Comparative Safety and Efficacy of Left Atrial Appendage Occlusion Technologies for Prevention of Stroke and Bleeding in Atrial Fibrillation: A Comprehensive Meta-Analysis of Watchman Versus Oral Anticoagulation and Alternative Device Platforms

Figures

• 

  Figure 1. PRISMA 2020 flow diagram: Database searches identified 10,348 records. After removing duplicates and screening, 21 studies met inclusion criteria. PRISMA: Preferred Reporting Items for Systematic Reviews and Meta-Analyses

• 

  Figure 2. Risk of bias assessment for randomised controlled trials (Top) Individual study assessment using the Cochrane Risk of Bias 2 (RoB 2) tool across five domains; (Bottom) Summary distribution showing percentage of low risk (green), some concerns (yellow), and high risk (red) across all trials. References: Fan 2025 [36], Galea 2022 [25], Holmes 2014 [21], Kapadia 2024 [12], Lakkireddy 2021 [24], Osmancik 2022 [8], Reddy 2014 [9], Saliba 2025 [22]

• 

  Figure 3. Primary efficacy outcomes comparing LAAO versus OAC (1.1) Transient ischaemic attack: five studies, n=4,058, OR 0.72 (95% CI 0.54-0.96), p=0.03; (1.2) Ischaemic stroke: four studies, n=3,116, OR 1.09 (95% CI 0.70-1.69), p=0.70. (1.3); Haemorrhagic stroke: six studies, n=4,116, OR 0.41 (95% CI 0.23-0.72), p=0.002. LAAO, left atrial appendage occlusion; OAC, oral anticoagulation; OR, odds ratio; CI: confidence interval References: [8-9, 12, 21, 23, 38]

• 

  Figure 4. Mortality outcomes comparing LAAO versus OAC (1.6) All-cause mortality: six studies, n=4,465, OR 0.73 (95% CI 0.61-0.87), p<0.001; (1.7) Cardiovascular mortality: three studies, n=3,307, OR 0.57 (95% CI 0.42-0.77), p<0.001. LAAO, left atrial appendage occlusion; OAC, oral anticoagulation; OR, odds ratio; CI: confidence interval References: [8-9, 12, 21, 23, 38]

• 

  Figure 5. Primary efficacy comparing Watchman versus other LAAO devices (2.1) TIA: 10 studies, n=4,171, OR 1.10 (95% CI 0.76-1.60), p=0.62; (2.2) Ischaemic stroke: seven studies, n=3,215, OR 0.96 (95% CI 0.61-1.50), p=0.85; (2.3) Haemorrhagic stroke: seven studies, n=1,636, OR 1.24 (95% CI 0.47-3.31), p=0.66. LAAO, left atrial appendage occlusion; OAC, oral anticoagulation; OR, odds ratio; CI: confidence interval; TIA: transient ischemic attack References: TIA: 10 studies [22, 25, 26, 29-33, 36, 37]; ischaemic stroke: seven studies [22, 24, 29, 32, 33, 35, 37]; haemorrhagic stroke: seven studies [24, 25, 29, 32, 33, 35, 37]

• 

  Figure 6. Key safety outcomes favoring Watchman (3.1) Device-related complications: 12 studies, n=4,154, OR 0.67 (95% CI 0.49-0.92), p=0.01; (3.3) Device embolisation: 13 studies, n=4,600, OR 0.45 (95% CI 0.25-0.82), p=0.009; (3.6) Procedural bleeding: 10 studies, n=4,465, OR 0.68 (95% CI 0.54-0.86), p=0.001. OR, odds ratio; CI, confidence interval References: Device-related complications: 12 studies [22, 24-28, 30-33, 35, 37]; Device embolisation: 13 studies [22, 24, 26, 27, 29-37]; Procedural bleeding: 10 studies [22, 24, 27, 29, 30, 32-36]

• 

  Figure 7. Peridevice leak comparison between devices (3.9) Major leak ≥5mm: nine studies, n=2,394, OR 1.84 (95% CI 1.12-3.03), p=0.02, favouring other devices; (3.10) Minor leak <5mm: seven studies, n=1,521, OR 1.09 (95% CI 0.77-1.54), p=0.63, with device-specific variability. OR, odds ratio; CI, confidence interval References: Major leak ≥5mm: nine studies [24, 29-33, 35-37]; Minor leak <5mm: seven studies [24, 27, 31, 33-36]

• 

  Figure 8. Cardiovascular mortality comparing Watchman versus other LAAO devices Six studies, n=3,026, OR 0.73 (95% CI 0.54-0.98), p=0.04, demonstrating survival benefit with Watchman. LAAO, left atrial appendage occlusion; OR, odds ratio; CI: confidence interval References: [22, 24, 31-33, 35]

• 

  Figure 9. Systemic embolism; (1.4) Forest plot comparing systemic embolisation incidence between LAAO and oral anticoagulation; (2.4) Forest plot comparing systemic embolism incidence between Watchman and control devices LAAO: left atrial appendage occlusion References: OPTION [22], PREVAIL [21], PROTECT AF [9], PRAGUE 17 [8], Amulet IDE [24], Kleinecke 2019 [23], Saad 2021 [26], SWISS APERO [25], Figini 2016 [31].

• 

  Figure 10. Major bleeding outcomes; (1.5) Forest plot comparing major bleeding incidence between LAAO and oral anticoagulation; (2.5) Forest plot comparing major bleeding incidence between Watchman and control devices LAAO: Left atrial appendage occlusion References: OPTION [22], PROTECT AF [9], WATCH-TAVR [12] PRAGUE 17 [8], Amulet IDE [24], Kleinecke 2019 [23], Kretzler 2022 [27], Saad 2021 [26], SWISS APERO [25], Figini 2016 [31], Cheung 2019 [33], LAARGE 2020 [34], LAmax [36].

• 

  Figure 11. Pericardial effusion; Forest plot comparing pericardial effusion incidence between Watchman and control devices References: Amulet IDE [24], Chen 2019 [38], Kleinecke 2019 [23], Kretzler 2022 [27], Saad 2021 [26], SWISS APERO [25], Fastner [32], Figini 2016 [31], Gonzalez [29], Kim 2018 [30], Cheung 2019 [33], Chiu 2022 [35], LAARGE 2020 [34], LAmax [36].

• 

  Figure 12. Device-related thrombosis; Forest plot comparing device-related thrombus incidence between Watchman and control devices. References: Amulet IDE [24], Chen 2019 [38], Kleinecke 2019 [23], Kretzler 2022 [27], Saad 2021 [26], SWISS APERO [25], Fastner [32], Mansour [28], Chiu [35], LAARGE 2020 [34]