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.
CITATION STYLE
Bilchick, K. C., Wang, Y., Curtis, J. P., Shadman, R., Dardas, T. F., Anand, I., … Levy, W. C. (2022). Survival Probability and Survival Benefit Associated With Primary Prevention Implantable Cardioverter-Defibrillator Generator Changes. Journal of the American Heart Association, 11(13). https://doi.org/10.1161/JAHA.121.023743
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