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Clinical Trial
. 2017 Dec:194:39-48.
doi: 10.1016/j.ahj.2017.08.006. Epub 2017 Aug 12.

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

Suzanne J Baron  1 , Suzanne V Arnold  1 , Matthew R Reynolds  2 , Kaijun Wang  1 , Michael Deeb  3 , Michael J Reardon  4 , James Hermiller  5 , Steven J Yakubov  6 , David H Adams  7 , Jeffrey J Popma  8 , David J Cohen  9 ; US CoreValve Investigators
Affiliations
Clinical Trial

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

Suzanne J Baron et al. Am Heart J. 2017 Dec.

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.

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Figures

Figure 1
Figure 1. Patient Flow Chart
Consort diagram showing patient flow in the quality of life substudy for the CoreValve U.S. Extreme Risk Trial
Figure 2
Figure 2
Figure 2A: Disease-Specific Health Status after TAVR in the Iliofemoral Cohort. Changes in disease-specific health status according to the KCCQ Overall Summary Scale and selected subscales at 1, 6, 12, 24 and 36 months after TAVR via the iliofemoral approach. Mean values and p-values were derived from pattern mixture models. Figure 2B. Generic Health Status after TAVR in the Iliofemoral Cohort. Changes in generic health status according to the Short Form-12 and EuroQoL-5D at 1, 6, 12, 24 and 36 months after TAVR via the iliofemoral approach. Mean values and p-values were derived from pattern mixture models.
Figure 2
Figure 2
Figure 2A: Disease-Specific Health Status after TAVR in the Iliofemoral Cohort. Changes in disease-specific health status according to the KCCQ Overall Summary Scale and selected subscales at 1, 6, 12, 24 and 36 months after TAVR via the iliofemoral approach. Mean values and p-values were derived from pattern mixture models. Figure 2B. Generic Health Status after TAVR in the Iliofemoral Cohort. Changes in generic health status according to the Short Form-12 and EuroQoL-5D at 1, 6, 12, 24 and 36 months after TAVR via the iliofemoral approach. Mean values and p-values were derived from pattern mixture models.
Figure 3
Figure 3
Figure 3A: Disease-Specific Health Status after TAVR in the Non-Iliofemoral Cohort. Changes in disease-specific health status according to the KCCQ Overall Summary Scale and selected subscales at 1, 6, 12, 24 and 36 months after TAVR via a non-iliofemoral approach. Mean values and p-values were derived from pattern mixture models. Figure 3B. Generic Health Status after TAVR in the Non-Iliofemoral Cohort. Changes in generic health status according to the Short Form-12 and EuroQoL-5D at 1, 6, 12, 24 and 36 months after TAVR via a non-iliofemoral approach. Mean values and p-values were derived from pattern mixture models.
Figure 3
Figure 3
Figure 3A: Disease-Specific Health Status after TAVR in the Non-Iliofemoral Cohort. Changes in disease-specific health status according to the KCCQ Overall Summary Scale and selected subscales at 1, 6, 12, 24 and 36 months after TAVR via a non-iliofemoral approach. Mean values and p-values were derived from pattern mixture models. Figure 3B. Generic Health Status after TAVR in the Non-Iliofemoral Cohort. Changes in generic health status according to the Short Form-12 and EuroQoL-5D at 1, 6, 12, 24 and 36 months after TAVR via a non-iliofemoral approach. Mean values and p-values were derived from pattern mixture models.
Figure 4
Figure 4. Clinical Improvement in Health Status from Baseline over Time in Surviving Patients
Proportion of surviving patients with clinically important improvement over time as measured by the KCCQ-Overall Summary Score in the iliofemoral cohort (panel A) and non-iliofemoral cohort (panel B).
See this image and copyright information in PMC

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