LB-6
No-Implant Interatrial Shunt for Heart Failure: Multicenter Clinical Outcomes
Presenter
Colin M. Barker, MD, FSCAI, Vanderbilt University Medical Center, Nashville, TN
Colin M. Barker, MD, FSCAI1, Gerard Wilkins2, Benjamin Wilkins2, Robert Gooley3, Siobahn Lockwood3, Peter S. Fail, M.D., FSCAI4, Christopher Meduri, M.D.5, Kari Feldt, M.D.5, Darrell Solet4, Jacob Kriegel6 and Tamaz Shaburishvili7, (1)Vanderbilt University Medical Center, Nashville, TN, (2)Dunedin Public Hospital, Dunedin, New Zealand, (3)MonashHeart, Clayton, VIC, Australia, (4)Cardiovascular Institute of the South, Houma, LA, (5)Karolinska University Hospital, Stockholm, Sweden, (6)Alleviant Medical, New York, NY, (7)Tbilisi Heart and Vascular Clinic, Tbilisi, Georgia
Keywords: Heart Failure and Structural Heart Disease (SHD)
Background
Heart failure with preserved and reduced ejection fraction (HFpEF and HFrEF) remain major unmet clinical needs. Implantable interatrial shunt devices have shown favorable safety and efficacy signals but require permanent implantation to maintain patency. We report the clinical outcomes of a no-implant approach to shunting using the Alleviant System across three studies - ALLEVIATE-HF-1 and ALLEVIATE-HF-2 for HFpEF, and a dedicated HFrEF study.
Methods
Patients aged ≥ 40 years, NYHA class II, III or ambulatory IV with elevated peak exercise PCWP were included in the study. Baseline screening included echocardiography, exercise right heart catheterization, KCCQ, and 6MWT. Femoral access was utilized and following transseptal puncture, the Alleviant System was used to excise a segment of the interatrial septum using a pulse of radiofrequency energy to create an interatrial shunt. Procedures were performed with fluoroscopic and echo guidance.
Results
A total of 30 patients (18 female, 12 male) were enrolled. Mean age was 67 ± 8 years. At baseline, 23 patients were NYHA class III and 7 were class II. Mean LVEF was 60.1 ± 8.4% in HFpEF patients and 30.0% ± 7.6% in HFrEF patients. All procedures were successful with no device-related adverse events; mean shunt size was 7.1 ± 0.9 mm (TEE). All patients have been followed through 3 mo. and 25 through 6 mo., with 1 patient missing at 1, 3 and 6 mo. visits. 5 patients have 12 mo. follow-up. Mean peak exercise PCWP decreased from baseline to 1 mo. and increases in overall KCCQ score were observed at all timepoints. Echo confirmed all shunts were patent at 1, 3 and 6 mo. At 6 mo., measurement demonstrated stability in shunt size (7.4 ± 1.1 mm, n=22); a decrease in left atrial diameter was observed in HFpEF patients (-2.4 mm, p=0.031); no significant changes in RVFAC or RAVI were observed. No device or procedure-related serious adverse events occurred through 6 mo.
Conclusions
This multi-center experience with the Alleviant System for the creation of an implant-free interatrial shunt demonstrated procedural safety and feasibility with a promising efficacy signal through 6 mo. in patients with HFpEF and 3 mo. for HFrEF. Continued follow up and subsequent studies are ongoing.