Author + information
- Received January 25, 2016
- Revision received April 17, 2016
- Accepted April 20, 2016
- Published online July 26, 2016.
- James B. Hermiller Jr., MDa,∗ (, )
- Steven J. Yakubov, MDb,
- Michael J. Reardon, MDc,
- G. Michael Deeb, MDd,
- David H. Adams, MDe,
- Jonathan Afilalo, MD, MScf,
- Jian Huang, MDg,
- Jeffrey J. Popma, MDh,
- CoreValve United States Clinical Investigators
- aSt. Vincent’s Heart Center of Indiana, Indianapolis, Indiana
- bRiverside Methodist Hospital, Columbus, Ohio
- cHouston-Methodist-Debakey Heart and Vascular Center, Houston, Texas
- dUniversity of Michigan Medical Center, Ann Arbor, Michigan
- eMount Sinai Health System, New York, New York
- fJewish General Hospital, McGill University, Montreal, Quebec, Canada
- gMedtronic, Minneapolis, Minneapolis
- hBeth Israel Deaconess Medical Center, Boston, Massachusetts
- ↵∗Reprint requests and correspondence:
Dr. James B. Hermiller Jr., St. Vincent’s Heart Center of Indiana, 10590 North Meridian Street, Indianapolis, Indiana 46290-1090.
Background Few studies have examined the impact of novel indices of comorbidity, frailty, and disability on outcomes after transcatheter aortic valve replacement (TAVR).
Objectives This study analyzed patients from the Medtronic CoreValve U.S. Pivotal Trial program to develop a simple scoring system that incorporates standard and novel predictor variables.
Methods A multidisciplinary heart team used objective criteria, such as The Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM), and subjective criteria to assess patients’ eligibility for TAVR. The analysis included 3,687 patients randomly divided (2:1) into a derivation cohort (n = 2,482) and a validation cohort (n = 1,205). The study evaluated predictors of all-cause death, which were used to calculate a risk score for each patient.
Results The overall mortality rate was 5.8% at 30 days and 22.8% at 1 year. Home oxygen use, assisted living, albumin levels <3.3 g/dl, and age >85 years predicted death at 30 days. Home oxygen use, albumin levels <3.3 g/dl, falls in the past 6 months, STS PROM score >7%, and severe (≥5) Charlson comorbidity score predicted death at 1 year. A simple scoring system created on the basis of these multivariable predictors effectively stratified risk at 30 days and 1 year into low-risk, moderate-risk, and high-risk subsets. This score showed a 3-fold difference in mortality rates for the low-risk and high-risk subsets at 30 days (3.6% and 10.9%, respectively) and 1 year (12.3% and 36.6%, respectively). The 1-year mortality model was more stable than the 30-day model (C-statistics: 0.79 vs. 0.75).
Conclusions A simple score dominated by novel predictors of outcome effectively stratified early and late mortality rates in extreme-risk and high-risk patients and may assist in selecting appropriate candidates for TAVR. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902)
This study was funded by Medtronic, Minneapolis, Minnesota. Dr. Hermiller serves on the steering committee for the report trial and the Speakers Bureau for Medtronic. Dr. Yakubov has received institutional research grants from Medtronic, Direct Flow Medical, and Boston Scientific; and serves on a medical advisory board for Medtronic and Boston Scientific. Dr. Reardon is a consultant and serves on a medical advisory board for Medtronic. Dr. Deeb has received grants from Medtronic; and serves on a medical advisory board and on the screening committees for the reported trial, and for the SURTAVI and Evolut R trials, but receives no personal compensation. Dr. Adams has received institutional grants and institutional royalties for patents with Medtronic; and has received institutional royalties for patents with Edwards Lifesciences. Dr. Huang is an employee and shareholder of Medtronic. Dr. Popma has received institutional research grants from Medtronic, Boston Scientific, Direct Flow Medical, and Abbott; and serves on a medical advisory board for Boston Scientific. Dr. Afilalo has reported that he has no relationships relevant to the contents of this paper to disclose.
Michael Mack, MD, served as Guest Editor for this paper.
- Received January 25, 2016.
- Revision received April 17, 2016.
- Accepted April 20, 2016.
- American College of Cardiology Foundation