Author + information
- Received May 17, 2016
- Revision received July 8, 2016
- Accepted July 22, 2016
- Published online October 25, 2016.
- Suzanne V. Arnold, MD, MHAa,b,∗ (, )
- Jonathan Afilalo, MD, MScc,
- John A. Spertus, MD, MPHa,b,
- Yuanyuan Tang, PhDa,
- Suzanne J. Baron, MD, MSca,b,
- Philip G. Jones, MSa,
- Michael J. Reardon, MDd,
- Steven J. Yakubov, MDe,
- David H. Adams, MDf,
- David J. Cohen, MD, MSca,b,
- U.S. CoreValve Investigators
- aSaint Luke’s Mid America Heart Institute, Kansas City, Missouri
- bDepartment of Medicine, Saint Luke’s Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Missouri
- cDepartment of Medicine, Jewish General Hospital, McGill University, Montreal, Quebec, Canada
- dDepartment of Cardiothoracic Surgery, Houston-Methodist-Debakey Heart and Vascular Center, Houston, Texas
- eRiverside Methodist Hospital, Columbus, Ohio
- fDepartment of Cardiothoracic Surgery, Mount Sinai Medical Center, New York, New York
- ↵∗Reprint requests and correspondence:
Dr. Suzanne V. Arnold, Department of Cardiovascular Research, Saint Luke’s Mid America, Heart Institute, 4401 Wornall Road, Kansas City, Missouri 64111.
Background A series of models have been developed to identify patients at high risk for poor outcomes after transcatheter aortic valve replacement (TAVR) to help guide treatment choices, offer patients realistic expectations of long-term outcomes, and support decision making.
Objectives This study examined the performance of the previously developed TAVR Poor Outcome risk models in an external dataset and explored the incremental contribution of geriatric domains to model performance.
Methods Poor outcome after TAVR was defined as death, poor quality of life (QOL), or decline in QOL, as assessed using the Kansas City Cardiomyopathy Questionnaire. We tested 4 TAVR Poor Outcome risk models: 6-month and 1-year full and clinical (reduced) models. We examined each model’s discrimination and calibration in the CoreValve trial dataset, and then tested the incremental contribution of frailty and disability markers to the model’s discrimination using the incremental discrimination index.
Results Among 2,830 patients who underwent TAVR in the CoreValve US Pivotal Extreme and High Risk trials and associated continued access registries, 31.2% experienced a poor outcome at 6 months following TAVR (death, 17.6%; very poor QOL, 11.6%; QOL decline, 2.0%) and 50.8% experienced a poor outcome at 1 year (death, 30.2%; poor QOL, 19.6%; QOL, decline 1.0%). The models demonstrated similar discrimination as in the Placement of Aortic Transcatheter Valves Trial cohorts (c-indexes, 0.637 to 0.665) and excellent calibration. Adding frailty as a syndrome increased the c-indexes by 0.000 to 0.004 (incremental discrimination index, p < 0.01 for all except the 1-year clinical model), with the most important individual components being disability and unintentional weight loss.
Conclusions Although discrimination of the TAVR Poor Outcome risk models was generally moderate, calibration was excellent among patients with different risk profiles and treated with a different TAVR device. These findings demonstrated the value of these models for individualizing outcome predictions in high-risk patients undergoing TAVR.
The CoreValve U.S. Pivotal trials and associated continued access registries were sponsored by Medtronic. All analyses, the preparation of the manuscript, and the decision to submit the manuscript for publication were done independently of the study sponsor. Dr. Arnold is supported by a Career Development Grant Award (K23 HL116799) from the National Heart, Lung, and Blood Institute. Dr. Spertus has an equity interest in Health Outcomes Sciences; and owns the copyright for the Kansas City Cardiomyopathy Questionnaire. Dr. Baron has received speaker honoraria and consulting income from Edwards Lifesciences; and consulting income from St. Jude Medical. Dr. Reardon has received honoraria from Medtronic for participation on a surgical advisory board. Dr. Yakubov is on the advisory board for Boston Scientific, Medtronic, and Abbott Vascular; and is a consultant for Medtronic. Dr. Adams has received royalties through his institution from Medtronic for a patent related to a triscupid-valve annuloplasty ring and from Edwards Lifesciences for a patent related to degenerative valvular disease-specific annuloplasty rings. Dr. Cohen has received research support from Edwards Lifesciences, Medtronic, Boston Scientific, Abbott Vascular, Eli Lilly, Daiichi-Sankyo, and AstraZeneca; consulting income from Medtronic, Abbott Vascular, AstraZeneca, Eli Lilly, and Merck; and speaking honoraria from AstraZeneca. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Michael Mack, MD, served as Guest Editor for this paper.
- Received May 17, 2016.
- Revision received July 8, 2016.
- Accepted July 22, 2016.
- American College of Cardiology Foundation