Retrospective Study
Copyright ©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Cardiol. Dec 26, 2016; 8(12): 735-745
Published online Dec 26, 2016. doi: 10.4330/wjc.v8.i12.735
Comparison between the SAPIEN S3 and the SAPIEN XT transcatheter heart valves: A single-center experience
Fadi J Sawaya, Marco Spaziano, Thierry Lefèvre, Andrew Roy, Phillippe Garot, Thomas Hovasse, Antoinette Neylon, Hakim Benamer, Mauro Romano, Thierry Unterseeh, Marie-Claude Morice, Bernard Chevalier
Fadi J Sawaya, Marco Spaziano, Thierry Lefèvre, Andrew Roy, Phillippe Garot, Thomas Hovasse, Antoinette Neylon, Hakim Benamer, Mauro Romano, Thierry Unterseeh, Marie-Claude Morice, Bernard Chevalier, Department of Cardiology, Générale de Santé, Institut Cardiovasculaire Paris-Sud - Hôpital Privé Jacques Cartier, 91300 Massy, France
Author contributions: Both Sawaya FJ and Spaziano M contributed equally to the preparation of this manuscript; Sawaya FJ, Spaziano M designed and performed the research and wrote the paper; Chevalier B designed the research and supervised the report; Roy A designed the research and contributed to the analysis; Garot P, Hovasse T, Neylon A, Benamer H, Romano M, Unterseeh T, Morice MC provided clinical advice; Lefèvre T and Chevalier B supervised the report.
Institutional review board statement: This study was reviewed and approved by the Ethics Committee of the Institut Cardiovasculaire Paris Sud.
Informed consent statement: Patients were not required to give informed consent to the study because the analysis used anonymous clinical data that were obtained after each patient agreed to treatment by written consent.
Conflict-of-interest statement: Dr. Thierry Lefèvre is a proctor for Edwards LifeSciences. All other authors report no conflict of interest regarding this manuscript.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Bernard Chevalier, MD, Department of Cardiology, Générale de Santé, Institut Cardiovasculaire Paris-Sud - Hôpital Privé Jacques Cartier, 6 Avenue du Noyer Lambert, 91300 Massy, France. bchevali@aol.com
Telephone: +33-78-5949543 Fax: +33-18-7653311
Received: July 22, 2016
Peer-review started: July 26, 2016
First decision: September 6, 2016
Revised: September 26, 2016
Accepted: October 22, 2016
Article in press: October 24, 2016
Published online: December 26, 2016
Abstract
AIM

To investigate the clinical outcomes of transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 transcatheter heart valve (S3-THV) vs the SAPIEN XT valve (XT-THV).

METHODS

We retrospectively analyzed 507 patients that underwent TAVI with the XT-THV and 283 patients that received the S3-THV at our institution between March 2010 and December 2015.

RESULTS

Thirty-day mortality (3.5% vs 8.7%; OR = 0.44, P = 0.21) and 1-year mortality (25.7% vs 20.1%, P = 0.55) were similar in the S3-THV and the XT-THV groups. The rates of both major vascular complication and paravalvular regurgitation (PVR) > 1 were almost 4 times lower in the S3-THV group than the XT-THV group (major vascular complication: 2.8% vs 9.9%, P < 0.0001; PVR > 1: 2.4% vs 9.7%, P < 0.0001). However, the rate of new pacemaker implantation was almost twice as high in the S3-THV group (17.3% vs 9.8%, P = 0.03). In the S3 group, independent predictors of new permanent pacemaker were pre-procedural RBBB (OR = 4.9; P = 0.001), pre-procedural PR duration (OR = 1.14, P = 0.05) and device lack of coaxiality (OR = 1.13; P = 0.05) during deployment.

CONCLUSION

The S3-THV is associated to lower rates of major vascular complications and PVR but higher rates of new pacemaker compared to the XT-THV. Sub-optimal visualization of the S3-THV in relation to the aortic valvular complex during deployment is a predictor of new permanent pacemaker.

Keywords: SAPIEN-3 valve, Vascular complications, Permanent pacemaker, Lack of coaxiality, Paravalvular regurgitation

Core tip: The SAPIEN 3 transcatheter heart valve (S3-THV) is associated to lower rates of major vascular complications and PVR but higher rates of new pacemaker compared to the SAPIEN XT valve (XT-THV). Sub-optimal visualization of the S3-THV in relation to the aortic valvular complex during deployment is a predictor of new permanent pacemaker (PPM). Our findings highlight the increased importance to adequately visualize the S3-THV in relation to the aortic valvular complex during deployment, in order to improve device positioning and potentially mitigate new PPM requirements.