Author + information
- Received December 2, 2019
- Revision received April 8, 2020
- Accepted April 14, 2020
- Published online July 6, 2020.
- Oliver K. Jawitz, MD, MHSa,b,∗ (, )@ojawitzMD,
- Brian C. Gulack, MD, MHSc,
- Maria V. Grau-Sepulveda, MD, MPHb,
- Roland A. Matsouaka, PhDb,
- Michael J. Mack, MDd,
- David R. Holmes Jr., MDe,
- John D. Carroll, MDf,
- Vinod H. Thourani, MDg and
- J. Matthew Brennan, MD, MPHh
- aDepartment of Surgery, Duke University Medical Center, Durham, North Carolina
- bDuke Clinical Research Institute, Durham, North Carolina
- cDepartment of Surgery, SickKids, Toronto, Ontario, Canada
- dDepartment of Cardiovascular Disease, Baylor Scott and White Health, Plano, Texas
- eDepartment of Cardiovascular Diseases, Mayo Clinic Health System, Minneapolis, Minnesota
- fDepartment of Medicine, University of Colorado School of Medicine, Aurora, Colorado
- gDepartment of Cardiovascular Surgery, Marcus Heart and Vascular Center, Piedmont Heart and Vascular Institute, Atlanta, Georgia
- hDepartment of Medicine, Duke University Medical Center, Durham, North Carolina
- ↵∗Address for correspondence:
Dr. Oliver K. Jawitz, Duke Clinical Research Institute, Department of Surgery, Duke University School of Medicine, DUMC Box #3850, Durham, North Carolina 27710.
Objectives This study sought to report the largest series of patients receiving a surgical reoperation after transcatheter aortic valve replacement (TAVR) using the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database.
Background TAVR has become an effective means of treating aortic stenosis. As TAVR is used in progressively lower-risk cohorts, management of device failure will become increasingly important.
Methods The STS Adult Cardiac Surgery Database was queried for patients with a history of prior TAVR undergoing surgical aortic valve replacement from 2011 to 2015. Observed-to-expected (O/E) mortality ratios were determined to facilitate comparison across reoperative indications and timing from index TAVR procedure.
Results A total of 123 patients met inclusion criteria (median age 77 years) with an STS Predicted Risk of Mortality of 4%, 4% to 8%, and >8% in 17%, 24%, and 59%, respectively. Median time to reoperation was 2.5 (interquartile range: 0.7 to 13.0) months, and the operative mortality rate was 17.1%. Common indications for reoperation included early TAVR device failures such as paravalvular leak (15%), structural prosthetic deterioration (11%), failed repair (11%), sizing or position issues (11%), and prosthetic valve endocarditis (10%). All pre-operative risk categories were associated with an increased O/E mortality ratio (Predicted Risk of Mortality <4%: O/E 5.5; 4% to 8%: O/E 1.7; >8%: O/E 1.2).
Conclusions SAVR following early failure of TAVR, while rare, is associated with worse-than-expected outcomes as compared with similar patients initially undergoing SAVR. Continued experience with this developing technology is needed to reduce the incidence of early TAVR failure and further define optimal treatment of failed TAVR prostheses.
The Society of Thoracic Surgeons National Database provided the data for this research. Analysis funding was provided by the Duke Clinical Research Institute and an Food and Drug Administration U01 grant (PI: Brennan). Dr. Jawitz has received funding provided by National Institutes of Health T-32 grant 5T32HL069749. Dr. Mack has served as a co-principal investigator for Edwards Lifesciences and Abbott; and has served as a study chair for Medtronic. Dr. Carroll has served as a local investigator for Medtronic and Edwards Lifesciences. Dr. Brennan has served as a consultant for Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Cardiovascular Interventions author instructions page.
- Received December 2, 2019.
- Revision received April 8, 2020.
- Accepted April 14, 2020.
- 2020 American College of Cardiology Foundation
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