Safety and efficacy of the Amplatzer Amulet and Watchman 2.5 for left atrial appendage occlusion: A systematic review and meta‐analysis

Zhu, Ming‐Zhen; Song, Hongjiang; Song, Guanhua; Bai, Xin

doi:10.1111/pace.14576

Cited by 5 publications

(3 citation statements)

References 39 publications

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“…Furthermore, there was no significant difference in perioperative peri-device leakage and follow-up stroke, major and minor bleeding events, transient ischemic attack, and thromboembolic events in either of the two groups. The results of our analysis concord with a previous meta-analysis conducted by Zhu et al comprising of seven studies involving 2926 patients [ 23 ]. The study reported no significant differences in the safety and efficacy of both devices.…”

Section: Discussionsupporting

confidence: 90%

Safety and efficacy of percutaneous Watchman 2.5 device versus Amplatzer Amulet for left atrial appendage closure in patients with non-valvular atrial fibrillation: A systematic review and study-level meta-analysis

Yasmin,

Ali,

Moeed

et al. 2024

PLoS ONE

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Introduction In patients with non-valvular atrial fibrillation (NVAF), mechanical occlusion of the left atrial appendage (LAA) using a permanently implanted device may be an effective alternative to oral anti-coagulants (OAC). To facilitate left atrial appendage closure (LAAC), multiple percutaneous devices have been proposed. Watchman Generation 2.5 and Amplatzer Amulet are the two most popular used devices for preventing stroke in patients with NVAF. We sought to compare safety and efficacy outcomes between Watchman 2.5 and Amplatzer Amulet in patients undergoing LAAC procedure. Methods We carried out a comprehensive and systematic search of the databases PubMed and Scopus, for all studies that compared the safety and efficacy of Watchman 2.5 and Amplatzer Amulet devices, from inception, till June 2023. We performed the statistical analysis using Review Manager (V.5.4.1 Cochrane Collaboration, London, United Kingdom). The safety outcomes of interest included device success, device-related thrombus, device embolization perioperatively and at follow-up, perioperative pericardial perfusion events, and perioperative cardiac tamponade events. Efficacy outcomes were all-cause mortality perioperatively and at follow-up, cardiovascular (CV) mortality at follow-up, stroke, major and minor bleeding events at follow-up, transient ischemic attack (TIA) in follow-up period, thromboembolic events in follow-up period, and peri-device leakage in perioperative period. All data was analysed using a random-effects model, and presented as risk ratios (RRs) with 95% confidence intervals (95%CIs). Results Regarding safety outcomes, device success was non-significantly reduced in Watchman group when compared with Amulet (RR 0.99, p = 0.57; I2 = 34%). In contrast, device-related thrombus was non-significantly increased in Watchman 2.5 group in comparison to Amulet (RR 1.44, p = 0.11; I2 = 0%). There was no significant difference between the devices in terms of device embolization in the perioperative (RR 0.36, p = 0.38; I2 = 22%) and follow-up (RR 2.24, p = 0.13; I2 = 0%) periods. Likewise, there was no significant difference in the risks of pericardial effusion (RR 0.98, p = 0.98; I2 = 0%), and cardiac tamponade (RR 0.65, p = 0.76; I2 = 62%) perioperatively. Regarding efficacy outcomes, no significant difference was observed in all-cause mortality between devices perioperatively (RR 0.51, p = 0.32; I2 = 0%) and at follow-up (RR 1.08, p = 0.56; I2 = 0%). CV-mortality was non-significantly reduced in Watchman group when compared with Amulet (RR 0.57, p = 0.20; I2 = 0%). The Amulet device was not superior to the Watchman device in terms of stroke at follow-up (RR 1.13, p = 0.63; I2 = 0%). Sub-group analysis showed comparable ischaemic and haemorrhagic stroke events between two devices. Furthermore, at follow-up, there was no significant difference in major (RR 1.06, p = 0.63; I2 = 0%) and minor bleeding events (RR 1.81, p = 0.17; I2 = 0%) between the two devices. No difference was observed for trans-ischemic attack (RR 1.89, p = 0.24; I2 = 0%) and thromboembolic events (RR 0.96, p = 0.96; I2 = 0%) at follow-up. No significant difference was observed between devices for peri-device leakage in perioperative period (RR 2.16, p = 0.05; I2 = 0%). Conclusion The data suggested that LAAC is safe and efficacious procedure irrespective of device used, with generally low complication rates. Watchman generation 2.5 remains non-superior to Amplatzer Amulet in terms of safety and efficacy outcomes.

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Section: Discussionsupporting

confidence: 90%

Safety and efficacy of percutaneous Watchman 2.5 device versus Amplatzer Amulet for left atrial appendage closure in patients with non-valvular atrial fibrillation: A systematic review and study-level meta-analysis

Yasmin,

Ali,

Moeed

et al. 2024

PLoS ONE

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“…Zhu et al demonstrated no significant difference in thromboembolic events between the Watchman 2.5 and the Amplatzer Amulet Left Atrial Appendage Closure Device (Abbott Laboratories, United States). Predictors of DRT include smoking, female sex, CHADS2 and CHA2DS2-VASc scores, platelet count, and ejection fraction (EF) [4][5][6][7].…”

Section: Discussionmentioning

confidence: 99%

Challenges and Insights in Managing Device-Related Thrombosis Post-WATCHMAN Implantation: A Case Report of Surgical Thrombectomy in an Elderly Jehovah’s Witness Patient With Atrial Fibrillation

Tsukioka,

Jeevanandam,

Johnson

2023

Cureus

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The WATCHMAN device offers a viable alternative to long-term oral anticoagulation for stroke prevention in nonvalvular atrial fibrillation, particularly for high-risk patients. Despite its success, device-related thrombosis (DRT) remains a concern, potentially restricting its wider use. We present an 83-year-old female Jehovah's Witness with atrial fibrillation who, after successful WATCHMAN device implantation, suffered multiple transient ischemic attacks six months later. Initial investigation revealed a thrombus on a slightly exposed strut of the almost completely endothelialized device. Despite treatment with warfarin and rivaroxaban, urgent surgical intervention was ultimately required to remove the thrombus completely. This case illustrates the risk of thrombus formation even with minimal strut exposure and the challenges in managing DRT. It also highlights the necessity for diligent monitoring and potential reassessment of postimplantation anticoagulation protocols. Our report adds to the limited literature regarding surgical thrombectomy following WATCHMAN implantation and provides valuable insights for clinicians managing similar scenarios.

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“…Percutaneous left atrial appendage occlusion (LAAO) is increasingly recognized as both a safe and effective measure for ischaemic stroke prevention in patients with atrial fibrillation (AF). 1 Nevertheless, data exploring its role in certain populations at high bleeding risk—such as those with hepatic cirrhosis—are lacking.…”

Section: Introductionmentioning

confidence: 99%

Left atrial appendage occlusion in patients with cirrhotic liver disease: the importance of patient selection

Calvert

Gupta

2023

EP Europace

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Safety and efficacy of the Amplatzer Amulet and Watchman 2.5 for left atrial appendage occlusion: A systematic review and meta‐analysis

Cited by 5 publications

References 39 publications

Safety and efficacy of percutaneous Watchman 2.5 device versus Amplatzer Amulet for left atrial appendage closure in patients with non-valvular atrial fibrillation: A systematic review and study-level meta-analysis

Safety and efficacy of percutaneous Watchman 2.5 device versus Amplatzer Amulet for left atrial appendage closure in patients with non-valvular atrial fibrillation: A systematic review and study-level meta-analysis

Challenges and Insights in Managing Device-Related Thrombosis Post-WATCHMAN Implantation: A Case Report of Surgical Thrombectomy in an Elderly Jehovah’s Witness Patient With Atrial Fibrillation

Left atrial appendage occlusion in patients with cirrhotic liver disease: the importance of patient selection

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