Study of device malfunctions in patients with impl

Authors: Koichi Kashiwa Takashi Nishimura Hitoshi Kubo Hisayoshi Tamai Atsushi Baba Minoru Ono Shinichi Takamoto Shunei Kyo

Publish Date: 2010/08/26

Volume: 13, Issue: 3, Pages: 134-138

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Abstract

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 31 031 events/patient/year Those with EVAHEART™ were Coolseal systemrelated 9 events and batteryrelated 6 events malfunctions Those with Jarvik2000 were batteryrelated 7 events alarm 1 event and uncertain cause 1 event malfunctions Those with Duraheart™ were batteryrelated 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 homelivingpatient support system covering extensive areas is urgently needed since this can facilitate rapid action to deal with serious device malfunctions

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