Predicting worsening heart failure hospitalizations in patients with implantable cardioverter defibrillators: Is it all about alerts? A pooled analysis of nine trials

Background and aims: To predict worsening heart failure hospitalizations (WHFH) in patients with implantable defibrillators and remote monitoring (RM), the HeartInsight algorithm (Biotronik, Berlin, Germany) calculates a heart failure (HF) score combining seven physiologic parameters: 24-hour heart rate (HR), nocturnal HR, HR variability, atrial tachyarrhythmia, ventricular extrasystoles, patient activity, and thoracic impedance. We compared temporal trends of the HF score and its components 12 weeks before a WHFH with 12-week trends in patients without WHFH, to assess whether trends indicate deteriorating HF regardless of alert status. Methods: Data from nine clinical trials were pooled, including 2,050 patients with a defibrillator capable of atrial sensing, ejection fraction ≤ 35%, NYHA class II/III, no long-standing atrial fibrillation, and 369 WHFH from 259 patients. Results: The mean HF score was higher in the WHFH group than in the no WHFH group (42.3 ± 26.1 versus 30.7 ± 20.6, p < 0.001) already at the beginning of 12 weeks. The mean HF score further increased to 51.6 ± 26.8 until WHFH (+22% versus no WHFH group, p = 0.003). As compared to the no WHFH group, the algorithm components either were already higher 12 weeks before WHFH (24 h HR, HR variability, thoracic impedance) or significantly increased until WHFH (nocturnal HR, atrial tachyarrhythmia, ventricular extrasystoles, patient activity). Conclusion: The HF score was significantly higher at, and further increased during 12 weeks before WHFH, as compared to the no WHFH group, with seven components showing different behavior and contribution. Temporal trends of HF score may serve as a quantitative estimate of HF condition and evolution prior to WHFH.