Utilization of implantable cardioverter-defibrillators for the prevention of sudden cardiac death in emerging countries: Improve SCA clinical trial

Improve SCA Investigators

Research output: Contribution to journalArticle

Abstract

Background: Implantable cardioverter-defibrillators (ICDs) are underutilized in Asia, Latin America, Eastern Europe, the Middle East, and Africa. The Improve SCA Study is the largest prospective study to evaluate the benefit of ICD therapy in underrepresented geographies. This analysis reports the primary objective of the study. Objectives: The objectives of this study was to determine whether patients with primary prevention (PP) indications with specific risk factors (1.5PP: syncope, nonsustained ventricular tachycardia, premature ventricular contractions >10/h, and low ventricular ejection fraction <25%) are at a similar risk of life-threatening arrhythmias as patients with secondary prevention (SP) indications and to evaluate all-cause mortality rates in 1.5PP patients with and without devices. Methods: A total of 3889 patients were included in the analysis to evaluate ventricular tachycardia or fibrillation therapy and mortality rates. Patients were stratified as SP (n = 1193) and patients with PP indications. The PP cohort was divided into 1.5PP patients (n = 1913) and those without any 1.5PP criteria (n = 783). The decision to undergo ICD implantation was left to the patient and/or physician. The Cox proportional hazards model was used to compute hazard ratios. Results: Patients had predominantly nonischemic cardiomyopathy. The rate of ventricular tachycardia or fibrillation in 1.5PP patients was not equivalent (within 30%) to that in patients with SP indications (hazard ratio 0.47; 95% confidence interval 0.38–0.57) but was higher than that in PP patients without any 1.5PP criteria (hazard ratio 0.67; 95% confidence interval 0.46–0.97) (P = .03). There was a 49% relative risk reduction in all-cause mortality in ICD implanted 1.5PP patients. In addition, the number needed to treat to save 1 life over 3 years was 10.0 in the 1.5PP cohort vs 40.0 in PP patients without any 1.5PP criteria. Conclusion: These data corroborate the mortality benefit of ICD therapy and support extension to a selected PP population from underrepresented geographies.

Original languageEnglish (US)
JournalHeart Rhythm
DOIs
StateAccepted/In press - Jan 1 2019

Fingerprint

Implantable Defibrillators
Sudden Cardiac Death
Clinical Trials
Primary Prevention
Ventricular Tachycardia
Secondary Prevention
Geography
Mortality
Ventricular Fibrillation
Confidence Intervals
Numbers Needed To Treat
Eastern Europe
Eastern Africa
Middle East
Ventricular Premature Complexes
Latin America
Syncope
Risk Reduction Behavior
Cardiomyopathies
Proportional Hazards Models

Keywords

  • Implantable cardioverter-defibrillators
  • Mortality
  • Primary prevention
  • Risk stratification
  • Secondary prevention
  • Sudden cardiac arrest

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

@article{d505023b5684497b8e638fe1307934e4,
title = "Utilization of implantable cardioverter-defibrillators for the prevention of sudden cardiac death in emerging countries: Improve SCA clinical trial",
abstract = "Background: Implantable cardioverter-defibrillators (ICDs) are underutilized in Asia, Latin America, Eastern Europe, the Middle East, and Africa. The Improve SCA Study is the largest prospective study to evaluate the benefit of ICD therapy in underrepresented geographies. This analysis reports the primary objective of the study. Objectives: The objectives of this study was to determine whether patients with primary prevention (PP) indications with specific risk factors (1.5PP: syncope, nonsustained ventricular tachycardia, premature ventricular contractions >10/h, and low ventricular ejection fraction <25{\%}) are at a similar risk of life-threatening arrhythmias as patients with secondary prevention (SP) indications and to evaluate all-cause mortality rates in 1.5PP patients with and without devices. Methods: A total of 3889 patients were included in the analysis to evaluate ventricular tachycardia or fibrillation therapy and mortality rates. Patients were stratified as SP (n = 1193) and patients with PP indications. The PP cohort was divided into 1.5PP patients (n = 1913) and those without any 1.5PP criteria (n = 783). The decision to undergo ICD implantation was left to the patient and/or physician. The Cox proportional hazards model was used to compute hazard ratios. Results: Patients had predominantly nonischemic cardiomyopathy. The rate of ventricular tachycardia or fibrillation in 1.5PP patients was not equivalent (within 30{\%}) to that in patients with SP indications (hazard ratio 0.47; 95{\%} confidence interval 0.38–0.57) but was higher than that in PP patients without any 1.5PP criteria (hazard ratio 0.67; 95{\%} confidence interval 0.46–0.97) (P = .03). There was a 49{\%} relative risk reduction in all-cause mortality in ICD implanted 1.5PP patients. In addition, the number needed to treat to save 1 life over 3 years was 10.0 in the 1.5PP cohort vs 40.0 in PP patients without any 1.5PP criteria. Conclusion: These data corroborate the mortality benefit of ICD therapy and support extension to a selected PP population from underrepresented geographies.",
keywords = "Implantable cardioverter-defibrillators, Mortality, Primary prevention, Risk stratification, Secondary prevention, Sudden cardiac arrest",
author = "{Improve SCA Investigators} and Shu Zhang and Ching, {Chi Keong} and Dejia Huang and Liu, {Yen Bin} and Rodriguez-Guerrero, {Diego A.} and Azlan Hussin and Kim, {Young Hoon} and Chasnoits, {Alexandr Robertovich} and Jeffrey Cerkvenik and Lexcen, {Daniel R.} and Katy Muckala and Brown, {Mark L.} and Alan Cheng and Balbir Singh",
year = "2019",
month = "1",
day = "1",
doi = "10.1016/j.hrthm.2019.09.023",
language = "English (US)",
journal = "Heart Rhythm",
issn = "1547-5271",
publisher = "Elsevier",

}

TY - JOUR

T1 - Utilization of implantable cardioverter-defibrillators for the prevention of sudden cardiac death in emerging countries

T2 - Improve SCA clinical trial

AU - Improve SCA Investigators

AU - Zhang, Shu

AU - Ching, Chi Keong

AU - Huang, Dejia

AU - Liu, Yen Bin

AU - Rodriguez-Guerrero, Diego A.

AU - Hussin, Azlan

AU - Kim, Young Hoon

AU - Chasnoits, Alexandr Robertovich

AU - Cerkvenik, Jeffrey

AU - Lexcen, Daniel R.

AU - Muckala, Katy

AU - Brown, Mark L.

AU - Cheng, Alan

AU - Singh, Balbir

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background: Implantable cardioverter-defibrillators (ICDs) are underutilized in Asia, Latin America, Eastern Europe, the Middle East, and Africa. The Improve SCA Study is the largest prospective study to evaluate the benefit of ICD therapy in underrepresented geographies. This analysis reports the primary objective of the study. Objectives: The objectives of this study was to determine whether patients with primary prevention (PP) indications with specific risk factors (1.5PP: syncope, nonsustained ventricular tachycardia, premature ventricular contractions >10/h, and low ventricular ejection fraction <25%) are at a similar risk of life-threatening arrhythmias as patients with secondary prevention (SP) indications and to evaluate all-cause mortality rates in 1.5PP patients with and without devices. Methods: A total of 3889 patients were included in the analysis to evaluate ventricular tachycardia or fibrillation therapy and mortality rates. Patients were stratified as SP (n = 1193) and patients with PP indications. The PP cohort was divided into 1.5PP patients (n = 1913) and those without any 1.5PP criteria (n = 783). The decision to undergo ICD implantation was left to the patient and/or physician. The Cox proportional hazards model was used to compute hazard ratios. Results: Patients had predominantly nonischemic cardiomyopathy. The rate of ventricular tachycardia or fibrillation in 1.5PP patients was not equivalent (within 30%) to that in patients with SP indications (hazard ratio 0.47; 95% confidence interval 0.38–0.57) but was higher than that in PP patients without any 1.5PP criteria (hazard ratio 0.67; 95% confidence interval 0.46–0.97) (P = .03). There was a 49% relative risk reduction in all-cause mortality in ICD implanted 1.5PP patients. In addition, the number needed to treat to save 1 life over 3 years was 10.0 in the 1.5PP cohort vs 40.0 in PP patients without any 1.5PP criteria. Conclusion: These data corroborate the mortality benefit of ICD therapy and support extension to a selected PP population from underrepresented geographies.

AB - Background: Implantable cardioverter-defibrillators (ICDs) are underutilized in Asia, Latin America, Eastern Europe, the Middle East, and Africa. The Improve SCA Study is the largest prospective study to evaluate the benefit of ICD therapy in underrepresented geographies. This analysis reports the primary objective of the study. Objectives: The objectives of this study was to determine whether patients with primary prevention (PP) indications with specific risk factors (1.5PP: syncope, nonsustained ventricular tachycardia, premature ventricular contractions >10/h, and low ventricular ejection fraction <25%) are at a similar risk of life-threatening arrhythmias as patients with secondary prevention (SP) indications and to evaluate all-cause mortality rates in 1.5PP patients with and without devices. Methods: A total of 3889 patients were included in the analysis to evaluate ventricular tachycardia or fibrillation therapy and mortality rates. Patients were stratified as SP (n = 1193) and patients with PP indications. The PP cohort was divided into 1.5PP patients (n = 1913) and those without any 1.5PP criteria (n = 783). The decision to undergo ICD implantation was left to the patient and/or physician. The Cox proportional hazards model was used to compute hazard ratios. Results: Patients had predominantly nonischemic cardiomyopathy. The rate of ventricular tachycardia or fibrillation in 1.5PP patients was not equivalent (within 30%) to that in patients with SP indications (hazard ratio 0.47; 95% confidence interval 0.38–0.57) but was higher than that in PP patients without any 1.5PP criteria (hazard ratio 0.67; 95% confidence interval 0.46–0.97) (P = .03). There was a 49% relative risk reduction in all-cause mortality in ICD implanted 1.5PP patients. In addition, the number needed to treat to save 1 life over 3 years was 10.0 in the 1.5PP cohort vs 40.0 in PP patients without any 1.5PP criteria. Conclusion: These data corroborate the mortality benefit of ICD therapy and support extension to a selected PP population from underrepresented geographies.

KW - Implantable cardioverter-defibrillators

KW - Mortality

KW - Primary prevention

KW - Risk stratification

KW - Secondary prevention

KW - Sudden cardiac arrest

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U2 - 10.1016/j.hrthm.2019.09.023

DO - 10.1016/j.hrthm.2019.09.023

M3 - Article

C2 - 31561030

AN - SCOPUS:85076551811

JO - Heart Rhythm

JF - Heart Rhythm

SN - 1547-5271

ER -