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Post-release shift with Watchman FLX devices during left atrial appendage closure: the "popcorn effect".

ABSTRACT:

SUBMITTER: Silva I

PROVIDER: S-EPMC9904382 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

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Post-release shift with Watchman FLX devices during left atrial appendage closure: the "popcorn effect".

Silva Iria I Beaudoin Jonathan J Champagne Jean J Paradis Jean-Michel JM Bernier Mathieu M O'Connor Kim K Dognin Nicolas N Lemyre Maryse M Rodés-Cabau Josep J O'Hara Gilles G Salaun Erwan E

EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 20220603 2

PMID: 35352680

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Circumflex to Left Atrial Appendage Fistula Associated With Watchman FLX Closure Device.

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First-in-human left atrial appendage closure using the WATCHMAN FLX Pro device: a case report.

Project description:BackgroundDevice-related thrombosis (DRT) is a known complication to left atrial appendage closure (LAAC). The surface of a LAAC device should ideally have antithrombotic properties. The novel WATCHMAN FLX Pro (WFP) incorporates a fluoropolymer-coated fabric membrane designed to increase thromboresistance and facilitate endothelialization. Such features could potentially allow for a minimal post-procedural antithrombotic regimen. Radiopaque platinum markers at the device shoulders and a large 40 mm device are other novel features of the WFP.Case summaryA 75-year-old man with atrial fibrillation was referred for LAAC due to prior subdural haemorrhage during direct-acting anticoagulation treatment. He underwent the first-in-human WFP implantation as part of the WATCHMAN FLX Pro CT study (NCT05567172). Computed tomography (CT) was used for pre-planning, and the procedure was performed under local analgesia guided by intracardiac echocardiography from the left atrium (LA) without any complications. Post-procedural antithrombotic treatment consisted of acetylsalicylic acid 75 mg/day only, and 45-day CT, transoesophageal echocardiography (TEE), and magnetic resonance imaging demonstrated optimal device position with complete LAAC. Hypoattenuated thickening (6 mm) appeared on the device as a smooth surface in continuity with the left atrial wall on CT and TEE. A specific magnetic resonance T1-weighted scan, used for visualization of fresh thrombus, suggested this to represent tissue ingrowth rather than thrombus.DiscussionThe advanced follow-up imaging protocol suggested a good WFP implantation result with signs of tissue ingrowth at 45 days. The added radiopaque markers facilitated optimal deployment, evaluation of device stability during tug test, and assessment of device protrusion into the LA.

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Transfabric Leaks After Percutaneous Left Atrial Appendage Occlusion Procedures with the WATCHMAN FLX Device.

Project description:BackgroundCardiac computed tomography imaging with contrast is being used increasingly to image left atrial appendage occlusion (LAAO) devices. Contrast flow across a device, also known as a transfabric leak (TFL), may indicate a lack of complete LAAO-device endothelialization. The data on the rate, predictors, and clinical events associated with TFL are limited.MethodsAll patients who underwent an LAAO-device implantation with a WATCHMAN FLX device and received a postimplantation computed tomography scan were included in this single-centre retrospective cohort study. Patients were classified as either having or not having a TFL, according to 3 currently proposed definitions of TFL. Clinical and procedural differences between the 2 groups were determined. An exploratory univariate logistic regression model to evaluate predictors of TFL was constructed.ResultsA total of 56 individuals were included in the cohort. The rate of TFL varied from 27% to 52%, depending on the radiographic definition employed. No clinically important patient or procedural characteristics were noted between the groups with vs without TFL. No predictors of TFL were identified. Six deaths and one stroke occurred during a median follow-up period of 673 days.ConclusionsTFLs occur commonly post-LAAO procedures, suggesting that complete endothelialization of LAAO devices in humans may not be similar to that reported in animal models. Additional study into the best imaging approach to identify TFLs, and clinical events associated with TFLs, is necessary to clarify the significance of TFLs.

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Project description: Not available

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Project description:BackgroundIntracardiac echocardiography (ICE) is an alternative to transesophageal echocardiography to guide left atrial appendage occlusion (LAAO). However, 2-dimensional ICE has important limitations that hinder its adoption in routine practice.ObjectivesThis prospective multicenter study (NCT04569734) investigated the feasibility and safety of ICE-guided LAAO with Watchman FLX using a novel 3-dimensional ICE catheter (VeriSight Pro, Philips).MethodsA total of 100 patients undergoing LAAO with the Watchman FLX device were recruited. All cases were performed under moderate sedation. A simplified 2 orthogonal view ICE imaging protocol was adopted to assess PASS (position, anchoring, sizing, and sealing) criteria. The feasibility endpoint was successful implantation of the FLX device and adequate seal (peri-device leak <5 mm) at 45 days. The safety endpoint was the incidence of major complications at 7 and 45 days. Physician experience and imaging quality scores were collected (1 = lowest, 5 = highest).ResultsThe mean age was 77.0 ± 8.1 years, and 39 (39%) were women. CHA2DS2-VASc score was 4.8 ± 1.5 and HAS-BLED score was 3.2 ± 1.1. Total procedural time was 54 ± 25 minutes. Mean contrast volume was 41 ± 46 ml, with no contrast used in 16 patients. The feasibility endpoint was achieved in 95 patients (95%); 4 patients were not implanted due to unsuitable anatomy, and 1 patient had a leak >5 mm at 45 days. There was 1 periprocedural stroke and 2 gastrointestinal bleeds requiring transfusion at 7 days with no other major complications. Physicians' rating of overall ICE imaging quality was 4.6 ± 0.6.ConclusionsThe novel 3-dimensional ICE VeriSight Pro Probe can safely and effectively guide LAAO with Watchman FLX using a simplified imaging protocol.

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