Author + information
- Received July 3, 2013
- Revision received October 1, 2013
- Accepted October 8, 2013
- Published online March 4, 2014.
- Joachim Schofer, MD∗∗ (, )
- Antonio Colombo, MD†,
- Silvio Klugmann, MD‡,
- Jean Fajadet, MD§,
- Federico DeMarco, MD‡,
- Didier Tchétché, MD§,
- Francesco Maisano, MD†,
- Giuseppe Bruschi, MD‡,
- Azeem Latib, MD†,
- Klaudija Bijuklic, 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
- Thierry Lefevre, MD∗∗∗
- ∗Medical Care Center Prof. Mathey, Prof. Schofer, Hamburg University Cardiovascular Center, Hamburg, Germany
- †San Raffaele Hospital, Milan, Italy
- ‡Azienda Ospedaliera Niguarda Ca Granda, Milan, Italy
- §Clinique Pasteur, Toulouse, France
- ‖MedStar Health Research Institute, Georgetown University, Washington, DC
- ¶University of California Davis, Davis, California
- #St. Thomas' Hospital, London, England
- ∗∗The Heart Hospital, London, England
- ††University Hospital Bonn, Bonn, Germany
- ‡‡Krankenhaus der Barmherzigen, Trier, Germany
- §§Asklepios Klinik St Georg, Hamburg, Germany
- ‖‖Northwestern Memorial Hospital, Chicago, Illinois
- ¶¶L'Institut Cardiovasculaire Paris Sud, L'Institut Hospitalier Jacques Cartier, Massy, France
- ∗∗∗Clinical Imaging Analytics, Guerneville, California
- ↵∗Reprint requests and correspondence:
Dr. Joachim Schofer, Medical Care Center Prof. Mathey, Prof. Schofer, Hamburg University Cardiovascular Center, Wördemanns Weg 25-27, Hamburg, Hamburg 22527, Germany.
Objectives The study sought a prospective multicenter nonrandomized evaluation of the Direct Flow Medical (DFM) system for the treatment of severe aortic stenosis.
Background The DFM transcatheter aortic valve system is a nonmetallic design with a pressurized support structure that allows precise positioning, retrieval, and assessment of valve performance prior to permanent implantation.
Methods One hundred high surgical risk patients with severe aortic stenosis were evaluated for the primary endpoint. There were 75 patients in the group evaluable for the secondary endpoints and 25 in the pre-specified roll-in training phase. Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events adjudicated by clinical event committee and classified according to Valve Academic Research Consortium (VARC) criteria.
Results There was 99% freedom from all cause mortality at 30 days (primary endpoint). VARC criteria defined 30 day combined freedom from patient safety event rate was 91% and overall device success was 93%. The post-implantation echocardiography results demonstrated mild or no aortic regurgitation in 99% (73 of 74) with a mean gradient of 12.6 ± 7.1 mm Hg (n = 72) and effective orifice area of 1.50 ± 0.56 cm2 and New York Heart Association functional class was I or II in 92% of cases.
Conclusions The present study demonstrates the safety and efficacy of the DFM system in surgical high risk patients with severe aortic stenosis and complex anatomy aortic regurgitation was less than moderate in 99% of patients.
Dr. Schoer is a consultant for Direct Flow Medical. Drs. Colombo and Davidson are consultants and minor share holders for Direct Flow Medical. Dr. DeMarco is a consultant for and has received proctoring fees from Direct Flow Medical. Dr. Maisano is a consultant for Abbott Vascular, Medtronic, St. Jude Medical, Valtech Cardio; has received royalties from Edwards Lifesciences; and is cofounder of 4Tech. Dr. Bruschi is a consultant for Medtronic and a proctor of CoreValve (Medtronic). Dr. Latib serves on the advisory board for Medtronic; and is a consultant and proctor for Direct Flow Medical. Dr. Weismann has received grant support from Direct Flow Medical, Abbott Vascular, Medtronic, St. Jude Medical, Sorin, and Edwards Lifesciences. Dr. Mullen is a consultant for Edwards Lifesciences. Dr. Lefevre is a proctor for Edwards Lifesciences; and has received minor fees from Direct Flow Medical and Symetis. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received July 3, 2013.
- Revision received October 1, 2013.
- Accepted October 8, 2013.
- American College of Cardiology Foundation