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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.
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with aortic stenosis qualified for TAVI | All consecutive patients with severe aortic stenosis qualified for TAVI according to current guidelines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laboratory biomarker analysis | Diagnostic Test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Aortic annulus diameter | Aortic annulus diameter in milimeters based on CT image | Baseline |
| Aortic annulus area | Aortic annulus area in squared milimeters based on CT image | Baseline |
| Aortic annulus perimeter | Aortic annulus perimeter in milimeters based on CT image | Baseline |
| Ilio-femoral artery diameter | Ilio-femoral artery diameter in milimeter based on CT image | Baseline |
| Neutrophils measured using whole blood count | This measurement is used to compute ratio of cell types using whole blood count | Baseline |
| Monocytes measured in whole blood count | Number of monocytes identified in blood sample using automatic whole blood count. It is used to compute cell type ratio. | Baseline |
| Lymphocytes measured using whole blood count | This measurement is used to compute ratio of cell types using whole blood count | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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All consecutive patients qualified for TAVI will be included in the analysis and compared in subpopulations.
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| Name | Affiliation | Role |
|---|---|---|
| Anna Olasinska-Wisniewska | Poznan University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Bortolo's Hospital, Division of Cardiac Surgery and Division of Cardiology, Vicenza, Italy | Vicenza | Italy | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38415894 | Background | Hakgor A, Dursun A, Kahraman BC, Yazar A, Savur U, Akhundova A, Olgun FE, Arman ME, Boztosun B. Prognostic impact of main pulmonary artery to ascending aorta diameter ratio in patients with severe aortic stenosis underwent transcatheter aortic valve implantation. Catheter Cardiovasc Interv. 2024 Apr;103(5):782-791. doi: 10.1002/ccd.31000. Epub 2024 Feb 28. | |
| 38996738 |
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| Computed tomography of aortic root and aorta | Diagnostic Test | Results of CT analysis performed as a routine diagnostic examination in the pre-procedural period will be recorded. |
|
| Poznan University of Medical Sciences |
| Poznan |
| 61-848 |
| Poland |
| Institute for Cardiovascular Diseases of Vojvodina, Serbia University of Novi Sad | Novi Sad | Serbia |
| King Chulalongkorn Memorial Hospital, Bangkok, Thailand | Bangkok | Thailand |
| Ankara Bilkent City Hospital, Ankara, Türkiye | Ankara | Turkey (Türkiye) |
| Yang Y, Richter R, Halfmann MC, Graafen D, Hell M, Vecsey-Nagy M, Laux G, Kavermann L, Jorg T, Geyer M, Varga-Szemes A, Emrich T. Prospective ECG-gated High-Pitch Photon-Counting CT Angiography: Evaluation of measurement accuracy for aortic annulus sizing in TAVR planning. Eur J Radiol. 2024 Sep;178:111604. doi: 10.1016/j.ejrad.2024.111604. Epub 2024 Jul 6. |
| 40156693 | Background | Schafer M, Glotzbach JP, Sharma V, Tandar A, Welt FG, L Goodwin M, Smego D, Selzman CH, Pereira SJ. Aortic shape and diameter variations are predictive of short-term complications in transcatheter aortic valve replacement. Int J Cardiovasc Imaging. 2025 May;41(5):955-965. doi: 10.1007/s10554-025-03381-2. Epub 2025 Mar 29. |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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