First-in-Human Implantable Inferior Vena Cava Sensor for Remote Care in Heart Failure
Paul R. Kalra, Irakli Gogorishvili, George Khabeishvili, Filip Málek, Ondřej Toman, Chris Critoph, Andrew Flett, Peter J. Cowburn, Mandeep R. Mehra, William S. Sheridan, J. Robert Britton, Teresa Buxó, Robyn M Kealy, Annette Kent, Barry R. Greene, Kaushik Guha, Roy S. Gardner, Ian Loke, Ali Vazir, Jasper J. Brugts, Alastair Gray, Jeffrey M. Testani, Kevin Damman
Abstract
BACKGROUND: Variations of inferior vena cava (IVC) area and collapsibility serve as early markers of congestion and predict risk for heart failure (HF) events. OBJECTIVES: 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. METHODS: 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. RESULTS: = 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. CONCLUSIONS: 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).