Determining Clinical and Cardiopulmonary exercise testing Parameters that may predict Improvement in Capacity After Transcatheter Aortic Valve Implantation
Transcatheter Aortic Valve Implantation (TAVI) has emerged as a less invasive alternative to surgical aortic valve replacement, especially for high-risk patients. However, existing research on functional outcomes after TAVI has yielded mixed results. To our knowledge, the potential functional benefit of TAVI has not been well explored using cardiopulmonary exercise testing (CPET). The present study aims to 1) characterize the mid-term exercise tolerance response to TAVI, and 2) determine the clinical (symptoms, frailty, quality of life, etc.) and functional factors (parameters derived from CPET) that determine the magnitude of this response. A positive functional response to TAVI will be considered as an increase in VO2 max \> 2.5ml/kg/min or \>10% of its baseline value one month post-TAVI. The exercise test will be conducted by a physiotherapist and supervised by a physician using a standard incremental cardiopulmonary exercise testing on cycle ergometer (Ergoline 900, Ergoline, Bitz, Germany (CE-0123) and Ergocard Professional, Medisoft, Sorinnes, Belgium (CE-1434)). To this end, 161 patients with severe aortic stenosis scheduled for TAVI will be included in 3 expert centres. They will be evaluated clinically and functionally (incremental CPET) in the 2 weeks prior to the procedure and 4-6 weeks after.
Study Type
OBSERVATIONAL
Enrollment
161
Hospital Clinic Barcelona
Barcelona, Spain
RECRUITINGDelta VO2 max and Delta VO2 at anaerobic threshold
Change in CPET parameters after Transcatheter Aortic valve implantation (TAVI): VO2 max, VO2 at anaerobic threshold
Time frame: CPET performed 2 weeks before TAVI and 4-6 weeks after
Clinical and functional pre-TAVI factors that predict improvement in functional capacity after TAVI
To identify clinical and functional pre-TAVI factors that predict improvement in functional capacity after TAVI (i.e., VO2 max increase \> 2.5 ml/kg/min or \>10% increase in VO2 max). ml/kg/min or \>10% increase in VO2 max).
Time frame: CPET performed 2 weeks before TAVI and 4-6 weeks after
Clinical predictors of improvement in quality of life
To identify clinical, echocardiographic and functional pre-TAVI variables that predict improvement in quality of life
Time frame: 2 weeks before TAVI and 4-6 weeks after
pre-TAVI CPET parameters that predict in-hospital complications.
Correlation between pre-TAVI CPET parameters and in-hospital complications.
Time frame: CPET performed 2 weeks before TAVI and 4-6 weeks after
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