Left atrial appendage occlusion: On the need of a numerical model to simulate the implant procedure.

finite element analysis in-silico modeling left appendix non-valvular atrial fibrillation percutaneous closure watchman FLX device

Journal

International journal for numerical methods in biomedical engineering
ISSN: 2040-7947
Titre abrégé: Int J Numer Method Biomed Eng
Pays: England
ID NLM: 101530293

Informations de publication

Date de publication:
19 Mar 2024
Historique:
revised: 23 01 2024
received: 13 10 2023
accepted: 10 03 2024
medline: 20 3 2024
pubmed: 20 3 2024
entrez: 20 3 2024
Statut: aheadofprint

Résumé

Left atrial appendage occlusion (LAAO) is a percutaneous procedure to prevent thromboembolism in patients affected by atrial fibrillation. Despite its demonstrated efficacy, the LAA morphological complexity hinders the procedure, resulting in postprocedural drawbacks (device-related thrombus and peri-device leakage). Local anatomical features may cause difficulties in the device's positioning and affect the effectiveness of the device's implant. The current work proposes a detailed FE model of the LAAO useful to investigate implant scenarios and derive clinical indications. A high-fidelity model of the Watchman FLX device and simplified parametric conduits mimicking the zone of the LAA where the device is deployed were developed. Device-conduit interactions were evaluated by looking at clinical indicators such as device-wall gap, possible cause of leakage, and device protrusion. As expected, the positioning of the crimped device before the deployment was found to significantly affect the implant outcomes: clinician's choices can be improved if FE models are used to optimize the pre-operative planning. Remarkably, also the wall mechanical stiffness plays an important role. However, this parameter value is unknown for a specific LAA, a crucial point that must be correctly defined for developing an accurate FE model. Finally, numerical simulations outlined how the device's configuration on which the clinician relies to assess the implant success (i.e., the deployed configuration with the device still attached to the catheter) may differ from the actual final device's configuration, relevant for achieving a safe intervention.

Identifiants

pubmed: 38504482
doi: 10.1002/cnm.3814
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

e3814

Subventions

Organisme : Ministero della Salute
Organisme : Italian Ministry of Health
ID : RF-2021-12375208

Informations de copyright

© 2024 John Wiley & Sons Ltd.

Références

Albaghdadi M, Kadlec A, Adler A, et al. Peri-device leaks after percutaneous left atrial appendage closure: clinical significance and unmet diagnostic needs. Structural Heart. 2020;4(6):475-481. doi:10.1080/24748706.2020.1817642
Dudzińska-Szczerba K, Kułakowski P, Michałowska I, Baran J. Association between left atrial appendage morphology and function and the risk of Ischaemic stroke in patients with atrial fibrillation. Arrhythmia Electrophysiol Rev. 2022;11:e09. doi:10.15420/AER.2022.08
Steinberg DH, Bertog S, Franke J, Wiebe J, Wunderlich N, Sievert H. Left atrial appendage occlusion. Structural Heart Disease Interventions. Vol 18. Wolters Kluwer Health; 2012:233-242. doi:10.4244/EIJ-D-22-00627
WatchmanFLX_Boston_Scientific.
Alkhouli M, du C, Killu A, et al. Clinical impact of residual leaks following left atrial appendage occlusion: insights from the NCDR LAAO registry. JACC Clin Electrophysiol. 2022;8(6):766-778. doi:10.1016/j.jacep.2022.03.001
Golzarian H, Mariam A, Shah SR, et al. Utilization of WATCHMAN FLX for surgically incomplete left atrial appendage occlusion: a multicentre case series. Eur Heart J Case Rep. 2023;7(4):ytad160. doi:10.1093/ehjcr/ytad160
Cepas-Guillén P, Flores-Umanzor E, Leduc N, et al. Impact of device implant depth after left atrial appendage occlusion. JACC Cardiovasc Interv. 2023;16:2139-2149. doi:10.1016/j.jcin.2023.05.045
Alkhouli M, Ellis CR, Daniels M, Coylewright M, Nielsen-Kudsk JE, Holmes DR. Left atrial appendage occlusion. JACC: Adv. 2022;1(5):100136. doi:10.1016/j.jacadv.2022.100136
Zhong Z, Gao Y, Kovács S, et al. Impact of left atrial appendage occlusion device position on potential determinants of device-related thrombus: a patient-specific in silico study. Clin Res Cardiol. 2023;16(22):2695-2707. doi:10.1007/s00392-023-02228-x
Sakriss C, Roehl P, Schwenzky A, Hoyme M, Ebelt H. Transition from WATCHMAN V.2.5 to WATCHMAN FLX for closure of the left atrial appendage: echocardiographic and clinical findings. Open Heart. 2023;10(1):2246. doi:10.1136/openhrt-2022-002246
Hildick-Smith D, Landmesser U, Camm AJ, et al. Left atrial appendage occlusion with the AmplatzerTM AmuletTM device: full results of the prospective global observational study. Eur Heart J. 2020;41(28):2894-2901. doi:10.1093/eurheartj/ehaa169
Pracon R, Bangalore S, Dzielinska Z, et al. Device thrombosis after percutaneous left atrial appendage occlusion is related to patient and procedural characteristics but not to duration of postimplantation dual antiplatelet therapy. Circ Cardiovasc Interv. 2018;11(3):5997. doi:10.1161/CIRCINTERVENTIONS.117.005997
Simard T, Jung RG, Lehenbauer K, et al. Predictors of device-related thrombus following percutaneous left atrial appendage occlusion. J Am Coll Cardiol. 2021;78(4):297-313. doi:10.1016/j.jacc.2021.04.098
Qiu D, Azadani AN. Structural analysis of regional transcatheter aortic valve under expansion and its implications for subclinical leaflet thrombosis. Int J Numer Method Biomed Eng. 2022;38(10):e3641. doi:10.1002/cnm.3641
Dallan LAP, Arruda M, Yoon SH, et al. Novel computed tomography angiography-based sizing methodology for WATCHMAN FLX device in left atrial appendage closure. J Cardiovasc Electrophysiol. 2022;33(8):1781-1787. doi:10.1111/jce.15548
Korsholm K, Berti S, Iriart X, et al. Expert recommendations on cardiac computed tomography for planning transcatheter left atrial appendage occlusion. JACC Cardiovasc Interv. 2020;13(3):277-292. doi:10.1016/j.jcin.2019.08.054
Kim WD, Cho I, Kim YD, et al. Improving left atrial appendage occlusion device size determination by three-dimensional printing-based preprocedural simulation. Front Cardiovasc Med. 2022;9:1-9. doi:10.3389/fcvm.2022.830062
Hong D, Moon S, Cho Y, Oh I-Y, Chun EJ, Kim N. Rehearsal simulation to determine the size of device for left atrial appendage occlusion using patient-specific 3D-printed phantoms based on CT images. Sci Rep. 2022;12:1-11. doi:10.1038/s41598-022-11967-2
Cloonan AJ, Shahmirzadi D, Li RX, Doyle BJ, Konofagou EE, McGloughlin TM. 3D-printed tissue-mimicking phantoms for medical imaging and computational validation applications. 3D Print Addit Manuf. 2014;1(1):14-23. doi:10.1089/3dp.2013.0010
Mendez K, Kennedy DG, Wang DD, O'Neill B, Roche ET. Left atrial appendage occlusion: current stroke prevention strategies and a shift toward data-driven, patient-specific approaches. J Soc Cardiovasc Angiogr Interventions. 2022;1(5):100405. doi:10.1016/j.jscai.2022.100405
FEops HEARTguide. https://feops.com/
Bavo AM, Wilkins BT, Garot P, et al. Validation of a computational model aiming to optimize preprocedural planning in percutaneous left atrial appendage closure. J Cardiovasc Comput Tomogr. 2020;14(2):149-154. doi:10.1016/j.jcct.2019.08.010
Hornstein G, Diep C, Masson J-B, et al. The use of three-dimensional printing in cardiac structural disease: a review. Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery. SAGE Publications Ltd; 2023. doi:10.1177/15569845231161287
Bosi GM, Cook A, Rai R, et al. Computational fluid dynamic analysis of the left atrial appendage to predict thrombosis risk. Front Cardiovasc Med. 2018;5(April):34. doi:10.3389/fcvm.2018.00034
Fanni BM, Capellini K, Di Leonardo M, et al. Correlation between LAA morphological features and computational fluid dynamics analysis for non-valvular atrial fibrillation patients. Appl Sci. 2020;10(4):1448. doi:10.3390/app10041448
Fanni BM, Gasparotti E, Vignali E, et al. P6223Importance of left atrium fluid dynamics for the planning of LAA closure procedure: an integrated computational fluid dynamics and morphological study. Eur Heart J. 2018;39:6223. doi:10.1093/eurheartj/ehy566.p6223
Aguado AM, Olivares AL, Yagüe C, et al. In silico optimization of left atrial appendage Occluder implantation using interactive and modeling tools. Front Physiol. 2019;10:237. doi:10.3389/fphys.2019.00237
Mill J, Agudelo V, Li CH, et al. Patient-specific flow simulation analysis to predict device-related thrombosis in left atrial appendage occluders. REC: Interv Cardiol. 2021;3(4):278-285. doi:10.24875/RECICE.M21000224
Mill J, Agudelo V, Olivares AL, et al. Sensitivity analysis of in silico fluid simulations to predict thrombus formation after left atrial appendage occlusion. Mathematics. 2021;9(18):1-19. doi:10.3390/math9182304
Berti S, de Caterina AR, Grasso C, et al. Periprocedural outcome in patients undergoing left atrial appendage occlusion with the watchman FLX device: the ITALIAN-FLX registry. Front Cardiovasc Med. 2023;10:1115811. doi:10.3389/fcvm.2023.1115811
Doshi SK, Kar S, Sadhu A, et al. Two-year outcomes with a next-generation left atrial appendage device: final results of the PINNACLE FLX trial. J Am Heart Assoc. 2023;12(4):e026295. doi:10.1161/JAHA.122.026295
Hemmler A, Lutz B, Reeps C, Gee MW. In silico study of vessel and stent-graft parameters on the potential success of endovascular aneurysm repair. Int J Numer Method Biomed Eng. 2019;35(11):e3237. doi:10.1002/cnm.3237
WATCHMAN FLX Device Product Brochure. https://www.watchman.com/content/dam/watchman/downloads/download-center/watchman-flx/WATCHMAN_FLX_Product_Brochure.pdf
Della Rocca DG, Horton RP, Tarantino N, et al. Use of a novel septal Occluder device for left atrial appendage closure in patients with postsurgical and Postlariat leaks or anatomies unsuitable for conventional percutaneous occlusion. Circ Cardiovasc Interv. 2020;13(10):E009227. doi:10.1161/CIRCINTERVENTIONS.120.009227
Mahmoudi K, Galea R, Elhadad S, et al. Computed tomography scan evidence for left atrial appendage short-term remodeling following percutaneous occlusion: impact of device oversizing. J Am Heart Assoc. 2023;12:e030037. doi:10.1161/JAHA.123.030037
Rajwani A, Shirazi MG, Disney PJS, et al. Left atrial appendage eccentricity and irregularity are associated with residual leaks after percutaneous closure. JACC Clin Electrophysiol. 2015;1(6):478-485. doi:10.1016/j.jacep.2015.08.006
Cho I, Kim WD, Lee OH, et al. Pre-procedural determination of device size in left atrial appendage occlusion using three-dimensional cardiac computed tomography. Sci Rep. 2021;11(1):1-9. doi:10.1038/s41598-021-03537-9
Bhatt H, Safi LM, Jelnin V, Pasala TKR, Simons GR. Successful new generation LAA closure device implantation after prior incomplete surgical LAA ligation. JACC Case Rep. 2021;3(12):1419-1421. doi:10.1016/j.jaccas.2021.06.027
Ellis CR, Jackson GG, Kanagasundram AN, et al. Left atrial appendage closure in patients with prohibitive anatomy: insights from PINNACLE FLX. Heart Rhythm. 2021;18(7):1153-1161. doi:10.1016/j.hrthm.2021.02.022
Sobrino A, Tzikas A, Freixa X, et al. Intra-procedural imaging of the left atrial appendage: implications for closure with the Amplatzer™ cardiac plug. Arch Cardiol Mex. 2014;84(1):17-24. doi:10.1016/j.acmx.2013.05.006
Nakatani Y, Sakamoto T, Yamaguchi Y, Tsujino Y, Kataoka N, Kinugawa K. Heterogeneity in the left atrial wall thickness contributes to atrial fibrillation recurrence after catheter ablation. Heart Vessel. 2018;33(12):1549-1558. doi:10.1007/s00380-018-1200-y
Słodowska K, Hołda J, Dudkiewicz D, et al. Thickness of the left atrial wall surrounding the left atrial appendage orifice. J Cardiovasc Electrophysiol. 2021;32(8):2262-2268. doi:10.1111/jce.15157
Jernigan SR, Buckner GD, Eischen JW, Cormier DR. Finite element modeling of the left atrium to facilitate the design of an endoscopic atrial retractor. J Biomech Eng. 2007;129(6):825-837. doi:10.1115/1.2801650
Pruitt Z, Bhave P, Daniel K, Whalen SP, Richardson K. Left atrial appendage occlusion device buckling: an avoidable deployment complication identified and corrected using intraprocedural transesophageal echocardiography. CASE J. 2023;7(1):27-34. doi:10.1016/j.case.2022.10.004
Zaccaria A, Danielli F, Gasparotti E, et al. Left atrial appendage occlusion device: development and validation of a finite element model. Med Eng Phys. 2020;82:104-118. doi:10.1016/j.medengphy.2020.05.019
Vad S, Eskinazi A, Corbett T, McGloughlin T, Vande Geest JP. Determination of coefficient of friction for self-expanding stent-grafts. J Biomech Eng. 2010;132(12):1-10. doi:10.1115/1.4002798
Kleinstreuer C, Li Z, Basciano CA, Seelecke S, Farber MA. Computational mechanics of nitinol stent grafts. J Biomech. 2008;41(11):2370-2378. doi:10.1016/j.jbiomech.2008.05.032
Kan X, Ma T, Lin J, Wang L, Dong Z, Xu XY. Patient-specific simulation of stent-graft deployment in type B aortic dissection: model development and validation. Biomech Model Mechanobiol. 2021;20(6):2247-2258. doi:10.1007/s10237-021-01504-x
Nematzadeh F. A computational study of effects of material properties, strain level, and friction coefficient on smart stent behavior and peripheral artery performance during the interaction process. J Intell Mater Syst Struct. 2022;33(5):703-714. doi:10.1177/1045389X211026380
Mozafari H, Dong P, Zhao S, Bi Y, Han X, Gu L. Migration resistance of esophageal stents: the role of stent design. Comput Biol Med. 2018;100:43-49. doi:10.1016/j.compbiomed.2018.06.031
Contact cohesive behavior. https://abaqus-docs.mit.edu/2017/English/SIMACAEITNRefMap/simaitn-c-cohesivebehavior.htm#simaitn-c-acohesivebehav-common-applications
Glikson M, Wolff R, Hindricks G, et al. EHRA/EAPCI expert consensus statement on catheter-based left atrial appendage occlusion - an update. EuroIntervention. 2020;15:1133-1180. doi:10.4244/EIJY19M08
Saw J, Holmes DR, Cavalcante JL, et al. SCAI/HRS expert consensus statement on transcatheter left atrial appendage closure. J Soc Cardiovasc Angiogr Interventions. 2023;2(3):100577. doi:10.1016/j.jscai.2022.100577
Blanca MJ, Alarcón R, Arnau J, Bono R, Bendayan R. Datos no normales: ¿es el ANOVA una opción válida? Psicothema. 2017;29(4):552-557. doi:10.7334/psicothema2016.383
Závodszky G, Csippa B, Paál G, Szikora I. A novel virtual flow diverter implantation method with realistic deployment mechanics and validated force response. Int J Numer Method Biomed Eng. 2020;36(6):e3340. doi:10.1002/cnm.3340
Rashid HN, Layland J. Association between device-related thrombus and the neo-appendage with left-atrial appendage occlusion devices. Eur Heart J. 2020;41(28):2894-2901. doi:10.1093/eurheartj/ehaa169

Auteurs

Francesca Danielli (F)

LaBS - Laboratory of Biological Structure Mechanics, Department of Chemistry, Materials and Chemical Engineering "Giulio Natta", Politecnico di Milano, Milan, Italy.

Francesca Berti (F)

LaBS - Laboratory of Biological Structure Mechanics, Department of Chemistry, Materials and Chemical Engineering "Giulio Natta", Politecnico di Milano, Milan, Italy.

Benigno Marco Fanni (BM)

BioCardioLab, Fondazione Toscana G. Monasterio, Massa, Italy.

Emanuele Gasparotti (E)

BioCardioLab, Fondazione Toscana G. Monasterio, Massa, Italy.

Simona Celi (S)

BioCardioLab, Fondazione Toscana G. Monasterio, Massa, Italy.

Giancarlo Pennati (G)

LaBS - Laboratory of Biological Structure Mechanics, Department of Chemistry, Materials and Chemical Engineering "Giulio Natta", Politecnico di Milano, Milan, Italy.

Lorenza Petrini (L)

Department of Civil and Environmental Engineering, Politecnico di Milano, Milan, Italy.

Classifications MeSH