Demographic and Interpopulation Variations in Evaluation and Results of TAVI

Официальное название

DIVER-TAVI Registry - Demographic and Interpopulation Variations in Evaluation and Results of TAVI

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест laboratory 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
• Диагностический тест Computed tomography of aortic root and aorta
  Results of CT analysis performed as a routine diagnostic examination in the pre-procedural period will be recorded.

Первичные конечные точки

• Aortic annulus diameter [Срок оценки: Baseline]
• Aortic annulus area [Срок оценки: Baseline]
• Aortic annulus perimeter [Срок оценки: Baseline]
• Ilio-femoral artery diameter [Срок оценки: Baseline]
• Neutrophils measured using whole blood count [Срок оценки: Baseline]
• Monocytes measured in whole blood count [Срок оценки: Baseline]
• Lymphocytes measured using whole blood count [Срок оценки: Baseline]

Критерии участия

Критерии включения

• Severe aortic stenosis qualified for TAVI

Критерии исключения

• Active infection (chronic inflammatory disease or neoplasm is not an exclusion criterion, however, will be considered in the laboratory analysis)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• San Bortolo's Hospital, Division of Cardiac Surgery and Division of Cardiology, Vicenza, I — Vicenza

Польша · 1 центр

• Poznan University of Medical Sciences — Poznan

Сербия · 1 центр

• Institute for Cardiovascular Diseases of Vojvodina, Serbia University of Novi Sad — Novi Sad

Таиланд · 1 центр

• King Chulalongkorn Memorial Hospital, Bangkok, Thailand — Bangkok

Turkey (Türkiye) · 1 центр

• Ankara Bilkent City Hospital, Ankara, Türkiye — Ankara

Публикации

• 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. PMID 38415894
• 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. PMID 38996738
• 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. PMID 40156693

Идентификаторы

NCT: NCT07258706 · 2025_538

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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