Survival Probability and Survival Benefit Associated With Primary Prevention Implantable Cardioverter-Defibrillator Generator Changes.

ABSTRACT

Background As patients derive variable benefit from generator changes (GCs) of implantable cardioverter-defibrillators (ICDs) with an original primary prevention (PP) indication, better predictors of outcomes are needed. Methods and Results In the National Cardiovascular Data Registry ICD Registry, patients undergoing GCs of initial non-cardiac resynchronization therapy PP ICDs in 2012 to 2016, predictors of post-GC survival and survival benefit versus control heart failure patients without ICDs were assessed. These included predicted annual mortality based on the Seattle Heart Failure Model, left ventricular ejection fraction (LVEF) >35%, and the probability that a patient's death would be arrhythmic (proportional risk of arrhythmic death [PRAD]). In 40 933 patients undergoing GCs of initial noncardiac resynchronization therapy PP ICDs (age 67.7±12.0 years, 24.5% women, 34.1% with LVEF >35%), Seattle Heart Failure Model-predicted annual mortality had the greatest effect size for decreased post-GC survival (P<0.0001). Patients undergoing GCs of initial noncardiac resynchronization therapy PP ICDs with LVEF >35% had a lower Seattle Heart Failure Model-adjusted survival versus 23 472 control heart failure patients without ICDs (model interaction hazard ratio, 1.21 [95% CI, 1.11-1.31]). In patients undergoing GCs of initial noncardiac resynchonization therapy PP ICDs with LVEF ≤35%, the model indicated worse survival versus controls in the 21% of patients with a PRAD <43% and improved survival in the 10% with PRAD >65%. The association of the PRAD with survival benefit or harm was similar in patients with or without pre-GC ICD therapies. Conclusions Patients who received replacement of an ICD originally implanted for primary prevention and had at the time of GC either LVEF >35% alone or both LVEF ≤35% and PRAD <43% had worse survival versus controls without ICDs.