FDA审批冠状动脉病变最新疗法

日期:2018-10-08    作者:林佑       分享 :

冠状动脉病变是一种心血管疾病。由于病情轻重不一,临床上有明显差异。普遍而言以心胸疼痛为主要症状,病情较轻者没有明显症状,严重者可以引起冠状动脉管腔狭窄,甚至穿孔,尽管冠状动脉穿孔相对罕见,如果不幸发生,血液会通过孔洞裂逢渗出血管外,导致心脏周围胞囊血液聚集,引起各种心脏丶血管并发症,最终危及生命。




美国食品药物管理局(FDA)近日批准了一种名为经皮冠状动脉介入治疗(PCI)方法,这种疗法使用了PK Papyrus覆盖冠状动脉支架网状装置,应用于冠状动脉病变患者的临床手术上。



概念及治疗程序



经皮冠状动脉介入治疗(PCI)主要用治因斑块(脂肪沉积和疤痕组织)积聚令心脏血管冠状动脉管壁狭窄的异常现象。



在PCI临床治疗过程,医生先在手术者的冠状动脉狭窄处插入一条薄壁柔性长管道,管道是中空的气囊,经充气后像气球一样扩张动脉狭窄部分,然后从气囊中植入网状支架到动脉狭窄处或破损处,令动脉持续开放,以维持充足的心肌供血量,确保手术过程顺利完全。



PCI治疗程序最大的特点是使用了PK Papyrus覆盖冠状动脉支架网状装置,这是一种可膨胀的气囊,利用球囊导管推进PK Papyrus支架到冠状动脉血管内,当支架到达患处,像是一道物理屏障,密封动脉壁中的撕裂/穿孔部分,与此同时仍然允许血液通过装置流向心肌。



使用PK Papyrus支架有以下三大优点:

一)快速封堵冠状动脉穿孔,防止血液渗漏血管外。

二)最大程度降低外在因素引起心血管并发症感染风险。

三)避免使用高风险的开胸手术治疗。



PCI手术禁用人群



那些不附合PCI手术治疗的患者,主要

针对PK Papyrus支架的禁用说明,明文规定如下:



一)正在服用抗凝血药物的患者(血液稀释剂提高血液渗漏风险)。

二)同时植入与PK Papyrus支架会产生化学反应的任何化合物(如:硅氧烷基聚氨酯、钴铬合金丶钨镍合金等等)。

三)对PK Papyrus装置有过敏的患者。



实验结果



FDA近日测试了80名利用经皮冠状动脉介入治疗(PCI)的冠状动脉穿孔患者。研究数据显示,80名患者当中有76例(95%)成功将PK Papyrus支架送至穿孔部位,73名患者成功封堵穿孔(91.3%)。在PCI治疗过程,2名患者因未能把PK Papyrus支架封堵穿孔处最终死亡。



FDA放射卫生中心.心血管设备主任Bram Zuckerman医学博士认为,经皮冠状动脉介入治疗(PCI)能为临床冠状动脉手术患者提供安全丶有效的治疗方法。



参考资料

FDA News Release. FDA approves device for treatment of acute coronary artery perforations. September 14, 2018

原文

FDA approves device for treatment of acute coronary artery perforations




September 14, 2018



The U.S. Food and Drug Administration today approved a device intended to treat acute coronary artery perforations, or tears in the blood vessels of the heart. The PK Papyrus Covered Coronary Stent System is the first device approved by the FDA for this indication in 17 years.

“An acute coronary artery perforation is a rare, but potentially life-threatening complication of heart vessel procedures,” said Bram Zuckerman, M.D., director of the Division of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health. “The PK Papyrus Covered Coronary Stent System provides health care providers with a new treatment option that can seal the perforation in order to stop blood leakage during the procedure and avoid a potentially life-threatening complication or a more invasive surgical procedure.”

A coronary artery perforation can occur during Percutaneous Coronary Intervention (PCI) procedures. PCI is used to treat heart blood vessels (coronary arteries) narrowed by the build-up of plaque (fatty deposits and scar tissue). During PCI, a thin flexible tube with a balloon on the end is inserted into a narrowed coronary artery. Once inserted, the balloon expands the artery, and then a small mesh device, known as a stent, is placed to hold the artery open and increase blood flow to the heart muscle. On very rare occasions, a deep tear occurs in the wall of the treated coronary artery during the PCI procedure. The tear is referred to as an acute coronary artery perforation. In some coronary perforations, blood can leak out through the tear leading to a life-threatening collection of blood in the sac surrounding the heart.

The PK Papyrus Stent System is a balloon-expandable covered coronary stent and delivery system. The device is advanced into the perforated coronary artery vessel using a balloon catheter, similar to the one used during the PCI procedure. Once the PK Papyrus Stent is implanted, it provides a physical barrier to seal the tear in the artery wall while still allowing blood to flow through the device to the heart muscle. Successful sealing of a coronary perforation with the PK Papyrus Covered Coronary Stent System can be a life-saving procedure without the need for open-heart surgery.

The FDA reviewed data for the PK Papyrus System through the humanitarian device exemption process. A Humanitarian Use Device is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects not more than 8,000 individuals in the U.S. per year.

The FDA reviewed real-world survey data from 80 patients who received PK Papyrus Stents to treat coronary artery perforations. PK Papyrus Stents were successfully delivered to the perforation site in 76 of the 80 patients (95 percent), and the device successfully sealed the perforation in 73 patients (91.3 percent). There were two deaths that occurred during the PCI procedure, and seven patients underwent treatment to drain a fluid collection around the heart. Post-procedure, in-hospital death occurred in five patients with perforations successfully sealed by PK Papyrus Stents and one patient in which the PK Papyrus Stent did not successfully seal the perforation.

The PK Papyrus System is contraindicated for patients who are not considered candidates for standard PCI procedures, such as individuals not able to take anti-platelet and/or anticoagulation therapy (“blood thinners”), patients with allergies to contrast media, and patients with uncorrected bleeding disorders. The device is also contraindicated for patients with a known allergy or hypersensitivity to amorphous silicon carbide or any other compound of the PK Papyrus Covered Coronary Stent System (Siloxane-based Polyurethane, L-605, and cobalt chromium alloy, including tungsten and nickel). Patients should discuss other contraindications with their health care providers. FDA granted the humanitarian device exemption to Biotronik.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


来源:FDA

译者简介:林佑,毕业于香港大学医学院。中医药学院理硕士学位。目前从事中药学相关的临床及科研工作,致力传播国外医药科学研究信息。

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