导管送阀可以帮助心脏缺陷的人避免多个手术

30名儿童和青年的多中心研究显示出良好的早期结果

2009年10月26日

波士顿，大众。•出生于某些心脏缺陷的儿童有从右心室流出的肺动脉血流量，需要植入的装置（称为右心室流出道导管）以保持流。然而，这些管道随着时间的推移而失效，孩子们在生命中通常会面对多个打开的心脏手术，重新打开通道。现在，一项前瞻性多中心研究，在10月27日的问题美国心脏病学院学报，由波士顿儿童医院的心脏病专家脱马科尔西尼，MD，发现良好的初步结果与一个阀门，可以提供非手术-线程的腿部静脉-可能避免重复打开心脏手术的需要。

该设备，被称为“旋律经导管肺动脉瓣”（美敦力，公司），得到了支持，从美国食品药品管理局顾问小组在七月，这表明美国食品药品管理局批准，可能会很快为某些患者。（见第）。该设备目前在欧洲和加拿大获得批准，如果美国食品药品管理局批准，它可能是第一个导管放置心脏瓣膜在美国批准

“一个导管阀门，你不必打开箱子，把病人心肺体外循环机，所有的需要，说：”麦埃尔轩尼。”患者可以进来，有一个导管程序，过夜，然后回家第二天。”

这项研究，第一项前瞻性，多中心研究的设备，涉及34名儿童和年轻人在波士顿儿童医院，迈阿密儿童医院和斯坦利摩根儿童医院(New York， NY) whose existing right-ventricular outflow conduits were malfunctioning， causing blood to flow backward from the pulmonary artery into the right ventricle (known as pulmonary regurgitation) or obstruction of blood from the right ventricle to the lungs。 They had various forms of congenital heart disease， including tetralogy of Fallot， truncus arteriosus， aortic valve disease 和 transposition of the great arteries。

All patients underwent cardiac catheterization with the intention of implanting the artificial valve， 和 30 of the 34 underwent actual implantation attempts， of which 29 were successful。 Three patients (9 percent) had complications during implantation， but all survived。

At follow-up six months later， no patient had more than mild pulmonary regurgitation。 Of 24 patients who had Class II or III heart failure (mild to moderate limitation of physical activity) before the procedure， 19 had improved by at least one functional class at six months， 和 no patient's function had declined。

Eight of the 29 devices developed partial fractures during follow-up， 和 3 patients required a second Melody valve (inserted inside the first one) for recurrent blockage。 In July， the advisory panel members called for longer-term monitoring of patients， but said the potential benefits outweighed concerns about fractures。 Medtronic is now working on an improved version。

"This study shows that the valve can be used safely 和 effectively in the h和s of many different trained cardiologists，" says McElhinney。 "These are early 和 short term data， but if the longer-term data are equally encouraging， this technology could have a major impact on the long-term health of our patients 和 their hearts。"

"Currently， when patients have conduits that become dysfunctional， we are faced with the choice of tolerating that dysfunction or sending them back to surgery，" McElhinney explains。 "Because conduits may develop regurgitation or obstruction relatively quickly， we almost inevitably end up accepting some degree of dysfunction， often for many years， because patients can't keep going for surgery every couple of years。"

Chronic conduit dysfunction can cause symptoms 和 eventually lead to dysfunction of the ventricle。 Because the transcatheter valve can be implanted without the risks 和 morbidity of surgery， the threshold for intervening can be lowered， offering patients a chance at an improved quality of life， preserved heart function 和 fewer surgeries， McElhinney says。

"Of course， we need to learn more before we know whether the promise of this technology is realized，" he adds。

接触：
Rob格雷厄姆
617-919-3110
rob。graham@childrens。harvard。edu

Founded in 1869 as a 20-bed hospital for children， 波士顿儿童医院 today is one of the nation's leading pediatric medical centers， the primary pediatric teaching hospital of Harvard Medical School， 和 the largest provider of health care to Massachusetts children。 In addition to 396 pediatric 和 adolescent inpatient beds 和 more than 100 outpatient programs， Children's houses the world's largest research enterprise based at a pediatric medical center， where its discoveries benefit both children 和 adults。 More than 500 scientists， including eight members of the National Academy of Sciences， 11 members of the Institute of Medicine 和 13 members of the Howard Hughes Medical Institute comprise Children's research community。 For more information about the hospital visit:www。childrenshospital。org\/newsroom。

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