Long-term Safety and Performance of an Implantable IVC Sensor for Congestion-Guided Management in Heart Failure:...

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.

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 <5%). Patient adherence was 93% and a sustained, significant reduction in IVC area was observed (8.1%, p<0.005), correlated with clinical improvements (p<0.001), despite no significant change in body weight. Improvements were observed in NYHA functional class (Class III: 74.5% improved to 40.0%; p<0.01) and NT-proBNP (median 1697 reduced to 998 ng/L; p<0.001). HF events (HFEs) were lower post-implant (0.31/year, 1.67/year pre-implant; 84.5% relative reduction; rate ratio: 0.18; 95% CI: 0.08-0.29). Medication adjustments (n=415) included diuretic titration (57%) and increased use of guideline directed medical therapy from baseline to 12-months (28%).

Congestion management through ambulatory IVC monitoring demonstrated excellent safety, sustained accuracy, and high levels of patient adherence at 12-months after sensor implantation. This was associated with improved HF congestion status and a lower observed rate of HFEs, supporting investigation of congestion-guided management using IVC monitoring in a pivotal randomized clinical trial.