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Cardiac resynchronization, ICDs benefit all ethnicities with heart failure

Both cardiac resynchronization therapy and implantable cardioverter-defibrillators reduce 2-year mortality in patients with heart failure, regardless of their racial or ethnic backgrounds, according to a report published online Aug. 18 in the Journal of the American College of Cardiology.

Guidelines contain class 1 recommendations for device therapies in the primary prevention of sudden cardiac death among patients with heart failure; cardiac resynchronization therapy (CRT) also has a class 1 recommendation for reducing the risk for events. Because of racial and ethnic disparities in the use of both therapies, as well as an underrepresentation of minorities in clinical trials of these treatments, questions have been raised as to whether black and Hispanic patients gain benefits comparable to those seen in white patients, said Dr. Boback Ziaeian of the division of cardiology at the University of California, Los Angeles, and his associates.

Dr. Ziaeian and his fellow researchers studied this issue using data from the IMPROVE HF registry (Registry to Improve the Use of Evidence-Based HF Therapies in the Outpatient Setting), a prospective observational cohort of 15,177 patients with left ventricular dysfunction and heart failure treated at 167 community and academic cardiology and multispecialty practices. Of 7,748 study participants who were eligible for ICDs/cardiac resynchronization defibrillators, 44% were non-Hispanic whites, 9% were non-Hispanic blacks, and 47% were of other racial/ethnic groups or had no race documented in their records. Of 1,188 who were eligible for cardiac resynchronization pacemakers, 50% were non-Hispanic whites, 8% were non-Hispanic blacks, and 42% were other ethnicities or had no race documented in their records.

At 2-year follow-up, 20.4% of patients who had received CRT or ICD therapy had died as compared with 27.8% of comparable patients who hadn’t received the devices, a 34% reduction in relative risk, the researchers said (J. Amer. Coll. Cardiol. 2014 Aug. 18 [doi:10.1016/j.jacc.2014.05.060]).

The findings "refute any meaningful differences in clinical effectiveness as a function of race/ethnicity for either ICD or CRT-D (implantable cardioverter defibrillator with bradycardia pacing capabilities) therapy ... [and] reinforce current class 1 recommendations from the American College of Cardiology/American Heart Association HF guidelines that selected HF patients without racial/ethnic differentiation should, in the absence of specific evidence to treat otherwise, have clinical screening and therapy in a manner identical to that provided to the broader HF population," the researchers concluded.

The study was supported by Medtronic. Dr. Ziaeian and his associates reported ties to numerous industry sources.

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Although this study by Ziaeian et al. was one of the largest trials to date to address the issue of ICD/CRT therapies with regard to race/ethnicity, the number of racial/ethnic minorities was still relatively small. The study was only modestly powered to detect interactions indicating that treatment benefits may vary according to the patient’s background.

Importantly, the ICD/CRT-D cohort only had 75% power to detect a device-race interaction, the ICD-only cohort only had 41% power to detect a device-race interaction, and the cardiac resynchronization pacemaker/CRT-D cohort only had 15% power to detect a device-race interaction. Nevertheless, the focus should now be on improving care delivery models to eliminate performance gaps and ensure equal care for all Americans.

Dr. Sean P. Pinney is at the Zena and Michael A. Weiner Cardiovascular Institute, Mount Sinai Hospital, New York. He reported receiving consulting fees and honoraria from CareDx and Thoratec. His remarks were taken from an editorial accompanying Dr. Ziaeian’s report (J. Amer. Coll. Cardiol. 2014 [doi:10.1016/j.jacc.2014.07.008]).

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Although this study by Ziaeian et al. was one of the largest trials to date to address the issue of ICD/CRT therapies with regard to race/ethnicity, the number of racial/ethnic minorities was still relatively small. The study was only modestly powered to detect interactions indicating that treatment benefits may vary according to the patient’s background.

Importantly, the ICD/CRT-D cohort only had 75% power to detect a device-race interaction, the ICD-only cohort only had 41% power to detect a device-race interaction, and the cardiac resynchronization pacemaker/CRT-D cohort only had 15% power to detect a device-race interaction. Nevertheless, the focus should now be on improving care delivery models to eliminate performance gaps and ensure equal care for all Americans.

Dr. Sean P. Pinney is at the Zena and Michael A. Weiner Cardiovascular Institute, Mount Sinai Hospital, New York. He reported receiving consulting fees and honoraria from CareDx and Thoratec. His remarks were taken from an editorial accompanying Dr. Ziaeian’s report (J. Amer. Coll. Cardiol. 2014 [doi:10.1016/j.jacc.2014.07.008]).

Body

Although this study by Ziaeian et al. was one of the largest trials to date to address the issue of ICD/CRT therapies with regard to race/ethnicity, the number of racial/ethnic minorities was still relatively small. The study was only modestly powered to detect interactions indicating that treatment benefits may vary according to the patient’s background.

Importantly, the ICD/CRT-D cohort only had 75% power to detect a device-race interaction, the ICD-only cohort only had 41% power to detect a device-race interaction, and the cardiac resynchronization pacemaker/CRT-D cohort only had 15% power to detect a device-race interaction. Nevertheless, the focus should now be on improving care delivery models to eliminate performance gaps and ensure equal care for all Americans.

Dr. Sean P. Pinney is at the Zena and Michael A. Weiner Cardiovascular Institute, Mount Sinai Hospital, New York. He reported receiving consulting fees and honoraria from CareDx and Thoratec. His remarks were taken from an editorial accompanying Dr. Ziaeian’s report (J. Amer. Coll. Cardiol. 2014 [doi:10.1016/j.jacc.2014.07.008]).

Title
Study was "modestly" powered
Study was "modestly" powered

Both cardiac resynchronization therapy and implantable cardioverter-defibrillators reduce 2-year mortality in patients with heart failure, regardless of their racial or ethnic backgrounds, according to a report published online Aug. 18 in the Journal of the American College of Cardiology.

Guidelines contain class 1 recommendations for device therapies in the primary prevention of sudden cardiac death among patients with heart failure; cardiac resynchronization therapy (CRT) also has a class 1 recommendation for reducing the risk for events. Because of racial and ethnic disparities in the use of both therapies, as well as an underrepresentation of minorities in clinical trials of these treatments, questions have been raised as to whether black and Hispanic patients gain benefits comparable to those seen in white patients, said Dr. Boback Ziaeian of the division of cardiology at the University of California, Los Angeles, and his associates.

Dr. Ziaeian and his fellow researchers studied this issue using data from the IMPROVE HF registry (Registry to Improve the Use of Evidence-Based HF Therapies in the Outpatient Setting), a prospective observational cohort of 15,177 patients with left ventricular dysfunction and heart failure treated at 167 community and academic cardiology and multispecialty practices. Of 7,748 study participants who were eligible for ICDs/cardiac resynchronization defibrillators, 44% were non-Hispanic whites, 9% were non-Hispanic blacks, and 47% were of other racial/ethnic groups or had no race documented in their records. Of 1,188 who were eligible for cardiac resynchronization pacemakers, 50% were non-Hispanic whites, 8% were non-Hispanic blacks, and 42% were other ethnicities or had no race documented in their records.

At 2-year follow-up, 20.4% of patients who had received CRT or ICD therapy had died as compared with 27.8% of comparable patients who hadn’t received the devices, a 34% reduction in relative risk, the researchers said (J. Amer. Coll. Cardiol. 2014 Aug. 18 [doi:10.1016/j.jacc.2014.05.060]).

The findings "refute any meaningful differences in clinical effectiveness as a function of race/ethnicity for either ICD or CRT-D (implantable cardioverter defibrillator with bradycardia pacing capabilities) therapy ... [and] reinforce current class 1 recommendations from the American College of Cardiology/American Heart Association HF guidelines that selected HF patients without racial/ethnic differentiation should, in the absence of specific evidence to treat otherwise, have clinical screening and therapy in a manner identical to that provided to the broader HF population," the researchers concluded.

The study was supported by Medtronic. Dr. Ziaeian and his associates reported ties to numerous industry sources.

Both cardiac resynchronization therapy and implantable cardioverter-defibrillators reduce 2-year mortality in patients with heart failure, regardless of their racial or ethnic backgrounds, according to a report published online Aug. 18 in the Journal of the American College of Cardiology.

Guidelines contain class 1 recommendations for device therapies in the primary prevention of sudden cardiac death among patients with heart failure; cardiac resynchronization therapy (CRT) also has a class 1 recommendation for reducing the risk for events. Because of racial and ethnic disparities in the use of both therapies, as well as an underrepresentation of minorities in clinical trials of these treatments, questions have been raised as to whether black and Hispanic patients gain benefits comparable to those seen in white patients, said Dr. Boback Ziaeian of the division of cardiology at the University of California, Los Angeles, and his associates.

Dr. Ziaeian and his fellow researchers studied this issue using data from the IMPROVE HF registry (Registry to Improve the Use of Evidence-Based HF Therapies in the Outpatient Setting), a prospective observational cohort of 15,177 patients with left ventricular dysfunction and heart failure treated at 167 community and academic cardiology and multispecialty practices. Of 7,748 study participants who were eligible for ICDs/cardiac resynchronization defibrillators, 44% were non-Hispanic whites, 9% were non-Hispanic blacks, and 47% were of other racial/ethnic groups or had no race documented in their records. Of 1,188 who were eligible for cardiac resynchronization pacemakers, 50% were non-Hispanic whites, 8% were non-Hispanic blacks, and 42% were other ethnicities or had no race documented in their records.

At 2-year follow-up, 20.4% of patients who had received CRT or ICD therapy had died as compared with 27.8% of comparable patients who hadn’t received the devices, a 34% reduction in relative risk, the researchers said (J. Amer. Coll. Cardiol. 2014 Aug. 18 [doi:10.1016/j.jacc.2014.05.060]).

The findings "refute any meaningful differences in clinical effectiveness as a function of race/ethnicity for either ICD or CRT-D (implantable cardioverter defibrillator with bradycardia pacing capabilities) therapy ... [and] reinforce current class 1 recommendations from the American College of Cardiology/American Heart Association HF guidelines that selected HF patients without racial/ethnic differentiation should, in the absence of specific evidence to treat otherwise, have clinical screening and therapy in a manner identical to that provided to the broader HF population," the researchers concluded.

The study was supported by Medtronic. Dr. Ziaeian and his associates reported ties to numerous industry sources.

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Cardiac resynchronization, ICDs benefit all ethnicities with heart failure
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Cardiac resynchronization, ICDs benefit all ethnicities with heart failure
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cardiac resynchronization therapy, implantable cardioverter-defibrillators, heart failure, racial, ethnic, Journal of the American College of Cardiology, CRT, Dr. Boback Ziaeian, University of California, Los Angeles,
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cardiac resynchronization therapy, implantable cardioverter-defibrillators, heart failure, racial, ethnic, Journal of the American College of Cardiology, CRT, Dr. Boback Ziaeian, University of California, Los Angeles,
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FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

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Key clinical point: Ethnicity should not influence which heart failure patients are candidates for device therapy.

Major finding: At 2-year follow-up, the mortality rate was 20.4% for patients who had received CRT or ICD therapy as recommended and 27.8% for those who hadn’t received the devices as recommended – a 34% difference in relative risk irrespective of ethnicity.

Data source: An analysis of the medical records of 8,936 heart failure patients who were eligible for either CRT or ICD therapy and were followed for 2 years.

Disclosures: This study was supported by Medtronic. Dr. Ziaeian and his associates reported ties to numerous industry sources.