Development of a successful novel technology for sudden cardiac death risk stratification for clinical use - LifeMap

心源性猝死（SCD）每年在全球造成超过300万人死亡，仅在英国就有10万人死亡。人们的死亡是因为他们的心脏突然产生了致命的心律，停止了协调和泵的工作。植入式心律转复除颤器（ICD）是一种小型的，价值10，000英镑的设备，类似于放置在皮肤下的起搏器，在小型手术中围绕肩膀。然后ICD安静地监测心脏;它可以在几秒钟内检测到致命的心律，并进行治疗以恢复正常功能，有时甚至没有病人意识到他们的生命已经被挽救。不幸的是，我们缺乏有效的手段来确定谁真正需要ICD。目前的指南是基于粗糙的临床信息，只有40%的ICD接受者被认为是“高风险”的这些指南曾经使用他们在第一个5年的随访。另一方面，大多数死于SCD的人可能有危险因素，例如先前的心肌梗死（心脏病发作），但指南将其视为“低风险”。对于这些患者，目前还没有办法确定谁真正处于低风险状态，谁真正需要ICD来保护他们。我们基于专利算法开发了两种新型ECG标记物，并在不同患者人群中提供了支持性临床科学证据。这种创新的测试被称为LifeMap，已被证明对心脏性猝死的风险评估非常有效。LifeMap可以分析心率范围内的ECG，可以在10分钟的微创手术或运动中进行。该提案旨在通过自动化软件，创建用户界面并直接获取干净的运动ECG信号，将目前费力的研究技术转化为有效的临床工具。这笔赠款将使LifeMap进入下一个发展阶段;准备进行大规模临床试验，然后可以将其应用于日常实践。

Sudden Cardiac Death (SCD) is responsible for over 3 million deaths worldwide annually, 100,000 deaths in the UK alone. People die because their heart suddenly develops a lethal heart rhythm that stops it from coordinating and working as a pump. An implantable cardioverter defibrillator (ICD) is a small, £10,000 device, similar to a pacemaker that is placed under the skin, around the shoulder in a small operation. The ICD then sits quietly monitoring the heart; it can detect a lethal heart rhythm in seconds and treat it to restore normal function sometimes without the patient even being aware that their life has been saved. Unfortunately, we lack an effective means to work out who really needs an ICD. Current guidelines are based on crude clinical information and only 40% of ICD recipients deemed "high-risk" by these guidelines ever make use of them during the first 5 years of follow up. On the other hand, the majority of people who die of SCD may have a risk factor, such as a previous myocardial infarction (heart attack) but the guidelines regard them as "low-risk". For these patients there is currently no way of working out who truly is at low risk and who really needs an ICD to protect them. We have developed two novel ECG markers based on patented algorithms with supportive clinical scientific evidence in different patient populations. This innovative test is called LifeMap and has been shown to be highly effective for risk assessment of sudden cardiac death. LifeMap analyses the ECG over a spectrum of heart rates and can be performed either in a 10 minute minimally invasive procedure or with exercise. This proposal aims to translate the currently laborious research technique into an effective clinical tool by automating the software, creating a user interface and making it straightforward to acquire clean exercise ECG signals. This grant would bring LifeMap to the next phase of development; ready for a large scale clinical trial following which it could be implemented into daily practice.