Periprocedural Risk and Survival after ICD Placement in Patients with Advanced Heart Failure

Abstract

Background Implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy-defibrillator (CRT-D) are not provided to all patients with heart failure (HF) who qualify clinically for these treatments. Little is known about utilization and outcomes of ICD/CRT-D in patients with advanced HF. Methods A post-hoc analysis was performed of Medicare fee-for-service beneficiaries enrolled in the National Cardiovascular Data Registry's (NCDR®) ICD Registry™ with a diagnosis of HF, an EF ≤35% and evidence of advanced HF defined as NYHA class IV symptoms, inotrope use within the past 60 days, left ventricular assist device (LVAD) in situ , or currently listed for orthotopic heart transplant (OHT). All eligible patients underwent initial ICD/CRT-D placement for primary prevention of sudden cardiac death before January 2015. Cox hazards model was used to test for association with baseline covariates. Results Among 81,492 Medicare patients with EF ≤35% that underwent primary prevention ICD/CDRT-D placement, there were 3,343 advanced-HF patients (4.1%). Amongst advanced HF patients 2,506 (75%) had NYHA class IV symptoms, 676 (20.2%) were currently or recently on inotropes, 129 (3.9%) had an LVAD, and 158 (4.7%) were listed for OHT. Patients had a mean age of 74±9 years and 28.3% were female (N=946). The majority received a CRT-D device (N=2,424, 72.6%). The aggregate in-hospital periprocedural complication rate was 3.74% (95% CI 3.12-4.44) with the majority of adverse events being in-hospital fatalities (1.82%, 95% CI 1.40-2.34) or resuscitated cardiac arrests (1.05%, 95% CI 0.73-1.45). All-cause survival rates are shown in the Figure . Median survival following device implantation was 1,178 days (95% CI 1,013-1,364). After adjusting for potential confounders, females had a lower rate of all-cause death (HR 0.81, 95% CI 0.71-0.93, p Conclusion A small proportion of older patients with advanced HF undergo initial ICD/CRT-D placement for primary prevention. These patients experience clinically important periprocedural complication rates driven by in-hospital deaths and aborted sudden cardiac arrest. Additional prospective research is necessary to clarify the role of primary prevention ICDs in patients with advanced HF.