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

• Published in: BMC cardiovascular disorders Vol. 20; no. 1; p. 78
• Main Authors: Ali, Muhammad, Rigopoulos, Angelos G, Mammadov, Mammad, Torky, Abdelrahman, Auer, Andrea, Matiakis, Marios, Abate, Elena, Bakogiannis, Constantinos, Tzikas, Stergios, Bigalke, Boris, Sedding, Daniel, Noutsias, Michel
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 12.02.2020; BioMed Central; BMC
• Subjects: Anticoagulants; Anticoagulation; Atrial fibrillation; Bleeding; Blood clots; Cardiac arrhythmia; Cardiac tamponade; Cardiovascular research; Care and treatment; Clinical trials; Closure device; Contrast media; Data analysis; Development and progression; Diagnostic imaging; Embolization; Fibrillation; Fluoroscopy; Heart surgery; LAmbre; Left atrial appendage; Left atrial appendage closure; Morphology; Mortality; Novels; Patient outcomes; Review; Safety; Stroke; Studies; Success; Systematic review; Tamponade; Thromboembolism; Thrombosis; Time; Germany; United States > US; China; Stroke; Closure device; Prognosis; Atrial fibrillation; Left atrial appendage closure; Mortality; Anticoagulation; LAmbre; Left atrial appendage
• ISSN: 1471-2261; 1471-2261
• DOI: 10.1186/s12872-020-01349-9

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™. 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. 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 DS -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. 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.