TY - JOUR
T1 - Transfemoral Implantation of a Fully Repositionable and Retrievable Transcatheter Valve for Noncalcified Pure Aortic Regurgitation
AU - Schofer, Joachim
AU - Nietlispach, Fabian
AU - Bijuklic, Klaudija
AU - Colombo, Antonio
AU - Gatto, Fernando
AU - De Marco, Federico
AU - Mangieri, Antonio
AU - Hansen, Lorenz
AU - Bruschi, Giuseppe
AU - Ruparelia, Neil
AU - Rieß, Friedrich Christian
AU - Maisano, Franscesco
AU - Latib, Azeem
N1 - Publisher Copyright:
© 2015 American College of Cardiology Foundation.
PY - 2015/12/21
Y1 - 2015/12/21
N2 - 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 aortic regurgitation (AR). Background The treatment of noncalcific AR has remained a relative contraindication with transcatheter heart valves due to challenges in anchoring devices in the absence of calcium, concerns of valve embolization, and the high risk of significant residual paravalvular leak. Methods The study population consisted of patients treated for severe noncalcific pure AR 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) patients (mean age 74.7 ± 12.9 years) were included. Device success was achieved in all patients. In 1 patient, 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 patients, with 1 patient 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 patients and a transprosthetic gradient of 7.7 ± 5.1 mm Hg at 30-day follow up. All patients 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 AR with the Direct Flow prosthesis via the transfemoral route.
AB - 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 aortic regurgitation (AR). Background The treatment of noncalcific AR has remained a relative contraindication with transcatheter heart valves due to challenges in anchoring devices in the absence of calcium, concerns of valve embolization, and the high risk of significant residual paravalvular leak. Methods The study population consisted of patients treated for severe noncalcific pure AR 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) patients (mean age 74.7 ± 12.9 years) were included. Device success was achieved in all patients. In 1 patient, 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 patients, with 1 patient 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 patients and a transprosthetic gradient of 7.7 ± 5.1 mm Hg at 30-day follow up. All patients 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 AR with the Direct Flow prosthesis via the transfemoral route.
KW - Direct Flow Medical
KW - pure aortic regurgitation
KW - transfemoral aortic valve replacement
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U2 - 10.1016/j.jcin.2015.08.022
DO - 10.1016/j.jcin.2015.08.022
M3 - Article
C2 - 26604062
AN - SCOPUS:84955670350
SN - 1936-8798
VL - 8
SP - 1842
EP - 1849
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 14
ER -