Left atrial pressure normalisation by graded radiofrequency atrial septostomy in heart failure with preserved ejection fraction: a single-arm pilot study.

Background: In heart failure with preserved ejection fraction (HFpEF), elevated mean left atrial pressure (MLAP) is a recognised haemodynamic feature. This pilot study explored the use of a personalised approach-combined radiofrequency ablation and balloon dilation (CURB)-to establish interatrial communication in patients with elevated resting MLAP.

Methods: Between September 2020 and March 2023, a single-arm study was conducted at Fuwai Hospital (Beijing, China) in patients with HFpEF and resting MLAP ≥18 mm Hg. CURB was performed using graded balloon dilation to achieve an MLAP target of <15 mm Hg, followed by rim stabilisation with radiofrequency ablation. Clinical status, interatrial fenestration and haemodynamic parameters were assessed during follow-up.

Results: Thirty-two patients were included (mean age 68.4 years; 59% male). The procedural target was achieved in 31 patients (97%). Median MLAP changed from 19.0 mm Hg (IQR 18.0, 21.0) to 13.0 mm Hg (IQR 12.0, 13.3), and mean pulmonary arterial pressure from 26.9 mm Hg (SD 3.9) to 23.5 mm Hg (SD 3.7). Over a median follow-up of 15.5 months (IQR 11.0, 18.0), fenestrations remained patent. The intervention was associated with favourable change in New York Heart Association functional class (median change: -1 class), 6 min walk distance (+48.5 m) and quality of life scores (-21.7 points). Reassessment in a subset (n=8) beyond 1 year showed sustained MLAP levels.

Conclusions: Among patients with HFpEF and elevated MLAP, the CURB technique was feasible and associated with mid-term changes in haemodynamics and functional measures. Further controlled studies are needed to assess long-term outcomes, safety and broader applicability.

Trial registration number: NCT04573166.