Heart failure & cardiomyopathiesResearch article
No-Implant Interatrial Shunt for Heart Failure with Preserved Ejection Fraction (HFpEF)
- Uncontrolled feasibility study
- multicentre
- single-group
Authors' conclusion
In these feasibility studies of a no-implant interatrial shunt, HFpEF/HFmrEF shunts exhibited stability with favorable safety and early efficacy signals.
Study context
- Population
- Patients with HFpEF/heart failure with mildly reduced ejection fraction (HFmrEF), NYHA class ≥II, EF >40%, exercise pulmonary capillary wedge pressure (PCWP) ≥25 mm Hg with PCWP-to-right atrial gradient ≥5 mm Hg
- Participants
- 28 patients
Main finding
As reported in the abstract
Peak exercise PCWP change · 1 month
Peak exercise PCWP decreased 5.4 ± 9.6 mm Hg, no change in right atrial pressure
P = 0.011
Further findings
6-minute walk distance, KCCQ Overall Summary Score, NT-proBNP, shunt patency · 6 months
- Mean 6-minute walk distance increased 101 ± 71 m
- P < 0.001
- KCCQ Overall Summary Score increased 26 ± 19 points
- P < 0.001
- NT-proBNP decreased 372 ± 857 pg/mL
- P = 0.018
- Shunt patency confirmed with unchanged diameter
Safety
Serious device or procedure-related adverse events · through 6 months
- No serious device or procedure-related adverse events
Original publication
No-Implant Interatrial Shunt for HFpEF. JACC Heart Fail. Published 26 April 2023. doi:10.1016/j.jchf.2023.01.024
Summarised from the published abstract; every number is checked against it