دورية أكاديمية
Impact of Computational Modeling on Transcatheter Left Atrial Appendage Closure Efficiency and Outcomes.
| العنوان: | Impact of Computational Modeling on Transcatheter Left Atrial Appendage Closure Efficiency and Outcomes. |
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| المؤلفون: | De Backer O; Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: ole.debacker@gmail.com., Iriart X; Bordeaux University Hospital, Fondation Bordeaux Université, Bordeaux, France., Kefer J; Cliniques Universitaires Saint-Luc, Brussels, Belgium., Nielsen-Kudsk JE; Aarhus University Hospital, Aarhus, Denmark., Aminian A; Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium., Rosseel L; Algemeen Stedelijk Ziekenhuis, Aalst, Belgium., Kofoed KF; Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark., Odenstedt J; Sahlgrenska University Hospital, Gothenburg, Sweden., Berti S; Fondazione CNR Regione Toscana, Massa, Italy., Saw J; Vancouver General Hospital, Vancouver, British Columbia, Canada., Søndergaard L; Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark., Garot P; Hôpital Jacques Cartier, Institut Cardiovasculaire Paris Sud, Ramsay-Santé, Massy, France. |
| المصدر: | JACC. Cardiovascular interventions [JACC Cardiovasc Interv] 2023 Mar 27; Vol. 16 (6), pp. 655-666. Date of Electronic Publication: 2023 Feb 22. |
| نوع المنشور: | Randomized Controlled Trial; Multicenter Study; Journal Article; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Country of Publication: United States NLM ID: 101467004 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1876-7605 (Electronic) Linking ISSN: 19368798 NLM ISO Abbreviation: JACC Cardiovasc Interv Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: New York : Elsevier |
| مواضيع طبية MeSH: | Atrial Fibrillation* , Atrial Appendage*/diagnostic imaging, Humans ; Prospective Studies ; Artificial Intelligence ; Treatment Outcome ; Computer Simulation ; Cardiac Catheterization/adverse effects ; Echocardiography, Transesophageal |
| مستخلص: | Background: When performing transcatheter left atrial appendage (LAA) closure, peridevice leaks and device-related thrombus (DRT) have been associated with worse clinical outcomes-hence, their risk should be mitigated. Objectives: The authors sought to assess whether use of preprocedural computational modeling impacts procedural efficiency and outcomes of transcatheter LAA closure. Methods: The PREDICT-LAA trial (NCT04180605) is a prospective, multicenter, randomized trial in which 200 patients were 1:1 randomized to standard planning vs cardiac computed tomography (CT) simulation-based planning of LAA closure with Amplatzer Amulet. The artificial intelligence-enabled CT-based anatomical analyses and computer simulations were provided by FEops (Belgium). Results: All patients had a preprocedural cardiac CT, 197 patients underwent LAA closure, and 181 of these patients had a postprocedural CT scan (standard, n = 91; CT + simulation, n = 90). The composite primary endpoint, defined as contrast leakage distal of the Amulet lobe and/or presence of DRT, was observed in 41.8% in the standard group vs 28.9% in the CT + simulation group (relative risk [RR]: 0.69; 95% CI: 0.46-1.04; P = 0.08). Complete LAA closure with no residual leak and no disc retraction into the LAA was observed in 44.0% vs 61.1%, respectively (RR: 1.44; 95% CI: 1.05-1.98; P = 0.03). In addition, use of computer simulations resulted in improved procedural efficiency with use of fewer Amulet devices (103 vs 118; P < 0.001) and fewer device repositionings (104 vs 195; P < 0.001) in the CT + simulation group. Conclusions: The PREDICT-LAA trial demonstrates the possible added value of artificial intelligence-enabled, CT-based computational modeling when planning for transcatheter LAA closure, leading to improved procedural efficiency and a trend toward better procedural outcomes. Competing Interests: Funding Support and Author Disclosures The PREDICT-LAA trial received funding from Abbott (United States), FEops NV (Belgium), and the European Union’s Horizon 2020 Research and Innovation Program under grant agreement No 945698. Dr De Backer has received institutional research grants and consulting fees from Abbott. Drs Kefer and Nielsen-Kudsk have served as proctors for Abbott. Dr Aminian has served as a proctor and consultant for Abbott and Boston Scientific. Dr Fuglsang Kofoed has received research grants from AP Møller og hustru Chastine McKinney Møllers Fond; the Research Council of Rigshopitalet; the University of Copenhagen; the Danish Heart Foundation; the Danish Agency for Science, Technology and Innovation by the Danish Council for Strategic Research; Novo Nordisk Foundation; Canon Medical Systems; and GE Healthcare. Dr Søndergaard has received institutional research grants and consulting fees from Abbott. Dr Saw has served as a proctor for Abbott and Boston Scientific. Dr Garot has served as a medical director and is a shareholder of CERC; and has received speaker fees from Abbott, Biosensors, Boston, Edwards Lifesciences, and GE Healthcare, outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.) |
| التعليقات: | Comment in: JACC Cardiovasc Interv. 2023 Mar 27;16(6):667-669. (PMID: 36990555) |
| فهرسة مساهمة: | Keywords: cardiac computed tomography; computational modeling; left atrial appendage closure; randomized controlled trial; simulations |
| سلسلة جزيئية: | ClinicalTrials.gov NCT04180605 |
| تواريخ الأحداث: | Date Created: 20230329 Date Completed: 20230331 Latest Revision: 20230405 |
| رمز التحديث: | 20240628 |
| DOI: | 10.1016/j.jcin.2023.01.008 |
| PMID: | 36990554 |
| قاعدة البيانات: | MEDLINE |
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