A multiparametric heart failure score at baseline is associated with long-term outcome in patients with remotely monitored implantable cardioverter-defibrillators: A pooled analysis of 9 clinical trials

Antonio D'Onofrio; Francesco Solimene; Alan Bulava; Morio Shoda; Cedric Klein; Alessio Gargaro; Tobias Timmel; Daniele Giacopelli; Gianluca Botto

doi:10.1016/j.hrthm.2024.10.005

A multiparametric heart failure score at baseline is associated with long-term outcome in patients with remotely monitored implantable cardioverter-defibrillators: A pooled analysis of 9 clinical trials

Heart Rhythm. 2024 Oct 9:S1547-5271(24)03418-0. doi: 10.1016/j.hrthm.2024.10.005. Online ahead of print.

Authors

Antonio D'Onofrio¹, Francesco Solimene², Alan Bulava³, Morio Shoda⁴, Cedric Klein⁵, Alessio Gargaro⁶, Tobias Timmel⁷, Daniele Giacopelli⁶, Gianluca Botto⁸

Affiliations

¹ Unità Operativa di Elettrofisiologia, Studio e Terapia delle Aritmie, Monaldi Hospital, Naples, Italy. Electronic address: donofrioant1@gmail.com.
² Electrophysiology, Montevergine Clinic, Mercogliano, Italy.
³ Ceske Budejovice Hospital, Faculty of Health and Social Sciences, University of South Bohemia in Ceske Budejovice, Ceske Budejovice, Czech Republic.
⁴ Clinical Research Division for Heart Rhythm Management, Department of Cardiology, Tokyo Women's Medical University, Tokyo, Japan.
⁵ University of Lille, CHU Lille, Lille University Hospital Center, Lille, Hauts-de-France, France.
⁶ Clinical Unit, Biotronik Italia S.p.a., Cologno Monzese (MI), Italy.
⁷ Center for Clinical Research, Biotronik SE & Co KG, Berlin, Germany.
⁸ U.O. Electrophysiology, ASST Rhodense, Garbagnate Milanese (MI), Italy.

PMID: 39383980
DOI: 10.1016/j.hrthm.2024.10.005

Abstract

Background: To predict worsening heart failure hospitalizations (WHFHs), the HeartInsight multiparametric algorithm calculates a heart failure (HF) Score based on temporal trends of physiologic parameters obtained through automatic daily remote monitoring of implantable cardioverter-defibrillators (ICDs).

Objective: We studied the association of the baseline HF Score, determined at algorithm activation, with long-term patient outcomes.

Methods: Data from 9 clinical trials were pooled, including 1841 ICD patients with a preimplantation ejection fraction ≤35%, New York Heart Association class II/III, and no long-standing atrial fibrillation. The primary end point was a composite of death or WHFH.

Results: After a median follow-up of 631 days (interquartile range, 385-865 days), there were 243 WHFHs in 173 patients (9.4%) and 122 deaths (6.6%), 52 of which (42.6%) were cardiovascular. The primary end point occurred in 265 patients (14.4%). A multivariable time-to-first-event analysis showed that a high baseline HF Score (>23, as determined by a time-dependent receiver operating characteristics curve analysis) was significantly associated with the occurrence of the primary end point (adjusted hazard ratio [HR], 2.05; 95% confidence interval [CI], 1.54-2.71; P < .0001), all-cause death (HR, 2.37; CI, 1.56-3.58; P < .0001), cardiovascular death (HR, 2.19; CI, 1.14-4.22; P = .019), and WHFH (HR, 1.91; CI, 1.35-2.71; P = .0003). In a hierarchical event analysis of all-cause death as the outcome with highest priority and WHFHs as repeated event outcomes, the win ratio was 2.47 (CI, 1.89-3.24; P < .0001).

Conclusion: Based on a retrospective analysis of clinical trial data with adjudicated events, baseline HF Score derived from device-monitored variables was able to stratify patients at higher long-term risk of death or WHFH.

Keywords: Death; Heart failure score; Implantable defibrillator; Remote monitoring; Risk stratification in heart failure patients; Worsening heart failure hospitalization.