Heart Rhythm 2014

SAN FRANCISCO – Among patients with implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators, mortality was lower in patients who received only antitachycardia pacing, compared with those who were treated with at least one ICD shock, results from a large database analysis showed.

"Over the past 5 or 10 years, there’s been an association of increasing mortality in people who get ICD shocks," lead author Dr. Adam Strickberger said in an interview at the annual scientific sessions of the Heart Rhythm Society, where the study was presented. "Trying to tease that apart has been hard to do. This study does not give us the mechanism of action for the association, but the message is that avoiding ICD shocks when you can is probably a good thing."

For the study, Dr. Strickberger and his associates evaluated the records of 71,691 patients who were implanted with a St. Jude Medical ICD and CRT-D device during January 2007–May 2012 and monitored on Merlin.net. They used Merlin.net to assess the remote transmission of tachycardia therapy records from January 2007 to November 2012, St. Jude’s device tracking registry to determine patient demographics at time of implant, and Social Security Death Index information to determine survival status as of 2012. Outcomes of interest were effectiveness of antitachycardia pacing (ATP) and mortality. ATP was considered effective if it was not followed by a shock and the patient survived the episode.

The mean age of the patients was 68 years and 73% were male. During a mean follow-up time of 2.5 years, ATP was effective in 89% of the 218,561 episodes delivered in 18,670 patients. In 77% of all ventricular tachycardia/ventricular fibrillation episodes, ATP was the only ICD therapy required.

The researchers also found that patients who received at least one ICD shock had higher mortality, compared with those who received ATP only (hazard ratio, 1.33 vs. 1.20, respectively; P value less than 0.001).

Dr. Strickberger, who is in a group arrhythmia physician practice in Fairfax, Va., acknowledged certain limitations of the study, including the fact that "it was not known what the underlying heart disease was, we don’t know ejection fraction, heart failure status, and we don’t know if the shocks delivered were appropriate or inappropriate."

Dr. Strickberger receives consulting fees from St. Jude Medical. Five of the study’s coauthors are employees of the company.

[email protected]

SAN FRANCISCO – Among patients with implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators, mortality was lower in patients who received only antitachycardia pacing, compared with those who were treated with at least one ICD shock, results from a large database analysis showed.

"Over the past 5 or 10 years, there’s been an association of increasing mortality in people who get ICD shocks," lead author Dr. Adam Strickberger said in an interview at the annual scientific sessions of the Heart Rhythm Society, where the study was presented. "Trying to tease that apart has been hard to do. This study does not give us the mechanism of action for the association, but the message is that avoiding ICD shocks when you can is probably a good thing."

For the study, Dr. Strickberger and his associates evaluated the records of 71,691 patients who were implanted with a St. Jude Medical ICD and CRT-D device during January 2007–May 2012 and monitored on Merlin.net. They used Merlin.net to assess the remote transmission of tachycardia therapy records from January 2007 to November 2012, St. Jude’s device tracking registry to determine patient demographics at time of implant, and Social Security Death Index information to determine survival status as of 2012. Outcomes of interest were effectiveness of antitachycardia pacing (ATP) and mortality. ATP was considered effective if it was not followed by a shock and the patient survived the episode.

The mean age of the patients was 68 years and 73% were male. During a mean follow-up time of 2.5 years, ATP was effective in 89% of the 218,561 episodes delivered in 18,670 patients. In 77% of all ventricular tachycardia/ventricular fibrillation episodes, ATP was the only ICD therapy required.

The researchers also found that patients who received at least one ICD shock had higher mortality, compared with those who received ATP only (hazard ratio, 1.33 vs. 1.20, respectively; P value less than 0.001).

Dr. Strickberger, who is in a group arrhythmia physician practice in Fairfax, Va., acknowledged certain limitations of the study, including the fact that "it was not known what the underlying heart disease was, we don’t know ejection fraction, heart failure status, and we don’t know if the shocks delivered were appropriate or inappropriate."

Dr. Strickberger receives consulting fees from St. Jude Medical. Five of the study’s coauthors are employees of the company.

[email protected]

SAN FRANCISCO – Among patients with implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators, mortality was lower in patients who received only antitachycardia pacing, compared with those who were treated with at least one ICD shock, results from a large database analysis showed.

"Over the past 5 or 10 years, there’s been an association of increasing mortality in people who get ICD shocks," lead author Dr. Adam Strickberger said in an interview at the annual scientific sessions of the Heart Rhythm Society, where the study was presented. "Trying to tease that apart has been hard to do. This study does not give us the mechanism of action for the association, but the message is that avoiding ICD shocks when you can is probably a good thing."

For the study, Dr. Strickberger and his associates evaluated the records of 71,691 patients who were implanted with a St. Jude Medical ICD and CRT-D device during January 2007–May 2012 and monitored on Merlin.net. They used Merlin.net to assess the remote transmission of tachycardia therapy records from January 2007 to November 2012, St. Jude’s device tracking registry to determine patient demographics at time of implant, and Social Security Death Index information to determine survival status as of 2012. Outcomes of interest were effectiveness of antitachycardia pacing (ATP) and mortality. ATP was considered effective if it was not followed by a shock and the patient survived the episode.

The mean age of the patients was 68 years and 73% were male. During a mean follow-up time of 2.5 years, ATP was effective in 89% of the 218,561 episodes delivered in 18,670 patients. In 77% of all ventricular tachycardia/ventricular fibrillation episodes, ATP was the only ICD therapy required.

The researchers also found that patients who received at least one ICD shock had higher mortality, compared with those who received ATP only (hazard ratio, 1.33 vs. 1.20, respectively; P value less than 0.001).

Dr. Strickberger, who is in a group arrhythmia physician practice in Fairfax, Va., acknowledged certain limitations of the study, including the fact that "it was not known what the underlying heart disease was, we don’t know ejection fraction, heart failure status, and we don’t know if the shocks delivered were appropriate or inappropriate."

Dr. Strickberger receives consulting fees from St. Jude Medical. Five of the study’s coauthors are employees of the company.

[email protected]

SAN FRANCISCO – Wireless endocardial left ventricular pacing provides an alternative approach to cardiac resynchronization pacing in heart failure patients, according to preliminary results from an ongoing multicenter trial.

At the annual scientific sessions of the Heart Rhythm Society, Dr. Vivek Y. Reddy presented preliminary results from 19 patients enrolled in the SELECT-LV (Safety and Performance of Electrodes Implanted in the Left Ventricle) study. The purpose of the open-label trial is to evaluate the safety and feasibility of leadless, ultrasound-based pacing using a wireless cardiac stimulation system (WiCS-LV) developed by EBR Systems.

"The idea is to use an existing standard ICD [implantable cardioverter defibrillator] or pacemaker and place this device, which has a transmitter as well as a battery, in a subcutaneous location, and then place a receiver-electrode ‘pellet’ on the left ventricle endocardial wall," explained Dr. Reddy, professor of medicine at Mount Sinai Hospital, New York. "The idea is that the transmitter emits ultrasound impulses detected by the pellet. In turn, the pellet transduces the ultrasound impulse into an electrical pacing pulse to stimulate the heart."

The battery, which is 42 cc in size, is placed subcutaneously in the subaxillary region. The transmitter, which is 13 cc in size, is placed between the ribs "in an optimal position so that there is an echo window which allows you to see the left ventricle," Dr. Reddy said. "Then, on the same day or the next day, the pellet (which is 0.05 cc in size) is placed on the left ventricle via a transfemoral catheter approach."

The SELECT-LV investigators intend to enroll 40 patients at seven centers to evaluate the performance and efficacy of the approach. The primary endpoints are device- and procedure-related complications perioperatively and at 1 month, and biventricular pacing capture on 12-lead ECG at 1 month. Secondary endpoints are device-related or major complications up to 6 months and LV pacing capture at 1, 2, and 6 months, as well as biventricular capture at 6 months on 12-lead ECG. Preliminary efficacy is measured by a composite score of all-cause mortality, heart failure hospitalization, New York Heart Association (NYHA) class, and patient global assessment at 6 months, as well as LV end systolic/diastolic volumes and LV ejection fraction at 6 months.

Patients are eligible for the trial if they have a failed implant of a coronary sinus lead or a chronic issue with their CS lead; if they have no clinical status improvement in 6 months of cardiac resynchronization pacing (CRT); or if they have a previously implanted pacemaker or ICD with a new indication for biventricular pacing but are at risk for a CRT upgrade due to venous occlusion or other factors.

Of the 19 patients who have been implanted to date, 16 (84%) were male, their mean age was 68 years, and they were relatively evenly split between ischemic and nonischemic substrates. Nearly half (47%) had a failed CS lead implant and their mean LV ejection fraction at baseline was 26%.

Primary and secondary endpoint data were available for 15 of the 19 patients, and 6-month data were available for 8 patients. At 1 month, all 15 patients demonstrated Bi-V pacing on 12-lead ECG. The QRS narrowed by 46 ms at 1 month and by 23 ms at 6 months. NYHA class also significantly improved between baseline and 6 months (from II to I; decline of 0.63 points). All patients experienced improvements on their clinical composite score.

No periprocedural adverse events and no device-related serious adverse events occurred within the first month of implant, but 10 serious adverse events occurred in six patients within the first 6 months, including one patient with a hematoma at the transmitter pocket and one patient who had a stroke 3 days after the procedure. "This is a patient who had atrial fibrillation," Dr. Reddy noted. "At the time of the procedure the [warfarin] was stopped. The patient was implanted, did well, but the [warfarin] hadn’t been restarted at the 3-day time point and the patient suffered a stroke. After this experience, we altered the protocol so that patients on anticoagulation for any indication need to continue active coagulation [with no interruption]. We’ll see how that fares."

The study was funded by EBR Systems. Dr. Reddy is a consultant to the company.

[email protected]

On Twitter @dougbrunk

SAN FRANCISCO – Wireless endocardial left ventricular pacing provides an alternative approach to cardiac resynchronization pacing in heart failure patients, according to preliminary results from an ongoing multicenter trial.

At the annual scientific sessions of the Heart Rhythm Society, Dr. Vivek Y. Reddy presented preliminary results from 19 patients enrolled in the SELECT-LV (Safety and Performance of Electrodes Implanted in the Left Ventricle) study. The purpose of the open-label trial is to evaluate the safety and feasibility of leadless, ultrasound-based pacing using a wireless cardiac stimulation system (WiCS-LV) developed by EBR Systems.

"The idea is to use an existing standard ICD [implantable cardioverter defibrillator] or pacemaker and place this device, which has a transmitter as well as a battery, in a subcutaneous location, and then place a receiver-electrode ‘pellet’ on the left ventricle endocardial wall," explained Dr. Reddy, professor of medicine at Mount Sinai Hospital, New York. "The idea is that the transmitter emits ultrasound impulses detected by the pellet. In turn, the pellet transduces the ultrasound impulse into an electrical pacing pulse to stimulate the heart."

The battery, which is 42 cc in size, is placed subcutaneously in the subaxillary region. The transmitter, which is 13 cc in size, is placed between the ribs "in an optimal position so that there is an echo window which allows you to see the left ventricle," Dr. Reddy said. "Then, on the same day or the next day, the pellet (which is 0.05 cc in size) is placed on the left ventricle via a transfemoral catheter approach."

The SELECT-LV investigators intend to enroll 40 patients at seven centers to evaluate the performance and efficacy of the approach. The primary endpoints are device- and procedure-related complications perioperatively and at 1 month, and biventricular pacing capture on 12-lead ECG at 1 month. Secondary endpoints are device-related or major complications up to 6 months and LV pacing capture at 1, 2, and 6 months, as well as biventricular capture at 6 months on 12-lead ECG. Preliminary efficacy is measured by a composite score of all-cause mortality, heart failure hospitalization, New York Heart Association (NYHA) class, and patient global assessment at 6 months, as well as LV end systolic/diastolic volumes and LV ejection fraction at 6 months.

Patients are eligible for the trial if they have a failed implant of a coronary sinus lead or a chronic issue with their CS lead; if they have no clinical status improvement in 6 months of cardiac resynchronization pacing (CRT); or if they have a previously implanted pacemaker or ICD with a new indication for biventricular pacing but are at risk for a CRT upgrade due to venous occlusion or other factors.

Of the 19 patients who have been implanted to date, 16 (84%) were male, their mean age was 68 years, and they were relatively evenly split between ischemic and nonischemic substrates. Nearly half (47%) had a failed CS lead implant and their mean LV ejection fraction at baseline was 26%.

Primary and secondary endpoint data were available for 15 of the 19 patients, and 6-month data were available for 8 patients. At 1 month, all 15 patients demonstrated Bi-V pacing on 12-lead ECG. The QRS narrowed by 46 ms at 1 month and by 23 ms at 6 months. NYHA class also significantly improved between baseline and 6 months (from II to I; decline of 0.63 points). All patients experienced improvements on their clinical composite score.

No periprocedural adverse events and no device-related serious adverse events occurred within the first month of implant, but 10 serious adverse events occurred in six patients within the first 6 months, including one patient with a hematoma at the transmitter pocket and one patient who had a stroke 3 days after the procedure. "This is a patient who had atrial fibrillation," Dr. Reddy noted. "At the time of the procedure the [warfarin] was stopped. The patient was implanted, did well, but the [warfarin] hadn’t been restarted at the 3-day time point and the patient suffered a stroke. After this experience, we altered the protocol so that patients on anticoagulation for any indication need to continue active coagulation [with no interruption]. We’ll see how that fares."

The study was funded by EBR Systems. Dr. Reddy is a consultant to the company.

[email protected]

On Twitter @dougbrunk

SAN FRANCISCO – Wireless endocardial left ventricular pacing provides an alternative approach to cardiac resynchronization pacing in heart failure patients, according to preliminary results from an ongoing multicenter trial.

At the annual scientific sessions of the Heart Rhythm Society, Dr. Vivek Y. Reddy presented preliminary results from 19 patients enrolled in the SELECT-LV (Safety and Performance of Electrodes Implanted in the Left Ventricle) study. The purpose of the open-label trial is to evaluate the safety and feasibility of leadless, ultrasound-based pacing using a wireless cardiac stimulation system (WiCS-LV) developed by EBR Systems.

"The idea is to use an existing standard ICD [implantable cardioverter defibrillator] or pacemaker and place this device, which has a transmitter as well as a battery, in a subcutaneous location, and then place a receiver-electrode ‘pellet’ on the left ventricle endocardial wall," explained Dr. Reddy, professor of medicine at Mount Sinai Hospital, New York. "The idea is that the transmitter emits ultrasound impulses detected by the pellet. In turn, the pellet transduces the ultrasound impulse into an electrical pacing pulse to stimulate the heart."

The battery, which is 42 cc in size, is placed subcutaneously in the subaxillary region. The transmitter, which is 13 cc in size, is placed between the ribs "in an optimal position so that there is an echo window which allows you to see the left ventricle," Dr. Reddy said. "Then, on the same day or the next day, the pellet (which is 0.05 cc in size) is placed on the left ventricle via a transfemoral catheter approach."

The SELECT-LV investigators intend to enroll 40 patients at seven centers to evaluate the performance and efficacy of the approach. The primary endpoints are device- and procedure-related complications perioperatively and at 1 month, and biventricular pacing capture on 12-lead ECG at 1 month. Secondary endpoints are device-related or major complications up to 6 months and LV pacing capture at 1, 2, and 6 months, as well as biventricular capture at 6 months on 12-lead ECG. Preliminary efficacy is measured by a composite score of all-cause mortality, heart failure hospitalization, New York Heart Association (NYHA) class, and patient global assessment at 6 months, as well as LV end systolic/diastolic volumes and LV ejection fraction at 6 months.

Patients are eligible for the trial if they have a failed implant of a coronary sinus lead or a chronic issue with their CS lead; if they have no clinical status improvement in 6 months of cardiac resynchronization pacing (CRT); or if they have a previously implanted pacemaker or ICD with a new indication for biventricular pacing but are at risk for a CRT upgrade due to venous occlusion or other factors.

Of the 19 patients who have been implanted to date, 16 (84%) were male, their mean age was 68 years, and they were relatively evenly split between ischemic and nonischemic substrates. Nearly half (47%) had a failed CS lead implant and their mean LV ejection fraction at baseline was 26%.

Primary and secondary endpoint data were available for 15 of the 19 patients, and 6-month data were available for 8 patients. At 1 month, all 15 patients demonstrated Bi-V pacing on 12-lead ECG. The QRS narrowed by 46 ms at 1 month and by 23 ms at 6 months. NYHA class also significantly improved between baseline and 6 months (from II to I; decline of 0.63 points). All patients experienced improvements on their clinical composite score.

No periprocedural adverse events and no device-related serious adverse events occurred within the first month of implant, but 10 serious adverse events occurred in six patients within the first 6 months, including one patient with a hematoma at the transmitter pocket and one patient who had a stroke 3 days after the procedure. "This is a patient who had atrial fibrillation," Dr. Reddy noted. "At the time of the procedure the [warfarin] was stopped. The patient was implanted, did well, but the [warfarin] hadn’t been restarted at the 3-day time point and the patient suffered a stroke. After this experience, we altered the protocol so that patients on anticoagulation for any indication need to continue active coagulation [with no interruption]. We’ll see how that fares."

The study was funded by EBR Systems. Dr. Reddy is a consultant to the company.

[email protected]

On Twitter @dougbrunk

SAN FRANCISCO – Lead pacing from inside the heart’s left ventricle – an alternate site compared with traditional implants – was successful in 89% of implant attempts, results from a multicenter study of 138 patients showed.

"The difficulty with conventional coronary sinus pacing is that we are limited by coronary sinus anatomy," Dr. John M. Morgan said in a press briefing at the annual scientific sessions of the Heart Rhythm Society. "But with the ability to get to inside the left ventricle, we have the landscape to choose the most appropriate pacing site. The reason that this outcome is important is that many patients who currently get cardiac pacing therapy do not benefit from it. About 10% of patients don’t get an implant because there is failure to achieve a pacing site with the conventional coronary sinus approach, and roughly one-third of patients, even when they have their implant, do not respond."

Courtesy Medtronic

In a trial known as ALSYNC (Alternate Site Cardiac Resynchronization), Dr. Morgan and his associates at 18 centers in Europe and Canada investigated the safety and efficacy of left ventricular endocardial pacing using a Medtronic Model 3830 lead delivered using a novel transseptal system. The system is not currently available for investigational or commercial use in the United States.

The 138 study participants were indicated for cardiac resynchronization therapy (CRT) but were unable to receive a conventional system or did not respond to the therapy at least 6 months post implant. "This so-called nonresponder group has been steadily present over the last decade and a half in all of the evaluations of this otherwise valuable therapy," he said. "We believe that we may be able to address those issues by offering patients who are very sick with heart failure the benefit of cardiac resynchronization by placing the device inside the left ventricle."

The potential downside of this technique, he continued, "is that it’s perhaps slightly more technically challenging, so we need good tools to do that. The other downside is that there is a risk of perhaps developing blood clots in the left side of the heart because we’re putting tools into the left side of the heart, and therefore exposing the circulation to potential development of blood clots that can cause stroke. That has been a major concern for clinicians. The other issue is that, with this technology, we are putting a pacing lead across the mitral valve. There is a possibility that the mitral valve would in some way be impeded or interfered with by this pacing lead."

The ALSYNC system consists of a deflectable catheter, a preshaped inner catheter, and radiofrequency-powered transseptal puncture guidewire/dilator, enabling a subclavian approach and targeted LVE lead delivery. The primary study objective was to show that the complication rates were less than 30% at 6 months in patients with an implant attempt.

The mean age of the patients in the study was 68 years, 78% were male, and 40% had ischemic disease. Dr. Morgan, a cardiologist at the University of Southampton (England), reported that, at 6 months’ follow-up, LVE pacing was successful in 118 out of 133 (89%) implant attempts. The study objective was met with an observed complication rate of 17.7%, which is comparable to the complication rates of conventional CRT implants, he said.

Based on the study results to date, "there is no unexpected adverse complication rate that bothers us about the procedure in clinical terms," Dr. Morgan said.

Concerns about stroke risk "are unfounded as long as our patients are anticoagulated in order to reduce thromboembolic risk. The ALSYNC study offers the potential for us to use this new tool and this new set of technologies to give cardiac resynchronization to patients who either don’t respond or who are not able to have conventional coronary sinus-placed pacing, and thereby should extend the reach and the benefit of cardiac resynchronization therapy to many patients," he said.

The learning curve for the ALSYNC system, he estimated, is "a few cases" for clinicians who have experience with transeptal puncture procedures. "Most interventional electrophysiologists will have that experience," Dr. Morgan said, but "doctors who implant devices may not. We do have some suggestion from the trial data that the higher-volume implanting centers in the trial were getting faster procedure times."

The study was funded by Medtronic. Dr. Morgan disclosed that he is a paid consultant to the company.

[email protected]

SAN FRANCISCO – Lead pacing from inside the heart’s left ventricle – an alternate site compared with traditional implants – was successful in 89% of implant attempts, results from a multicenter study of 138 patients showed.

"The difficulty with conventional coronary sinus pacing is that we are limited by coronary sinus anatomy," Dr. John M. Morgan said in a press briefing at the annual scientific sessions of the Heart Rhythm Society. "But with the ability to get to inside the left ventricle, we have the landscape to choose the most appropriate pacing site. The reason that this outcome is important is that many patients who currently get cardiac pacing therapy do not benefit from it. About 10% of patients don’t get an implant because there is failure to achieve a pacing site with the conventional coronary sinus approach, and roughly one-third of patients, even when they have their implant, do not respond."

Courtesy Medtronic

In a trial known as ALSYNC (Alternate Site Cardiac Resynchronization), Dr. Morgan and his associates at 18 centers in Europe and Canada investigated the safety and efficacy of left ventricular endocardial pacing using a Medtronic Model 3830 lead delivered using a novel transseptal system. The system is not currently available for investigational or commercial use in the United States.

The 138 study participants were indicated for cardiac resynchronization therapy (CRT) but were unable to receive a conventional system or did not respond to the therapy at least 6 months post implant. "This so-called nonresponder group has been steadily present over the last decade and a half in all of the evaluations of this otherwise valuable therapy," he said. "We believe that we may be able to address those issues by offering patients who are very sick with heart failure the benefit of cardiac resynchronization by placing the device inside the left ventricle."

The potential downside of this technique, he continued, "is that it’s perhaps slightly more technically challenging, so we need good tools to do that. The other downside is that there is a risk of perhaps developing blood clots in the left side of the heart because we’re putting tools into the left side of the heart, and therefore exposing the circulation to potential development of blood clots that can cause stroke. That has been a major concern for clinicians. The other issue is that, with this technology, we are putting a pacing lead across the mitral valve. There is a possibility that the mitral valve would in some way be impeded or interfered with by this pacing lead."

The ALSYNC system consists of a deflectable catheter, a preshaped inner catheter, and radiofrequency-powered transseptal puncture guidewire/dilator, enabling a subclavian approach and targeted LVE lead delivery. The primary study objective was to show that the complication rates were less than 30% at 6 months in patients with an implant attempt.

The mean age of the patients in the study was 68 years, 78% were male, and 40% had ischemic disease. Dr. Morgan, a cardiologist at the University of Southampton (England), reported that, at 6 months’ follow-up, LVE pacing was successful in 118 out of 133 (89%) implant attempts. The study objective was met with an observed complication rate of 17.7%, which is comparable to the complication rates of conventional CRT implants, he said.

Based on the study results to date, "there is no unexpected adverse complication rate that bothers us about the procedure in clinical terms," Dr. Morgan said.

Concerns about stroke risk "are unfounded as long as our patients are anticoagulated in order to reduce thromboembolic risk. The ALSYNC study offers the potential for us to use this new tool and this new set of technologies to give cardiac resynchronization to patients who either don’t respond or who are not able to have conventional coronary sinus-placed pacing, and thereby should extend the reach and the benefit of cardiac resynchronization therapy to many patients," he said.

The learning curve for the ALSYNC system, he estimated, is "a few cases" for clinicians who have experience with transeptal puncture procedures. "Most interventional electrophysiologists will have that experience," Dr. Morgan said, but "doctors who implant devices may not. We do have some suggestion from the trial data that the higher-volume implanting centers in the trial were getting faster procedure times."

The study was funded by Medtronic. Dr. Morgan disclosed that he is a paid consultant to the company.

[email protected]

SAN FRANCISCO – Lead pacing from inside the heart’s left ventricle – an alternate site compared with traditional implants – was successful in 89% of implant attempts, results from a multicenter study of 138 patients showed.

"The difficulty with conventional coronary sinus pacing is that we are limited by coronary sinus anatomy," Dr. John M. Morgan said in a press briefing at the annual scientific sessions of the Heart Rhythm Society. "But with the ability to get to inside the left ventricle, we have the landscape to choose the most appropriate pacing site. The reason that this outcome is important is that many patients who currently get cardiac pacing therapy do not benefit from it. About 10% of patients don’t get an implant because there is failure to achieve a pacing site with the conventional coronary sinus approach, and roughly one-third of patients, even when they have their implant, do not respond."

Courtesy Medtronic

In a trial known as ALSYNC (Alternate Site Cardiac Resynchronization), Dr. Morgan and his associates at 18 centers in Europe and Canada investigated the safety and efficacy of left ventricular endocardial pacing using a Medtronic Model 3830 lead delivered using a novel transseptal system. The system is not currently available for investigational or commercial use in the United States.

The 138 study participants were indicated for cardiac resynchronization therapy (CRT) but were unable to receive a conventional system or did not respond to the therapy at least 6 months post implant. "This so-called nonresponder group has been steadily present over the last decade and a half in all of the evaluations of this otherwise valuable therapy," he said. "We believe that we may be able to address those issues by offering patients who are very sick with heart failure the benefit of cardiac resynchronization by placing the device inside the left ventricle."

The potential downside of this technique, he continued, "is that it’s perhaps slightly more technically challenging, so we need good tools to do that. The other downside is that there is a risk of perhaps developing blood clots in the left side of the heart because we’re putting tools into the left side of the heart, and therefore exposing the circulation to potential development of blood clots that can cause stroke. That has been a major concern for clinicians. The other issue is that, with this technology, we are putting a pacing lead across the mitral valve. There is a possibility that the mitral valve would in some way be impeded or interfered with by this pacing lead."

The ALSYNC system consists of a deflectable catheter, a preshaped inner catheter, and radiofrequency-powered transseptal puncture guidewire/dilator, enabling a subclavian approach and targeted LVE lead delivery. The primary study objective was to show that the complication rates were less than 30% at 6 months in patients with an implant attempt.

The mean age of the patients in the study was 68 years, 78% were male, and 40% had ischemic disease. Dr. Morgan, a cardiologist at the University of Southampton (England), reported that, at 6 months’ follow-up, LVE pacing was successful in 118 out of 133 (89%) implant attempts. The study objective was met with an observed complication rate of 17.7%, which is comparable to the complication rates of conventional CRT implants, he said.

Based on the study results to date, "there is no unexpected adverse complication rate that bothers us about the procedure in clinical terms," Dr. Morgan said.

Concerns about stroke risk "are unfounded as long as our patients are anticoagulated in order to reduce thromboembolic risk. The ALSYNC study offers the potential for us to use this new tool and this new set of technologies to give cardiac resynchronization to patients who either don’t respond or who are not able to have conventional coronary sinus-placed pacing, and thereby should extend the reach and the benefit of cardiac resynchronization therapy to many patients," he said.

The learning curve for the ALSYNC system, he estimated, is "a few cases" for clinicians who have experience with transeptal puncture procedures. "Most interventional electrophysiologists will have that experience," Dr. Morgan said, but "doctors who implant devices may not. We do have some suggestion from the trial data that the higher-volume implanting centers in the trial were getting faster procedure times."

The study was funded by Medtronic. Dr. Morgan disclosed that he is a paid consultant to the company.

[email protected]

SAN FRANCISCO – Bariatric surgery appears to have a preventive effect on the incidence of atrial fibrillation in patients who are morbidly obese, results from a study of more than 400 patients showed.

"Bariatric surgery is a preventative measure that obese patients may choose to take and our study shows that the surgery helps them not only lose weight, but also reduces their risk of developing a serious cardiac condition, like AF," Dr. Yong-Mei Cha, professor of medicine at Mayo Clinic, Rochester, Minn., said in a prepared statement.

In an interview at the annual scientific sessions of the Heart Rhythm Society, Dr. John D. Day, a Murray, Utah–based electrophysiologist and cardiologist who was not involved in the research, characterized the findings as "a message of hope. Too often here in the United States people get a diagnosis of AF and they feel like it’s going to be with them the rest of their lives. The message of hope is that AF – if aggressive lifestyle changes are made early on – is a potentially reversible condition. This study showed that point. And this was just by eliminating the weight. How much more powerful would it be if they made comprehensive lifestyle changes that include more physical activity, dietary changes, and stress reduction?"

Dr. Cha and her associates retrospectively evaluated data from 438 patients in Olmsted County, Minn., who had a body mass index of 40 kg/m² or higher and were considered good candidates for bariatric surgery. One electrophysiologist reviewed the medical records and the diagnosis of AF was documented by ECG or ambulatory monitors. The researchers collected metabolic profiles at baseline and at follow-up.

Of the 438 patients, 326 (74%) underwent bariatric surgery while the remaining 112 were managed medically and served as the control group. At baseline, BMI was significantly greater in the surgery group compared with the control group (a mean of 46.9 vs. 43.2 kg/m², respectively), but the prevalence of AF was similar between the two groups (3.7 vs. 4.5%).

After a mean follow-up of 7.2 years, new onset of AF occurred in 3.1% of the surgery group, compared with 12.5% in the control group, a difference that reached statistical significance. The surgery group also had a significant reduction in BMI and improvements in their metabolic profiles, compared with the control group.

Dr. Day said that the study’s single-center, retrospective design is a limitation, as is the fact that bariatric surgery "is pretty extreme; you can’t offer it to everybody. But [the findings] fit in line with current data. We know that obesity is a powerful risk factor for atrial fibrillation."

The researchers reported no financial conflicts of interest.

[email protected]

SAN FRANCISCO – Bariatric surgery appears to have a preventive effect on the incidence of atrial fibrillation in patients who are morbidly obese, results from a study of more than 400 patients showed.

"Bariatric surgery is a preventative measure that obese patients may choose to take and our study shows that the surgery helps them not only lose weight, but also reduces their risk of developing a serious cardiac condition, like AF," Dr. Yong-Mei Cha, professor of medicine at Mayo Clinic, Rochester, Minn., said in a prepared statement.

In an interview at the annual scientific sessions of the Heart Rhythm Society, Dr. John D. Day, a Murray, Utah–based electrophysiologist and cardiologist who was not involved in the research, characterized the findings as "a message of hope. Too often here in the United States people get a diagnosis of AF and they feel like it’s going to be with them the rest of their lives. The message of hope is that AF – if aggressive lifestyle changes are made early on – is a potentially reversible condition. This study showed that point. And this was just by eliminating the weight. How much more powerful would it be if they made comprehensive lifestyle changes that include more physical activity, dietary changes, and stress reduction?"

Dr. Cha and her associates retrospectively evaluated data from 438 patients in Olmsted County, Minn., who had a body mass index of 40 kg/m² or higher and were considered good candidates for bariatric surgery. One electrophysiologist reviewed the medical records and the diagnosis of AF was documented by ECG or ambulatory monitors. The researchers collected metabolic profiles at baseline and at follow-up.

Of the 438 patients, 326 (74%) underwent bariatric surgery while the remaining 112 were managed medically and served as the control group. At baseline, BMI was significantly greater in the surgery group compared with the control group (a mean of 46.9 vs. 43.2 kg/m², respectively), but the prevalence of AF was similar between the two groups (3.7 vs. 4.5%).

After a mean follow-up of 7.2 years, new onset of AF occurred in 3.1% of the surgery group, compared with 12.5% in the control group, a difference that reached statistical significance. The surgery group also had a significant reduction in BMI and improvements in their metabolic profiles, compared with the control group.

Dr. Day said that the study’s single-center, retrospective design is a limitation, as is the fact that bariatric surgery "is pretty extreme; you can’t offer it to everybody. But [the findings] fit in line with current data. We know that obesity is a powerful risk factor for atrial fibrillation."

The researchers reported no financial conflicts of interest.

[email protected]

SAN FRANCISCO – Bariatric surgery appears to have a preventive effect on the incidence of atrial fibrillation in patients who are morbidly obese, results from a study of more than 400 patients showed.

"Bariatric surgery is a preventative measure that obese patients may choose to take and our study shows that the surgery helps them not only lose weight, but also reduces their risk of developing a serious cardiac condition, like AF," Dr. Yong-Mei Cha, professor of medicine at Mayo Clinic, Rochester, Minn., said in a prepared statement.

In an interview at the annual scientific sessions of the Heart Rhythm Society, Dr. John D. Day, a Murray, Utah–based electrophysiologist and cardiologist who was not involved in the research, characterized the findings as "a message of hope. Too often here in the United States people get a diagnosis of AF and they feel like it’s going to be with them the rest of their lives. The message of hope is that AF – if aggressive lifestyle changes are made early on – is a potentially reversible condition. This study showed that point. And this was just by eliminating the weight. How much more powerful would it be if they made comprehensive lifestyle changes that include more physical activity, dietary changes, and stress reduction?"

Dr. Cha and her associates retrospectively evaluated data from 438 patients in Olmsted County, Minn., who had a body mass index of 40 kg/m² or higher and were considered good candidates for bariatric surgery. One electrophysiologist reviewed the medical records and the diagnosis of AF was documented by ECG or ambulatory monitors. The researchers collected metabolic profiles at baseline and at follow-up.

Of the 438 patients, 326 (74%) underwent bariatric surgery while the remaining 112 were managed medically and served as the control group. At baseline, BMI was significantly greater in the surgery group compared with the control group (a mean of 46.9 vs. 43.2 kg/m², respectively), but the prevalence of AF was similar between the two groups (3.7 vs. 4.5%).

After a mean follow-up of 7.2 years, new onset of AF occurred in 3.1% of the surgery group, compared with 12.5% in the control group, a difference that reached statistical significance. The surgery group also had a significant reduction in BMI and improvements in their metabolic profiles, compared with the control group.

Dr. Day said that the study’s single-center, retrospective design is a limitation, as is the fact that bariatric surgery "is pretty extreme; you can’t offer it to everybody. But [the findings] fit in line with current data. We know that obesity is a powerful risk factor for atrial fibrillation."

The researchers reported no financial conflicts of interest.

[email protected]

SAN FRANCISCO – Among cases of sports-associated sudden cardiac death in middle-age men, 51% had known preexisting cardiac disease and at least two documented cardiac risk factors, and 31% had cardiovascular symptoms that preceded the sudden cardiac arrest event, results from large ongoing prospective study showed.

"The prevention of SCD during sports should include education of sport participants: The way of practicing sports should be different if you have a known heart disease," and warning symptoms should be heeded, one of the study authors, Dr. Eloi Marijon said in an interview after the annual scientific sessions of the Heart Rhythm Society, where the study was presented.

In the ongoing Oregon-SUDS (Oregon Sudden Unexpected Death Study), Dr. Marijon and his associates identified sudden cardiac arrest (SCA) cases among 944 men aged 35-65 years in the metropolitan area of Portland, Oregon, during 2002-2012, including systematic and comprehensive assessment of their lifetime medical history. "This is the first work aiming to study sudden cardiac death during sports in the community in United States," said Dr. Marijon, a visiting faculty scientist at Cedars-Sinai Medical Center, Los Angeles. "There are some data in the European Union, but data from the United States were coming only from studies carried out among young competitive athletes," he said. These U.S. studies have allowed for significant improvements in the field, notably initiation and optimization of preventive strategies.

However, "recent European experience has emphasized that, in the community, the largest burden of sports-associated SCA results from events among male middle-age participants. However, except for limited data on specific recreational sport activities there are, to the best of our knowledge, no studies evaluating SCA during sports among middle-age subjects in any United States community."

The researchers found that among the 944 SCA cases, 59 (6%) occurred during sports at a mean age of 51 years, which translated into an incidence of 41/million per year. SCA cases associated with sports activity were significantly more likely to be a witnessed event than were those not related to sports (86% vs. 53, respectively), with higher rates of bystander cardiopulmonary resuscitation (46% vs. 26%) and ventricular fibrillation as the presenting rhythm (84% vs. 57%). In addition, survival to hospital discharge was nearly twice as high for sports-related SCA cases than for nonsports–related SCA cases (25% vs. 13%).

The researchers also found that slightly more than half of sports-related SCA cases (51%) had known preexisting cardiac disease and at least two documented cardiac risk factors, while nearly one-third (31%) had cardiovascular symptoms that preceded the SCA event, "opening room for intervention," Dr. Marijon said.

Even though the researchers considered lifetime past medical history in all cases, "investigation of SCA remains particularly challenging, especially since a great majority of subjects die in the field, and consequently the information collected by emergency medical services is often restricted to data regarding the resuscitation process," Dr. Marijon noted. "Details of the past medical history of SCA patients (especially those that cannot be resuscitated) are thus usually sparse and very rarely considered systematically."

The principal investigator of Oregon-SUDS is Dr. Sumeet S. Chugh of the department of genomic cardiology at the Cedars-Sinai Heart Institute.

The study was funded by the National Heart, Lung, and Blood Institute. Dr. Marijon had no relevant financial conflicts of interest to disclose.

[email protected]

SAN FRANCISCO – Among cases of sports-associated sudden cardiac death in middle-age men, 51% had known preexisting cardiac disease and at least two documented cardiac risk factors, and 31% had cardiovascular symptoms that preceded the sudden cardiac arrest event, results from large ongoing prospective study showed.

"The prevention of SCD during sports should include education of sport participants: The way of practicing sports should be different if you have a known heart disease," and warning symptoms should be heeded, one of the study authors, Dr. Eloi Marijon said in an interview after the annual scientific sessions of the Heart Rhythm Society, where the study was presented.

In the ongoing Oregon-SUDS (Oregon Sudden Unexpected Death Study), Dr. Marijon and his associates identified sudden cardiac arrest (SCA) cases among 944 men aged 35-65 years in the metropolitan area of Portland, Oregon, during 2002-2012, including systematic and comprehensive assessment of their lifetime medical history. "This is the first work aiming to study sudden cardiac death during sports in the community in United States," said Dr. Marijon, a visiting faculty scientist at Cedars-Sinai Medical Center, Los Angeles. "There are some data in the European Union, but data from the United States were coming only from studies carried out among young competitive athletes," he said. These U.S. studies have allowed for significant improvements in the field, notably initiation and optimization of preventive strategies.

However, "recent European experience has emphasized that, in the community, the largest burden of sports-associated SCA results from events among male middle-age participants. However, except for limited data on specific recreational sport activities there are, to the best of our knowledge, no studies evaluating SCA during sports among middle-age subjects in any United States community."

The researchers found that among the 944 SCA cases, 59 (6%) occurred during sports at a mean age of 51 years, which translated into an incidence of 41/million per year. SCA cases associated with sports activity were significantly more likely to be a witnessed event than were those not related to sports (86% vs. 53, respectively), with higher rates of bystander cardiopulmonary resuscitation (46% vs. 26%) and ventricular fibrillation as the presenting rhythm (84% vs. 57%). In addition, survival to hospital discharge was nearly twice as high for sports-related SCA cases than for nonsports–related SCA cases (25% vs. 13%).

The researchers also found that slightly more than half of sports-related SCA cases (51%) had known preexisting cardiac disease and at least two documented cardiac risk factors, while nearly one-third (31%) had cardiovascular symptoms that preceded the SCA event, "opening room for intervention," Dr. Marijon said.

Even though the researchers considered lifetime past medical history in all cases, "investigation of SCA remains particularly challenging, especially since a great majority of subjects die in the field, and consequently the information collected by emergency medical services is often restricted to data regarding the resuscitation process," Dr. Marijon noted. "Details of the past medical history of SCA patients (especially those that cannot be resuscitated) are thus usually sparse and very rarely considered systematically."

The principal investigator of Oregon-SUDS is Dr. Sumeet S. Chugh of the department of genomic cardiology at the Cedars-Sinai Heart Institute.

The study was funded by the National Heart, Lung, and Blood Institute. Dr. Marijon had no relevant financial conflicts of interest to disclose.

[email protected]

SAN FRANCISCO – Among cases of sports-associated sudden cardiac death in middle-age men, 51% had known preexisting cardiac disease and at least two documented cardiac risk factors, and 31% had cardiovascular symptoms that preceded the sudden cardiac arrest event, results from large ongoing prospective study showed.

"The prevention of SCD during sports should include education of sport participants: The way of practicing sports should be different if you have a known heart disease," and warning symptoms should be heeded, one of the study authors, Dr. Eloi Marijon said in an interview after the annual scientific sessions of the Heart Rhythm Society, where the study was presented.

In the ongoing Oregon-SUDS (Oregon Sudden Unexpected Death Study), Dr. Marijon and his associates identified sudden cardiac arrest (SCA) cases among 944 men aged 35-65 years in the metropolitan area of Portland, Oregon, during 2002-2012, including systematic and comprehensive assessment of their lifetime medical history. "This is the first work aiming to study sudden cardiac death during sports in the community in United States," said Dr. Marijon, a visiting faculty scientist at Cedars-Sinai Medical Center, Los Angeles. "There are some data in the European Union, but data from the United States were coming only from studies carried out among young competitive athletes," he said. These U.S. studies have allowed for significant improvements in the field, notably initiation and optimization of preventive strategies.

However, "recent European experience has emphasized that, in the community, the largest burden of sports-associated SCA results from events among male middle-age participants. However, except for limited data on specific recreational sport activities there are, to the best of our knowledge, no studies evaluating SCA during sports among middle-age subjects in any United States community."

The researchers found that among the 944 SCA cases, 59 (6%) occurred during sports at a mean age of 51 years, which translated into an incidence of 41/million per year. SCA cases associated with sports activity were significantly more likely to be a witnessed event than were those not related to sports (86% vs. 53, respectively), with higher rates of bystander cardiopulmonary resuscitation (46% vs. 26%) and ventricular fibrillation as the presenting rhythm (84% vs. 57%). In addition, survival to hospital discharge was nearly twice as high for sports-related SCA cases than for nonsports–related SCA cases (25% vs. 13%).

The researchers also found that slightly more than half of sports-related SCA cases (51%) had known preexisting cardiac disease and at least two documented cardiac risk factors, while nearly one-third (31%) had cardiovascular symptoms that preceded the SCA event, "opening room for intervention," Dr. Marijon said.

Even though the researchers considered lifetime past medical history in all cases, "investigation of SCA remains particularly challenging, especially since a great majority of subjects die in the field, and consequently the information collected by emergency medical services is often restricted to data regarding the resuscitation process," Dr. Marijon noted. "Details of the past medical history of SCA patients (especially those that cannot be resuscitated) are thus usually sparse and very rarely considered systematically."

The principal investigator of Oregon-SUDS is Dr. Sumeet S. Chugh of the department of genomic cardiology at the Cedars-Sinai Heart Institute.

The study was funded by the National Heart, Lung, and Blood Institute. Dr. Marijon had no relevant financial conflicts of interest to disclose.

[email protected]

SAN FRANCISCO – Adding an electrocardiogram to standard preparticipation screening of high school athletes significantly increased the likelihood of identifying disorders associated with sudden cardiac death, a prospective study of nearly 5,000 athletes showed.

"At this point I’m not advocating that an ECG should definitely be added to the screening, and I’m not advocating that the ECG should replace the history and physical," lead author Dr. Jordan M. Prutkin emphasized in an interview at the annual scientific sessions of the Heart Rhythm Society.

Doug Brunk/Frontline Medical News

"I think we need to be doing more research to figure out what the correct history questions to be asking are. For instance, I think a family history is one of the most important questions to ask about, as is syncope. We also need to find the best ECG criteria that are going to give you the best sensitivity and specificity in an athletic population."

The American Heart Association currently recommends the use of a history and physical in the preparticipation screening of athletes, but it does not recommend use of an ECG.

No definitive data exist to support using a history and physical only to detect heart abnormalities, noted Dr. Prutkin, an electrophysiologist at the University of Washington’s Center for Sports Cardiology, Seattle. "We also don’t have a lot of data that compares the history and physical to an ECG," he said. "The idea of using ECG for screening is a debated topic. In this study we tried to compare the ECG to a history and physical in terms of picking up those things that portend a risk of sudden cardiac arrest on the playing field or in life."

Between October 2010 and June 2013 the researchers conducted preparticipation screening of 4,812 athletes aged 13-19 at 23 high schools in the Seattle area. The protocol included a heart health questionnaire, physical exam recommendations based on AHA guidelines, and a resting 12-lead ECG that was interpreted according to athlete-specific criteria and limited echocardiography.

Slightly more than half of the athletes (54%) were male and 65% were white. In all, 23 athletes (.5%) were found to have a significant cardiac abnormality that required further evaluation. Abnormal history or physical exam led to a diagnosis in 61% of the disorders, while an abnormal ECG led to a diagnosis in 70% of the disorders. In addition, history, physical examination, and ECG had false-positive rates of 22.3%, 14.9%, and 3.6%, respectively, and positive predictive values of 1.0%, 1.0%, and 8.6%.

"Our results matched what we had been seeing [in practice], which is that trying to do a good history in a high school student is very difficult, because a lot of them will complain of chest pain or palpitations," Dr. Prutkin said. "Some of the problems with the history and physical [center around] what are the more directed questions to ask? Do we need to revise the preparticipation examination to get better questions? Also, when interpreting the ECGs, you need to use athlete-specific criteria. By doing that, you can significantly decrease your false-positive rate. You can’t just interpret an ECG the way that you would normally interpret an ECG in a 50-year-old."

He acknowledged certain limitations of the study, including the fact that a screening echocardiogram was used instead of a full echocardiogram. "We looked for coronary artery anomalies, but that’s not always possible to see on a screening echocardiogram, so we may have missed some of those," he said. "We also may have missed some cases of long QT syndrome or hypertropic cardiomyopathy. This is screening; even with the ECG it’s not going to be perfect, but hopefully we are finding those who are at highest risk."

The Nick of Time Foundation helped to arrange the screenings. Dr. Prutkin said that he had no conflicts of interest to disclose.

[email protected]

SAN FRANCISCO – Adding an electrocardiogram to standard preparticipation screening of high school athletes significantly increased the likelihood of identifying disorders associated with sudden cardiac death, a prospective study of nearly 5,000 athletes showed.

"At this point I’m not advocating that an ECG should definitely be added to the screening, and I’m not advocating that the ECG should replace the history and physical," lead author Dr. Jordan M. Prutkin emphasized in an interview at the annual scientific sessions of the Heart Rhythm Society.

Doug Brunk/Frontline Medical News

"I think we need to be doing more research to figure out what the correct history questions to be asking are. For instance, I think a family history is one of the most important questions to ask about, as is syncope. We also need to find the best ECG criteria that are going to give you the best sensitivity and specificity in an athletic population."

The American Heart Association currently recommends the use of a history and physical in the preparticipation screening of athletes, but it does not recommend use of an ECG.

No definitive data exist to support using a history and physical only to detect heart abnormalities, noted Dr. Prutkin, an electrophysiologist at the University of Washington’s Center for Sports Cardiology, Seattle. "We also don’t have a lot of data that compares the history and physical to an ECG," he said. "The idea of using ECG for screening is a debated topic. In this study we tried to compare the ECG to a history and physical in terms of picking up those things that portend a risk of sudden cardiac arrest on the playing field or in life."

Between October 2010 and June 2013 the researchers conducted preparticipation screening of 4,812 athletes aged 13-19 at 23 high schools in the Seattle area. The protocol included a heart health questionnaire, physical exam recommendations based on AHA guidelines, and a resting 12-lead ECG that was interpreted according to athlete-specific criteria and limited echocardiography.

Slightly more than half of the athletes (54%) were male and 65% were white. In all, 23 athletes (.5%) were found to have a significant cardiac abnormality that required further evaluation. Abnormal history or physical exam led to a diagnosis in 61% of the disorders, while an abnormal ECG led to a diagnosis in 70% of the disorders. In addition, history, physical examination, and ECG had false-positive rates of 22.3%, 14.9%, and 3.6%, respectively, and positive predictive values of 1.0%, 1.0%, and 8.6%.

"Our results matched what we had been seeing [in practice], which is that trying to do a good history in a high school student is very difficult, because a lot of them will complain of chest pain or palpitations," Dr. Prutkin said. "Some of the problems with the history and physical [center around] what are the more directed questions to ask? Do we need to revise the preparticipation examination to get better questions? Also, when interpreting the ECGs, you need to use athlete-specific criteria. By doing that, you can significantly decrease your false-positive rate. You can’t just interpret an ECG the way that you would normally interpret an ECG in a 50-year-old."

He acknowledged certain limitations of the study, including the fact that a screening echocardiogram was used instead of a full echocardiogram. "We looked for coronary artery anomalies, but that’s not always possible to see on a screening echocardiogram, so we may have missed some of those," he said. "We also may have missed some cases of long QT syndrome or hypertropic cardiomyopathy. This is screening; even with the ECG it’s not going to be perfect, but hopefully we are finding those who are at highest risk."

The Nick of Time Foundation helped to arrange the screenings. Dr. Prutkin said that he had no conflicts of interest to disclose.

[email protected]

SAN FRANCISCO – Adding an electrocardiogram to standard preparticipation screening of high school athletes significantly increased the likelihood of identifying disorders associated with sudden cardiac death, a prospective study of nearly 5,000 athletes showed.

"At this point I’m not advocating that an ECG should definitely be added to the screening, and I’m not advocating that the ECG should replace the history and physical," lead author Dr. Jordan M. Prutkin emphasized in an interview at the annual scientific sessions of the Heart Rhythm Society.

Doug Brunk/Frontline Medical News

"I think we need to be doing more research to figure out what the correct history questions to be asking are. For instance, I think a family history is one of the most important questions to ask about, as is syncope. We also need to find the best ECG criteria that are going to give you the best sensitivity and specificity in an athletic population."

The American Heart Association currently recommends the use of a history and physical in the preparticipation screening of athletes, but it does not recommend use of an ECG.

No definitive data exist to support using a history and physical only to detect heart abnormalities, noted Dr. Prutkin, an electrophysiologist at the University of Washington’s Center for Sports Cardiology, Seattle. "We also don’t have a lot of data that compares the history and physical to an ECG," he said. "The idea of using ECG for screening is a debated topic. In this study we tried to compare the ECG to a history and physical in terms of picking up those things that portend a risk of sudden cardiac arrest on the playing field or in life."

Between October 2010 and June 2013 the researchers conducted preparticipation screening of 4,812 athletes aged 13-19 at 23 high schools in the Seattle area. The protocol included a heart health questionnaire, physical exam recommendations based on AHA guidelines, and a resting 12-lead ECG that was interpreted according to athlete-specific criteria and limited echocardiography.

Slightly more than half of the athletes (54%) were male and 65% were white. In all, 23 athletes (.5%) were found to have a significant cardiac abnormality that required further evaluation. Abnormal history or physical exam led to a diagnosis in 61% of the disorders, while an abnormal ECG led to a diagnosis in 70% of the disorders. In addition, history, physical examination, and ECG had false-positive rates of 22.3%, 14.9%, and 3.6%, respectively, and positive predictive values of 1.0%, 1.0%, and 8.6%.

"Our results matched what we had been seeing [in practice], which is that trying to do a good history in a high school student is very difficult, because a lot of them will complain of chest pain or palpitations," Dr. Prutkin said. "Some of the problems with the history and physical [center around] what are the more directed questions to ask? Do we need to revise the preparticipation examination to get better questions? Also, when interpreting the ECGs, you need to use athlete-specific criteria. By doing that, you can significantly decrease your false-positive rate. You can’t just interpret an ECG the way that you would normally interpret an ECG in a 50-year-old."

He acknowledged certain limitations of the study, including the fact that a screening echocardiogram was used instead of a full echocardiogram. "We looked for coronary artery anomalies, but that’s not always possible to see on a screening echocardiogram, so we may have missed some of those," he said. "We also may have missed some cases of long QT syndrome or hypertropic cardiomyopathy. This is screening; even with the ECG it’s not going to be perfect, but hopefully we are finding those who are at highest risk."

The Nick of Time Foundation helped to arrange the screenings. Dr. Prutkin said that he had no conflicts of interest to disclose.

[email protected]

SAN FRANCISCO – Defibrillation testing at the time of implantable cardioverter defibrillator implantation is safe, but it does not improve clinical shock efficacy or prevent death, results from a large, randomized trial showed.

"Implanting an ICD without routine testing should be the preferred approach now. In some countries, like Canada, this has been the approach for 80% of people," Dr. Jeffrey S. Healey said during a press briefing at the annual scientific sessions of the Heart Rhythm Society. The results have the potential to "change guidelines, especially in the United States where the majority of ICDs are implanted with testing."

For the study, known as the SIMPLE (Shockless Implant Evaluation) trial, 2,500 patients at 85 sites in 18 countries undergoing their initial ICD implant were randomized to defibrillation testing (DT) or to no DT at the time of implant. The DT protocol required one or more successful terminations of ventricular fibrillation at 17 J or two terminations at 21J, with system revision if criteria were not met. The primary outcome was a composite of failed appropriate clinical shocks or arrhythmic death. "We thought this was an important clinical outcome because that’s really what the testing is meant to do; it’s meant to improve the likelihood that the device will successfully terminate an episode of ventricular tachycardia and ventricular fibrillation," said Dr. Healey, the study’s lead author who is director of arrhythmia services at Hamilton (Canada) Health Sciences. "We also looked at all-cause mortality because that’s clearly important."

The researchers additionally evaluated two safety clusters of periprocedural risk within 30 days of surgery. The first safety cluster looked at any complication which conceivably could be related to DT itself. The second safety cluster looked at episodes that are more clearly established to be related to DT, such as the need for cardiopulmonary resuscitation, unplanned intubation, stroke, heart failure, and death.

The mean age of patients was 63 years and 81% were men. During a follow-up of 3.1 years, 1.7% of patients were lost to follow-up. Failed appropriate clinical shocks or arrhythmic death occurred at an annual rate of 7.2% in the study arm of patients who did not have device testing, compared with a rate of 8.3% in the arm that had device testing (hazard ratio 0.86; P value of less than .001 for noninferiority). Total mortality was similar in both groups (HR 1.04: P = 0.65).

Device testing "did not seem to improve outcomes at all," commented Dr. Healey. "We set this up as a noninferiority trial to show that implantation of an ICD without testing was noninferior to implantation with testing. We very much succeeded in showing that was the case. The P value was less than .001 for noninferiority."

In terms of safety, the researchers observed a nonsignificant trend in favor of a slight increase in complications in the first safety cluster. "The second safety cluster of events more closely linked to shock testing was significantly increased with a borderline P value of .047, or a 50% increase, going from a 3% complication rate to 4.5% complication rate with testing," he said.

The likelihood of successful shock was numerically higher in patients who did not having the testing, "but this was not statistically significant; the P value was .08," Dr. Healey said. "We conclude that ICD implantation without testing does not give up any of the benefit of the ICD, that it is noninferior to implantation with testing using that primary outcome of failed shock or arrhythmic death. Overall, the complication rates from either strategy are low. There was a small but measurable increase with the testing procedure but overall we’ve come a long way with ICD therapy in the last 20 years. The therapy works; it’s highly effective, and clinicians can place it with very low risk."

SIMPLE was funded by a grant from Boston Scientific. Dr. Healey said that he had no relevant financial conflicts to disclose.

[email protected]

SAN FRANCISCO – Defibrillation testing at the time of implantable cardioverter defibrillator implantation is safe, but it does not improve clinical shock efficacy or prevent death, results from a large, randomized trial showed.

"Implanting an ICD without routine testing should be the preferred approach now. In some countries, like Canada, this has been the approach for 80% of people," Dr. Jeffrey S. Healey said during a press briefing at the annual scientific sessions of the Heart Rhythm Society. The results have the potential to "change guidelines, especially in the United States where the majority of ICDs are implanted with testing."

For the study, known as the SIMPLE (Shockless Implant Evaluation) trial, 2,500 patients at 85 sites in 18 countries undergoing their initial ICD implant were randomized to defibrillation testing (DT) or to no DT at the time of implant. The DT protocol required one or more successful terminations of ventricular fibrillation at 17 J or two terminations at 21J, with system revision if criteria were not met. The primary outcome was a composite of failed appropriate clinical shocks or arrhythmic death. "We thought this was an important clinical outcome because that’s really what the testing is meant to do; it’s meant to improve the likelihood that the device will successfully terminate an episode of ventricular tachycardia and ventricular fibrillation," said Dr. Healey, the study’s lead author who is director of arrhythmia services at Hamilton (Canada) Health Sciences. "We also looked at all-cause mortality because that’s clearly important."

The researchers additionally evaluated two safety clusters of periprocedural risk within 30 days of surgery. The first safety cluster looked at any complication which conceivably could be related to DT itself. The second safety cluster looked at episodes that are more clearly established to be related to DT, such as the need for cardiopulmonary resuscitation, unplanned intubation, stroke, heart failure, and death.

The mean age of patients was 63 years and 81% were men. During a follow-up of 3.1 years, 1.7% of patients were lost to follow-up. Failed appropriate clinical shocks or arrhythmic death occurred at an annual rate of 7.2% in the study arm of patients who did not have device testing, compared with a rate of 8.3% in the arm that had device testing (hazard ratio 0.86; P value of less than .001 for noninferiority). Total mortality was similar in both groups (HR 1.04: P = 0.65).

Device testing "did not seem to improve outcomes at all," commented Dr. Healey. "We set this up as a noninferiority trial to show that implantation of an ICD without testing was noninferior to implantation with testing. We very much succeeded in showing that was the case. The P value was less than .001 for noninferiority."

In terms of safety, the researchers observed a nonsignificant trend in favor of a slight increase in complications in the first safety cluster. "The second safety cluster of events more closely linked to shock testing was significantly increased with a borderline P value of .047, or a 50% increase, going from a 3% complication rate to 4.5% complication rate with testing," he said.

The likelihood of successful shock was numerically higher in patients who did not having the testing, "but this was not statistically significant; the P value was .08," Dr. Healey said. "We conclude that ICD implantation without testing does not give up any of the benefit of the ICD, that it is noninferior to implantation with testing using that primary outcome of failed shock or arrhythmic death. Overall, the complication rates from either strategy are low. There was a small but measurable increase with the testing procedure but overall we’ve come a long way with ICD therapy in the last 20 years. The therapy works; it’s highly effective, and clinicians can place it with very low risk."

SIMPLE was funded by a grant from Boston Scientific. Dr. Healey said that he had no relevant financial conflicts to disclose.

[email protected]

SAN FRANCISCO – Defibrillation testing at the time of implantable cardioverter defibrillator implantation is safe, but it does not improve clinical shock efficacy or prevent death, results from a large, randomized trial showed.

"Implanting an ICD without routine testing should be the preferred approach now. In some countries, like Canada, this has been the approach for 80% of people," Dr. Jeffrey S. Healey said during a press briefing at the annual scientific sessions of the Heart Rhythm Society. The results have the potential to "change guidelines, especially in the United States where the majority of ICDs are implanted with testing."

For the study, known as the SIMPLE (Shockless Implant Evaluation) trial, 2,500 patients at 85 sites in 18 countries undergoing their initial ICD implant were randomized to defibrillation testing (DT) or to no DT at the time of implant. The DT protocol required one or more successful terminations of ventricular fibrillation at 17 J or two terminations at 21J, with system revision if criteria were not met. The primary outcome was a composite of failed appropriate clinical shocks or arrhythmic death. "We thought this was an important clinical outcome because that’s really what the testing is meant to do; it’s meant to improve the likelihood that the device will successfully terminate an episode of ventricular tachycardia and ventricular fibrillation," said Dr. Healey, the study’s lead author who is director of arrhythmia services at Hamilton (Canada) Health Sciences. "We also looked at all-cause mortality because that’s clearly important."

The researchers additionally evaluated two safety clusters of periprocedural risk within 30 days of surgery. The first safety cluster looked at any complication which conceivably could be related to DT itself. The second safety cluster looked at episodes that are more clearly established to be related to DT, such as the need for cardiopulmonary resuscitation, unplanned intubation, stroke, heart failure, and death.

The mean age of patients was 63 years and 81% were men. During a follow-up of 3.1 years, 1.7% of patients were lost to follow-up. Failed appropriate clinical shocks or arrhythmic death occurred at an annual rate of 7.2% in the study arm of patients who did not have device testing, compared with a rate of 8.3% in the arm that had device testing (hazard ratio 0.86; P value of less than .001 for noninferiority). Total mortality was similar in both groups (HR 1.04: P = 0.65).

Device testing "did not seem to improve outcomes at all," commented Dr. Healey. "We set this up as a noninferiority trial to show that implantation of an ICD without testing was noninferior to implantation with testing. We very much succeeded in showing that was the case. The P value was less than .001 for noninferiority."

In terms of safety, the researchers observed a nonsignificant trend in favor of a slight increase in complications in the first safety cluster. "The second safety cluster of events more closely linked to shock testing was significantly increased with a borderline P value of .047, or a 50% increase, going from a 3% complication rate to 4.5% complication rate with testing," he said.

The likelihood of successful shock was numerically higher in patients who did not having the testing, "but this was not statistically significant; the P value was .08," Dr. Healey said. "We conclude that ICD implantation without testing does not give up any of the benefit of the ICD, that it is noninferior to implantation with testing using that primary outcome of failed shock or arrhythmic death. Overall, the complication rates from either strategy are low. There was a small but measurable increase with the testing procedure but overall we’ve come a long way with ICD therapy in the last 20 years. The therapy works; it’s highly effective, and clinicians can place it with very low risk."

SIMPLE was funded by a grant from Boston Scientific. Dr. Healey said that he had no relevant financial conflicts to disclose.

[email protected]

SAN FRANCISCO – Patients with implantable pacemakers and defibrillators who engage in remote monitoring at more than 75% adherence rates have a 2.4-fold higher rate of survival than those who do not engage in remote monitoring, based on data from 262,574 patients.

"All patients should be enrolled in remote monitoring and [be] encouraged to engage with remote monitoring at a high level, because the mortality reductions associated with remote monitoring are of a very significant and sizeable proportion," Dr. Suneet Mittal said during a press briefing at the annual scientific sessions of the Heart Rhythm Society.

Most patients who undergo device implantation in the United States "are not enrolled in a remote monitoring program, or, if enrolled in a monitoring program, do not reliably engage in remote monitoring," said Dr. Mittal, director of electrophysiology for Valley Health System of New York and New Jersey, Ridgewood, New Jersey. "This is concerning, because one prior study looking at individuals who underwent remote monitoring of their defibrillators suggest a nearly 50% reduction in mortality in the group of patients who were using remote monitoring [Circulation 2010;122[23]:2359-67]."

In a first-of-its-kind study, Dr. Mittal and his associates set out to determine whether this association also applied to pacemaker patients, whether there was a relationship between the amount of remote monitoring of patient use and their ultimate outcome, and whether there were any variables that could be used to identify patients who were or were not using remote monitoring. The population included 262,574 patients with a mean age of 71 years who received implantable pacemakers, cardiac resynchronization therapy pacemakers (CRT-Ps), cardiac resynchronization therapy cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy defibrillators (CRT-Ds). The majority were implanted with a St. Jude Medical pacemaker (112,692), CRT-P (7,704), ICD (82,621), or CRT-D (59,547). Nearly two-thirds of the patients (65%) were men.

Patients who adhered to remote monitoring more than 75% of the time had a 2.4-fold higher rate of survival, compared with patients who were never remotely monitored. "Even more importantly, those who were being remotely monitored more than 75% of the time had a 1.5-fold higher survival than patients who were being remotely monitored but were only engaged in remote monitoring less than 75% of the time," Dr. Mittal added. The magnitude of benefit was the same regardless of the type of device that was implanted, "suggesting that this is a device-independent effect."

Dr. Mittal reported that 54% of patients never enrolled in remote monitoring.

The researchers analyzed U.S. Census data including demographics, poverty level, and education level in an effort to identify potential explanatory variables, but "we could not identify any variable that identified whether patients were using remote monitoring or not," Dr. Mittal said. "Somewhat surprisingly, patients living in the highest population density zones in the U.S. were the least likely to be enrolled and using remote monitoring as opposed to those individuals living in the Midwest and the Pacific Northwest."

Dr. Mittal disclosed that he is a consultant to multiple device makers including St. Jude Medical.

[email protected]

On Twitter @dougbrunk

SAN FRANCISCO – Patients with implantable pacemakers and defibrillators who engage in remote monitoring at more than 75% adherence rates have a 2.4-fold higher rate of survival than those who do not engage in remote monitoring, based on data from 262,574 patients.

"All patients should be enrolled in remote monitoring and [be] encouraged to engage with remote monitoring at a high level, because the mortality reductions associated with remote monitoring are of a very significant and sizeable proportion," Dr. Suneet Mittal said during a press briefing at the annual scientific sessions of the Heart Rhythm Society.

Most patients who undergo device implantation in the United States "are not enrolled in a remote monitoring program, or, if enrolled in a monitoring program, do not reliably engage in remote monitoring," said Dr. Mittal, director of electrophysiology for Valley Health System of New York and New Jersey, Ridgewood, New Jersey. "This is concerning, because one prior study looking at individuals who underwent remote monitoring of their defibrillators suggest a nearly 50% reduction in mortality in the group of patients who were using remote monitoring [Circulation 2010;122[23]:2359-67]."

In a first-of-its-kind study, Dr. Mittal and his associates set out to determine whether this association also applied to pacemaker patients, whether there was a relationship between the amount of remote monitoring of patient use and their ultimate outcome, and whether there were any variables that could be used to identify patients who were or were not using remote monitoring. The population included 262,574 patients with a mean age of 71 years who received implantable pacemakers, cardiac resynchronization therapy pacemakers (CRT-Ps), cardiac resynchronization therapy cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy defibrillators (CRT-Ds). The majority were implanted with a St. Jude Medical pacemaker (112,692), CRT-P (7,704), ICD (82,621), or CRT-D (59,547). Nearly two-thirds of the patients (65%) were men.

Patients who adhered to remote monitoring more than 75% of the time had a 2.4-fold higher rate of survival, compared with patients who were never remotely monitored. "Even more importantly, those who were being remotely monitored more than 75% of the time had a 1.5-fold higher survival than patients who were being remotely monitored but were only engaged in remote monitoring less than 75% of the time," Dr. Mittal added. The magnitude of benefit was the same regardless of the type of device that was implanted, "suggesting that this is a device-independent effect."

Dr. Mittal reported that 54% of patients never enrolled in remote monitoring.

The researchers analyzed U.S. Census data including demographics, poverty level, and education level in an effort to identify potential explanatory variables, but "we could not identify any variable that identified whether patients were using remote monitoring or not," Dr. Mittal said. "Somewhat surprisingly, patients living in the highest population density zones in the U.S. were the least likely to be enrolled and using remote monitoring as opposed to those individuals living in the Midwest and the Pacific Northwest."

Dr. Mittal disclosed that he is a consultant to multiple device makers including St. Jude Medical.

[email protected]

On Twitter @dougbrunk

SAN FRANCISCO – Patients with implantable pacemakers and defibrillators who engage in remote monitoring at more than 75% adherence rates have a 2.4-fold higher rate of survival than those who do not engage in remote monitoring, based on data from 262,574 patients.

"All patients should be enrolled in remote monitoring and [be] encouraged to engage with remote monitoring at a high level, because the mortality reductions associated with remote monitoring are of a very significant and sizeable proportion," Dr. Suneet Mittal said during a press briefing at the annual scientific sessions of the Heart Rhythm Society.

Most patients who undergo device implantation in the United States "are not enrolled in a remote monitoring program, or, if enrolled in a monitoring program, do not reliably engage in remote monitoring," said Dr. Mittal, director of electrophysiology for Valley Health System of New York and New Jersey, Ridgewood, New Jersey. "This is concerning, because one prior study looking at individuals who underwent remote monitoring of their defibrillators suggest a nearly 50% reduction in mortality in the group of patients who were using remote monitoring [Circulation 2010;122[23]:2359-67]."

In a first-of-its-kind study, Dr. Mittal and his associates set out to determine whether this association also applied to pacemaker patients, whether there was a relationship between the amount of remote monitoring of patient use and their ultimate outcome, and whether there were any variables that could be used to identify patients who were or were not using remote monitoring. The population included 262,574 patients with a mean age of 71 years who received implantable pacemakers, cardiac resynchronization therapy pacemakers (CRT-Ps), cardiac resynchronization therapy cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy defibrillators (CRT-Ds). The majority were implanted with a St. Jude Medical pacemaker (112,692), CRT-P (7,704), ICD (82,621), or CRT-D (59,547). Nearly two-thirds of the patients (65%) were men.

Patients who adhered to remote monitoring more than 75% of the time had a 2.4-fold higher rate of survival, compared with patients who were never remotely monitored. "Even more importantly, those who were being remotely monitored more than 75% of the time had a 1.5-fold higher survival than patients who were being remotely monitored but were only engaged in remote monitoring less than 75% of the time," Dr. Mittal added. The magnitude of benefit was the same regardless of the type of device that was implanted, "suggesting that this is a device-independent effect."

Dr. Mittal reported that 54% of patients never enrolled in remote monitoring.

The researchers analyzed U.S. Census data including demographics, poverty level, and education level in an effort to identify potential explanatory variables, but "we could not identify any variable that identified whether patients were using remote monitoring or not," Dr. Mittal said. "Somewhat surprisingly, patients living in the highest population density zones in the U.S. were the least likely to be enrolled and using remote monitoring as opposed to those individuals living in the Midwest and the Pacific Northwest."

Dr. Mittal disclosed that he is a consultant to multiple device makers including St. Jude Medical.

[email protected]

On Twitter @dougbrunk