Implantable Vena Cava Sensor Successful in First Human Study

TOPLINE:

The implantation of a novel inferior vena cava (IVC) sensor demonstrated promising safety and feasibility in patients with heart failure, with its measurements showing a strong correlation with those derived using CT, researchers found. The device may serve as a new tool for ambulatory management of congestion to facilitate remote care in these patients, they said.

METHODOLOGY:

• Researchers analyzed data from the FUTURE-HF first-in-human study to evaluate the safety and feasibility of implanting a sensor in the IVC for the remote management of adult patients diagnosed with heart failure for over 3 months. The included patients were receiving optimal care and had to have experienced decompensation events in the previous year and/or have elevated levels of natriuretic peptides.
• A total of 50 patients (mean age, 65 years; 14% women; 72% in New York Heart Association functional class III) received the sensor between November 2019 and September 2024 at 13 clinical centers in five countries.
• They used a belt-worn device with an embedded radiofrequency antenna and a processing unit for taking daily readings for about 1 minute and transmitting IVC area and collapsibility measurements to a cloud-based web application.
• Primary safety endpoints were procedural success without acute device- or procedure-related or sensor-related complications at 3 months. The technical endpoint was signal acquisition immediately postimplantation and within 3 months of implantation at a clinic visit.
• IVC area measurements derived from the sensor were compared with CT scans at 3 months. Relevant clinical outcomes were evaluated at 6 months.

TAKEAWAY:

• The implantation was 100% successful, featuring signal transmission immediately and at 3 months, according to the researchers. No serious adverse events related to the device or procedure were recorded at 3 months, they reported.
• Sensor-derived measurements of IVC area demonstrated a strong correlation with CT measurements (mean absolute error, 3.55%; coefficient of determination, 0.98).
• At 6 months postimplantation, a significant decrease in N-terminal pro–B-type natriuretic peptide levels (P = .026), improvement in quality of life (P < .010), and change in functional class were observed. Heart failure events decreased by 80.3%.
• The median daily adherence rate per patient-month was 96.11% at 6 months postimplantation.

IN PRACTICE:

“Although the present data provide reassurance about the feasibility of implantation and shorter term durability of the implanted devices, the 2-year follow-up for this study will provide long-term performance data, with additional 3-year follow-up for safety,” the authors of the study wrote.

SOURCE:

This study was led by Paul R. Kalra, MD, of the Portsmouth Hospitals University NHS Trust in Portsmouth, England. It was published online on April 9, 2025, in JACC: Heart Failure.

LIMITATIONS:

This first-in-human study is still ongoing and not designed to exhibit a significant clinical impact. The findings on clinical outcomes and biomarkers were exploratory in nature. The study population lacked diversity in terms of sex, heart failure phenotype, and race or ethnicity.

DISCLOSURES:

The study was funded by Foundry Innovation and Research 1. Several authors reported receiving grants, consulting and lecturing honoraria, speaker fees, personal fees, and other ties with various pharmaceutical and healthcare companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.