Rao P S, Kim S H, Choi J Y, Rey C, Haddad J, Marcon F, Walsh K, Sideris E B
Division of Pediatric Cardiology, University of Wisconsin Medical School, Madison, USA.
J Am Coll Cardiol. 1999 Mar;33(3):820-6. doi: 10.1016/s0735-1097(98)00610-x.
The purpose of this presentation is to document results of buttoned device (BD) occlusion of patent ductus arteriosus (PDA) in a large number of patients with particular emphasis on long-term follow-up in an attempt to provide evidence for feasibility, safety and effectiveness of this method of PDA closure.
Immediate and short-term results of BD occlusion of PDA have been documented in a limited number of children.
During a six-year period ending August 1996, transcatheter BD closure of PDA was attempted in 284 patients, ages 0.3 to 92 years (median 7) under a protocol approved by the local institutional review boards and FDA with an investigational device exemption in U.S. cases.
The PDAs measured 1 to 15 mm (median 4) at the narrowest diameter; 20 were larger than 8 mm and 10 larger than 10 mm. They were occluded with devices measuring from 15 to 35 mm delivered via 7F (N = 140) or 8F (N = 144) sheaths. Successful implantation of the device was accomplished in 278 (98%) of 284 patients. The Qp:Qs decreased from 1.8+/-0.6 (mean+/-SD) to 1.09+/-0.19 (p < 0.001). Effective occlusion defined as no (N = 167 [60%]) or trivial (N = 79 [28%]) residual shunt was achieved in 246 (88%) patients. All types of PDAs, irrespective of the shape (conical, tubular or short), size (small or large) or length (short or long) of the PDA and previously implanted Rashkind devices, could be occluded. Follow-up data, 1 to 60 months (median 24) after device implantation, were available in 234 (84%) patients. Seven (3%) patients required reintervention to treat residual shunt with (N = 2) or without (N = 5) hemolysis. Actuarial reintervention-free rates were 95% at 1 and 5 years. There was gradual reduction of actuarial residual shunts and were 40%, 28%, 21%, 14%, 11%, 10%, 6% and 0% respectively at 1 day, 1, 6, 12, 24, 36, 48 and 60 months after device implantation. Incorporation of folding plug over the button loop in 10 additional patients produced immediate and complete occlusion of PDA.
This large multiinstitutional experience confirms the feasibility, safety and effectiveness of buttoned device closure of PDAs. All types of PDAs irrespective of the shape, length and diameter can be effectively occluded. Incorporation of folding plug over the button loop produces complete PDA occlusion at the time of device implantation.
本报告旨在记录大量患者使用纽扣式装置（BD）封堵动脉导管未闭（PDA）的结果，特别强调长期随访情况，以便为这种PDA封堵方法的可行性、安全性和有效性提供证据。
PDA的BD封堵术的即刻和短期结果已在少数儿童中得到记录。
在截至1996年8月的六年期间，根据当地机构审查委员会和美国食品药品监督管理局批准的方案，对284例年龄在0.3至92岁（中位数7岁）的患者尝试进行经导管BD封堵PDA，在美国的病例中使用了研究性器械豁免。
PDA最窄直径为1至15毫米（中位数4毫米）；20例大于8毫米，10例大于10毫米。通过7F（N = 140）或8F（N = 144）鞘管输送的尺寸为15至35毫米的装置对其进行封堵。284例患者中有278例（98%）成功植入装置。肺循环血流量与体循环血流量比值（Qp:Qs）从1.8±0.6（平均值±标准差）降至1.09±0.19（p < 0.001）。246例（88%）患者实现了有效封堵，定义为无（N = 167 [60%]）或微量（N = 79 [28%]）残余分流。所有类型的PDA，无论其形状（圆锥形、管状或短管形）、大小（小或大）或长度（短或长）以及先前是否植入过Rashkind装置，均可被封堵。234例（84%）患者有装置植入后1至60个月（中位数24个月）的随访数据。7例（3%）患者因残余分流需要再次干预，其中2例伴有溶血，5例不伴有溶血。1年和5年的无再次干预精算率分别为95%。植入装置后1天、1个月、6个月、12个月、24个月、36个月、48个月和60个月的残余分流精算率逐渐降低，分别为40%、28%、21%、14%、11%、10%、6%和0%。另外10例患者在纽扣环上加装折叠塞后实现了PDA的即刻完全封堵。
这项大型多机构研究证实了使用纽扣式装置封堵PDA的可行性、安全性和有效性。所有类型的PDA，无论其形状、长度和直径如何，均可有效封堵。在纽扣环上加装折叠塞可在装置植入时实现PDA的完全封堵。
