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

IF 11.8 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS JACC. Heart failure Pub Date : 2025-06-01 Epub Date: 2025-04-09 DOI:10.1016/j.jchf.2025.01.019

Paul R. Kalra MA, MB BChir, MD , Irakli Gogorishvili MD , George Khabeishvili MD , Filip Málek MD, PhD, MBA , Ondřej Toman PhD, MHA , Chris Critoph BM, MD , Andrew S. Flett MBBS, MD, CCDS , Peter J. Cowburn MD , Mandeep R. Mehra MD, MSc , William S. Sheridan PhD , John R. Britton PhD, MBA , Teresa Buxo MSc , Robyn M. Kealy MSc , Annette Kent PhD , Barry R. Greene PhD , Kaushik Guha MD , Roy S. Gardner MBChB, MD , Ian Loke MBChB, MD , Ali Vazir PhD, MBBS , Jasper J. Brugts MD, PhD, MSc , Kevin Damman MD, PhD

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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

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.

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).

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用于心力衰竭远程护理的首次人类植入式下腔静脉传感器：FUTURE-HF

下腔静脉（IVC）面积和可折叠性的变化是充血的早期标志，可预测心力衰竭（HF）事件的风险。

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来源期刊

JACC. Heart failure CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

21.20

自引率

2.30%

发文量

164

期刊介绍： JACC: Heart Failure publishes crucial findings on the pathophysiology, diagnosis, treatment, and care of heart failure patients. The goal is to enhance understanding through timely scientific communication on disease, clinical trials, outcomes, and therapeutic advances. The Journal fosters interdisciplinary connections with neuroscience, pulmonary medicine, nephrology, electrophysiology, and surgery related to heart failure. It also covers articles on pharmacogenetics, biomarkers, and metabolomics.