Durability of quality of life benefits of transcatheter aortic valve replacement: Long-term results from the CoreValve US extreme risk trial.

Authors

• Suzanne J Baron
• Suzanne V Arnold
• Matthew R Reynolds
• Kaijun Wang
• Michael Deeb
• Michael J Reardon
• James Hermiller
• Steven J Yakubov
• David H Adams
• Jeffrey J Popma
• David J Cohen
• US CoreValve Investigators

Document Type

Article

Publication Title

American heart journal

Abstract

BACKGROUND: For patients with severe aortic stenosis (AS) at extreme surgical risk, transcatheter aortic valve replacement (TAVR) leads to improved survival and health status when compared with medical therapy. Whether the early health status benefits of TAVR in these patients are sustained beyond 1 year of follow-up is unknown.

METHODS AND RESULTS: Six hundred thirty-nine patients with severe AS at extreme surgical risk underwent TAVR in the CoreValve US Extreme Risk Pivotal trial. Health status was evaluated at baseline and at 1, 6, 12, 24, and 36 months using the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Short-Form-12, and the EuroQoL-5D. Analyses were performed using pattern mixture models to account for both death and missing data and were stratified by iliofemoral (IF) and non-iliofemoral (non-IF) access. After TAVR, there was substantial health status improvement in disease-specific and generic scales by 6 to 12 months. Although there were small declines in health status after 12 months, the initial benefits of TAVR were largely sustained through 3 years for both IF and non-IF cohorts (change from baseline in KCCQ Overall Summary score 19.0 points in IF patients and 14.9 points in non-IF patients; P< .01 for both comparisons). Among surviving patients, clinically meaningful (≥10 point) improvements in the KCCQ Overall Summary Score at 3 years were observed in 85.0% and 83.4% of IF and non-IF patients respectively.

CONCLUSIONS: Among extreme risk patients with severe AS, TAVR resulted in large initial health status benefits that were sustained through 3-year follow-up. Although late mortality was high in this population, these findings demonstrate that TAVR offers substantial and durable health status improvements for surviving patients.

First Page

39

Last Page

48

DOI

10.1016/j.ahj.2017.08.006

Publication Date

12-1-2017

Recommended Citation

Baron SJ, Arnold SV, Reynolds MR, Wang K, Deeb M, Reardon MJ, Hermiller J, Yakubov SJ, Adams DH, Popma JJ, Cohen DJ; US CoreValve Investigators. Durability of quality of life benefits of transcatheter aortic valve replacement: Long-term results from the CoreValve US extreme risk trial. Am Heart J. 2017 Dec;194:39-48. doi: 10.1016/j.ahj.2017.08.006. Epub 2017 Aug 12. PMID: 29223434; PMCID: PMC5821894.