Digital Twin and Ml-basEd MOdel of TEVAR Interventions (MEMO)
調査の概要
詳細な説明
In recent years, Thoracic Endovascular Aortic Repair (TEVAR) has become increasingly utilized for the treatment of thoracic aortic pathologies. Over the past two decades, the adoption of TEVAR has grown significantly, progressively replacing open surgery as the preferred treatment approach in many cases. Initially designed for interventions involving the descending thoracic aorta, TEVAR is now being extended to more complex anatomies, including the aortic arch and even regions closer to the aortic root.
Successful TEVAR procedures rely on accurate preoperative planning and detailed clinical assessment to optimize patient outcomes. Although TEVAR offers several advantages over open surgery, including reduced procedural risk, shorter recovery time, and lower morbidity, it is not without limitations. Major complications include endoleaks, stent-induced new entry tears, vessel obstruction, and stent migration, all of which may significantly affect patient prognosis. Despite existing manufacturer guidelines and deployment strategies, these complications remain difficult to predict.
Previous studies have reported endoleak rates ranging from 4% to 15%, stent migration rates between 1.0% and 2.8%, and device-related complications occurring in up to 38% of cases. Recent advances in computational modeling have demonstrated considerable potential for improving TEVAR planning and risk prediction. Finite element analysis (FEA) and fluid-structure interaction (FSI) simulations have proven valuable for assessing stent behavior within patient-specific anatomies. Through in silico simulations, different stent types and diameter configurations can be virtually tested, providing surgeons with critical insights for clinical decision-making.
However, despite their high accuracy, these techniques are computationally intensive and require large datasets as well as specialized expertise, limiting their accessibility for routine clinical practice. To address these challenges, numerical models (e.g., finite element simulations) and machine learning (ML) approaches represent promising alternatives for real-time, data-driven perioperative decision support. By integrating finite element simulations with clinical imaging data, ML algorithms can be trained to predict procedural outcomes, optimize prosthesis selection, and estimate post-interventional risks. This approach not only enhances pre-procedural planning but also facilitates postoperative risk assessment, ultimately contributing to improved patient management.
A critical challenge in developing robust ML models for TEVAR planning is the limited accessibility of high-quality annotated datasets and their integration into clinical workflows. To overcome this limitation, the study proposes a comprehensive methodology aimed at:
I) collecting clinical and imaging data relevant to TEVAR procedures; II) augmenting patient-specific anatomical data using statistical shape modeling (SSM) to generate a diverse training dataset; III) developing high-fidelity digital twins that provide personalized virtual replicas of individual TEVAR cases; and IV) training ML models on these augmented datasets to predict procedural outcomes based on patient-specific characteristics.
Using these techniques, the study aims to develop a clinically viable framework capable of predicting surgical outcomes and increasing the information available for surgeons during preoperative decision-making, thereby improving patient outcomes in TEVAR interventions.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:SANTI TRIMARCHI, MD, PHD
- 電話番号:+390255032438
- メール:santi.trimarchi@policlinico.mi.it
研究場所
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Milan、イタリア
- 募集
- Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
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コンタクト:
- SANTI TRIMARCHI, MD, PHD
- 電話番号:+390255032438
- メール:santi.trimarchi@policlinico.mi.it
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- ≥18 Years and older (Adult, Older Adult)
- Female and male
- Received TEVAR for: Chronic or acute dissection, Aneurysm, Penetrating aortic ulcer, aortic thrombus, intramural hematoma or traumatic injury
Exclusion Criteria:
- Younger than 18 years old
- Received TEVAR in surgical graft that replaced native aorta
- Poor CT image quality that leads to failure in generating a high-fidelity 3D FE model of patient anatomy (no preoperative multidetector contrast-enhanced CT-scan available, preoperative CTscan slice thickness greater than 1mm, preoperative CT-scan with artifacts, motion artifacts due to the presence of other implanted devices affecting the region of interest)
研究計画
研究はどのように設計されていますか?
デザインの詳細
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Determine the accuracy of patient-specific numerical simulations in replicating TEVAR deployment outcomes
時間枠:up to 1 year
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Accuracy of the simulations, expressed in terms of the match between simulated and post-operative device-vessel interaction (e.g., configuration, sealing quality, apposition), as assessed via comparison of post-operative CT image with the simulation results
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up to 1 year
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Assess the predictive performance of the ML model in forecasting clinical complications
時間枠:up to 1 year
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Sensitivity, specificity, and AUC of the model in predicting complications using retrospective clinical follow-up data
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up to 1 year
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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