Comparative Effectiveness of Cardiac Resynchronization Therapy Defibrillators Versus Standard Implantable

Robbert Zusterzeel1, Daniel A Caños1, William E Sanders1

  • 1Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.

Insights

Cardiac resynchronization therapy defibrillators (CRT-D) reduce mortality in patients with left bundle branch block (LBBB). However, CRT-D increases mortality in patients with right bundle branch block (RBBB) compared to standard implantable cardioverter-defibrillators (ICDs).

Area of Science:

  • Cardiology
  • Medical Devices
  • Health Services Research

Background:

  • Cardiac resynchronization therapy defibrillators (CRT-D) show varied effectiveness based on bundle branch block type.
  • Previous studies yielded mixed results for CRT-D in patients without left bundle branch block (LBBB).

Purpose of the Study:

  • To compare the effectiveness of CRT-D versus standard implantable cardioverter-defibrillators (ICDs).
  • To evaluate CRT-D effectiveness separately in patients with LBBB and right bundle branch block (RBBB).

Main Methods:

  • Analysis of Medicare claims data from 2002-2009 for CRT-D and ICD recipients.
  • Propensity score matching used to create comparable patient groups.
  • Follow-up of up to 48 months to assess outcomes.

Main Results:

  • In LBBB patients, CRT-D was associated with a 12% lower risk of heart failure hospitalization or death and a 5% lower death risk compared to ICD.
  • In RBBB patients, CRT-D was associated with a 15% higher risk of heart failure hospitalization or death and a 13% higher death risk compared to ICD.
  • Sensitivity analysis suggested potential unmeasured confounders might influence RBBB outcomes.

Conclusions:

  • CRT-D is associated with reduced mortality in LBBB patients but increased mortality in RBBB patients within the Medicare population.
  • Claims data limitations, particularly uncaptured covariates influencing treatment selection, may impact comparative effectiveness findings.

Related Concept Videos

Cardiomyopathy V: Interprofessional Care01:29

Cardiomyopathy V: Interprofessional Care

Managing cardiomyopathy involves addressing underlying or precipitating causes, treating heart failure with medications, and implementing dietary changes and a balanced exercise and rest regimen.Lifestyle ModificationsCardiomyopathy patients should adopt a low-sodium diet to reduce fluid retention and manage heart failure. A personalized exercise and rest plan helps maintain physical fitness without overstraining the heart. Avoiding alcohol and tobacco is essential to prevent further damage to...
702
Cardiomyopathy II: Dilated Cardiomyopathy01:30

Cardiomyopathy II: Dilated Cardiomyopathy

Dilated cardiomyopathy, or DCM, is a progressive myocardial disorder characterized by ventricular chamber dilation and contractile dysfunction.EtiologyVarious factors can cause DCM, including hypertension and heavy alcohol intake, which contribute to the weakening and enlargement of the heart muscle. Viral infections, such as Coxsackievirus B, adenoviruses, and influenza, can lead to DCM by causing inflammation and damage to heart tissue. Certain chemotherapeutic agents, including daunorubicin,...
801
Heart Failure VI: Adjunct Therapies01:22

Heart Failure VI: Adjunct Therapies

Additional therapies for treating patients with heart failure (HF) may include procedural interventions, supplemental oxygen, the management of sleep disorders, and nutritional therapy.Procedural InterventionsImplantable Cardioverter-Defibrillator: For patients at risk of life-threatening arrhythmias due to severe left ventricular dysfunction, an Implantable Cardioverter-Defibrillator (ICD) can detect and terminate these arrhythmias, preventing sudden cardiac death and improving survival rates.
602
Dysrhythmias VI: Management of Dysrhythmias01:25

Dysrhythmias VI: Management of Dysrhythmias

Dysrhythmia management involves a multifaceted approach, incorporating pharmacological treatments, medical procedures, surgical interventions, lifestyle modifications, and patient education.Pharmacological ManagementAntiarrhythmic Drugs:Class I (Sodium Channel Blockers): This class includes quinidine and procainamide, which reduce the speed of impulse conduction in the heart, stabilize the cardiac membrane, and control arrhythmias. Quinidine and procainamide are Class IA agents that prolong the...
635
Heart Failure V: Medical Management01:30

Heart Failure V: Medical Management

Medical Management of Acute Decompensated Heart Failure (ADHF)The primary goals of therapy for patients hospitalized with acute decompensated heart failure (ADHF) include:Relieving symptomsOptimizing volume statusSupporting oxygenation and ventilationMaintaining cardiac output (CO) and end-organ perfusionIdentifying and addressing the cause of ADHFPreventing complicationsProviding patient education on factors precipitating HF exacerbationPlanning for dischargeOngoing monitoring and assessment...
567
Cardiopulmonary Resuscitation III: AED Use01:23

Cardiopulmonary Resuscitation III: AED Use

Introduction to AEDAn Automated External Defibrillator (AED) is a portable medical device that analyzes the heart's rhythm and, if necessary, delivers an electrical shock to help the heart re-establish an effective rhythm during sudden cardiac arrest (SCA). SCA occurs when the heart suddenly and unexpectedly stops beating, leading to a loss of blood flow to the brain and other vital organs. In such emergencies, time is of the essence, and using an AED, combined with Cardiopulmonary...
1.5K