Long-term safety and performance of an implantable IVC sensor for congestion-guided management in heart failure: 12-month results from the FUTURE-HF trial portfolio

AIMS: Congestion signals heart failure progression and drives decompensation. Reliable management strategies remain poorly developed. We evaluated 12-months of congestion-guided clinical management following implantation of an inferior vena cava (IVC) sensor. METHODS AND RESULTS: Data were combined from two prospective studies (FUTURE-HF and FUTURE-HFII) (N=65, mean age 65.7±9.5 years; 75.4% NYHA III; 90.8% HFrEF). Patients recorded daily IVC parameters. Adjudicated safety outcomes, sensor-derived IVC area measurement versus CT imaging, medication adjustments, and clinical outcomes at 12-months were analysed.No adjudicated device or procedure-related serious adverse events occurred. Excellent correlation was observed between sensor-derived and CT-derived IVC area (n=44; R2=0.97; mean relative error