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医汇心血管学术 > 主动脉撕裂修补的全国性试验

主动脉撕裂修补的全国性试验

发表于 2014-10-09 14:38:55
National Trial For Torn Aorta Repair (来源:丁香园)  沿岸每年有数千人群受累于大动脉的撕裂,很快就会有微创技术可以戏剧性的提高患者生存的几率。一项全国性的研究被指定由Thomas Jefferson大学医院的血管外科进行,即探索一项新的微创方法以降低患者开胸手术的创伤及危险性。  Jefferson 大动脉中心的主任Joseph V及 Lombardi博士(http://www.jeffersonhosptal.org/aortic),同时也是美国食品及药物管理全国主要审查者(PI),主要提供血管内支架移植以治疗主动脉夹层的安全有效性的临床评估,这一疾病曾导致演员John Ritter 的猝死。  Thomas Jefferson 大学的Jefferson医学院的外科副教授Lombardi博士介绍说:“对于这种在美国最具致死性危险之一的疾病,血管内支架移植作为病状特异性的方法具有潜在消除有开胸手术修补术的高度危险性。仅在费城这一地区,每年就有超过60例患者需要急诊手术治疗主动脉夹层,而这一手术方法具有很多危险性包括高死亡率及长恢复期,而血管内支架这一装置可以帮助降低侵入性手术的需要并挽救许多生命。”  根据美国心脏病学会研究,主动脉夹层在美国每年影响到超过10,000的人群,尽管这一疾病的发病在整个国家人群中所占的比例很小,但因为具有很高的死亡率,促使了新的创新性的技术的开发。  主动脉夹层是主动脉内膜于中层之间的撕裂,作为在人体内最大的运输血离心的最大的动脉,裂口出现导致血液流入内膜及中层之间,最终使内膜中层撕裂分离,血液选择这一新的通道使血管内径压缩并最终影响主要器官的血供,这种及其严重的情况可迅速导致死亡。  Lombardi博士同时还负责一项平行的临床试验包括欧洲的8个地区及澳洲的2个地区。作为全球性的主要负责人,Lombardi’s博士主要职责是负责监督临床方面包括试验及随着试验的进程及时作出调整。他将在试验的进程中不断的向全国及世界的医学公众进行数据更新并及时向FDA反馈试验结果。Thomas Jefferson大学的 Jefferson 医学院的 Robert Larson博士,外科副教授将作为Jefferson大学医院的主要地区负责人,同时一个由内科医师、心胸外科医师心脏病学专家及麻醉科医师共同组成的多学科综合小组将有Lombardi 和 Larson医师的加入。  主动脉夹层可以在急诊室或重症监护病房以药物降低血压及减慢心率进行治疗,有些病例需要手术治疗,现在除了直接开胸钳夹血管外,内科医生通过股动脉小切口植入自行扩张,内膜覆盖的支架治疗损伤部位。导管在X线透视的指导下通过患者的血管直到支架到达动脉破口部位。支架通过导管扩张撑开在动脉内使破口封闭形成连续性的通道,降低损伤血管的血压,恢复正常血流。第二个支架植入再扩张受压迫的血管恢复所有重要器官血流。  通过使用微创技术,外科医师降低了患者的健康危险性,尤其是许多年老的可能伴随患有高血压,糖尿病等疾病的患者。胸主动脉夹层可能发生于任何人,但多于40~70岁男性。确切的发病机理未明,高危因素主要包括:高血压、吸烟、动脉粥样硬化、创伤及Marfan’s综合症。主要症状包括突发剧烈胸痛、头晕、任何部位的感觉减弱、大汗及呼吸急促。  任何患有主动脉夹层得患者可以作为这项试验的入选者,尽管需要考虑到一定的影响因素,包括有无接受药物治疗、有无因器官缺乏血流导致的脏器衰竭、是否患者快速的主动脉扩张(动脉瘤的形成)。  在澳洲已经有联合血管内装置进行研究并证明有效。一例50岁的患者因剧烈的胸痛被送进Monash医学中心,经过及时支架植入治疗使腿及左肾血流恢复,挽救了他的腿及器官。National Trial For Torn Aorta RepairTears in the aorta which affect thousands of people each year coast to coast, may soon be treated with a much less invasive technique that could dramatically improve patients’ chances of survival.A national study being directed by a vascular surgeon at Thomas Jefferson University Hospital is exploring a new minimally invasive method that could spare patients the trauma and risk of open chest surgery.Joseph V. Lombardi, M.D., Director of the Jefferson Aortic Center (http://www.jeffersonhosptal.org/aortic) is the National Principal Investigator (PI) in the U.S. Food and Drug Administration--approved clinical study assessing the safety and effectiveness of an endovascular stent-graft to treat aortic dissection, a condition that led to the sudden death of actor John Ritter.This pathology specific endovascular device has the potential to eliminate the need for highly invasive, open chest surgery to repair one of the most deadly aortic diseases in the U.S.," said Dr. Lombardi, assistant professor of Surgery, Jefferson Medical College of Thomas Jefferson University. "In Philadelphia alone, up to 60 patients per year are treated for aortic dissection with emergency procedures, which have numerous risks, high mortalities and long recovery periods. This device could help limit our need for invasive procedures and save many lives."According to the American Heart Association, aortic dissection affects up to 10,000 people annually in the United States. Though the disease is rare among the country’s population, its mortality rate is high, creating a need for new and innovative treatments.Aortic dissection is a laceration of the aorta, the largest artery in the body and the primary transporter of blood away from the heart. A tear in this artery causes blood to flow between the layers of its wall, eventually splitting the layers apart. Blood then collects in these new channels, compressing blood vessels that feed vital organs. It is an extremely serious medical condition that can quickly result in death.Dr. Lombardi is also responsible for a parallel clinical trial including eight European and two Australian sites. As the global principal investigator, Dr. Lombardi’s role is to oversee all clinical aspects of both trials and making any necessary adjustments as it moves forward. He will continuously update the national and international medical community on the trial’s progress and will prepare the results for submission to the FDA. Robert Larson, M.D., assistant professor of Surgery, Jefferson Medical College of Thomas Jefferson University, will be serving as the Site PI for Jefferson University Hospital. A multidisciplinary team of physicians, cardiothoracic surgeons, cardiologists and anesthesiologists will all be involved with Drs. Lombardi and Larson.Aortic dissection can be treated in the emergency room or intensive care unit with medications to lower blood pressure and heart rate. In some cases, surgery is needed. Now, rather than opening the chest cavity and clamping off the aorta to implant a graft to treat the damaged section, physicians will insert a catheter loaded with a self-expanding, fabric-covered stent-graft through a small incision in the femoral artery. The catheter is guided through the patient’s blood vessels under fluoroscopy (a technique for obtaining "live" x-ray images) until the device is positioned across the diseased or injured part of the aorta. The stent-graft expands upon deployment from the catheter to form a continuous tube through the aorta that carries the blood and reduces pressure on the damaged vessel, restoring normal blood flow. The second stent is placed to re-expand the compressed blood vessel and restore flow to all of the vital organs below.By using less invasive techniques, surgeons reduce the health risks for their patients, especially for many older individuals who might suffer from other significant medical conditions such as diabetes or hypertension. Thoracic aortic dissection can occur in anyone, but is most often seen in men 40 to 70 years of age. The exact cause is unknown, but risks include high blood pressure, smoking, atherosclerosis (hardening of the arteries), trauma and Marfan’s syndrome. Symptoms comprise sudden, severe chest pain, dizziness, decreased sensation in any location, profuse sweating and shortness of breath.Any patient with aortic dissection may be a candidate for this trial, though certain factors will be taken into account, including whether the individual was treated with medical therapy; whether the patient has organ failure from lack of blood flow to these organs; and whether the patient has a rapidly expanding aorta (aneurysm).The combination endovascular device has already been studied in Australia with some evidence of effectiveness. It restored blood flow to both legs and the left kidney of a 50-year-old patient admitted to Monash Medical Centre in Melbourne with crushing chest pain, saving both limbs and the organ.
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