Transfemoral Implantation of a Fully Repositionable and Retrievable Transcatheter Valve for Noncalcified Pure Aortic Regurgitation
| Autor: | Friedrich Christian Rieß, Fabian Nietlispach, Azeem Latib, Giuseppe Bruschi, Neil Ruparelia, Antonio Colombo, Lorenz Hansen, Franscesco Maisano, Fernando Gatto, Federico De Marco, Joachim Schofer, Antonio Mangieri, Klaudija Bijuklic |
|---|---|
| Rok vydání: | 2015 |
| Předmět: |
medicine.medical_specialty
pure aortic regurgitation business.industry medicine.medical_treatment Direct Flow Medical Hemodynamics Regurgitation (circulation) transfemoral aortic valve replacement medicine.disease Prosthesis Surgery medicine.anatomical_structure Aortic valve replacement Internal medicine Clinical endpoint Cardiology Medicine Heart valve Embolization Cardiology and Cardiovascular Medicine business Contraindication |
| Zdroj: | JACC: Cardiovascular Interventions. 8:1842-1849 |
| ISSN: | 1936-8798 |
| DOI: | 10.1016/j.jcin.2015.08.022 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|