Heart failure & cardiomyopathies
Long-term safety and performance of an implantable inferior vena cava (IVC) sensor for congestion-guided management in heart failure: 12-month results from the FUTURE-HF trial portfolio
Authors' conclusion
Congestion management through ambulatory IVC monitoring demonstrated excellent safety, sustained accuracy, and high levels of patient adherence at 12-months after sensor implantation. This was associated with improved HF congestion status and a lower observed rate of HFEs
Study context
- Population
- HF patients (mean age 65.7±9.5 years; 75.4% NYHA III; 90.8% HFrEF)FUTURE-HF and FUTURE-HFII
- Participants
- 65 patients
- Outcome
- Adjudicated safety outcomes, sensor-derived IVC area vs CT, medication adjustments and clinical outcomes
- Follow-up
- 12 months
Methodological detailssingle-group
- Single-group
Pooled result
As reported in the abstract
Adjudicated device- or procedure-related serious adverse events
- No adjudicated device- or procedure-related serious adverse events occurred
Further pooled results
| Outcome | Rate ratio (95% CI) | |
|---|---|---|
| HF events, post-implant vs pre-implant0.31/yearvs 1.67/year; 84.5% relative reduction | 0.18 (0.08–0.29) | |
| 0.050.21520Rate ratio (log scale) |
Sensor-derived vs CT-derived IVC area
- Correlation, R2 (n=44)
- 0.97
- Mean relative error
- <5%
Patient adherence and IVC area
- Patient adherence
- 93%
- Sustained, significant reduction in IVC area
- 8.1%, p<0.005
- IVC area reduction correlated with clinical improvements
- P < 0.001
- No significant change in body weight
NYHA class III · 12 months
- NYHA class III, baseline to follow-up
- 74.5% to 40.0%; p<0.01
NT-proBNP · 12 months
- Median NT-proBNP, baseline to follow-up
- 1697 to 998 ng/L; p<0.001
Medication adjustments · baseline to 12 months
- Medication adjustments, n
- 415
- Diuretic titration
- 57%
- Increased use of guideline-directed medical therapy
- 28%
Safety
Adjudicated device- or procedure-related serious adverse events · 12 months
- No adjudicated device- or procedure-related serious adverse events occurred
Original publication
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. Eur J Heart Fail. Published 17 March 2026. doi:10.
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