Author + information
- Antonio Colombo,
- Federico De Marco,
- Jean Fadajet,
- Francesco Maisano,
- Azeem Latib,
- Didier Tchétché,
- Silvio Klugmann,
- Giuseppe Bruschi,
- Klaudija Bijuklic,
- Charles J. Davidson,
- Thierry Lefevre and
- Joachim Schofer
The 18F Direct Flow Medical transcatheter aortic valve system is a second generation technology that has the potential to improve the outcome of TAVR. This design has conformable sealing rings which minimizes aortic regurgitation and permits full assessment of valve performance prior to permanent implantation.
The DISCOVER Trial is a prospective, multicenter, non–randomized CE evaluation of the 18F Direct Flow Percutaneous Aortic Valve System for the treatment of severe aortic stenosis. In the CE cohort, 40 patients were enrolled to determine the safety and performance of the device. Patients were required to have a logistic EuroScore ≥ 20 or other high surgical risk features not reflected by the EuroSCORE. Patients were reviewed by an independent Patient Review Committee consisting of cardiac surgeons and interventional cardiologists. All echocardiographic and angiographic data are evaluated by an independent core laboratory (Medstar) and adverse events adjudicated by clinical event committee. The 6–month clinical and echocardiographic VARC defined outcomes are being evaluated
Average age of the 40 patients enrolled was 83 (range: 71 – 94) years. The baseline logistic EuroSCORE was 27% (range: 7 – 55%) and STS score was 11.0% +/– 10.5%. Other baseline characteristics included: LVEF = 62+/– 6%, 50% with CAD, and 15% prior CABG. A 25mm valve was used in 48% and 27 mm in 52%. There was 97% freedom from all cause mortality at 30 days with 1 death from pneumonia at day 12. VARC defined 30 day freedom from the combined safety endpoint was 91% and device success was 97%. Core lab assessment of post–procedure echocardiograms demonstrated 95% had mild or no AR. 82% of patients were in NYHA Class I/II at 30 days. The complete 6 month clinical and echocardiographic will be available at the time of presentation.
The Direct Flow Medical Transcatheter Aortic Valve System allows full assessment of patient outcomes prior to final device deployment. This unique technology provides precise placement and annular sealing with the potential to improve clinical outcomes of TAVR. The 6 month clinical and device outcomes will be available at the time of presentation.
West, Room 2010
Sunday, March 10, 2013, Noon–12:15 p.m.
Session Title: Valvular Heart Disease: Prognostic Features and Technical Advances to Optimize TAVR Outcomes
Abstract Category: 32. Valvular Heart Disease: Therapy
Presentation Number: 931–8
- 2013 American College of Cardiology Foundation