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Benefits of Cardiac Resynchronization Therapy in an Asynchronous Heart Failure Model Induced by Left Bundle Branch Ablation and Rapid Pacing
Published on: December 11, 2017
Implantable cardioverter defibrillators and cardiac resynchronization therapy in patients with left ventricular
Sana M Al-Khatib1, Gillian D Sanders, Daniel B Mark
1The Duke Clinical Research Institute, Durham, NC 27715, USA. alkha001@mc.duke.edu
Insights
Implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy (CRT) effectiveness in specific patient groups requires further study. Experts convened to review evidence on ICD for sudden cardiac death prevention and CRT for heart failure survival.
Area of Science:
- Cardiovascular Medicine
- Health Policy
- Biostatistics
Background:
- Implantable cardioverter defibrillator (ICD) therapy improves survival in patients with left ventricular dysfunction.
- Cardiac resynchronization therapy (CRT) shows benefits in hemodynamics and quality of life for heart failure patients.
- Uncertainty remains regarding the impact of ICD therapy on specific subgroups and CRT's effect on survival and quality of life.
Purpose of the Study:
- To review and discuss clinical trial evidence on ICD therapy for primary prevention of sudden cardiac death.
- To evaluate the effect of CRT on survival and quality of life in patients with congestive heart failure.
- To address uncertainties surrounding the effectiveness of ICD and CRT in defined patient populations.
Main Methods:
- Convened an ad hoc group of experts in cardiovascular medicine, biostatistics, economics, and health policy.
- Included representatives from regulatory and funding agencies (FDA, CMS, AHRQ) and the device industry.
- Reviewed available clinical trial evidence and expert discussions on ICD and CRT therapies.
Main Results:
- Evidence on ICD therapy's effectiveness in specific patient subgroups requires further clarification.
- The impact of CRT on patient survival and the extent of quality of life improvements remain areas of ongoing investigation.
- The meeting summarized existing evidence and expert discussions, highlighting areas needing further research.
Conclusions:
- Further research is needed to fully understand the effectiveness of ICD therapy in diverse patient subgroups.
- The long-term survival benefits and quality of life impact of CRT require continued evaluation.
- The review highlighted critical knowledge gaps in the application of advanced cardiac therapies.
Abstract:
Although many studies have shown that implantable cardioverter defibrillator (ICD) therapy improves the survival of patients with significant left ventricular dysfunction, the magnitude of effectiveness of ICD therapy in clinically defined subgroups remains uncertain. Similarly, although studies have shown an improvement in patients' hemodynamics and quality of life with cardiac resynchronization therapy (CRT), there is a continuing uncertainty about the effect of CRT on patients' survival and the magnitude of improvement in quality of life with this therapy. On August 24, 2004, an ad hoc group of experts representing clinical cardiovascular medicine, biostatistics, economics, and health policy were joined by representatives of the Food and Drug Administration, Centers for Medicare and Medicaid Services (Baltimore, Md), Agency for Healthcare Research and Quality (Rockville, Md), and the device industry for a 1-day round table to review the available clinical trial evidence on the effect of ICD therapy in the primary prevention of sudden cardiac death and the effect of CRT in patients with congestive heart failure. The meeting was organized by the Duke Clinical Research Institute, Durham, NC, and funded in part by the Agency for Healthcare Research and Quality. This document summarizes the evidence reviewed at that meeting and the discussions of that evidence.
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