CHANGES IN PATIENT-REPORTED OUTCOMES AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION: INSIGHTS FROM THE 3M TAVR STUDY

Abstract

Patient-reported outcome measurements (PROMs) refer to the standardized and validated assessment of self-reported health status. Transcatheter aortic valve implantation (TAVI) is associated with significantly improvement in PROMs. However, changes in PROMs at early follow-up ( < 1 month), and following next-day discharge are poorly understood. The Multimodality, Multidisciplinary but Minimalist TAVR (3M TAVR) study demonstrated the safety and reproducibility of the Vancouver Clinical Pathway to facilitate safe next-day discharge home. In 2015-2017, a total of 411 patients at 13 centers were enrolled. PROMs were evaluated using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) in participants with a baseline score and at least one score at 2 weeks, 30 days and 1 year. Study endpoints were change in (1) KCCQ-Overall Summary Score (KCCQ-OS) and (2) minimal clinically important differences (MCID). Mixed effects models were used to explore patterns of change from baseline, with fixed terms for time, status at 1-year and their interaction terms, and a random intercept for subject to account for within subject correlation. Descriptive statistics were used to report MCID. Data were available for 358 (87.1%) participants. 216 (60.3%) were men with a median age 84.0 and STS 5.0 There was significant increase in PROMs 2 weeks after TAVR (p≤0.01), and further significant improvement at the 1-month timepoint (p < 0.01) for participants who were alive at 1 year. Sex, age category, and STS score category did not have a significant effect on the change in PROMs (p>0.05). In the first 2 weeks, moderate (10-20 points) and large (>20 points) improvements were observed in 19.9% and 49.0% of the surviving patients, respectively; at 1-year, similar MCID were seen in 14.6% and 64.0% respectively. This is the first study to report significant increase in PROMs 2 weeks after TAVI, with sustained improvement during the first year in patients treated with the Vancouver Clinical Pathway. Further studies are necessary to determine whether alternative clinical pathways yield similar findings.