James B Hermiller1, Steven J Yakubov2, Michael J Reardon3, G Michael Deeb4, David H Adams5, Jonathan Afilalo6, Jian Huang7, Jeffrey J Popma8. 1. St. Vincent's Heart Center of Indiana, Indianapolis, Indiana. Electronic address: james.hermiller@stvincent.org. 2. Riverside Methodist Hospital, Columbus, Ohio. 3. Houston-Methodist-Debakey Heart and Vascular Center, Houston, Texas. 4. University of Michigan Medical Center, Ann Arbor, Michigan. 5. Mount Sinai Health System, New York, New York. 6. Jewish General Hospital, McGill University, Montreal, Quebec, Canada. 7. Medtronic, Minneapolis, Minneapolis. 8. Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Abstract
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).
RCT Entities:
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).
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