Left Atrial Appendage Closure With the New Occlutech® Device: First in Man Experience and Neurological Outcome

Bellmann, Barbara; Schnupp, Steffen; Kühnlein, Peter; Javernik, Christian; Kleinecke, Caroline; Rillig, Andreas; Landmesser, Ulf; Brachmann, Johannes; Park, Jai‐Wun

doi:10.1111/jce.13141

Cited by 20 publications

(10 citation statements)

References 17 publications

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“…Newer devices include the CE-marked WaveCrest Left Atrial Appendage Occlusion System (Coherex Medical, Salt Lake City, UT, USA), the ultrasept LAA closure device, the LAmbre LAA Closure system (Lifetech Scientific, Shenzhen, China), and the Occlutech LAA occluder (the latter two also CE-marked; Occlutech, Helsingborg, Sweden) [ 18 , 31 , 32 ]. For the Occlutech and LAmbre devices small series with 30 and 60 patients respectively have been published, showing results generally in line with the other publications [ 33 , 34 ]. The TigerPaw II System (Laax, Livermore, CA, USA) has had a major U.S. Food and Drug Administration (FDA) recall in 2015 and to our knowledge is not further developed.…”

Section: Devices Outside Randomized Controlled Trialssupporting

confidence: 88%

Percutaneous Left Atrial Appendage Occlusion for the Prevention of Stroke in Patients with Atrial Fibrillation: Review and Critical Appraisal

et al. 2018

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The authors review the current status of percutaneous left atrial appendage (LAA) occlusion therapy in patients with atrial fibrillation with the goal to prevent ischemic stroke and systemic embolism and to reduce oral anticoagulation associated bleeding. While we cover the historical and also surgical background, and all tested devices, the main focus rests on the single currently U.S. Food and Drug Administration (FDA) approved LAA occluder, the WATCHMAN device, and its approval process. The authors also give a critical appraisal beyond the review of mere facts, trying to put the current data into perspective.

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Section: Devices Outside Randomized Controlled Trialssupporting

confidence: 88%

Percutaneous Left Atrial Appendage Occlusion for the Prevention of Stroke in Patients with Atrial Fibrillation: Review and Critical Appraisal

et al. 2018

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“…The data available in the published reports about LAAC in NVAF patients with thrombus present in the LAA using special techniques are sparse [33]. The first case of LAAC with the Conformité Européenne (CE) mark-obtaining LAmbre™ device in the presence of Table 4 Pre-and thrombus was reported in 2017.…”

Section: Discussionmentioning

confidence: 99%

Systematic review on left atrial appendage closure with the LAmbre device in patients with non-valvular atrial fibrillation

Ali

Rigopoulos

Mammadov

et al. 2020

BMC Cardiovasc Disord

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Background: Percutaneous closure (LAAC) of the left atrial appendage (LAA) is an efficacious preventive procedure for patients with non-valvular atrial fibrillation (NVAF) and considerable bleeding risk. We sought to systematically review the available LAAC data on the novel occluder device LAmbre™. Methods: For this systematic review, a search of the literature was conducted by 3 independent reviewers, reporting the safety and therapeutic success of LAAC in patients being treated with a LAmbre™. Publications reporting the safety and therapeutic success of LAAC using LAmbre™ in n > 5 patients were included. Results: The literature search retrieved n = 10 publications, encompassing n = 403 NVAF patients treated with a LAmbre™ LAAC, with relevant data regarding safety and therapeutic success of the procedure. The mean CHA 2 DS 2-VASc Score was 4.0 + 0.9, and the mean HAS-BLED score was 3.4 + 0.5. The implantation success was 99.7%, with a mean procedure time of 45.4 ± 18.7 min, and a fluoroscopy time of 9.6 ± 5.9 min, and a contrast agent volume of 96.7 ± 0.7 ml. The anticoagulation regimen was switched to DAPT post procedure in the majority of the patients (96.8%). Partial and full recapture were done in 45.5% and in 25.6%, respectively. Major complications were reported in 2.9%, with 0.3% mortality, 1.7% pericardial tamponade, 0.3% stroke, and 0.6% major bleeding complications; no device embolization was observed. During follow up at 6 or 12 months, major adverse cardiovascular events were reported in 3.3%: Stroke or TIA in 1.7%, thrombus formation on the device in 0.7%, and residual flow > 5 mm in 1.0%. In some publications, the favorable implantion properties of the LAmbre™ for difficult anatomies such as shallow or multilobular LAA anatomies were described. Conclusions: This systematic review on the LAmbre™ LAA-occluder including n = 403 NVAF patients demonstrates an excellent implantion success rate, promising follow-up clinical data, and favorable properties for also challenging LAA anatomies,. While its design seems to be helpful in preventing device embolization, pericardial tamponade may not be substantially reduced by the LAmbre™ as compared with other established LAAC devices. Further larger prospective multicenter registries and randomized trials are needed to scrutinize the value of the LAmbre™ compared with established LAAC devices.

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“…However, even though some centers administer heparin before the transseptal puncture, several centers prefer heparin administration after the transseptal puncture during LAA closure procedures or other electrophysiologic interventions. 5,21 Although ACTs in electrophysiologic procedures are increasingly targeted at .300 seconds, during LAA occluder implantation, a target ACT .250 seconds is still chosen in a large proportion of high-volume centers. 5,22 It might be reasonable to target higher ACTs .300 seconds; however, periprocedural pericardial effusion remains a significant complication of the LAA closure procedure.…”

Section: Discussionmentioning

confidence: 99%

“…5,21 Although ACTs in electrophysiologic procedures are increasingly targeted at .300 seconds, during LAA occluder implantation, a target ACT .250 seconds is still chosen in a large proportion of high-volume centers. 5,22 It might be reasonable to target higher ACTs .300 seconds; however, periprocedural pericardial effusion remains a significant complication of the LAA closure procedure. Further studies are needed to determine the optimal approach in these patients.…”

Section: Discussionmentioning

confidence: 99%

“…Percutaneous catheter-based left atrial appendage closure (LAAC) is a procedure being performed more frequently, particularly in patients with atrial fibrillation (AF) who have bleeding complications or who are considered at high risk for bleeding while receiving long-term anticoagulation. [1][2][3][4][5][6][7] LAAC also is used after electrical left atrial appendage isolation. 8 Beyond the initial learning curve, recent studies have reported a low incidence of devicerelated complications, including neurologic events.…”

Section: Introductionmentioning

confidence: 99%

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Left atrial appendage angiography is associated with the incidence and number of magnetic resonance imaging–detected brain lesions after percutaneous catheter-based left atrial appendage closure

et al. 2018

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Left Atrial Appendage Closure With the New Occlutech® Device: First in Man Experience and Neurological Outcome

Abstract: In this uncontrolled, nonrandomized study, acute and 3-month follow-up success of LAAC using OD was high. No patient showed significant neurological deficits.

Cited by 20 publications

References 17 publications

Percutaneous Left Atrial Appendage Occlusion for the Prevention of Stroke in Patients with Atrial Fibrillation: Review and Critical Appraisal

Percutaneous Left Atrial Appendage Occlusion for the Prevention of Stroke in Patients with Atrial Fibrillation: Review and Critical Appraisal

Systematic review on left atrial appendage closure with the LAmbre device in patients with non-valvular atrial fibrillation

Left atrial appendage angiography is associated with the incidence and number of magnetic resonance imaging–detected brain lesions after percutaneous catheter-based left atrial appendage closure

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