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.

 

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Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing comprehensive coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Cardiac Interventions Today premiered in March 2007 and each edition contains a variety of topics in a flexible format, including articles covering various perspectives on current clinical topics, in-depth interviews with expert physicians, overviews of available technologies, industry news, and insights into the issues affecting today's interventional cardiology practices.