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

Published on Mar 1, 2020in Heart Rhythm5.731
· DOI :10.1016/J.HRTHM.2019.09.023
Shu Zhang28
Estimated H-index: 28
(Peking Union Medical College),
Chi Keong Ching14
Estimated H-index: 14
+ 12 AuthorsImprove Sca Investigators1
Estimated H-index: 1
Sources
Abstract
Abstract Background Implantable cardioverter defibrillators (ICDs) are underutilized in Asia, Latin America, Eastern Europe, Middle East, and Africa. Improve SCA is the largest prospective study to evaluate the benefit of ICD therapy in under-represented geographies. This analysis reports the primary objective of the study. Objectives To determine whether primary prevention (PP) patients with specific risk factors (1.5PP: syncope, NSVT, PVCs>10/h, LVEF Methods A total of 3,889 patients were included in the analysis to evaluate VT/VF therapy and mortality rates. Patients were stratified as SP (N=1193) and PP. 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 patient/physician. The Cox proportional hazards model was used to compute hazard ratios. Results Patients had predominantly non-ischemic cardiomyopathy. The rate of VT/VF in 1.5PP patients was not equivalent (within 30%) to SP patients (HR 0.47, 95% [CI] 0.38-0.57) but was higher than PP patients without any 1.5PP criteria [HR 0.67, 95% [CI] 0.46-0.97, P=0.03]. There was a 49% relative-risk reduction in all-cause mortality among ICD-implanted 1.5PP patients. Additionally, the NNT to save one life over 3 years was 10.0 in the 1.5PP cohort vs. 40.0 in PP patients without any 1.5PP criteria. Conclusions These data corroborate the mortality benefit of ICD therapy, and support extension to a selected PP population from under-represented geographies.
References24
Newest
#1Balbir Singh (Medanta)H-Index: 7
#2Shu ZhangH-Index: 28
Last. Katy A. MuckalaH-Index: 2
view all 12 authors...
BACKGROUND: Despite available evidence that implantable cardioverter defibrillators (ICDs) reduce all-cause mortality among patients at risk for sudden cardiac death, utilization of ICDs is low especially in developing countries. OBJECTIVE: To summarize reasons for ICD or cardiac resynchronization therapy defibrillator implant refusal by patients at risk for sudden cardiac arrest (Improve SCA) in developing countries. METHODS: Primary prevention (PP) and secondary prevention (SP) patients from c...
5 CitationsSource
#1Yvonne May Fen Chia (NUS: National University of Singapore)H-Index: 3
#2Tiew-Hwa Katherine Teng (UWA: University of Western Australia)H-Index: 21
Last. Carolyn S.P. Lam (NUS: National University of Singapore)H-Index: 78
view all 22 authors...
Background— Implantable cardioverter defibrillators (ICDs) are lifesaving devices for patients with heart failure (HF) and reduced ejection fraction. However, utilization and determinants of ICD insertion in Asia are poorly defined. We determined the utilization, associations of ICD uptake, patient-perceived barriers to device therapy and, impact of ICDs on mortality in Asian patients with HF. Methods and Results— Using the prospective ASIAN-HF (Asian Sudden Cardiac Death in Heart Failure) regis...
15 CitationsSource
#1Valentina Kutyifa (URMC: University of Rochester Medical Center)H-Index: 27
#2Christopher A. Beck (URMC: University of Rochester Medical Center)H-Index: 26
Last. Arthur J. Moss (URMC: University of Rochester Medical Center)H-Index: 129
view all 20 authors...
Patients with diabetes mellitus, prior myocardial infarction, older age, and a relatively preserved left ventricular ejection fraction remain at risk for sudden cardiac death that is potentially amenable by the subcutaneous implantable cardioverter defibrillator with a good risk-benefit profile. The launched MADIT S-ICD study is designed to test the hypothesis that post–myocardial infarction diabetes patients with relatively preserved ejection fraction of 36%-50% will have a survival benefit fro...
27 CitationsSource
#1Ryan T. Borne (Anschutz Medical Campus)H-Index: 10
#2David F. Katz (University of Colorado Hospital)H-Index: 69
Last. Frederick A. Masoudi (Anschutz Medical Campus)H-Index: 107
view all 5 authors...
First used in humans in 1980, the implantable cardioverter defibrillator (ICD) was designed to recognize and treat malignant ventricular arrhythmias and thus prevent arrhythmic death.[1][1] Among patients with an aborted episode of sudden cardiac arrest (SCA) due to ventricular arrhythmias without a
14 CitationsSource
#3Jens Nielsen (UCPH: University of Copenhagen)H-Index: 218
BackgroundThe benefit of an implantable cardioverter–defibrillator (ICD) in patients with symptomatic systolic heart failure caused by coronary artery disease has been well documented. However, the evidence for a benefit of prophylactic ICDs in patients with systolic heart failure that is not due to coronary artery disease has been based primarily on subgroup analyses. The management of heart failure has improved since the landmark ICD trials, and many patients now receive cardiac resynchronizat...
859 CitationsSource
#1Nileshkumar J. Patel (UM: University of Miami)H-Index: 21
#2Sushruth EdlaH-Index: 6
Last. Marcin Kowalski (Staten Island University Hospital)H-Index: 21
view all 21 authors...
Prior studies have highlighted disparities in cardiac lifesaving procedure utilization, particularly among women and in minorities. Although there has been a significant increase in implantable cardioverter-defibrillator (ICD) insertion, socioeconomic disparities still exist in the trend of ICD utilization. With the use of the Nationwide Inpatient Sample from 2003 through 2011, we identified subjects with ICD insertion (procedure code 37.94) and cardiac resynchronization defibrillator (procedure...
29 CitationsSource
#1Shu Zhang (Peking Union Medical College)H-Index: 28
#2Balbir Singh (Medanta)H-Index: 7
Last. Young Hoon Kim (Korea University Medical Center)H-Index: 24
view all 11 authors...
Aims This study aims to demonstrate that primary prevention (PP) patients with one or more additional risk factors are at a similar risk of life-threatening ventricular arrhythmias when compared with secondary prevention (SP) patients, and would receive similar benefit from an implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy-defibrillator (CRT-D) implant. The study evaluates the benefits of therapy for high-risk patients in countries where defibrillation therapy...
14 CitationsSource
#1Jay Chen (UW: University of Washington)H-Index: 2
#2George JohnsonH-Index: 31
Last. Jeanne E. Poole (UW: University of Washington)H-Index: 50
view all 8 authors...
Objectives The aim of this study was to examine rapid-rate nonsustained ventricular tachycardia (RR-NSVT) during routine implantable cardioverter-defibrillator (ICD) evaluation in patients with heart failure and its relationship to outcomes. Background The clinical implications of RR-NSVT identified during routine ICD interrogation are unclear. In this study, the occurrence of RR-NSVT and its association with ICD shocks and mortality in SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial) were...
46 CitationsSource
#1Atul Verma (Southlake Regional Health Center)H-Index: 67
#2Bradley Sarak (Southlake Regional Health Center)H-Index: 4
Last. Yaariv Khaykin (Southlake Regional Health Center)H-Index: 26
view all 8 authors...
Background: We sought to assess predictors of appropriate implantable cardioverter defibrillator (ICD) therapy in patients receiving primary prevention ICDs. Methods: Four hundred twenty-one consecutive patients (ischemic and nonischemic) undergoing primary prevention ICD implantation were studied. Patients were grouped based on the presence/absence of appropriate ICD therapy. Summary data and stored electrograms from ICDs were reviewed to determine appropriateness of therapy. Predictors of ther...
41 CitationsSource
#1Marcos Roberto de Sousa (UFMG: Universidade Federal de Minas Gerais)H-Index: 17
#2Carlos A. Morillo (Population Health Research Institute)H-Index: 72
Last. Antonio Luiz Pinho Ribeiro (UFMG: Universidade Federal de Minas Gerais)H-Index: 69
view all 5 authors...
Background: Identifying patients at risk of sudden cardiac death (SCD) remains a challenge. Aim: To evaluate the performance of non-sustained ventricular tachycardia (NSVT) from 24 hour ambulatory electrocardiography as a predictor of SCD in patients with heart failure or non-ischaemic dilated cardiomyopathy with left ventricular systolic dysfunction (LVSD). Methods and results: Study search and selection were performed by independent reviewers using a validated strategy. Eleven prognostic studi...
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Cited By7
Newest
#1Chi Keong ChingH-Index: 14
#2Yu‐Cheng Hsieh (NYMU: National Yang-Ming University)
Last. Dorn Bv
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Abstract Background: Implantable cardiac defibrillators (ICDs) therapy for primary prevention (PP) of sudden cardiac arrest (SCA) is well-established but underutilized globally. The Improve SCA study has identified a cohort of patients called 1.5 primary prevention (1.5PP), based on PP patients with the presence of documented risk factors: non-sustained ventricular tachycardia, frequent premature ventricular contractions, left ventricular ejection fraction < 25%, and pre-syncope or syncope. Obje...
1 CitationsSource
#1Liane A. Arcinas (UM: University of Manitoba)H-Index: 4
#2Derek S. Chew (U of C: University of Calgary)H-Index: 4
Last. William F. McIntyre (UM: University of Manitoba)H-Index: 8
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BACKGROUND Implantable Cardioverter Defibrillators (ICDs) are indicated for the primary prevention of sudden cardiac death in patients with reduced left ventricular ejection fraction (LVEF). The ongoing risk/benefit profile of an ICD at generator replacement is unknown. This study aimed to identify predictors of appropriate implantable cardioverter defibrillator (ICD) shocks and therapies after first ICD generator replacement, and its procedure-related complications. METHODS We conducted a multi...
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OBJECTIVE The mortality benefit of implantable cardioverter defibrillators (ICDs) for primary prevention (PP) of sudden cardiac arrest (SCA) has been well-established, but ICD therapy remains globally underutilized. The results of the Improve SCA study showed a 49% relative risk reduction in all-cause mortality among ICD patients with 1.5 primary prevention (1.5PP) characteristics (patients with one or more risk factors, P < 0.0001). We evaluated the cost-effectiveness of ICD compared to no ICD ...
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Background: Results from studies on the effects of obesity on sudden cardiac death (SCD) or ventricular tachycardia/ventricular fibrillation (VT/VF) in patients with an implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D) are inconsistent. Our study aimed to explore the impact of BMI on VT/VF in patients with an ICD/CRT-D. Methods: We retrospectively analyzed the data from the Study of Home Monitoring System Safety and Efficacy in Cardiac Implantable...
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#1Reece HolbrookH-Index: 2
#2Lucas HigueraH-Index: 2
Last. Yen-Bin Liu (NTU: National Taiwan University)H-Index: 16
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Objective Implantable cardiac defibrillators (ICDs) for primary prevention (PP) of sudden cardiac arrest (SCA) are well-established but underutilized globally. The Improve SCA study has identified a cohort of patients called 1.5 primary prevention (1.5PP) based on PP patients with the presence of certain risk factors. We evaluated the cost-effectiveness of ICD therapy compared to no ICD among the PP population and the subset of 1.5PP patients in Taiwan. Methods A Markov model was run over a life...
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#2Shuang ZhaoH-Index: 2
#3Xiaohan FanH-Index: 14
Last. Shu ZhangH-Index: 28
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Objective To investigate whether plasma big endothelin-1 (ET-1) predicts ventricular arrythmias (VAs) and end-stage events in primary prevention implantable cardioverter-defibrillator (ICD) indication patigents. Methods In total, 207 patients fulfilling the inclusion criteria from Fuwai Hospital between January 2013 and December 2015 were retrospectively analyzed. The cohort was divided into three groups according to baseline plasma big ET-1 tertiles: tertile 1 ( 0.7 pmol/L, n = 70). The primary...
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