1. 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)
UC EE

2. 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

3. 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

4. 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

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

6. 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

7. Engager CE Pivotal │Subject Disposition

8. Engager CE Pivotal │Baseline Characteristics

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

10. 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).

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

12. 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.

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

14. Engager CE Pivotal │Pacemaker Implantation

15. 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