PARTNER: Transapical TAVR shows similar QOL outcomes to SAVR
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Transapical transcatheter aortic valve replacement was associated with comparable long-term quality-of-life improvements as surgical aortic valve replacement, according to an analysis from the PARTNER trial.
The researchers hypothesized that increasing operator experience with transapical TAVR may have led to improvements in health-related QOL. They evaluated health-related QOL outcomes at 1, 6 and 12 months for 875 patients who underwent transapical procedures in the nonrandomized continued access (NRCA) registry of the PARTNER randomized controlled trial. Those findings were compared with the outcomes reported for patients undergoing SAVR as part of the PARTNER trial.
Clinicians evaluated health-related quality of life using the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Medical Outcomes Study Short-Form 12 (SF-12) and the EuroQoL-5D, with overall KCCQ score as the primary endpoint.
The researchers observed statistically significant and clinically meaningful increases in health status measures and disease-specific metrics from baseline, apart from the SF-12 mental scale, among patients undergoing transapical procedures in the nonrandomized cohort. These improvements began at 1 month and increased through 6 months but leveled off after that. The improvement in KCCQ summary scores was 12.7 points at 1 month, 25.9 at 6 months and 25.2 at 12 months.
Similar improvements were reported for patients undergoing transapical procedures in the nonrandomized cohort as were observed for those undergoing SAVR. However, 1-month data for the randomized transapical group indicated no significant improvement in the Kansas City social limitation scale. In the randomized SAVR group, 1-month improvements in the physical limitation scale and the social limitation scales were nonsignificant.
Follow-up health-related QOL outcomes as measured by the overall Kansas City score or any of the disease specific subscales were not significantly different between the nonrandomized TAVR group and the randomized SAVR group at any evaluated time point.
“Although there was a suggestion of modest early improvement in [health-related QOL] in patients treated with [transapical]-TAVR in the NRCA registry compared with the [randomized controlled trial], the magnitude of these differences was small and there remained no evidence of either early or late [health-related QOL] improvement with [transapical]-TAVR compared with SAVR,” the researchers concluded. “These findings have important implications for access-site selection for patients undergoing TAVR.” – by Rob Volansky
Disclosure: Some of the researchers report grant/research support and/or consulting fees from Abbott Vascular, Boston Scientific, Cordis, DirectFlow Medical, Edwards Lifesciences, Eli Lilly, Eli Lilly-Daiichi Sankyo, Medtronic, MedRad, Merck/Schering-Plough, MicroInterventional Devices, Sorin Medical, St. Jude Medical and The Medicines Company.