No difference in sustained health status improvements in TAVR vs. surgical AVR
Health status was similar at 5 years in patients who had transcatheter aortic valve replacement compared with those who had surgical AVR, although there was a short-term health status benefit in the TAVR group, researchers reported.
In this analysis of the CoreValve High-Risk trial, published in JAMA Cardiology, early treatment benefits based on Kansas City Cardiomyopathy Questionnaire (KCCQ) score that favored TAVR with a self-expanding valve (CoreValve, Medtronic) over surgical AVR were no longer apparent at 6 months.
In addition, among those who survived to 5 years, more than 60% of patients who had TAVR or surgical AVR had KCCQ scores greater than 60 at the end of follow-up, up from 47% at baseline.
“In this multicenter trial of high-risk patients with severe aortic stenosis, surviving patients treated with either TAVR or surgical AVR had substantial improvements in disease-specific and generic health status. These improvements were maximal at approximately 6 to 12 months and maintained through 2 years with gradual decline in physical health status thereafter,” Suzanne V. Arnold, MD, MHA, cardiologist at Saint Luke’s Mid America Heart Institute in Kansas City, Missouri, associate professor of medicine at University of Missouri-Kansas City and a Cardiology Today Next Gen Innovator, and colleagues wrote. “While patients treated with iliofemoral TAVR had early health status benefit compared with surgical AVR across all disease-specific and generic health status domains, there were no significant between-group differences by 6 months through 5 years, and the pattern of gradual decline was consistent across treatments.”
The analysis included patients with severe aortic stenosis who were at high surgical risk, completed a KCCQ at baseline and were randomly assigned to self-expanding TAVR or surgical AVR and stratified by access site (n = 713; 53% men; mean age, 83 years). The primary outcome was 5-year change in KCCQ and the SF-12.
Patients in the surgical AVR arm had a greater prevalence of diabetes compared with the TAVR arm.
Survival in TAVR, surgical AVR
Among patients who survived to 5 years, the overall KCCQ summary score increased among both groups with more early benefit observed among patients who underwent iliofemoral TAVR compared with surgical AVR (1-month difference, 16.8 points; 95% CI, 12.4-21.2). This treatment difference became nonsignificant after 6 months (6-month difference, 5.2 points; 95% CI 2.5 to 13). There was no benefit in short-term KCCQ summary score for those who had TAVR with non-iliofemoral access compared with those who had surgery.
Overall, 44% of patients with severe aortic stenosis who underwent iliofemoral TAVR survived to 5 years and 39% of those who underwent surgical AVR survived.
Sustained health status improvement
The baseline mean KCCQ overall summary score was 46.7 among the entire cohort.
According to the study, 61% of 5-year survivors in the TAVR group and 65% of the surgical AVR group had a KCCQ overall summary score of more than 60 (P = .61).
“Another important insight from this study is the similar health status trajectories from 6 months through 5 years for those treated with TAVR and surgical AVR,” the researchers wrote. “In light of concerns about potential deleterious effects of TAVR-related complications, including paravalvular leak, need for permanent pacing, leaflet thrombosis or structural valve deterioration (each of which could adversely affect health status), our findings are reassuring that there were no long-term differences in health status by treatment, despite differential rates of complications.”