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Health Status After TAVR or SAVR in Severe Aortic Stenosis
Study Questions:
What are the health status outcomes for patients treated with either self-expanding transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR)?
Methods:
Between 2011 and 2012, 795 patients with severe aortic stenosis at increased surgical risk were randomized to TAVR or SAVR in the CoreValve US Pivotal Trial. Health status was assessed at baseline, 1 month, 6 months, and 1 year using the Kansas City Cardiomyopathy Questionnaire, Medical Outcomes Study Short-Form 12 Questionnaire, and EuroQOL 5-dimension questionnaire; growth curve models were used to examine changes over time. For each of the primary and secondary health status outcomes, longitudinal random-effects growth curve models were used to examine the relative effect of TAVR versus SAVR over time.
Results:
Over the 1-year follow-up period, disease-specific and generic health status improved substantially for both treatment groups. At 1 month, there was a significant interaction between the benefit of TAVR over SAVR and access site. Among surviving patients eligible for iliofemoral access, there was a clinically relevant early benefit with TAVR across all disease-specific and generic health status measures. Among the non-iliofemoral cohort, however, most health status measures were similar for TAVR and SAVR, although there was a trend toward early benefit with TAVR on the Short-Form 12 Questionnaire’s physical health scale. There were no consistent differences in health status between TAVR and SAVR at the later time points.
Conclusions:
The authors concluded that health status improved substantially in surviving patients with increased surgical risk who were treated with either self-expanding TAVR or SAVR.
Perspective:
This study reports that patients with severe symptomatic aortic stenosis who were at increased surgical risk, treated with TAVR with a self-expanding valve or with SAVR, had substantial improvements in health status. Among surviving patients eligible for iliofemoral access, those treated with TAVR had an early health status benefit compared with SAVR, with greater improvements in heart failure symptoms, physical function, and quality of life at 1 month. However, by 6 months, there were no differences between groups, and there was little change in health status in either group between 6 months and 1 year. Additional studies are indicated to determine how to optimize the health status recovery of patients requiring noniliofemoral access and to examine whether there are any differences among the alternative access sites (transapical, transaortic, or subclavian).
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Structural Heart Disease
Keywords: Aortic Valve Stenosis, Cardiac Surgical Procedures, Heart Valve Diseases, Heart Valve Prosthesis, Health Status, Transcatheter Aortic Valve Replacement
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