评估Amplatzer间隔封堵器在封堵继发孔型房间隔缺损中的安全性和有效性。
Amplatzer中隔封堵器(ASO;雅培,圣保罗,MN)是FDA批准的经皮封堵继发孔型房间隔缺损(ASD)的装置。以前的小型队列试验显示了良好的安全性和技术疗效。
我们对评估ASO安全性和植入疗效的所有前瞻性病例系列和对照试验进行了系统回顾和荟萃分析。主要终点是植入的技术成功率。次要结果包括心律失常和栓塞特异性不良事件的比例。
我们共纳入12项研究,共2972名患者。装置植入的比例按性别为2:1[女性:男性]。综合技术成功率为98%(95%CI:0.968~0.990,P<0.01)。累计不良事件发生率为5.1%(95%CI:0.035-0.068,P<0.01),其中心律失常和栓塞特异性不良事件发生率为1.8%(95%CI:0.007-0.032,P<0.01)和0.7%(95%CI:0.002-0.013,P<0.01),分别。敏感性分析对成功率和不良事件的汇总结果没有显着影响;森林地块和Begg's和Egger's回归测试均支持对称性。
当将ASO植入secundum型ASD时,可以预期技术成功的可能性很高。预计每20名患者中就有1名患者出现不良事件,因此,我们的结果支持ASO在secondum型ASDs闭合中的安全使用。
AMPLATZER间隔封堵器是FDA批准的经皮封堵装置,用于继发孔型房间隔缺损(ASD)。我们对评估ASO安全性和植入疗效的所有前瞻性病例系列和对照试验进行了系统回顾和荟萃分析。我们共纳入12项研究,共2972名患者。综合技术成功率为98%(P<0.01)。累计不良事件发生率为5.1%(P<0.01),心律失常发生率1.8%(P<0.01),栓塞率0.7%(P<0.01)。在不良事件发生率低的情况下,技术成功的可能性很高。
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.