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Meta-Analysis
. 2022 Apr:37:52-60.
doi: 10.1016/j.carrev.2021.06.002. Epub 2021 Jun 17.

Safety and Efficacy of the Amplatzer Septal Occluder: A Systematic Review and Meta-Analysis

Joseph N Heaton  1 , Alexis K Okoh  2 , Seungmo Suh  3 , Ebru Ozturk  2 , Arash Salemi  2 , Sergio Waxman  2 , Rajiv Tayal  2
Affiliations
Meta-Analysis

Safety and Efficacy of the Amplatzer Septal Occluder: A Systematic Review and Meta-Analysis

Joseph N Heaton et al. Cardiovasc Revasc Med. 2022 Apr.

Abstract

Objectives: To assess the safety and efficacy of the Amplatzer Septal Occluder in the closure of secundum type atrial septal defects.

Background: The Amplatzer Septal Occluder (ASO; Abbott, St. Paul, MN) is an FDA-approved device for percutaneous closure of secundum type atrial septal defects (ASD). Previous small cohort trials have shown a favorable safety and technical efficacy profile.

Methods: We conducted a systemic review and meta-analysis of all prospective case series and controlled trials that evaluated the ASO's safety and implant efficacy. The primary endpoint was the technical success rate of implantations. Secondary outcomes included proportions of arrhythmias and embolism specific-adverse events.

Results: We included a total of 12 studies with 2972 patients. The ratio of device implantation was 2:1 by sex [female: male]. Pooled technical success rate of implantation was 98% (95% CI: 0.968-0.990, P < 0.01). The cumulative adverse event rate was 5.1% (95% CI: 0.035-0.068, P < 0.01), which included arrhythmia and embolism specific adverse event rates of 1.8% (95% CI: 0.007-0.032, P < 0.01) and 0.7% (95% CI: 0.002-0.013, P < 0.01), respectively. Sensitivity analysis did not significantly affect pooled outcomes for success rate and adverse events; both forest plot and Begg's and Egger's regression tests supported symmetricity.

Conclusion: A high likelihood of technical success can be expected when implanting the ASO in secundum type ASDs. Adverse event rates are expected for one in twenty patients, and thus, our results support the safe use of ASO in secundum type ASDs closure.

Condensed abstract: The AMPLATZER Septal Occluder is an FDA-approved device for percutaneous closure of secundum type atrial septal defects (ASD). We conducted a systemic review and meta-analysis of all prospective case series and controlled trials that evaluated the ASO's safety and implant efficacy. We included a total of 12 studies with 2972 patients. Pooled technical success rate of implantation was 98% (P < 0.01). The cumulative adverse event rate was 5.1% (P < 0.01), 1.8% (P < 0.01) rate of arrhythmias, and 0.7% (P < 0.01) rate of embolisms. A high likelihood of technical success can be expected with a low rate of adverse events.

Keywords: Amplatzer; Congenital heart defect; Secundum type atrial septal defect; Septal occluder.

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Conflict of interest statement

Declaration of competing interest The authors report no conflicts of interest regarding the content herein.

Figures

Fig. 1.
Fig. 1.
Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flowchart summarizing the article selection process.
Fig. 2.
Fig. 2.
a. Forrest plot of studies on ASO success rate using random effects modeling. Black boxes represent the individual studies contribution and black lines represent their 95% confidence interval. The black diamond represents the summary effect. b. Funnel plot assessing the bias of studies on success rate. c. Baujat plot assessing the influence of studies on success rate.
Fig. 3.
Fig. 3.
a. Forrest plot of studies on ASO adverse event rate using random effects modeling. Black boxes represent the individual studies contribution and black lines represent their 95% confidence interval. The black diamond represents the summary effect. b. Funnel plot assessing the bias of studies on adverse events rate. c. Baujat plot assessing the influence of studies on adverse event rate.
Fig. 4.
Fig. 4.
a. Forrest plot of studies on ASO rate of arrhythmias using random effects modeling. Black boxes represent the individual studies contribution and black lines represent their 95% confidence interval. The black diamond represents the summary effect. b. Funnel plot assessing the bias of studies on rates of arrhythmias. c. Baujat plot assessing the influence of studies on the rate of arrhythmias.
Fig. 5.
Fig. 5.
a. Forrest plot of studies on ASO rate of embolisms using random effects modeling. Black boxes represent the individual studies contribution and black lines represent their 95% confidence interval. The black diamond represents the summary effect. b. Funnel plot assessing the bias of studies on the rate of embolisms. c. Baujat plot assessing the influence of studies on the rate of embolisms.
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