Validation of a computational model aiming to optimize preprocedural planning in percutaneous left atrial appendage closure

Bavo, Alessandra; Wilkins, Benjamin T.; Garot, Philippe; Bock, Sander De; Saw, Jacqueline; Søndergaard, Lars; Iannaccone, Francesco

doi:10.1016/j.jcct.2019.08.010

Cited by 39 publications

(23 citation statements)

References 6 publications

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“…Preprocedural planning of the cases in the CE Mark approval study will be based on this thorough preclinical testing model, relying on cardiac CT analysis and bench tests using patient‐specific 3D models (Figure 5). Interestingly, patient‐specific computer simulations may be replacing in vitro 3D model tests in the future 19 …”

Section: Discussionmentioning

confidence: 99%

State‐of‐the‐art preclinical testing of the OMEGA^TM left atrial appendage occluder

Hussein

Fabre

Lertsapcharoen

et al. 2020

Cathet Cardio Intervent

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Objectives This study aimed to present a new approach of thorough preclinical testing of a novel left atrial appendage (LAA) occluder device. Background The development of a safe and effective LAA occluder has been shown to be challenging. Methods The novel OMEGATM LAA occluder (Eclipse Medical, Ireland) was tested in a porcine model and three‐dimensional (3D) human LAA models – this as a prelude to its first‐in‐human use. Results In a first series of in‐vivo experiments, the OMEGATM LAA occluder was shown to have a satisfactory device biocompatibility in a porcine model. The design of the OMEGATM device was further refined and optimized following three more series of in‐vivo experiments. The second generation OMEGATM device was designed with thinner wires, leading to a profile reduction. Based on in‐vitro testing of different OMEGATM device sizes implanted at different depths in human three‐dimensional (3D) LAA models, it could be determined that (1) the landing zone should be measured at a median depth of 12 mm from the LAA ostium; (2) the distal self‐retaining inverted cup should have 10%‐25% compression to minimize device embolization risk; and (3) the disc should be slightly inverted, i.e. pulled into the LAA, to promote complete LAA occlusion. The combined in‐vivo and in‐vitro testing resulted in an optimized pre‐procedural planning of the first‐in‐human case treated with the OMEGATM device. Conclusions This series of carefully planned in‐vivo and in‐vitro experiments allowed demonstration of the safety and efficacy of the OMEGATM LAA occluder. This approach of thorough preclinical testing of medical devices may reduce the risk of complications in first‐in‐human cases and may become the standard approach for device development and preclinical testing in the future.

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Section: Discussionmentioning

confidence: 99%

State‐of‐the‐art preclinical testing of the OMEGA^TM left atrial appendage occluder

Hussein

Fabre

Lertsapcharoen

et al. 2020

Cathet Cardio Intervent

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“…At least two days before the procedure, patients were scheduled for preprocedural CT scan (Aquilion One, Canon Medical CT systems, Japan) and 3D transoesophageal echocardiography (TOE) (EPIC 7C, Philips, Netherlands) on the same morning, after an overnight fast and after intravenous fluid administration of 500 ml NaCl 0.9% over 2 hours before imaging. CT scans were uploaded into the commercially available FEops HEARTguide portal (FEops, Belgium) and 3D simulations were performed as previously described [ 5 ]. All 3D computational simulations were performed independently by FEops, without interaction with the implanting team.…”

Section: Methodsmentioning

confidence: 99%

“…Simulation technology such as 3D printing or computational in silico modelling offers the tactile and/or visual evaluation of the exact left atrial appendage anatomy with the different devices in situ , allowing diligent preprocedural device size selection and adequate positioning. FEops HEARTguide™ is a CE-marked and commercially available computational tomography- (CT-) based simulation technology suite, offering physicians detailed preoperative insights into the interaction between the closure devices and the patient's left atrial appendage anatomy [ 5 ].…”

Section: Introductionmentioning

confidence: 99%

Clinical Impact of Preprocedural CT-Based 3D Computational Simulation of Left Atrial Appendage Occlusion with Amulet

Buysschaert

Viaene²

2021

Journal of Interventional Cardiology

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Aims. Standard of care (SoC) device size selection with transoesophageal echocardiography (TOE) and computed tomography (CT) in LAAO can be challenging due to a certain degree of variability at both patient and device levels. The aim of this study was to prospectively evaluate the clinical impact of 3D computational modelling software in the decision-making of left atrial appendage occlusion (LAAO) with Amplatzer Amulet. Methods and Results. SoC preprocedural assessments as well as CT-based 3D computational simulations (FEops) were performed in 15 consecutive patients scheduled for LAAO with Amulet. Preprocedural device size selection and degree of confidence were determined after SoC and after FEops-based assessments and compared to the implanted device. FEops-based preprocedural assessment correctly selected the implanted device size in 11 out of 15 patients (73.3%), compared to 7 patients (46.7%) for SoC-based assessment. In 4 patients (26.7%), FEops induced a change in device size initially selected by SoC. In the 7 patients (46.7%) in which FEops confirmed the SoC device size selection, the degree of confidence of the size selection increased from 6.4 ± 1.4 for SoC to 8.1 ± 0.7 for FEops. One patient (6.7%) could not be implanted for anatomical reason, as correctly identified by FEops. Conclusions. Preprocedural 3D computational simulation by FEops impacts Amulet size selection in LAAO compared to TOE and CT-based SoC assessment. Operators could consider FEops computational simulation in their preprocedural device size selection.

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“…The patient-specific computational simulation aims to reproduce the mechanical interaction between device and the patient's anatomy and provides a deeper insight into the behaviour of the LAA closure device before the procedure. The FEops HEARTguide simulation technology (FEops NV, Ghent, Belgium) has been validated for LAA closure 6 as well as for transcatheter aortic valve replacement procedures. 7 8 The PREDICT-LAA clinical study investigates the hypothesis that a better preprocedural planning can be achieved by consulting FEops HEARTguide, simulating different LAA closure device sizes and positions in a patient-specific LAA anatomy and thereby providing the implanter an overview of possible optimal and suboptimal scenarios.…”

Section: Introductionmentioning

confidence: 99%

“…The patient-specific computational simulation aims to reproduce the mechanical interaction between device and the patient’s anatomy and provides a deeper insight into the behaviour of the LAA closure device before the procedure. The FEops HEARTguide simulation technology (FEops NV, Ghent, Belgium) has been validated for LAA closure 6 as well as for transcatheter aortic valve replacement procedures. 7 8 …”

Section: Introductionmentioning

confidence: 99%

Value of FEops HEARTguide patient-specific computational simulations in the planning of left atrial appendage closure with the Amplatzer Amulet closure device: rationale and design of the PREDICT-LAA study

et al. 2020

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BackgroundOptimal preprocedural planning is essential to ensure successful device closure of the left atrial appendage (LAA).DesignThe PREDICT-LAA study is a prospective, international, multicentre, randomised controlled trial (ClinicalTrials.gov NCT04180605). Two hundred patients eligible for LAA closure with an Amplatzer Amulet device (Abbott, USA) will be enrolled in the study. Patients will be allocated to a computational simulation arm (experimental) or standard treatment arm (control) using a 1:1 randomisation. For patients randomised to the computational simulation arm, preprocedural planning will be based on the analysis of cardiac computed tomography (CCT)-based patient-specific computational simulations (FEops HEARTguide, Ghent, Belgium) in order to predict optimal device size and position. For patients in the control arm, preprocedural planning will be based on local practice including CCT analysis. The LAA closure procedure and postprocedural antithrombotic therapy will follow local practice in both arms. The primary endpoint of the study is incomplete LAA closure and device-related thrombus as assessed at 3 months postprocedural CCT. Secondary endpoints encompass procedural efficiency (number of devices used, number of repositioning, procedural time, radiation exposure, contrast dye), procedure-related complications within 7 days postprocedure and a composite of all-cause death and thromboembolic events at 12 months.ConclusionThe objective of the PREDICT-LAA study is to test the hypothesis that a preprocedural planning for LAA closure with the Amplatzer Amulet device based on patient-specific computational simulations can result in a more efficient procedure, optimised procedural outcomes and better clinical outcomes as compared with a standard preprocedural planning.Trial registration numberClinicalTrials.gov Registry (NCT04180605).

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Validation of a computational model aiming to optimize preprocedural planning in percutaneous left atrial appendage closure

Cited by 39 publications

References 6 publications

State‐of‐the‐art preclinical testing of the OMEGA^TM left atrial appendage occluder

State‐of‐the‐art preclinical testing of the OMEGA^TM left atrial appendage occluder

Clinical Impact of Preprocedural CT-Based 3D Computational Simulation of Left Atrial Appendage Occlusion with Amulet

Value of FEops HEARTguide patient-specific computational simulations in the planning of left atrial appendage closure with the Amplatzer Amulet closure device: rationale and design of the PREDICT-LAA study

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Validation of a computational model aiming to optimize preprocedural planning in percutaneous left atrial appendage closure

Cited by 39 publications

References 6 publications

State‐of‐the‐art preclinical testing of the OMEGATM left atrial appendage occluder

State‐of‐the‐art preclinical testing of the OMEGATM left atrial appendage occluder

Clinical Impact of Preprocedural CT-Based 3D Computational Simulation of Left Atrial Appendage Occlusion with Amulet

Value of FEops HEARTguide patient-specific computational simulations in the planning of left atrial appendage closure with the Amplatzer Amulet closure device: rationale and design of the PREDICT-LAA study

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State‐of‐the‐art preclinical testing of the OMEGA^TM left atrial appendage occluder

State‐of‐the‐art preclinical testing of the OMEGA^TM left atrial appendage occluder