One-Year Safety and Clinical Outcomes of a Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure With Preserved Ejection Fraction in the Reduce Elevated Left Atrial Pressure in Patients With Heart Failure (REDUCE LAP-HF I) Trial: A Randomized Clinical Trial.

摘要: Importance In patients with heart failure (HF) and left ventricular ejection fraction (LVEF) equal to or greater than 40%, a transcatheter interatrial shunt device (IASD; Corvia Medical) reduces exercise pulmonary capillary wedge pressure (PCWP) is safe compared sham control treatment at 1 month of follow-up. The longer-term safety patency the IASD has not yet been demonstrated in setting randomized clinical trial (RCT). Objective: To evaluate 1-year outcomes treatment. Design, Setting, Participants: This phase 2, double-blind, 1-to-1 sham-controlled multicenter RCT implantation vs procedure (femoral venous access imaging septum without IASD) was conducted 22 centers United States, Europe, Australia on New York Heart Association (NYHA) class III ambulatory IV HF, LVEF PCWP 25 mm Hg, PCWP-right atrial gradient 5 Hg. Main Outcomes Measures: Safety assessed by major adverse cardiac, cerebrovascular, renal events (MACCRE). Exploratory evaluated year were hospitalizations for NYHA class, quality life, 6-minute walk test, patency. Results: After year, shunts patent all IASD-treated patients; MACCRE did differ significantly arm (2 21 [9.5%]) (5 [22.7%]; P = .41), no strokes occurred. yearly rate HF 0.22 0.63 (P = .06). Median improvement (IQR, −1 0) 0 0; P = .08). Quality life test distance similar both groups. At 6 months, there an increase right size (mean [SD], 7.9 [8.0] mL/m2) (−1.8 [9.6] mL/m2; P = .002), consistent left-to-right shunting through device; further occurred 12 months. Conclusions Relevance: REDUCE LAP-HF I confirms IASD. Through follow-up, appears safe, significant differences receiving those who received treatment. Trial Registration: ClinicalTrials.gov identifier: NCT02600234