This study investigates the impact of transcatheter aortic valve implantation (TAVI) on the composition and function of the gut microbiota in patients with severe aortic valve stenosis. The improvement in haemodynamics following TAVI may positively influence gut microbial balance by increasing splanchnic perfusion and reducing intestinal congestion. A total of 40 patients undergoing TAVI at the "Hippokration" General Hospital of Athens will be enrolled, with the aim of analysing stool and blood samples before and after the procedure. The primary endpoint is the change in gut microbiota composition two months post-TAVI, assessed via 16S rRNA sequencing. Secondary endpoints include changes in serum TMAO levels and their association with the severity of aortic stenosis and post-procedural valve haemodynamics. Data will be collected at two timepoints (1 month up to 1 day pre-TAVI and 3 to 4 months post-TAVI), along with dietary questionnaires to account for potential confounding factors. This observational study aims to highlight the potential relationship between cardiac function and the gut microbiome, offering new perspectives for targeted therapeutic strategies in cardiovascular disease.
Aortic stenosis suitable for TAVI
Use of antibiotics, systemic corticosteroids, antivirals, probiotics, bile acid sequestrants, or new medications within one month prior to enrollment.
History of inflammatory bowel disease.
End-stage renal disease requiring dialysis.
End-stage chronic liver disease.
The study will include 40 patients undergoing clinically indicated TAVI at the Hemodynamic Laboratory of the "Hippokration" General Hospital of Athens. This sample size is considered sufficient based on the limited available literature. Interim analysis will be conducted after the first 10 patients have completed the study to reassess and, if necessary, adjust the final sample size. Written informed consent is a prerequisite for inclusion.
Cohort
Prospective
TAVI
Procedure/SurgeryTranscatheter Aortic Valve Implantation (TAVI) is a minimally invasive method for replacing the aortic valve in patients with severe aortic stenosis. The procedure involves the placement of a bioprosthetic valve within the patient's degenerated aortic valve via a catheter.
Change in gut microbiota composition (via 16S rRNA sequencing)
Change in serum trimethylamine N-oxide (TMAO) levels
Correlation of microbiota changes with severity of aortic stenosis at baseline
Correlation of microbiota changes with haemodynamic parameters
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