AltaValve Early Feasibility Study: One-Year Outcomes with Atrial Fixation Transcatheter Mitral Valve Replacement
Presenter
Konstantinos Voudris, M.D., Ph.D., FSCAI, Minneapolis Heart Institute - Abbott Northwestern Hospital, Minneapolis , MN
Ninios Vlasis, M.D., Interbalkan Medical Center, Thessaloniki, Thessaloniki, Greece, Krzysztof Wróbel, M.D., Ph.D., Lazarski University, Warsaw, Warsaw, Masovian Voivodeship, Poland, Marek Grygier, M.D., Chair and 1st Department of Cardiology, Poznan University of Medical Sciences, Pozan, Wielkopolskie Voivodeship, Poland, Paul Sorajja, M.D., FSCAI, Banner Health, Phoenix, AZ, Naeem K. Tahirkheli, M.D., Oklahoma Cardiovascular Associates, Edmond, OK, Philippe Genereux MD, M.D., Atlantic Health System, Morristown, NJ, Michael J. Rinaldi, M.D., FSCAI, Sanger Heart & Vascular Institute, Charlotte, NC, Michael J. Reardon, MD, Houston Methodist Hospital, Houston, TX, Michael O Zembala, M.D., Department of Cardiac Surgery, Heart and Lung Transplantation and Mechanical Circulatory Support, Silesian Center For Heart Diseases, Zabrze, Silesian Voivodeship, Poland, Hiram G Bezerra, M.D., Ph.D., Tampa General Hospital, tAMPA, FL, Thomas E. Waggoner, D.O., Pima Heart & Vascular - Westside, Tucson, AZ, Konstantinos Voudris, M.D., Ph.D., FSCAI, Minneapolis Heart Institute - Abbott Northwestern Hospital, Minneapolis , MN, Ron Waksman, M.D., MedStar Washington Hospital Center, Washington, DC and Vinayak Bapat, M.D., Valve Science Center, Minneapolis Heart Institute Foundation, Minneapolis, MN
Keywords: TEER/TMVR/Mitral Valve
Background
The aim of this study was to evaluate long-term outcomes of the AltaValve™ System, a novel atrial fixation TMVR (4C Medical Technologies Inc., Minneapolis, MN) designed to treat a broad patient population including patients with narrow left ventricular outflow tract (LVOT), large a mitral valve annulus size, and mitral annular calcification.
Methods
This prospective, multi-center, single arm AltaValve Early Feasibility Study (EFS) evaluated the safety and performance of AltaValve System in patients (N=30) with symptomatic (≥3+) mitral regurgitation (MR) who were determined to be high surgical risk and unsuitable for transcatheter edge-to-edge repair. All patients were NYHA Class ≥II. Subjects were treated via transapical (n=13) or transseptal (n=17) approach. Safety, performance, functional and quality of life outcomes were assessed at baseline, discharge, 30-day, 6-month, and 1-year follow-up. 1-year hemodynamic assessment of AltaValve performance, based on an independent assessment, will be presented for the first time.
Results
At baseline, MR etiology was 43% degenerative, 50% functional, and 7% mixed. The study population had a mean age of 77.0 ± 6.2 years, was 63% female, and 80% presented with NYHA Class III/IV. Technical success and MR reduction was achieved in 97% of cases. At the 1-year follow-up, MR reduction (≤1+) and NYHA class I/II was maintained in 95% of patients. Echocardiographic assessment documented maintained LVEF (53% at 1-year as compared to 54% at baseline), mean mitral gradient 4.0mmHg and LVOT gradient 1.8mmHg at 1-year. Functional outcomes also improved, with average 6-minute walk test increasing by 43m. One patient developed HALT and thrombus due to non-adherence to medical therapy. No instances of stroke, device embolization, new atrial fibrillation, life-threatening bleeding, or new pacemaker replacement were observed.
Conclusions
The 1-year results from the AltaValve EFS show that the AltaValve System provides durable efficacy with a low rate of complications and sustained clinical benefit. These findings are now being further validated in the statistically powered ATLAS Pivotal Trial.