Abstract 11592: Real-World Performance of Heartlogic Index in Subjects With CRT and ICD Devices

Abstract

Introduction: The HeartLogic heart failure (HF) diagnostic was developed from data in subjects implanted with CRT-D devices. Diagnostic performance in subjects with ICDs (without CRT) is less well characterized. Objective: Compare HeartLogic performance in ICD and CRT subgroups. Methods: Data from US post-market HeartLogic CRT/ICD devices were directly linked with Medicare claims and subjects with continuous Medicare Part A&B fee-for-service coverage were analyzed. Claims HF events (HFE) were defined using primary HF diagnosis codes (DRG 291-3, I50.xx) and included acute inpatient events, and outpatient events with IV diuretic therapy. Baseline characteristics included patient demographics, implant data, and claims chronic conditions flags (CCFs). Diagnostic performance was defined as the sensitivity to detect HFEs and the false-positive alert rate (FPR), from which a modified receiver operator characteristic (ROC) curve was generated. Continuous variables were expressed as mean±SD and categorical variables as proportions. Two-sided 95% confidence intervals (CI) were calculated for sensitivity (binomial distribution) and FPR (negative binomial model). Results: Out of 4190 subjects,1567 linked subjects were included in the analysis with an average follow-up of 1.4±0.5 years. The CRT group (N=1078, 69%) was more likely to be Caucasian (88% vs 82%), less likely to have de novo devices (62% vs 80%), more likely to have CCFs of AF (43% vs 33%) and congestive HF (89% vs 75%), and a HF hospitalization in the year prior to implant (23% vs 16%). CRT and ICD groups provided 296 and 139 HFEs for performance evaluation. HeartLogic ROCs were similar in both groups with no difference in the nominal sensitivity (83% [CI: 78, 87] vs 80% [72, 86%], p =0.41) or FPR (1.386 [CI: 1.337,1.511] vs 1.322 [1.238,1.488], p =0.41). Conclusions: HeartLogic diagnostic performance determined using real-world claims data was not different in subjects implanted with ICDs and CRT-Ds.