Author + information
- Received October 24, 2017
- Revision received December 19, 2017
- Accepted January 2, 2018
- Published online March 19, 2018.
- Suzanne V. Arnold, MD, MHAa,∗ (, )
- Sean M. O’Brien, PhDb,
- Sreekanth Vemulapalli, MDb,
- David J. Cohen, MD, MSca,
- Amanda Stebbins, MSb,
- J. Matthew Brennan, MD, MPHb,
- David M. Shahian, MDc,
- Fred L. Grover, MDd,
- David R. Holmes, MDe,
- Vinod H. Thourani, MDf,
- Eric D. Peterson, MD, MPHb,
- Fred H. Edwards, MDg,
- for the STS/ACC TVT Registry
- aSaint Luke’s Mid America Heart Institute and the University of Missouri–Kansas City, Kansas City, Missouri
- bDuke University, Durham, North Carolina
- cLahey Hospital and Medical Center and Harvard Clinical Research Institute, Boston, Massachusetts
- dUniversity of Colorado School of Medicine, Aurora, Colorado
- eMayo Clinic, Rochester, Minnesota
- fMedstar Washington Hospital Center/Georgetown University, Washington, District of Columbia
- gUniversity of Florida College of Medicine–Jacksonville, Jacksonville, Florida
- ↵∗Address for correspondence:
Dr. Suzanne V. Arnold, Saint Luke’s Mid America Heart Institute, 4401 Wornall Road, Kansas City, Missouri 64111.
Objectives The aim of this study was to develop and validate a risk adjustment model for 30-day mortality after transcatheter aortic valve replacement (TAVR) that accounted for both standard clinical factors and pre-procedural health status and frailty.
Background Assessment of risk for TAVR is important both for patient selection and provider comparisons. Prior efforts for risk adjustment have focused on in-hospital mortality, which is easily obtainable but can be biased because of early discharge of ill patients.
Methods Using data from patients who underwent TAVR as part of the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry (June 2013 to May 2016), a hierarchical logistic regression model to estimate risk for 30-day mortality after TAVR based only on pre-procedural factors and access site was developed and internally validated. The model included factors from the original TVT Registry in-hospital mortality model but added the Kansas City Cardiomyopathy Questionnaire (health status) and gait speed (5-m walk test).
Results Among 21,661 TAVR patients at 188 sites, 1,025 (4.7%) died within 30 days. Independent predictors of 30-day death included older age, low body weight, worse renal function, peripheral artery disease, home oxygen, prior myocardial infarction, left main coronary artery disease, tricuspid regurgitation, nonfemoral access, worse baseline health status, and inability to walk. The predicted 30-day mortality risk ranged from 1.1% (lowest decile of risk) to 13.8% (highest decile of risk). The model was able to stratify risk on the basis of patient factors with good discrimination (C = 0.71 [derivation], C = 0.70 [split-sample validation]) and excellent calibration, both overall and in key patient subgroups.
Conclusions A clinical risk model was developed for 30-day death after TAVR that included clinical data as well as health status and frailty. This model will facilitate tracking outcomes over time as TAVR expands to lower risk patients and to less experienced sites and will allow an objective comparison of short-term mortality rates across centers.
The STS/ACC TVT Registry is an initiative of the Society of Thoracic Surgeons and the American College of Cardiology. This research was supported by the American College of Cardiology’s National Cardiovascular Data Registry. The views expressed in this report represent those of the authors and do not necessarily represent the official views of the National Cardiovascular Data Registry or its associated professional societies, identified at https://cvquality.acc.org/NCDR-Home. The study sponsors were not involved in the design and conduct of the study; analysis and interpretation of the data; preparation of the manuscript; or decision to submit the manuscript for publication. Dr. Arnold is supported by a Career Development Grant Award (K23 HL116799) from the National Heart, Lung, and Blood Institute. Dr. Brennan is supported by a grant from the Patient-Centered Outcomes Research Institute (CER-1306-04350). Dr. Cohen has received research grant support from Edwards Lifesciences, Medtronic, and Boston Scientific; and consulting fees from Medtronic and Edwards Lifesciences. Dr. Thourani has served as an adviser for Edwards Lifesciences, Abbott Vascular, Boston Scientific, and Gore Vascular. Dr. Peterson has received grants and personal fees from Janssen and Eli Lilly; and personal fees from Boehringer Ingelheim, Bayer, and AstraZeneca. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received October 24, 2017.
- Revision received December 19, 2017.
- Accepted January 2, 2018.
- 2018 American College of Cardiology Foundation