Comparison between Amulet and Watchman left atrial appendage closure devices: A real-world, single center experience.

Saad, Mohammed; Risha, Osama; Sano, Makoto; Fink, Thomas; Heeger, Christian‐Hendrik; Vogler, Julia; Sciacca, Vanessa; Eitel, Charlotte; Stiermaier, Thomas; Joost, Alexander; Keelani, Ahmad; Fuernau, Georg; Meyer‐Saraei, Roza; Kück, Karl‐Heinz; Eitel, Ingo; Tilz, Roland Richard

doi:10.21203/rs.3.rs-412824/v1

Cited by 4 publications

(7 citation statements)

References 20 publications

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“…A total of 2926 patients from seven studies (Table 2) 12,15–20 underwent LAAO, with a total of 1508 patients in the Watchman 2.5 group and 1418 patients in the Amplatzer Amulet group included in the meta‐analysis (Figure 1 and Table 2). Seven total studies, including Lakkireddy 2021, 12 Saad 2021, 20 and Radinovic 2021 19 which scored 8 points on the Newcastle‐Ottawa Scale (Table 1), and Mansour 2021, 18 Chen 2019, 15 Fastner 2018, 16 and Kefer 2018 17 scored 7 points on the Newcastle‐Ottawa Scale (Table 1), indicating good quality. A descriptive comparison of the baseline characteristics and follow‐up durations is shown in Table 2.…”

Section: Resultsmentioning

confidence: 99%

“…Lakkireddy 2021, 12 Saad 2021, 20 and Radinovic 2021 19 which scored 8 points on the Newcastle-Ottawa Scale (Table 1), and Mansour 2021, 18 Chen 2019, 15 Fastner 2018, 16 and Kefer 2018 17 scored 7 points on the Newcastle-Ottawa Scale (Table 1), indicating good quality. A descriptive comparison of the baseline characteristics and follow-up durations is shown in Table 2.…”

Section: Follow Up Adequacy Scorementioning

confidence: 99%

“…Of the seven studies reviewed, one randomized controlled trial and six cohort studies directly compared the safety and efficacy of the Amplatzer Amulet and the Watchman 2.5 device. 12,[15][16][17][18][19][20] Nevertheless, these studies were limited in their sample size; so, we conducted a meta-analysis of studies that directly compared the Amplatzer Amulet and Watchman 2.5 devices, emphasizing on efficacy and safety outcomes. 21 Additionally, we review their latest technological advances.…”

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confidence: 99%

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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

Zhu

Song

et al. 2022

Pacing Clinical Electrophis

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Background Left atrial appendage occlusion (LAAO) is an alternative to oral anticoagulation (OAC) to decrease the risk of stroke in patients with nonvalvular atrial fibrillation (NVAF); however, certain complications remain a concern. Amplatzer Amulet and Watchman are the two most popular used devices for preventing stroke in patients with NVAF. We assessed the safety and efficacy of LAAO using the Amplatzer Amulet and Watchman. Methods A meta‐analysis was conducted to compare the safety and efficacy outcomes associated with the use of the Amplatzer Amulet and Watchman 2.5. The Newcastle‐Ottawa Scale has been utilized to assess the quality of study. Results The meta‐analysis includes seven studies involving 2926 patients (1418 patients with an amulet and 1508 with a Watchman 2.5). Generally, adverse event rates for both systems were minimal. No significant differences between the two devices were found in safety (pericardial effusion, device embolization, and cardiac tamponade) or efficacy outcomes (death, TIA, stroke, major/minor bleeding, device leak, and thromboembolic events). Conclusions The data suggest LAAO is a safe procedure, regardless of which device was used. LAAO devices generally have low complication rates. Outcomes were comparable between the two groups with no significant differences in their safety or efficacy.

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Section: Resultsmentioning

confidence: 99%

Section: Follow Up Adequacy Scorementioning

confidence: 99%

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confidence: 99%

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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

Zhu

Song

et al. 2022

Pacing Clinical Electrophis

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“…However, the results from studies which directly compared the efficacy and safety of the Watchman and ACP/Amulet devices for NVAF patients were contradictory 7–25 . Therefore, a meta‐analysis was performed in this study to compare the safety and efficacy of the two devices.…”

Section: Introductionmentioning

confidence: 99%

Clinical efficacy and safety comparison of Watchman device versus ACP/Amulet device for percutaneous left atrial appendage closure in patients with nonvalvular atrial fibrillation: A study‐level meta‐analysis of clinical trials

Sun

Chen

2022

Clinical Cardiology

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Left atrial appendage occlusion is not inferior to oral anticoagulants in the prevention of stroke in several randomized controlled trials. However, the clinical efficacy and safety comparison of the Watchman and amplatzer cardiac plug (ACP)/Amulet devices for percutaneous left atrial appendage closure (LAAC) in patients with non‐valvular atrial fibrillation was controversial. A database search was conducted using PubMed, EMBASE, Cochrane Library, and http://Clinicaltrials.gov for trials that compared Watchman device vs ACP/Amulet device. The effective outcomes were stroke and systemic embolism. Safety outcomes were all‐cause death, cardiovascular death, and major bleeding. Device‐related complications included device‐related thrombus (DRT), peri‐device leaks (PDL > 5 mm). A total of 19 articles involving 6224 patients were included in the present study. The Watchman and ACP/Amulet groups comprised 3267 and 2957 patients, respectively. No statistically significant differences were detected in the stroke (odd ratio [OR]:1.24, 95% confidence interval [CI]: 0.92−1.67, p = .17, I2 = 0), systemic embolism (OR:1.10, 95% CI: 0.51−2.35, p = .81, I2 = 0%), all‐cause death (OR:0.97, 95% CI: 0.80−1.18, p = .77, I2 = 1%), cardiogenic death (OR:0.99, 95% CI: 0.77−1.29, p = .96, I2 = 0%), major bleeding (OR:1.18, 95% CI: 0.98−1.43, p = .08, I2 = 25%). DRT (OR:1.48, 95% CI: 1.06−2.06, p = .02, I2 = 0%) and PDL > 5 mm (OR:2.57, 95% CI: 1.63−4.04, p < .0001, I2 = 0%) were significantly lower in ACP/Amulet group compared to Watchman group. The effective and safety outcomes were comparable between two groups. ACP/Amulet group had significantly lower rates of DRT and PDL > 5 mm than Watchman group.

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“…Amplatzer Cardiac Plug and the 2nd generation Amplatzer Amulet devices featured favorable outcomes in some observational studies [11][12][13]. There were several observational studies [14][15][16][17][18][19][20][21][22][23][24] and randomized controlled trials (RCTs) [25][26][27][28] directly comparing Amplatzer and Watchman devices. However, results from these studies were not consistent and were underpowered to evaluate rare outcomes such as stroke.…”

Section: Introductionmentioning

confidence: 99%

Comparison between Amplatzer and Watchman Left Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation: A Systematic Review and Meta-Analysis

et al. 2022

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Introduction: The Amplatzer and Watchman left atrial appendage closure (LAAC) devices are the two most frequently used devices for left atrial appendage closure devices worldwide. This meta-analysis aims to compare the safety and efficacy of the two devices. Methods: We searched the PubMed, EMBASE and the Cochrane Library for studies up to 6 February 2022 that compared the safety and efficacy of the Amplatzer and Watchman devices. Results: Fifteen studies including 2,150 patients in randomized controlled trials (RCTs) and 2,526 patients in observational studies were included in the meta-analysis. Amplatzer device was associated with higher rates of major procedure-related complications (odds ratio [OR]: 1.99, 95% confidence interval [CI]: 1.45–2.74, P <0.0001) and device embolization (OR: 1.99, 95% CI: 1.09–3.64, P =0.03). However, Amplatzer device had lower rates of total peridevice leak (PDL) (OR:0.48, 95% CI: 0.27–0.83, P =0.009), significant PDL (OR:0.27, 95% CI: 0.12–0.57, P =0.0007) and device-related thrombus (DRT) (OR:0.67, 95% CI: 0.48–0.95, P =0.02). No statistical differences were observed between the two devices in other safety and efficacy endpoints, such as pericardial effusion, cardiac tamponade, air embolism, vascular complications, ischemic stroke/ transient ischemic attack (TIA), hemorrhagic stroke, all-cause death, cardiovascular death and bleeding. Conclusions: Amplatzer LAAC device was associated with higher rates of major procedure-related complications, especially in device embolization. Watchman LAAC device was associated with higher rates of PDL and DRT. There were no significant differences between two devices in ischemic stroke/TIA, hemorrhagic stroke, all-cause death, cardiovascular death and bleeding.

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Comparison between Amulet and Watchman left atrial appendage closure devices: A real-world, single center experience.

Cited by 4 publications

References 20 publications

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

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

Clinical efficacy and safety comparison of Watchman device versus ACP/Amulet device for percutaneous left atrial appendage closure in patients with nonvalvular atrial fibrillation: A study‐level meta‐analysis of clinical trials

Comparison between Amplatzer and Watchman Left Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation: A Systematic Review and Meta-Analysis

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