Counterpulsation Device with Integrated EKG System for Chronic Partial Circulator

描述(由申请人提供)：心力衰竭(HF)仍然是当今医疗保健领域最大的悬而未决的问题之一，并且在发病率和成本上继续增加(2008年美国的心力衰竭金额为348亿美元)。预后仍然有限，特别是在晚期心力衰竭患者。对于患有晚期心力衰竭的患者来说，移植通常是最好的选择，他们的心脏无法恢复，但受到许多因素的限制，主要是可用的供体心脏数量很少(在美国为2500/年)。目前的机械循环支持(MCS)装置的使用虽然在增加，但也受到了限制，原因包括需要进行大手术、对IV级患者的限制、康复时间长以及费用(装置本身超过10万美元)。我们已经开发出一种新型的MCS设备(交响乐)，它与心脏同步工作，可以通过小手术放置，并利用已证实的反搏动的好处。SYMPHONY提供部分循环支持，以增强(而不是取代)天然心脏功能。最近的临床研究为部分支持的益处提供了强有力的证据。此外，实验数据有力地支持了部分支持而不是完全卸载心脏以促进心肌恢复的好处。交响乐装置通过一个8厘米长的锁骨下切口放置，类似于放置永久起搏器的切口。在锁骨下动脉缝合一小段移植物，连接到泵上，然后放置在胸肌浅层。交响乐与EKG计时，在收缩时充盈，在舒张期射出。最近在一项第一阶段研究中的工作表明，对于QRS检测和触发，皮下EKG导联与心外膜导联一样有效。在这项第二阶段的研究中，我们将完成皮下EKG导联系统的开发，集成到SYMPHONY设备和轻便、便携的驱动器中，并展示所有系统组件的有效性、安全性和可靠性。开发一种与心脏同步工作的装置，提供部分支持(从而促进恢复)，并可以放置在“起搏器口袋”手术入路中，可能会对扩大循环支持在治疗心力衰竭患者中的作用产生重大影响。低成本的额外优势(由于设计简单和有限的操作方法)可能会进一步将这种设备的机械支撑的使用扩大到目前巨大的、尚未实现的全球市场。

DESCRIPTION (provided by applicant): Heart failure (HF) remains one of the largest unsolved problems in health care today and continues to increase in incidence and cost ($34.8 billion in US in 2008). Prognosis remains limited especially in patients with advanced heart failure. Transplantation is often the best option for patients with advanced HF whose hearts are not recoverable but is limited by many factors, primarily the small number of available donor hearts (<2500/yr in US). Use of current mechanical circulatory support (MCS) devices, though increasing, has also been limited due to the need for a major operation, restriction to Class IV patients, prolonged convalescence, and cost (over $100,000 US for the device itself). We have developed a novel MCS device (Symphony) that works synchronously with the heart, can be placed with a minor operation, and takes advantage of the proven benefits of counterpulsation. Symphony provides partial circulatory support to augment (not replace) native heart function. Recent clinical studies have provided strong evidence for the benefits of partial support. Also, experimental data strongly supports the benefits of partial support rather than complete unloading of the heart to promote myocardial recovery. The Symphony device is placed through an 8-cm infraclavicular incision similar to that used for placement of a permanent pacemaker. A short graft is sewn to the subclavian artery, connected to the pump, and then positioned superficial to the pectoralis muscle. Symphony is timed with the EKG to fill during systole and eject during diastole. Recent work in a Phase 1 study demonstrated subcutaneous EKG leads were as effective as epicardial leads for QRS detection and triggering. In this phase II study, we will complete development of the subcutaneous EKG lead system with integration to the Symphony device and lightweight, portable driver, and demonstrate efficacy, safety, and reliability of all system components. The development of a device that works synchronously with the heart, provides partial support (thereby promoting recovery), and can be placed with a "pacemaker pocket" operative approach may have a significant impact in expanding the role of circulatory support in the treatment of HF patients. The additional advantage of low cost (due to simplicity of design and a limited operative approach) may further expand the use of mechanical support with this device to currently large, unrealized, global markets.