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

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Abstract
Aims: Congestion signals heart failure (HF) 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% heart failure with reduced ejection fraction. 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 < .005), correlated with clinical improvements (P < .001), despite no significant change in body weight. Improvements were observed in the New York Heart Association (NYHA) functional class (Class III: 74.5% improved to 40.0%; P < .01) and N-terminal pro-B-type natriuretic peptide (median 1697 reduced to 998 ng/L; P < .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%). Conclusions: 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.
Funding Information
  • Foundry Innovation and Research 1, Ireland

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