating these patients radially, he said. Another issue was that these patients are more heavily treated with antiplatelet drugs, which magnified the benefit from radial access in cutting bleeding complications.

The subgroup findings convinced some cardiologists that RIVAL, in sum, scored a triumph for radial access.

"At the least, radial access reduced bleeding, and at best it improved the hard outcomes of death and MI" at the high volume centers, noted Dr. Khandelwal. "Perhaps our goal should be to emulate the operators in the top tertile," he said in an interview.

But Dr. Stone had the take of a femoral-artery enthusiast. "I don’t think in and of itself these data will change practice. What might change practice," he conceded, "is patient comfort."

Dr. Jolly said that he has received consultant fees or honoraria from Boehringer-Ingelheim, GlaxoSmithKline, and Sanofi-Aventis, and research grants from Merck. Dr. McNulty said he had no disclosures. Dr. Leon said he has been an unpaid consultant to Abbott, Boston Scientific, and Medtronic. Dr. Stone said that he has been a consultant to Inspire MD, Reva, Osprey, Lilly, BMS/Sanofi, Medtronic, AstraZeneca, Vascular Solutions, Gilead, The Medicines Company, Abbott Vascular, Boston Scientific, Ortho-McNeil, Edwards, and Merck; he has an ownership or partnership role in MiCardia, Biostar I and II, FlowCardia, Embrella, Caliber, Medfocus I and II, Accelerator, and Access Closure; and he has received research funds from InfraReDx, TherOx, Atrium, and Volcano. Dr. Khandelwal said he had no disclosures.

NEW ORLEANS – With broader use of radial-artery access for percutaneous coronary interventions already gaining momentum in the United States, results from the largest study by far to compare radial- and femoral-artery approaches may give an extra boost to the radial camp.

While results from the Radial vs Femoral Access for Coronary Intervention (RIVAL) trial showed primary end point equivalence for the two arterial access strategies in a 7,000-patient randomized trial, radial access may have won by not losing.

"The similar efficacy helps the radial approach, because there was a persistent uncertainty whether it really was as good as femoral, Dr. Sanjit S. Jolly, lead investigator of the trial, said at the annual meeting of the American College of Cardiology.

In addition, the study’s findings "in high-volume centers and in patients with ST elevation myocardial infarctions will produce more momentum for a shift," he predicted.

Interventional cardiologists in some countries have embraced radial-artery access for placing catheters aimed at the coronaries into patients. Dr. Jolly, a cardiologist at McMaster University in Hamilton, Canada, cited a greater than 90% rate among French interventionalists and a greater than 95% rate in Canada. But as recently as last summer, U.S. cardiologists used radial access for a mere 4% of their coronary catheterizations, based on data collected by the National Cardiovascular Data Registry, said Dr. Edward J. McNulty, an interventional cardiologist at Kaiser Permanente San Francisco.

The U.S. numbers clearly have a long way to go before they start to resemble what is now routine in many other places, but some clues at the meeting suggest they began trending up even before Dr. Jolly delivered the RIVAL results. For example, in a separate talk earlier in the meeting, Detroit interventionalist Dr. Akshay Khandelwal recounted his personal experience introducing radial access into his practice starting about 18 months ago. His cases gradually shifted, and by March roughly 75% of his coronary procedures used radial access. Following his lead, his colleagues at Henry Ford Hospital, Detroit, began to become radialists, too, and as of March 2011 a quarter of his cath lab’s coronary work occurred via the patient’s wrist, said Dr. Khandelwal, director of outpatient cardiovascular services at Henry Ford.

"At Columbia [University’s Center for Interventional Vascular Therapy] the frequency of radial access has increased," agreed Dr. Martin B. Leon, who directs the center in New York. "It was in single digits in 2010, but now, for the first time, it’s more than 20%. It’s climbing quickly. Many operators are becoming more interested in gaining expertise, particularly younger operators," he said.

Part of this shift is driven by physicians who believe they might achieve better results, with less bleeding and access site complications, and part comes from patient demand because most patients find the radial approach more comfortable. "Patients like it, and I think that will drive the option," Dr. McNulty said. Another important factor is cost.

"There is a recent trend in the U.S. to do more outpatient angioplasty in low-risk and stable patients," Dr. Leon said, and radial access makes same-day discharge feasible much more often than does femoral access. "If that trend continues, and the predictions are it will, you can imagine that the radial approach will be attractive."

Until RIVAL, prior comparisons of radial and femoral entry had been too small for a definitive comparison. Dr. Jolly and his associates designed their study to test their hunch that radial entry might actually produce better outcomes. (Dr. Jolly admitted that in his own interventional practice he performs about 80% of his cases by radial entry.) "Our hypothesis was a paradigm shift" that radial would result in a significantly reduced rate of a primary outcome of death, myocardial infarction, stroke, and bleeding not related to coronary bypass during the 30 days following percutaneous coronary intervention in patients with acute coronary syndrome.

The ambitious study enrolled 7,021 patients at 158 sites in 32 countries, piggybacked onto an acute coronary syndrome trial that tested clopidogrel and aspirin treatment (CURRENT–OASIS 7). The patient’s average age was 62 years, nearly three-quarters were men, and 45% had unstable angina, with the remaining patients split evenly between ST elevation myocardial infarction (MI) and non–ST-elevation MI.

The combined end point occurred in roughly 4% of patients in both groups. The rate of major bleeds not associated with coronary artery bypass surgery also occurred at roughly similar rates, just under 1%, in both the radial and femoral groups, an unexpected failure for the radial approach. "We expected to see a large decrease in major bleeds" in the radial access patients, Dr. Jolly said. "A take-home message is that in acute coronary syndrome both access site and non–access site bleeds are important." Concurrently with Dr. Jolly’s report, an article with the results was published online in The Lancet (Lancet 2011 April 4 [doi:10.1016/S0140-6736(11)60404-2]).

The only prespecified end point where radial access outperformed femoral access was in the secondary measure of major vascular access site complications: large hematomas, pseudoaneurysms requiring closure, arteriovenous fistula, and other vascular surgery related to the access site. In the radial group, this occurred in 1.4% of patients and in 3.7% of those in the femoral group, a statistically significant 63% relative risk reduction.

"By going radial you prevent complications at the access site," explained Dr. Jolly. These complications "don’t cause deaths," he admitted, "but they are important to patients. They can cause significant discomfort."

But others minimized the importance of access site complications.

"Access-site hematomas don’t impact mortality. Large bleeds are associated with mortality. Gastrointestinal bleeds, genitourinary bleeds, and intracranial bleeds really impact mortality," commented Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research and education at Columbia. Dr. Stone noted that he performs 99% of his coronary interventions via the femoral route.

Aside from the basic findings, perhaps the most notable results focused on the importance of operator and center experience in performing radial catheterizations. One prespecified subgroup analysis split the participating centers into tertiles based on their annual volume of radial-access procedures: those that did at least 146 a year (the highest tertile), those that did 61-145 radial procedures annually (middle tertile), and those performing 60 or fewer annually. The highest tertile centers showed a statistically significant reduction in the study’s primary end point when using radial access.

Also, focusing on outcomes in patients with an ST elevation MI showed that in this subgroup radial access produced a statistically significant reduction in the primary end point, an effect that Dr. Jolly speculated related to individual operator experience. "Radial access in the ST elevation MI patients primarily was done by the high-volume operators because of the time pressure." Only the most experienced operators were comfortable treating these patients radially, he said. Another issue was that these patients are more heavily treated with antiplatelet drugs, which magnified the benefit from radial access in cutting bleeding complications.

The subgroup findings convinced some cardiologists that RIVAL, in sum, scored a triumph for radial access.

"At the least, radial access reduced bleeding, and at best it improved the hard outcomes of death and MI" at the high volume centers, noted Dr. Khandelwal. "Perhaps our goal should be to emulate the operators in the top tertile," he said in an interview.

But Dr. Stone had the take of a femoral-artery enthusiast. "I don’t think in and of itself these data will change practice. What might change practice," he conceded, "is patient comfort."

Dr. Jolly said that he has received consultant fees or honoraria from Boehringer-Ingelheim, GlaxoSmithKline, and Sanofi-Aventis, and research grants from Merck. Dr. McNulty said he had no disclosures. Dr. Leon said he has been an unpaid consultant to Abbott, Boston Scientific, and Medtronic. Dr. Stone said that he has been a consultant to Inspire MD, Reva, Osprey, Lilly, BMS/Sanofi, Medtronic, AstraZeneca, Vascular Solutions, Gilead, The Medicines Company, Abbott Vascular, Boston Scientific, Ortho-McNeil, Edwards, and Merck; he has an ownership or partnership role in MiCardia, Biostar I and II, FlowCardia, Embrella, Caliber, Medfocus I and II, Accelerator, and Access Closure; and he has received research funds from InfraReDx, TherOx, Atrium, and Volcano. Dr. Khandelwal said he had no disclosures.

NEW ORLEANS – With broader use of radial-artery access for percutaneous coronary interventions already gaining momentum in the United States, results from the largest study by far to compare radial- and femoral-artery approaches may give an extra boost to the radial camp.

While results from the Radial vs Femoral Access for Coronary Intervention (RIVAL) trial showed primary end point equivalence for the two arterial access strategies in a 7,000-patient randomized trial, radial access may have won by not losing.

"The similar efficacy helps the radial approach, because there was a persistent uncertainty whether it really was as good as femoral, Dr. Sanjit S. Jolly, lead investigator of the trial, said at the annual meeting of the American College of Cardiology.

In addition, the study’s findings "in high-volume centers and in patients with ST elevation myocardial infarctions will produce more momentum for a shift," he predicted.

Interventional cardiologists in some countries have embraced radial-artery access for placing catheters aimed at the coronaries into patients. Dr. Jolly, a cardiologist at McMaster University in Hamilton, Canada, cited a greater than 90% rate among French interventionalists and a greater than 95% rate in Canada. But as recently as last summer, U.S. cardiologists used radial access for a mere 4% of their coronary catheterizations, based on data collected by the National Cardiovascular Data Registry, said Dr. Edward J. McNulty, an interventional cardiologist at Kaiser Permanente San Francisco.

The U.S. numbers clearly have a long way to go before they start to resemble what is now routine in many other places, but some clues at the meeting suggest they began trending up even before Dr. Jolly delivered the RIVAL results. For example, in a separate talk earlier in the meeting, Detroit interventionalist Dr. Akshay Khandelwal recounted his personal experience introducing radial access into his practice starting about 18 months ago. His cases gradually shifted, and by March roughly 75% of his coronary procedures used radial access. Following his lead, his colleagues at Henry Ford Hospital, Detroit, began to become radialists, too, and as of March 2011 a quarter of his cath lab’s coronary work occurred via the patient’s wrist, said Dr. Khandelwal, director of outpatient cardiovascular services at Henry Ford.

"At Columbia [University’s Center for Interventional Vascular Therapy] the frequency of radial access has increased," agreed Dr. Martin B. Leon, who directs the center in New York. "It was in single digits in 2010, but now, for the first time, it’s more than 20%. It’s climbing quickly. Many operators are becoming more interested in gaining expertise, particularly younger operators," he said.

Part of this shift is driven by physicians who believe they might achieve better results, with less bleeding and access site complications, and part comes from patient demand because most patients find the radial approach more comfortable. "Patients like it, and I think that will drive the option," Dr. McNulty said. Another important factor is cost.

"There is a recent trend in the U.S. to do more outpatient angioplasty in low-risk and stable patients," Dr. Leon said, and radial access makes same-day discharge feasible much more often than does femoral access. "If that trend continues, and the predictions are it will, you can imagine that the radial approach will be attractive."

Until RIVAL, prior comparisons of radial and femoral entry had been too small for a definitive comparison. Dr. Jolly and his associates designed their study to test their hunch that radial entry might actually produce better outcomes. (Dr. Jolly admitted that in his own interventional practice he performs about 80% of his cases by radial entry.) "Our hypothesis was a paradigm shift" that radial would result in a significantly reduced rate of a primary outcome of death, myocardial infarction, stroke, and bleeding not related to coronary bypass during the 30 days following percutaneous coronary intervention in patients with acute coronary syndrome.

The ambitious study enrolled 7,021 patients at 158 sites in 32 countries, piggybacked onto an acute coronary syndrome trial that tested clopidogrel and aspirin treatment (CURRENT–OASIS 7). The patient’s average age was 62 years, nearly three-quarters were men, and 45% had unstable angina, with the remaining patients split evenly between ST elevation myocardial infarction (MI) and non–ST-elevation MI.

The combined end point occurred in roughly 4% of patients in both groups. The rate of major bleeds not associated with coronary artery bypass surgery also occurred at roughly similar rates, just under 1%, in both the radial and femoral groups, an unexpected failure for the radial approach. "We expected to see a large decrease in major bleeds" in the radial access patients, Dr. Jolly said. "A take-home message is that in acute coronary syndrome both access site and non–access site bleeds are important." Concurrently with Dr. Jolly’s report, an article with the results was published online in The Lancet (Lancet 2011 April 4 [doi:10.1016/S0140-6736(11)60404-2]).

The only prespecified end point where radial access outperformed femoral access was in the secondary measure of major vascular access site complications: large hematomas, pseudoaneurysms requiring closure, arteriovenous fistula, and other vascular surgery related to the access site. In the radial group, this occurred in 1.4% of patients and in 3.7% of those in the femoral group, a statistically significant 63% relative risk reduction.

"By going radial you prevent complications at the access site," explained Dr. Jolly. These complications "don’t cause deaths," he admitted, "but they are important to patients. They can cause significant discomfort."

But others minimized the importance of access site complications.

"Access-site hematomas don’t impact mortality. Large bleeds are associated with mortality. Gastrointestinal bleeds, genitourinary bleeds, and intracranial bleeds really impact mortality," commented Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research and education at Columbia. Dr. Stone noted that he performs 99% of his coronary interventions via the femoral route.

Aside from the basic findings, perhaps the most notable results focused on the importance of operator and center experience in performing radial catheterizations. One prespecified subgroup analysis split the participating centers into tertiles based on their annual volume of radial-access procedures: those that did at least 146 a year (the highest tertile), those that did 61-145 radial procedures annually (middle tertile), and those performing 60 or fewer annually. The highest tertile centers showed a statistically significant reduction in the study’s primary end point when using radial access.

Also, focusing on outcomes in patients with an ST elevation MI showed that in this subgroup radial access produced a statistically significant reduction in the primary end point, an effect that Dr. Jolly speculated related to individual operator experience. "Radial access in the ST elevation MI patients primarily was done by the high-volume operators because of the time pressure." Only the most experienced operators were comfortable treating these patients radially, he said. Another issue was that these patients are more heavily treated with antiplatelet drugs, which magnified the benefit from radial access in cutting bleeding complications.

The subgroup findings convinced some cardiologists that RIVAL, in sum, scored a triumph for radial access.

"At the least, radial access reduced bleeding, and at best it improved the hard outcomes of death and MI" at the high volume centers, noted Dr. Khandelwal. "Perhaps our goal should be to emulate the operators in the top tertile," he said in an interview.

But Dr. Stone had the take of a femoral-artery enthusiast. "I don’t think in and of itself these data will change practice. What might change practice," he conceded, "is patient comfort."

Dr. Jolly said that he has received consultant fees or honoraria from Boehringer-Ingelheim, GlaxoSmithKline, and Sanofi-Aventis, and research grants from Merck. Dr. McNulty said he had no disclosures. Dr. Leon said he has been an unpaid consultant to Abbott, Boston Scientific, and Medtronic. Dr. Stone said that he has been a consultant to Inspire MD, Reva, Osprey, Lilly, BMS/Sanofi, Medtronic, AstraZeneca, Vascular Solutions, Gilead, The Medicines Company, Abbott Vascular, Boston Scientific, Ortho-McNeil, Edwards, and Merck; he has an ownership or partnership role in MiCardia, Biostar I and II, FlowCardia, Embrella, Caliber, Medfocus I and II, Accelerator, and Access Closure; and he has received research funds from InfraReDx, TherOx, Atrium, and Volcano. Dr. Khandelwal said he had no disclosures.

NEW ORLEANS – With broader use of radial-artery access for percutaneous coronary interventions already gaining momentum in the United States, results from the largest study by far to compare radial- and femoral-artery approaches may give an extra boost to the radial camp.

While results from the Radial vs Femoral Access for Coronary Intervention (RIVAL) trial showed primary end point equivalence for the two arterial access strategies in a 7,000-patient randomized trial, radial access may have won by not losing.

"The similar efficacy helps the radial approach, because there was a persistent uncertainty whether it really was as good as femoral, Dr. Sanjit S. Jolly, lead investigator of the trial, said at the annual meeting of the American College of Cardiology.

In addition, the study’s findings "in high-volume centers and in patients with ST elevation myocardial infarctions will produce more momentum for a shift," he predicted.

Interventional cardiologists in some countries have embraced radial-artery access for placing catheters aimed at the coronaries into patients. Dr. Jolly, a cardiologist at McMaster University in Hamilton, Canada, cited a greater than 90% rate among French interventionalists and a greater than 95% rate in Canada. But as recently as last summer, U.S. cardiologists used radial access for a mere 4% of their coronary catheterizations, based on data collected by the National Cardiovascular Data Registry, said Dr. Edward J. McNulty, an interventional cardiologist at Kaiser Permanente San Francisco.

The U.S. numbers clearly have a long way to go before they start to resemble what is now routine in many other places, but some clues at the meeting suggest they began trending up even before Dr. Jolly delivered the RIVAL results. For example, in a separate talk earlier in the meeting, Detroit interventionalist Dr. Akshay Khandelwal recounted his personal experience introducing radial access into his practice starting about 18 months ago. His cases gradually shifted, and by March roughly 75% of his coronary procedures used radial access. Following his lead, his colleagues at Henry Ford Hospital, Detroit, began to become radialists, too, and as of March 2011 a quarter of his cath lab’s coronary work occurred via the patient’s wrist, said Dr. Khandelwal, director of outpatient cardiovascular services at Henry Ford.

"At Columbia [University’s Center for Interventional Vascular Therapy] the frequency of radial access has increased," agreed Dr. Martin B. Leon, who directs the center in New York. "It was in single digits in 2010, but now, for the first time, it’s more than 20%. It’s climbing quickly. Many operators are becoming more interested in gaining expertise, particularly younger operators," he said.

Part of this shift is driven by physicians who believe they might achieve better results, with less bleeding and access site complications, and part comes from patient demand because most patients find the radial approach more comfortable. "Patients like it, and I think that will drive the option," Dr. McNulty said. Another important factor is cost.

"There is a recent trend in the U.S. to do more outpatient angioplasty in low-risk and stable patients," Dr. Leon said, and radial access makes same-day discharge feasible much more often than does femoral access. "If that trend continues, and the predictions are it will, you can imagine that the radial approach will be attractive."

Until RIVAL, prior comparisons of radial and femoral entry had been too small for a definitive comparison. Dr. Jolly and his associates designed their study to test their hunch that radial entry might actually produce better outcomes. (Dr. Jolly admitted that in his own interventional practice he performs about 80% of his cases by radial entry.) "Our hypothesis was a paradigm shift" that radial would result in a significantly reduced rate of a primary outcome of death, myocardial infarction, stroke, and bleeding not related to coronary bypass during the 30 days following percutaneous coronary intervention in patients with acute coronary syndrome.

The ambitious study enrolled 7,021 patients at 158 sites in 32 countries, piggybacked onto an acute coronary syndrome trial that tested clopidogrel and aspirin treatment (CURRENT–OASIS 7). The patient’s average age was 62 years, nearly three-quarters were men, and 45% had unstable angina, with the remaining patients split evenly between ST elevation myocardial infarction (MI) and non–ST-elevation MI.

The combined end point occurred in roughly 4% of patients in both groups. The rate of major bleeds not associated with coronary artery bypass surgery also occurred at roughly similar rates, just under 1%, in both the radial and femoral groups, an unexpected failure for the radial approach. "We expected to see a large decrease in major bleeds" in the radial access patients, Dr. Jolly said. "A take-home message is that in acute coronary syndrome both access site and non–access site bleeds are important." Concurrently with Dr. Jolly’s report, an article with the results was published online in The Lancet (Lancet 2011 April 4 [doi:10.1016/S0140-6736(11)60404-2]).

The only prespecified end point where radial access outperformed femoral access was in the secondary measure of major vascular access site complications: large hematomas, pseudoaneurysms requiring closure, arteriovenous fistula, and other vascular surgery related to the access site. In the radial group, this occurred in 1.4% of patients and in 3.7% of those in the femoral group, a statistically significant 63% relative risk reduction.

"By going radial you prevent complications at the access site," explained Dr. Jolly. These complications "don’t cause deaths," he admitted, "but they are important to patients. They can cause significant discomfort."

But others minimized the importance of access site complications.

"Access-site hematomas don’t impact mortality. Large bleeds are associated with mortality. Gastrointestinal bleeds, genitourinary bleeds, and intracranial bleeds really impact mortality," commented Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research and education at Columbia. Dr. Stone noted that he performs 99% of his coronary interventions via the femoral route.

Aside from the basic findings, perhaps the most notable results focused on the importance of operator and center experience in performing radial catheterizations. One prespecified subgroup analysis split the participating centers into tertiles based on their annual volume of radial-access procedures: those that did at least 146 a year (the highest tertile), those that did 61-145 radial procedures annually (middle tertile), and those performing 60 or fewer annually. The highest tertile centers showed a statistically significant reduction in the study’s primary end point when using radial access.

Also, focusing on outcomes in patients with an ST elevation MI showed that in this subgroup radial access produced a statistically significant reduction in the primary end point, an effect that Dr. Jolly speculated related to individual operator experience. "Radial access in the ST elevation MI patients primarily was done by the high-volume operators because of the time pressure." Only the most experienced operators were comfortable treating these patients radially, he said. Another issue was that these patients are more heavily treated with antiplatelet drugs, which magnified the benefit from radial access in cutting bleeding complications.

The subgroup findings convinced some cardiologists that RIVAL, in sum, scored a triumph for radial access.

"At the least, radial access reduced bleeding, and at best it improved the hard outcomes of death and MI" at the high volume centers, noted Dr. Khandelwal. "Perhaps our goal should be to emulate the operators in the top tertile," he said in an interview.

But Dr. Stone had the take of a femoral-artery enthusiast. "I don’t think in and of itself these data will change practice. What might change practice," he conceded, "is patient comfort."

Dr. Jolly said that he has received consultant fees or honoraria from Boehringer-Ingelheim, GlaxoSmithKline, and Sanofi-Aventis, and research grants from Merck. Dr. McNulty said he had no disclosures. Dr. Leon said he has been an unpaid consultant to Abbott, Boston Scientific, and Medtronic. Dr. Stone said that he has been a consultant to Inspire MD, Reva, Osprey, Lilly, BMS/Sanofi, Medtronic, AstraZeneca, Vascular Solutions, Gilead, The Medicines Company, Abbott Vascular, Boston Scientific, Ortho-McNeil, Edwards, and Merck; he has an ownership or partnership role in MiCardia, Biostar I and II, FlowCardia, Embrella, Caliber, Medfocus I and II, Accelerator, and Access Closure; and he has received research funds from InfraReDx, TherOx, Atrium, and Volcano. Dr. Khandelwal said he had no disclosures.

NEW ORLEANS – With broader use of radial-artery access for percutaneous coronary interventions already gaining momentum in the United States, results from the largest study by far to compare radial- and femoral-artery approaches may give an extra boost to the radial camp.

While results from the Radial vs Femoral Access for Coronary Intervention (RIVAL) trial showed primary end point equivalence for the two arterial access strategies in a 7,000-patient randomized trial, radial access may have won by not losing.

"The similar efficacy helps the radial approach, because there was a persistent uncertainty whether it really was as good as femoral, Dr. Sanjit S. Jolly, lead investigator of the trial, said at the annual meeting of the American College of Cardiology.

In addition, the study’s findings "in high-volume centers and in patients with ST elevation myocardial infarctions will produce more momentum for a shift," he predicted.

Interventional cardiologists in some countries have embraced radial-artery access for placing catheters aimed at the coronaries into patients. Dr. Jolly, a cardiologist at McMaster University in Hamilton, Canada, cited a greater than 90% rate among French interventionalists and a greater than 95% rate in Canada. But as recently as last summer, U.S. cardiologists used radial access for a mere 4% of their coronary catheterizations, based on data collected by the National Cardiovascular Data Registry, said Dr. Edward J. McNulty, an interventional cardiologist at Kaiser Permanente San Francisco.

The U.S. numbers clearly have a long way to go before they start to resemble what is now routine in many other places, but some clues at the meeting suggest they began trending up even before Dr. Jolly delivered the RIVAL results. For example, in a separate talk earlier in the meeting, Detroit interventionalist Dr. Akshay Khandelwal recounted his personal experience introducing radial access into his practice starting about 18 months ago. His cases gradually shifted, and by March roughly 75% of his coronary procedures used radial access. Following his lead, his colleagues at Henry Ford Hospital, Detroit, began to become radialists, too, and as of March 2011 a quarter of his cath lab’s coronary work occurred via the patient’s wrist, said Dr. Khandelwal, director of outpatient cardiovascular services at Henry Ford.

"At Columbia [University’s Center for Interventional Vascular Therapy] the frequency of radial access has increased," agreed Dr. Martin B. Leon, who directs the center in New York. "It was in single digits in 2010, but now, for the first time, it’s more than 20%. It’s climbing quickly. Many operators are becoming more interested in gaining expertise, particularly younger operators," he said.

Part of this shift is driven by physicians who believe they might achieve better results, with less bleeding and access site complications, and part comes from patient demand because most patients find the radial approach more comfortable. "Patients like it, and I think that will drive the option," Dr. McNulty said. Another important factor is cost.

"There is a recent trend in the U.S. to do more outpatient angioplasty in low-risk and stable patients," Dr. Leon said, and radial access makes same-day discharge feasible much more often than does femoral access. "If that trend continues, and the predictions are it will, you can imagine that the radial approach will be attractive."

Until RIVAL, prior comparisons of radial and femoral entry had been too small for a definitive comparison. Dr. Jolly and his associates designed their study to test their hunch that radial entry might actually produce better outcomes. (Dr. Jolly admitted that in his own interventional practice he performs about 80% of his cases by radial entry.) "Our hypothesis was a paradigm shift" that radial would result in a significantly reduced rate of a primary outcome of death, myocardial infarction, stroke, and bleeding not related to coronary bypass during the 30 days following percutaneous coronary intervention in patients with acute coronary syndrome.

The ambitious study enrolled 7,021 patients at 158 sites in 32 countries, piggybacked onto an acute coronary syndrome trial that tested clopidogrel and aspirin treatment (CURRENT–OASIS 7). The patient’s average age was 62 years, nearly three-quarters were men, and 45% had unstable angina, with the remaining patients split evenly between ST elevation myocardial infarction (MI) and non–ST-elevation MI.

The combined end point occurred in roughly 4% of patients in both groups. The rate of major bleeds not associated with coronary artery bypass surgery also occurred at roughly similar rates, just under 1%, in both the radial and femoral groups, an unexpected failure for the radial approach. "We expected to see a large decrease in major bleeds" in the radial access patients, Dr. Jolly said. "A take-home message is that in acute coronary syndrome both access site and non–access site bleeds are important." Concurrently with Dr. Jolly’s report, an article with the results was published online in The Lancet (Lancet 2011 April 4 [doi:10.1016/S0140-6736(11)60404-2]).

The only prespecified end point where radial access outperformed femoral access was in the secondary measure of major vascular access site complications: large hematomas, pseudoaneurysms requiring closure, arteriovenous fistula, and other vascular surgery related to the access site. In the radial group, this occurred in 1.4% of patients and in 3.7% of those in the femoral group, a statistically significant 63% relative risk reduction.

"By going radial you prevent complications at the access site," explained Dr. Jolly. These complications "don’t cause deaths," he admitted, "but they are important to patients. They can cause significant discomfort."

But others minimized the importance of access site complications.

"Access-site hematomas don’t impact mortality. Large bleeds are associated with mortality. Gastrointestinal bleeds, genitourinary bleeds, and intracranial bleeds really impact mortality," commented Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research and education at Columbia. Dr. Stone noted that he performs 99% of his coronary interventions via the femoral route.

Aside from the basic findings, perhaps the most notable results focused on the importance of operator and center experience in performing radial catheterizations. One prespecified subgroup analysis split the participating centers into tertiles based on their annual volume of radial-access procedures: those that did at least 146 a year (the highest tertile), those that did 61-145 radial procedures annually (middle tertile), and those performing 60 or fewer annually. The highest tertile centers showed a statistically significant reduction in the study’s primary end point when using radial access.

Also, focusing on outcomes in patients with an ST elevation MI showed that in this subgroup radial access produced a statistically significant reduction in the primary end point, an effect that Dr. Jolly speculated related to individual operator experience. "Radial access in the ST elevation MI patients primarily was done by the high-volume operators because of the time pressure." Only the most experienced operators were comfortable treating these patients radially, he said. Another issue was that these patients are more heavily treated with antiplatelet drugs, which magnified the benefit from radial access in cutting bleeding complications.

The subgroup findings convinced some cardiologists that RIVAL, in sum, scored a triumph for radial access.

"At the least, radial access reduced bleeding, and at best it improved the hard outcomes of death and MI" at the high volume centers, noted Dr. Khandelwal. "Perhaps our goal should be to emulate the operators in the top tertile," he said in an interview.

But Dr. Stone had the take of a femoral-artery enthusiast. "I don’t think in and of itself these data will change practice. What might change practice," he conceded, "is patient comfort."

Dr. Jolly said that he has received consultant fees or honoraria from Boehringer-Ingelheim, GlaxoSmithKline, and Sanofi-Aventis, and research grants from Merck. Dr. McNulty said he had no disclosures. Dr. Leon said he has been an unpaid consultant to Abbott, Boston Scientific, and Medtronic. Dr. Stone said that he has been a consultant to Inspire MD, Reva, Osprey, Lilly, BMS/Sanofi, Medtronic, AstraZeneca, Vascular Solutions, Gilead, The Medicines Company, Abbott Vascular, Boston Scientific, Ortho-McNeil, Edwards, and Merck; he has an ownership or partnership role in MiCardia, Biostar I and II, FlowCardia, Embrella, Caliber, Medfocus I and II, Accelerator, and Access Closure; and he has received research funds from InfraReDx, TherOx, Atrium, and Volcano. Dr. Khandelwal said he had no disclosures.

LAS VEGAS – The evidence supporting use of extracorporeal membrane oxygenation for treating adult patients with severe hypoxic lung failure remains uncompelling, according to Dr. Alan H. Morris.

He particularly advised against widespread use of extracorporeal membrane oxygenation (ECMO) in patients who have severe acute respiratory distress syndrome secondary to H1N1 influenza infection, as there is also no evidence that H1N1 patients treated with ECMO had better outcomes than those treated with standard ventilation support.

"We need results from a credible randomized controlled trial to define the conditions surrounding ECMO, before ECMO becomes a routine therapy option," said Dr. Morris, a pulmonologist and professor of medicine at the University of Utah and Intermountain Health Medical Center in Salt Lake City.

"There are indications and applications of extracorporeal support that are straightforward," such as when it is used intraoperatively, he said. But for patients with severe hypoxic lung failure, "I do not see compelling evidence that extracorporeal support is followed by more favorable outcomes than other approaches that are used," he said in an interview. "The evidence from the H1N1 novel influenza epidemic indicates to me that survival appears to be roughly the same with or without extracorporeal support," he added. "We do not offer ECMO as treatment for adult patients with severe hypoxic lung failure in my hospital."

The only two studies that examined the efficacy of ECMO in rigorously controlled clinical trials, published as reports in 1979 and in 1994, both failed to show that ECMO improved patient survival, he noted (JAMA 1979;242:2193-6; Am. J. Respir. Crit. Care Med. 1994;149:295-305). More recent results from a British multicenter randomized trial with 180 adults with severe respiratory failure claimed to show evidence that patient survival with ECMO surpassed survival with usual care (Lancet 2009;374:1351-63). But the newer study had the flaw of failing to define the usual care received by the control patients. In addition, the control patients were distributed to many centers, while all the ECMO patients received their treatment at one center, Dr. Morris said. The conventional ventilation that control patients received could be whatever their attending intensivist thought appropriate.

"How does a clinician know which patients will benefit [from ECMO] without knowing what was conventional treatment?" he said.

To assess the impact of ECMO in patients with acute respiratory distress secondary to H1N1 infection, Dr. Morris summarized data reported on 150 patients in a University of Michigan registry; 14 patients seen in Salt Lake County, Utah, and reported last year in a paper at the American Thoracic Society; a series of 68 patients reported from Australia and New Zealand (JAMA 2009;302:1888-95); and 896 U.S. patients entered into a registry of the National Heart, Lung, and Blood Institute during April 2009 to April 2010. These data showed a consistent pattern of no improved survival with ECMO treatment in H1N1 patients, compared with H1N1 patients who did not receive ECMO, Dr. Morris said.

He also expressed concern that a well-designed study to compare modern ECMO with other ventilation support methods would be a challenge. A major problem is that the physicians "who have ECMO skills are convinced of its efficacy. Those who do ECMO don’t believe that better testing is needed," Dr. Morris said.

He reported having no relevant financial disclosures.

LAS VEGAS – The evidence supporting use of extracorporeal membrane oxygenation for treating adult patients with severe hypoxic lung failure remains uncompelling, according to Dr. Alan H. Morris.

He particularly advised against widespread use of extracorporeal membrane oxygenation (ECMO) in patients who have severe acute respiratory distress syndrome secondary to H1N1 influenza infection, as there is also no evidence that H1N1 patients treated with ECMO had better outcomes than those treated with standard ventilation support.

"We need results from a credible randomized controlled trial to define the conditions surrounding ECMO, before ECMO becomes a routine therapy option," said Dr. Morris, a pulmonologist and professor of medicine at the University of Utah and Intermountain Health Medical Center in Salt Lake City.

"There are indications and applications of extracorporeal support that are straightforward," such as when it is used intraoperatively, he said. But for patients with severe hypoxic lung failure, "I do not see compelling evidence that extracorporeal support is followed by more favorable outcomes than other approaches that are used," he said in an interview. "The evidence from the H1N1 novel influenza epidemic indicates to me that survival appears to be roughly the same with or without extracorporeal support," he added. "We do not offer ECMO as treatment for adult patients with severe hypoxic lung failure in my hospital."

The only two studies that examined the efficacy of ECMO in rigorously controlled clinical trials, published as reports in 1979 and in 1994, both failed to show that ECMO improved patient survival, he noted (JAMA 1979;242:2193-6; Am. J. Respir. Crit. Care Med. 1994;149:295-305). More recent results from a British multicenter randomized trial with 180 adults with severe respiratory failure claimed to show evidence that patient survival with ECMO surpassed survival with usual care (Lancet 2009;374:1351-63). But the newer study had the flaw of failing to define the usual care received by the control patients. In addition, the control patients were distributed to many centers, while all the ECMO patients received their treatment at one center, Dr. Morris said. The conventional ventilation that control patients received could be whatever their attending intensivist thought appropriate.

"How does a clinician know which patients will benefit [from ECMO] without knowing what was conventional treatment?" he said.

To assess the impact of ECMO in patients with acute respiratory distress secondary to H1N1 infection, Dr. Morris summarized data reported on 150 patients in a University of Michigan registry; 14 patients seen in Salt Lake County, Utah, and reported last year in a paper at the American Thoracic Society; a series of 68 patients reported from Australia and New Zealand (JAMA 2009;302:1888-95); and 896 U.S. patients entered into a registry of the National Heart, Lung, and Blood Institute during April 2009 to April 2010. These data showed a consistent pattern of no improved survival with ECMO treatment in H1N1 patients, compared with H1N1 patients who did not receive ECMO, Dr. Morris said.

He also expressed concern that a well-designed study to compare modern ECMO with other ventilation support methods would be a challenge. A major problem is that the physicians "who have ECMO skills are convinced of its efficacy. Those who do ECMO don’t believe that better testing is needed," Dr. Morris said.

He reported having no relevant financial disclosures.

LAS VEGAS – The evidence supporting use of extracorporeal membrane oxygenation for treating adult patients with severe hypoxic lung failure remains uncompelling, according to Dr. Alan H. Morris.

He particularly advised against widespread use of extracorporeal membrane oxygenation (ECMO) in patients who have severe acute respiratory distress syndrome secondary to H1N1 influenza infection, as there is also no evidence that H1N1 patients treated with ECMO had better outcomes than those treated with standard ventilation support.

"We need results from a credible randomized controlled trial to define the conditions surrounding ECMO, before ECMO becomes a routine therapy option," said Dr. Morris, a pulmonologist and professor of medicine at the University of Utah and Intermountain Health Medical Center in Salt Lake City.

"There are indications and applications of extracorporeal support that are straightforward," such as when it is used intraoperatively, he said. But for patients with severe hypoxic lung failure, "I do not see compelling evidence that extracorporeal support is followed by more favorable outcomes than other approaches that are used," he said in an interview. "The evidence from the H1N1 novel influenza epidemic indicates to me that survival appears to be roughly the same with or without extracorporeal support," he added. "We do not offer ECMO as treatment for adult patients with severe hypoxic lung failure in my hospital."

The only two studies that examined the efficacy of ECMO in rigorously controlled clinical trials, published as reports in 1979 and in 1994, both failed to show that ECMO improved patient survival, he noted (JAMA 1979;242:2193-6; Am. J. Respir. Crit. Care Med. 1994;149:295-305). More recent results from a British multicenter randomized trial with 180 adults with severe respiratory failure claimed to show evidence that patient survival with ECMO surpassed survival with usual care (Lancet 2009;374:1351-63). But the newer study had the flaw of failing to define the usual care received by the control patients. In addition, the control patients were distributed to many centers, while all the ECMO patients received their treatment at one center, Dr. Morris said. The conventional ventilation that control patients received could be whatever their attending intensivist thought appropriate.

"How does a clinician know which patients will benefit [from ECMO] without knowing what was conventional treatment?" he said.

To assess the impact of ECMO in patients with acute respiratory distress secondary to H1N1 infection, Dr. Morris summarized data reported on 150 patients in a University of Michigan registry; 14 patients seen in Salt Lake County, Utah, and reported last year in a paper at the American Thoracic Society; a series of 68 patients reported from Australia and New Zealand (JAMA 2009;302:1888-95); and 896 U.S. patients entered into a registry of the National Heart, Lung, and Blood Institute during April 2009 to April 2010. These data showed a consistent pattern of no improved survival with ECMO treatment in H1N1 patients, compared with H1N1 patients who did not receive ECMO, Dr. Morris said.

He also expressed concern that a well-designed study to compare modern ECMO with other ventilation support methods would be a challenge. A major problem is that the physicians "who have ECMO skills are convinced of its efficacy. Those who do ECMO don’t believe that better testing is needed," Dr. Morris said.

He reported having no relevant financial disclosures.

LAS VEGAS – The evidence supporting use of extracorporeal membrane oxygenation for treating adult patients with severe hypoxic lung failure remains uncompelling, according to Dr. Alan H. Morris.

He particularly advised against widespread use of extracorporeal membrane oxygenation (ECMO) in patients who have severe acute respiratory distress syndrome secondary to H1N1 influenza infection, as there is also no evidence that H1N1 patients treated with ECMO had better outcomes than those treated with standard ventilation support.

"We need results from a credible randomized controlled trial to define the conditions surrounding ECMO, before ECMO becomes a routine therapy option," said Dr. Morris, a pulmonologist and professor of medicine at the University of Utah and Intermountain Health Medical Center in Salt Lake City.

"There are indications and applications of extracorporeal support that are straightforward," such as when it is used intraoperatively, he said. But for patients with severe hypoxic lung failure, "I do not see compelling evidence that extracorporeal support is followed by more favorable outcomes than other approaches that are used," he said in an interview. "The evidence from the H1N1 novel influenza epidemic indicates to me that survival appears to be roughly the same with or without extracorporeal support," he added. "We do not offer ECMO as treatment for adult patients with severe hypoxic lung failure in my hospital."

The only two studies that examined the efficacy of ECMO in rigorously controlled clinical trials, published as reports in 1979 and in 1994, both failed to show that ECMO improved patient survival, he noted (JAMA 1979;242:2193-6; Am. J. Respir. Crit. Care Med. 1994;149:295-305). More recent results from a British multicenter randomized trial with 180 adults with severe respiratory failure claimed to show evidence that patient survival with ECMO surpassed survival with usual care (Lancet 2009;374:1351-63). But the newer study had the flaw of failing to define the usual care received by the control patients. In addition, the control patients were distributed to many centers, while all the ECMO patients received their treatment at one center, Dr. Morris said. The conventional ventilation that control patients received could be whatever their attending intensivist thought appropriate.

"How does a clinician know which patients will benefit [from ECMO] without knowing what was conventional treatment?" he said.

To assess the impact of ECMO in patients with acute respiratory distress secondary to H1N1 infection, Dr. Morris summarized data reported on 150 patients in a University of Michigan registry; 14 patients seen in Salt Lake County, Utah, and reported last year in a paper at the American Thoracic Society; a series of 68 patients reported from Australia and New Zealand (JAMA 2009;302:1888-95); and 896 U.S. patients entered into a registry of the National Heart, Lung, and Blood Institute during April 2009 to April 2010. These data showed a consistent pattern of no improved survival with ECMO treatment in H1N1 patients, compared with H1N1 patients who did not receive ECMO, Dr. Morris said.

He also expressed concern that a well-designed study to compare modern ECMO with other ventilation support methods would be a challenge. A major problem is that the physicians "who have ECMO skills are convinced of its efficacy. Those who do ECMO don’t believe that better testing is needed," Dr. Morris said.

He reported having no relevant financial disclosures.

LAS VEGAS – The evidence supporting use of extracorporeal membrane oxygenation for treating adult patients with severe hypoxic lung failure remains uncompelling, according to Dr. Alan H. Morris.

He particularly advised against widespread use of extracorporeal membrane oxygenation (ECMO) in patients who have severe acute respiratory distress syndrome secondary to H1N1 influenza infection, as there is also no evidence that H1N1 patients treated with ECMO had better outcomes than those treated with standard ventilation support.

"We need results from a credible randomized controlled trial to define the conditions surrounding ECMO, before ECMO becomes a routine therapy option," said Dr. Morris, a pulmonologist and professor of medicine at the University of Utah and Intermountain Health Medical Center in Salt Lake City.

"There are indications and applications of extracorporeal support that are straightforward," such as when it is used intraoperatively, he said. But for patients with severe hypoxic lung failure, "I do not see compelling evidence that extracorporeal support is followed by more favorable outcomes than other approaches that are used," he said in an interview. "The evidence from the H1N1 novel influenza epidemic indicates to me that survival appears to be roughly the same with or without extracorporeal support," he added. "We do not offer ECMO as treatment for adult patients with severe hypoxic lung failure in my hospital."

The only two studies that examined the efficacy of ECMO in rigorously controlled clinical trials, published as reports in 1979 and in 1994, both failed to show that ECMO improved patient survival, he noted (JAMA 1979;242:2193-6; Am. J. Respir. Crit. Care Med. 1994;149:295-305). More recent results from a British multicenter randomized trial with 180 adults with severe respiratory failure claimed to show evidence that patient survival with ECMO surpassed survival with usual care (Lancet 2009;374:1351-63). But the newer study had the flaw of failing to define the usual care received by the control patients. In addition, the control patients were distributed to many centers, while all the ECMO patients received their treatment at one center, Dr. Morris said. The conventional ventilation that control patients received could be whatever their attending intensivist thought appropriate.

"How does a clinician know which patients will benefit [from ECMO] without knowing what was conventional treatment?" he said.

To assess the impact of ECMO in patients with acute respiratory distress secondary to H1N1 infection, Dr. Morris summarized data reported on 150 patients in a University of Michigan registry; 14 patients seen in Salt Lake County, Utah, and reported last year in a paper at the American Thoracic Society; a series of 68 patients reported from Australia and New Zealand (JAMA 2009;302:1888-95); and 896 U.S. patients entered into a registry of the National Heart, Lung, and Blood Institute during April 2009 to April 2010. These data showed a consistent pattern of no improved survival with ECMO treatment in H1N1 patients, compared with H1N1 patients who did not receive ECMO, Dr. Morris said.

He also expressed concern that a well-designed study to compare modern ECMO with other ventilation support methods would be a challenge. A major problem is that the physicians "who have ECMO skills are convinced of its efficacy. Those who do ECMO don’t believe that better testing is needed," Dr. Morris said.

He reported having no relevant financial disclosures.

LAS VEGAS – The evidence supporting use of extracorporeal membrane oxygenation for treating adult patients with severe hypoxic lung failure remains uncompelling, according to Dr. Alan H. Morris.

He particularly advised against widespread use of extracorporeal membrane oxygenation (ECMO) in patients who have severe acute respiratory distress syndrome secondary to H1N1 influenza infection, as there is also no evidence that H1N1 patients treated with ECMO had better outcomes than those treated with standard ventilation support.

"We need results from a credible randomized controlled trial to define the conditions surrounding ECMO, before ECMO becomes a routine therapy option," said Dr. Morris, a pulmonologist and professor of medicine at the University of Utah and Intermountain Health Medical Center in Salt Lake City.

"There are indications and applications of extracorporeal support that are straightforward," such as when it is used intraoperatively, he said. But for patients with severe hypoxic lung failure, "I do not see compelling evidence that extracorporeal support is followed by more favorable outcomes than other approaches that are used," he said in an interview. "The evidence from the H1N1 novel influenza epidemic indicates to me that survival appears to be roughly the same with or without extracorporeal support," he added. "We do not offer ECMO as treatment for adult patients with severe hypoxic lung failure in my hospital."

The only two studies that examined the efficacy of ECMO in rigorously controlled clinical trials, published as reports in 1979 and in 1994, both failed to show that ECMO improved patient survival, he noted (JAMA 1979;242:2193-6; Am. J. Respir. Crit. Care Med. 1994;149:295-305). More recent results from a British multicenter randomized trial with 180 adults with severe respiratory failure claimed to show evidence that patient survival with ECMO surpassed survival with usual care (Lancet 2009;374:1351-63). But the newer study had the flaw of failing to define the usual care received by the control patients. In addition, the control patients were distributed to many centers, while all the ECMO patients received their treatment at one center, Dr. Morris said. The conventional ventilation that control patients received could be whatever their attending intensivist thought appropriate.

"How does a clinician know which patients will benefit [from ECMO] without knowing what was conventional treatment?" he said.

To assess the impact of ECMO in patients with acute respiratory distress secondary to H1N1 infection, Dr. Morris summarized data reported on 150 patients in a University of Michigan registry; 14 patients seen in Salt Lake County, Utah, and reported last year in a paper at the American Thoracic Society; a series of 68 patients reported from Australia and New Zealand (JAMA 2009;302:1888-95); and 896 U.S. patients entered into a registry of the National Heart, Lung, and Blood Institute during April 2009 to April 2010. These data showed a consistent pattern of no improved survival with ECMO treatment in H1N1 patients, compared with H1N1 patients who did not receive ECMO, Dr. Morris said.

He also expressed concern that a well-designed study to compare modern ECMO with other ventilation support methods would be a challenge. A major problem is that the physicians "who have ECMO skills are convinced of its efficacy. Those who do ECMO don’t believe that better testing is needed," Dr. Morris said.

He reported having no relevant financial disclosures.

LAS VEGAS – The evidence supporting use of extracorporeal membrane oxygenation for treating adult patients with severe hypoxic lung failure remains uncompelling, according to Dr. Alan H. Morris.

He particularly advised against widespread use of extracorporeal membrane oxygenation (ECMO) in patients who have severe acute respiratory distress syndrome secondary to H1N1 influenza infection, as there is also no evidence that H1N1 patients treated with ECMO had better outcomes than those treated with standard ventilation support.

"We need results from a credible randomized controlled trial to define the conditions surrounding ECMO, before ECMO becomes a routine therapy option," said Dr. Morris, a pulmonologist and professor of medicine at the University of Utah and Intermountain Health Medical Center in Salt Lake City.

"There are indications and applications of extracorporeal support that are straightforward," such as when it is used intraoperatively, he said. But for patients with severe hypoxic lung failure, "I do not see compelling evidence that extracorporeal support is followed by more favorable outcomes than other approaches that are used," he said in an interview. "The evidence from the H1N1 novel influenza epidemic indicates to me that survival appears to be roughly the same with or without extracorporeal support," he added. "We do not offer ECMO as treatment for adult patients with severe hypoxic lung failure in my hospital."

The only two studies that examined the efficacy of ECMO in rigorously controlled clinical trials, published as reports in 1979 and in 1994, both failed to show that ECMO improved patient survival, he noted (JAMA 1979;242:2193-6; Am. J. Respir. Crit. Care Med. 1994;149:295-305). More recent results from a British multicenter randomized trial with 180 adults with severe respiratory failure claimed to show evidence that patient survival with ECMO surpassed survival with usual care (Lancet 2009;374:1351-63). But the newer study had the flaw of failing to define the usual care received by the control patients. In addition, the control patients were distributed to many centers, while all the ECMO patients received their treatment at one center, Dr. Morris said. The conventional ventilation that control patients received could be whatever their attending intensivist thought appropriate.

"How does a clinician know which patients will benefit [from ECMO] without knowing what was conventional treatment?" he said.

To assess the impact of ECMO in patients with acute respiratory distress secondary to H1N1 infection, Dr. Morris summarized data reported on 150 patients in a University of Michigan registry; 14 patients seen in Salt Lake County, Utah, and reported last year in a paper at the American Thoracic Society; a series of 68 patients reported from Australia and New Zealand (JAMA 2009;302:1888-95); and 896 U.S. patients entered into a registry of the National Heart, Lung, and Blood Institute during April 2009 to April 2010. These data showed a consistent pattern of no improved survival with ECMO treatment in H1N1 patients, compared with H1N1 patients who did not receive ECMO, Dr. Morris said.

He also expressed concern that a well-designed study to compare modern ECMO with other ventilation support methods would be a challenge. A major problem is that the physicians "who have ECMO skills are convinced of its efficacy. Those who do ECMO don’t believe that better testing is needed," Dr. Morris said.

He reported having no relevant financial disclosures.

LAS VEGAS – The evidence supporting use of extracorporeal membrane oxygenation for treating adult patients with severe hypoxic lung failure remains uncompelling, according to Dr. Alan H. Morris.

He particularly advised against widespread use of extracorporeal membrane oxygenation (ECMO) in patients who have severe acute respiratory distress syndrome secondary to H1N1 influenza infection, as there is also no evidence that H1N1 patients treated with ECMO had better outcomes than those treated with standard ventilation support.

"We need results from a credible randomized controlled trial to define the conditions surrounding ECMO, before ECMO becomes a routine therapy option," said Dr. Morris, a pulmonologist and professor of medicine at the University of Utah and Intermountain Health Medical Center in Salt Lake City.

"There are indications and applications of extracorporeal support that are straightforward," such as when it is used intraoperatively, he said. But for patients with severe hypoxic lung failure, "I do not see compelling evidence that extracorporeal support is followed by more favorable outcomes than other approaches that are used," he said in an interview. "The evidence from the H1N1 novel influenza epidemic indicates to me that survival appears to be roughly the same with or without extracorporeal support," he added. "We do not offer ECMO as treatment for adult patients with severe hypoxic lung failure in my hospital."

The only two studies that examined the efficacy of ECMO in rigorously controlled clinical trials, published as reports in 1979 and in 1994, both failed to show that ECMO improved patient survival, he noted (JAMA 1979;242:2193-6; Am. J. Respir. Crit. Care Med. 1994;149:295-305). More recent results from a British multicenter randomized trial with 180 adults with severe respiratory failure claimed to show evidence that patient survival with ECMO surpassed survival with usual care (Lancet 2009;374:1351-63). But the newer study had the flaw of failing to define the usual care received by the control patients. In addition, the control patients were distributed to many centers, while all the ECMO patients received their treatment at one center, Dr. Morris said. The conventional ventilation that control patients received could be whatever their attending intensivist thought appropriate.

"How does a clinician know which patients will benefit [from ECMO] without knowing what was conventional treatment?" he said.

To assess the impact of ECMO in patients with acute respiratory distress secondary to H1N1 infection, Dr. Morris summarized data reported on 150 patients in a University of Michigan registry; 14 patients seen in Salt Lake County, Utah, and reported last year in a paper at the American Thoracic Society; a series of 68 patients reported from Australia and New Zealand (JAMA 2009;302:1888-95); and 896 U.S. patients entered into a registry of the National Heart, Lung, and Blood Institute during April 2009 to April 2010. These data showed a consistent pattern of no improved survival with ECMO treatment in H1N1 patients, compared with H1N1 patients who did not receive ECMO, Dr. Morris said.

He also expressed concern that a well-designed study to compare modern ECMO with other ventilation support methods would be a challenge. A major problem is that the physicians "who have ECMO skills are convinced of its efficacy. Those who do ECMO don’t believe that better testing is needed," Dr. Morris said.

He reported having no relevant financial disclosures.

LAS VEGAS – The evidence supporting use of extracorporeal membrane oxygenation for treating adult patients with severe hypoxic lung failure remains uncompelling, according to Dr. Alan H. Morris.

He particularly advised against widespread use of extracorporeal membrane oxygenation (ECMO) in patients who have severe acute respiratory distress syndrome secondary to H1N1 influenza infection, as there is also no evidence that H1N1 patients treated with ECMO had better outcomes than those treated with standard ventilation support.

"We need results from a credible randomized controlled trial to define the conditions surrounding ECMO, before ECMO becomes a routine therapy option," said Dr. Morris, a pulmonologist and professor of medicine at the University of Utah and Intermountain Health Medical Center in Salt Lake City.

"There are indications and applications of extracorporeal support that are straightforward," such as when it is used intraoperatively, he said. But for patients with severe hypoxic lung failure, "I do not see compelling evidence that extracorporeal support is followed by more favorable outcomes than other approaches that are used," he said in an interview. "The evidence from the H1N1 novel influenza epidemic indicates to me that survival appears to be roughly the same with or without extracorporeal support," he added. "We do not offer ECMO as treatment for adult patients with severe hypoxic lung failure in my hospital."

The only two studies that examined the efficacy of ECMO in rigorously controlled clinical trials, published as reports in 1979 and in 1994, both failed to show that ECMO improved patient survival, he noted (JAMA 1979;242:2193-6; Am. J. Respir. Crit. Care Med. 1994;149:295-305). More recent results from a British multicenter randomized trial with 180 adults with severe respiratory failure claimed to show evidence that patient survival with ECMO surpassed survival with usual care (Lancet 2009;374:1351-63). But the newer study had the flaw of failing to define the usual care received by the control patients. In addition, the control patients were distributed to many centers, while all the ECMO patients received their treatment at one center, Dr. Morris said. The conventional ventilation that control patients received could be whatever their attending intensivist thought appropriate.

"How does a clinician know which patients will benefit [from ECMO] without knowing what was conventional treatment?" he said.

To assess the impact of ECMO in patients with acute respiratory distress secondary to H1N1 infection, Dr. Morris summarized data reported on 150 patients in a University of Michigan registry; 14 patients seen in Salt Lake County, Utah, and reported last year in a paper at the American Thoracic Society; a series of 68 patients reported from Australia and New Zealand (JAMA 2009;302:1888-95); and 896 U.S. patients entered into a registry of the National Heart, Lung, and Blood Institute during April 2009 to April 2010. These data showed a consistent pattern of no improved survival with ECMO treatment in H1N1 patients, compared with H1N1 patients who did not receive ECMO, Dr. Morris said.

He also expressed concern that a well-designed study to compare modern ECMO with other ventilation support methods would be a challenge. A major problem is that the physicians "who have ECMO skills are convinced of its efficacy. Those who do ECMO don’t believe that better testing is needed," Dr. Morris said.

He reported having no relevant financial disclosures.

LAS VEGAS – The electronic health record mandate for physicians who participate in Medicare or Medicaid may have the unintended consequence of being the cudgel that drives many remaining private practice physicians out of business, Dr. Steve G. Peters said at the annual meeting of the National Association for Medical Direction of Respiratory Care.

"No one will admit it, but there is de facto pressure [from the electronic health record mandate] that there won’t be private practice in the foreseeable future," said Dr. Peters, a critical care physician and professor of medicine at the Mayo Clinic in Rochester, Minn. "Everyone will need to report measures on hundreds of patients," and to afford to do that they will likely have to become part of an organization, he said.

The challenge of meeting the electronic health record (EHR) reporting requirements will ratchet up over the next several years as the increasingly demanding stages of the Health Information Technology for Economic and Clinical Health (HITECH) Act begin to kick in.

In stage 1, which started this year, physicians using a certified EHR and participating in Medicare or Medicaid must report to the Center for Medicare and Medicaid Services (CMS) three core measures for each patient – height, weight, and blood pressure – as well as three additional measures from a list of 38 options. During the next few years, the program will expand into stages 2 and 3 with additional data reporting requirements.

"It sounds easy, but it’s not," Dr. Peters said. The way to program an EHR to report these various measures "differs from measure to measure, and when you get into it, it’s very complicated. We’re [currently] working this through at Mayo. We have a full EHR at Mayo, but extracting out the data for reporting is proving to be difficult. We have 85% of it, but the gap, the final 15%, is hard."

As an example, he cited the challenge of automatically reporting to the CMS what happens with patients who have a body mass index of 30 kg/m² or greater. "You need to record and report an action plan of what you’ll do about this, and if not, why not. You need to somehow capture it in a file that can be reported out of your computer why you did not achieve the measure."

The EHR information demands required by the HITECH law are "overwhelming," commented Dr. Alan H. Morris, a pulmonologist and professor of medicine at the University of Utah in Salt Lake City. "It’s a huge operation. What if a physician does not have the infrastructure of the Mayo Clinic?"

Those consequences were exemplified by an attendee at the meeting, Dr. Theodore S. Ingrassia III, a pulmonologist in private practice who maintains an office cooperatively with two other pulmonologists in Rockford, Ill.

"The EHR is a disaster for us, because the cost of the hardware and software is just a fraction of the total cost. There is the expensive cost of getting an IT person to help maintain it and keep it current with all the demands. It may drive us out" of private practice, Dr. Ingrassia said during the session.

"Many predicted that the [$44,000 ] incentive from CMS will not buy much EHR for a big, complex practice. It is a sobering phenomenon," Dr. Peters said.

"The EHR is supposed to be a tool to help physicians organize their care, but it is being turned into something like an enemy," said Dr. Dennis E. Doherty, a pulmonologist and critical care medicine physician and professor of medicine at the University of Kentucky in Lexington.

The three major hospitals in Rockford recognized the information technology and cost challenges that the new EHR requirements pose, and have offered to provide Dr. Ingrassia with the IT support he needs to meet CMS reporting demands if he gives up his private practice and joins their staff. It’s a tempting proposal, he said, but he remains very reluctant to abandon the private practice he built over the past 20 years, he said in an interview. For the time being, his strategy rests on deferring the EHR with the hope that the financial penalties scheduled to start in 2015 for noncompliance may get delayed or that some other option emerges.

Dr. Peters, Dr. Morris, Dr. Ingrassia, and Dr. Doherty had no disclosures relevant to this topic.

LAS VEGAS – The electronic health record mandate for physicians who participate in Medicare or Medicaid may have the unintended consequence of being the cudgel that drives many remaining private practice physicians out of business, Dr. Steve G. Peters said at the annual meeting of the National Association for Medical Direction of Respiratory Care.

"No one will admit it, but there is de facto pressure [from the electronic health record mandate] that there won’t be private practice in the foreseeable future," said Dr. Peters, a critical care physician and professor of medicine at the Mayo Clinic in Rochester, Minn. "Everyone will need to report measures on hundreds of patients," and to afford to do that they will likely have to become part of an organization, he said.

The challenge of meeting the electronic health record (EHR) reporting requirements will ratchet up over the next several years as the increasingly demanding stages of the Health Information Technology for Economic and Clinical Health (HITECH) Act begin to kick in.

In stage 1, which started this year, physicians using a certified EHR and participating in Medicare or Medicaid must report to the Center for Medicare and Medicaid Services (CMS) three core measures for each patient – height, weight, and blood pressure – as well as three additional measures from a list of 38 options. During the next few years, the program will expand into stages 2 and 3 with additional data reporting requirements.

"It sounds easy, but it’s not," Dr. Peters said. The way to program an EHR to report these various measures "differs from measure to measure, and when you get into it, it’s very complicated. We’re [currently] working this through at Mayo. We have a full EHR at Mayo, but extracting out the data for reporting is proving to be difficult. We have 85% of it, but the gap, the final 15%, is hard."

As an example, he cited the challenge of automatically reporting to the CMS what happens with patients who have a body mass index of 30 kg/m² or greater. "You need to record and report an action plan of what you’ll do about this, and if not, why not. You need to somehow capture it in a file that can be reported out of your computer why you did not achieve the measure."

The EHR information demands required by the HITECH law are "overwhelming," commented Dr. Alan H. Morris, a pulmonologist and professor of medicine at the University of Utah in Salt Lake City. "It’s a huge operation. What if a physician does not have the infrastructure of the Mayo Clinic?"

Those consequences were exemplified by an attendee at the meeting, Dr. Theodore S. Ingrassia III, a pulmonologist in private practice who maintains an office cooperatively with two other pulmonologists in Rockford, Ill.

"The EHR is a disaster for us, because the cost of the hardware and software is just a fraction of the total cost. There is the expensive cost of getting an IT person to help maintain it and keep it current with all the demands. It may drive us out" of private practice, Dr. Ingrassia said during the session.

"Many predicted that the [$44,000 ] incentive from CMS will not buy much EHR for a big, complex practice. It is a sobering phenomenon," Dr. Peters said.

"The EHR is supposed to be a tool to help physicians organize their care, but it is being turned into something like an enemy," said Dr. Dennis E. Doherty, a pulmonologist and critical care medicine physician and professor of medicine at the University of Kentucky in Lexington.

The three major hospitals in Rockford recognized the information technology and cost challenges that the new EHR requirements pose, and have offered to provide Dr. Ingrassia with the IT support he needs to meet CMS reporting demands if he gives up his private practice and joins their staff. It’s a tempting proposal, he said, but he remains very reluctant to abandon the private practice he built over the past 20 years, he said in an interview. For the time being, his strategy rests on deferring the EHR with the hope that the financial penalties scheduled to start in 2015 for noncompliance may get delayed or that some other option emerges.

Dr. Peters, Dr. Morris, Dr. Ingrassia, and Dr. Doherty had no disclosures relevant to this topic.

LAS VEGAS – The electronic health record mandate for physicians who participate in Medicare or Medicaid may have the unintended consequence of being the cudgel that drives many remaining private practice physicians out of business, Dr. Steve G. Peters said at the annual meeting of the National Association for Medical Direction of Respiratory Care.

"No one will admit it, but there is de facto pressure [from the electronic health record mandate] that there won’t be private practice in the foreseeable future," said Dr. Peters, a critical care physician and professor of medicine at the Mayo Clinic in Rochester, Minn. "Everyone will need to report measures on hundreds of patients," and to afford to do that they will likely have to become part of an organization, he said.

The challenge of meeting the electronic health record (EHR) reporting requirements will ratchet up over the next several years as the increasingly demanding stages of the Health Information Technology for Economic and Clinical Health (HITECH) Act begin to kick in.

In stage 1, which started this year, physicians using a certified EHR and participating in Medicare or Medicaid must report to the Center for Medicare and Medicaid Services (CMS) three core measures for each patient – height, weight, and blood pressure – as well as three additional measures from a list of 38 options. During the next few years, the program will expand into stages 2 and 3 with additional data reporting requirements.

"It sounds easy, but it’s not," Dr. Peters said. The way to program an EHR to report these various measures "differs from measure to measure, and when you get into it, it’s very complicated. We’re [currently] working this through at Mayo. We have a full EHR at Mayo, but extracting out the data for reporting is proving to be difficult. We have 85% of it, but the gap, the final 15%, is hard."

As an example, he cited the challenge of automatically reporting to the CMS what happens with patients who have a body mass index of 30 kg/m² or greater. "You need to record and report an action plan of what you’ll do about this, and if not, why not. You need to somehow capture it in a file that can be reported out of your computer why you did not achieve the measure."

The EHR information demands required by the HITECH law are "overwhelming," commented Dr. Alan H. Morris, a pulmonologist and professor of medicine at the University of Utah in Salt Lake City. "It’s a huge operation. What if a physician does not have the infrastructure of the Mayo Clinic?"

Those consequences were exemplified by an attendee at the meeting, Dr. Theodore S. Ingrassia III, a pulmonologist in private practice who maintains an office cooperatively with two other pulmonologists in Rockford, Ill.

"The EHR is a disaster for us, because the cost of the hardware and software is just a fraction of the total cost. There is the expensive cost of getting an IT person to help maintain it and keep it current with all the demands. It may drive us out" of private practice, Dr. Ingrassia said during the session.

"Many predicted that the [$44,000 ] incentive from CMS will not buy much EHR for a big, complex practice. It is a sobering phenomenon," Dr. Peters said.

"The EHR is supposed to be a tool to help physicians organize their care, but it is being turned into something like an enemy," said Dr. Dennis E. Doherty, a pulmonologist and critical care medicine physician and professor of medicine at the University of Kentucky in Lexington.

The three major hospitals in Rockford recognized the information technology and cost challenges that the new EHR requirements pose, and have offered to provide Dr. Ingrassia with the IT support he needs to meet CMS reporting demands if he gives up his private practice and joins their staff. It’s a tempting proposal, he said, but he remains very reluctant to abandon the private practice he built over the past 20 years, he said in an interview. For the time being, his strategy rests on deferring the EHR with the hope that the financial penalties scheduled to start in 2015 for noncompliance may get delayed or that some other option emerges.

Dr. Peters, Dr. Morris, Dr. Ingrassia, and Dr. Doherty had no disclosures relevant to this topic.

LAS VEGAS – The electronic health record mandate for physicians who participate in Medicare or Medicaid may have the unintended consequence of being the cudgel that drives many remaining private practice physicians out of business, Dr. Steve G. Peters said at the annual meeting of the National Association for Medical Direction of Respiratory Care.

"No one will admit it, but there is de facto pressure [from the electronic health record mandate] that there won't be private practice in the foreseeable future," said Dr. Peters, a critical care physician and professor of medicine at the Mayo Clinic in Rochester, Minn. "Everyone will need to report measures on hundreds of patients," and to afford to do that they will likely have to become part of an organization, he said.

The challenge of meeting the electronic health record (EHR) reporting requirements will ratchet up over the next several years as the increasingly demanding stages of the Health Information Technology for Economic and Clinical Health (HITECH) Act begin to kick in.

In stage 1, which started this year, physicians using a certified EHR and participating in Medicare or Medicaid must report to the Center for Medicare and Medicaid Services (CMS) three core measures for each patient – height, weight, and blood pressure – as well as three additional measures from a list of 38 options. During the next few years, the program will expand into stages 2 and 3 with additional data reporting requirements.

"It sounds easy, but it's not," Dr. Peters said. The way to program an EHR to report these various measures "differs from measure to measure, and when you get into it, it's very complicated. We're [currently] working this through at Mayo. We have a full EHR at Mayo, but extracting out the data for reporting is proving to be difficult. We have 85% of it, but the gap, the final 15%, is hard."

As an example, he cited the challenge of automatically reporting to the CMS what happens with patients who have a body mass index of 30 kg/m² or greater. "You need to record and report an action plan of what you’ll do about this, and if not, why not. You need to somehow capture it in a file that can be reported out of your computer why you did not achieve the measure."

The EHR information demands required by the HITECH law are "overwhelming," commented Dr. Alan H. Morris, a pulmonologist and professor of medicine at the University of Utah in Salt Lake City. "It's a huge operation. What if a physician does not have the infrastructure of the Mayo Clinic?"

Those consequences were exemplified by an attendee at the meeting, Dr. Theodore S. Ingrassia III, a pulmonologist in private practice who maintains an office cooperatively with two other pulmonologists in Rockford, Ill.

"The EHR is a disaster for us, because the cost of the hardware and software is just a fraction of the total cost. There is the expensive cost of getting an IT person to help maintain it and keep it current with all the demands. It may drive us out" of private practice, Dr. Ingrassia said during the session.

"Many predicted that the [$44,000 ] incentive from CMS will not buy much EHR for a big, complex practice. It is a sobering phenomenon," Dr. Peters said.

"The EHR is supposed to be a tool to help physicians organize their care, but it is being turned into something like an enemy," said Dr. Dennis E. Doherty, a pulmonologist and critical care medicine physician and professor of medicine at the University of Kentucky in Lexington.

The three major hospitals in Rockford recognized the information technology and cost challenges that the new EHR requirements pose, and have offered to provide Dr. Ingrassia with the IT support he needs to meet CMS reporting demands if he gives up his private practice and joins their staff. It's a tempting proposal, he said, but he remains very reluctant to abandon the private practice he built over the past 20 years, he said in an interview. For the time being, his strategy rests on deferring the EHR with the hope that the financial penalties scheduled to start in 2015 for noncompliance may get delayed or that some other option emerges.

Dr. Peters, Dr. Morris, Dr. Ingrassia, and Dr. Doherty had no disclosures relevant to this topic.

LAS VEGAS – The electronic health record mandate for physicians who participate in Medicare or Medicaid may have the unintended consequence of being the cudgel that drives many remaining private practice physicians out of business, Dr. Steve G. Peters said at the annual meeting of the National Association for Medical Direction of Respiratory Care.

"No one will admit it, but there is de facto pressure [from the electronic health record mandate] that there won't be private practice in the foreseeable future," said Dr. Peters, a critical care physician and professor of medicine at the Mayo Clinic in Rochester, Minn. "Everyone will need to report measures on hundreds of patients," and to afford to do that they will likely have to become part of an organization, he said.

The challenge of meeting the electronic health record (EHR) reporting requirements will ratchet up over the next several years as the increasingly demanding stages of the Health Information Technology for Economic and Clinical Health (HITECH) Act begin to kick in.

In stage 1, which started this year, physicians using a certified EHR and participating in Medicare or Medicaid must report to the Center for Medicare and Medicaid Services (CMS) three core measures for each patient – height, weight, and blood pressure – as well as three additional measures from a list of 38 options. During the next few years, the program will expand into stages 2 and 3 with additional data reporting requirements.

"It sounds easy, but it's not," Dr. Peters said. The way to program an EHR to report these various measures "differs from measure to measure, and when you get into it, it's very complicated. We're [currently] working this through at Mayo. We have a full EHR at Mayo, but extracting out the data for reporting is proving to be difficult. We have 85% of it, but the gap, the final 15%, is hard."

As an example, he cited the challenge of automatically reporting to the CMS what happens with patients who have a body mass index of 30 kg/m² or greater. "You need to record and report an action plan of what you’ll do about this, and if not, why not. You need to somehow capture it in a file that can be reported out of your computer why you did not achieve the measure."

The EHR information demands required by the HITECH law are "overwhelming," commented Dr. Alan H. Morris, a pulmonologist and professor of medicine at the University of Utah in Salt Lake City. "It's a huge operation. What if a physician does not have the infrastructure of the Mayo Clinic?"

Those consequences were exemplified by an attendee at the meeting, Dr. Theodore S. Ingrassia III, a pulmonologist in private practice who maintains an office cooperatively with two other pulmonologists in Rockford, Ill.

"The EHR is a disaster for us, because the cost of the hardware and software is just a fraction of the total cost. There is the expensive cost of getting an IT person to help maintain it and keep it current with all the demands. It may drive us out" of private practice, Dr. Ingrassia said during the session.

"Many predicted that the [$44,000 ] incentive from CMS will not buy much EHR for a big, complex practice. It is a sobering phenomenon," Dr. Peters said.

"The EHR is supposed to be a tool to help physicians organize their care, but it is being turned into something like an enemy," said Dr. Dennis E. Doherty, a pulmonologist and critical care medicine physician and professor of medicine at the University of Kentucky in Lexington.

The three major hospitals in Rockford recognized the information technology and cost challenges that the new EHR requirements pose, and have offered to provide Dr. Ingrassia with the IT support he needs to meet CMS reporting demands if he gives up his private practice and joins their staff. It's a tempting proposal, he said, but he remains very reluctant to abandon the private practice he built over the past 20 years, he said in an interview. For the time being, his strategy rests on deferring the EHR with the hope that the financial penalties scheduled to start in 2015 for noncompliance may get delayed or that some other option emerges.

Dr. Peters, Dr. Morris, Dr. Ingrassia, and Dr. Doherty had no disclosures relevant to this topic.

LAS VEGAS – The electronic health record mandate for physicians who participate in Medicare or Medicaid may have the unintended consequence of being the cudgel that drives many remaining private practice physicians out of business, Dr. Steve G. Peters said at the annual meeting of the National Association for Medical Direction of Respiratory Care.

"No one will admit it, but there is de facto pressure [from the electronic health record mandate] that there won't be private practice in the foreseeable future," said Dr. Peters, a critical care physician and professor of medicine at the Mayo Clinic in Rochester, Minn. "Everyone will need to report measures on hundreds of patients," and to afford to do that they will likely have to become part of an organization, he said.

The challenge of meeting the electronic health record (EHR) reporting requirements will ratchet up over the next several years as the increasingly demanding stages of the Health Information Technology for Economic and Clinical Health (HITECH) Act begin to kick in.

In stage 1, which started this year, physicians using a certified EHR and participating in Medicare or Medicaid must report to the Center for Medicare and Medicaid Services (CMS) three core measures for each patient – height, weight, and blood pressure – as well as three additional measures from a list of 38 options. During the next few years, the program will expand into stages 2 and 3 with additional data reporting requirements.

"It sounds easy, but it's not," Dr. Peters said. The way to program an EHR to report these various measures "differs from measure to measure, and when you get into it, it's very complicated. We're [currently] working this through at Mayo. We have a full EHR at Mayo, but extracting out the data for reporting is proving to be difficult. We have 85% of it, but the gap, the final 15%, is hard."

As an example, he cited the challenge of automatically reporting to the CMS what happens with patients who have a body mass index of 30 kg/m² or greater. "You need to record and report an action plan of what you’ll do about this, and if not, why not. You need to somehow capture it in a file that can be reported out of your computer why you did not achieve the measure."

The EHR information demands required by the HITECH law are "overwhelming," commented Dr. Alan H. Morris, a pulmonologist and professor of medicine at the University of Utah in Salt Lake City. "It's a huge operation. What if a physician does not have the infrastructure of the Mayo Clinic?"

Those consequences were exemplified by an attendee at the meeting, Dr. Theodore S. Ingrassia III, a pulmonologist in private practice who maintains an office cooperatively with two other pulmonologists in Rockford, Ill.

"The EHR is a disaster for us, because the cost of the hardware and software is just a fraction of the total cost. There is the expensive cost of getting an IT person to help maintain it and keep it current with all the demands. It may drive us out" of private practice, Dr. Ingrassia said during the session.

"Many predicted that the [$44,000 ] incentive from CMS will not buy much EHR for a big, complex practice. It is a sobering phenomenon," Dr. Peters said.

"The EHR is supposed to be a tool to help physicians organize their care, but it is being turned into something like an enemy," said Dr. Dennis E. Doherty, a pulmonologist and critical care medicine physician and professor of medicine at the University of Kentucky in Lexington.

The three major hospitals in Rockford recognized the information technology and cost challenges that the new EHR requirements pose, and have offered to provide Dr. Ingrassia with the IT support he needs to meet CMS reporting demands if he gives up his private practice and joins their staff. It's a tempting proposal, he said, but he remains very reluctant to abandon the private practice he built over the past 20 years, he said in an interview. For the time being, his strategy rests on deferring the EHR with the hope that the financial penalties scheduled to start in 2015 for noncompliance may get delayed or that some other option emerges.

Dr. Peters, Dr. Morris, Dr. Ingrassia, and Dr. Doherty had no disclosures relevant to this topic.

LAS VEGAS – The electronic health record mandate for physicians who participate in Medicare or Medicaid may have the unintended consequence of being the cudgel that drives many remaining private practice physicians out of business, Dr. Steve G. Peters said at the annual meeting of the National Association for Medical Direction of Respiratory Care.

"No one will admit it, but there is de facto pressure [from the electronic health record mandate] that there won’t be private practice in the foreseeable future," said Dr. Peters, a critical care physician and professor of medicine at the Mayo Clinic in Rochester, Minn. "Everyone will need to report measures on hundreds of patients," and to afford to do that they will likely have to become part of an organization, he said.

The challenge of meeting the electronic health record (EHR) reporting requirements will ratchet up over the next several years as the increasingly demanding stages of the Health Information Technology for Economic and Clinical Health (HITECH) Act begin to kick in.

In stage 1, which started this year, physicians using a certified EHR and participating in Medicare or Medicaid must report to the Center for Medicare and Medicaid Services (CMS) three core measures for each patient – height, weight, and blood pressure – as well as three additional measures from a list of 38 options. During the next few years, the program will expand into stages 2 and 3 with additional data reporting requirements.

"It sounds easy, but it’s not," Dr. Peters said. The way to program an EHR to report these various measures "differs from measure to measure, and when you get into it, it’s very complicated. We’re [currently] working this through at Mayo. We have a full EHR at Mayo, but extracting out the data for reporting is proving to be difficult. We have 85% of it, but the gap, the final 15%, is hard."

As an example, he cited the challenge of automatically reporting to the CMS what happens with patients who have a body mass index of 30 kg/m² or greater. "You need to record and report an action plan of what you’ll do about this, and if not, why not. You need to somehow capture it in a file that can be reported out of your computer why you did not achieve the measure."

The EHR information demands required by the HITECH law are "overwhelming," commented Dr. Alan H. Morris, a pulmonologist and professor of medicine at the University of Utah in Salt Lake City. "It’s a huge operation. What if a physician does not have the infrastructure of the Mayo Clinic?"

Those consequences were exemplified by an attendee at the meeting, Dr. Theodore S. Ingrassia III, a pulmonologist in private practice who maintains an office cooperatively with two other pulmonologists in Rockford, Ill.

"The EHR is a disaster for us, because the cost of the hardware and software is just a fraction of the total cost. There is the expensive cost of getting an IT person to help maintain it and keep it current with all the demands. It may drive us out" of private practice, Dr. Ingrassia said during the session.

"Many predicted that the [$44,000 ] incentive from CMS will not buy much EHR for a big, complex practice. It is a sobering phenomenon," Dr. Peters said.

"The EHR is supposed to be a tool to help physicians organize their care, but it is being turned into something like an enemy," said Dr. Dennis E. Doherty, a pulmonologist and critical care medicine physician and professor of medicine at the University of Kentucky in Lexington.

The three major hospitals in Rockford recognized the information technology and cost challenges that the new EHR requirements pose, and have offered to provide Dr. Ingrassia with the IT support he needs to meet CMS reporting demands if he gives up his private practice and joins their staff. It’s a tempting proposal, he said, but he remains very reluctant to abandon the private practice he built over the past 20 years, he said in an interview. For the time being, his strategy rests on deferring the EHR with the hope that the financial penalties scheduled to start in 2015 for noncompliance may get delayed or that some other option emerges.

Dr. Peters, Dr. Morris, Dr. Ingrassia, and Dr. Doherty had no disclosures relevant to this topic.

LAS VEGAS – The electronic health record mandate for physicians who participate in Medicare or Medicaid may have the unintended consequence of being the cudgel that drives many remaining private practice physicians out of business, Dr. Steve G. Peters said at the annual meeting of the National Association for Medical Direction of Respiratory Care.

"No one will admit it, but there is de facto pressure [from the electronic health record mandate] that there won’t be private practice in the foreseeable future," said Dr. Peters, a critical care physician and professor of medicine at the Mayo Clinic in Rochester, Minn. "Everyone will need to report measures on hundreds of patients," and to afford to do that they will likely have to become part of an organization, he said.

The challenge of meeting the electronic health record (EHR) reporting requirements will ratchet up over the next several years as the increasingly demanding stages of the Health Information Technology for Economic and Clinical Health (HITECH) Act begin to kick in.

In stage 1, which started this year, physicians using a certified EHR and participating in Medicare or Medicaid must report to the Center for Medicare and Medicaid Services (CMS) three core measures for each patient – height, weight, and blood pressure – as well as three additional measures from a list of 38 options. During the next few years, the program will expand into stages 2 and 3 with additional data reporting requirements.

"It sounds easy, but it’s not," Dr. Peters said. The way to program an EHR to report these various measures "differs from measure to measure, and when you get into it, it’s very complicated. We’re [currently] working this through at Mayo. We have a full EHR at Mayo, but extracting out the data for reporting is proving to be difficult. We have 85% of it, but the gap, the final 15%, is hard."

As an example, he cited the challenge of automatically reporting to the CMS what happens with patients who have a body mass index of 30 kg/m² or greater. "You need to record and report an action plan of what you’ll do about this, and if not, why not. You need to somehow capture it in a file that can be reported out of your computer why you did not achieve the measure."

The EHR information demands required by the HITECH law are "overwhelming," commented Dr. Alan H. Morris, a pulmonologist and professor of medicine at the University of Utah in Salt Lake City. "It’s a huge operation. What if a physician does not have the infrastructure of the Mayo Clinic?"

Those consequences were exemplified by an attendee at the meeting, Dr. Theodore S. Ingrassia III, a pulmonologist in private practice who maintains an office cooperatively with two other pulmonologists in Rockford, Ill.

"The EHR is a disaster for us, because the cost of the hardware and software is just a fraction of the total cost. There is the expensive cost of getting an IT person to help maintain it and keep it current with all the demands. It may drive us out" of private practice, Dr. Ingrassia said during the session.

"Many predicted that the [$44,000 ] incentive from CMS will not buy much EHR for a big, complex practice. It is a sobering phenomenon," Dr. Peters said.

"The EHR is supposed to be a tool to help physicians organize their care, but it is being turned into something like an enemy," said Dr. Dennis E. Doherty, a pulmonologist and critical care medicine physician and professor of medicine at the University of Kentucky in Lexington.

The three major hospitals in Rockford recognized the information technology and cost challenges that the new EHR requirements pose, and have offered to provide Dr. Ingrassia with the IT support he needs to meet CMS reporting demands if he gives up his private practice and joins their staff. It’s a tempting proposal, he said, but he remains very reluctant to abandon the private practice he built over the past 20 years, he said in an interview. For the time being, his strategy rests on deferring the EHR with the hope that the financial penalties scheduled to start in 2015 for noncompliance may get delayed or that some other option emerges.

Dr. Peters, Dr. Morris, Dr. Ingrassia, and Dr. Doherty had no disclosures relevant to this topic.

LAS VEGAS – The electronic health record mandate for physicians who participate in Medicare or Medicaid may have the unintended consequence of being the cudgel that drives many remaining private practice physicians out of business, Dr. Steve G. Peters said at the annual meeting of the National Association for Medical Direction of Respiratory Care.

"No one will admit it, but there is de facto pressure [from the electronic health record mandate] that there won’t be private practice in the foreseeable future," said Dr. Peters, a critical care physician and professor of medicine at the Mayo Clinic in Rochester, Minn. "Everyone will need to report measures on hundreds of patients," and to afford to do that they will likely have to become part of an organization, he said.

The challenge of meeting the electronic health record (EHR) reporting requirements will ratchet up over the next several years as the increasingly demanding stages of the Health Information Technology for Economic and Clinical Health (HITECH) Act begin to kick in.

In stage 1, which started this year, physicians using a certified EHR and participating in Medicare or Medicaid must report to the Center for Medicare and Medicaid Services (CMS) three core measures for each patient – height, weight, and blood pressure – as well as three additional measures from a list of 38 options. During the next few years, the program will expand into stages 2 and 3 with additional data reporting requirements.

"It sounds easy, but it’s not," Dr. Peters said. The way to program an EHR to report these various measures "differs from measure to measure, and when you get into it, it’s very complicated. We’re [currently] working this through at Mayo. We have a full EHR at Mayo, but extracting out the data for reporting is proving to be difficult. We have 85% of it, but the gap, the final 15%, is hard."

As an example, he cited the challenge of automatically reporting to the CMS what happens with patients who have a body mass index of 30 kg/m² or greater. "You need to record and report an action plan of what you’ll do about this, and if not, why not. You need to somehow capture it in a file that can be reported out of your computer why you did not achieve the measure."

The EHR information demands required by the HITECH law are "overwhelming," commented Dr. Alan H. Morris, a pulmonologist and professor of medicine at the University of Utah in Salt Lake City. "It’s a huge operation. What if a physician does not have the infrastructure of the Mayo Clinic?"

Those consequences were exemplified by an attendee at the meeting, Dr. Theodore S. Ingrassia III, a pulmonologist in private practice who maintains an office cooperatively with two other pulmonologists in Rockford, Ill.

"The EHR is a disaster for us, because the cost of the hardware and software is just a fraction of the total cost. There is the expensive cost of getting an IT person to help maintain it and keep it current with all the demands. It may drive us out" of private practice, Dr. Ingrassia said during the session.

"Many predicted that the [$44,000 ] incentive from CMS will not buy much EHR for a big, complex practice. It is a sobering phenomenon," Dr. Peters said.

"The EHR is supposed to be a tool to help physicians organize their care, but it is being turned into something like an enemy," said Dr. Dennis E. Doherty, a pulmonologist and critical care medicine physician and professor of medicine at the University of Kentucky in Lexington.

The three major hospitals in Rockford recognized the information technology and cost challenges that the new EHR requirements pose, and have offered to provide Dr. Ingrassia with the IT support he needs to meet CMS reporting demands if he gives up his private practice and joins their staff. It’s a tempting proposal, he said, but he remains very reluctant to abandon the private practice he built over the past 20 years, he said in an interview. For the time being, his strategy rests on deferring the EHR with the hope that the financial penalties scheduled to start in 2015 for noncompliance may get delayed or that some other option emerges.

Dr. Peters, Dr. Morris, Dr. Ingrassia, and Dr. Doherty had no disclosures relevant to this topic.