Results From the REDUCE LAP-HF I Trial Published
November 20, 2017—Thirty-day results from the REDUCE LAP-HF I trial were published online ahead of print by Ted Feldman, MD, et al in Circulation. REDUCE LAP-HFI is the first phase 2, randomized, parallel-group, blinded, sham-controlled, multicenter trial to evaluate the IASD interatrial shunt device system (Corvia Medical) in patients with New York Heart Association class III or ambulatory class IV heart failure (HF), ejection fraction (EF) ≥ 40%, exercise pulmonary capillary wedge pressure ≥ 25 mm Hg, and pulmonary capillary wedge pressure–right atrial pressure gradient ≥ 5 mm Hg.
The background of the study is that in nonrandomized, open-label studies, use of a transcatheter interatrial shunt device was associated with lower pulmonary capillary wedge pressure, fewer symptoms, and greater quality of life and exercise capacity in patients with HF and midrange or preserved EF (≥ 40%).
According to the article in Circulation, participants were randomized 1:1 to undergo implantation of the IASD versus a sham procedure (femoral venous access with intracardiac echocardiography, but no device placement). A total of 94 patients (mean age, 70 ± 9 years; 50% women) were enrolled, 44 of which met inclusion/exclusion criteria and were randomized to the IASD (n = 22) and control (n = 22) groups. The participants and investigators were blinded to the treatment assignment.
The primary effectiveness endpoint was exercise pulmonary capillary wedge pressure at 1 month, and the primary safety endpoint was major adverse cardiac, cerebrovascular, and renal events at 1 month. Pulmonary capillary wedge pressure during exercise was compared between treatment groups using a mixed effects repeated measures model analysis of covariance that included data from all available stages of exercise.
At 1 month, implantation of the IASD resulted in a greater reduction in pulmonary capillary wedge pressure compared to the sham control (P = .028, accounting for all stages of exercise). Peak pulmonary capillary wedge pressure decreased by 3.5 ± 6.4 mm Hg in the treatment group versus 0.5 ± 5 mm Hg in the control group (P = .14). There were no periprocedural or 1-month major adverse cardiac, cerebrovascular, or renal events in the IASD group and one event (worsening renal function) in the control group (P = 1).
In patients with HF and EF ≥ 40%, IASD treatment reduces pulmonary capillary wedge pressure during exercise. Whether this mechanistic effect will translate into sustained improvements in symptoms and outcomes requires further evaluation, reported the investigators in Circulation.