Clinical and cardiopulmonary predictors of functional recovery and complications after transcatheter aortic valve implantation: Protocol of a prospective interventional study.

Martinez-Otero S; Department of Anaesthesia and ICU, Hospital Clinic de Barcelona, Spain.
Gimenez-Mila M; Arguis MJ; Regueiro A; Rodriguez-Arias
JJ; Sanz de la Garza M; Berenguel A; Gadella A; Kenneally LF;
Martinez-Palli G

PLoS ONE [Electronic Resource]. 21(5):e0348568, 2026.

INTRODUCTION: Transcatheter Aortic Valve Implantation (TAVI) has emerged
as a less invasive alternative to surgical aortic valve replacement,
especially for high-risk patients. While TAVI is expected to improve
symptoms and functional status, clinical recovery is often heterogeneous,
and subjective assessments may not fully capture the degree of
improvement. To our knowledge, the changes in functional capacity
following TAVI have not been well explored using cardiopulmonary exercise
testing (CPET). The study aims to characterise mid-term changes in
exercise tolerance after TAVI and identify clinical and functional
predictors of improvement in exercise capacity and complications after
TAVI.

METHODS AND ANALYSIS: A total of 161 patients with severe aortic stenosis
scheduled for TAVI will be prospectively enrolled across three expert
centres. Each will undergo clinical assessment and incremental CPET within
two weeks before and four to six weeks after the procedure. The primary
outcome is a change in VO2 peak and VO2 at the anaerobic threshold.
Secondary outcomes include exploratory associations between baseline
characteristics and observed changes in functional capacity, quality of
life and complications.

ETHICS AND DISSEMINATION: The bioethics committee of the Hospital Clinic
de Barcelona, Spain, approved this protocol (HCB/2024/0782). All the
participating centres obtained local approval prior to patient
recruitment. The findings will be published in a peer-reviewed journal and
submitted to relevant conferences.