Author + information
- Received March 22, 2019
- Revision received May 2, 2019
- Accepted May 7, 2019
- Published online September 16, 2019.
- Jennifer A. Rymer, MD, MBAa,∗ (, )@jennifer_rymer,
- Qun Xiang, MSb,
- Alice Wang, MDc,
- David J. Cohen, MD, MScd,
- Nimesh D. Desai, MDe,
- Ajay J. Kirtane, MDf,
- G. Chad Hughes, MDc,
- J. Kevin Harrison, MDg,
- Andrzej S. Kosinski, PhDb,g and
- Sreekanth Vemulapalli, MDa
- aDepartment of Medicine, Duke University Medical Center, Durham, North Carolina
- bDuke Clinical Research Institute, Durham, North Carolina
- cDepartment of Surgery, Duke University Medical Center, Durham, North Carolina
- dSaint Luke’s Mid America Heart Institute and University of Missouri–Kansas City School of Medicine, Kansas City, Missouri
- eDepartment of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania
- fDepartment of Medicine, Columbia University Medical Center, New York, New York
- gDepartment of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, North Carolina
- ↵∗Address for correspondence:
Dr. Jennifer A. Rymer, Duke Clinical Research Institute, 200 Morris Street, Durham, North Carolina 27701.
Objectives This study sought to evaluate the outcomes and factors associated with aborted procedures among patients undergoing elective transcatheter aortic valve replacement (TAVR).
Background Elective TAVR procedures can be aborted because of device limitations or aborted for other reasons, including patient and procedural factors. Little is known about 30-day outcomes and factors associated with aborted procedures and procedures aborted because of device limitations (ADs).
Methods Patients undergoing elective TAVR procedures from 2011 to 2017 in the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry were examined. The incidence of aborted procedures, both ADs and procedures aborted for other reasons (AOs), was examined. Rates of 30-day all-cause death or stroke and a composite of vascular complications and bleeding events were compared between patients with and those without aborted procedures and between patients with ADs and those with AOs. Multivariate modeling identified factors associated with aborted procedures and ADs.
Results Among 106,169 patients who underwent TAVR between 2011 and 2017, procedures were aborted in 1,150 (1.1%) (581 ADs and 569 AOs). Patients with aborted procedures were more likely female with peripheral artery disease and more often treated at lower volume centers compared with those with nonaborted procedures (p < 0.01 for all). The incidence of aborted procedures and ADs decreased over the study period (p < 0.01). The adjusted rates of 30-day death and stroke were greater for aborted versus nonaborted procedures (odds ratio: 5.02; 95% confidence interval: 4.13 to 6.11). Peripheral artery disease, alternative access, and low institutional TAVR volume were factors associated with aborted procedures and ADs (p < 0.05 for all).
Conclusions The incidence of aborted procedures is declining, but peripheral artery disease and low institutional TAVR volume remain associated with aborted procedures. A thorough pre-procedural assessment and referral of challenging cases to high-volume centers may be strategies to minimize aborted procedures.
The Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry is an initiative of the Society of Thoracic Surgeons and the American College of Cardiology Foundation. This research was supported by the American College of Cardiology Foundation’s National Cardiovascular Data Registry and the Society of Thoracic Surgeons. Dr. Rymer was supported during the conduct of this study by an American College of Cardiology grant (William F. Keating award); and has received research grants from Boston Scientific and Abbott Vascular. Dr. Cohen has received research grants from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific; and has served as a consultant for Edwards Lifesciences and Medtronic. Dr. Desai has an unrestricted research grant from Gore; and has received speaking honoraria from Gore, Medtronic, and Edwards Lifesciences. Dr. Kirtane has received institutional funding from Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, AbioMed, Cardiovascular Systems, Inc., CathWorks, Siemens, Philips, and ReCor Medical. Dr. Kosinski’s research grants/ contracts from the Society of Thoracic Surgeons and the American College of Cardiology are research grants/contracts to the institution (Duke Clinical Research Institute) for the data warehouse and analytic center for the STS National Database and the Analytic Center for the Transcatheter Valve Therapeutics Database. Dr. Kosinski’s salary is in part supported by these research grants/contracts. Dr. Vemulapalli has received research grants from the American College of Cardiology, the Society of Thoracic Surgeons, Boston Scientific, Abbott Vascular, Patient Centered Outcomes Research Institute; and has served as a consultant for Boston Scientific, Premiere, Janssen, and Zafgen. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received March 22, 2019.
- Revision received May 2, 2019.
- Accepted May 7, 2019.
- 2019 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.