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

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F65269705%3A_____%2F25%3A00081827" target="_blank" >RIV/65269705:_____/25:00081827 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00023884:_____/25:00010066

Výsledek na webu

<a href="https://www.sciencedirect.com/science/article/pii/S2213177925001726" target="_blank" >https://www.sciencedirect.com/science/article/pii/S2213177925001726</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.jchf.2025.01.019" target="_blank" >10.1016/j.jchf.2025.01.019</a>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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).

Název v anglickém jazyce

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

Popis výsledku anglicky

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).

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30201 - Cardiac and Cardiovascular systems

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2025

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

JACC-Heart Failure

ISSN

2213-1779

e-ISSN

2213-1787

Svazek periodika

13

Číslo periodika v rámci svazku

6

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

11

Strana od-do

1000-1010

Kód UT WoS článku

001506129800013

EID výsledku v databázi Scopus

2-s2.0-105002317892