Author + information
- Received May 22, 2018
- Revision received August 14, 2018
- Accepted August 14, 2018
- Published online August 28, 2018.
- Shmuel Chen, MD, PhD1,#∗ (, )
- Bjorn Redfors, MD, PhD1,2,∗,
- Ori Ben-Yehuda, MD1,
- Aaron Crowley, MA1,
- Kevin L. Greason, MD3,
- Maria C. Alu, MS4,
- Matthew T. Finn, MD4,
- Torsten P. Vahl, MD4,
- Tamim Nazif, MD4,
- Vinod H. Thourani, MD5,
- Rakesh M. Suri, MD, DPhil6,
- Lars Svensson, MD, PhD6,
- John G. Webb, MD7,
- Susheel K. Kodali, MD4 and
- Martin B. Leon, MD1,4
- 1Cardiovascular Research Foundation, New York, NY
- 2Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden
- 3Department of Cardiovascular Surgery, Mayo Clinic, Rochester, MN
- 4Columbia University Medical Center/ NewYork-Presbyterian Hospital, New York, NY
- 5Medstar Heart & Vascular Institute, Washington, DC
- 6Cleveland Clinic, Cleveland, OH
- 7St. Paul’s Hospital, University of British Columbia, Vancouver, BC, Canada
- ↵#Address for Correspondence: Shmuel Chen, MD, PhD Cardiovascular Research Foundation 1700 Broadway, 8th Floor New York, NY 10019 Phone: 646-434-4135 Fax: 646-434-4700
Background Prior cardiac surgery (PCS) is associated with increased surgical risk and post-operative complications following surgical aortic valve replacement (SAVR), but whether this risk is similar in transcatheter aortic valve replacement (TAVR) is unclear.
Objectives We sought to further evaluate clinical outcomes in patients with and without PCS.
Methods In the PARTNER 2A trial, 2032 patients with severe AS at intermediate surgical risk were randomized to TAVR with the SAPIEN XT valve or SAVR. Adverse clinical outcomes at 30-days and 2-years were compared using Kaplan Meier event rates and multivariable Cox proportional hazards regression models. The primary end point of the PARTNER 2 trial was all cause death and disabling stroke.
Results 509 patients (25.1%) had PCS, mostly (98.2%) coronary artery bypass grafting (CABG). There were no significant differences between TAVR and SAVR in patients with or without PCS, in the rates of the primary endpoint at 30 days or 2 years. Nevertheless, an interaction was observed between PCS and treatment arm; while no-PCS patients treated with TAVR had higher rates of 30-day major vascular complications than patients treated with SAVR (adjusted HR 2.66, 95% CI 1.68-4.22), the opposite is true for patients with PCS (adjusted HR 0.27, 95% CI 0.11-0.66) (pinteraction<0.0001). A similar interaction was observed for life threatening or disabling bleeding.
Conclusions In the PARTNER 2A Trial of intermediate-risk patients with severe AS undergoing SAVR versus TAVR, the relative risk of two-year adverse clinical outcomes were similar between TAVR and SAVR in patients with or without PCS.
- Transcatheter aortic valve replacement (TAVR)
- transcatheter heart valve (THV)
- aortic stenosis (AS)
- surgical aortic valve replacement (SAVR)
↵∗ equal contributors
The PARTNER 2 Trial was funded by Edwards Lifesciences.
Ms. Alu has received consulting fees from Claret Medical.
Dr. Nazif has received consulting fees from Edwards Lifesciences.
Dr. Thourani is an advisor for Edwards Lifesciences, Abbott Vascular, Gore Vascular, Bard Medical, JenaValve, and Boston Scientific.
Dr. Suri has received research grants from Sorin, Abbott, Edwards Lifesciences, and St. Jude Medical.
Dr. Svensson is a member of the PARTNER Trial Executive Committee (no direct compensation).
Dr. Webb is a consultant for Edwards Lifesciences and a member of the PARTNER Trial Executive Committee (no direct compensation).
Dr. Kodali has received consulting fees from Edwards Lifesciences and Claret Medical and serves on the advisory boards of Thubrikar Aortic Valve, Inc., Duratech, and VS Medtech.
Dr. Leon is a member of the PARTNER Trial Executive Committee (no direct compensation).
The other authors report nothing to disclose.
- Received May 22, 2018.
- Revision received August 14, 2018.
- Accepted August 14, 2018.