Two-year follow-up from the PARTNER 2 trial revealed that transcatheter and surgical aortic valve replacement were associated with similar health status benefits for patients with severe aortic stenosis at intermediate surgical risk.
“To our knowledge, this is the first study to compare the effects of TAVR with those of [surgical] AVR on detailed disease-specific and generic patient-reported health status in individuals with severe, symptomatic [aortic stenosis] at intermediate surgical risk,” Suzanne Baron, MD, MSc, from Saint Luke’s Mid America Heart Institute and the School of Medicine at the University of Missouri in Kansas City, and colleagues wrote.
To compare quality of life among patients at intermediate risk with severe aortic stenosis treated with TAVR or surgical AVR, Baron and colleagues analyzed 2,032 patients who were randomly assigned to TAVR with a balloon-expandable valve (Sapien XT, Edwards Lifesciences) or surgical AVR in the PARTNER 2 trial between December 2011 and November 2013.
The primary analytic cohort consisted of 1,833 patients (950 TAVR, 883 surgery; mean age, 81 years; 55% men) with available baseline health status.
At baseline, 1 month, 1 year and 2 years, researchers used the Kansas City Cardiomyopathy Questionnaire (KCCQ), 36-item Short Form Health Survey and EuroQoL-5D to assess health status.
Additionally, researchers conducted analysis of covariance to examine health status changes over time while adjusting for baseline status.
Both disease-specific (16-22 points on the KCCQ overall summary [KCCQ-OS] scale) and generic health status (3.9-5.1 points on the SF-36 physical summary scale) showed significant improvements for both TAVR and surgical AVR at 2 years.
TAVR was associated with better health status than surgical AVR at 1 month, but this difference was only seen in patients treated via transfemoral access (mean difference in KCCQ-OS score, 14.1 points; 95% CI, 11.7-16.4) and did not apply to patients treated via transthoracic access (mean difference in KCCQ-OS, 3.5 points; 95% CI, –1.4 to 8.4).
The researchers found no significant differences between TAVR and surgical AVR in any health status measures at 1 or 2 years.
“The improvements in health status at 1- and 2-year follow-up were substantial with both TAVR and [surgical] AVR, regardless of access site,” Baron and colleagues wrote. “With more than 60% of surviving patients experiencing improvements of more than 10 points in the KCCQ-OS score at 2 years, these changes are not only statistically significant, but also clinically meaningful, as prior studies in patients with HF have shown that improvements as small as 5 points on the KCCQ-OS are associated with mortality and health care costs.” – by Dave Quaile
Disclosures: The study was funded by a research grant from Edwards Lifesciences. Baron reports receiving consultant fees from Edwards Lifesciences and St. Jude Medical. Please see the study for all other researchers’ relevant financial disclosures.