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Long-term safety and performance of an implantable IVC sensor for congestion-guided management in heart failure: 12-month results from the FUTURE-HF trial portfolio

Title: Long-term safety and performance of an implantable IVC sensor for congestion-guided management in heart failure: 12-month results from the FUTURE-HF trial portfolio
Authors: Damman, Kevin; Uriel, Nir; Mehra, Mandeep R; Testani, Jeffrey; Fudim, Marat; Bhatt, Kunjan; Kahwash, Rami; Martyn, Trejeeve; Feitell, Scott; Khabeishvili, George; Neuzil, Petr; Sayer, Gabriel; Gogorishvili, Irakli; Critoph, Chris; Sharif, Faisal; Loke, Ian; Gardner, Roy S; Toman, Ondrej; Flett, Andrew; Brugts, Jasper J; Vazir, Ali; Buxo, Teresa; Gray, Alastair; Greene, Barry R; Kalra, Paul R
Contributors: Foundry Innovation and Research 1, Ireland
Source: European Journal of Heart Failure ; ISSN 1388-9842 1879-0844
Publisher Information: Oxford University Press (OUP)
Publication Year: 2026
Description: Aims Congestion signals heart failure (HF) progression and drives decompensation. Reliable management strategies remain poorly developed. We evaluated 12 months of congestion-guided clinical management following implantation of an inferior vena cava (IVC) sensor. Methods and Results Data were combined from two prospective studies (FUTURE-HF and FUTURE-HFII) (N =65, mean age 65.7 ± 9.5 years; 75.4% NYHA III; 90.8% heart failure with reduced ejection fraction. Patients recorded daily IVC parameters. Adjudicated safety outcomes, sensor-derived IVC area measurement versus CT imaging, medication adjustments, and clinical outcomes at 12 months were analysed. No adjudicated device or procedure-related serious adverse events occurred. Excellent correlation was observed between sensor-derived and CT-derived IVC area (n = 44; R2 = 0.97; mean relative error
Document Type: article in journal/newspaper
Language: English
DOI: 10.1093/ejhf/xuag080
DOI: 10.1093/ejhf/xuag080/67380978/xuag080.pdf
Availability: https://doi.org/10.1093/ejhf/xuag080; https://academic.oup.com/eurjhf/advance-article-pdf/doi/10.1093/ejhf/xuag080/67380978/xuag080.pdf
Rights: https://creativecommons.org/licenses/by/4.0/
Accession Number: edsbas.6A84FEE2
Database: BASE