Mechanical properties of currently available left atrial appendage occlusion devices: A bench‐testing analysis

Menne, Matthias; Schrickel, Jan W.; Nickenig, Georg; Al‐Kassou, Baravan; Nelles, Dominik; Schmitz‐Rode, Thomas; Steinseifer, Ulrich; Sedaghat, Alexander

doi:10.1111/aor.13414

Cited by 6 publications

(7 citation statements)

References 17 publications

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“…In detail, n = 10 publications were excluded because they were case reports, and one further publication was a review. After full-text reading, an additional publication was excluded since it was a benchmark testing, without reporting clinical data [13].…”

Section: Resultsmentioning

confidence: 99%

“…The Amplatzer Cardiac Plug has also been extensively tested with satisfactory results as a method for the prevention of LAA thrombosis and of cardioembolic stroke in chronic NVAF patients [8,27]. However, both these most frequently used LAAC devices are accompanied by disadvantages such as the need for relatively large delivery sheaths (12)(13)(14), and only limited potential for recapturing and for repositioning [10,29]. The percutaneous LAAC requires considerable technical and theoretical skills as well as adequate training under the supervision of expert colleagues [29].…”

Section: Discussionmentioning

confidence: 99%

“…Although no far-reaching conclusions can be drawn so far in light of the limited experience with this fairly novel occluder, the umbrella consisting of 8 hooks stabilizing the device in the trabeculae of the LAA may be a unique advantage of the LAmbre™ device in this regard. An additional feature contributing to the low frequency of device embolizations may be attributed to the comparably high radial force of the LAmbre™ LAAC device [13].…”

Section: Discussionmentioning

confidence: 99%

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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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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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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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“…Given their structural similarities, LAA closure devices were distinguished into pacifier occluders and nonpacifier occluders. 9 The Amplatzer ACP and Amulet (Abbott Laboratories, Chicago, IL), LAmbre (Lifetech Scientific, Shenzhen, China) and Ultraseal (Cardia Inc, Eagan, MN) devices, which feature a proximal disc that covers the LAA ostium, were categorized as pacifier occluders. In contrast, nonpacifier occluders included the WATCHMAN (Boston Scientific Inc, Marlborough, MA), Wavecrest (Biosense Webster Inc, Irvine, CA), and Occlutech LAA occluder (Occlutech International AB; Helsingborg, Sweden).…”

Section: Methodsmentioning

confidence: 99%

Device-Related Thrombus After Left Atrial Appendage Closure: Data on Thrombus Characteristics, Treatment Strategies, and Clinical Outcomes From the EUROC-DRT-Registry

Sedaghat

Vij

Al‐Kassou

et al. 2021

Circ: Cardiovascular Interventions

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Background: Left atrial appendage closure is an established therapy in patients with atrial fibrillation. Although device-related thrombosis (DRT) is relatively rare, it is potentially linked to adverse events. As data on DRT characteristics, outcome, and treatment regimen are scarce, we aimed to assess these questions in a multicenter approach. Methods: One hundred fifty-six patients with the diagnosis of DRT after left atrial appendage closure were included in the multinational EUROC-DRT registry. Baseline characteristics included clinical and echocardiographic data. After inclusion, all patients underwent further clinical and echocardiographic follow-up to assess DRT dynamics, treatment success, and outcome. Results: DRT was detected after a median of 93 days (interquartile range, 54–161 days) with 17.9% being detected >6 months after left atrial appendage closure. Patients with DRT were at high ischemic and bleeding risk (CHA 2 DS 2 -VASc 4.5±1.7, HAS-BLED 3.3±1.2) and had nonparoxysmal atrial fibrillation (67.3%), previous stroke (53.8%), and spontaneous echo contrast (50.6%). The initial treatment regimens showed comparable resolution rates (antiplatelet monotherapy: 57.1%, dual antiplatelet therapy: 85.7%, vitamin K antagonists: 80.0%, novel oral anticoagulants: 75.0%, and heparin: 68.6%). After intensification or switch of treatment, complete DRT resolution was achieved in 79.5% of patients. Two-year follow-up revealed a high risk of mortality (20.0%) and ischemic stroke (13.8%) in patients with DRT. Patients with incomplete DRT resolution showed numerically higher stroke rates and increased mortality rates (stroke: 17.6% versus 12.3%, P =0.29; mortality: 31.3% versus 13.1%, P =0.05). Conclusions: A substantial proportion of DRT is detected >6 months after left atrial appendage closure, highlighting the need for imaging follow-up. Patients with DRT appear to be at a high risk for stroke and mortality. While DRT resolution was achieved in most patients, incomplete DRT resolution appeared to identify patients at even higher risk. Optimal DRT diagnostic criteria and treatment regimens are warranted.

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“…Matthias F. Menne et al of the Helmholtz Institute, RWTH Aachen University, Aachen, Germany investigated in vitro the mechanical properties, radial (RF) and tug force (TF), of currently available left atrial appendage occlusion devices. Seven different occluder systems of various sizes (24 in total) underwent testing throughout their recommended sizing range.…”

Section: Surgical Supportmentioning

confidence: 99%

Artificial Organs 2019: A year in review

Malchesky¹

2020

Artificial Organs

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In this Editor’s Review, articles published in 2019 are organized by category and summarized. These provide a brief reflection of the research and progress in artificial organs intended to advance and better human life while providing insight for continued application of these technologies and methods. Artificial Organs continues in the original mission of its founders “to foster communications in the field of artificial organs on an international level.” Artificial Organs continues to publish developments and clinical applications of artificial organ technologies in this broad and expanding field of organ Replacement, Recovery, and Regeneration from all over the world. Peer‐reviewed Special Issues this year included contributions from the 14th International Conference on Pediatric Mechanical Circulatory Support Systems and Pediatric Cardiopulmonary Perfusion edited by Dr Akif Undar, and the 26th Congress of the International Society for Mechanical Circulatory Support edited by Dr Minoru Ono and Dr Francesco Moscato. Additionally, important editorials highlighted the need for sustainability in hemodialysis, challenges and opportunities in mechanical circulatory support, progress in artificial pancreas development, historical perspectives on ventilators and dialysis, tissue engineering for cardiac support, and regional updates from India and China. Our Pioneer Series continues to highlight the many researchers who created this field of study. This year we debuted a new series entitled “Recent Progress in Artificial Organs” prepared by Vakhtang Tchantchaleishvili and Elizabeth Maynes of Thomas Jefferson University, Philadelphia, PA, USA. This series highlights recent advances and new developments in the field. We take this time also to express our gratitude to our authors for contributing their work to this journal. We offer our very special thanks to our reviewers who give so generously of their time and expertise to review, critique, and especially provide meaningful suggestions to the author’s work. Without our dedicated expert reviewers, the quality expected from such a journal would not be possible. We also express our special thanks to our Publisher, John Wiley & Sons, for their expert attention and support in the production Artificial Organs. We look forward to reporting further advances in the coming years.

show abstract

Mechanical properties of currently available left atrial appendage occlusion devices: A bench‐testing analysis

Cited by 6 publications

References 17 publications

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

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

Device-Related Thrombus After Left Atrial Appendage Closure: Data on Thrombus Characteristics, Treatment Strategies, and Clinical Outcomes From the EUROC-DRT-Registry

Artificial Organs 2019: A year in review

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