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

Author:

Santobuono Vincenzo Ezio1,Favale Stefano1,D'Onofrio Antonio2,Manzo Michele3,Calò Leonardo4,Bertini Matteo5,Savarese Gianluca6,Santini Luca7,Dello Russo Antonio8,Lavalle Carlo9,Viscusi Miguel10,Amellone Claudia11,Calvanese Raimondo12,Arena Giuseppe13,Pangallo Antonio14,Rapacciuolo Antonio15,Porcelli Daniele16,Campari Monica17,Valsecchi Sergio17,Guaricci Andrea Igoren1

Affiliation:

1. Interdisciplinary Department of Medicine, Cardiology Unit Polyclinic of Bari University of Bari ‘Aldo Moro’ Bari Italy

2. Unità Operativa di Elettrofisiologia, Studio e Terapia delle Aritmie’ Monaldi Hospital Naples Italy

3. OO.RR. San Giovanni di Dio Ruggi d'Aragona Salerno Italy

4. Policlinico Casilino Rome Italy

5. University of Ferrara, S. Anna University Hospital Ferrara Italy

6. S. Giovanni Battista Hospital Foligno Italy

7. ‘Giovan Battista Grassi’ Hospital Rome Italy

8. Università Politecnica delle Marche, ‘Ospedali Riuniti’ Ancona Italy

9. Policlinico Umberto I Rome Italy

10. S. Anna e S. Sebastiano Hospital Caserta Italy

11. ‘Maria Vittoria’ Hospital Turin Italy

12. Ospedale del Mare, ASL NA1 Naples Italy

13. Ospedale Civile Apuane Massa Italy

14. ‘Bianchi‐Melacrino‐Morelli’ Hospital Reggio Calabria Italy

15. Policlinico Federico II Naples Italy

16. S. Pietro Fatebenefratelli Hospital Rome Italy

17. Boston Scientific Italia Milan Italy

Abstract

AbstractAimsThe 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 resultsThe 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).ConclusionsThe 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.

Publisher

Wiley

Subject

Cardiology and Cardiovascular Medicine

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