• Thierry Lefèvre, Antonio Colombo, Didier Tchétché, Azeem Latib, Silvio Klugmann, Jean Fajadet, Federico De Marco, Francesco Maisano, Giuseppe Bruschi, Klaudija Bijuklic, Stefano Nava, Neil Weissman, Reginald Low, Martyn Thomas, Christopher Young, Simon Redwood, Michael Mullen, John Yap, Eberhard Grube, Georg Nickenig, Jan-Malte Sinning, Karl Eugen Hauptmann, Ivar Friedrich, Michael Lauterbach, Michael Schmoeckel, Charles Davidson, and Joachim Schofer.
• Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France. Electronic address: t.lefevre@icps.com.fr.
• JACC Cardiovasc Interv. 2016 Jan 11; 9 (1): 68-75.

ObjectivesThe aim of this study was to assess the 1-year outcome after transcatheter aortic valve replacement (TAVR) of the Direct Flow Medical (DFM) valve in patients with severe symptomatic aortic stenosis who were contraindicated or high risk for surgery.BackgroundThe DFM transcatheter heart valve is a new-generation, nonmetallic aortic valve with a pressurized support structure and conformable double-ring annular sealing delivered through an 18-F sheath. The device allows repositioning, retrieval, and assessment of valve performance before permanent implantation.MethodsA prospective multicenter European registry was set up to determine the safety and performance of the valve in 100 consecutive patients (10 centers). Echocardiographic and angiographic data were evaluated by an independent core laboratory, and adverse events were adjudicated by a clinical events committee using Valve Academic Research Consortium criteria.ResultsPatients were 83.1 ± 5.9 years of age and had a logistic EuroSCORE of 22.5 ± 11.3% and a Society of Thoracic Surgeons score of 9.7 ± 8.7%. Correct valve positioning was obtained in 99% of cases with a combined 30-day safety endpoint at 10%, including major stroke in 5.0%, major vascular complications in 2.0%, and death in 1%. At 12 months, 95% of patients were in New York Heart Association functional class I or II. Freedom from any death was 90%, and freedom from any death or major stroke was 85%. Echocardiography demonstrated none/trace to mild aortic regurgitation in 100% of patients and an unchanged mean aortic gradient of 12.2 ± 6.6 mm Hg and effective orifice area of 1.6 ± 0.4 cm(2).ConclusionsAt 1 year, the DFM transcatheter heart valve had durable hemodynamics. This study demonstrates that the low rate of early complications and the low risk of significant aortic regurgitation translated into midterm clinical benefit.Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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