The objective of the study was to assess events after 30 days with the DirectFLOW Medical Valve device in patients with severe aortic stenosis and high surgical risk. The device is designed to reduce post-implant aortic regurgitation; it has a low profile and high navigability and requires no post-dilatation or rapid pacing. The study included 70 patients who received the new valve and were evaluated according to the VARC criteria.
The 30-day survival was 99% and none required post-dilation or pacing. The success rate according to the VARC criteria was 89% and severe aortic regurgitation was observed post-implantation.
Conclusion: The use of the DirectFLOW device was safe and effective, virtually eliminating the occurrence of severe aortic regurgitation.
joachim_schofer_europcr
Joachim Schofer, MD.
2013-05-22
Original title: Prospective, multicentre evaluation of the 18f Direct Flow transcatheter aorticvalve: CE mark study.