第58届ACC会议对植入泵维持治疗难治性心力衰竭患者的心功能进行了热烈讨论。大会提到的植入难治性心力衰竭患者的泵装置仅有AA电池大小，重25克，可提供部分循环支持，并能改善血流动力学及心功能。

    Synergy™的掌上微泵可扩展循环辅助装置的使用范围，可用于那些尝试过所有非侵入治疗后无好转但又不够植入全力支持心室辅助装置（VADs）指征的慢性心力衰竭患者。传统的心室辅助装置通过替代即将发生或已处于心源性休克中的终末期心力衰竭患者心脏的主要心室泵，从而提供全心支持。但由于外科手术创伤大及具有侵入性和风险性，其使用受到一定限制。

    纽约的Daniel Burkhoff博士，现担任哥伦比亚大学副教授，及在开发Synergy设备CircuLite公司中担任首席医疗官。Burkhoff博士在本次大会中说到，“传统VADs泵仅依据生理需要每分钟泵5-7升的血液，因此，他们必须很大。正在接受调查的最小Synergy设备支持心功能每分钟泵2.5-3.0升的血液。本研究是为了确定该部分支持是否对NYHA分级IIIB级和早期IV级的患者带来充足的长期益处。”

    该研究入选了16例患者（男13例）植入Synergy™泵，平均年龄52岁，平均基线射血分数为20%。植入前，患者的平均动脉压为71 mmHg，平均肺毛细血管楔压为29 mmHg，平均心脏指数为1.9 L/min/m2。部分支持时限为6至213天，中位数为81天。3个月时16患者中有13例存活，占81%。其中，7例患者在10.6±6周时进行了右心导管术。平均动脉压（70±6 mmHg vs 80±10 mmHg，p = 0.04）和心脏指数（ 2.1±0.4 vs 2.9±0.6，p= 0.02）较前增加，毛细血管楔入压（30 ± 5 vs. 16 ± 4， p = 0.002）较前大大降低。摄氧量峰值较前增加了3.0 ± 0.5 ml/kg/min（10.7 ± 2.2 vs. 13.7 ± 2.2， p = 0.008）。

    Burkhoff 教授说，“先前研究表明，植入全心室支持装置后患者的血流动力学和心脏功能都会得到改善。本研究的意义是，首次证实长期局部循环支持可显着改善患者的血流动力学状况，并且这些改善将持续一段时间。这是真正意义上证实使用局部循环支持是可行的，并且可能具有一定的临床意义。本研究的最终目标是利用局部循环支持作为一项长期治疗，而不是作为心脏移植的桥梁。在欧洲，作为心脏移植的桥梁还是最为长期支持治疗，并没有清楚的区分开，这是因为等待一颗心脏需要很长的时间。在这么长的时间里，即使是在作为桥梁的情况下，该设备也可维持患者6到24个月或以上。”

（任芳 吕树铮  首都医科大学附属北京安贞医院）
 

英文原文：

ARTIAL CIRCULATORY SUPPORT IMPROVES HEART FUNCTION IN MEDICALLY REFRACTORY HEART FAILURE PATIENTS

Tiny Circulatory Assist Device Offers an Alternative to Full Ventricular Support in Chronic Heart Failure Patients

Orlando， FL – A pump the size of an AA battery weighing 25 grams provided partial circulatory support and improved hemodynamics and cardiac function when implanted in patients with medically refractory heart failure， according to research presented today at the American College of Cardiology’s 58th annual scientific session. ACC.09 is the premier cardiovascular medical meeting， connecting cardiologists and cardiovascular specialists to the latest and most innovative findings in cardiovascular science.

The Synergy™ Pocket Micro-pump may expand the use of circulatory assist devices in a large population of chronic heart failure patients who are not sick enough to justify being implanted with a full support ventricular assist device (VADs) but who have tried all other less invasive options without success. Traditional ventricular assist devices provide full support， taking over the work of the heart’s main pumping chamber in end-stage heart failure patients in or near cardiogenic shock. Their use is restricted because the surgery required for their insertion is major， invasive and risky.

“Traditional VADs pump five to seven liters of blood per minute and therefore， just by physical necessity， they have to be large，” said Daniel Burkhoff， M.D.， Ph.D， adjunct associate professor at Columbia University， New York， and chief medical officer of CircuLite， Inc.， developer of the Synergy device. “Synergy， the smallest device being investigated in adults， supports cardiac function by pumping just 2.5 to 3.0 liters of blood per minute.” 

“This study was done to determine if such partial support would be adequate to provide long-term benefits in NYHA Class IIIb and early Class IV patients.”

In the study， 16 patients (13 males)， mean age 52 years， with a mean baseline ejection fraction of 20 percent， were implanted with the Synergy™ pump. Before implantation， their mean arterial pressure was 71 mmHg， mean pulmonary capillary wedge pressure was 29 mmHg， and mean cardiac index was 1.9 L/min/m2. The duration of their partial support was a median 81 days and ranged from six to 213 days. 

Thirteen of the 16 patients (81 percent) were alive at three months. Of these， seven patients had right heart catheterization at 10.6 ± 6 weeks. Increases in mean arterial pressure (70 ± 6 mmHg vs 80 ± 10 mmHg， p = 0.04) and cardiac index (2.1 ± 0.4 vs. 2.9 ± 0.6， p = 0.02) with large reductions in capillary wedge pressure (30 ± 5 vs. 16 ± 4， p = 0.002) were observed. Peak VO2 increased by 3.0 ± 0.5 ml/kg/min (10.7 ± 2.2 vs. 13.7 ± 2.2， p = 0.008).

“Prior studies have shown that when you implant a full ventricular support device， patients’ hemodynamic function and heart function improve. The significance of this research is that we have shown for the first time that with long-term partial circulatory support， patients’ hemodynamic condition is significantly improved and these improvements are sustained over time，” Burkhoff said. “This is real proof of concept that the use of partial circulatory support is feasible and likely to be clinically meaningful.  The ultimate goal is to use partial circulatory support not as a bridge to transplant， but as a long-term therapy. In Europe， the distinction between bridge to transplant and long-term support is blurred because the wait times are so long for a heart that patients can be supported for six to 24 months or more， even in a bridge situation.”