Author + information
- Received December 18, 2018
- Revision received May 20, 2019
- Accepted July 30, 2019
- Published online January 20, 2020.
- Ulrich Schäfer, MDa,∗ (, )
- Jörg Kempfert, MDb,
- Stefan Verheye, MDc,
- Francesco Maisano, MDd,
- Holger Thiele, MDe,
- Martin Landt, MDf,
- Michael Haude, MDg,
- Tanja K. Rudolph, MDh,
- Hüseyin Ince, MDi,j,
- Stephan Kische, MDi,j,
- Hendrik Treede, MDk,
- Pim Tonino, MDl and
- Lenard Conradi, MDm
- aDepartment of General and Interventional Cardiology, University Heart Center Hamburg, Hamburg, Germany
- bDepartment of Cardiothoracic and Vascular Surgery, German Heart Center Berlin, Berlin, Germany
- cInterventional Cardiology, ZNA Middelheim Hospital, Antwerp, Belgium
- dDivision of Cardiac Surgery, University Hospital Zurich, Zurich, Switzerland
- eDepartment of Internal Medicine/Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany
- fHeart Center, Segeberger Kliniken (Academic Teaching Hospital of the Universities of Kiel, Lübeck, and Hamburg), Bad Segeberg, Germany
- gMedical Clinic I Städtische Kliniken Neuss Lukaskrankenhaus, Neuss, Germany
- hClinic for Cardiology, Angiology, and Pneumology and Intensive Care Medicine, Heart Center of the University Clinic Cologne, Cologne, Germany
- iDepartment of Cardiology, Vivantes Klinikum im Friedrichshain und Am Urban, Berlin, Germany
- jDepartment of Cardiology, Universitätsmedizin Rostock, Rostock, Germany
- kDepartment of Cardiac Surgery, Mid-German Heart Centre, University Hospital Halle, Halle, Germany
- lDepartment of Cardiology, Catharina Ziekenhuis, Eindhoven, the Netherlands
- mDepartment of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany
- ↵∗Address for correspondence:
Prof. Dr. med. Ulrich Schäfer, Department of General and Interventional Cardiology, Marienkrankenhaus Hamburg, Alfredstrasse 9, 22087 Hamburg, Germany.
Objectives The aim of this study was to assess the safety and performance of a newly introduced transfemoral self-expanding supra-annular transcatheter heart valve.
Background Transcatheter aortic valve replacement has become an established procedure, and newer transcatheter heart valves aim to supplement the current armamentarium.
Methods BIOVALVE-I is a prospective, single-center feasibility study enrolling 13 high-risk patients with severe aortic stenosis, and BIOVALVE-II is a multicenter pilot study enrolling a further 55 patients under the same protocol.
Results Patients’ mean age was 82.4 ± 5.3 years, 57.4% had concomitant coronary artery disease, 50.0% had renal insufficiency stage ≥3, 32.4% had diabetes mellitus, 29.4% had current anemia, 19.1% had chronic obstructive pulmonary disease, 19.1% were frail, and 17.6% had prior cerebrovascular events. The primary endpoint, early safety according to the Valve Academic Research Consortium-2 guidelines, was observed in 13 patients (19.1%). One patient (1.5%) died through 30 days of a noncardiac cause, and 4 patients (7.8%) died through 180 days. Disabling stroke occurred at 30 days in 1 patient (1.5%) and at 180 days in 2 patients (3.2%). New permanent pacemakers up to 30 days were implanted in 9 patients (13.4%). Two patients (3.8%) had moderate or severe paravalvular leakage at 30 days and 4 (9.1%) at 6 months, mean effective orifice area was 2.0 ± 0.4 cm2 and 1.9 ± 0.5 cm2, and mean gradient was 6.4 mm Hg at 30 days and 6 months.
Conclusions Clinical outcomes with the Biovalve self-expanding transcatheter heart valve were similar to those seen in other first-in-human studies with first-generation devices for severe aortic stenosis.
This study was sponsored by Biotronik (Buelach, Switzerland). Dr. Schäfer is a consultant and proctor for Edwards Lifesciences, Abbott Vascular, Biotronik, Jena Valve Technology, Medtronic, Symetis, and Boston Scientific; has received speaker honoraria and travel compensation from JenaValve Technology, Edwards Lifesciences, Abbott Vascular, Medtronic, Biotronik, Direct Flow Medical, Symetis, and Boston Scientific; and has received study grants from JenaValve Technology, Edwards Lifesciences, Abbott Vascular, Biotronik, Symetis, and Boston Scientific. Dr. Ince is a proctor for Abbott and Boston Scientific. Dr. Verheye has received speaker honoraria from Alvimedica, Biotronik, and Elixir Medical; and is a consultant to Neovasc. Dr. Haude has received study grants and personal fees from Biotronik, Abbott Vascular, Cardiac Dimensions, and Philips. Dr. Treede is a consultant and proctor for Biotronik. Dr. Rudolph is a proctor for Boston Scientific; and has received speaker honoraria from Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic. Dr. Kempfert is a proctor for Biotronik, Medtronic, Boston, Abbott, and Edwards Lifesciences. Dr. Conradi has received lecture fees and travel support from Biotronik. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received December 18, 2018.
- Revision received May 20, 2019.
- Accepted July 30, 2019.
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