Thirty-day Outcomes from the Multi-centre European Pivotal Trial for Transapical Transcatheter Aortic Valve Implantation with a Self-expanding Prosthesis.

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Presentation transcript:

Thirty-day Outcomes from the Multi-centre European Pivotal Trial for Transapical Transcatheter Aortic Valve Implantation with a Self-expanding Prosthesis D. Holzhey University of Leipzig Heart Center, Leipzig, Germany H. Treede University Heart Center Hamburg, Hamburg, Germany S. Bleiziffer German Heart Center, Munich, Germany J. Börgermann Herz- und Diabeteszentrum, Bad Oeynhausen, Germany T. Walther Kerckhoff-Klinik, Bad Nauheim, Germany E. Raanani The Sheba Medical Center, Tel Hashomer, Israel J-L. Vanoverschelde Clinique Universitaires Saint Luc, Brussels, Belgium V. Falk University Hospital, Zurich, Switzerland (on behalf of the Engager Investigators) UC201400446 EE

Potential Conflicts of Interest Speaker's name: David Holzhey  I have the following potential conflicts of interest to report: Proctor: Medtronic The sponsor (Medtronic) contributed to this presentation by: Providing background information Compiling (analyzing and confirming accuracy of) data Creation of tables/charts/graphs depicting data

Engager │Background Optimal TAVI requires accurate valve positioning Engager TAVI System Allows anatomically correct rotational positioning of the valve Captures the native leaflets for sealing Is expected to ensure optimal positioning of the valve within the annulus Provides possible reduction of paravalvular regurgitation First report of the complete 30-day patient outcomes for all patients from the Engager European Pivotal Trial

Engager CE Pivotal │Study Overview Primary Endpoint: All-cause mortality at 30 days 100% of all subjects monitored Assessment by an independent echocardiography core lab All serious adverse events adjudicated by independent Clinical Events Committee Clinical and safety endpoints reported according to Valve Academia Research Consortium (VARC I) definition

Engager │Valve Design Control arms Self-expanding nitinol frame and polyester skirt Supra-annular valve function Anatomic alignment Bovine pericardial tissue

Engager │Pivotal Trial Sites Germany Leipzig University Hospital (Leipzig) Dr. D. Holzhey / Prof. A. Linke Hamburg University Hospital (Hamburg) Dr. H. Treede / Prof. S. Baldus German Heart Center (Munich) Dr. S. Bleiziffer / Dr. A. Wagner Heart & Diabetes Center (Bad Oeynhausen) Dr. J. Börgermann / Dr. W. Scholtz Kerckhoff Clinic (Bad Nauheim) Dr. T. Walther / Dr. H. Möllmann Switzerland University Hospital Zurich (Zurich) Prof. V. Falk / Dr. R. Corti Belgium Cliniques Universitaires Saint-Luc (Brussels) Prof. J.-L. Vanoverschelde / Dr. P. Astarci Israel Sheba Medical Center (Tel Hashomer) Dr. E. Raanani / Dr. V. Guetta

Engager CE Pivotal │Subject Disposition

Engager CE Pivotal │Baseline Characteristics

Engager CE Pivotal │Procedural Results *124 patients received the Engager bioprosthesis.

Engager CE Pivotal │Functional Status NYHA At 30 days, 23 patients could not be included: unable to assess (n=9), death(n=10), withdrawal (n=4).

Engager CE Pivotal │30-day Outcomes (N=125) NYHA *Calculated for all implanted patients (n=124)

Engager CE Pivotal │Paravalvular Regurgitation Independent Echo Core Lab Evaluation Core lab echocardiograms were reviewed for N=80 patients. 8/80 echos (10%) were unable to be assessed.

Engager CE Pivotal │Valve Performance Displayed as mean ± standard deviation.

Engager CE Pivotal │Pacemaker Implantation

Engager CE Pivotal │Conclusions Transapical implantation of the Engager valve provides A positive risk/benefit High degree of procedure success and valve positioning The low incidence of mild (4.2%) and absence of moderate or severe paravalvular leak is consistent with the design intent