A Study to Evaluate the IASD System II to Reduce Elevated Left Atrial Pressure in Patients with Heart Failure evaluates the effects of a transcatheter interarterial shunt device (IASD System, Corvia Medical) on outcomes in patients with HF with preserved ejection fraction.
Design: Open-label, single-arm
Results: The rate of 1-year survival was 95%. There was one stroke. At 1 year, NYHA class improved (P < .001), Minnesota Living With Heart Failure Questionnaire Score declined by 15 (P < .001) and 6-minute walk distance rose by 33 m (P < .01). There was a significant increase in right ventricular ejection fraction (P < .01), a stable modest fall in left ventricular end diastolic volume (P < .001) and a minimal rise in RV end diastolic volume (P < .001). No changes in atrial volume were observed.
Kaye DM, et al. Circ Heart Fail. 2016;doi:10.1161/CIRCHEARTFAILURE.116.003662.
Healio/Cardiology News Coverage:
REDUCE LAP-HF: Transcatheter interarterial shunt device shows benefit for patients with HFpEF at 1 year