Key result
The LAmbre left atrial appendage closure device demonstrated a 99.7% implantation success rate and a 2.9% major complication rate in patients with non-valvular atrial fibrillation.
Why the study?
Percutaneous left atrial appendage closure is effective in non-valvular atrial fibrillation with bleeding risk, but data on the novel LAmbre occluder needed systematic review.
Does percutaneous left atrial appendage closure with the LAmbre device provide safe and effective therapeutic success in patients with non-valvular atrial fibrillation?
Systematic Review (n=403)
Open-label
Yes
Does percutaneous left atrial appendage closure with the LAmbre device provide safe and effective therapeutic success in patients with non-valvular atrial fibrillation?
The LAmbre device for left atrial appendage closure demonstrates excellent implantation success and promising short-term safety in NVAF patients, though pericardial tamponade rates remain comparable to established devices.
Supports LAmbre LAAC safety and success in high-bleeding-risk NVAF; extends options but leaves comparative RCTs open.
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: -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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Ali et al. (2020) conducted a systematic review in Non-valvular atrial fibrillation (n=403). LAmbre left atrial appendage closure device was evaluated on Implantation success rate. The LAmbre left atrial appendage closure device demonstrated a 99.7% implantation success rate and a 2.9% major complication rate in patients with non-valvular atrial fibrillation.
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