所有置入Riata ICD电极者均应行X线检查

美国食品药品管理局(FDA)建议所有接受了置入式心脏复律除颤器(ICD)或心脏再同步治疗(CRT)除颤器并使用了Riata或Riata ST电极的患者都接受X线检查以明确是否存在异常。2011年11月，圣犹达医疗(St. Jude Medical)宣布主动召回Riata或Riata ST电极产品，原因是有报告显示覆盖在电导线上的绝缘材料存在绝缘故障或过早磨损的风险。尽管该公司在2010年就停止销售这类Riata电极，但据估计全美大约有79,000个电极仍然置入在患者体内。


图片来自美国国立癌症研究所

这种连接除颤器与心脏以监测心律的电极通常覆盖有多层绝缘材料，以保护电极内的导线。但一旦出现绝缘故障，则可能导致脉冲异常、脉冲消失、或危及生命的异常心脏搏动。FDA现要求圣犹达医疗开展为期3年的上市后监测研究，以进一步了解这一缺陷对于医生和患者意味着什么。

FDA医疗器械与放射健康中心主任Jeffrey Shuren博士在声明中说：“大部分Riata和Riata ST电极，包括那些有导线移位或外露迹象的电极，仍然可以继续正常工作，为患者提供生命支持。”然而，“FDA目前没有足够的数据来确定这类电极出现绝缘故障的频率和时间；因此，我们要求生产商开展上市后监测研究以明确医患双方都能获得相关的数据，从而更好地指导临床决策。”

上市后研究将解答的问题包括出现电极绝缘故障的时间、与电极不能正常工作相关的严重不良反应以及X线检查是否能够检测出绝缘故障。

此外，圣犹达医疗还主动召回了另外2个系列的电极产品QuickSite LV CRT 电极和QuickFlex LV CRT电极，召回原因是绝缘材料磨损。CRT电极由电池供电，用于心衰患者以确保左右两侧的心脏搏动协调一致。与Riata电极一样，CRT电极也包裹了绝缘材料以便监测心律并传送电脉冲。

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By: FRANCES CORREA, Cardiology News Digital Network

The Food and Drug Administration is recommending that all patients with implanted cardioverter defibrillators or cardiac resynchronization therapy defibrillators with Riata or Riata ST leads get an x-ray to check for abnormalities. St. Jude Medical voluntarily recalled those leads in November 2011 after reports of insulation failure or premature erosion of the insulation surrounding the electrical conductor wires. While the company stopped selling the Riata leads in 2010, they estimate that 79,000 leads are still implanted in patients across the country.

The leads, which connect the defibrillator to the heart to monitor its rhythms, are typically made with layers of insulation around them to protect the electrical wiring within the lead. However, insulation failure can cause inappropriate impulses, no impulses at all, or life-threatening abnormal heart beats. The FDA is ordering St. Jude Medical to conduct 3-year postmarket surveillance studies to learn more about what patients and physicians should expect.

"The majority of Riata and Riata ST leads, including those that show signs of electrical conductor migration or externalization, continue to function normally and provide life-saving support for patients," said Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiology Health, in a statement. However, "The agency does not have enough information to determine the frequency and timing of insulation failure in these leads; therefore, the postmarket surveillance studies will ensure that health care professionals and patients get the data they need to better guide clinical management decisions."

The postmarket studies will address issues including the timing of lead insulation failure, serious side effects associated with treatment for malfunctioning leads, and whether the insulation failure can be detected with an x-ray.

St. Jude Medical has also voluntarily recalled two other sets of leads, QuickSite LV CRT leads and QuickFlex LV CRT leads, because of insulation abrasion. CRT leads are battery-powered units implanted in patients with heart failure to keep the left and right sides of the heart beating in unison. Like the Riata leads, CRT leads are insulated to monitor health rhythm and deliver electrical impulses.