Quality of Life After Transcatheter Aortic Valve Implantation

Transcatheter aortic valve implantation (TAVI) results in substantial hemodynamic improvement in patients with severe aortic stenosis, including reduction in transvalvular pressure gradient and left ventricular afterload. However, objective improvements in valve hemodynamic may not necessarily correspond to improvements in patients' perceived health status and quality of life.

This observational cohort study will examine the relationship between changes in patient-reported health status and changes in objective and functional clinical parameters following TAVI. Patient-reported health status will be assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) used as the primary patient-reported outcome measure.

Changes in KCCQ from baseline to follow-up will be evaluated in relation to changes in mean transvalvular gradient and left ventricular ejection fraction as well as changes in New York Heart Association functional class.

Secondary analyses will investigate factors potentially associated with variation in quality-of-life improvement after TAVI. These include demographic and clinical characteristics such as age, sex, weight, type 2 diabetes mellitus, ischemic heart disease, hypertension, atrial fibrillation, and chronic kidney disease. Anatomical and procedural characteristics, including aortic annulus size, transcatheter valve size, pre- and post-dilatation, and procedural complications, will also be evaluated.

Particular attention will be given to whether sex and anatomical characteristics are associated with differences in the relationship between hemodynamic improvement and patient-reported outcomes.

The study combines prospectively collected KCCQ data with clinical, echocardiographic, anatomical, and procedural information obtained from patient records. By examining patient-reported outcomes alongside conventional measures of treatment response, the study seeks to characterize potential discordance between objective improvement following TAVI and improvement experienced by the patient.

Primary outcomes

• Kansas City Cardiomyopathy Questionnaire [Baseline (before TAVI) to 1-3 months after TAVI]: Change in patient-reported health status from baseline to follow-up after TAVI, assessed using the Kansas City Cardiomyopathy Questionnaire. Scores range from 0 to 100, with higher scores indicating better health status. The outcome will be calculated as the difference between follow-up and baseline KCCQ scores.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Age ≥18 years
* Undergoing transcatheter aortic valve implantation (TAVI)
* TAVI performed within the study recruitment period
* Available baseline KCCQ assessment
* Able to participate in follow-up assessment

Exclusion Criteria:

* Severe cognitive impairment preventing completion of the KCCQ
* Language barrier preventing completion of the KCCQ
* Severe illness or clinical condition preventing participation in follow-up

• Al-Azizi, K., Abo Hajar, M. B., Pickering, T., Moubarak, G., Dorton, C. W., McCullough, K. A., Ladner, J., Elias, M., Parro, C., McCoy, S. L., Saeed, U., Ma, T.-W., Hale, S., Gupta, S., Harrington, K. B., Schaffer, J. M., Mohiuddin, A., Brinkman, W. T., Alsaid, A., … Mack, M. J. (2026). Impact of Measured and Predicted Patient-Prosthesis Mismatch on Quality of Life Following Transcatheter Aortic Valve Implantation. Structural Heart, 10(1). https://doi.org/10.1016/j.shj.2025.100759 Arnold, S. V, Spertus, J. A., Vemulapalli, S., Li, Z., Matsouaka, R. A., Baron, S. J., Vora, A. N., Mack, M. J., Reynolds, M. R., Rumsfeld, J. S., & Cohen, D. J. (2017). Quality-of-life outcomes after transcatheter aortic valve replacement in an unselected population: A report from the STS/ACC transcatheter valve therapy registry. JAMA Cardiology, 2(4), 409-416. https://doi.org/10.1001/jamacardio.2016.5302 Cabrucci, F., Baudo, M., Yamashita, Y., Dokollari, A., Sicouri, S., & Ramlawi, B. (2024). Short and Long-Term Outcomes of Transcatheter Aortic Valve Implantation in the Small Aortic Annulus: A Systematic Literature Review. In Journal of Personalized Medicine (Vol. 14, Number 9). Multidisciplinary Digital Publishing Institute (MDPI). https://doi.org/10.3390/jpm14090937 Capodanno, D., Petronio, A. S., Prendergast, B., Eltchaninoff, H., Vahanian, A., Modine, T., Lancellotti, P., Sondergaard, L., Ludman, P. F., Tamburino, C., Piazza, N., Hancock, J., Mehilli, J., Byrne, R. A., Baumbach, A., Kappetein, A. P., Windecker, S., Bax, J., & Haude, M. (2017). Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: A consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). European Heart Journal, 38(45), 3382-3390. https://doi.org/1

• Ashkan Eftekhari, MD PhD, Principal investigator, Aalborg University Hospital Dept. of Cardiology