Author + information
- Received June 7, 2018
- Revision received August 7, 2018
- Accepted August 20, 2018
- Published online November 12, 2018.
- Samir R. Kapadia, MDa,∗ (, )@ClevelandClinic,
- Chetan P. Huded, MD, MSca,
- Susheel K. Kodali, MDb,
- Lars G. Svensson, MD, PhDc,
- E. Murat Tuzcu, MDa,
- Suzanne J. Baron, MDd,
- David J. Cohen, MDd,
- D. Craig Miller, MDe,
- Vinod H. Thourani, MDf,
- Howard C. Herrmann, MDg,
- Michael J. Mack, MDh,
- Molly Szerlip, MDi,
- Raj R. Makkar, MDj,
- John G. Webb, MDk,
- Craig R. Smith, MDl,
- Jeevanantham Rajeswaran, PhDm,
- Eugene H. Blackstone, MDc,m,
- Martin B. Leon, MDn,
- for the PARTNER Trial Investigators
- aDepartment of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio
- bDepartment of Medicine, Division of Cardiology, Columbia University Medical Center/New York Presbyterian Hospital, New York, New York
- cDepartment of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio
- dDepartment of Cardiology, Saint Luke’s Health System, Kansas City, Missouri
- eDepartment of Cardiothoracic Surgery, Stanford University, Stanford, California
- fDepartment of Cardiac Surgery, MedStar Washington Hospital Center, Washington, DC
- gDivision of Cardiology, University of Pennsylvania Health System, Philadelphia, Pennsylvania
- hDepartment of Cardiovascular Surgery, Baylor Scott & White Health, Plano, Texas
- iDepartment of Cardiology, Baylor Scott & White Health, Plano, Texas
- jDepartment of Medicine, Cedars-Sinai Medical Center, Los Angeles, California
- kDivision of Cardiology, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada
- lDepartment of Surgery, Columbia University Medical Center/New York Presbyterian Hospital, New York, New York
- mDepartment of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio
- nDivision of Cardiology, Columbia University Medical Center/New York Presbyterian Hospital, New York, New York
- ↵∗Address for correspondence:
Dr. Samir Kapadia, Cleveland Clinic, 9500 Euclid Avenue, J2-3, Cleveland, Ohio 44195.
Background Transfemoral-transcatheter aortic valve replacement (TF-TAVR) is increasingly used to treat aortic stenosis, but risk of post-procedure stroke is uncertain.
Objectives The purpose of this study was to assess stroke risk and its association with quality of life after surgical aortic valve replacement (SAVR) versus TF-TAVR.
Methods The authors performed a propensity-matched study of 1,204 pairs of patients with severe aortic stenosis treated with SAVR versus TF-TAVR in the PARTNER (Placement of AoRTic TraNscathetER Valves) trials from April 2007 to October 2014. Outcomes were: 1) 30-day neurological events; 2) time-varying risk of neurological events early (≤7 days) and late (7 days to 48 months) post-procedure; and 3) association between stroke and quality of life 1 year post-procedure by the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score.
Results Thirty-day stroke (5.1% vs. 3.7%; p = 0.09) was similar, but 30-day major stroke (3.9% vs. 2.2%; p = 0.018) was lower after TF-TAVR than SAVR. In both groups, risk of stroke peaked in the first post-procedure day, followed by a near-constant low-level risk to 48 months. Major stroke was associated with a decline in quality of life at 1 year in both SAVR (KCCQ score median [15th, 85th percentile]: 79 [53, 94] without major stroke vs. 64 [30, 94] with major stroke; p = 0.03) and TF-TAVR (78 [49, 96] without major stroke vs. 60 [8, 99] with major stroke; p = 0.04).
Conclusions Despite similar early-peaking (<1 day post-procedure) neurological risk profiles, SAVR is associated with a higher risk of early major stroke than TF-TAVR. Periprocedural strategies are needed to reduce stroke risk after aortic valve procedures. (Placement of AoRTic TraNscathetER Valve Trial [PARTNER]; NCT00530894)
The PARTNER trial is funded by Edwards Lifesciences. Drs. Svensson, Miller, Mack, Webb, Smith, and Leon are members 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. Baron has served as a consultant for Edwards Lifesciences; and has received travel reimbursement from Medtronic. Dr. Cohen has received research grant support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott Vascular; and has received consulting income from Edwards Lifesciences and Medtronic. Dr. Miller has served as co-Principal Investigator of the Abbott Vascular COAPT MitraClip Trial; has served as a consultant for Medtronic; and has served as a Stanford Principal Investigator for the Medtronic SURTAVI Trial and the Edwards Lifesciences COMMENCE Trial and PARTNER I, II, and III Trials. Dr. Thourani is an advisor for Edwards Lifesciences, Abbott Vascular, Gore Vascular, Bard Medical, JenaValve, and Boston Scientific. Dr. Szerlip has served on the speakers bureau; and served as a proctor for Edwards Lifesciences. Dr. Makkar has served as a consultant with Cordis and Medtronic; and has research grants with Edwards Lifesciences and St. Jude Medical. Dr. Webb has served as a consultant for Edwards Lifesciences. Dr. Blackstone is head of the Cleveland Clinic PARTNER Publications Office, which carries out independent analyses of data stemming from the PARTNER trials. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received June 7, 2018.
- Revision received August 7, 2018.
- Accepted August 20, 2018.
- 2018 American College of Cardiology Foundation
This article requires a subscription or purchase to view the full text. If you are a subscriber or member, click Login or the Subscribe link (top menu above) to access this article.