Key result
HeartLogic alert state predicts ~13-fold higher rate of cardiovascular hospitalization or death versus non-alert periods.
Why the study?
HeartLogic predicts impending heart failure decompensation in CRT-D patients, but its performance in non-CRT ICD patients and across co-morbidities needed evaluation.
Does the HeartLogic algorithm predict cardiovascular hospitalizations or death in patients with an implantable defibrillator?
Observational (n=568)
Yes
Does the HeartLogic algorithm predict cardiovascular hospitalizations or death in patients with an implantable defibrillator?
Effect estimate: IRR 13.35 (95% CI 8.83-20.51)
Absolute Event Rate: 0.48% vs 0.04%
p-value: p=< 0.001
The HeartLogic algorithm effectively identifies periods of significantly increased risk for cardiovascular hospitalization or death in ICD and CRT-D patients, regardless of comorbidities like atrial fibrillation or chronic kidney disease.
HeartLogic alerts flag high-risk intervals in non-CRT ICD patients; extends CRT-D data but remains hypothesis-generating pending prospective trials.
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.
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Santobuono et al. (2023) conducted an observational in Heart Failure (n=568). HeartLogic algorithm (IN alert state) vs. OUT of alert state was evaluated on Cardiovascular hospitalizations or death (IRR 13.35, 95% CI 8.83-20.51, p=< 0.001). The HeartLogic algorithm IN alert state predicted a higher rate of cardiovascular hospitalizations or death compared to OUT of alert state (IRR 13.35; 95% CI 8.83-20.51; P<0.001).
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