据美国罗切斯特大学医学中心John Bisognano博士与美国明尼阿珀利市装置制造者CVRx公司在美国心脏病协会2006年芝加哥科技会议上公布了RheosTM压力反射高血压治疗系统的初步临床结果。结果显示该装置能够显著降低通过改变生活方式和使用降压药不能控制的重度高血压患者的血压。
初步临床评估试验纳入联用至少3种降压药（含1种利尿剂）而收缩压仍在160 mmHg或以上的高血压患者。本次报道了该试验中最早的10名受试者的情况。植入术后1个月，测定基础血压后便激活这个装置。经Rheos系统治疗3个月后，收缩压平均降低22 mmHg（从180 mmHg降到158 mmHg），舒张压平均降低18mmHg（从105 mmHg 降到87 mmHg），所有血压均用袖套法测量。植入物耐受良好，没有发生植入物和手术相关严重不良反应。
据Bisognano博士介绍，Rheos系统是一种全新的装置，它可以激活人体自身的血压调控系统——颈动脉窦压力感受器。这个系统通过电激活颈动脉窦压力反射系统而起作用。低水平电刺激这个区域后，这个信号会“告诉”大脑，让大脑通过各种机制降低血压，包括扩张血管、降低心率以及促进肾脏排出体液。这个系统提供一种生理方式，即让大脑来指挥机体的自身调控机制，从而降低血压。这个系统由电池供电的可植入式发生器和两根颈动脉窦导线组成，发生器包埋在锁骨附近的皮下，而两根导线由发生器分别连接到左右颈动脉窦。虽然这种植入手术有点棘手，但一般原则与心脏起博器的植入相似。
10月份， CVRx公司获得了美国食品与药物管理局的检测装置免除证明许可证，批准CVRx公司在更多患者中开展决定性临床试验，来评估RheosTM压力反射高血压治疗系统的安全性和有效性。
http://www.eurekalert.org/pub_releases/2006-11/uorm-sri111506.php
Significant reduction in blood pressure with implantable device system
A device first implanted in the United States at the University of Rochester Medical Center as part of a clinical trial is showing a significant reduction in blood pressure in patients who suffer from severe hypertension and cannot control their condition with medications or lifestyle changes.
Early findings were shared this week by University of Rochester Medical Center cardiologist John Bisognano, M.D., Ph.D., and Minneapolis-based device-maker CVRx at the American Heart Association 2006 Scientific Sessions in Chicago.
The ongoing study is assessing the safety and clinical efficacy of the RheosTM Baroreflex Hypertension TherapyTM System, an implantable device for the treatment of hypertension in patients with drug-resistant hypertension, who have a systolic blood pressure of 160 mmHg or greater. The University of Rochester implanted the first device in the U.S. in March 2005, and performed a total of three of the initial 10 implantations.
Hypertension affects about 65 million people in the U.S. It is estimated to cause one in every eight deaths worldwide. Each increase of 20 mmHg in systolic blood pressure or 10 mmHg in diastolic blood pressure above normal level is associated with a two-fold increase in death rates from stroke, coronary heart disease and other vascular causes. Approximately 25 percent of people with hypertension cannot control their high blood pressure, despite the use of multiple medications.
"The Rheos System is a novel device that activates the carotid baroreflex, the body's own system for regulating blood pressure," Bisognano said. "We are pleased with the clinical results to date and look forward to expanding the clinical evaluation of the Rheos System. New approaches to the widespread, chronic and costly problem of hypertension are needed. The Rheos System has the potential to prevent the progression to more serious illnesses, including heart and kidney disease, stroke and death."
The system works by electrically activating the baroreflex system based in the carotid arteries in the neck. Low-level electrical stimulation to this area sends signals to the brain, "telling" it to take action to lower blood pressure through a variety of mechanisms, including blood vessel dilatation, heart rate reduction and promotion of fluid excretion by the kidneys. In this way, the system provides a physiologic approach to reducing high blood pressure by allowing the brain to direct the body's own control mechanisms. It consists of a battery-powered implantable generator, which is inserted under the skin near the collarbone, and two carotid sinus leads, which run from the generator to the left and right carotid sinus in the neck. While implantation is slightly more involved, the general principle is similar to the implantation of cardiac pacemakers.
The trial is designed to assess device safety and efficacy in patients with systolic blood pressure of 160 mmHg or greater, despite being on at least three anti-hypertension medications, including one diuretic. The presentation reported on the first 10 U.S. patients enrolled in the trial. After one month of surgical recovery, baseline blood pressure was assessed and the device was activated. Three months of active Rheos therapy reduced systolic blood pressure by an average of 22 mmHg (180 mmHg vs. 158 mmHg) and diastolic blood pressure by an average of 18 mmHg (105 mmHg vs. 87 mmHg), using office cuff measurements. The implants were well tolerated and there were no unanticipated serious adverse events related to the system or procedure.
In October, CVRx received a conditional investigational device exemption (IDE) approval from the U.S. Food and Drug Administration to begin a pivotal clinical trial that will evaluate the safety and effectiveness of the RheosTM Baroreflex Hypertension TherapyTM System in a much larger number of patients. The University of Rochester team recently implanted a fourth device as part of the study.
"These interim clinical results are favorable and promising for the many people with drug-resistant hypertension," said Nadim Yared, president and CEO of CVRx. "We are excited about launching our pivotal trial and look forward to working with our investigators."
