Author + information
- Received August 28, 2018
- Revision received June 16, 2019
- Accepted June 18, 2019
- Published online August 26, 2019.
- Tarun Chakravarty, MDa,
- Akshar Patel, MDa,
- Samir Kapadia, MDb,
- Matthias Raschpichler, MDa,
- Richard W. Smalling, MDc,
- Wilson Y. Szeto, MDd,
- Yigal Abramowitz, MDa,
- Wen Cheng, MDa,
- Pamela S. Douglas, MDe,
- Rebecca T. Hahn, MDf,
- Howard C. Herrmann, MDd,
- Dean Kereiakes, MDg,
- Lars Svensson, MD, PhDb,
- Sung-Han Yoon, MDa,
- Vasilis C. Babaliaros, MDh,
- Susheel Kodali, MDf,
- Vinod H. Thourani, MDi,
- Maria C. Alu, MSf,
- Yangbo Liu, PhDj,
- Thomas McAndrew, PhDj,
- Michael Mack, MDk,
- Martin B. Leon, MDf,j and
- Raj R. Makkar, MDa,∗ ()
- aSmidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California
- bCleveland Clinic, Cleveland, Ohio
- cUniversity of Texas Health Science Center at Houston, Houston, Texas
- dUniversity of Pennsylvania, Philadelphia, Pennsylvania
- eDuke University Medical Center/Duke Clinical Research Institute, Durham, North Carolina
- fColumbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York, New York
- gThe Christ Hospital, Cincinnati, Ohio
- hEmory University, Atlanta, Georgia
- iMedstar Heart & Vascular Institute, Washington Hospital Center, Washington, DC
- jCardiovascular Research Foundation, New York, New York
- kBaylor Scott & White Health, Plano, Texas
- ↵∗Address for correspondence:
Dr. Raj R. Makkar, Cedars-Sinai Heart Institute, 8700 Beverly Boulevard, Los Angeles, California 90048.
Background There is paucity of evidence on the impact of anticoagulation (AC) after bioprosthetic aortic valve replacement (AVR) on valve hemodynamics and clinical outcomes.
Objectives The study aimed to assess the impact of AC after bioprosthetic AVR on valve hemodynamics and clinical outcomes.
Methods Data on antiplatelet and antithrombotic therapy were collected. Echocardiograms were performed at 30 days and 1 year post-AVR. Linear regression model and propensity-score adjusted cox proportional model were used to assess the impact of AC on valve hemodynamics and clinical outcomes, respectively.
Results A total of 4,832 patients undergoing bioprosthetic AVR (transcatheter aortic valve replacement [TAVR], n = 3,889 and surgical AVR [SAVR], n = 943) in the pooled cohort of PARTNER2 (Placement of Aortic Transcatheter Valves) randomized trials and nonrandomized registries were studied. Following adjustment for valve size, annular diameter, atrial fibrillation, and ejection fraction at the time of assessment of hemodynamics, there was no significant difference in aortic valve mean gradients or aortic valve areas between patients discharged on AC vs. those not discharged on AC, for either TAVR or SAVR cohorts. A significantly greater proportion of patients not discharged on AC had an increase in mean gradient >10 mm Hg from 30 days to 1 year, compared with those discharged on AC (2.3% vs. 1.1%, p = 0.03). There was no independent association between AC after TAVR and adverse outcomes (death, p = 0.15; rehospitalization, p = 0.16), whereas AC after SAVR was associated with significantly fewer strokes (hazard ratio [HR]: 0.17; 95% confidence interval [CI]: 0.05–0.60; p = 0.006).
Conclusions In the short term, early AC after bioprosthetic AVR did not result in adverse clinical events, did not significantly affect aortic valve hemodynamics (aortic valve gradients or area), and was associated with decreased rates of stroke after SAVR (but not after TAVR). Whether early AC after bioprosthetic AVR has impact on long-term outcomes remains to be determined. (Placement of AoRTic TraNscathetER Valves [PARTNERII A]; NCT01314313)
The PARTNER 2 Trial was funded by Edwards Lifesciences. Dr. Chakravarty has been a proctor and consultant for Edwards Lifesciences and Medtronic. Dr. Szeto has received grant support from Edwards Lifesicences and Metronic; and has served as a consultant for MicroInterventional Devices. Dr. Douglas has core lab contracts with Edwards Lifesciences. Dr. Hahn has core lab contracts with Edwards Lifesciences. Dr. Herrmann has received grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic; and has served as a consultant for Edwards Lifesciences. Dr. Kereiakes has served as a consultant for Boston Scientific, Abbott Vascular, and REVA Medical Inc. Dr. Svensson has served as an unpaid member of the PARTNER Trial Executive Committee (Edwards Lifesciences); holds equity in Cardiosolutions and ValvXchange; and holds intellectual property rights for Posthorax. Dr. Babaliaros has served as a consultant for Edwards Lifesciences and Abbott Vascular. Dr. Kodali has served as a consultant for Abbott Vascular, Merrill Lifesciences, and Claret Medical; and has served on the Scientific Advisory Boards of Thubrikar Aortic Valve, Inc., Dura Biotech, and Biotrace Medical. Dr. Thourani has served on the Advisory Boards of Abbott Vascular, Gore Vascular, Bard Medical, JenaValve, and Boston Scientific. Dr. Mack has served as an unpaid member of the PARTNER Trial Executive Committee (Edwards Lifesciences). Dr. Leon has served as an unpaid member of the PARTNER Trial Executive Committee (Edwards Lifesciences). Dr. Makkar has received grant support from Edwards Lifesciences and St. Jude Medical; and has served as a consultant for Abbott Vascular, Cordis, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.
- Received August 28, 2018.
- Revision received June 16, 2019.
- Accepted June 18, 2019.
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