Donti Andrea, Formigari Roberto, Bonvicini Marco, Prandstraller Daniela, Bronzetti Gabriele, Picchio Fernando M
University of Bologna, Bologna, Italy.
Ital Heart J. 2002 Feb;3(2):122-7.
Many devices currently used for the closure of the patent ductus arteriosus are claimed to be safe and cost-effective, but only few data exist with respect to the gold standard of the Rashkind occluder. The aim of this study was to assess the efficacy and safety of three new different devices and to compare the results to those of a control group of patients carrying a Rashkind occluder. This should provide the basis for further cost-analysis studies.
The records of all patients who underwent closure of the patent ductus at our Institution from April 1989 to May 2001 were reviewed. Eighty patients (median age 10.3 years, median weight 27.6 kg) were treated (25 with a Rashkind device, 11 with Duct-Occlud coils, 35 with Cook detachable coils, 9 with the Amplatzer system).
Kaplan-Meyer estimates of long-term complete occlusion of the ductus showed, compared to the Rashkind device, a significant improvement for the Cook and Amplatzer (p = 0.025 and p = 0.003, respectively) devices but not for the Duct-Occlud coils (p = 0.165). One patient of the Duct-Occlud group (9%) and 3 with the Rashkind device (12%) featured a significant residual shunt and needed a second intervention. The complication rate was 4% for the Rashkind occluder, 5% for the Cook coils, 9% for the Duct-Occlud system, and 11% for the Amplatzer device (p > 0.05).
The new devices are as safe as the Rashkind occluder and provide effective treatment. The Cook coils and the Amplatzer occluder offer better results compared to the Rashkind and Duct-Occlud devices.
目前许多用于闭合动脉导管未闭的装置都声称安全且具有成本效益，但关于拉什金德封堵器这一黄金标准的相关数据却很少。本研究的目的是评估三种新型不同装置的有效性和安全性，并将结果与携带拉什金德封堵器的对照组患者的结果进行比较。这应为进一步的成本分析研究提供依据。
回顾了1989年4月至2001年5月在我们机构接受动脉导管未闭封堵治疗的所有患者的记录。80例患者（中位年龄10.3岁，中位体重27.6kg）接受了治疗（25例使用拉什金德装置，11例使用Duct - Occlud线圈，35例使用库克可分离线圈，9例使用Amplatzer系统）。
与拉什金德装置相比，卡普兰 - 迈耶法对导管长期完全闭塞的估计显示，库克装置和Amplatzer装置有显著改善（分别为p = 0.025和p = 0.003），但Duct - Occlud线圈没有（p = 0.165）。Duct - Occlud组有1例患者（9%）和使用拉什金德装置的3例患者（12%）有明显残余分流，需要二次干预。拉什金德封堵器的并发症发生率为4%，库克线圈为5%，Duct - Occlud系统为9%，Amplatzer装置为11%（p>0.05）。
新型装置与拉什金德封堵器一样安全，并能提供有效的治疗。与拉什金德和Duct - Occlud装置相比，库克线圈和Amplatzer封堵器效果更好。
