Prospective Multicenter Evaluation of the Direct Flow Medical Transcatheter Aortic Valve System 12-Month Outcomes of the Evaluation of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the Treatment of Patients with Severe Aortic Stenosis (DISCOVER) Study

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 NickenigJan Malte Sinning, Karl Eugen Hauptmann, Ivar Friedrich, Michael Lauterbach, Michael Schmoeckel, Charles Davidson, Joachim Schofer

Research output: Contribution to journalReview article

27 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)68-75
Number of pages8
JournalJACC: Cardiovascular Interventions
Volume9
Issue number1
DOIs
StatePublished - Jan 11 2016

Keywords

  • aortic stenosids
  • transcatheter aortic valve replacement
  • transfemoral transcatheter aortic valve replacement

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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    Lefèvre, T., Colombo, A., Tchétché, D., Latib, A., Klugmann, S., Fajadet, J., De Marco, F., Maisano, F., Bruschi, G., Bijuklic, K., Nava, S., Weissman, N., Low, R., Thomas, M., Young, C., Redwood, S., Mullen, M., Yap, J., Grube, E., ... Schofer, J. (2016). Prospective Multicenter Evaluation of the Direct Flow Medical Transcatheter Aortic Valve System 12-Month Outcomes of the Evaluation of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the Treatment of Patients with Severe Aortic Stenosis (DISCOVER) Study. JACC: Cardiovascular Interventions, 9(1), 68-75. https://doi.org/10.1016/j.jcin.2015.09.027