Results of Quality-of-Life Assessment Published From the PARTNER S3i Trial

June 18, 2018—Suzanne J. Baron, MD, et al published findings from a study that sought to evaluate whether transcatheter aortic valve replacement (TAVR) with the Sapien 3 transcatheter heart valve (S3-TAVR; Edwards Lifesciences) results in improved quality of life (QOL) compared with previous-generation TAVR devices or surgical aortic valve replacement (SAVR). The study is available online in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions.

The background of the study is that in patients with severe aortic stenosis at intermediate surgical risk, TAVR using the Sapien XT heart valve (XT-TAVR; Edwards Lifesciences) results in similar QOL compared with SAVR. Compared with Sapien XT, the Sapien 3 valve offers a lower delivery profile and modifications to reduce paravalvular regurgitation.

As summarized in JACC: Cardiovascular Interventions, 1,078 patients with severe aortic stenosis at intermediate surgical risk were treated with S3-TAVR in the PARTNER S3i trial between February and December 2014.

QOL was assessed at baseline, 1 month, and 1 year using the Kansas City Cardiomyopathy Questionnaire, 36-Item Short Form Health Survey, and EuroQoL five dimensions. QOL outcomes of S3-TAVR patients were compared with those in the SAVR and XT-TAVR arms of the PARTNER 2A trial using propensity score stratification to adjust for differences between the treatment groups.

The investigators reported that at 1 year, S3-TAVR was associated with substantial improvements in QOL compared with baseline. At 1 month, S3-TAVR was associated with better QOL than either SAVR or XT-TAVR (adjusted differences in Kansas City Cardiomyopathy Questionnaire overall summary score, 15.6 and 3.7 points, respectively; P < .001). At 1 year, the differences in QOL between S3-TAVR and both SAVR and XT-TAVR were reduced but remained statistically significant (adjusted differences, 2.0 and 2.2 points, respectively; P < .05). Similar results were seen for generic QOL outcomes.

Among patients with severe aortic stenosis at intermediate surgical risk, S3-TAVR resulted in improved QOL at both 1 month and 1 year compared with both XT-TAVR and SAVR, concluded the investigators in JACC: Cardiovascular Interventions.