Direct flow medical percutaneous aortic valve: proof of concept.
OBJECTIVE
This paper reports the technical feasibility of using the Direct Flow Medical percutaneous aortic valve (PAV) to treat patients with severe aortic stenosis (AS).


RESULTS
Eight patients with critical AS underwent temporary implantation of the PAV. Two patients received open surgical implantation of the device while six patients underwent percutaneous implantation. The mean age of these eight patients was 58.1 years, mean pre-procedural aortic valve area was <0.65 cm2 and pre-procedural gradient was 87.6 +/- 12.4 mmHg. Procedural success was achieved in seven out of eight patients, with a mean post-implantation gradient of 17.9 +/- 9.1 mmHg. There was one death related to inferior hypogastric artery dissection. All other patients subsequently received open surgical explantation of the PAV and aortic valve replacement with a mechanical valve.


CONCLUSIONS
The Direct Flow Medical PAV is technically feasible and safe to deploy in humans with severe AS and results in a significant transaortic gradient reduction.
Low
Reginald I
RI
University of California, Davis Medical Center, Sacramento, CA, USA. reginald.low@ucdmc.ucdavis.edu
Bolling
Steven F
SF
Yeo
Khung Keong
KK
Ebner
Adrian
A
D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000601:surgery*; D005240:Feasibility Studies; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation; D006801:Humans; D008875:Middle Aged; D011183:Postoperative Complications; D011474:Prosthesis Design; D011859:Radiography; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014463:Ultrasonography