Aim: The study aimed to determine the proportion of patients with significant improvements in Health-Related Quality of Life (HRQoL) 12 months after Transcatheter Aortic Valve Implantation (TAVI), using a threshold for physical function (PF) and physical role (RP) domains of the SF-36 questionnaire. Additionally, we explored shared baseline characteristics of patients reporting these improvements.
Methodology: In this prospective observational study, 88 patients with symptomatic, severe aortic stenosis (AS) and preserved ejection fraction were enrolled between April 2017 and February 2020. Exclusion criteria were clinical instability, pacemaker, chronic AF, comorbidities with life expectancy < 1 year. HRQoL was evaluated before and 12 months after transfemoral TAVI using the Norwegian version 2.0 of SF-36, and presented as mean (95% confidence interval). Other outcome measures were 6-minute walking test and NYHA- classification. Independent samples t-test or Mann-Whitney U test was used for between-group comparisons as appropriate. Logistic regression or Chi2-test were used to explore associations between changes in PF and RP and clinical parameters. Statistical significance was set at p ≤ 0.05, and clinically significant changes in HRQoL were defined as increase of ≥ 15 points in the PF and RP categories.
Results: Mean age of the cohort was 80 ± 6 years. 44 (50%) patients reported clinically significant improvement in PF, and 46 (52%) in the RP domain. Baseline scores were significantly lower in patients reporting clinical improvement after TAVI, with PF scores pre intervention 43.07 (37.37-48.78) vs. 65.34 (59.01-71.68), p < 0.001, and RP 36.01 (29.56-42.46) vs. 59.92 (50.91-68.92), p < 0.001. No significant associations were found between improvement in domain scores and parameters from the routine baseline examination, but having ≥ 15-point improvement correlated to baseline PF and RP scores.
Conclusion: Our study highlights the importance of defining a uniform threshold for clinically significant improvement in the SF-36 HRQoL questionnaire for patients undergoing TAVI. Half of the patients reported favorable long-term outcome for PF and RP aspects of SF-36. This emphasizes the importance of HRQoL assessment in the preoperative work up for patients undergoing TAVI.
Trial registration: https://www.
Clinicaltrials: gov/ 05.04.2017 with ID NCT03107923.
Keywords: Aortic stenosis (AS); Health related quality of life (HRQoL); Minimal clinically important difference (MCID); SF-36; Transcatheter aortic valve implantation (TAVI).
Severe aortic stenosis is in the elderly treated with transcatheter aortic valve implantation, aiming to improve survival and relieve symptoms. Health- related quality of life is an important outcome to measure after the procedure. However, there are no defined values for what constitutes a significant improvement in this patient group when measuring quality of life using the widely used health-related quality of life questionnaire SF-36.Our study aimed to investigate how many patients had clinically important improvement in physical aspects of quality of life one year after valve implantation. Eighty-eight patients with an average age of 80 years were included. We proposed a new threshold of 15 points for improvement in the physical function and physical role domains of the questionnaire. We found that half of the patients improved in quality of life, and those who improved had lower scores before surgery.The study emphasizes the need for a clear standard for improvement in quality of life in these patients, highlighting the value of assessment of quality of life before and after TAVI.
© 2025. The Author(s).