Grabitz R G, Schräder R, Sigler M, Seghaye M C, Dzionsko C, Handt S, Schneidt B, Von Bernuth G
Department of Pediatric Cardiology, Aachen University of Technology, Germany.
Invest Radiol. 1997 Sep;32(9):523-8. doi: 10.1097/00004424-199709000-00004.
The clinically most widely used devices (Porstmann-plug, Rashkind-umbrella, Botallooccluder) have inherent specific limitations (eg, transarterial approach, residual shunts, limited retrieval). The authors assess practicability, efficacy, and tissue reaction of the new retrievable transvenous plug device for the occlusion of the persistent patent ductus arteriosus (PDA).
A foam plug (polyvinyl alcohol) is mounted on a titanium core pin where, at both ends, small legs (titanium nickel alloy) with titanium heads are anchored, to ensure safe fixation in the ductus. The device is introduced transvenously through a long sheath (Mullins sheath) and held by a modified biopsy forceps allowing complete retrieval until final release. A common lamb model of large PDAs (n = 11) was used to test for practicability and the histomorphologic outcome. Clinical results were obtained from a consecutive series of 16 patients (aged 13 to 71 years).
In all lambs, placement of the plug within the PDA was possible. Histopathology (follow-up 10 to 215 days; mean 112 days) revealed an adequate ingrowing of the device and no pathologic foreign body reaction. The diameter of the human PDAs ranged from 3 to 7 mm (mean 5 mm). The size of the sheath used for introducing the plug (diameter 8 to 16 mm) ranged from 8 to 16 French. Fourteen of 16 PDAs were closed immediately after or on day 1 after implantation, 1 was closed after the 12-month follow-up, and 1 needed an additional plug after 30 months for definitive closure.
The device demonstrated practicability and biocompatibility in our experimental lamb model and effectively closed the PDA in a consecutive series of 16 patients. A greater number of patients and a longer follow-up period are necessary for the definitive clinical assessment of the new device.
临床上应用最广泛的器械（波斯曼封堵器、拉什金德伞、博塔洛封堵器）存在固有的特定局限性（例如，经动脉途径、残余分流、回收受限）。作者评估了新型可回收经静脉封堵器用于封堵持续性动脉导管未闭（PDA）的实用性、有效性及组织反应。
一个泡沫封堵器（聚乙烯醇）安装在钛芯针上，在两端固定有带钛头的小腿（钛镍合金），以确保在动脉导管内安全固定。该器械通过一个长鞘（穆林斯鞘）经静脉引入，并用改良活检钳夹持，在最终释放前可完全回收。使用11只大PDA的普通羔羊模型来测试实用性和组织形态学结果。临床结果来自连续的16例患者（年龄13至71岁）。
在所有羔羊中，均能将封堵器放置在PDA内。组织病理学（随访10至215天；平均112天）显示封堵器植入良好，无病理性异物反应。人类PDA的直径范围为3至7毫米（平均5毫米）。用于引入封堵器的鞘管尺寸（直径8至16毫米）范围为8至16法式。16例PDA中有14例在植入后即刻或第1天闭合，1例在12个月随访后闭合，1例在30个月后需要额外植入一个封堵器才能最终闭合。
该器械在我们的实验羔羊模型中显示出实用性和生物相容性，并在连续的16例患者中有效闭合了PDA。对于该新器械的最终临床评估，需要更多患者和更长的随访期。
