Abstract

Objective: To evaluate the health status outcomes of TAVI patients using two standardised and validated patient-reported outcome measures (PROMs). Methods: From April to October 2018, TAVI Registry patients were requested via phone, email, mail or direct contact to complete the PROMs at two timepoints: pre-procedure (416 patients) and 30-day follow-up (273 eligible patients). The PROMs include: a generic quality of life questionnaire, the EQ-5D and a disease specific instrument, the Kansas City Cardiomyopathy Questionnaire (KCCQ). Results: The cohort mean age was 83 years (range 59-87) and 57% male. For both PROMs there was a high completion rate: the pre-procedure timepoint (KCCQ n = 384 (92%), EQ5D n = 390 (94%)) was lower than at 30-days (KCCQ n = 262 (96%) EQ5D n = 264 (97%)). The mean KCCQ-overall score increased from 49.7 ± 22.7 pre-procedure to 76.0 ± 21.2 at 30-days (p value < 0.0001). All KCCQ domains increased when comparing pre-procedure and 30-day follow-up. The overall mean EQ5D visual analogue scale (score 0-100) increased from 59.8 ± 18.9 to 72.9 ± 17.0 at 30-days (p value < 0.001). A comparison of pre-procedure and 30-day follow-up data using EQ5D showed a significant increase in all five domains. Conclusion: A dramatic improvement at 30-days is being reported by patients supporting the clinical benefits of the TAVI procedure. This significance was demonstrated throughout all domain variables and as an overall score in both PROMs. As the TAVI Registry reaches its 1-year timepoint, it is expected the outcomes will continue to improve which aligns with the PROMs data reported from other international registries.

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