A subanalysis of PARTNER 3 quality of life data found a modest, but significant, improvement in one-year disease-specific quality of life after transcatheter aortic valve implantation (TAVI) compared with surgical aortic valve replacement (SAVR) in low-risk patients with severe aortic stenosis. The findings were presented by Suzanne J Baron (Lahey Hospital and Medical Center, Burlington, USA) at a late-breaking session at the 31st Transcatheter Cardiovascular Therapeutics scientific symposium (TCT 2019; 25–29 September, San Francisco, USA) and simultaneously published in the Journal of American College of Cardiology.
The randomised PARTNER 3 trial demonstrated that TAVI with the Sapien 3 balloon expandable valve (Edwards Lifesciences) resulted in lower rates of death and rehospitalisation at one year compared with surgical replacement in patients with severe aortic stenosis at low surgical risk. However, the effect of treatment strategy on early and late health-related quality of life in this population is unknown.
To address this, the researchers compared health status at one, six, and 12 months in low risk patients with severe aortic stenosis treated with either TAVI or SAVR in the PARTNER 3 trial. They found that over the one-year follow-up period, treatment with either TAVI or SAVR resulted in substantial improvements in both disease-specific and generic health status compared with baseline, despite most patients having only NYHA Class I or II symptoms at baseline. Consistent with previous studies of transfemoral TAVI, TAVI was associated with significantly better health status than SAVR at one month on all scales (mean difference in KCCQ-OS 16.0 points; p<0.04 for both).
TAVI also demonstrated a significant health status benefit compared with SAVR at all timepoints (p<0.05) in analyses incorporating both survival and change in health status together. Exploratory analyses demonstrated that the late health status benefits seen with TAVI were driven by a difference in the proportion of patients who experienced a large (≥20 point) improvement in the KCCQ score. These benefits may be explained, in part, by differential rates of postprocedural complications between TAVI and SAVR.
Baron cautioned that the results may not be generalisable to other types of TAVI prostheses, alternative access routes, or to other patient groups excluded from the PARTNER 3 trial. In addition, it is not yet know whether the health status differences between the cohorts persist beyond one year.
But, she added: “Taken together with the clinical outcomes of the PARTNER 3 trial, these findings further support the use of TAVI in patients with severe aortic stenosis at low surgical risk. Longer term follow-up is necessary, and ongoing, to determine whether the health status benefits of TAVR at one year are durable.”