Left atrial appendage closure (LAAC) is a crucial intervention for stroke prevention in patients with non-valvular atrial fibrillation who are unsuitable for long-term anticoagulation. Amulet and Watchman are the most implanted devices worldwide for performing LAAC, and the aim of this review is to provide a comprehensive comparison focusing on their efficacy, safety, and short- and long-term outcomes. The Watchman device, the first to gain FDA approval, has been extensively studied and demonstrates significant reductions in stroke and systemic embolism rates. The Amulet device, a newer alternative, promises enhanced design features for more efficient appendage sealing. Current data highlight that both devices offer similar efficacy and safety for LAAC. While the two devices differ in terms of intraprocedural complication rates, they offer similar short- to long-term outcomes in terms of peri-device leaks, device-related thrombosis, and mortality. Both devices are indicated for patients who are unable to tolerate OAC, given their similar risk and safety profiles. Newer clinical studies are directed at establishing the efficacy of both devices as the primary method for stroke prevention in AF as an alternative to OAC.

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BACKGROUND: Chronic kidney disease (CKD) and end stage renal disease (ESRD) are associated with increased risk of bleeding events, including hemorrhagic stroke, and periprocedural and gastrointestinal bleeding among patients with atrial fibrillation who are on anticoagulation. Safety of percutaneous left atrial appendage occlusion (LAAO) among this patient population has been uncertain with studies showing contradictory results.
METHODS: PubMed and Google Scholar databases were queried for studies comparing outcomes among patients with and without significant CKD, and with and without ESRD who underwent LAAO device implantation. Data on outcomes from the selected studies were extracted and analyzed using random effects model. Heterogeneity was assessed using I2 test.
RESULTS: Data from eleven studies with 61,724 patients with and without kidney disease were included in the final analyses. There was an increased risk of in-hospital mortality (OR 2.76, 95 % CI [1.15-6.64]; p = 0.02) and peri-procedural bleeding (1.51 [1.33-1.71]; p < 0.01) associated with kidney disease. There was no significant difference in risk of stroke (1.19 [0.70-2.03]; p = 0.53), pericardial effusion (1.22 [0.77-1.92]; p = 0.40), vascular complications (1.18 [0.92-1.52]; p = 0.20), or device related thrombus (1.13 [0.53-2.40]; p = 0.75).
CONCLUSIONS: This study shows an increased risk of complications among patients with kidney disease, who undergo LAAO device implantation. These findings suggest the need for studies with randomized control design specifically designed to compare outcomes with LAAO versus anticoagulation in the CKD and ESRD populations.

In this case report, we explore a novel technique to remove an embolized Watchman device (Boston Scientific) into the thoracic aorta endovascularly. The technique involves a wire + snare combination that is threaded through the metal struts of the Watchman. This combination technique along with the threading provides increased stability during removal and decreases the risk of the Watchman slipping from the devices and causing further embolization. Further work is required to elucidate the efficacy of this technique in other scenarios.

Left atrial appendage closure devices reduce the risk of stroke in patients with nonvalvular atrial fibrillation while avoiding the risks associated with therapeutic anticoagulation. This significant value comes with additional unique risks associated with device implantation or surgical closure. We discuss an uncommon complication of Watchman device (Boston Scientific) implantation wherein an asymptomatic fistulous connection developed between the left atrial appendage and the left circumflex artery. Additionally, we review other documented cases of left atrial appendage fistulas and current management approaches for iatrogenic fistulous connections associated with procedural left atrial appendage closure.

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UNASSIGNED: A recent analysis of a large registry showed differences in periprocedural outcomes of the Watchman left atrial appendage closure device in males compared with females. The objective of our study was to investigate the 5-year event rate in males and females enrolled in the Watchman device premarket clinical studies submitted for US Food and Drug Administration review.
UNASSIGNED: We conducted a patient-level meta-analysis of 2256 patients from 4 studies: the PROTECT AF (Embolic Protection in Patients with Atrial Fibrillation) and PREVAIL (Prospective Randomized Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients with Atrial Fibrillation vs Long-Term Warfarin Therapy) randomized controlled trials and their continued-access registries-CAP1 (Continued Access to PROTECT AF) and CAP2 (Continued Access to PREVAIL). The outcomes evaluated were ischemic stroke (IS), IS/systemic embolism, hemorrhagic stroke (HS), and all-cause mortality. Mixed-effects Cox regression models and statistical testing for treatment-by-sex interaction were used to compare left atrial appendage closure vs warfarin in males and females. Hazard ratios adjusted (aHRs) for CHADS2 scores were generated using the same model with CHADS2 score as a covariate. Time-to-event end points were evaluated using the Kaplan-Meier method and log-rank test.
UNASSIGNED: For Watchman vs warfarin in the 2 randomized controlled trials, there was no significant interaction between sex and treatment for IS, IS/systemic embolism, HS, and all-cause mortality (P > .05); both males and females in the Watchman group had a lower aHR for HS than that in the warfarin group, which was statistically significant for males (aHR, 0.163; 95% CI, 0.045-0.593). In addition, there were no differences in outcomes between females and males treated with the Watchman device when pooling all studies.
UNASSIGNED: These data suggest that sex does not significantly affect the long-term safety and effectiveness of the Watchman device in patients with nonvalvular atrial fibrillation; however, further studies are needed.

UNASSIGNED: In the pivotal WATCHMAN trials, warfarin was used exclusively for postprocedural anticoagulation following left atrial appendage closure. We sought to investigate the safety and efficacy of direct oral anticoagulants (DOACs) in high-risk patients with atrial fibrillation who underwent left atrial appendage closure with WATCHMAN.
UNASSIGNED: This was a retrospective study of 318 patients who underwent the WATCHMAN procedure in a tertiary referral center (June 2016-September 2020). We compared the outcomes of patients who were discharged on DOACs versus warfarin after the WATCHMAN procedure. The primary outcome was the composite of any bleeding, thromboembolism, or cardiovascular death through 7 ​days and 45 ​days after the procedure.
UNASSIGNED: The final analysis included 301 patients, of whom 82.4% (248/301) were discharged on DOACs and 17.6% (53/301) were discharged on warfarin. The mean CHA2DS2-VASc and HAS-BLED scores were 4.9 ​± ​1.6 and 2.9 ​± ​0.9, respectively. The primary composite outcome was similar between the DOAC and warfarin groups through 7 ​days (3.2% vs 5.6%; adjusted odds ratio [OR], 0.65; 95% confidence interval [CI], 0.13-3.17; P ​= ​.59) and 45 days after procedure (10.1% vs 11.3%; adjusted OR, 1.18; 95% CI, 0.41-3.45; P ​= ​.76). Major bleeding (5.2% vs 9.5%; P ​= ​.34) and all-cause readmission (12.5% vs 16.9%; P ​= ​.85) at 45 ​days were comparable between the DOAC and warfarin groups. The overall incidence of device-related thrombus and significant peri-device flow at 45 ​days were low (<0.5%).
UNASSIGNED: In high-risk patients with atrial fibrillation, the primary composite outcome of any bleeding, thromboembolism, or cardiovascular death through 7 ​days and 45 ​days following WATCHMAN implantation was similar in patients receiving DOACs versus warfarin.

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Atrial fibrillation (AFib) is recognized as a risk factor linked to arterial thromboembolism stemming from blood clot formation in the left atrium, associated with increased morbidity and mortality. Most of these thrombi originate in the left atrial appendage (LAA). Oral anticoagulation (OAC) therapy can help mitigate this risk. LAA occlusion (LAAO) has emerged as an option for patients who cannot safely tolerate long-term OAC. Watchman is one of the commonly used devices with a favorable safety profile demonstrated in numerous studies. One of the most concerning complications of LAAO is device-related thrombus (DRT), which may form on the atrial side of the device and potentially lead to embolization. We present a rare case of immediate DRT formation following the deployment of a Watchman device in a 78-year-old male with persistent AFib. Despite appropriate periprocedural management, a thrombus was observed immediately post implantation. This case emphasizes the need for vigilant surveillance, prompt diagnosis, and therapeutic intervention to manage such complications. The patient was successfully managed with a heparin drip, leading to thrombus resolution. This report underscores the complexities of managing DRT and the importance of ongoing research to optimize outcomes for patients undergoing LAAO.