Author + information
- Received April 9, 2015
- Revision received September 9, 2015
- Accepted September 24, 2015
- Published online January 11, 2016.
- Thierry Lefèvre, MD∗∗ (, )
- Antonio Colombo, MD†,
- Didier Tchétché, MD‡,
- Azeem Latib, MD†,
- Silvio Klugmann, MD§,
- Jean Fajadet, MD‡,
- Federico De Marco, MD§,
- Francesco Maisano, MD†,
- Giuseppe Bruschi, MD§,
- Klaudija Bijuklic, MD‖,
- Stefano Nava, MD§,
- Neil Weissman, MD¶,
- Reginald Low, MD#,
- Martyn Thomas, MD∗∗,
- Christopher Young, MD∗∗,
- Simon Redwood, MD∗∗,
- Michael Mullen, MD††,
- John Yap, MD††,
- Eberhard Grube, MD‡‡,
- Georg Nickenig, MD‡‡,
- Jan-Malte Sinning, MD‡‡,
- Karl Eugen Hauptmann, MD§§,
- Ivar Friedrich, MD§§,
- Michael Lauterbach, MD§§,
- Michael Schmoeckel, MD‖‖,
- Charles Davidson, MD¶¶ and
- Joachim Schofer, MD‖
- ∗Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France
- †San Raffaele Hospital, Milan, Italy
- ‡Clinique Pasteur, Toulouse, France
- §Azienda Ospedaliera Niguarda Ca Granda, Milan, Italy
- ‖Medical Care Center Hamburg University Cardiovascular Center, Hamburg, Germany
- ¶MedStar Health Research Institute, Georgetown University, Washington, DC
- #University of California Davis, Davis, California
- ∗∗St. Thomas’ Hospital, London, United Kingdom
- ††The Heart Hospital, London, United Kingdom
- ‡‡University Hospital Bonn, Bonn, Germany
- §§Krankenhaus der Barmherzigen, Trier, Germany
- ‖‖Asklepios Klinik St Georg, Hamburg, Germany
- ¶¶Northwestern Memorial Hospital, Chicago, Illinois
- ↵∗Reprint requests and correspondence:
Dr. Thierry Lefèvre, Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, 6 avenue du Noyer Lambert, 91300 Massy, France.
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 cm2.
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.
- aortic stenosids
- transcatheter aortic valve replacement
- transfemoral transcatheter aortic valve replacement
Dr. Lefèvre has received minor fees from Direct Flow Medical. Dr. Colombo is a shareholder in Direct Flow Medical. Dr. Latib is on the Advisory Board of Medtronic and is a consultant and proctor for Direct Flow Medical. Dr. De Marco is a consultant and proctor for Direct Flow Medical. Dr. Maisano is a cofounder of TSP Medical and has received royalties from Edwards Lifesciences. Dr. Bruschi is a consultant for Direct Flow Medical and Medtronic. Dr. Weissman has received grant support from Direct Flow Medical. Abbott Vascular, Boston Scientific, Medtronic, St. Jude Medical, Edwards Lifesciences, and Sorin. Dr. Low is a consultant for Abbott Vascular, Boston Scientific, and Direct Flow Medical; has received honoraria from Abbott Vascular and Boston Scientific; and has equity in Direct Flow Medical. Dr. Sinning has received speaker honoraria from Medtronic, Edwards Lifesciences, and Direct Flow Medical and has received research grants from Medtronic and Edwards Lifesciences. Dr. Davidson is a consultant for and has stock options in Direct Flow Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received April 9, 2015.
- Revision received September 9, 2015.
- Accepted September 24, 2015.
- 2016 American College of Cardiology Foundation