Prospective Multicenter Evaluation of the Direct Flow Medical Transcatheter Aortic Valve System
| Autor: | Ivar Friedrich, Didier Tchetche, Giuseppe Bruschi, Francesco Maisano, Martyn Thomas, Federico De Marco, Jan Malte Sinning, Karl Eugen Hauptmann, Michael Lauterbach, Neil J. Weissman, Antonio Colombo, Jean Fajadet, Klaudija Bijuklic, Michael J. Mullen, Charles J. Davidson, Thierry Lefèvre, Christopher Young, Reginald I. Low, Michael Schmoeckel, Azeem Latib, Stefano Nava, Simon Redwood, Joachim Schofer, John Yap, Eberhard Grube, Silvio Klugmann, Georg Nickenig |
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| Rok vydání: | 2016 |
| Předmět: |
Aortic valve
medicine.medical_specialty business.industry medicine.medical_treatment Regurgitation (circulation) 030204 cardiovascular system & hematology medicine.disease Surgery 03 medical and health sciences Stenosis 0302 clinical medicine medicine.anatomical_structure Valve replacement Internal medicine Aortic valve stenosis Cardiology Medicine 030212 general & internal medicine Heart valve Cardiology and Cardiovascular Medicine business Stroke Cardiac catheterization |
| Zdroj: | JACC: Cardiovascular Interventions. 9:68-75 |
| ISSN: | 1936-8798 |
| Popis: | Objectives The 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. Background The 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. Methods A 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. Results Patients 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 . Conclusions At 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. |
| Databáze: | OpenAIRE |
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