Introduction
Heart failure (HF) across the ejection fraction spectrum remains a leading cause of morbidity and mortality, which is largely driven by congestion. Earlier and precise assessment of changing intravascular volume and guided clinical management can improve patient outcomes. Preclinical data suggest that signals of change in Inferior Vena Cava (IVC) area and collapsibility represent a marker of volume shifts, predate changes in pressure-based metrics, and may improve outcomes in HF.
Hypothesis
The novel implantable IVC sensor (FIRE1) accurately and safely measures IVC metrics as an indicator of intravascular fluid status changes. Extended data from the ongoing early feasibility study (EFS) will serve to support its long-term utility for ambulatory HF management.
Methods
An ongoing prospective, single-arm EFS enrolled 15 patients with a diagnosis of HF irrespective of ejection fraction. All participants experienced a HF hospitalization (HFH) or HF event in the last year, had elevated NT-proBNP levels, and were receiving ≥40 mg furosemide equivalent at enrollment to IVC sensor implantation. The primary endpoints (procedural success; freedom from device-related complications at 3 months) and interim analysis at 6 months were previously reported. Updated data at 12 months (n=12) for safety, medication changes in response to IVC sensor data, NYHA class, QOL, and sensor-derived IVC area vs. CT (n=10) are now reported.
Results
As previously reported, all patients met the primary safety and effectiveness endpoints. At the time of writing (total 230 patient months follow up), no serious device- or procedure-related events occurred. Medication changes (139) were made in 14 participants. These changes involved diuretics (73%), GDMT (17%), and vasodilators (10%). At 12 months, a significantly smaller proportion of Class III patients (NYHA class III% at baseline 83.3; 12 months 25.0; p=0.041) and a positive trend for KCCQ (baseline 56.4±23.9; 12 months 69.4±19.6) were observed. Sensor-derived IVC area continued to show excellent agreement with concurrent CT at 12 months (R2 = 0.99, mean absolute error=8.75mm2).
Conclusion
The implantable IVC sensor (FIRE1) demonstrates an excellent safety profile and provides evidence of improved clinical outcomes at 1-year of follow-up. These findings support the potential of IVC sensor based monitoring of intravascular volume status in HF patients and lay the foundation for a pivotal RCT on physician directed patient self-management.
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