Introduction: The Amplatzer and Watchman left atrial appendage closure (LAAC) devices are the two most frequently used devices for LAAC devices worldwide. This meta-analysis aimed to compare the safety and efficacy of the two devices. Methods: We searched the PubMed, EMBASE, and the Cochrane Library for studies up to February 6, 2022 that compared the safety and efficacy of the Amplatzer and Watchman devices. Results: Fifteen studies including 2,150 patients in randomized controlled trials 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.

The most worrisome consequence of atrial fibrillation (AF) remains thromboembolism, most importantly stroke [1]. Oral anticoagulation is the first-line therapy for stroke prevention in AF, but is often underutilized due to poor patient compliance, contraindications, and potential bleeding complications [2]. Taking into consideration that more than 90% of thrombi are located in the left atrial appendage (LAA) in patients with nonvalvular AF [3], percutaneous left atrial appendage closure (LAAC) has emerged as a safe and effective nonpharmacological treatment option [4-7].

An ideal LAAC device should be ease of use, safe and effective [8]. The Amplatzer (Abbott, Chicago, IL, USA) and Watchman (Boston Scientific, Marlborough, MA, USA) devices are the two most frequently used devices for LAAC worldwide. The Watchman device has been approved in many countries worldwide and has been the only device studied in randomized trials so far [4, 5]. The new-generation Watchman FLX device also showed outstanding safety and efficacy outcomes [9, 10]. Amplatzer Cardiac Plug and the 2nd generation Amplatzer Amulet devices featured favorable outcomes in some observational studies [11-13]. There were several observational studies [14-24] and randomized controlled trials (RCTs) [25-28] directly comparing Amplatzer and Watchman devices. However, results from these studies were not consistent and were underpowered to evaluate rare outcomes such as stroke. Therefore, we performed a meta-analysis to compare the safety and efficacy of the two devices.

This study was performed following the PRISMA guidelines. The PRISMA checklist is shown in the online supplementary material (see www.karger.com/doi/10.1159/000524626 for all online suppl. material).

Data Source and Search Strategy

The search strategy involved a literature search of published articles through the medical databases of PubMed, EMBASE and Cochrane Central Register of Controlled Trials (CENTRAL) up to February 6, 2022. The following medical subject headings and keyword search terms were included for MEDLINE search and adapted for other databases as needed: “Watchman,” “Amplatzer Cardiac Plug,” “ACP,” “Amulet,” “left atrial appendage occlusion,” “left atrial appendage occluder,” “left atrial appendage closure,” “stroke prophylaxis,” and “stroke prevention”. In addition, the reference lists of retrieved articles were scanned for relevant studies. We did not apply any restrictions on languages.

Study Inclusion and Exclusion Criteria

Trials were included if they directly compared the Amplatzer and Watchman devices and provided safety or efficacy data. All RCTs and observational studies that fulfilled the inclusion criteria were included. Studies involving single-arm studies, case reports, editorial, and systematic reviews were not considered in this analysis. Some conference abstracts without access to full text for quality assessment and data extraction were also excluded.

Data Extraction and Quality Assessment

Two authors (J.Q. and B.Z.) reviewed the trials to ensure that they met the inclusion criteria. Data extraction was conducted by mutual agreement. Disagreements were resolved through consensus of a third reviewer (E.X.). The quality of RCTs was assessed by evaluating the following methodological criteria recommended by Cochrane Collaboration: sequence generation of the allocation, concealment of allocation, blinding, incomplete outcome data, selective outcome reporting, and other sources of bias [29]. The quality of observational studies was assessed by the Newcastle-Ottawa Scale criteria [30].

Study Outcomes and Definitions

The primary safety endpoint was major procedure-related complications (composite of pericardial effusion, cardiac tamponade, device embolization, air embolism, vascular complications and procedure/device-related death, stroke, or bleeding, etc.). Definitions of major procedure-related complications are described in the online supplementary Table S1. The other safety endpoints included pericardial effusion, cardiac tamponade, device embolization, air embolism, and vascular complications. The primary efficacy endpoint was ischemic stroke/transient ischemic attack (TIA). The other efficacy endpoints included all deaths, cardiac death, hemorrhagic stroke, bleeding, peridevice leakage (PDL), and device-related thrombosis (DRT). Definitions of some clinical events are described in the online supplementary Table S1.

Statistical Analyses

Review Manager (RevMan5.3, The Cochrane Collaboration, Oxford, UK) was utilized for meta-analyses. All outcomes in this study were categorical data and the results were expressed as odds ratio (OR) with 95% confidence intervals (CI). Heterogeneity was assessed using the I2 statistic, with values <25%, 25–50%, >50% indicating low, moderate, and high heterogeneity, respectively [31]. Pooled analyses were calculated using fixed-effect models (Mantel-Haenszel method), whereas random-effect models (DerSimonian and Laird method) were applied if I2 >50%. Publication bias was estimated visually by funnel plots. All tests were two-sided and p ≤ 0.05 was considered statistically significant.

Search Results

The literature search yielded 767 potentially relevant articles (Fig. 1). Through a review of titles and abstracts, 742 articles were excluded for being duplicated or not relevant. The remaining 25 full-text articles were reviewed and assessed according to the inclusion or exclusion criteria. Ultimately, 15 articles [14-28] met the inclusion criteria and were included in the meta-analysis (Fig. 1), yielding a total of 4,676 patients. Among them, 3 studies (2,150 patients) were RCTs, and the other 12 studies (2,526 patients) were observational studies.

Fig. 1.

Flow chart of the study selection procedure.

Fig. 1.

Flow chart of the study selection procedure.

Close modal

Study Characteristics

The baseline characteristics of individual studies are summarized in the Table 1. Sample size between the studies varied. The smallest sample size was 31, while the largest was 1,878. Most participants were male, with an average age varying from 64.7 to 83.0 years. Of all patients, 66–100% had hypertension, 19–40.0% had diabetes, 3.8–80.4% had a history of heart failure, and 15–48% had stroke/TIA previously. The average CHA2DS2-VASc score ranged from 3.3 to 5.0. The average HAS-BLED score ranged from 2.7 to 4.7. The follow-up period ranged from 45 days to 3.92 years. The implantation success rate was high for both the Amplatzer (96.33%) and the Watchman (96.48%) devices. Transesophageal echocardiography (TEE)/cardiac computed tomography angiography time after the procedure ranged from 45 days to 12 months (online suppl. Table S1). Regimens of anticoagulation/antiplatelets are described in the online supplementary Table S1. The quality scales of these studies are shown in online supplementary Tables S2 and S3.

Table 1.

Baseline characteristics of the included studies

Baseline characteristics of the included studies
Baseline characteristics of the included studies

Primary Safety Endpoint

Three RCTs and 8 observational studies contributed to the analysis of major procedure-related complications. The Amplatzer group had a significantly higher rate of major procedure-related complications compared to the Watchman group in both RCTs (OR: 2.10, 95% CI: 1.30–3.37, p = 0.002; Fig. 2) and observational studies (OR: 1.91, 95% CI: 1.24–2.94, p = 0.003; Fig. 2). No heterogeneity was observed when the results of randomized and nonrandomized studies were combined (I2 = 0). The funnel plot did not suggest publication bias (online suppl. Fig. S1).

Fig. 2.

Forest plot of major procedure-related complications. CI, confidence interval; M-H, Mantel-Haenszel.

Fig. 2.

Forest plot of major procedure-related complications. CI, confidence interval; M-H, Mantel-Haenszel.

Close modal

Higher major procedure-related complications in the Amplatzer group were largely related to more frequent device embolization (OR: 1.99, 95% CI: 1.09–3.64, p = 0.03; Table 2). No significant differences were found in other safety endpoints, which included pericardial effusion, cardiac tamponade, air embolism, and vascular complications (Table 2).

Table 2.

Statistical comparison of other safety outcomes

Statistical comparison of other safety outcomes
Statistical comparison of other safety outcomes

Primary Efficacy Endpoint

Three RCTs and 9 observational studies contributed to the analysis of ischemic stroke/TIA. The results were not significantly different between the two groups both in RCTs (OR: 0.84, 95% CI: 0.49–1.45, p = 0.53; Fig. 3) and in observational studies (OR: 0.63, 95% CI: 0.39–1.04, p = 0.07; Fig. 3). Pooled analysis of RCTs and observational studies also showed no significant difference between the two groups (OR: 0.72, 95% CI: 0.50–1.04, p = 0.08; Fig. 3). Moderate heterogeneity was observed in RCTs (I2 = 28%). No heterogeneity was observed when results of randomized and nonrandomized studies were combined (I2 = 0). The funnel plot did not suggest publication bias (online suppl. Fig. S2).

Fig. 3.

Forest plot of ischemic stroke/TIA. CI, confidence interval; M-H, Mantel-Haenszel.

Fig. 3.

Forest plot of ischemic stroke/TIA. CI, confidence interval; M-H, Mantel-Haenszel.

Close modal

Other Efficacy Endpoints

No significant differences were observed in the incidence of all-cause death, cardiovascular death, hemorrhagic stroke, total bleeding, major bleeding, and minor bleeding (Table 3). Compared with the Watchman group, the Amplatzer group had a significantly lower rate of either total PDL (OR: 0.48, 95% CI: 0.27–0.83, p = 0.009; Table 3) or significant PDL (OR: 0.27, 95% CI: 0.12–0.57, p = 0.0007; Table 3). In addition, the Amplatzer group had a significantly lower rate of DRT compared to the Watchman group (OR: 0.67, 95% CI: 0.48–0.95, p = 0.02; Table 3).

Table 3.

Statistical comparison of other efficacy outcomes

Statistical comparison of other efficacy outcomes
Statistical comparison of other efficacy outcomes

Amplatzer and Watchman LAAC devices are different in design and mechanism of action. The Amplatzer device seals the LAA according to the pacifier principle, by which a lobe or an umbrella is delivered into the neck of the LAA and an additional disk is placed on the left atrial (LA) side of the LAA ostium. The Watchman LAAC device is a single-lobe endocardial device deployed in the neck of the LAA, thereby preventing blood flow from entering the LAA [32].

Our meta-analysis found that major procedure-related complications were more frequent in the Amplatzer group comparing with the Watchman group, especially in device embolization. The EWOLUTION trial [33] for Watchman, as well as multicenter registries for Amplatzer Cardiac Plug [11] and Amulet [12], reported complication rates of 2.8%, 5.0%, and 3.2%, respectively. However, these trials were not controlled, and the definitions of procedure-related complications were different. The absence of an additional disk in the Watchman device perhaps simplified the implantation procedure and therefore decreased the complication rate [34]. Moreover, Watchman device implantation was more widely used in experienced centers, which possibly contributed to lower complication rates.

In our meta-analysis, we observed a significantly higher rate of PDL in the Watchman group. PDL may occur with any LAAC devices because the morphology of the LAA and the LA ostium are extremely complex and heterogeneous, whereas these devices are circular [35]. The Amplatzer device with “lobe and disk” design has 2 layers of barrier between the left atrium and LAA interface may relate to a lower incidence of PDL than the Watchman device. However, the presence of PDL was not proven to be associated with major adverse cardiovascular or embolic events, as shown in previously published studies [36-38]. Our meta-analysis also found no differences between the two devices in ischemic stroke/TIA, all-cause death, and cardiovascular death.

It is worth noting that most studies in our meta-analysis used TEE to identify the presence of PDL. Both TEE and/or cardiac computed tomography angiography were performed in the SWISS-APERO trial [15] and Mansour et al. [16] study. PDL occurrence is substantially higher with CT than TEE [38].

We also found a significantly higher rate of DRT in the Watchman group compared to the Amplatzer group, attributed by higher rates of PDL. Persistent residual flow between the LAA and the LA after an incomplete occlusion may cause thrombosis because of blood turbulence and stagnation and may further contribute to higher incidents of stroke and systemic embolism [39, 40]. In the literature, the incidence of DRT varied from 0.3% [11],3.7% [40] to 7.2% [39]. However, we did not observe an increased rate of ischemic stroke/TIA in our meta-analysis. It is possible that DRT was dissolved with a strict antithrombotic strategy without many adverse events [20, 25, 26].

Our comparative findings were not completely consistent with a previous meta-analysis [41], which showed similar safety and efficacy outcomes between the Amplatzer and Watchman groups. It is partially because our meta-analysis included more new research and 3 RCTs [14-16], comprising data from 4,676 patients, while the other article only included 6 studies, with a total population of 614. Well-designed RCTs provide more convincing evidence in a specific, selected, well-defined target population.

This meta-analysis has several limitations. First, because of limited randomized data, this meta-analysis included both randomized and observational studies. The observational studies are subjected to unmeasured confounding and selection bias, although we made stratified analysis of randomized and observational studies before the pooled estimate of primary endpoints. Second, the definition of some clinical events such as major procedure-related complications was not unanimous across studies; however, it was unlikely to have a huge impact on the final conclusion. Third, this meta-analysis only included studies with full-text articles. Some conference abstracts without access to full text for quality assessment and data extraction were excluded. There may be publication bias in our study. Fourth, the follow-up duration in each study varied, which may have negatively influenced the outcomes. Last but most importantly, we failed to analyze patients with different generations of the two LAAC devices because individual data were not available.

In this comparative meta-analysis, the 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. No significant differences between two devices in long-term effectiveness, such as ischemic stroke/TIA, all-cause death, cardiovascular death, hemorrhagic stroke, and bleeding, were observed. Results of large-scale RCTs with long-term follow-up might shed further light on clinical endpoints, such as death and stroke.

An ethics statement is not applicable because this study is based exclusively on published literature.

The authors have no conflicts of interest to declare.

The authors did not receive any funding for conducting the study.

Jianzhong Qiao contributed to conceptualization, methodology, software, formal analysis, and writing – original draft. Bin Zhang, Jie Wang, Lingxin Pan, Tieniu Cheng, and Yuan Wang contributed to methodology, writing – review and editing, and supervision. Enlai Xiong contributed to writing – review and editing and supervision.

All data generated or analyzed during this study are included in this article and its online supplementary material. Further inquiries can be directed to the corresponding author.

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