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年美国为348亿美元）。预后仍然有限，特别是在晚期心力衰竭患者中。移植通常是晚期HF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较少（美国<2500/年）。目前的机械循环支持（MCS）装置的使用虽然在增加，但由于需要大手术、仅限于IV类患者、恢复期延长和成本（装置本身超过10万美元），也受到限制。我们开发了一种新型的MCS设备（Symphony），它与心脏同步工作，可以通过小手术放置，并利用反搏的已证实的好处。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，实验数据强烈支持部分支持而不是完全卸载心脏以促进心肌恢复的益处。Symphony器械通过一个8 cm锁骨下切口置入，该切口类似于用于置入永久性起搏器的切口。一个短的移植物被缝到锁骨下动脉，连接到泵，然后定位在胸肌的表面。Symphony与EKG同步，在心脏收缩期间填充，在心脏舒张期间弹出。最近的一项I期研究表明，皮下EKG电极导线与心外膜电极导线在QRS检测和触发方面同样有效。在本II期研究中，我们将完成皮下EKG电极导线系统的开发，并将其集成到Symphony器械和轻便便携式驱动器中，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、提供部分支持（从而促进恢复）并可采用“起搏器囊袋”手术方法放置的器械，可能会对扩大循环支持在HF患者治疗中的作用产生重大影响。低成本的额外优势（由于设计简单和有限的操作方法）可以进一步将该装置的机械支撑的使用扩展到当前大的、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.