Banner University Hospital, Tucson, AZ.
SynCardia Systems, Tucson, AZ.
Surg Technol Int. 2021 Jun 28;39:243-248. doi: 10.52198/21.STI.38.CV1449.
The SynCardia Total Artificial Heart (TAH, SynCardia Systems, Tucson, AZ) is the only biventricular cardiac replacement approved for bridge to transplantation by the U.S. Food and Drug Administration (FDA) and which carries the European Union CE mark. It has been implanted in about 2000 patients. In experienced centers, 60 to 80 % of implanted patients have been transplanted and over 80 % of those transplanted have lived for over 1 year. The SynCardia TAH has supported potential cardiac recipients with irreversible biventricular failure for up to 6 years, providing physiologic pulsatile flows of 6 to 8 L/min at filling pressures of less than 10 mmHg allowing for optimal perfusion and recovery of organs such as the kidneys and liver. It is a tested device that provides a method for recovering potential transplant candidates who rapidly decompensate from biventricular failure or who have chronic cardiac failure from a variety of etiologies. This article covers the history, mechanical function and monitoring, implantation, patient selection and management, and outpatient use. It also reviews outcome data from the original FDA study as well as contemporary data from experienced centers.
SynCardia 全人工心脏（TAH，SynCardia Systems，Tucson，AZ）是唯一一款获得美国食品和药物管理局（FDA）批准用于移植桥接的双心室心脏替代物，并获得欧盟 CE 标志。它已经在大约 2000 名患者中植入。在有经验的中心，植入的患者中有 60%到 80%已经接受了移植，并且接受移植的患者中有超过 80%的患者存活时间超过 1 年。SynCardia TAH 已经为不可逆性双心室衰竭的潜在心脏接受者提供了长达 6 年的支持，以低于 10mmHg 的充盈压提供 6 到 8L/min 的生理性搏动流，从而实现最佳的灌注和肾脏和肝脏等器官的恢复。这是一种经过测试的设备，为从双心室衰竭迅速恶化或因各种病因导致慢性心力衰竭的潜在移植候选者提供了一种恢复方法。本文涵盖了该设备的历史、机械功能和监测、植入、患者选择和管理以及门诊使用。它还回顾了原始 FDA 研究的结果数据以及来自经验丰富的中心的当代数据。
