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中最大的未解决问题之一，其发病率和成本持续增加（2008年在美国为348亿美元）。预后仍然有限，尤其是晚期心力衰竭患者。移植通常是晚期心衰患者的最佳选择，这些患者的心脏无法恢复，但受到许多因素的限制，主要是可用供体心脏数量少（在美国<2500/年）。目前机械循环支持（MCS）设备的使用虽然在增加，但由于需要进行大手术，限制IV级患者，长期恢复期和成本（设备本身超过10万美元），也受到限制。我们已经开发出一种新的MCS设备（Symphony），它与心脏同步工作，可以通过一个小手术放置，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好处提供了强有力的证据。此外，实验数据强烈支持部分支持而不是完全卸载心脏促进心肌恢复的好处。Symphony装置通过锁骨下8厘米切口放置，类似于放置永久性起搏器。一个短移植物被缝在锁骨下动脉上，连接到泵上，然后放置在胸肌表面。交响乐与心电图同步，收缩期充盈，舒张期弹射。最近一期研究表明，对于QRS的检测和触发，皮下心电图导联与心外膜导联一样有效。在这项II期研究中，我们将完成与Symphony设备集成的皮下心电图导联系统和轻量级便携式驱动器的开发，并证明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），并且可以放置在“起搏器口袋”手术入路中，这可能对扩大循环支持在心衰患者治疗中的作用产生重大影响。低成本的额外优势（由于设计简单和操作方法有限）可能会进一步扩大机械支架在该设备上的使用，目前尚未实现的巨大全球市场。

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.