SELENE HF

Combining home monitoring temporal trends from implanted defibrillators and baseline patient risk profile to predict heart failure hospitalizations (SELENE HF)

D’Onofrio A et al. Europace 2021
doi: 10.1093/europace/euab170.

International, multi-center, prospective, observational, event-driven cohort study
34 centers in Italy and Spain
918 ICD and CRT-D patients with NYHA Class II-III, LVEF ≤ 35%
To develop an algorithm to predict HF hospitalization based on seven Home Monitoring parameters and a baseline risk stratification (Seattle Heart Failure Model)
Home Montoring parameters: Mean heart rate, mean heart rate at rest, premature ventricular contractions (PVC), atrial burden, heart rate variability (HRV), patient activity, and thoracic impedance (TI)
Primary endpoint: First HF-related hospitalization
Collection of ≥ 50 primary endpoint events
Post-hoc randomization into 2 cohorts for algorithm development and validation

The algorithm predicted heart failure hospitalizations early, with high sensitivity and with a low false alert rate.

Endpoint

Sensitivity

(%)

Alerting time

(days)

False alert rate

(ppy)

First post-implant HF hospitalizations

65.5

(45.7-82.1)

(21-89)

0.69

(0.64-0.74)

Table 1: Main performance parameters of the predicting algorithm
(Numbers in brackets: confidence intervals, except for alerting time (IQR).

Heart failure is associated with poor prognosis and high hospitalization rates. Recurrent hospital admission due to heart failure results in a gradual worsening of the health status of patients and constitutes a considerable healthcare burden.
Early prevention of HF decompensation is a key strategy to improve patient outcomes. An CIED-based algorithm that predicts impending heart failure hospitalization could help reduce hospitalization among high-risk heart failure patients.

Study Objective	To develop an algorithm to predict HF hospitalization based on seven Home Monitoring parameters and a baseline risk stratification (Seattle Heart Failure Model)
Primary Endpoint	First HF-related hospitalization
Major Secondary Endpoints	Any (first or subsequent) hospitalization or death for worsening HF Outpatient intravenous interventions (IVI) for worsening HF
Clinical Sites	34 (Italy, Spain)
Sample Size	918 patients
Main Inclusion Criteria	ICD or CRT-D patients LVEF ≤ 35% NYHA class II or III ≥18years of age
Main Exclusion Criteria	Permanent AF Acutely decompensated HF History of stroke Planned cardiac surgery Short life expectancy <6 months Insufficient mobile phone service coverage at home
Study Flowchart
Follow-Up	The study was event driven. The median follow-up duration was 22.5 months.
Study Duration	May 2012 to March 2017
Reference no.	NCT01836510
Principal Investigators	D’Onofrio A., AORN Azienda Ospedaliera dei Colli Monaldi, Naples, Italy