Enhanced Thromboresistance and Endothelialization of a Novel Fluoropolymer-Coated Left Atrial Appendage Closure Device

Saliba, Walid; Kawai, Kenji; Sato, Yu; Kopesky, E; Cheng, Qi; Ghosh, Saikat; Herbst, Thomáš; Kawakami, Rika; Konishi, Takao; Virmani, Renu; Jaber, Wael A.; Gibson, Douglas; Shah, Manish H.; Gibson, Michael; Holmes, David R.; Finn, Aloke V.

doi:10.1016/j.jacep.2023.04.013

Cited by 15 publications

(6 citation statements)

References 18 publications

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“…33 The rate of ischaemic stroke may even be further reduced with the newest generation devices, which have a lower rate of peri-device leaks thanks to more available sizes and lower DRT risk thanks to the new antithrombotic HEMOCOAT Technology as in WATCHMAN FLX PRO. 34 Combination of our safety and efficacy results demonstrates the substantial overall benefit achieved through LAAC, as it effectively reduces the risk of both haemorrhagic and ischaemic stroke in a high ICH risk patient population. The '2023 Guidelines for the Diagnosis and Management of Atrial Fibrillation' upgraded the level of recommendation for LAAC to 2a for AF patients with moderate to high risk of stroke and a contraindication to long-term OAC use including spontaneous ICH due to non-reversible cause or serious bleeding related to current falls when cause of falls is not felt to be treatable.…”

Section: Discussionmentioning

confidence: 63%

Left atrial appendage closure for patients with atrial fibrillation at high intracranial haemorrhagic risk

Abramovitz Fouks,

Yaghi,

Gokcal

et al. 2024

Stroke Vasc Neurol

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Background and objectivesAlthough left atrial appendage closure (LAAC) is performed in patients with non-valvular atrial fibrillation (NVAF) at increased risk of intracranial haemorrhage (ICH), outcome data are scarce. We assessed the detailed neurological indications for LAAC and outcomes after LAAC in high ICH risk patients.MethodsStudy population included consecutive patients with NVAF who underwent LAAC in a single hospital network between January 2015 and October 2021 because of prior ICH or the presence of high ICH risk imaging markers on brain MRI (cerebral microbleeds (CMBs)). Primary safety and efficacy outcome measures were the occurrence of ICH and thromboembolic events, respectively, after LAAC.ResultsAmong 146 patients with NVAF who underwent LAAC for high ICH risk, 122 had a history of ICH, while 24 presented with high ICH risk imaging markers only. Mean age was 75.7±7.61, 42 (28.8%) were women. Mean CHA2DS2-VASc score was 5.23±1.52. Of 122 patients with ICH history, 58 (47.5%) had intraparenchymal haemorrhage (IPH), 40 (32.8%) had traumatic ICH (T-ICH) and 18 (14.7%) had non-traumatic subdural haemorrhage. Of 85 patients with brain MRIs including necessary sequences, 43 (50.6%) were related to cerebral amyloid angiopathy and 37 (43.5%) to hypertensive microangiopathy. While 70% of patients were discharged on oral anticoagulants (OAC), 92% were not taking OAC at 1 year. Over 2.12 years mean follow-up, one patient had recurrent non-traumatic IPH (incidence rate (IR) 0.32 per 100 patient-years), five had T-ICH (IR 1.61 per 100 patient-years) and six had an ischaemic stroke (IR 1.94 per 100 patient-years).ConclusionsAmong patients with NVAF at high ICH risk, LAAC demonstrated a low risk of recurrent ICH or ischaemic stroke compared with previously published data. LAAC in high ICH risk populations should be considered in clinical practice per FDA approval and recent guidelines.

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Section: Discussionmentioning

confidence: 63%

Left atrial appendage closure for patients with atrial fibrillation at high intracranial haemorrhagic risk

Abramovitz Fouks,

Yaghi,

Gokcal

et al. 2024

Stroke Vasc Neurol

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“… 32 The latest fluoropolymer‐coated Watchman FLX Pro may further reduce inflammation and promote endothelialization in preclinical trial. 33 Whether Watchman FLX is associated with better endothelialization is unknown and needs further study.…”

Section: Discussionmentioning

confidence: 99%

Pattern of Endothelialization in Left Atrial Appendage Occluder by Optic Coherence Tomography: A Pilot Study

Chen,

Chiu,

Chang

et al. 2024

JAHA

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Background Implantation of the left atrial appendage occluder (LAAO) has been proven to prevent stroke effectively in patients with atrial fibrillation who cannot tolerate anticoagulants. Incomplete endothelization of LAAO may cause device‐related thrombus, and currently no good image modality exists to clearly see LAAO endothelialization. We aimed to use coronary optic coherence tomography (OCT) to visualize LAAO endothelialization. Methods and Results We enrolled 14 patients (72.8±9.4 years old) undergoing pulmonary vein isolation with a preexisting LAAO implanted more than 1 year ago (5 Watchman and 9 Amulet). After pulmonary vein isolation, we did OCT via steerable sheath and coronary guiding catheter to adjust OCT probe location and injected contrast medium to visualize the LAAO surface. In vitro testing was also performed to see the bare occluder. In vitro OCT showed the surface of the bare device as an interrupted granule pattern, which included the Watchman surface polytetrafluoroethylene membrane string, Amulet disc metal strut, and inner polytetrafluoroethylene membrane string. In the implanted Watchman, OCT showed endothelialization as a smooth surface layer with noninterrupted coarser granules. In the implanted Amulet, OCT showed endothelialization as thin (early) or thick (late) endothelialization layer covering struts with OCT shadows. Among patients with Watchman, 2 showed no, 2 early, and 1 complete endothelialization. Among patients with Amulet, 2 showed no, 3 early, and 4 late endothelialization. Conclusions We demonstrated the feasibility of OCT to visualize LAAO endothelization with high resolution. Further studies are needed to determine antithrombotic regimens if incomplete endothelization is detected. A new OCT catheter may be designed specifically for LAAO.

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“…In one study, utilizing a DAPT post-procedural therapy, complete endothelial coverage of the atrial surface of the Watchman FLX device was observed in four out of five cases at 45 days [26]. Comparably, in a later study using no antithrombotic therapy, at 45 days neo-endocardial coverage was observed in only two out of six Watchman FLX-implanted canines versus all cases implanted with the new Watchman FLX Pro [80]. In this same study, 90 day evaluation by scanning electron microscopy of FLX and FLX Pro devices, implanted in a porcine right atrial appendage model, displayed 62.8% and 87.7% endothelial coverage on the FLX and FLX Pro cases, respectively.…”

Section: Device Healing-in Vivomentioning

confidence: 94%

“…With newer generation LAAO devices incoming, the need for aggressive post-procedural therapy may diminish. Animal data and recently presented human experience with the Watchman FLX Pro device indicate better facilitation of endothelialization and potentially a reduced risk of DRT by adding a fluoropolymer coating to the device fabric membrane [80]. Other devices, such as the Conformal and Laminar technologies, might further challenge the need for post-procedural treatment.…”

Section: Next-generation Devicesmentioning

confidence: 99%

Left Atrial Appendage Occlusion and Post-procedural Antithrombotic Management

Kramer,

Patti,

Nielsen-Kudsk

et al. 2024

JCM

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Left atrial appendage occlusion (LAAO) is an established alternative to oral anticoagulation for stroke prevention in atrial fibrillation. Antithrombotic therapy is used in the post-procedural period to prevent device-related thrombosis (DRT). The risk of DRT is considered highest in the first 45–90 days after device implantation, based on animal studies of the device healing process. Clinically applied antithrombotic regimens vary greatly across studies, continents, and centers. This article gives an overview of the evidence behind current antithrombotic regimens, ongoing randomized trials, and future post-procedural management.

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Enhanced Thromboresistance and Endothelialization of a Novel Fluoropolymer-Coated Left Atrial Appendage Closure Device

Cited by 15 publications

References 18 publications

Left atrial appendage closure for patients with atrial fibrillation at high intracranial haemorrhagic risk

Left atrial appendage closure for patients with atrial fibrillation at high intracranial haemorrhagic risk

Pattern of Endothelialization in Left Atrial Appendage Occluder by Optic Coherence Tomography: A Pilot Study

Left Atrial Appendage Occlusion and Post-procedural Antithrombotic Management

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