Left atrial appendage occlusion using LAmbre Amulet and Watchman in atrial fibrillation

Abstract

A B S T R A C TBackground: Left atrial appendage closure (LAAC) has been suggested as an alternative to anticoagulation in non-valvular atrial fibrillation (AF). The present study aimed to compare a LAmbre LAA occluder system [Lifetech Scientific (Shenzhen) Co. Ltd., Shenzhen, China] with the most investigated Amulet (St. Jude Medical Inc., St. Paul, MN, USA) and Watchman (Boston Scientific, Plymouth, MN, USA) devices in terms of peri-procedural and short-term outcomes. Methods: This is a prospective observational study. Results: Overall, 140 patients (50 female, mean age 76.2 AE 8.4 years) were consecutively enrolled. Mean CHA2DS2-VASc score was 3.8 AE 1.5, and mean HAS-BLED score was 3.9 AE 1.1. Baseline clinical characteristics were comparable between the three groups (LAmbre, n = 30; Amulet, n = 74; Watchman, n = 36); the LAmbre group had significantly more patients with complicated LAA morphology (p = 0.006). The implant success rate was 100% in LAmbre, 99% in Amulet, and 100% in Watchman group (p = 0.638). The number of device repositions was not significantly different between groups (0.7 AE 1.1 in LAmbre, 1.0 AE 2.0 in Amulet, and 1.4 AE 1.8 in Watchman group, p = 0.345). Fluoroscopic and procedural times were similar between groups. Major peri-procedural adverse events did not differ between groups (0% vs. 0% vs. 2.8%, p = 0.233). Six months' follow-up showed good device stability and patients' clinical condition in all groups. Conclusion: LAmbre, Amulet, and Watchman exhibit remarkable implant success rate, low risk of periprocedural adverse events, and good clinical outcomes.

Late clinical outcomes of lambre versus amplatzer occluders for left atrial appendage closure

“…The rate for ischemic stroke only in the LAmbre group was respectively 2.7 events per 100 patient‐years, resulting in a 60% risk reduction for stroke, compared with the expected stroke rate with a mean CHA 2 DS 2 ‐VASc score of 4.8 (expected rate of 6.7 events per 100 patient‐years 28 ). All other LAmbre registries with shorter follow‐up times from 6 to 12 months observed low rates of ischemic stroke (0%, 15–17 1.3% 12 ).…”

“…Small registry studies showed high implant success rates and acceptable periprocedural complication rates, as well as favorable short‐term clinical outcomes of the LAmbre device 12–16 . Another head‐to‐head comparison demonstrated comparable peri‐procedural and clinical outcomes for up to 6 months for LAmbre, Amulet, and Watchman 17 . Currently, a 3‐year global post‐market surveillance study investigates the performance of the LAmbre device in 500 participants.…”

“…[12][13][14][15][16] Another head-to-head comparison demonstrated comparable peri-procedural and clinical outcomes for up to 6 months for LAmbre, Amulet, and Watchman. 17 Currently, a 3-year global post-market surveillance study investigates the performance of the LAmbre device in 500 participants. However, the late clinical outcomes of the LAmbre occluder have not been published yet.…”

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

“…The 10 publications included in the data analysis of this systematic review were published from 2016 until 2019 [9,[14][15][16][17][18][19][20][21][22]. The reported total cohort in these 10 publications comprised n = 403 NVAF patients, treated with implantation of a LAmbre™ device.…”

“…DAPT Dual antiplatelet therapy (aspirin plus clopidogrel) LMWH Low-molecular weight heparin N/A Not available NOAC New oral anticoagulants OAC Oral anticoagulation SAPT Single antiplatelet therapy (aspirin or clopidogrel) VKA Vitamin K antagonistsTable 4 Pre-and postprocedural regimens, complications and outcomes Major procedure-related complications (n= / %) Minor procedurerelated complications (n= / %) Follow up time / Outcome (AE) (n= / %) Chen et al (2019)[21] Total: n = 0 / 0% 0% 6 months: Total: n = 0 / 0%; Stroke/TIA: n = 0 / 0%; TFD: n = 0 / 0%; RF > 5 mm: n = 0 / 0%; Major Bleeding: n = 0 / 0%; Device embolization: n = 0 / 0% RF < 5 mm: n = 9 / 30.0%; Minor Bleeding: n = 0 / 0%Feng et al (2019) [22] Total: n = 1 / 5.9%; Death: n = 0 / 0%; PerTam: n = 1 / 5.9% n = 2 / 11.8% (haematoma) 12 months: Total: n = 0 / 0%; Stroke/TIA: n = 0 / 0%; TFD: n = 0 / 0%; RF > 5 mm: n = 0 / 0%; Major Bleeding: n = 0 / 0%; Device embolization: n = 0 / 0% RF < 5 mm: n = 2 / 11.8%; Minor Bleeding: n = 0 / 0%; n = 1 / 5.9% sudden cardiac death at 545 days Reinsch et al (2018) [19] Total: n = 0 / 0%; Death: n = 0 / 0% 0% 6 months: Total: n = 0 / 0%; Stroke/TIA: 0%; TFD: 0%; RF > 5 mm: 0%; Major Bleeding: n = 0 / 0%; Device embolization: n = 0 / 0% RF < 5 mm: 0%; Minor Bleeding: n = 0 / 0% Park et al (2018) [18] Total: n = 4 / 6.7%; Death: n = 1 / 1.7%; PerTam: n = 3 / 5.0%; PerTam requiring surgery with fatal outcome: n = 1 / 1.7%; Pseudoaneurysm of right AFC requiring surgical repair: n = 1 / 1.7% 0% 12 months: Total: n = 5 / 6.7%; Stroke/TIA: n = 2 / 1.6%; TFD: 0%; RF > 5 mm: n = 3 / 5% a ; Major bleeding: 0%; Device embolization: n = 0 / 0% RF < 5 mm: n = 14 / 24.6%; Minor bleeding: n = 5 / 5% Death unrelated to LAAC: 3% Kleinecke et al (2018) [17] Total: n = 0 / 0%; Death: n = 0 . (2017) [15] Total: n = 5 / 3.3%; Death: n = 0 / 0%; PerTam: n = 2 / 1.3; Stroke: n = 1 / 0.7%; Major bleeding: n = 1 / 0.7% n = 4 / 2.6% (Femoral hematoma: n = 2; Arteriovenous fistula: n = 1 Pseudoaneurysm; n = 1)12 months: Total: n = 5 / 3.9%; Stroke: n = 3 / 2.0%; TFD: n = 2 / 1.3%; RF > 5 mm: 0%; Major Bleeding: n = 0 / 0%; Device embolization: n = 0 / 0% Death unrelated to LAAC: n = 1 / 1.3% Available TEE at 12 months: n = 121…”