LB-10
Update from the First-in-human Study with the Novel DurAVR Biomimetic Transcatheter Heart Valve
Presenter
Azeem Latib, M.D., FSCAI, Montefiore Medical Center, Bronx, NY
Christopher Meduri, M.D., Karolinska Institutet, Stockholm, Sweden, Susheel K. Kodali, M.D., NewYork-Presbyterian Columbia University Irving Medical Center, New York, NY, Azeem Latib, M.D., FSCAI, Montefiore Medical Center, Bronx, NY, Rishi Puri, M.D., PhD, Cleveland Clinic Main Campus, Cleveland, OH, Alan Zajarias, M.D., Washington University School ofMedicine, St. Louis, MO, Kari Feldt, M.D., Karolinska University Hospital, Stockholm, Sweden, Joao L. Cavalcante, M.D., Minneapolis Heart Institute® - Abbott Northwestern Hospital, Minneapolis, MN, Pankaj Garg, M.D., University of East Anglia, Norwich, United Kingdom, Karl Poon, M.B.B.S., Beaumont Hospital - Royal Oak, Royal Oak, MI, Vinayak Bapat, M.D., Valve Science Center, Minneapolis Heart Institute Foundation, Minneapolis, MN and Rebecca Tung Hahn, MD, Columbia University, New York, NY
Keywords: Structural Heart Disease (SHD) and TAVI/TAVR/Aortic Valve
Background
The Anteris DurAVR transcatheter heart valve (THV) system (Anteris Technologies, Minneapolis, USA) is a first-in-class biomimetic THV with differentiating design features: single-piece leaflet geometry for optimal hemodynamics and flow characteristics; ADAPT anti-calcification process to reduce SVD; balloon-expandable platform with large open-cell geometry for coronary access. Methods
Prospective, non-randomized, single-arm, single-center, First-in-Human (FIH) study, designed to evaluate safety and feasibility in patients with severe symptomatic AS. Clinical, echo, CT, and Cardiac MRI assessments were performed up to 1 year.
Results
Twenty-eight patients were enrolled. Baseline characteristics: mean age 73.68±6.21 years, 75% female, mean STS 2.73±1.76 %, NYHA class II 64% and III 36%, and mean CT annulus diameter 22.61±1.27 mm. DurAVR THV was successfully implanted in 100% of the cases. Mean leaflet coaptation length was 8.3 mm at TEE. All patients showed excellent post-procedural hemodynamic results, despite a small mean annulus size: effective orifice area (EOA) of 2.17±0.22 cm
2, mean pressure gradient (MPG) of 8.34±1.87 mmHg, and dimensionless index (DI) of 0.61±0.07. No moderate or severe paravalvular leak or central aortic regurgitation were observed. The 1-year TTE completed for the first 12 patients confirmed sustained hemodynamics with EOA=1.98±0.15 cm
2 and MPG=9.22±3.01 mmHg. Additionally, laminar flow was consistently displayed on TEE and TTE. DurAVR showed a favorable safety profile in all patients at the latest follow-up. No valve-related complications, strokes, bleeding, or reoperations occurred. One patient died of a car accident (non-cardiac death) on post-operative day (POD) 343, three had access site complications, and a pacemaker was implanted in a patient with pre-existing conduction disturbances. No cases of moderate or severe prosthesis-patient mismatch were observed.
Additional Late-Breaking Science data is expected to be presented at SCAI 2024. Conclusions
The DurAVR THV FIH study provides at 1 year encouraging evidence of improved hemodynamics and normalized flow characteristics associated with its unique single-piece leaflet design. Additional studies are warranted.