Norman John C.
Cardiovascular Surgical Research Laboratories and Section of Surgery, the Texas Heart Institute of St. Luke's Episcopal and Texas Children's Hospitals, Texas Medical Center, Houston, Texas.
Cardiovasc Dis. 1976;3(3):249-288.
The purpose of this report is to present documenting evidence of the clinical readiness of an abdominal left ventricular assist device (ALVAD) according to NHLI criteria,( double dagger ) and the initiation of clinical trials of this device in otherwise irretrievable adult post-cardiotomy patients at the Texas Heart Institute of St. Luke's Episcopal and Texas Children's Hospitals. The ALVAD system has been developed, modified, and improved under NHLI auspices over the last eight years,( double dagger double dagger ) with annual reviews. Over 20,000 hours of in-vivo testing in the calf have been accomplished in our laboratories. The current clinical trials underwent two federal reviews (May 22, 1973 and October 17, 1974) and were the topic of an Ad Hoc Workshop at NHLI on October 28, 1973.( double dagger double dagger double dagger ) More recently, a consecutive series of 26 bovine ALVAD implantations were undertaken; acute and chronic hemodynamic effectiveness with maintenance or augmentation of the systemic circulation during profound ventricular unloading without undue blood trauma, intra-or extra-prosthetic thrombosis, or sepsis was demonstrated; no biomaterials problems were encountered. In-vivo realibility and durability, histologic and pathologic results were detailed, summarized, and submitted to NHLI. Patient acceptability surveys and geometric and volumetric human configuration studies were analyzed. Categorizations of the patients at risk in our institutions and the needs for such a device were documented. The periods of intended use (two weeks-one month), weaning procedures, and the possibility of pump dependence have been discussed. The legal, moral, ethical and informed consent issues were addressed. Clinical protocols (anesthesia, surgical, cardiologic, hematologic, engineering, computerized data-acquisition, follow-up) and cost analyses were developed. The device has now been used in four terminal patients since December, 1975; all subsequently succumbed, but their circulations were temporarily supported during total left ventricular unloading for periods up to eight hours. Continued systematic, controlled clinical investigations of this nature are warranted. A comprehensive listing of pertinent references is included.
本报告的目的是根据美国国立心肺血液研究所（NHLI）的标准（‡），提供腹部左心室辅助装置（ALVAD）临床就绪的文献证据，并在圣卢克圣公会德克萨斯心脏研究所和德克萨斯儿童医院，对其他治疗方法均无效的成年心脏切开术后患者启动该装置的临床试验。在过去八年中（‡‡），在NHLI的支持下，ALVAD系统不断得到开发、改进和完善，并进行年度审查。我们的实验室已经在小牛身上完成了超过20000小时的体内测试。当前的临床试验经过了两次联邦审查（1973年5月22日和1974年10月17日），并在1973年10月28日成为NHLI特设研讨会的主题（‡‡‡）。最近，连续进行了26例牛ALVAD植入手术；证明了在不造成过度血液损伤、假体内部或外部血栓形成或败血症的情况下，该装置在深度心室卸载期间能够维持或增强体循环，具有急性和慢性血液动力学有效性；未遇到生物材料问题。详细记录、总结了体内可靠性和耐用性、组织学和病理学结果，并提交给了NHLI。分析了患者可接受性调查以及人体几何和容积配置研究。记录了我们机构中高危患者的分类以及对这种装置的需求。讨论了预期使用期限（两周至一个月）、撤机程序以及泵依赖的可能性。讨论了法律、道德、伦理和知情同意问题。制定了临床方案（麻醉、外科、心脏病学、血液学、工程学、计算机化数据采集、随访）和成本分析。自1975年12月以来，该装置已用于4例终末期患者；所有患者随后均死亡，但在完全左心室卸载期间，他们的循环系统得到了长达8小时的临时支持。有必要继续进行这种系统的、受控的临床研究。本文还列出了相关参考文献的完整清单。
