Joachim Schofer1, Fabian Nietlispach2, Klaudija Bijuklic3, Antonio Colombo4, Fernando Gatto5, Federico De Marco6, Antonio Mangieri4, Lorenz Hansen7, Giuseppe Bruschi6, Neil Ruparelia4, Friedrich-Christian Rieß7, Franscesco Maisano2, Azeem Latib4. 1. Albertinen Heart Center, Hamburg, Germany; Medical Care Center Prof. Mathey Prof. Schofer, Hamburg, Germany. Electronic address: Schofer@herz-hh.de. 2. University Heart Center, Cardiology and Cardiovascular Surgery, University Hospital Zürich, Zurich, Switzerland. 3. Medical Care Center Prof. Mathey Prof. Schofer, Hamburg, Germany. 4. Interventional Cardiology Unit, San Raffaele Scientific Institute & EMO-GVM Centro Cuore Colombus, Milan, Italy. 5. Herz-Zentrum Saar, SHG-Kliniken Völklingen, Völklingen, Germany. 6. Cardiology and Cardiac Surgery Department, Niguarda Ca' Granda Hospital, Milan, Italy. 7. Albertinen Heart Center, Hamburg, Germany.
Abstract
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.
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.
Authors: Paola Angela Maria Purita; Luisa Salido Tahoces; Chiara Fraccaro; Luca Nai Fovino; Won-Keun Kim; Cláudio Espada-Guerreiro; Ole De Backer; Morritz Seiffert; Luis Nombela-Franco; Raul Moreno Gomez; Antonio Mangieri; Anna Franzone; Francesco Bedogni; Fausto Castriota; Tiziana Attisano; Lars Søndergaard; Rosana Hernandez Antolin; Giuseppe Tarantini Journal: Int J Cardiol Heart Vasc Date: 2020-02-12