TCT-468 No-implant interatrial shunt for heart failure with preserved and mildly reduced ejection fraction: 12-month outcomes from multicenter pilot feasibility studies.

Abstract

Background: Permanent device implantation to maintain interatrial shunt patency may have a number of drawbacks. However, concerns remain regarding the durability of implant-free techniques. Here we report pooled 12-month data for a no-implant shunt therapy for patients with HFpEF/HFmrEF. Method(s): Patients >= 40 yrs old, NYHA class II, III or ambulatory IV, EF > 40% and elevated PCWP during supine ergometry were enrolled in the ALLEVIATE-HF-1 and ALLEVIATE-HF-2 early phase trials. Under fluoroscopic and echographic guidance, the Alleviant System was used to excise and capture a segment of interatrial septum form a femoral venous approach. In both studies, assessments included a repeat exercise hemodynamic study at 1 month and echo and biomarker evaluation through 12 months. The HF-2 study additionally included NYHA, KCCQ and six-minute walk test (6MWT) assessments through 12 months. Result(s): 28 patients were enrolled, 68% female, age 68 +/- 9 years. Baseline resting and peak exercise PCWP were 19 +/- 6 and 39 +/- 10 mm Hg, respectively. All procedures were successful. Mean shunt diameter was 7.1 +/- 0.9 mm and no procedural adverse events were observed. Peak exercise PCWP decreased 5.6 +/- 7.9 mm Hg (P = 0.002) with no change in RA pressure. There was no HF mortality or serious device or procedure-related adverse events through 12 months. At 12 months, 6MWT distance increased 25 +/- 73 meters (P = NS); KCCQ overall summary score increased 21 +/- 22 points (P = 0.01); NT-proBNP decreased 428 +/- 601 pg/mL (P = 0.008). There were no significant changes in right atrial or ventricular size or function at 12 months. Shunt patency was confirmed in all patients with evaluable echos, with Qp:Qs 1.2 +/- 0.2 at 12 months, indicative of left-to-right flow. Conclusion(s): In these uncontrolled studies of a no-implant interatrial shunt for HFpEF/HFmrEF, we demonstrated excellent technical success and favorable safety and efficacy signals through 1 year. Shunts remained patent and were stable in size, as well as magnitude and direction of shunting. The results support the ongoing evaluation of this promising approach in the randomized sham-controlled ALLAY-HF pivotal trial. Categories: STRUCTURAL: Heart Failure.Copyright © 2024