Kashiwa Koichi, Nishimura Takashi, Kubo Hitoshi, Tamai Hisayoshi, Baba Atsushi, Ono Minoru, Takamoto Shinichi, Kyo Shunei
Department of Medical Engineering, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
J Artif Organs. 2010 Sep;13(3):134-8. doi: 10.1007/s10047-010-0514-z. Epub 2010 Aug 26.
Clinical introduction of implantable ventricular assist devices (VADs) is expected to encourage VAD therapy for severe heart failure patients in Japan. Since even minor device malfunctions can lead to serious outcomes in these patients, it is very important to collect and analyze data on device malfunctions occurring during their use at home. This study was undertaken to collect and analyze such data from 9 patients with implanted VADs (EVAHEART™, 4 patients; Jarvik2000, 3 patients; Duraheart™, 2 patients) living at home, within the framework of a clinical trial carried out at our hospital. During the home stay period of 449 ± 253 days (range 12-801 days, total 4044 days), the total number of device malfunctions was 31 (0.31 events/patient/year). Those with EVAHEART™ were Cool-seal system-related (9 events) and battery-related (6 events) malfunctions. Those with Jarvik2000 were battery-related (7 events), alarm (1 event) and uncertain cause (1 event) malfunctions. Those with Duraheart™ were battery-related (3 events), alarm (3 events) and other component (1 event) malfunctions. Although the incidence was not very high and none of these device malfunctions led to cessation of blood pump operation in this study, it is necessary to establish a communication system for properly obtaining detailed information in the event of serious device malfunctions. Furthermore, establishment of a home-living-patient support system covering extensive areas is urgently needed, since this can facilitate rapid action to deal with serious device malfunctions.
植入式心室辅助装置（VAD）的临床应用有望推动日本针对重度心力衰竭患者的VAD治疗。由于即使是轻微的设备故障也可能给这些患者带来严重后果，因此收集和分析在家使用期间发生的设备故障数据非常重要。本研究旨在收集并分析我院开展的一项临床试验框架内9例在家使用植入式VAD患者（EVAHEART™，4例；Jarvik2000，3例；Duraheart™，2例）的此类数据。在449±253天（范围12 - 801天，共计4044天）的居家期间，设备故障总数为31次（0.31次/患者/年）。使用EVAHEART™的患者出现与Cool-seal系统相关的故障（9次）和与电池相关的故障（6次）。使用Jarvik2000的患者出现与电池相关的故障（7次）、警报故障（1次）和原因不明的故障（1次）。使用Duraheart™的患者出现与电池相关的故障（3次）、警报故障（3次）和其他部件故障（1次）。尽管本研究中设备故障发生率不高，且这些故障均未导致血泵运行停止，但有必要建立一个通信系统，以便在发生严重设备故障时能够正确获取详细信息。此外，迫切需要建立一个覆盖广泛区域的居家患者支持系统，因为这有助于迅速采取行动应对严重的设备故障。
