Chen Zhao-yang, Wu Li-ming, Luo Yu-kun, Lin Chao-gui, Peng Ya-fei, Zhen Xing-chun, Chen Liang-long
Department of Cardiology, Union Hospital, Fujian Medical University, Fuzhou, Fujian 350001, China.
Chin Med J (Engl). 2009 May 20;122(10):1123-7.
Transcatheter Amplatzer occlusion of patent ductus artertiosus (PDA) has emerged as a minimally invasive alternative to surgical closure. The goal of this study was to compare long-term clinical outcomes between two procedures, especially on chronic residual shunt, late or very late procedure-related complications, and regression of pulmonary hypertension and left ventricular dilation.
A total 255 patients having isolated PDA with a minimal diameter of >or= 4 mm treated from January 2000 to July 2003 were included in this study and have been followed up until July 2008. The patients were assigned to either the device or surgical closure group according to the patients' and/or their parents' preference. Baseline physical exams, chest roentgenography, electrocardiography, and echocardiography were performed preprocedure and at each follow-up.
Seventy-two patients accepted the transcatheter procedure (Group-TC) and 183 underwent surgical operation (Group-SO) for PDA closure, both groups were similar in their demographics and preoperative clinical characteristics. There were no cardiac deaths and late complications such as infectious endocarditis and Amplatzer duct occluder (ADO) dislodge in either group. More acute procedure-related complications were recorded in Group-SO (13.7%) compared with Group-TC (1.4%) (P = 0.004). The recovery time was (8.7 +/- 2.3) days for the Group-SO and (1.3 +/- 0.5) days for the Group-TC (P < 0.001). The survival freedom from persistent residual shunt, defined as residual shunt that can not resolve automatically, was 91.3% for Group-SO and 98.6% for Group-TC (P = 0.037 by Log-rank test). There was no significant difference in regression of pulmonary hypertension and left ventricular dilation; neither survival freedom from pulmonary hypertension nor abnormal left ventricular end-diastolic volume index were significantly different between the surgical group and the Amplatzer group.
Our study confirmed the long-term safety and efficacy of transcatheter Amplatzer occlusion. In comparison to the time-proven surgical closure, transcatheter Amplatzer occlusion was less invasive and associated with fewer complications and residual shunt, and as effective in the regression of pulmonary hypertension and left ventricular dilation.
经导管使用Amplatzer封堵器闭合动脉导管未闭(PDA)已成为一种微创替代手术闭合的方法。本研究的目的是比较两种手术的长期临床结果,特别是在慢性残余分流、晚期或极晚期手术相关并发症以及肺动脉高压和左心室扩张的消退方面。
纳入2000年1月至2003年7月期间治疗的255例最小直径≥4mm的孤立性PDA患者,并随访至2008年7月。根据患者和/或其父母的意愿,将患者分为器械封堵组或手术闭合组。术前及每次随访时均进行基线体格检查、胸部X线检查、心电图和超声心动图检查。
72例患者接受经导管手术(TC组),183例接受手术治疗(SO组)以闭合PDA,两组在人口统计学和术前临床特征方面相似。两组均无心脏死亡及感染性心内膜炎、Amplatzer动脉导管封堵器(ADO)移位等晚期并发症。与TC组(1.4%)相比,SO组记录到更多的急性手术相关并发症(13.7%)(P = 0.004)。SO组的恢复时间为(8.7±2.3)天,TC组为(1.3±0.5)天(P < 0.001)。持续残余分流(定义为不能自动消失的残余分流)的无事件生存率,SO组为91.3%,TC组为98.6%(对数秩检验P = 0.037)。肺动脉高压和左心室扩张消退方面无显著差异;手术组和Amplatzer组在肺动脉高压无事件生存率和左心室舒张末期容积指数异常方面也无显著差异。
我们的研究证实了经导管Amplatzer封堵术的长期安全性和有效性。与经过时间验证的手术闭合相比,经导管Amplatzer封堵术侵入性较小,并发症和残余分流较少,在肺动脉高压和左心室扩张消退方面同样有效。