Heart failure & cardiomyopathies
Percutaneous Endocardial Alginate–Hydrogel Injection in the Treatment of Heart Failure: First-in-Human Study
Authors' conclusion
TEAi is feasible and safe for the treatment of HFrEF
Study context
- Population
- HF with reduced ejection fraction (HFrEF) patients (New York Heart Association (NYHA) class III–IV, left ventricular ejection fraction (LVEF) ≤35%)
- Participants
- 10 patients
- Outcome
- Incidence of procedure- or device-related serious adverse events (SADEs)
- Follow-up
- 30 days
Methodological detailssingle-arm
- Single-arm
Main finding
As reported in the abstract
Procedure- or device-related SADEs
- No serious adverse events (SADEs) at 30 days; all 10 patients successfully underwent TEAi
Secondary outcomes
Device success
- Patients successfully undergoing TEAi
- 10
LVEF (MRI), baseline vs 6 months
- LVEF baseline → 6 months
- 17.7% ± 3.8% to 24.9% ± 11.2% (P = 0.021)
End-systolic volume, baseline vs 6 months
- ESV baseline → 6 months
- 297.5 ± 67.9 mL to 264.8 ± 101.4 mL (P = 0.029)
KCCQ score, baseline vs 6 months
- KCCQ baseline → 6 months
- 49.7 ± 3.9 to 79.0 ± 8.07 (P = 0.008)
End-diastolic volume, NT-proBNP, 6MWT · 6 months
- No statistically significant changes vs baseline
Peak LV end-diastolic wall stress (biomechanical analysis), pre vs post
- Pre vs post
- 6.5 ± 1.1 kPa vs. 5.9 ± 1.3 kPa, P = 0.043
Death and heart failure (HF) hospitalization · 6 months
- Deaths
- 1
- HF hospitalizations
- 2
Original publication
Percutaneous Endocardial Alginate–Hydrogel Injection in the Treatment of Heart Failure: First-in-Human Study. ESC Heart Fail. Published 4 October 2025. doi:10.
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