Author + information
- Received February 28, 2020
- Revision received March 6, 2020
- Accepted March 10, 2020
- Published online June 1, 2020.
- Neel M. Butala, MD, MBAa,b,
- Mabel Chung, MD, MPHa,c,
- Eric A. Secemsky, MD, MSca,
- Pratik Manandhar, MSd,
- Guillaume Marquis-Gravel, MD, MScd,
- Andrzej S. Kosinski, PhDd,
- Sreekanth Vemulapalli, MDd,
- Robert W. Yeh, MD, MSca and
- David J. Cohen, MD, MSce,∗ ()
- aRichard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts
- bCardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts
- cDepartment of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts
- dDuke Clinical Research Institute, Durham, North Carolina
- eUniversity of Missouri–Kansas City, Kansas City, Missouri
- ↵∗Address for correspondence:
Dr. David J. Cohen, 824 West 56th Street, Kansas City, Missouri 64113.
Objectives The aims of this study were to examine variation in the use of conscious sedation (CS) for transcatheter aortic valve replacement (TAVR) across hospitals and over time and to evaluate outcomes of CS compared with general anesthesia (GA) using instrumental variable analysis, a quasi-experimental method to control for unmeasured confounding.
Background Despite increasing use of CS for TAVR, contemporary data on utilization patterns are lacking, and existing studies evaluating the impact of sedation choice on outcomes may suffer from unmeasured confounding.
Methods Among 120,080 patients in the TVT (Transcatheter Valve Therapy) Registry who underwent transfemoral TAVR between January 2016 and March 2019, the relationship between anesthesia choice and TAVR outcomes was evaluated using hospital proportional use of CS as an instrumental variable.
Results Over the study period, the proportion of TAVR performed using CS increased from 33% to 64%, and CS was used in a median of 0% and 91% of cases in the lowest and highest quartiles of hospital CS use, respectively. On the basis of instrumental variable analysis, CS was associated with decreases in in-hospital mortality (adjusted risk difference: 0.2%; p = 0.010) and 30-day mortality (adjusted risk difference: 0.5%; p < 0.001), shorter length of hospital stay (adjusted difference: 0.8 days; p < 0.001), and more frequent discharge to home (adjusted risk difference: 2.8%; p < 0.001) compared with GA. The magnitude of benefit for most endpoints was less than in a traditional propensity score–based approach, however.
Conclusions In contemporary U.S. practice, the use of CS for TAVR continues to increase, although there remains wide variation across hospitals. The use of CS for TAVR is associated with improved outcomes (including reduced mortality) compared with GA, although the magnitude of benefit appears to be less than in previous studies.
Dr. Butala is funded by the John S. LaDue Memorial Fellowship at Harvard Medical School; and has received consulting fees and has ownership interest in HiLabs, outside the submitted work. Dr. Marquis-Gravel has received honoraria and/or speaking fees from Servier and Novartis (unrelated to study content). Dr. Secemsky has received grants from AstraZeneca, BD Bard, Boston Scientific, Cook Medical, Cardiovascular Systems, Inc., Medtronic, Philips, and the University of California, San Francisco; is a consultant for Cardiovascular Systems, Inc., Medtronic, and Philips; and is on the Speakers Bureau of BD Bard, Cook Medical, and Medtronic. Dr. Yeh has received additional grant support from Abiomed, AstraZeneca, and Boston Scientific; and has received consulting fees from Abbott, Boston Scientific, Medtronic, and Teleflex, outside the submitted work. Dr. Vemulapalli has received grants and contracts from the National Institutes of Health, the Patient-Centered Outcomes Research Institute, the U.S. Food and Drug Administration (NEST), the American College of Cardiology, the Society of Thoracic Surgeons, Abbott Vascular, and Boston Scientific; and is a consultant or advisory board member for Boston Scientific, HeartFlow, Baylabs (Caption Health), and Janssen. Dr. Cohen has received institutional grant support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; and has received consulting fees from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott. 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 February 28, 2020.
- Revision received March 6, 2020.
- Accepted March 10, 2020.
- 2020 American College of Cardiology Foundation
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