Outcome of Patients Treated With Engager Transapical Aortic Valve Implantation: One-Year Results of the Feasibility Study

Sündermann, Simon H. MD*; Grünenfelder, Jürg MD, PhD*; Corti, Roberto MD, PhD; Rastan, Ardawan J. MD; Linke, Axel MD, PhD§; Lange, Rüdiger MD, PhD; Falk, Volkmar MD, PhD*; Bleiziffer, Sabine MD

Innovations: Technology & Techniques in Cardiothoracic & Vascular Surgery: September/October 2013 - Volume 8 - Issue 5 - p 332–336
doi: 10.1097/IMI.0000000000000018
Original Articles

Objective: The aim of this study was to investigate the short-term and midterm outcome of the Engager transcatheter aortic valve implantation (TAVI) system, a transapical self-expanding valve device with anatomic orientation.

Methods: Transapical aortic valve implantation with the Engager valve prosthesis was performed in 10 patients. Endpoints were defined according to the Valve Academic Research Consortium recommendations for reporting outcomes of TAVI in clinical trials. Follow-up has been completed after 30 days and 1 year.

Results: All patients underwent the implantation procedure successfully. No device-related or delivery system–related complications were observed. One patient died of non–device-related reasons at postoperative day 23 in multiorgan failure. At 30-day follow-up, no more than mild transvalvular and paravalvular aortic regurgitation were seen. After 1 year, no transvalvular regurgitation was observed as assessed by transthoracic echocardiography. None of the patients had more than mild paravalvular leakage. The mean ± SD gradient was 15.3 ± 4.2 mm Hg. New York Heart Association class decreased one degree in mean and sustained until 1-year follow-up. No more patients died until 1-year follow-up.

Conclusions: Application of the Engager TAVI system is safe and reliable. Prosthesis deployment in an anatomically correct position was facilitated by the design of the valve prosthesis and successful in all patients. No device-related or delivery system–related complications occurred. Procedural, short-term, and midterm results up to 1 year concerning the aortic valve performance are promising, with stable mean gradients and low rates of even mild regurgitation.

From the *Division of Cardiovascular Surgery, and †Division of Cardiology, University Hospital Zurich, Zurich, Switzerland; ‡Department of Cardiac Surgery, and §Department of Cardiology, Heart Center Leipzig, Leipzig, Germany; and ∥Department of Cardiovascular Surgery, German Heart Centre Munich, Munich, Germany.

Accepted for publication September 13, 2013.

Disclosures: Roberto Corti, MD, PhD; Axel Linke, MD, PhD; Rüdiger Lange, MD, PhD; Volkmar Falk, MD, PhD; and Sabine Bleiziffer, MD, are consultants for Medtronic, Inc, Minneapolis, MN USA. Simon H. Sündermann, MD; Jürg Grünenfelder, MD, PhD; and Ardawan J. Rastan, MD, declare no conflicts of interest.

Address correspondence and reprint requests to Simon Sündermann, MD, Division of Cardiovascular Surgery, University Hospital Zurich, Rämistrasse 100, 8091 Zurich, Switzerland. E-mail: simon.suendermann@usz.ch.

©2013 by the International Society for Minimally Invasive Cardiothoracic Surgery