One-year follow-up data from the REDUCE LAP-HF I clinical study of the Interatrial Shunt Device (IASD, Corvia Medical) demonstrate shunt patency (blood flow from the left to right atrium) for all participants who received the implant. The IASD is the world’s first transcatheter device for heart failure with preserved and mid-range ejection fraction.
Data was presented in the late-breaking scientific session at the 2018 European Society of Cardiology (ESC) Congress (25–29 August, Munich, Germany) by Ted Feldman (Evanston Hospital, Evanston, USA). REDUCE LAP- HF I is a prospective, double-blind, mechanistic study of 44 patients randomised to IASD or sham control. Primary study endpoints at 30 days included effectiveness of the IASD as measured by exercise pulmonary capillary wedge pressure (PCWP) reduction compared to sham control, and procedural safety as assessed by major adverse cardiovascular, cerebral, or renal events (MACCRE). The study met its primary endpoint.
The one-year results demonstrate shunt patency (blood flow from the left to right atrium) for all participants who received the implant. Results further showed the IASD is safe, improved quality of life and is associated with favourable trends in heart failure hospitalisation and reduction in New York Heart Association (NYHA) heart class. As well as being presented at the ESC, the results were published in JAMA Cardiology.
Feldman, the co-principal investigator, comments: “The REDUCE LAP-HF I clinical study is of tremendous interest to me because heart failure with preserved ejection fraction is a clinical problem for which there is no effective therapy. We have now studied the IASD in several consecutive trials. The early single-arm studies demonstrated that people felt better and their exercise capacity improved. Now, a sham-controlled randomized study conclusively proves the mechanism of action and again suggests clinical efficacy in midterm follow-up.”
Sanjiv Shah (Northwestern Memorial Hospital’s Center for Heart Failure, the Bluhm Cardiovascular Institute, Chicago, USA), a co-principal investigator, comments: “I am pleased with the results of the REDUCE LAP-HF trials so far. By leading and taking part in these studies, we hope to make a significant difference for patients who suffer from the devastating effects of this type of heart failure.”
REDUCE LAP-HF II is a large multi-national prospective, double-blind, sham-controlled trial randomising 608 HFpEF and HFmrEF patients. Recruitment is ongoing.