Background: Cardiovascular and non-cardiovascular comorbidities are common in heart failure (HF) patients and impact disease severity and prognosis. Select modern implantable defibrillators (ICDs) are equipped with multisensor algorithms for HF monitoring. The HeartLogic index com bines multiple ICD-based sensor data (heart rate, heart sounds, thoracic impedance, respiration, activity), and the associated alert has proved to be a sensitive and timely predictor of impending HF decompensation in cardiac resynchronization therapy (CRT-D) patients The algorithm was de veloped using data from CRT-D patients; the performance in non-CRT ICD patients and the impact of selected comorbidities on performance requires further study. Methods: The HeartLogic feature was activated in 568 ICD patients (410 with CRT) from 26 centers. The median follow-up was 25 months [25th 75th percentile: 15–35]. Results: During follow-up, 97 hospitalizations were reported (53 cardio vascular) and 55 patients died. We recorded 1200 HeartLogic alerts (0.71 alerts/patient-year) in 370 patients. Overall, the time IN the alert state was 13%of the total observation period. The rate of cardiovascular hospitaliza tions or death was 0.48/patient-year (95% CI: 0.37–0.60) with the Heart Logic IN alert state and 0.04/patient-year (95% CI: 0.03–0.05) OUT of 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) at 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. Heart Logic alerts were not associated with CRT vs. non-CRT device implan tation (HR: 1.03, 95% CI: 0.82–1.30, p=0.775). The 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/non-CRT, AF/non-AF, CKD/non-CKD. Indeed, after multivariate correction for CKD and AF at implantation, the time IN the HeartLogic alert state >13% was associated with the occur rence of the combined endpoint of cardiovascular hospitalization or death (HR: 2.54, 95% CI: 1.61–4.01, p<0.001). Conclusions: The burden of HeartLogic alerts appears similar between CRT and non-CRT patients, while patients with AF and CKD seem more exposed to alerts. Nonetheless, the ability of the HeartLogic algorithm to identify patients during periods of significantly increased risk of clinical events is confirmed regardless of the type of device, the presence of AF, or CKD.

Performance of a multisensor implantable defibrillator algorithm for HF monitoring in presence of comorbidities

Santobuono, V E
;
Favale, S
2022-01-01

Abstract

Background: Cardiovascular and non-cardiovascular comorbidities are common in heart failure (HF) patients and impact disease severity and prognosis. Select modern implantable defibrillators (ICDs) are equipped with multisensor algorithms for HF monitoring. The HeartLogic index com bines multiple ICD-based sensor data (heart rate, heart sounds, thoracic impedance, respiration, activity), and the associated alert has proved to be a sensitive and timely predictor of impending HF decompensation in cardiac resynchronization therapy (CRT-D) patients The algorithm was de veloped using data from CRT-D patients; the performance in non-CRT ICD patients and the impact of selected comorbidities on performance requires further study. Methods: The HeartLogic feature was activated in 568 ICD patients (410 with CRT) from 26 centers. The median follow-up was 25 months [25th 75th percentile: 15–35]. Results: During follow-up, 97 hospitalizations were reported (53 cardio vascular) and 55 patients died. We recorded 1200 HeartLogic alerts (0.71 alerts/patient-year) in 370 patients. Overall, the time IN the alert state was 13%of the total observation period. The rate of cardiovascular hospitaliza tions or death was 0.48/patient-year (95% CI: 0.37–0.60) with the Heart Logic IN alert state and 0.04/patient-year (95% CI: 0.03–0.05) OUT of 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) at 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. Heart Logic alerts were not associated with CRT vs. non-CRT device implan tation (HR: 1.03, 95% CI: 0.82–1.30, p=0.775). The 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/non-CRT, AF/non-AF, CKD/non-CKD. Indeed, after multivariate correction for CKD and AF at implantation, the time IN the HeartLogic alert state >13% was associated with the occur rence of the combined endpoint of cardiovascular hospitalization or death (HR: 2.54, 95% CI: 1.61–4.01, p<0.001). Conclusions: The burden of HeartLogic alerts appears similar between CRT and non-CRT patients, while patients with AF and CKD seem more exposed to alerts. Nonetheless, the ability of the HeartLogic algorithm to identify patients during periods of significantly increased risk of clinical events is confirmed regardless of the type of device, the presence of AF, or CKD.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11586/475046
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