What is the effect of transcatheter aortic valve replacement vs surgical aortic valve replacement on health status in patients with severe aortic stenosis at intermediate surgical risk?
In this substudy of the PARTNER 2 randomized clinical trial involving 1833 patients, transcatheter aortic valve replacement and surgical aortic valve replacement were associated with health status improvement at 2 years. Patients undergoing transfemoral transcatheter aortic valve replacement demonstrated better early health status than those who underwent surgical aortic valve replacement, but by 1 year, there was no significant difference between the procedures.
In patients with severe aortic stenosis at intermediate risk, transcatheter aortic valve replacement results in long-term health status benefits similar to those of surgical aortic valve replacement.
In patients with severe aortic stenosis (AS) at intermediate surgical risk, treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) results in similar 2-year survival. The effect of TAVR vs SAVR on health status in patients at intermediate surgical risk is unknown.
To compare health-related quality of life among intermediate-risk patients with severe AS treated with either TAVR or SAVR.
Design, Setting, and Participants
Between December 2011 and November 2013, 2032 intermediate-risk patients with severe AS were randomized to TAVR with the Sapien XT valve or SAVR in the Placement of Aortic Transcatheter Valve 2 Trial and were followed up for 2 years. Data analysis was conducted between March 1, 2016, to April 30, 2017.
Main Outcomes and Measures
Health status was assessed at baseline, 1 month, 1 year, and 2 years using the Kansas City Cardiomyopathy Questionnaire (KCCQ) (23 items covering physical function, social function, symptoms, self-efficacy and knowledge, and quality of life on a 0- to 100-point scale; higher scores indicate better quality of life), Medical Outcomes Study Short Form-36 (36 items covering 8 dimensions of health status as well as physical and mental summary scores; higher scores represent better health status), and EuroQOL-5D (assesses 5 dimensions of general health on a 3-level scale, with utility scores ranging from 0 [death] to 1 [ideal health]). Analysis of covariance was used to examine changes in health status over time, adjusting for baseline status.
Of the 2032 randomized patients, baseline health status was available for 1833 individuals (950 TAVR, 883 SAVR) who formed the primary analytic cohort. A total of 1006 (54.9%) of the population were men; mean (SD) age was 81.4 (6.8) years. Over 2 years, both TAVR and SAVR were associated with significant improvements in both disease specific (16-22 points on the KCCQ-OS scale) and generic health status (3.9-5.1 points on the SF-36 physical summary scale). At 1 month, TAVR was associated with better health status than SAVR, but this difference was restricted to patients treated via transfemoral access (mean difference in the KCCQ overall summary [KCCQ-OS] score, 14.1 points; 95% CI, 11.7 to 16.4; P < .01) and was not seen in patients treated via transthoracic access (mean difference in KCCQ-OS, 3.5 points; 95% CI, −1.4 to 8.4; P < .01 for interaction). There were no significant differences between TAVR and SAVR in any health status measures at 1 or 2 years.
Conclusions and Relevance
Among intermediate-risk patients with severe AS, health status improved significantly with both TAVR and SAVR through 2 years of follow up. Early health status improvement was greater with TAVR, but only among patients treated via transfemoral access. Longer term follow-up is needed to assess the durability of quality-of-life improvement with TAVR vs SAVR in this population.
clinicaltrials.gov Identifier: NCT01314313
Baron SJ, Arnold SV, Wang K, Magnuson EA, Chinnakondepali K, Makkar R, Herrmann HC, Kodali S, Thourani VH, Kapadia S, Svensson L, Brown DL, Mack MJ, Smith CR, Leon MB, Cohen DJ, for the PARTNER 2 Investigators. Health Status Benefits of Transcatheter vs Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Intermediate Surgical RiskResults From the PARTNER 2 Randomized Clinical Trial. JAMA Cardiol. Published online June 28, 2017. doi:10.1001/jamacardio.2017.2039