Transfemoral Implantation of a Fully  Repositionable and Retrievable  Transcatheter Valve for Noncalcified Pure  XXXX .

@entity1 @entity2478 @entity337 @entity460
OBJECTIVES: This study sought to evaluate the use of the Direct Flow Medical (DFM) transcatheter heart valve (Direct Flow Medical, Santa Rosa, California) for the treatment of noncalcific pure @entity337 ( @entity337 ). BACKGROUND: The treatment of noncalcific @entity337 has remained a relative contraindication with transcatheter heart valves due to challenges in anchoring devices in the absence of @entity460 , concerns of valve embolization, and the high risk of significant residual @entity2478 . METHODS: The study population consisted of @entity1 treated for severe noncalcific pure @entity337 with transfemoral implantation of a DFM transcatheter heart valve at 6 European centers. The primary endpoint was the composite endpoint of device success and the secondary endpoint was the composite early safety endpoint (according to the VARC-2 criteria). RESULTS: Eleven high-risk (STS score 8.84    8.9, Logistic EuroSCORE 19.9    7.1) @entity1 (mean age 74.7    12.9 years) were included. Device success was achieved in all @entity1 . In 1 @entity1 , the initial valve prosthesis was retrieved after pull-through, and a second valve was successfully deployed. The early safety endpoint was reached in 91% of the @entity1 , with 1 @entity1 requiring surgical aortic valve replacement secondary to downward dislocation of the prosthesis that was successfully managed with surgical aortic valve replacement. DFM implantation resulted in excellent hemodynamics with none or trivial paravalvular regurgitation in 9 @entity1 and a transprosthetic gradient of 7.7    5.1 mm  Hg at  30-day follow up. All @entity1 derived symptomatic benefit following the procedure, with 72% in New York Heart Association functional class I or II. CONCLUSIONS: This study reports the feasibility of treating severe noncalcific @entity337 with the Direct Flow prosthesis via the transfemoral route.
