Heart failure & cardiomyopathies
Stem-Cell–Derived Biologic Ventricular Assist Tissue in Heart Failure
Authors' conclusion
In this interim analysis, cardiac remuscularization with BioVAT was associated with an increase in the target heart-wall thickness, left ventricular ejection fraction, and KCCQ-OSS at 3 months; all the patients had at least one adverse event.
Study context
- Population
- Patients with HF, LVEF ≤35% and ≥1 hypokinetic or dyskinetic LV segment12 with 3-month interim follow-up
- Participants
- 20 patients
- Primary endpoint
- Change from baseline in target heart-wall thickness, LVEF and KCCQ-OSS
- Follow-up
- 3 months
Methodological detailssingle-group, prespecified 3-month interim analysis
- Single-group
- Prespecified 3-month interim analysis
Primary result
As reported in the abstract
Change from baseline (safe maximal dose, 20 units)
- Target-wall thickness, least-squares mean increase 4.5 mm (90% CI 3.7 to 5.4)
- P<0.001
- LVEF increase 3.9 percentage points (90% CI 0.9 to 6.8)
- P = 0.04
- Kansas City Cardiomyopathy Questionnaire-Overall Summary Score (KCCQ-OSS) increase 6.7 points (90% CI 1.0 to 12.5)
- P = 0.06
Safety
- Heart transplantation
- 1
- Immunosuppression discontinued (LV assist device 2, renal failure 1, urothelial carcinoma 1)
- 4
- All patients had at least one adverse event
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Stem-Cell–Derived Biologic Ventricular Assist Tissue in Heart Failure. N Engl J Med. Published 28 May 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →