Aortic Stenosis, Computed Tomography, Inflammation, Inflammatory Response During Cardiac Surgery, TAVI(Transcatheter Aortic Valve Implantation)
Conditions
Keywords
Aortic stenosis, transcatheter aortic valve implantation, TAVI, Computed Tomography, Inflammation
Brief summary
The aim of the project is to evaluate demographic, clinical, and laboratory variations in patients with aortic stenosis treated with TAVI in different countries. Moreover, the study will evaluate interpopulation differences in aortic root anatomy based on computed tomography analysis.
Detailed description
Aortic stenosis represents the most common valvular heart disease in developed countries, with a significant epidemiologic increase related to the aging population. Currently, surgical and transcatheter interventions are the only therapeutic options, as pharmacotherapy is still insufficient in the disease management. Transcatheter aortic valve implantation is recommended in selected groups of patients and provides optimal short and long-term outcomes. Racial and ethnic disparities in aortic stenosis prevalence, management, and outcomes of treatment have been postulated. Data on discrepancies in aortic stenosis characteristics in patients qualified for transcatheter aortic valve implantation across populations are lacking. The current project will conduct the analysis in populations of patients with aortic stenosis qualified for transcatheter aortic valve implantation from different countries to reveal potential disparities in clinical characteristics and in requirements for variations in prostheses sizes. This is a retrospective, multicentre, observational registry of patients with severe aortic stenosis qualified for transcatheter aortic valve implantation. Inclusion criteria - each site will include consecutive 100 patients who underwent transcatheter aortic valve implantation between January and June 2025. Exclusion criteria - active infection (chronic inflammatory disease or neoplasm is not an exclusion criterion, however, will be considered in the laboratory analysis) Data concerning * patients' demographics, * clinical characteristics * results of aortic root and aorta analyses by computed tomography * echocardiography results * results of common laboratory tests (blood morphology, inflammatory ratios of neutrophils, monocytes and platelets to lymphocytes, glomerular filtration rate, N-terminal prohormone of brain natriuretic peptide) obtained during the routine care in the pre-procedural period will be collected at each site. Simple procedural results (inc. prosthesis type and size) and outcomes (survival, bleeding, vascular complications, and acute kidney injury) will be recorded. Collected data will be compared between study populations.
Interventions
DIAGNOSTIC_TESTlaboratory biomarker analysis
Results of common laboratory tests obtained during routine care in the pre-procedural period (simple blood morphology, creatinine, GFR, NTproBNP). Inflammatory indices - NLR, MLR, PLR
DIAGNOSTIC_TESTComputed tomography of aortic root and aorta
Results of CT analysis performed as a routine diagnostic examination in the pre-procedural period will be recorded.
Sponsors
Poznan University of Medical Sciences
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Severe aortic stenosis qualified for TAVI
Exclusion criteria
* Active infection (chronic inflammatory disease or neoplasm is not an exclusion criterion, however, will be considered in the laboratory analysis)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aortic annulus diameter | Baseline | Aortic annulus diameter in milimeters based on CT image |
| Aortic annulus area | Baseline | Aortic annulus area in squared milimeters based on CT image |
| Aortic annulus perimeter | Baseline | Aortic annulus perimeter in milimeters based on CT image |
| Ilio-femoral artery diameter | Baseline | Ilio-femoral artery diameter in milimeter based on CT image |
| Neutrophils measured using whole blood count | Baseline | This measurement is used to compute ratio of cell types using whole blood count |
| Monocytes measured in whole blood count | Baseline | Number of monocytes identified in blood sample using automatic whole blood count. It is used to compute cell type ratio. |
| Lymphocytes measured using whole blood count | Baseline | This measurement is used to compute ratio of cell types using whole blood count |
Countries
Italy, Poland, Serbia, Thailand, Turkey (Türkiye)
Outcome results
None listed