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
• Leipzig University Hospital (Leipzig)
• Hamburg University Hospital (Hamburg)
• German Heart Center (Munich)
• Heart & Diabetes Center (Bad Oeynhausen)
• Kerckhoff Clinic (Bad Nauheim)
Dr. D. Holzhey / Prof. A. Linke
Dr. H. Treede / Prof. S. Baldus
Dr. S. Bleiziffer / Dr. A. Wagner
Dr. J. Börgermann / Dr. W. Scholtz
Dr. T. Walther / Dr. H. Möllmann
• University Hospital Zurich (Zurich)
Prof. V. Falk / Dr. R. Corti
• Cliniques Universitaires Saint-Luc (Brussels)
• Sheba Medical Center (Tel Hashomer)
Prof. J.-L. Vanoverschelde /
Dr. P. Astarci
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
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
*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
Engager CE Pivotal │Conclusions
• Transapical implantation of the Engager valve
– A positive risk/benefit
– High degree of procedure success and valve
• The low incidence of mild (4.2%) and absence
of moderate or severe paravalvular leak is
consistent with the design intent

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