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Temporal Trends in Patient Characteristics and Outcomes Among Medicare Beneficiaries Undergoing Primary Prevention Implantable Cardioverter-Defibrillator Placement in the United States, 2006-2010: Results From the NCDR® ICD Registry
Study Questions:
What are the temporal trends in patient characteristics and outcomes among older patients undergoing primary prevention implantable cardioverter-defibrillator (ICD) therapy in US hospitals between 2006 and 2010?
Methods:
Using the NCDR® ICD Registry, the authors included Medicare fee-for-service beneficiaries ages ≥65 years with left ventricular ejection fraction <35% who underwent primary prevention ICD implantation, including those receiving concomitant cardiac resynchronization therapy (CRT-D), between 2006 and 2010, and those who could be matched to Medicare claims. Outcomes were mortality and hospitalization (all-cause and heart failure) at 180 days, and device-related complications. Multivariable hierarchical logistic regression was employed to assess temporal trends in outcomes accounting for changes in patient, physician, and hospital characteristics.
Results:
The cohort included 117,100 patients. Between 2006 and 2010, only modest changes in patient characteristics were noted. Fewer single-lead devices and more CRT devices were used over time. Between 2006 and 2010, there were significant declines in all outcomes, including 6-month all-cause mortality (7.1% in 2006, 6.5% in 2010; adjusted odds ratio [OR], 0.88; 95% confidence interval [CI], 0.82-0.95), 6-month re-hospitalization (36.3% in 2006, 33.7% in 2010; OR, 0.87; 95% CI, 0.83-0.91), and device-related complications (5.8% in 2006, 4.8% in 2010; OR, 0.80; 95% CI, 0.74-0.88).
Conclusions:
The clinical characteristics of Medicare patients undergoing primary prevention ICD implantation were stable between 2006 and 2010. Simultaneous improvements in outcomes suggest meaningful advances in the care for this patient population.
Perspective:
The current report is a testament to the success of the NCDR® ICD Registry, and to the improvements in various aspects of heart failure and ICD care delivery. Importantly, the real-life outcomes appear to reflect those of the carefully selected patients in the primary prevention trials. Improvements in coordination of care and guideline-directed medical therapy, device technology and programming, higher volumes of implants done by electrophysiologists (EPs) (as opposed to non-EP physicians), and remote monitoring, all may have contributed to the reduction in 6-month mortality, re-hospitalization, and device-related complications. This is a remarkable accomplishment and occasion for celebration!
Keywords: Odds Ratio, Registries, Heart Failure, Stroke Volume, Confidence Intervals, Medicare, Hospitalization, Death, Sudden, Cardiac, Defibrillators, Implantable, Logistic Models, Primary Prevention, Cardiac Resynchronization Therapy
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