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. 2023 Aug;10(4):2469-2478.
doi: 10.1002/ehf2.14416. Epub 2023 Jun 5.

Performance of a multisensor implantable defibrillator algorithm for heart failure monitoring related to co-morbidities

Vincenzo Ezio Santobuono  1 , Stefano Favale  1 , Antonio D'Onofrio  2 , Michele Manzo  3 , Leonardo Calò  4 , Matteo Bertini  5 , Gianluca Savarese  6 , Luca Santini  7 , Antonio Dello Russo  8 , Carlo Lavalle  9 , Miguel Viscusi  10 , Claudia Amellone  11 , Raimondo Calvanese  12 , Giuseppe Arena  13 , Antonio Pangallo  14 , Antonio Rapacciuolo  15 , Daniele Porcelli  16 , Monica Campari  17 , Sergio Valsecchi  17 , Andrea Igoren Guaricci  1
Affiliations

Performance of a multisensor implantable defibrillator algorithm for heart failure monitoring related to co-morbidities

Vincenzo Ezio Santobuono et al. ESC Heart Fail. 2023 Aug.

Abstract

Aims: The HeartLogic algorithm combines multiple implantable defibrillator (ICD) sensor data and has proved to be a sensitive and timely predictor of impending heart failure (HF) decompensation in cardiac resynchronization therapy (CRT-D) patients. We evaluated the performance of this algorithm in non-CRT ICD patients and in the presence of co-morbidities.

Methods and results: The HeartLogic feature was activated in 568 ICD patients (410 with CRT-D) from 26 centres. The median follow-up was 26 months [25th-75th percentile: 16-37]. During follow-up, 97 hospitalizations were reported (53 cardiovascular) and 55 patients died. We recorded 1200 HeartLogic alerts in 370 patients. Overall, the time IN the alert state was 13% of the total observation period. The rate of cardiovascular hospitalizations or death was 0.48/patient-year (95% CI: 0.37-0.60) with the HeartLogic IN the alert state and 0.04/patient-year (95% CI: 0.03-0.05) OUT of the alert state, with an incidence rate ratio of 13.35 (95% CI: 8.83-20.51, P < 0.001). Among patient characteristics, atrial fibrillation (AF) on implantation (HR: 1.62, 95% CI: 1.27-2.07, P < 0.001) and chronic kidney disease (CKD) (HR: 1.53, 95% CI: 1.21-1.93, P < 0.001) independently predicted alerts. HeartLogic alerts were not associated with CRT-D versus ICD implantation (HR: 1.03, 95% CI: 0.82-1.30, P = 0.775). Comparisons of the clinical event rates in the IN alert state with those in the OUT of alert state yielded incidence rate ratios ranging from 9.72 to 14.54 (all P < 0.001) in all groups of patients stratified by: CRT-D/ICD, AF/non-AF, and CKD/non-CKD. After multivariate correction, the occurrence of alerts was associated with cardiovascular hospitalization or death (HR: 1.92, 95% CI: 1.05-3.51, P = 0.036).

Conclusions: The burden of HeartLogic alerts was similar between CRT-D and ICD patients, while patients with AF and CKD seemed more exposed to alerts. Nonetheless, the ability of the HeartLogic algorithm to identify periods of significantly increased risk of clinical events was confirmed, regardless of the type of device and the presence of AF or CKD.

Trial registration: ClinicalTrials.gov NCT02275637.

Keywords: Atrial fibrillation; CRT; Chronic kidney disease; Heart failure; ICD; Risk stratification.

PubMed Disclaimer

Conflict of interest statement

M. Campari and S. Valsecchi are employees of Boston Scientific, Inc. No other conflicts of interest exist.

Figures

Figure 1
Figure 1
Kaplan–Meier analysis of time to first HeartLogic alert. Patients are stratified according to device type (CRT‐D: HR: 1.03, 95% CI: 0.82–1.30; P = 0.775) (A), chronic kidney disease at baseline (HR: 1.71; 95% CI: 1.33–2.18; P < 0.001) (B), and atrial fibrillation on implantation (HR: 1.77, 95% CI: 1.33–2.37; P < 0.001) (C).
Figure 2
Figure 2
Multivariate analysis. After correction for CKD and AF on implantation, the occurrence of at least one HeartLogic alert was associated with the occurrence of the combined endpoint of cardiovascular hospitalization (HR: 3.44, 95% CI: 1.22–9.76, P = 0.021) and cardiovascular hospitalization or death (HR: 1.92, 95% CI: 1.05–3.51, P = 0.036).
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