Heart Failure

The first in-human trials of a no-implant approach to interatrial shunting to alleviate heart failure symptoms have shown a signal that the procedure reduces peak exercise wedge pressure in recipients a month afterward, according to early trial results.

Colin M. Barker, MD, reported 30-day results of 31 patients who had no-implant interatrial shunting for heart failure across three studies, at the Society for Cardiovascular Angiography & Interventions scientific sessions. The studies included patients with HF with preserved and reduced ejection fraction (HFpEF and HFrEF).

“At 30 days, there was a response with a decrease in the wedge pressures both at rest and at peak exercise, and that was consistent through all three of these initial trials,” Dr. Barker said. In all 33 patients who have been treated to date, there were no major adverse cardiac and cerebrovascular or thromboembolic events through 1 month. (Two of the patients weren’t included in the results Dr. Barker presented.)

The three studies he reported on were the Alleviate-HF-1 (n = 15), Alleviate-HF-2 (n = 11) for patients with HFpEF, and Alleviate-HFrEF (n = 5). The average patient age was 67 years, and all were New York Heart Association class II, III, or IV with elevated peak pulmonary capillary wedge pressure (PCWP).

The device that creates the no-implant shunt as “not very exotic, but it is very effective, and what it does is create a very predictable, reproducible atrial septostomy” between the left and right atria. The device obtains “almost a biopsy” that’s 7 mm in diameter. “There’s no hardware or foreign bodies left inside the patient,” said Dr. Barker, director of interventional cardiology at Vanderbilt University in Nashville, Tenn. “There’s a natural healing process at the rims after the radiofrequency ablation has been done.” Femoral access was used.

Study participants were also asked to complete the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline and at 1 and 3 months across all three studies, and at 6 months in the Alleviate-HF-1 study. “Just as important is how patients feel,” Dr. Barker said. KCCQ overall summary scores increased at each time interval across all three studies.

“Durability has been proven with multiple different imaging modalities,” Dr. Barker added, explaining that CT scans in 10 of 10 shunts demonstrated patency through 12 months, and 15 of 15 at 6 months. He noted that none of the created shunts have closed yet. At 6 months, the average shunt measured 7.5 mm (± 1.1 mm, n = 22), left atrial diameter decreased 2.4 mm (P = .031) in HFpEF patients, and no significant changes were observed in right ventricular fractional area change or right atrial volume index.

None of the septostomies have had to be closed or enlarged to date, Dr. Barker said. “We are creating an atrial septal defect that we have a lot of comfort and experience with closing with other devices if need be, but that hasn’t been an issue,” he said. “As of now, it’s one size, but as you can imagine, one-size-fits-all is not the way this will go, and this does allow for variations in size ultimately.”

Kirk N. Garratt, MD, director of the Center for Heart and Vascular Health at Christiana Care in Newark, Del., noted that the approach to unload the left atrium “is novel, but I think is becoming well accepted in the advanced HF population. There remain questions about long-term consequences of an intentional interatrial shunt – what happens to pulmonary flow dynamics and the like – but to date the impact of this approach has been favorable.

“The liabilities that come with an implanted device in the septal space, both in terms of the durability of the shunt and the impact that it would have on the ability to perform other transseptal procedures, is overcome with this approach,” he added. 

Dr. Barker disclosed he is an advisory board member and consultant to Alleviant Medical. Dr. Garratt is an advisory board member for Abbott.
 

The first in-human trials of a no-implant approach to interatrial shunting to alleviate heart failure symptoms have shown a signal that the procedure reduces peak exercise wedge pressure in recipients a month afterward, according to early trial results.

Colin M. Barker, MD, reported 30-day results of 31 patients who had no-implant interatrial shunting for heart failure across three studies, at the Society for Cardiovascular Angiography & Interventions scientific sessions. The studies included patients with HF with preserved and reduced ejection fraction (HFpEF and HFrEF).

“At 30 days, there was a response with a decrease in the wedge pressures both at rest and at peak exercise, and that was consistent through all three of these initial trials,” Dr. Barker said. In all 33 patients who have been treated to date, there were no major adverse cardiac and cerebrovascular or thromboembolic events through 1 month. (Two of the patients weren’t included in the results Dr. Barker presented.)

The three studies he reported on were the Alleviate-HF-1 (n = 15), Alleviate-HF-2 (n = 11) for patients with HFpEF, and Alleviate-HFrEF (n = 5). The average patient age was 67 years, and all were New York Heart Association class II, III, or IV with elevated peak pulmonary capillary wedge pressure (PCWP).

The device that creates the no-implant shunt as “not very exotic, but it is very effective, and what it does is create a very predictable, reproducible atrial septostomy” between the left and right atria. The device obtains “almost a biopsy” that’s 7 mm in diameter. “There’s no hardware or foreign bodies left inside the patient,” said Dr. Barker, director of interventional cardiology at Vanderbilt University in Nashville, Tenn. “There’s a natural healing process at the rims after the radiofrequency ablation has been done.” Femoral access was used.

Study participants were also asked to complete the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline and at 1 and 3 months across all three studies, and at 6 months in the Alleviate-HF-1 study. “Just as important is how patients feel,” Dr. Barker said. KCCQ overall summary scores increased at each time interval across all three studies.

“Durability has been proven with multiple different imaging modalities,” Dr. Barker added, explaining that CT scans in 10 of 10 shunts demonstrated patency through 12 months, and 15 of 15 at 6 months. He noted that none of the created shunts have closed yet. At 6 months, the average shunt measured 7.5 mm (± 1.1 mm, n = 22), left atrial diameter decreased 2.4 mm (P = .031) in HFpEF patients, and no significant changes were observed in right ventricular fractional area change or right atrial volume index.

None of the septostomies have had to be closed or enlarged to date, Dr. Barker said. “We are creating an atrial septal defect that we have a lot of comfort and experience with closing with other devices if need be, but that hasn’t been an issue,” he said. “As of now, it’s one size, but as you can imagine, one-size-fits-all is not the way this will go, and this does allow for variations in size ultimately.”

Kirk N. Garratt, MD, director of the Center for Heart and Vascular Health at Christiana Care in Newark, Del., noted that the approach to unload the left atrium “is novel, but I think is becoming well accepted in the advanced HF population. There remain questions about long-term consequences of an intentional interatrial shunt – what happens to pulmonary flow dynamics and the like – but to date the impact of this approach has been favorable.

“The liabilities that come with an implanted device in the septal space, both in terms of the durability of the shunt and the impact that it would have on the ability to perform other transseptal procedures, is overcome with this approach,” he added. 

Dr. Barker disclosed he is an advisory board member and consultant to Alleviant Medical. Dr. Garratt is an advisory board member for Abbott.
 

The first in-human trials of a no-implant approach to interatrial shunting to alleviate heart failure symptoms have shown a signal that the procedure reduces peak exercise wedge pressure in recipients a month afterward, according to early trial results.

Colin M. Barker, MD, reported 30-day results of 31 patients who had no-implant interatrial shunting for heart failure across three studies, at the Society for Cardiovascular Angiography & Interventions scientific sessions. The studies included patients with HF with preserved and reduced ejection fraction (HFpEF and HFrEF).

“At 30 days, there was a response with a decrease in the wedge pressures both at rest and at peak exercise, and that was consistent through all three of these initial trials,” Dr. Barker said. In all 33 patients who have been treated to date, there were no major adverse cardiac and cerebrovascular or thromboembolic events through 1 month. (Two of the patients weren’t included in the results Dr. Barker presented.)

The three studies he reported on were the Alleviate-HF-1 (n = 15), Alleviate-HF-2 (n = 11) for patients with HFpEF, and Alleviate-HFrEF (n = 5). The average patient age was 67 years, and all were New York Heart Association class II, III, or IV with elevated peak pulmonary capillary wedge pressure (PCWP).

The device that creates the no-implant shunt as “not very exotic, but it is very effective, and what it does is create a very predictable, reproducible atrial septostomy” between the left and right atria. The device obtains “almost a biopsy” that’s 7 mm in diameter. “There’s no hardware or foreign bodies left inside the patient,” said Dr. Barker, director of interventional cardiology at Vanderbilt University in Nashville, Tenn. “There’s a natural healing process at the rims after the radiofrequency ablation has been done.” Femoral access was used.

Study participants were also asked to complete the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline and at 1 and 3 months across all three studies, and at 6 months in the Alleviate-HF-1 study. “Just as important is how patients feel,” Dr. Barker said. KCCQ overall summary scores increased at each time interval across all three studies.

“Durability has been proven with multiple different imaging modalities,” Dr. Barker added, explaining that CT scans in 10 of 10 shunts demonstrated patency through 12 months, and 15 of 15 at 6 months. He noted that none of the created shunts have closed yet. At 6 months, the average shunt measured 7.5 mm (± 1.1 mm, n = 22), left atrial diameter decreased 2.4 mm (P = .031) in HFpEF patients, and no significant changes were observed in right ventricular fractional area change or right atrial volume index.

None of the septostomies have had to be closed or enlarged to date, Dr. Barker said. “We are creating an atrial septal defect that we have a lot of comfort and experience with closing with other devices if need be, but that hasn’t been an issue,” he said. “As of now, it’s one size, but as you can imagine, one-size-fits-all is not the way this will go, and this does allow for variations in size ultimately.”

Kirk N. Garratt, MD, director of the Center for Heart and Vascular Health at Christiana Care in Newark, Del., noted that the approach to unload the left atrium “is novel, but I think is becoming well accepted in the advanced HF population. There remain questions about long-term consequences of an intentional interatrial shunt – what happens to pulmonary flow dynamics and the like – but to date the impact of this approach has been favorable.

“The liabilities that come with an implanted device in the septal space, both in terms of the durability of the shunt and the impact that it would have on the ability to perform other transseptal procedures, is overcome with this approach,” he added. 

Dr. Barker disclosed he is an advisory board member and consultant to Alleviant Medical. Dr. Garratt is an advisory board member for Abbott.
 

A voice can carry a long distance, but in patients with heart failure (HF) a voice can also carry otherwise hidden signs useful for predicting short-term risk for worsening disease, even acute decompensation. Potentially, it only has to reach a smartphone to do it, suggests a preliminary study of a mobile app designed to alert patients and clinicians to such looming HF events, if possible in time to avert them.

The proprietary app and analysis system (HearO, Cordio Medical), used daily at home by 180 patients with stable HF, demonstrated 82% accuracy in picking out vocal signals of early congestion that would soon be followed by a need for intensified therapy or acute decompensation.

Andrew D. Bowser/MDedge News

In practice, clinicians receiving the system’s alerts about altered fluid status would intervene with medication adjustments before the patient deteriorates and possibly heads for the ED. That would be the plan; there were no interventions in the current study, which was designed only to explore the strategy’s feasibility and accuracy.

The system could emerge as “a useful tool in remote monitoring of heart failure patients, providing early warning of worsening heart failure,” said William Abraham, MD, from Ohio State University Wexner Medical Center, Columbus. “It has the potential to reduce acute decompensated heart failure hospitalizations and improve patient quality of life and economic outcomes. But, of course, we have to show that now in larger and randomized clinical studies.”

Abraham presented the Cordio HearO Community Study preliminary results at the Heart Failure Association of the European Society of Cardiology sessions. It follows a recent small study that showed the same app could identify vocal signals linked to altered fluid status in patients with HF hospitalized with acute decompensation.

In the current study, researchers prospectively tracked any worsening HF events that hit patients within a month after the system sent them an alert suggesting early changes in fluid status. Then, they retrospectively assessed the strategy’s predictive accuracy for an initial episode.

The system correctly predicted 32 of 39 first HF events, for an 82% sensitivity and a false-positive rate of 18%. On an annualized basis, Dr. Abraham said, the patients experienced an estimated two to three false alarms per year, alerts that were not followed by HF events. For context, the standard practice of monitoring the patient’s weight “has a sensitivity of about 10%-20%. So this performs very well as a noninvasive technology.”

On average, Dr. Abraham said, “we were able to detect future events about 18 days prior to the worsening heart failure event,” which in practice would provide “a pretty broad window for intervention.”

The false positives were not a surprise. Lung fluid status can change in conditions other than heart failure, he observed, and the HearO system alerts aren’t meant to be followed blindly.

“I don’t know that we clearly understand what those false-positives represent just yet,” Dr. Abraham said. “The bottom line is, as with any diagnostic tool, you have to use the totality of clinical information you have available. If you get an alert and the patient has a fever and a cough, you might think of pneumonia before worsening heart failure.”

“The false positives don’t appear to be alarming,” agreed Antoni Bayés-Genís, MD, PhD, Hospital Universitari Germans Trias i Pujol, Badalona, Spain, and Universitat Autònoma de Barcelona.

The study suggests that the HearO system, combined with sound clinical judgment, “has the potential to identify early congestion that may allow for treatment management, and then avoiding hospital admission,” Dr. Bayés-Genís, who isn’t connected with the study, said in an interview.

The entirely noninvasive, smartphone-based app would be more appealing than implanted devices that, for example, measure thoracic bioimpedance or pulmonary artery pressure and are also intended as congestion early-warning systems, he proposed. “Its scalability makes it very attractive as well.”

But all that “would have to be validated in a large clinical trial,” Dr. Bayés-Genís, who comoderated the conference session featuring Dr. Abraham’s presentation, said when interviewed.

The ongoing study has enrolled 430 clinically stable adult patients with HF in New York Heart Association functional class II or III, regardless of left ventricular ejection fraction, who were cared for by teams at eight centers in Israel. At the outset, during a period of stability, each patient spoke a few sentences into the app to establish a vocal-pattern baseline.

Once home, their assignment was to speak the same sentences into their phones once a day. The app, working through a cloud-based, artificial intelligence–derived processing system, compared each day’s vocal signature with the baseline and alerted researchers when it detected signs of altered fluid status.

About 460,000 recordings were collected from the 180 patients in the current analysis, of whom about 27% were women. They used the app for a mean of 512 days.

The system seems to work well regardless of language or dialect, Dr. Abraham said. About 70% of the current study’s patients spoke Hebrew, and most of the rest spoke either Russian or Arabic.

Most patients (almost 80%) used the app at least 70% of the prescribed time. Only 14 patients used the app less than 60% of the time, he reported.

Dr. Bayés-Genís proposed that, in practice, unfamiliarity with or resistance to smartphone technology would be unlikely to figure greatly in any nonadherence with the daily app regimen, except “maybe for the eldest of the eldest.” The current cohort’s mean age was 70 years. In his experience, he said, most older persons younger than age 80 use a smartphone, at least in more developed countries.

Dr. Abraham disclosed serving on an advisory board for and receiving consulting fees from Cordio Medical; receiving consulting fees from Abbott, Boehringer Ingelheim, CVRx, Edwards Lifesciences, and Respicardia; receiving salary from V-Wave Medical; and receiving research support from the National Heart, Lung, and Blood Institute. Dr. Bayés-Genís reported receiving personal fees from AstraZeneca, Vifor-Fresenius, Novartis, Boehringer Ingelheim, Abbott, Roche Diagnostics, and Critical Diagnostics.

A version of this article first appeared on Medscape.com.

A voice can carry a long distance, but in patients with heart failure (HF) a voice can also carry otherwise hidden signs useful for predicting short-term risk for worsening disease, even acute decompensation. Potentially, it only has to reach a smartphone to do it, suggests a preliminary study of a mobile app designed to alert patients and clinicians to such looming HF events, if possible in time to avert them.

The proprietary app and analysis system (HearO, Cordio Medical), used daily at home by 180 patients with stable HF, demonstrated 82% accuracy in picking out vocal signals of early congestion that would soon be followed by a need for intensified therapy or acute decompensation.

Andrew D. Bowser/MDedge News

In practice, clinicians receiving the system’s alerts about altered fluid status would intervene with medication adjustments before the patient deteriorates and possibly heads for the ED. That would be the plan; there were no interventions in the current study, which was designed only to explore the strategy’s feasibility and accuracy.

The system could emerge as “a useful tool in remote monitoring of heart failure patients, providing early warning of worsening heart failure,” said William Abraham, MD, from Ohio State University Wexner Medical Center, Columbus. “It has the potential to reduce acute decompensated heart failure hospitalizations and improve patient quality of life and economic outcomes. But, of course, we have to show that now in larger and randomized clinical studies.”

Abraham presented the Cordio HearO Community Study preliminary results at the Heart Failure Association of the European Society of Cardiology sessions. It follows a recent small study that showed the same app could identify vocal signals linked to altered fluid status in patients with HF hospitalized with acute decompensation.

In the current study, researchers prospectively tracked any worsening HF events that hit patients within a month after the system sent them an alert suggesting early changes in fluid status. Then, they retrospectively assessed the strategy’s predictive accuracy for an initial episode.

The system correctly predicted 32 of 39 first HF events, for an 82% sensitivity and a false-positive rate of 18%. On an annualized basis, Dr. Abraham said, the patients experienced an estimated two to three false alarms per year, alerts that were not followed by HF events. For context, the standard practice of monitoring the patient’s weight “has a sensitivity of about 10%-20%. So this performs very well as a noninvasive technology.”

On average, Dr. Abraham said, “we were able to detect future events about 18 days prior to the worsening heart failure event,” which in practice would provide “a pretty broad window for intervention.”

The false positives were not a surprise. Lung fluid status can change in conditions other than heart failure, he observed, and the HearO system alerts aren’t meant to be followed blindly.

“I don’t know that we clearly understand what those false-positives represent just yet,” Dr. Abraham said. “The bottom line is, as with any diagnostic tool, you have to use the totality of clinical information you have available. If you get an alert and the patient has a fever and a cough, you might think of pneumonia before worsening heart failure.”

“The false positives don’t appear to be alarming,” agreed Antoni Bayés-Genís, MD, PhD, Hospital Universitari Germans Trias i Pujol, Badalona, Spain, and Universitat Autònoma de Barcelona.

The study suggests that the HearO system, combined with sound clinical judgment, “has the potential to identify early congestion that may allow for treatment management, and then avoiding hospital admission,” Dr. Bayés-Genís, who isn’t connected with the study, said in an interview.

The entirely noninvasive, smartphone-based app would be more appealing than implanted devices that, for example, measure thoracic bioimpedance or pulmonary artery pressure and are also intended as congestion early-warning systems, he proposed. “Its scalability makes it very attractive as well.”

But all that “would have to be validated in a large clinical trial,” Dr. Bayés-Genís, who comoderated the conference session featuring Dr. Abraham’s presentation, said when interviewed.

The ongoing study has enrolled 430 clinically stable adult patients with HF in New York Heart Association functional class II or III, regardless of left ventricular ejection fraction, who were cared for by teams at eight centers in Israel. At the outset, during a period of stability, each patient spoke a few sentences into the app to establish a vocal-pattern baseline.

Once home, their assignment was to speak the same sentences into their phones once a day. The app, working through a cloud-based, artificial intelligence–derived processing system, compared each day’s vocal signature with the baseline and alerted researchers when it detected signs of altered fluid status.

About 460,000 recordings were collected from the 180 patients in the current analysis, of whom about 27% were women. They used the app for a mean of 512 days.

The system seems to work well regardless of language or dialect, Dr. Abraham said. About 70% of the current study’s patients spoke Hebrew, and most of the rest spoke either Russian or Arabic.

Most patients (almost 80%) used the app at least 70% of the prescribed time. Only 14 patients used the app less than 60% of the time, he reported.

Dr. Bayés-Genís proposed that, in practice, unfamiliarity with or resistance to smartphone technology would be unlikely to figure greatly in any nonadherence with the daily app regimen, except “maybe for the eldest of the eldest.” The current cohort’s mean age was 70 years. In his experience, he said, most older persons younger than age 80 use a smartphone, at least in more developed countries.

Dr. Abraham disclosed serving on an advisory board for and receiving consulting fees from Cordio Medical; receiving consulting fees from Abbott, Boehringer Ingelheim, CVRx, Edwards Lifesciences, and Respicardia; receiving salary from V-Wave Medical; and receiving research support from the National Heart, Lung, and Blood Institute. Dr. Bayés-Genís reported receiving personal fees from AstraZeneca, Vifor-Fresenius, Novartis, Boehringer Ingelheim, Abbott, Roche Diagnostics, and Critical Diagnostics.

A version of this article first appeared on Medscape.com.

A voice can carry a long distance, but in patients with heart failure (HF) a voice can also carry otherwise hidden signs useful for predicting short-term risk for worsening disease, even acute decompensation. Potentially, it only has to reach a smartphone to do it, suggests a preliminary study of a mobile app designed to alert patients and clinicians to such looming HF events, if possible in time to avert them.

The proprietary app and analysis system (HearO, Cordio Medical), used daily at home by 180 patients with stable HF, demonstrated 82% accuracy in picking out vocal signals of early congestion that would soon be followed by a need for intensified therapy or acute decompensation.

Andrew D. Bowser/MDedge News

In practice, clinicians receiving the system’s alerts about altered fluid status would intervene with medication adjustments before the patient deteriorates and possibly heads for the ED. That would be the plan; there were no interventions in the current study, which was designed only to explore the strategy’s feasibility and accuracy.

The system could emerge as “a useful tool in remote monitoring of heart failure patients, providing early warning of worsening heart failure,” said William Abraham, MD, from Ohio State University Wexner Medical Center, Columbus. “It has the potential to reduce acute decompensated heart failure hospitalizations and improve patient quality of life and economic outcomes. But, of course, we have to show that now in larger and randomized clinical studies.”

Abraham presented the Cordio HearO Community Study preliminary results at the Heart Failure Association of the European Society of Cardiology sessions. It follows a recent small study that showed the same app could identify vocal signals linked to altered fluid status in patients with HF hospitalized with acute decompensation.

In the current study, researchers prospectively tracked any worsening HF events that hit patients within a month after the system sent them an alert suggesting early changes in fluid status. Then, they retrospectively assessed the strategy’s predictive accuracy for an initial episode.

The system correctly predicted 32 of 39 first HF events, for an 82% sensitivity and a false-positive rate of 18%. On an annualized basis, Dr. Abraham said, the patients experienced an estimated two to three false alarms per year, alerts that were not followed by HF events. For context, the standard practice of monitoring the patient’s weight “has a sensitivity of about 10%-20%. So this performs very well as a noninvasive technology.”

On average, Dr. Abraham said, “we were able to detect future events about 18 days prior to the worsening heart failure event,” which in practice would provide “a pretty broad window for intervention.”

The false positives were not a surprise. Lung fluid status can change in conditions other than heart failure, he observed, and the HearO system alerts aren’t meant to be followed blindly.

“I don’t know that we clearly understand what those false-positives represent just yet,” Dr. Abraham said. “The bottom line is, as with any diagnostic tool, you have to use the totality of clinical information you have available. If you get an alert and the patient has a fever and a cough, you might think of pneumonia before worsening heart failure.”

“The false positives don’t appear to be alarming,” agreed Antoni Bayés-Genís, MD, PhD, Hospital Universitari Germans Trias i Pujol, Badalona, Spain, and Universitat Autònoma de Barcelona.

The study suggests that the HearO system, combined with sound clinical judgment, “has the potential to identify early congestion that may allow for treatment management, and then avoiding hospital admission,” Dr. Bayés-Genís, who isn’t connected with the study, said in an interview.

The entirely noninvasive, smartphone-based app would be more appealing than implanted devices that, for example, measure thoracic bioimpedance or pulmonary artery pressure and are also intended as congestion early-warning systems, he proposed. “Its scalability makes it very attractive as well.”

But all that “would have to be validated in a large clinical trial,” Dr. Bayés-Genís, who comoderated the conference session featuring Dr. Abraham’s presentation, said when interviewed.

The ongoing study has enrolled 430 clinically stable adult patients with HF in New York Heart Association functional class II or III, regardless of left ventricular ejection fraction, who were cared for by teams at eight centers in Israel. At the outset, during a period of stability, each patient spoke a few sentences into the app to establish a vocal-pattern baseline.

Once home, their assignment was to speak the same sentences into their phones once a day. The app, working through a cloud-based, artificial intelligence–derived processing system, compared each day’s vocal signature with the baseline and alerted researchers when it detected signs of altered fluid status.

About 460,000 recordings were collected from the 180 patients in the current analysis, of whom about 27% were women. They used the app for a mean of 512 days.

The system seems to work well regardless of language or dialect, Dr. Abraham said. About 70% of the current study’s patients spoke Hebrew, and most of the rest spoke either Russian or Arabic.

Most patients (almost 80%) used the app at least 70% of the prescribed time. Only 14 patients used the app less than 60% of the time, he reported.

Dr. Bayés-Genís proposed that, in practice, unfamiliarity with or resistance to smartphone technology would be unlikely to figure greatly in any nonadherence with the daily app regimen, except “maybe for the eldest of the eldest.” The current cohort’s mean age was 70 years. In his experience, he said, most older persons younger than age 80 use a smartphone, at least in more developed countries.

Dr. Abraham disclosed serving on an advisory board for and receiving consulting fees from Cordio Medical; receiving consulting fees from Abbott, Boehringer Ingelheim, CVRx, Edwards Lifesciences, and Respicardia; receiving salary from V-Wave Medical; and receiving research support from the National Heart, Lung, and Blood Institute. Dr. Bayés-Genís reported receiving personal fees from AstraZeneca, Vifor-Fresenius, Novartis, Boehringer Ingelheim, Abbott, Roche Diagnostics, and Critical Diagnostics.

A version of this article first appeared on Medscape.com.

For the past 2 decades, catheter ablation stole most of the excitement in electrophysiology. Cardiac pacing was seen as necessary but boring. His-bundle pacing earned only modest attention. 

But at the annual scientific sessions of the Heart Rhythm Society, cardiac pacing consolidated its comeback and entered the super-cool category.

Not one but three late-breaking clinical trials considered the role of pacing the heart’s conduction system for both preventive and therapeutic purposes. Conduction system pacing, or CSP as we call it, includes pacing the His bundle or the left bundle branch. Left bundle–branch pacing has now largely replaced His-bundle pacing.

Before I tell you about the studies, let’s review why CSP disrupts the status quo.

The core idea goes back to basic physiology: After the impulse leaves the atrioventricular node, the heart’s specialized conduction system allows rapid and synchronous conduction to both the right and left ventricles.

Standard cardiac pacing means fixing a pacing lead into the muscle of the right ventricle. From that spot, conduction spreads via slower muscle-to-muscle conduction, which leads to a wide QRS complex and the right ventricle contracts before the left ventricle.

While such dyssynchronous contraction is better than no contraction, this approach leads to a pacing-induced cardiomyopathy in a substantial number of cases. (The incidence reported in many studies varies widely.)

The most disruptive effect of conduction system pacing is that it is a form of cardiac resynchronization therapy (CRT). And that is nifty because, until recently, resynchronizing the ventricles required placing two ventricular leads: one in the right ventricle and the other in the coronary sinus to pace the left ventricle.
 

Left bundle-branch pacing vs. biventricular pacing

The first of the three HRS studies is the LBBP-RESYNC randomized controlled trial led by Jiangang Zou, MD, PhD, and performed in multiple centers in China. It compared the efficacy of left bundle–branch pacing (LBBP) with that of conventional biventricular pacing in 40 patients with heart failure who were eligible for CRT. The primary endpoint was the change in left ventricular ejection fraction (LVEF) from baseline to 6-month follow-up.

The results favored LBBP. Although both pacing techniques improved LVEF from baseline, the between-group difference in LVEF was greater in the LBBP arm than the biventricular pacing arm by a statistically significant 5.6% (95% confidence interval, 0.3%-10.9%). Secondary endpoints, such as reductions in left ventricular end-systolic volume, N-terminal of the prohormone brain natriuretic peptide, and QRS duration, also favored LBBP.
 

Conduction system pacing vs. biventricular pacing

A second late-breaking study, from the Geisinger group, led by Pugazhendhi Vijayaraman, MD, was simultaneously published in Heart Rhythm.

This nonrandomized observational study compared nearly 500 patients eligible for CRT treated at two health systems. One group favors conduction system pacing and the other does traditional biventricular pacing, which set up a two-armed comparison.

CSP was accomplished by LBBP (65%) and His-bundle pacing (35%).

The primary endpoint of death or first hospitalization for heart failure occurred in 28.3% of patients in the CSP arm versus 38.4% of the biventricular arm (hazard ratio, 1.52; 95% CI, 1.08-2.09). QRS duration and LVEF also improved from baseline in both groups.
 

LBB area pacing as a bailout for failed CRT

The Geisinger group also presented and published an international multicenter study that assessed the feasibility of LBBP as a bailout when standard biventricular pacing did not work – because of inadequate coronary sinus anatomy or CRT nonresponse, defined as lack of clinical or echocardiographic improvement.

This series included 212 patients in whom CRT failed and who underwent attempted LBBP pacing. The bailout was successful in 200 patients (91%). The primary endpoint was defined as an increase in LVEF above 5% on echocardiography.

During 12-month follow-up, 61% of patients had an improvement in LVEF above 5% and nearly 30% had a “super-response,” defined as a 20% or greater increase or normalization of LVEF. Similar to the previous studies, LBBP resulted in shorter QRS duration and improved echocardiography parameters.
 

Am I persuaded?

I was an early adopter of His-bundle pacing. When successful, it delivered both aesthetically pleasing QRS complexes and clinical efficacy. But there were many challenges: it is technically difficult, and capture thresholds are often high at implant and get higher over time, which leads to shorter battery life.

Pacing the left bundle branch mitigates these challenges. Here, the operator approaches from the right side and screws the lead a few millimeters into the septum, so the tip of the lead can capture the left bundle or one of its branches. This allows activation of the heart’s specialized conduction system and thus synchronizes right and left ventricle contraction.

Although there is a learning curve, LBBP is technically easier than His-bundle pacing and ultimately results in far better pacing and sensing parameters. What’s more, the preferred lead for LBBP has a stellar efficacy record – over years.

Chormail/Dreamstime.com

The barriers to getting more CSP trials

The challenge going forward will be funding new trials. CSP stands to prevent pacing-induced cardiomyopathy and offer less costly alternatives to standard biventricular pacing for CRT. This is great for patients, but it would mean that fewer higher-cost CRT devices will be sold.

Heart rhythm research is largely industry-funded because in most cases better therapies for patients mean more profits for industry. In the case of CSP, there is no such confluence of interests.

Conduction system pacing has come about because of the efforts of a few tireless champions who not only published extensively but were also skilled at using social media to spread the excitement. Trials have been small and often self-funded.

The data presented at HRS provides enough equipoise to support a large outcomes-based randomized controlled trial. Imagine if our CSP champions were able to find public-funding sources for such future trials.

Now that would be super cool.

Dr. Mandrola practices cardiac electrophysiology in Louisville, Ky., and is a writer and podcaster for Medscape. He participates in clinical research and writes often about the state of medical evidence. He has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

For the past 2 decades, catheter ablation stole most of the excitement in electrophysiology. Cardiac pacing was seen as necessary but boring. His-bundle pacing earned only modest attention. 

But at the annual scientific sessions of the Heart Rhythm Society, cardiac pacing consolidated its comeback and entered the super-cool category.

Not one but three late-breaking clinical trials considered the role of pacing the heart’s conduction system for both preventive and therapeutic purposes. Conduction system pacing, or CSP as we call it, includes pacing the His bundle or the left bundle branch. Left bundle–branch pacing has now largely replaced His-bundle pacing.

Before I tell you about the studies, let’s review why CSP disrupts the status quo.

The core idea goes back to basic physiology: After the impulse leaves the atrioventricular node, the heart’s specialized conduction system allows rapid and synchronous conduction to both the right and left ventricles.

Standard cardiac pacing means fixing a pacing lead into the muscle of the right ventricle. From that spot, conduction spreads via slower muscle-to-muscle conduction, which leads to a wide QRS complex and the right ventricle contracts before the left ventricle.

While such dyssynchronous contraction is better than no contraction, this approach leads to a pacing-induced cardiomyopathy in a substantial number of cases. (The incidence reported in many studies varies widely.)

The most disruptive effect of conduction system pacing is that it is a form of cardiac resynchronization therapy (CRT). And that is nifty because, until recently, resynchronizing the ventricles required placing two ventricular leads: one in the right ventricle and the other in the coronary sinus to pace the left ventricle.
 

Left bundle-branch pacing vs. biventricular pacing

The first of the three HRS studies is the LBBP-RESYNC randomized controlled trial led by Jiangang Zou, MD, PhD, and performed in multiple centers in China. It compared the efficacy of left bundle–branch pacing (LBBP) with that of conventional biventricular pacing in 40 patients with heart failure who were eligible for CRT. The primary endpoint was the change in left ventricular ejection fraction (LVEF) from baseline to 6-month follow-up.

The results favored LBBP. Although both pacing techniques improved LVEF from baseline, the between-group difference in LVEF was greater in the LBBP arm than the biventricular pacing arm by a statistically significant 5.6% (95% confidence interval, 0.3%-10.9%). Secondary endpoints, such as reductions in left ventricular end-systolic volume, N-terminal of the prohormone brain natriuretic peptide, and QRS duration, also favored LBBP.
 

Conduction system pacing vs. biventricular pacing

A second late-breaking study, from the Geisinger group, led by Pugazhendhi Vijayaraman, MD, was simultaneously published in Heart Rhythm.

This nonrandomized observational study compared nearly 500 patients eligible for CRT treated at two health systems. One group favors conduction system pacing and the other does traditional biventricular pacing, which set up a two-armed comparison.

CSP was accomplished by LBBP (65%) and His-bundle pacing (35%).

The primary endpoint of death or first hospitalization for heart failure occurred in 28.3% of patients in the CSP arm versus 38.4% of the biventricular arm (hazard ratio, 1.52; 95% CI, 1.08-2.09). QRS duration and LVEF also improved from baseline in both groups.
 

LBB area pacing as a bailout for failed CRT

The Geisinger group also presented and published an international multicenter study that assessed the feasibility of LBBP as a bailout when standard biventricular pacing did not work – because of inadequate coronary sinus anatomy or CRT nonresponse, defined as lack of clinical or echocardiographic improvement.

This series included 212 patients in whom CRT failed and who underwent attempted LBBP pacing. The bailout was successful in 200 patients (91%). The primary endpoint was defined as an increase in LVEF above 5% on echocardiography.

During 12-month follow-up, 61% of patients had an improvement in LVEF above 5% and nearly 30% had a “super-response,” defined as a 20% or greater increase or normalization of LVEF. Similar to the previous studies, LBBP resulted in shorter QRS duration and improved echocardiography parameters.
 

Am I persuaded?

I was an early adopter of His-bundle pacing. When successful, it delivered both aesthetically pleasing QRS complexes and clinical efficacy. But there were many challenges: it is technically difficult, and capture thresholds are often high at implant and get higher over time, which leads to shorter battery life.

Pacing the left bundle branch mitigates these challenges. Here, the operator approaches from the right side and screws the lead a few millimeters into the septum, so the tip of the lead can capture the left bundle or one of its branches. This allows activation of the heart’s specialized conduction system and thus synchronizes right and left ventricle contraction.

Although there is a learning curve, LBBP is technically easier than His-bundle pacing and ultimately results in far better pacing and sensing parameters. What’s more, the preferred lead for LBBP has a stellar efficacy record – over years.

Chormail/Dreamstime.com

The barriers to getting more CSP trials

The challenge going forward will be funding new trials. CSP stands to prevent pacing-induced cardiomyopathy and offer less costly alternatives to standard biventricular pacing for CRT. This is great for patients, but it would mean that fewer higher-cost CRT devices will be sold.

Heart rhythm research is largely industry-funded because in most cases better therapies for patients mean more profits for industry. In the case of CSP, there is no such confluence of interests.

Conduction system pacing has come about because of the efforts of a few tireless champions who not only published extensively but were also skilled at using social media to spread the excitement. Trials have been small and often self-funded.

The data presented at HRS provides enough equipoise to support a large outcomes-based randomized controlled trial. Imagine if our CSP champions were able to find public-funding sources for such future trials.

Now that would be super cool.

Dr. Mandrola practices cardiac electrophysiology in Louisville, Ky., and is a writer and podcaster for Medscape. He participates in clinical research and writes often about the state of medical evidence. He has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

For the past 2 decades, catheter ablation stole most of the excitement in electrophysiology. Cardiac pacing was seen as necessary but boring. His-bundle pacing earned only modest attention. 

But at the annual scientific sessions of the Heart Rhythm Society, cardiac pacing consolidated its comeback and entered the super-cool category.

Not one but three late-breaking clinical trials considered the role of pacing the heart’s conduction system for both preventive and therapeutic purposes. Conduction system pacing, or CSP as we call it, includes pacing the His bundle or the left bundle branch. Left bundle–branch pacing has now largely replaced His-bundle pacing.

Before I tell you about the studies, let’s review why CSP disrupts the status quo.

The core idea goes back to basic physiology: After the impulse leaves the atrioventricular node, the heart’s specialized conduction system allows rapid and synchronous conduction to both the right and left ventricles.

Standard cardiac pacing means fixing a pacing lead into the muscle of the right ventricle. From that spot, conduction spreads via slower muscle-to-muscle conduction, which leads to a wide QRS complex and the right ventricle contracts before the left ventricle.

While such dyssynchronous contraction is better than no contraction, this approach leads to a pacing-induced cardiomyopathy in a substantial number of cases. (The incidence reported in many studies varies widely.)

The most disruptive effect of conduction system pacing is that it is a form of cardiac resynchronization therapy (CRT). And that is nifty because, until recently, resynchronizing the ventricles required placing two ventricular leads: one in the right ventricle and the other in the coronary sinus to pace the left ventricle.
 

Left bundle-branch pacing vs. biventricular pacing

The first of the three HRS studies is the LBBP-RESYNC randomized controlled trial led by Jiangang Zou, MD, PhD, and performed in multiple centers in China. It compared the efficacy of left bundle–branch pacing (LBBP) with that of conventional biventricular pacing in 40 patients with heart failure who were eligible for CRT. The primary endpoint was the change in left ventricular ejection fraction (LVEF) from baseline to 6-month follow-up.

The results favored LBBP. Although both pacing techniques improved LVEF from baseline, the between-group difference in LVEF was greater in the LBBP arm than the biventricular pacing arm by a statistically significant 5.6% (95% confidence interval, 0.3%-10.9%). Secondary endpoints, such as reductions in left ventricular end-systolic volume, N-terminal of the prohormone brain natriuretic peptide, and QRS duration, also favored LBBP.
 

Conduction system pacing vs. biventricular pacing

A second late-breaking study, from the Geisinger group, led by Pugazhendhi Vijayaraman, MD, was simultaneously published in Heart Rhythm.

This nonrandomized observational study compared nearly 500 patients eligible for CRT treated at two health systems. One group favors conduction system pacing and the other does traditional biventricular pacing, which set up a two-armed comparison.

CSP was accomplished by LBBP (65%) and His-bundle pacing (35%).

The primary endpoint of death or first hospitalization for heart failure occurred in 28.3% of patients in the CSP arm versus 38.4% of the biventricular arm (hazard ratio, 1.52; 95% CI, 1.08-2.09). QRS duration and LVEF also improved from baseline in both groups.
 

LBB area pacing as a bailout for failed CRT

The Geisinger group also presented and published an international multicenter study that assessed the feasibility of LBBP as a bailout when standard biventricular pacing did not work – because of inadequate coronary sinus anatomy or CRT nonresponse, defined as lack of clinical or echocardiographic improvement.

This series included 212 patients in whom CRT failed and who underwent attempted LBBP pacing. The bailout was successful in 200 patients (91%). The primary endpoint was defined as an increase in LVEF above 5% on echocardiography.

During 12-month follow-up, 61% of patients had an improvement in LVEF above 5% and nearly 30% had a “super-response,” defined as a 20% or greater increase or normalization of LVEF. Similar to the previous studies, LBBP resulted in shorter QRS duration and improved echocardiography parameters.
 

Am I persuaded?

I was an early adopter of His-bundle pacing. When successful, it delivered both aesthetically pleasing QRS complexes and clinical efficacy. But there were many challenges: it is technically difficult, and capture thresholds are often high at implant and get higher over time, which leads to shorter battery life.

Pacing the left bundle branch mitigates these challenges. Here, the operator approaches from the right side and screws the lead a few millimeters into the septum, so the tip of the lead can capture the left bundle or one of its branches. This allows activation of the heart’s specialized conduction system and thus synchronizes right and left ventricle contraction.

Although there is a learning curve, LBBP is technically easier than His-bundle pacing and ultimately results in far better pacing and sensing parameters. What’s more, the preferred lead for LBBP has a stellar efficacy record – over years.

Chormail/Dreamstime.com

The barriers to getting more CSP trials

The challenge going forward will be funding new trials. CSP stands to prevent pacing-induced cardiomyopathy and offer less costly alternatives to standard biventricular pacing for CRT. This is great for patients, but it would mean that fewer higher-cost CRT devices will be sold.

Heart rhythm research is largely industry-funded because in most cases better therapies for patients mean more profits for industry. In the case of CSP, there is no such confluence of interests.

Conduction system pacing has come about because of the efforts of a few tireless champions who not only published extensively but were also skilled at using social media to spread the excitement. Trials have been small and often self-funded.

The data presented at HRS provides enough equipoise to support a large outcomes-based randomized controlled trial. Imagine if our CSP champions were able to find public-funding sources for such future trials.

Now that would be super cool.

Dr. Mandrola practices cardiac electrophysiology in Louisville, Ky., and is a writer and podcaster for Medscape. He participates in clinical research and writes often about the state of medical evidence. He has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

Topline results from the phase 3 DELIVER trial show dapagliflozin (Farxiga) significantly reduced the primary endpoint of cardiovascular death or worsening heart failure in patients with mildly reduced or preserved ejection fraction, AstraZeneca announced today.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor is not approved in this setting but is already approved for treatment of type 2 diabetes, chronic kidney disease, and heart failure with reduced ejection fraction.

“The results of DELIVER extend the benefit of dapagliflozin to the full spectrum of patients with heart failure,” principal investigator of the trial, Scott Solomon, MD, Harvard Medical School and Brigham and Women’s Hospital, Boston, said in the news release.

The safety and tolerability of dapagliflozin in the trial were consistent with its established safety profile, the company says.

The full trial results will be submitted for presentation at a forthcoming medical meeting, and regulatory submissions will be made in the coming months, it notes.

A version of this article first appeared on Medscape.com.

Topline results from the phase 3 DELIVER trial show dapagliflozin (Farxiga) significantly reduced the primary endpoint of cardiovascular death or worsening heart failure in patients with mildly reduced or preserved ejection fraction, AstraZeneca announced today.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor is not approved in this setting but is already approved for treatment of type 2 diabetes, chronic kidney disease, and heart failure with reduced ejection fraction.

“The results of DELIVER extend the benefit of dapagliflozin to the full spectrum of patients with heart failure,” principal investigator of the trial, Scott Solomon, MD, Harvard Medical School and Brigham and Women’s Hospital, Boston, said in the news release.

The safety and tolerability of dapagliflozin in the trial were consistent with its established safety profile, the company says.

The full trial results will be submitted for presentation at a forthcoming medical meeting, and regulatory submissions will be made in the coming months, it notes.

A version of this article first appeared on Medscape.com.

Topline results from the phase 3 DELIVER trial show dapagliflozin (Farxiga) significantly reduced the primary endpoint of cardiovascular death or worsening heart failure in patients with mildly reduced or preserved ejection fraction, AstraZeneca announced today.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor is not approved in this setting but is already approved for treatment of type 2 diabetes, chronic kidney disease, and heart failure with reduced ejection fraction.

“The results of DELIVER extend the benefit of dapagliflozin to the full spectrum of patients with heart failure,” principal investigator of the trial, Scott Solomon, MD, Harvard Medical School and Brigham and Women’s Hospital, Boston, said in the news release.

The safety and tolerability of dapagliflozin in the trial were consistent with its established safety profile, the company says.

The full trial results will be submitted for presentation at a forthcoming medical meeting, and regulatory submissions will be made in the coming months, it notes.

A version of this article first appeared on Medscape.com.

The heart from a genetically modified pig transplanted to a Maryland patient in January in a pioneering, acclaimed, and widely critiqued surgery appears to have carried an unwanted passenger.

A porcine cytomegalovirus (PCMV) in the heart had gone undetected before the operation and may or may not have been instrumental in David Bennett’s death 2 months later, according to a report published in MIT Technology Review.  

University of Maryland Medical Center

“The issue is now a subject of wide discussion among specialists, who think the infection was a potential contributor to Mr. Bennett’s death and a possible reason why the heart did not last longer,” states the article, written by staff journalist Antonio Regalado.

As described in the story, the xenotransplant saga’s new twist comes from the surgeon who performed the operation, Bartley P. Griffith, MD, University of Maryland, Baltimore, who related the PCMV finding in an April 20 online presentation hosted by the American Society of Transplantation.

Mr. Bennett’s initially promising but later turbulent clinical course, described by his surgeons and widely reported upon his death, included repeated skirmishes with infection and retaliatory adjustments to his immunosuppressant regimen. Those episodes were thought to have contributed to his death, the actual cause of which is undetermined or at least not yet reported.

“We are beginning to learn why he passed on,” Dr. Griffith said in Mr. Regalado’s article, acknowledging further that the porcine virus “maybe was the actor, or could be the actor,” that set off the events leading to Bennett’s death.

Xenotransplant specialists know that PCMV is a potential problem with pig organs and know to test for it before attempting the procedure in animal models, notes the article. It refers to a published series of pig-heart transplants to baboons in Germany. The hearts “lasted only a couple of weeks if the virus was present, while organs free from the infection could survive more than half a year.”

The heart Mr. Bennett received had been extensively screened for bacteria, viruses, and other issues that could have threatened the organ and Mr. Bennett, but the effort apparently fell short. In the MIT Technology Review story, the first author of the German baboon series speculates on how the University of Maryland team might have missed PCMV.

“The U.S. team appears to have tested the pig’s snout for the virus, but often it is lurking deeper in the tissues,” Joachim Denner, PhD, Institute of Virology, Free University of Berlin, said in the article. The virus, he contended, “can be detected and easily removed from pig populations, but unfortunately they didn’t use a good assay and didn’t detect the virus.”

That PCMV escaped detection before the operation “could now factor into some people’s questions over whether the experiment should have taken place at all,” the MIT Technology Review article proposes. “It’s a big red flag,” bioethicist Arthur Caplan, PhD, New York University, said in a quote, adding: “If doctors can’t prevent or control infection, ‘then such experiments are tough to justify.’ ”

A version of this article first appeared on Medscape.com.

The heart from a genetically modified pig transplanted to a Maryland patient in January in a pioneering, acclaimed, and widely critiqued surgery appears to have carried an unwanted passenger.

A porcine cytomegalovirus (PCMV) in the heart had gone undetected before the operation and may or may not have been instrumental in David Bennett’s death 2 months later, according to a report published in MIT Technology Review.  

University of Maryland Medical Center

“The issue is now a subject of wide discussion among specialists, who think the infection was a potential contributor to Mr. Bennett’s death and a possible reason why the heart did not last longer,” states the article, written by staff journalist Antonio Regalado.

As described in the story, the xenotransplant saga’s new twist comes from the surgeon who performed the operation, Bartley P. Griffith, MD, University of Maryland, Baltimore, who related the PCMV finding in an April 20 online presentation hosted by the American Society of Transplantation.

Mr. Bennett’s initially promising but later turbulent clinical course, described by his surgeons and widely reported upon his death, included repeated skirmishes with infection and retaliatory adjustments to his immunosuppressant regimen. Those episodes were thought to have contributed to his death, the actual cause of which is undetermined or at least not yet reported.

“We are beginning to learn why he passed on,” Dr. Griffith said in Mr. Regalado’s article, acknowledging further that the porcine virus “maybe was the actor, or could be the actor,” that set off the events leading to Bennett’s death.

Xenotransplant specialists know that PCMV is a potential problem with pig organs and know to test for it before attempting the procedure in animal models, notes the article. It refers to a published series of pig-heart transplants to baboons in Germany. The hearts “lasted only a couple of weeks if the virus was present, while organs free from the infection could survive more than half a year.”

The heart Mr. Bennett received had been extensively screened for bacteria, viruses, and other issues that could have threatened the organ and Mr. Bennett, but the effort apparently fell short. In the MIT Technology Review story, the first author of the German baboon series speculates on how the University of Maryland team might have missed PCMV.

“The U.S. team appears to have tested the pig’s snout for the virus, but often it is lurking deeper in the tissues,” Joachim Denner, PhD, Institute of Virology, Free University of Berlin, said in the article. The virus, he contended, “can be detected and easily removed from pig populations, but unfortunately they didn’t use a good assay and didn’t detect the virus.”

That PCMV escaped detection before the operation “could now factor into some people’s questions over whether the experiment should have taken place at all,” the MIT Technology Review article proposes. “It’s a big red flag,” bioethicist Arthur Caplan, PhD, New York University, said in a quote, adding: “If doctors can’t prevent or control infection, ‘then such experiments are tough to justify.’ ”

A version of this article first appeared on Medscape.com.

The heart from a genetically modified pig transplanted to a Maryland patient in January in a pioneering, acclaimed, and widely critiqued surgery appears to have carried an unwanted passenger.

A porcine cytomegalovirus (PCMV) in the heart had gone undetected before the operation and may or may not have been instrumental in David Bennett’s death 2 months later, according to a report published in MIT Technology Review.  

University of Maryland Medical Center

“The issue is now a subject of wide discussion among specialists, who think the infection was a potential contributor to Mr. Bennett’s death and a possible reason why the heart did not last longer,” states the article, written by staff journalist Antonio Regalado.

As described in the story, the xenotransplant saga’s new twist comes from the surgeon who performed the operation, Bartley P. Griffith, MD, University of Maryland, Baltimore, who related the PCMV finding in an April 20 online presentation hosted by the American Society of Transplantation.

Mr. Bennett’s initially promising but later turbulent clinical course, described by his surgeons and widely reported upon his death, included repeated skirmishes with infection and retaliatory adjustments to his immunosuppressant regimen. Those episodes were thought to have contributed to his death, the actual cause of which is undetermined or at least not yet reported.

“We are beginning to learn why he passed on,” Dr. Griffith said in Mr. Regalado’s article, acknowledging further that the porcine virus “maybe was the actor, or could be the actor,” that set off the events leading to Bennett’s death.

Xenotransplant specialists know that PCMV is a potential problem with pig organs and know to test for it before attempting the procedure in animal models, notes the article. It refers to a published series of pig-heart transplants to baboons in Germany. The hearts “lasted only a couple of weeks if the virus was present, while organs free from the infection could survive more than half a year.”

The heart Mr. Bennett received had been extensively screened for bacteria, viruses, and other issues that could have threatened the organ and Mr. Bennett, but the effort apparently fell short. In the MIT Technology Review story, the first author of the German baboon series speculates on how the University of Maryland team might have missed PCMV.

“The U.S. team appears to have tested the pig’s snout for the virus, but often it is lurking deeper in the tissues,” Joachim Denner, PhD, Institute of Virology, Free University of Berlin, said in the article. The virus, he contended, “can be detected and easily removed from pig populations, but unfortunately they didn’t use a good assay and didn’t detect the virus.”

That PCMV escaped detection before the operation “could now factor into some people’s questions over whether the experiment should have taken place at all,” the MIT Technology Review article proposes. “It’s a big red flag,” bioethicist Arthur Caplan, PhD, New York University, said in a quote, adding: “If doctors can’t prevent or control infection, ‘then such experiments are tough to justify.’ ”

A version of this article first appeared on Medscape.com.

Takotsubo syndrome, a condition that’s also been called “broken heart syndrome,” can be triggered by both positive and negative life stressors, especially in men, a new study suggests.

The findings show that although Takotsubo syndrome, a type of acute heart failure related to atypical patterns of transient left ventricular contraction abnormalities, is often triggered by negative emotional stressors, it can also stem from positive life events, something the researchers are calling “happy heart syndrome.”

In this registry study, males were more likely to experience Takotsubo syndrome from a positive life event, as were those with atypical, nonapical ballooning, reported Thomas Stiermaier, MD, of University Hospital Schleswig-Holstein in Lübeck, Germany, and colleagues.

Patients with negative and positive emotional triggers experienced similar short- and long-term outcomes, they found.

The results were published online in JACC: Heart Failure.

Previous studies have shown that Takotsubo syndrome can be related to negative emotional triggers, physical triggers such as heavy physical activity, or medical procedures (or, in some cases, neither of these), or even a combination of emotional and physical triggers, the authors said. Research shows that physical triggers are most often linked to poor outcomes.

A vast number of clinical scenarios may lead up to Takotsubo syndrome, noted Jason H. Rogers, MD, professor of cardiovascular medicine at the University of California, Davis, who commented on these findings.

“Examples would include other medical illness, such as infection or recent surgery, having a heated argument with someone, running to catch a flight at the airport, and even being awakened suddenly by a sick pet,” Dr. Rogers told this news organization.

But not all patients experience unhappy life stressors before these events occur, he added. “It is possible for patients to have happy life stressors that can lead to Takotsubo syndrome also.”

For this analysis, the research team evaluated 2,482 patients using data from the multicenter German-Italian-Spanish Takotsubo (GEIST) Registry, one of the largest of its kind. Of these patients, 910 experienced an emotional trigger; of these, 873 had negative preceding events, and 37 had pleasant preceding events. The mean age was 70 years in both groups.

The study team then compared patients with negative emotional triggers to those with positive emotional triggers, which included weddings, the birth of grandchildren, birthday parties, or anticipation of a trip or Christmas.

There was a 1.5% incidence of pleasant emotional triggers among all Takotsubo syndrome patients.

Among patients with positive prior triggers, there was a higher incidence of atypical ballooning (27.0% vs. 12.5%; P = .01), and a higher percentage of these patients were male (18.9% vs. 5.0%; P < .01) in comparison with those with negative events prior to Takotsubo syndrome.

Long-term death rates (8.8% vs. 2.7%; P = .20) and rates of in-hospital complication outcomes, including cardiogenic shock, stroke, death, or pulmonary edema (12.3% vs. 8.1%; P = .45), were similar for patients with negative preceding events and for those with positive preceding events.

Study limitations included that it cannot provide insight into the specific mechanisms of Takotsubo syndrome, it was observational, the sample size of patients in the positive events group was small, and the contributing research facilities assessed cardiac biomarker levels differently.

“Additional research efforts are needed to explore whether numerically lower cardiac-related event rates in patients with happy heart syndrome would be statistically significant in a larger sample size,” the researchers concluded.

Dr. Stiermaier reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Takotsubo syndrome, a condition that’s also been called “broken heart syndrome,” can be triggered by both positive and negative life stressors, especially in men, a new study suggests.

The findings show that although Takotsubo syndrome, a type of acute heart failure related to atypical patterns of transient left ventricular contraction abnormalities, is often triggered by negative emotional stressors, it can also stem from positive life events, something the researchers are calling “happy heart syndrome.”

In this registry study, males were more likely to experience Takotsubo syndrome from a positive life event, as were those with atypical, nonapical ballooning, reported Thomas Stiermaier, MD, of University Hospital Schleswig-Holstein in Lübeck, Germany, and colleagues.

Patients with negative and positive emotional triggers experienced similar short- and long-term outcomes, they found.

The results were published online in JACC: Heart Failure.

Previous studies have shown that Takotsubo syndrome can be related to negative emotional triggers, physical triggers such as heavy physical activity, or medical procedures (or, in some cases, neither of these), or even a combination of emotional and physical triggers, the authors said. Research shows that physical triggers are most often linked to poor outcomes.

A vast number of clinical scenarios may lead up to Takotsubo syndrome, noted Jason H. Rogers, MD, professor of cardiovascular medicine at the University of California, Davis, who commented on these findings.

“Examples would include other medical illness, such as infection or recent surgery, having a heated argument with someone, running to catch a flight at the airport, and even being awakened suddenly by a sick pet,” Dr. Rogers told this news organization.

But not all patients experience unhappy life stressors before these events occur, he added. “It is possible for patients to have happy life stressors that can lead to Takotsubo syndrome also.”

For this analysis, the research team evaluated 2,482 patients using data from the multicenter German-Italian-Spanish Takotsubo (GEIST) Registry, one of the largest of its kind. Of these patients, 910 experienced an emotional trigger; of these, 873 had negative preceding events, and 37 had pleasant preceding events. The mean age was 70 years in both groups.

The study team then compared patients with negative emotional triggers to those with positive emotional triggers, which included weddings, the birth of grandchildren, birthday parties, or anticipation of a trip or Christmas.

There was a 1.5% incidence of pleasant emotional triggers among all Takotsubo syndrome patients.

Among patients with positive prior triggers, there was a higher incidence of atypical ballooning (27.0% vs. 12.5%; P = .01), and a higher percentage of these patients were male (18.9% vs. 5.0%; P < .01) in comparison with those with negative events prior to Takotsubo syndrome.

Long-term death rates (8.8% vs. 2.7%; P = .20) and rates of in-hospital complication outcomes, including cardiogenic shock, stroke, death, or pulmonary edema (12.3% vs. 8.1%; P = .45), were similar for patients with negative preceding events and for those with positive preceding events.

Study limitations included that it cannot provide insight into the specific mechanisms of Takotsubo syndrome, it was observational, the sample size of patients in the positive events group was small, and the contributing research facilities assessed cardiac biomarker levels differently.

“Additional research efforts are needed to explore whether numerically lower cardiac-related event rates in patients with happy heart syndrome would be statistically significant in a larger sample size,” the researchers concluded.

Dr. Stiermaier reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Takotsubo syndrome, a condition that’s also been called “broken heart syndrome,” can be triggered by both positive and negative life stressors, especially in men, a new study suggests.

The findings show that although Takotsubo syndrome, a type of acute heart failure related to atypical patterns of transient left ventricular contraction abnormalities, is often triggered by negative emotional stressors, it can also stem from positive life events, something the researchers are calling “happy heart syndrome.”

In this registry study, males were more likely to experience Takotsubo syndrome from a positive life event, as were those with atypical, nonapical ballooning, reported Thomas Stiermaier, MD, of University Hospital Schleswig-Holstein in Lübeck, Germany, and colleagues.

Patients with negative and positive emotional triggers experienced similar short- and long-term outcomes, they found.

The results were published online in JACC: Heart Failure.

Previous studies have shown that Takotsubo syndrome can be related to negative emotional triggers, physical triggers such as heavy physical activity, or medical procedures (or, in some cases, neither of these), or even a combination of emotional and physical triggers, the authors said. Research shows that physical triggers are most often linked to poor outcomes.

A vast number of clinical scenarios may lead up to Takotsubo syndrome, noted Jason H. Rogers, MD, professor of cardiovascular medicine at the University of California, Davis, who commented on these findings.

“Examples would include other medical illness, such as infection or recent surgery, having a heated argument with someone, running to catch a flight at the airport, and even being awakened suddenly by a sick pet,” Dr. Rogers told this news organization.

But not all patients experience unhappy life stressors before these events occur, he added. “It is possible for patients to have happy life stressors that can lead to Takotsubo syndrome also.”

For this analysis, the research team evaluated 2,482 patients using data from the multicenter German-Italian-Spanish Takotsubo (GEIST) Registry, one of the largest of its kind. Of these patients, 910 experienced an emotional trigger; of these, 873 had negative preceding events, and 37 had pleasant preceding events. The mean age was 70 years in both groups.

The study team then compared patients with negative emotional triggers to those with positive emotional triggers, which included weddings, the birth of grandchildren, birthday parties, or anticipation of a trip or Christmas.

There was a 1.5% incidence of pleasant emotional triggers among all Takotsubo syndrome patients.

Among patients with positive prior triggers, there was a higher incidence of atypical ballooning (27.0% vs. 12.5%; P = .01), and a higher percentage of these patients were male (18.9% vs. 5.0%; P < .01) in comparison with those with negative events prior to Takotsubo syndrome.

Long-term death rates (8.8% vs. 2.7%; P = .20) and rates of in-hospital complication outcomes, including cardiogenic shock, stroke, death, or pulmonary edema (12.3% vs. 8.1%; P = .45), were similar for patients with negative preceding events and for those with positive preceding events.

Study limitations included that it cannot provide insight into the specific mechanisms of Takotsubo syndrome, it was observational, the sample size of patients in the positive events group was small, and the contributing research facilities assessed cardiac biomarker levels differently.

“Additional research efforts are needed to explore whether numerically lower cardiac-related event rates in patients with happy heart syndrome would be statistically significant in a larger sample size,” the researchers concluded.

Dr. Stiermaier reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The risk for dementia goes up in patients with atrial fibrillation (AFib), but some evidence suggests that risk can be blunted with therapies that restore sinus rhythm. However, a new cohort study suggests that the treatment effect’s magnitude might depend on the rhythm control strategy. It hinted that AFib catheter ablation might be more effective than pharmacologic rhythm control alone at cutting the risk for dementia.

The case-matched study of more than 38,000 adults with AFib saw a 41% reduction (P < .0001) in risk for dementia among those who underwent catheter ablation after attempted rhythm control with antiarrhythmic drugs (AAD), compared with those managed with pharmacologic rhythm control therapy alone.

The observational study comprising 20 years of data comes with big limitations and can’t say for sure whether catheter ablation is better than AAD-only at cutting the dementia risk in AFib. But it and other evidence support the idea, which has yet to be explored in a randomized fashion.

In a secondary finding, the analysis showed a similar reduction in dementia risk from catheter ablation, compared with AAD, in women and in men by 40% and 45%, respectively (P < .0001 for both). The findings are particularly relevant “given the higher life-long risk of dementia among women and the lower likelihood that women will be offered ablation, which has been demonstrated repeatedly,” Emily P. Zeitler, MD, MHS, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, told this news organization. “I think this is another reason to try to be more generous in offering ablation to women.”

Management of AFib certainly evolved in important ways from 2000 to 2021, the period covered by the study. But a sensitivity analysis based on data from 2010 to 2021 showed “no meaningful differences” in the results, said Dr. Zeitler, who is slated to present the findings April 30 at the Heart Rhythm Society 2022 Scientific Sessions, conducted virtually and live in San Francisco.

Dr. Zeitler acknowledged that the observational study, even with its propensity-matched ablation and AAD cohorts, can only hint at a preference for ablation over AAD for lowering risk for AFib-associated dementia. “We know there’s unmeasured and unfixable confounding between those two groups, so we see this really as hypothesis-generating.”

It was “a well-done analysis,” and the conclusion that the dementia risk was lower with catheter ablation is “absolutely correct,” but only as far as the study and its limitations allow, agreed David Conen, MD, MPH, McMaster University, Hamilton, Ontario, who is not a coauthor.

“Even with propensity matching, you can get rid of some sorts of confounding, but you can never get rid of all selection bias issues.” That, he said when interviewed, takes randomized trials.

Dr. Conen, who is studying cognitive decline in AFib as a SWISS-AF trial principal investigator, pointed to a secondary finding of the analysis as evidence for such confounding. He said the ablation group’s nearly 50% drop (P < .0001) in competing risk for death, compared with patients managed with AAD, isn’t plausible.

A version of this article first appeared on Medscape.com.

The risk for dementia goes up in patients with atrial fibrillation (AFib), but some evidence suggests that risk can be blunted with therapies that restore sinus rhythm. However, a new cohort study suggests that the treatment effect’s magnitude might depend on the rhythm control strategy. It hinted that AFib catheter ablation might be more effective than pharmacologic rhythm control alone at cutting the risk for dementia.

The case-matched study of more than 38,000 adults with AFib saw a 41% reduction (P < .0001) in risk for dementia among those who underwent catheter ablation after attempted rhythm control with antiarrhythmic drugs (AAD), compared with those managed with pharmacologic rhythm control therapy alone.

The observational study comprising 20 years of data comes with big limitations and can’t say for sure whether catheter ablation is better than AAD-only at cutting the dementia risk in AFib. But it and other evidence support the idea, which has yet to be explored in a randomized fashion.

In a secondary finding, the analysis showed a similar reduction in dementia risk from catheter ablation, compared with AAD, in women and in men by 40% and 45%, respectively (P < .0001 for both). The findings are particularly relevant “given the higher life-long risk of dementia among women and the lower likelihood that women will be offered ablation, which has been demonstrated repeatedly,” Emily P. Zeitler, MD, MHS, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, told this news organization. “I think this is another reason to try to be more generous in offering ablation to women.”

Management of AFib certainly evolved in important ways from 2000 to 2021, the period covered by the study. But a sensitivity analysis based on data from 2010 to 2021 showed “no meaningful differences” in the results, said Dr. Zeitler, who is slated to present the findings April 30 at the Heart Rhythm Society 2022 Scientific Sessions, conducted virtually and live in San Francisco.

Dr. Zeitler acknowledged that the observational study, even with its propensity-matched ablation and AAD cohorts, can only hint at a preference for ablation over AAD for lowering risk for AFib-associated dementia. “We know there’s unmeasured and unfixable confounding between those two groups, so we see this really as hypothesis-generating.”

It was “a well-done analysis,” and the conclusion that the dementia risk was lower with catheter ablation is “absolutely correct,” but only as far as the study and its limitations allow, agreed David Conen, MD, MPH, McMaster University, Hamilton, Ontario, who is not a coauthor.

“Even with propensity matching, you can get rid of some sorts of confounding, but you can never get rid of all selection bias issues.” That, he said when interviewed, takes randomized trials.

Dr. Conen, who is studying cognitive decline in AFib as a SWISS-AF trial principal investigator, pointed to a secondary finding of the analysis as evidence for such confounding. He said the ablation group’s nearly 50% drop (P < .0001) in competing risk for death, compared with patients managed with AAD, isn’t plausible.

A version of this article first appeared on Medscape.com.

The risk for dementia goes up in patients with atrial fibrillation (AFib), but some evidence suggests that risk can be blunted with therapies that restore sinus rhythm. However, a new cohort study suggests that the treatment effect’s magnitude might depend on the rhythm control strategy. It hinted that AFib catheter ablation might be more effective than pharmacologic rhythm control alone at cutting the risk for dementia.

The case-matched study of more than 38,000 adults with AFib saw a 41% reduction (P < .0001) in risk for dementia among those who underwent catheter ablation after attempted rhythm control with antiarrhythmic drugs (AAD), compared with those managed with pharmacologic rhythm control therapy alone.

The observational study comprising 20 years of data comes with big limitations and can’t say for sure whether catheter ablation is better than AAD-only at cutting the dementia risk in AFib. But it and other evidence support the idea, which has yet to be explored in a randomized fashion.

In a secondary finding, the analysis showed a similar reduction in dementia risk from catheter ablation, compared with AAD, in women and in men by 40% and 45%, respectively (P < .0001 for both). The findings are particularly relevant “given the higher life-long risk of dementia among women and the lower likelihood that women will be offered ablation, which has been demonstrated repeatedly,” Emily P. Zeitler, MD, MHS, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, told this news organization. “I think this is another reason to try to be more generous in offering ablation to women.”

Management of AFib certainly evolved in important ways from 2000 to 2021, the period covered by the study. But a sensitivity analysis based on data from 2010 to 2021 showed “no meaningful differences” in the results, said Dr. Zeitler, who is slated to present the findings April 30 at the Heart Rhythm Society 2022 Scientific Sessions, conducted virtually and live in San Francisco.

Dr. Zeitler acknowledged that the observational study, even with its propensity-matched ablation and AAD cohorts, can only hint at a preference for ablation over AAD for lowering risk for AFib-associated dementia. “We know there’s unmeasured and unfixable confounding between those two groups, so we see this really as hypothesis-generating.”

It was “a well-done analysis,” and the conclusion that the dementia risk was lower with catheter ablation is “absolutely correct,” but only as far as the study and its limitations allow, agreed David Conen, MD, MPH, McMaster University, Hamilton, Ontario, who is not a coauthor.

“Even with propensity matching, you can get rid of some sorts of confounding, but you can never get rid of all selection bias issues.” That, he said when interviewed, takes randomized trials.

Dr. Conen, who is studying cognitive decline in AFib as a SWISS-AF trial principal investigator, pointed to a secondary finding of the analysis as evidence for such confounding. He said the ablation group’s nearly 50% drop (P < .0001) in competing risk for death, compared with patients managed with AAD, isn’t plausible.

A version of this article first appeared on Medscape.com.

The Society for Cardiovascular Angiography and Interventions (SCAI) has issued the first statement on best practices for percutaneous axillary arterial access and training.

The position statement helps fill a gap amid increasing use of transaxillary access as an alternative to the femoral route for large-bore transcatheter aortic valve replacement (TAVR), endovascular aortic repair (EVAR), and mechanical circulatory support.

“The need for alternative access has increased as we are using more and more TAVR for our elderly population, and EVAR has also increased,” writing committee chair Arnold H. Seto, MD, Long Beach VA Health Care System (California) said in an interview. “There’s also a set of patients who require balloon pumps for a prolonged period, and people were using balloon pumps from the axillary approach, which were not custom-designed for that purpose.”

He noted that the evidence base leans heavily on case reports and case series, and that they were approached for guidance by a vendor developing a balloon pump specific to axillary access. “So that helped spur all of us to get together and decide to write up something on this topic, which was developing, but was certainly picking up steam rapidly.”

The statement was published in the Journal of the Society for Cardiovascular Angiography and Interventions, and it reflects the consensus of experts in heart failure, interventional cardiology and radiology, and cardiothoracic and vascular surgery. It reviews anatomic considerations and risks for percutaneous axillary access and suggests techniques for insertion, closure, and complication management.

Although the femoral artery is the most frequent access site for percutaneous large-bore procedures, the document notes that this approach may be limited in 13%-20% of patients because of prior surgeries or severe aortoiliac and/or iliofemoral atherosclerotic disease, tortuosity, or calcification.

“Absolutely, the femoral should be the predominant access site,” Dr. Seto said. Whenever there is a compromised femoral artery, “the axillary artery, which is rarely involved with atherosclerosis, makes for the most optimal alternative access. Other forms of alternative access, including transcaval and transcarotid, are possible but have their own issues and difficulties.”

Axillary access has traditionally been done through an open surgical approach, which allows for direct puncture, primary arterial repair, or placement of a sidearm conduit. Percutaneous transaxillary access avoids a surgical incision and general anesthesia and, theoretically, reduces the risk of infection, he said. It also allows for better mobility for patients, for example, who may have a balloon pump in place for weeks or even a month when waiting for a bridge to transplant.

In terms of technique, key recommendations include:

• Gaining access preferably through the left axillary
• Inserting the needle directly through the pectoralis minor into the second segment of the axillary artery
• Using a shallow-needle angle of 25-30 degrees to improve access success and decrease sheath malformation, kinking, bleeding, or vessel perforation
• Using micropuncture needles to minimize trauma to adjacent tissues
• Abducting the patient’s arm to 45-90 degrees to reduce tortuosity
• Using angiographic and ultrasound techniques to optimize vascular access

The latter point was the one area of debate among the writing committee, Dr. Seto observed. “That is one of the controversies: Should we make ultrasound mandatory? ... Everybody agreed that it can be quite useful and was likely to be useful because of its success in every other access area,” he said. “But in the absence of randomized evidence, we couldn’t make it mandatory or a strong recommendation. We just had to make it one of several options for the operator.”

The document highlights the need for familiarity with potential axillary artery complications and their management, noting that the axillary is more fragile than the femoral artery and, thus, potentially more prone to complications during instrumentation.

Data from the ARMS study in 102 patients undergoing transaxillary access for mechanical hemodynamic support reported 17 procedural complications, including 10 minor access site bleeding events, one stroke, and one pseudoaneurysm. A small study of 25 complex EVAR procedures reported a perioperative access complication rate of 8%, including one axillary artery dissection and one stenosis.

“Despite the brachial plexus being around there, there’s actually rare reports of neurologic injury and certainly none that have been permanent,” Dr. Seto said. “Also, stroke risk is probably more related to your device size and type of device rather than the approach itself.”

A significant amount of the paper is also devoted to training and privileging suggestions with an emphasis on a multidisciplinary team. The writing group recommends graduate medical education programs develop training curricula in percutaneous axillary artery access.

Those already in practice should participate in a formal training program that focuses on axillary artery anatomy, training in large bore access and closure devices, and didactic training in imaging modalities as applied to the axillary artery. Training can occur hands-on or using online simulations.

They also recommend outlining the potential need or role for proctoring and call for ongoing formal professional monitoring programs to evaluate operator outcomes using local or registry data.

“From a privileging standpoint, it was important for hospitals to be equally fair, regardless of the specialty that a requesting practitioner came from,” Dr. Seto said. “In other words, treat the vascular surgeons and interventional cardiologists and radiologists equally in terms of who has the privilege to do transaxillary access.”

The SCAI position statement has been endorsed by the American College of Cardiology, the Heart Failure Society of America, the Society of Interventional Radiology, and the Vascular & Endovascular Surgery Society.

Dr. Seto reported receiving honoraria from Getinge prior to initiation of the document. Disclosures for the rest of the writing group are available with the original article.

A version of this article first appeared on Medscape.com.

The Society for Cardiovascular Angiography and Interventions (SCAI) has issued the first statement on best practices for percutaneous axillary arterial access and training.

The position statement helps fill a gap amid increasing use of transaxillary access as an alternative to the femoral route for large-bore transcatheter aortic valve replacement (TAVR), endovascular aortic repair (EVAR), and mechanical circulatory support.

“The need for alternative access has increased as we are using more and more TAVR for our elderly population, and EVAR has also increased,” writing committee chair Arnold H. Seto, MD, Long Beach VA Health Care System (California) said in an interview. “There’s also a set of patients who require balloon pumps for a prolonged period, and people were using balloon pumps from the axillary approach, which were not custom-designed for that purpose.”

He noted that the evidence base leans heavily on case reports and case series, and that they were approached for guidance by a vendor developing a balloon pump specific to axillary access. “So that helped spur all of us to get together and decide to write up something on this topic, which was developing, but was certainly picking up steam rapidly.”

The statement was published in the Journal of the Society for Cardiovascular Angiography and Interventions, and it reflects the consensus of experts in heart failure, interventional cardiology and radiology, and cardiothoracic and vascular surgery. It reviews anatomic considerations and risks for percutaneous axillary access and suggests techniques for insertion, closure, and complication management.

Although the femoral artery is the most frequent access site for percutaneous large-bore procedures, the document notes that this approach may be limited in 13%-20% of patients because of prior surgeries or severe aortoiliac and/or iliofemoral atherosclerotic disease, tortuosity, or calcification.

“Absolutely, the femoral should be the predominant access site,” Dr. Seto said. Whenever there is a compromised femoral artery, “the axillary artery, which is rarely involved with atherosclerosis, makes for the most optimal alternative access. Other forms of alternative access, including transcaval and transcarotid, are possible but have their own issues and difficulties.”

Axillary access has traditionally been done through an open surgical approach, which allows for direct puncture, primary arterial repair, or placement of a sidearm conduit. Percutaneous transaxillary access avoids a surgical incision and general anesthesia and, theoretically, reduces the risk of infection, he said. It also allows for better mobility for patients, for example, who may have a balloon pump in place for weeks or even a month when waiting for a bridge to transplant.

In terms of technique, key recommendations include:

• Gaining access preferably through the left axillary
• Inserting the needle directly through the pectoralis minor into the second segment of the axillary artery
• Using a shallow-needle angle of 25-30 degrees to improve access success and decrease sheath malformation, kinking, bleeding, or vessel perforation
• Using micropuncture needles to minimize trauma to adjacent tissues
• Abducting the patient’s arm to 45-90 degrees to reduce tortuosity
• Using angiographic and ultrasound techniques to optimize vascular access

The latter point was the one area of debate among the writing committee, Dr. Seto observed. “That is one of the controversies: Should we make ultrasound mandatory? ... Everybody agreed that it can be quite useful and was likely to be useful because of its success in every other access area,” he said. “But in the absence of randomized evidence, we couldn’t make it mandatory or a strong recommendation. We just had to make it one of several options for the operator.”

The document highlights the need for familiarity with potential axillary artery complications and their management, noting that the axillary is more fragile than the femoral artery and, thus, potentially more prone to complications during instrumentation.

Data from the ARMS study in 102 patients undergoing transaxillary access for mechanical hemodynamic support reported 17 procedural complications, including 10 minor access site bleeding events, one stroke, and one pseudoaneurysm. A small study of 25 complex EVAR procedures reported a perioperative access complication rate of 8%, including one axillary artery dissection and one stenosis.

“Despite the brachial plexus being around there, there’s actually rare reports of neurologic injury and certainly none that have been permanent,” Dr. Seto said. “Also, stroke risk is probably more related to your device size and type of device rather than the approach itself.”

A significant amount of the paper is also devoted to training and privileging suggestions with an emphasis on a multidisciplinary team. The writing group recommends graduate medical education programs develop training curricula in percutaneous axillary artery access.

Those already in practice should participate in a formal training program that focuses on axillary artery anatomy, training in large bore access and closure devices, and didactic training in imaging modalities as applied to the axillary artery. Training can occur hands-on or using online simulations.

They also recommend outlining the potential need or role for proctoring and call for ongoing formal professional monitoring programs to evaluate operator outcomes using local or registry data.

“From a privileging standpoint, it was important for hospitals to be equally fair, regardless of the specialty that a requesting practitioner came from,” Dr. Seto said. “In other words, treat the vascular surgeons and interventional cardiologists and radiologists equally in terms of who has the privilege to do transaxillary access.”

The SCAI position statement has been endorsed by the American College of Cardiology, the Heart Failure Society of America, the Society of Interventional Radiology, and the Vascular & Endovascular Surgery Society.

Dr. Seto reported receiving honoraria from Getinge prior to initiation of the document. Disclosures for the rest of the writing group are available with the original article.

A version of this article first appeared on Medscape.com.

The Society for Cardiovascular Angiography and Interventions (SCAI) has issued the first statement on best practices for percutaneous axillary arterial access and training.

The position statement helps fill a gap amid increasing use of transaxillary access as an alternative to the femoral route for large-bore transcatheter aortic valve replacement (TAVR), endovascular aortic repair (EVAR), and mechanical circulatory support.

“The need for alternative access has increased as we are using more and more TAVR for our elderly population, and EVAR has also increased,” writing committee chair Arnold H. Seto, MD, Long Beach VA Health Care System (California) said in an interview. “There’s also a set of patients who require balloon pumps for a prolonged period, and people were using balloon pumps from the axillary approach, which were not custom-designed for that purpose.”

He noted that the evidence base leans heavily on case reports and case series, and that they were approached for guidance by a vendor developing a balloon pump specific to axillary access. “So that helped spur all of us to get together and decide to write up something on this topic, which was developing, but was certainly picking up steam rapidly.”

The statement was published in the Journal of the Society for Cardiovascular Angiography and Interventions, and it reflects the consensus of experts in heart failure, interventional cardiology and radiology, and cardiothoracic and vascular surgery. It reviews anatomic considerations and risks for percutaneous axillary access and suggests techniques for insertion, closure, and complication management.

Although the femoral artery is the most frequent access site for percutaneous large-bore procedures, the document notes that this approach may be limited in 13%-20% of patients because of prior surgeries or severe aortoiliac and/or iliofemoral atherosclerotic disease, tortuosity, or calcification.

“Absolutely, the femoral should be the predominant access site,” Dr. Seto said. Whenever there is a compromised femoral artery, “the axillary artery, which is rarely involved with atherosclerosis, makes for the most optimal alternative access. Other forms of alternative access, including transcaval and transcarotid, are possible but have their own issues and difficulties.”

Axillary access has traditionally been done through an open surgical approach, which allows for direct puncture, primary arterial repair, or placement of a sidearm conduit. Percutaneous transaxillary access avoids a surgical incision and general anesthesia and, theoretically, reduces the risk of infection, he said. It also allows for better mobility for patients, for example, who may have a balloon pump in place for weeks or even a month when waiting for a bridge to transplant.

In terms of technique, key recommendations include:

• Gaining access preferably through the left axillary
• Inserting the needle directly through the pectoralis minor into the second segment of the axillary artery
• Using a shallow-needle angle of 25-30 degrees to improve access success and decrease sheath malformation, kinking, bleeding, or vessel perforation
• Using micropuncture needles to minimize trauma to adjacent tissues
• Abducting the patient’s arm to 45-90 degrees to reduce tortuosity
• Using angiographic and ultrasound techniques to optimize vascular access

The latter point was the one area of debate among the writing committee, Dr. Seto observed. “That is one of the controversies: Should we make ultrasound mandatory? ... Everybody agreed that it can be quite useful and was likely to be useful because of its success in every other access area,” he said. “But in the absence of randomized evidence, we couldn’t make it mandatory or a strong recommendation. We just had to make it one of several options for the operator.”

The document highlights the need for familiarity with potential axillary artery complications and their management, noting that the axillary is more fragile than the femoral artery and, thus, potentially more prone to complications during instrumentation.

Data from the ARMS study in 102 patients undergoing transaxillary access for mechanical hemodynamic support reported 17 procedural complications, including 10 minor access site bleeding events, one stroke, and one pseudoaneurysm. A small study of 25 complex EVAR procedures reported a perioperative access complication rate of 8%, including one axillary artery dissection and one stenosis.

“Despite the brachial plexus being around there, there’s actually rare reports of neurologic injury and certainly none that have been permanent,” Dr. Seto said. “Also, stroke risk is probably more related to your device size and type of device rather than the approach itself.”

A significant amount of the paper is also devoted to training and privileging suggestions with an emphasis on a multidisciplinary team. The writing group recommends graduate medical education programs develop training curricula in percutaneous axillary artery access.

Those already in practice should participate in a formal training program that focuses on axillary artery anatomy, training in large bore access and closure devices, and didactic training in imaging modalities as applied to the axillary artery. Training can occur hands-on or using online simulations.

They also recommend outlining the potential need or role for proctoring and call for ongoing formal professional monitoring programs to evaluate operator outcomes using local or registry data.

“From a privileging standpoint, it was important for hospitals to be equally fair, regardless of the specialty that a requesting practitioner came from,” Dr. Seto said. “In other words, treat the vascular surgeons and interventional cardiologists and radiologists equally in terms of who has the privilege to do transaxillary access.”

The SCAI position statement has been endorsed by the American College of Cardiology, the Heart Failure Society of America, the Society of Interventional Radiology, and the Vascular & Endovascular Surgery Society.

Dr. Seto reported receiving honoraria from Getinge prior to initiation of the document. Disclosures for the rest of the writing group are available with the original article.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has approved mavacamten (Camzyos, Bristol Myers Squibb) to improve functional capacity and symptoms in adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM).

Mavacamten is the first FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of the genetic disorder. It’s available in 2.5-mg, 5-mg, 10-mg, and 15-mg capsules.

“The approval of Camzyos represents a significant milestone for appropriate symptomatic obstructive HCM patients and their families, who have long awaited a new treatment option for this chronic and progressive disease,” Anjali T. Owens, MD, medical director of the Center for Inherited Cardiac Disease and assistant professor of medicine, University of Pennsylvania, Philadelphia, said in a news release.
 

‘Revolutionary’ change

The approval of mavacamten was based on data from the pivotal EXPLORER-HCM and EXPLORER-LTE (long-term extension) trial of adults with symptomatic NYHA class II-III oHCM.

In EXPLORER-HCM, treatment with mavacamten over 30 weeks led to significant improvement in exercise capacity, left ventricular outflow tract (LVOT) obstruction, NYHA functional class, and health status, as reported by this news organization.

The safety and efficacy findings seen at the end of the blinded, randomized, initial 30-week phase of EXPLORER-LTE were maintained in patients who continued treatment for a median of about 62 weeks.

Mavacamten represents “an almost revolutionary change” for the treatment of oHCM, Maya E. Guglin, MD, professor of clinical medicine and an advanced heart failure physician at Indiana University, Indianapolis, said during a press briefing earlier this month at the American College of Cardiology 2022 Scientific Session earlier this month.

“Until now, there was no good medical treatment for symptomatic oHCM. This will change the landscape, and without question it will change guidelines for treating oHCM,” Dr. Guglin said.

The product information for mavacamten includes a boxed warning citing a risk for heart failure.

Echocardiogram assessments of left ventricular ejection fraction (LVEF) are required before and during treatment.

Starting mavacamten in patients with LVEF below 55% is not recommended and the drug should be interrupted if LVEF falls below 50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status.

Concomitant use of mavacamten with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers can increase the risk for heart failure attributable to systolic dysfunction. Therefore, its use is contraindicated in patients using moderate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors, and moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers.

Because of the risk for heart failure attributable to systolic dysfunction, mavacamten is only available through the Camzyos Risk Evaluation and Mitigation Strategy (REMS) Program.

Full prescribing information is available online.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has approved mavacamten (Camzyos, Bristol Myers Squibb) to improve functional capacity and symptoms in adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM).

Mavacamten is the first FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of the genetic disorder. It’s available in 2.5-mg, 5-mg, 10-mg, and 15-mg capsules.

“The approval of Camzyos represents a significant milestone for appropriate symptomatic obstructive HCM patients and their families, who have long awaited a new treatment option for this chronic and progressive disease,” Anjali T. Owens, MD, medical director of the Center for Inherited Cardiac Disease and assistant professor of medicine, University of Pennsylvania, Philadelphia, said in a news release.
 

‘Revolutionary’ change

The approval of mavacamten was based on data from the pivotal EXPLORER-HCM and EXPLORER-LTE (long-term extension) trial of adults with symptomatic NYHA class II-III oHCM.

In EXPLORER-HCM, treatment with mavacamten over 30 weeks led to significant improvement in exercise capacity, left ventricular outflow tract (LVOT) obstruction, NYHA functional class, and health status, as reported by this news organization.

The safety and efficacy findings seen at the end of the blinded, randomized, initial 30-week phase of EXPLORER-LTE were maintained in patients who continued treatment for a median of about 62 weeks.

Mavacamten represents “an almost revolutionary change” for the treatment of oHCM, Maya E. Guglin, MD, professor of clinical medicine and an advanced heart failure physician at Indiana University, Indianapolis, said during a press briefing earlier this month at the American College of Cardiology 2022 Scientific Session earlier this month.

“Until now, there was no good medical treatment for symptomatic oHCM. This will change the landscape, and without question it will change guidelines for treating oHCM,” Dr. Guglin said.

The product information for mavacamten includes a boxed warning citing a risk for heart failure.

Echocardiogram assessments of left ventricular ejection fraction (LVEF) are required before and during treatment.

Starting mavacamten in patients with LVEF below 55% is not recommended and the drug should be interrupted if LVEF falls below 50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status.

Concomitant use of mavacamten with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers can increase the risk for heart failure attributable to systolic dysfunction. Therefore, its use is contraindicated in patients using moderate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors, and moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers.

Because of the risk for heart failure attributable to systolic dysfunction, mavacamten is only available through the Camzyos Risk Evaluation and Mitigation Strategy (REMS) Program.

Full prescribing information is available online.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has approved mavacamten (Camzyos, Bristol Myers Squibb) to improve functional capacity and symptoms in adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM).

Mavacamten is the first FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of the genetic disorder. It’s available in 2.5-mg, 5-mg, 10-mg, and 15-mg capsules.

“The approval of Camzyos represents a significant milestone for appropriate symptomatic obstructive HCM patients and their families, who have long awaited a new treatment option for this chronic and progressive disease,” Anjali T. Owens, MD, medical director of the Center for Inherited Cardiac Disease and assistant professor of medicine, University of Pennsylvania, Philadelphia, said in a news release.
 

‘Revolutionary’ change

The approval of mavacamten was based on data from the pivotal EXPLORER-HCM and EXPLORER-LTE (long-term extension) trial of adults with symptomatic NYHA class II-III oHCM.

In EXPLORER-HCM, treatment with mavacamten over 30 weeks led to significant improvement in exercise capacity, left ventricular outflow tract (LVOT) obstruction, NYHA functional class, and health status, as reported by this news organization.

The safety and efficacy findings seen at the end of the blinded, randomized, initial 30-week phase of EXPLORER-LTE were maintained in patients who continued treatment for a median of about 62 weeks.

Mavacamten represents “an almost revolutionary change” for the treatment of oHCM, Maya E. Guglin, MD, professor of clinical medicine and an advanced heart failure physician at Indiana University, Indianapolis, said during a press briefing earlier this month at the American College of Cardiology 2022 Scientific Session earlier this month.

“Until now, there was no good medical treatment for symptomatic oHCM. This will change the landscape, and without question it will change guidelines for treating oHCM,” Dr. Guglin said.

The product information for mavacamten includes a boxed warning citing a risk for heart failure.

Echocardiogram assessments of left ventricular ejection fraction (LVEF) are required before and during treatment.

Starting mavacamten in patients with LVEF below 55% is not recommended and the drug should be interrupted if LVEF falls below 50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status.

Concomitant use of mavacamten with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers can increase the risk for heart failure attributable to systolic dysfunction. Therefore, its use is contraindicated in patients using moderate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors, and moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers.

Because of the risk for heart failure attributable to systolic dysfunction, mavacamten is only available through the Camzyos Risk Evaluation and Mitigation Strategy (REMS) Program.

Full prescribing information is available online.

A version of this article first appeared on Medscape.com.

Patients implanted with the Medtronic HeartWare ventricular assist device (HVAD) System who develop pump thrombosis could have a welding defect in the internal pump causing the pump to malfunction, the Food and Drug Administration said in a letter to health care professionals. 

Medtronic has sent providers an urgent medical device notice about the pump weld defect and is trying to identify which HVAD pumps are affected.

The Medtronic HVAD System was approved as a bridge to heart transplantation in 2012. Since then, it has been fraught with problems.

This past June, the company announced it was stopping all sales of the device and advised physicians to stop implanting it, as reported by this news organization. 
 

Pump thrombosis

Medtronic has received complaints of suspected pump thrombosis in three patients with the HVAD System.

All three patients presented with one or more of the following signs or symptoms: grinding sound, transient power spikes on log files and high watt alarms, elevated lactate dehydrogenase, and low motor speed resulting in low perfusion or dizziness or lightheadedness.

Inspection of the returned pumps in these three cases identified a malfunction of the internal pump. The pumps were exchanged in all three patients. Two patients died after the pump exchange.

The FDA does not recommend the elective removal of properly functioning systems.

“Decisions about removing or exchanging the Medtronic HVAD System should be made by health care providers and patients on a case-by-case basis, considering the patient’s clinical status and surgical risks,” the agency advised.

Patients who present with one or more of the signs or symptoms of pump thrombosis should be first treated for pump thrombosis.

If symptoms fail to resolve, providers may consider whether the patient is a candidate for pump exchange, heart transplant, or pump explant for recovery, taking into account the patient’s clinical condition and surgical risks.

For patients with any of the signs and symptoms of pump thrombosis, logfiles from the controller should be uploaded to Medtronic.

The FDA is working with Medtronic to monitor for any adverse events related to pump weld defects and ensure patients with the HVAD implant continue to receive appropriate follow-up monitoring.

Problems related to the Medtronic HVAD System should be reported to the FDA’s MedWatch program.

A version of this article first appeared on Medscape.com.

Patients implanted with the Medtronic HeartWare ventricular assist device (HVAD) System who develop pump thrombosis could have a welding defect in the internal pump causing the pump to malfunction, the Food and Drug Administration said in a letter to health care professionals. 

Medtronic has sent providers an urgent medical device notice about the pump weld defect and is trying to identify which HVAD pumps are affected.

The Medtronic HVAD System was approved as a bridge to heart transplantation in 2012. Since then, it has been fraught with problems.

This past June, the company announced it was stopping all sales of the device and advised physicians to stop implanting it, as reported by this news organization. 
 

Pump thrombosis

Medtronic has received complaints of suspected pump thrombosis in three patients with the HVAD System.

All three patients presented with one or more of the following signs or symptoms: grinding sound, transient power spikes on log files and high watt alarms, elevated lactate dehydrogenase, and low motor speed resulting in low perfusion or dizziness or lightheadedness.

Inspection of the returned pumps in these three cases identified a malfunction of the internal pump. The pumps were exchanged in all three patients. Two patients died after the pump exchange.

The FDA does not recommend the elective removal of properly functioning systems.

“Decisions about removing or exchanging the Medtronic HVAD System should be made by health care providers and patients on a case-by-case basis, considering the patient’s clinical status and surgical risks,” the agency advised.

Patients who present with one or more of the signs or symptoms of pump thrombosis should be first treated for pump thrombosis.

If symptoms fail to resolve, providers may consider whether the patient is a candidate for pump exchange, heart transplant, or pump explant for recovery, taking into account the patient’s clinical condition and surgical risks.

For patients with any of the signs and symptoms of pump thrombosis, logfiles from the controller should be uploaded to Medtronic.

The FDA is working with Medtronic to monitor for any adverse events related to pump weld defects and ensure patients with the HVAD implant continue to receive appropriate follow-up monitoring.

Problems related to the Medtronic HVAD System should be reported to the FDA’s MedWatch program.

A version of this article first appeared on Medscape.com.

Patients implanted with the Medtronic HeartWare ventricular assist device (HVAD) System who develop pump thrombosis could have a welding defect in the internal pump causing the pump to malfunction, the Food and Drug Administration said in a letter to health care professionals. 

Medtronic has sent providers an urgent medical device notice about the pump weld defect and is trying to identify which HVAD pumps are affected.

The Medtronic HVAD System was approved as a bridge to heart transplantation in 2012. Since then, it has been fraught with problems.

This past June, the company announced it was stopping all sales of the device and advised physicians to stop implanting it, as reported by this news organization. 
 

Pump thrombosis

Medtronic has received complaints of suspected pump thrombosis in three patients with the HVAD System.

All three patients presented with one or more of the following signs or symptoms: grinding sound, transient power spikes on log files and high watt alarms, elevated lactate dehydrogenase, and low motor speed resulting in low perfusion or dizziness or lightheadedness.

Inspection of the returned pumps in these three cases identified a malfunction of the internal pump. The pumps were exchanged in all three patients. Two patients died after the pump exchange.

The FDA does not recommend the elective removal of properly functioning systems.

“Decisions about removing or exchanging the Medtronic HVAD System should be made by health care providers and patients on a case-by-case basis, considering the patient’s clinical status and surgical risks,” the agency advised.

Patients who present with one or more of the signs or symptoms of pump thrombosis should be first treated for pump thrombosis.

If symptoms fail to resolve, providers may consider whether the patient is a candidate for pump exchange, heart transplant, or pump explant for recovery, taking into account the patient’s clinical condition and surgical risks.

For patients with any of the signs and symptoms of pump thrombosis, logfiles from the controller should be uploaded to Medtronic.

The FDA is working with Medtronic to monitor for any adverse events related to pump weld defects and ensure patients with the HVAD implant continue to receive appropriate follow-up monitoring.

Problems related to the Medtronic HVAD System should be reported to the FDA’s MedWatch program.

A version of this article first appeared on Medscape.com.