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.
Abstract:
Previous analyses have shown that there is lower mortality with cardiac resynchronization therapy defibrillators (CRT-D) in patients with left bundle branch block (LBBB) but demonstrated mixed results in patients without LBBB. We evaluated the comparative effectiveness of CRT-D versus standard implantable defibrillators (ICDs) separately in patients with LBBB and right bundle branch block (RBBB) using Medicare claims data. Medicare records from CRT-D and ICD recipients from 2002 to 2009 that were followed up for up to 48 months were analyzed. We used propensity scores to match patients with ICD to those with CRT-D. In LBBB, 1:1 matching with replacement resulted in 54,218 patients with CRT-D and 20,763 with ICD, and in RBBB, 1:1 matching resulted in 7,298 patients with CRT-D and 7,298 with ICD. In LBBB, CRT-D had a 12% lower risk of heart failure hospitalization or death (hazard ratio [HR] 0.88, 95% confidence interval 0.86 to 0.90) and 5% lower death risk (HR 0.95, 0.92 to 0.97) compared with ICD. In RBBB, CRT-D had a 15% higher risk of heart failure hospitalization or death (HR 1.15, 1.10 to 1.20) and 13% higher death risk (HR 1.13, 1.07 to 1.18). Sensitivity analysis revealed that accounting for covariates not captured in the Medicare database may lead to increased benefit with CRT-D in LBBB and no difference in RBBB. In conclusion, in a large Medicare population, CRT-D was associated with lower mortality in LBBB but higher mortality in RBBB. The absence of certain covariates, in particular those that determine treatment selection, may affect the results of comparative effectiveness studies using claims data.
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