Department of Medicine, The Brooklyn Hospital Center, Brooklyn, NY, United States of America; Cardiovascular Research Unit, RWJ Barnabas Health. NBIMC, Newark, NJ, United States of America.
Cardiovascular Research Unit, RWJ Barnabas Health. NBIMC, Newark, NJ, United States of America.
Cardiovasc Revasc Med. 2022 Apr;37:52-60. doi: 10.1016/j.carrev.2021.06.002. Epub 2021 Jun 17.
To assess the safety and efficacy of the Amplatzer Septal Occluder in the closure of secundum type atrial septal defects.
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.
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.
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.
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.
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.
评估 Amplatzer 房间隔封堵器在继发孔型房间隔缺损（ASD）封堵中的安全性和有效性。
Amplatzer 房间隔封堵器（ASO；雅培，明尼苏达州圣保罗）是经美国食品药品监督管理局批准的用于经皮封堵继发孔型 ASD 的器械。先前的小队列试验显示了良好的安全性和技术功效。
我们对所有评估 ASO 安全性和植入功效的前瞻性病例系列和对照试验进行了系统评价和荟萃分析。主要终点是植入的技术成功率。次要结局包括心律失常和栓塞特定不良事件的比例。
我们共纳入了 12 项研究，共 2972 例患者。按性别（女性：男性），器械植入比例为 2:1。植入的汇总技术成功率为 98%（95%CI：0.968-0.990，P < 0.01）。累积不良事件发生率为 5.1%（95%CI：0.035-0.068，P < 0.01），其中包括心律失常和栓塞特定不良事件发生率分别为 1.8%（95%CI：0.007-0.032，P < 0.01）和 0.7%（95%CI：0.002-0.013，P < 0.01）。敏感性分析并未显著影响成功率和不良事件的汇总结果；森林图和 Begg's 和 Egger's 回归检验均支持对称性。
在继发孔型 ASD 中植入 ASO 可获得较高的技术成功率。预计每 20 名患者中就会有 1 名发生不良事件，因此，我们的结果支持在继发孔型 ASD 封堵中安全使用 ASO。
