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

J 2025

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

KALRA, Paul R; Irakli GOGORISHVILI; George KHABEISHVILI; Filip MALEK; Ondřej TOMAN et al.

Základní údaje

Originální název

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

Autoři

Vydání

JACC-HEART FAILURE, UNITED STATES, ELSEVIER SCI LTD, 2025, 2213-1779

Další údaje

Typ výsledku

Článek v odborném periodiku

Utajení

není předmětem státního či obchodního tajemství

Impakt faktor

Impact factor: 11.800 v roce 2024

Označené pro přenos do RIV

Organizační jednotka

Lékařská fakulta

DOI

https://doi.org/10.1016/j.jchf.2025.01.019

UT WoS

001506129800013

Klíčová slova anglicky

congestion monitoring; FUTURE-HF; heart failure; inferior vena cava sensor; remote care; volume status

Změněno: 16. 1. 2026 11:46, Mgr. Tereza Miškechová

Anotace

V originále

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 f 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). (JACC Heart Fail. 2025;13:1000-1010) (c) 2025 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).

Citovat

KALRA, Paul R; Irakli GOGORISHVILI; George KHABEISHVILI; Filip MALEK; Ondřej TOMAN; Chris CRITOPH; Andrew S FLETT; Peter J COWBURN; Mandeep R MEHRA; William S SHERIDAN; John R BRITTON; Teresa BUXO; 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 a Kevin DAMMAN. First-in-Human Implantable Inferior Vena Cava Sensor for Remote Care in Heart Failure. JACC-HEART FAILURE. UNITED STATES: ELSEVIER SCI LTD, 2025, roč. 13, č. 6, s. 1000-1010. ISSN 2213-1779. Dostupné z: https://doi.org/10.1016/j.jchf.2025.01.019.

@article{2547597,
   author = {Kalra, Paul R and Gogorishvili, Irakli and Khabeishvili, George and Malek, Filip and Toman, Ondřej and Critoph, Chris and Flett, Andrew S and Cowburn, Peter J and Mehra, Mandeep R and Sheridan, William S and Britton, John R and Buxo, Teresa and Kealy, Robyn M and Kent, Annette and Greene, Barry R and Guha, Kaushik and Gardner, Roy S and Loke, Ian and Vazir, Ali and Brugts, Jasper J and Gray, Alastair and Testani, Jeffrey M and Damman, Kevin},
   article_location = {UNITED STATES},
   article_number = {6},
   doi = {https://doi.org/10.1016/j.jchf.2025.01.019},
   keywords = {congestion monitoring; FUTURE-HF; heart failure; inferior vena cava sensor; remote care; volume status},
   issn = {2213-1779},
   journal = {JACC-HEART FAILURE},
   note = {Bez aifliace k MU.},
   title = {First-in-Human Implantable Inferior Vena Cava Sensor for Remote Care in Heart Failure},
   volume = {13},
   year = {2025}
}

TY  - JOUR
ID  - 2547597
AU  - Kalra, Paul R - Gogorishvili, Irakli - Khabeishvili, George - Malek, Filip - Toman, Ondřej - Critoph, Chris - Flett, Andrew S - Cowburn, Peter J - Mehra, Mandeep R - Sheridan, William S - Britton, John R - Buxo, Teresa - Kealy, Robyn M - Kent, Annette - Greene, Barry R - Guha, Kaushik - Gardner, Roy S - Loke, Ian - Vazir, Ali - Brugts, Jasper J - Gray, Alastair - Testani, Jeffrey M - Damman, Kevin
PY  - 2025
TI  - First-in-Human Implantable Inferior Vena Cava Sensor for Remote Care in Heart Failure
JF  - JACC-HEART FAILURE
VL  - 13
IS  - 6
SP  - 1000-1010
EP  - 1000-1010
PB  - ELSEVIER SCI LTD
SN  - 22131779
N1  - Bez aifliace k MU.
KW  - congestion monitoring
KW  - FUTURE-HF
KW  - heart failure
KW  - inferior vena cava sensor
KW  - remote care
KW  - volume status
N2  - 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 f 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). (JACC Heart Fail. 2025;13:1000-1010) (c) 2025 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).
ER  -

KALRA, Paul R; Irakli GOGORISHVILI; George KHABEISHVILI; Filip MALEK; Ondřej TOMAN; Chris CRITOPH; Andrew S FLETT; Peter J COWBURN; Mandeep R MEHRA; William S SHERIDAN; John R BRITTON; Teresa BUXO; 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 a Kevin DAMMAN. First-in-Human Implantable Inferior Vena Cava Sensor for Remote Care in Heart Failure. \textit{JACC-HEART FAILURE}. UNITED STATES: ELSEVIER SCI LTD, 2025, roč.~13, č.~6, s.~1000-1010. ISSN~2213-1779. Dostupné z: https://doi.org/10.1016/j.jchf.2025.01.019.

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