PerDeCT device (Pericardial Device for monitoring Cardiac output and the diagnosis of Tamponade)

在英国，每年有45,000名患者接受心脏直视手术。大多数手术是冠状动脉搭桥术，其余包括瓣膜手术，移植和先天性心脏病手术。在手术中，通过中线打开胸部，打开包含心脏（心包）的囊。当手术完成时，骨骼（胸骨），肌肉和皮肤被关闭。心包保持开放，但仍在心脏周围形成封闭的囊。一些术后出血是不可避免的，因此至少有一个管（引流管）留在心包内以排出任何血液。患者可能需要输血，偶尔必须返回手术室止血。在多达3%的患者中，血液聚集在心包内的心脏周围并开始凝结，这可能会阻塞引流管。少量并不重要，但如果凝块和血液的收集足够大，它将开始压缩心脏并停止其正常工作。这就是所谓的心脏压塞，如果不及时治疗，心脏最终会完全停止泵血，发生心脏骤停。这是非常危险的，因为心脏已经被完全压缩，体外胸外按压（CPR）不起作用。如果早期诊断，患者将返回手术室，重新打开胸部，取出血栓。然而，诊断通常非常困难，因为常规监测的生命体征可能由于其他原因而发生变化，并且无法看到心包中的血液聚集。如果诊断延迟，则必须在重症监护室重新打开胸部。这项研究项目是开发一种简单的、获得专利的球囊装置（PerDeCT），该装置在手术中插入心包腔。在肺动脉周围也放置一个小探头，以精确测量心脏的血流。轻轻地充盈球囊并测量流量可以更早地检测到心包填塞。球囊和探头可以在胸腔引流的同时取出，而无需重新打开胸腔。我们的团队由资深心胸外科医生领导，汇集了医疗器械设计、测试和监管支持方面的专家。PerDeCT将对患者的安全性产生重大影响，并且错过填塞的成本非常高。

45,000 patients a year have open heart surgery in the UK. Most surgery is coronary artery bypass, the rest includes valve surgery, transplantation and congenital heart surgery.At surgery the chest is opened through the midline and the sac containing the heart (pericardium) is opened. When the surgery is finished the bone (sternum), muscle and skin are closed. The pericardium is left open but still forms a closed sac around the heart. Some bleeding postoperatively is inevitable and so at least one tube (drain) is left inside the pericardium to drain any blood. Patients may require blood transfusion and occasionally must return to theatre to stop the bleeding.In up to 3% of patients, blood collects around the heart inside the pericardium and starts to clot which may block the drains. Small amounts do not matter but if the collection of clot and blood is large enough it will start to compress the heart and stop it working properly. This is called cardiac tamponade, left untreated the heart will eventually stop pumping completely and a cardiac arrest occurs. This is very dangerous as external chest compression (CPR) doesn't work as the heart is already fully compressed.If the diagnosis is made early, the patient is returned to theatre, the chest re-opened, and the clot removed. However, the diagnosis is often very difficult as the vital signs monitored routinely can change as the result of other causes and the blood cannot be seen collecting in the pericardium. If diagnosis is delayed, then the chest will have to be re-opened in the Intensive Care Unit. This is far from ideal and leads to up to a tenfold increase in mortality and morbidity.This research project is to develop a simple, patented, balloon device (PerDeCT) which is inserted into the pericardial space at surgery. A small probe is also placed around the pulmonary artery to allow accurate measurements of the flow of blood from the heart. Gently inflating the balloon and measuring the flow allows for the much earlier detection of cardiac tamponade. The balloon and probe can be removed at the same time as the chest drains without the need to re-open the chest.Our team is led by a senior cardiothoracic surgeon and brings together experts in medical device design, testing and regulatory support. PerDeCT will have a major impact on patient safety and the very significant costs of missed tamponade.