Masura J, Walsh K P, Thanopoulous B, Chan C, Bass J, Goussous Y, Gavora P, Hijazi Z M
Department of Cardiology, Children University Hospital, Bratislava, Slovak Republic.
J Am Coll Cardiol. 1998 Mar 15;31(4):878-82. doi: 10.1016/s0735-1097(98)00013-8.
The aim of this study was to assess the immediate and short-term results of anterograde catheter closure of a moderate- to large-sized patent ductus arteriosus (PDA) using the new self-expandable, respositionable Amplatzer duct occluder (ADO) device.
Transcatheter closure of a PDA using devices or coils is technically challenging and may be accompanied by a 38% incidence of residual shunts.
Twenty-four patients (6 male, 18 female) underwent attempted transcatheter closure of a PDA using the ADO at a median age of 3.8 years (range 0.4 to 48) and a median weight of 15.5 kg (range 6 to 70). The mean PDA diameter at its narrowest segment was 3.7+/-1.5 mm. A 6F long sheath was used for delivery of the ADO. Follow-up evaluation was performed with color flow mapping of the main pulmonary artery within 24 h and at 1 and 3 months after closure.
Twenty three of the 24 patients had successful device placement. Angiography showed that 7 patients had complete immediate closure, 14 had a trace shunt (foaming through the device with no jet), and 2 had a small residual shunt (with a jet). Within 24 h, color Doppler revealed complete closure in all patients. The unsuccessful attempt was during an initial trial with a prototype that has been modified. The median fluoroscopy time was 13.5 min (range 6.3 to 47). All patients were discharged home the next day. There were no complications. Of the 23 patients, 21 completed the 1-month follow-up, all (95% confidence interval [CI] 86% to 100%) with complete closure, and 18 of 23 patients completed the 3-month follow-up, also all (95% CI 83% to 100%) with complete closure.
Anterograde transcatheter closure using the new ADO is an effective therapy for patients with a PDA diameter up to 6 mm. Further clinical trials are underway.
本研究旨在评估使用新型可自膨胀、可重新定位的Amplatzer动脉导管封堵器（ADO）对中至大型动脉导管未闭（PDA）进行顺行导管封堵的即刻和短期效果。
使用器械或线圈经导管封堵PDA在技术上具有挑战性，且可能伴有38%的残余分流发生率。
24例患者（6例男性，18例女性）尝试使用ADO经导管封堵PDA，中位年龄3.8岁（范围0.4至48岁），中位体重15.5 kg（范围6至70 kg）。PDA最窄处的平均直径为3.7±1.5 mm。使用6F长鞘管输送ADO。在封堵后24小时内以及1个月和3个月时，通过对主肺动脉进行彩色血流成像进行随访评估。
24例患者中有23例成功植入器械。血管造影显示，7例患者即刻完全封堵，14例有微量分流（通过器械有泡沫但无射流），2例有少量残余分流（有射流）。在24小时内，彩色多普勒显示所有患者均完全封堵。封堵失败发生在对一个已改良的原型器械进行的首次试验中。中位透视时间为13.5分钟（范围6.3至47分钟）。所有患者次日均出院。无并发症发生。23例患者中，21例完成了1个月随访，全部（95%置信区间[CI] 86%至100%）完全封堵；23例患者中的18例完成了3个月随访，同样全部（95% CI 83%至100%）完全封堵。
使用新型ADO进行顺行经导管封堵对于直径达6 mm的PDA患者是一种有效的治疗方法。进一步的临床试验正在进行中。
