First-in-Human Implantable Inferior Vena Cava Sensor for Remote Care in Heart Failure: FUTURE-HF

Variations of inferior vena cava (IVC) area and collapsibility serve as early markers of congestion and predict risk for heart failure (HF) events.

The aim of this first-in-human study (FUTURE-HF [First in Human Clinical Investigation of the FIRE1 System in Heart Failure Patients]) was to evaluate the safety and feasibility of a novel implantable IVC sensor for remote management in patients with HF. This paper is the final report on primary (3-month) and exploratory (6-month) endpoints.

Patients with HF hospitalizations within the previous year, with elevated natriuretic peptide levels, and on optimal HF treatment were included. The primary safety endpoints were procedural success without device- or procedure-related complications at 3 months. The primary technical endpoint was signal acquisition following implantation and at a clinic visit within 3 months. Sensor-derived IVC area was compared with computed tomography (CT)-based IVC dimensions. Patient adherence to daily readings and exploratory clinical findings at 6 months were assessed.

Fifty patients underwent successful implantation (mean age 65 ± 9 years, 14% women, 72% in NYHA functional class III), with 49 contributing to the primary safety and technical endpoints at 3 months. Sensor-derived IVC area demonstrated excellent agreement with CT measurement (mean absolute error 13.53 mm² [3.55%] R² = 0.98). Median adherence was 96% at 6-month follow-up. Exploratory analyses of clinical outcomes suggested improvements in N-terminal pro-B-type natriuretic peptide, NYHA functional class, and quality of life and reduced HF events.

This first-in-human experience demonstrated that the implantation of an IVC sensor was safe and feasible. Sensor-derived IVC area demonstrated excellent correlation with CT-derived IVC area, and exploratory clinical outcomes suggest that this may serve as a novel tool for ambulatory management of congestion to facilitate remote care in HF. (First in Human Clinical Investigation of the FIRE1 System in Heart Failure Patients [FUTURE-HF]; NCT04203576).