The DISCOVER CE Trial: multicenter prospective trial of the direct flow medical transcatheter aortic valve

Abstract

Background: The 18F Direct Flow Medical transcatheter aortic valve system is a next generation technology that has the potential to improve the outcome of TAVR. This design has conformable sealing rings which minimizes paravalvular aortic regurgitation (AR) and permits full assessment of valve performance prior to permanent implantation. Objectives: The DISCOVER Trial is a prospective, multicenter, non-randomized CE evaluation of the safety and performance of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the treatment of severe aortic stenosis in patients considered ineligible for surgery or at high risk for surgical complications. Methods: Patients were required to have a logistic EuroScore ≥ 20 or other high surgical risk features not reflected by the logistic EuroSCORE. Patients were reviewed by an independent Patient Review Committee consisting of cardiac surgeons and interventional cardiologists. Acute procedural, 6 and 12 month clinical and echocardiographic VARC defined outcomes are assessed. All echocardiographic and angiographic data are evaluated by an independent core laboratory (Medstar) and adverse events adjudicated by an independent clinical event committee. Results: At the time of abstract submission, 50 patients have been enrolled in the CE cohort. The average age was 84±5 (range of 71 to 94) years. The baseline logistic EuroSCORE was 27±12% (range: 2 – 55%) and STS score was 11.3±10.3%. Other baseline characteristics included: LVEF = 55.4±10%, 50% with CAD, 15% prior CABG, and 29% with CKD. A 25mm valve was used in 48% and 27 mm in 52%. There was 98% freedom from all cause mortality at 30 days. VARC defined 30 day patient safety freedom from events was 91% and device success was 97%. Core lab assessment of post procedure echocardiograms demonstrated 97% mild or less paravalvular AR and a mean gradient of 11.4±5.2 mmHg. 82% of the patients were reported in NYHA Class I/II at 30 days. The complete 6 month and available 12 month clinical and echocardiographic data will be presented. Conclusions: The Direct Flow Medical Transcatheter Aortic Valve System provides excellent acute and midterm results including virtual elimination of aortic regurgitation. This technology has the potential to provide next generation clinical outcomes. The complete 6 month and available 12 month hemodynamic and clinical data will be available at the time of presentation.