Guideline Focused Update on Indication and Operation of PCPS/ECMO/IMPELLA (JCS/JSCVS/JCC/CVIT 2023)
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Abstract
Mechanical circulatory support (MCS) plays a significant role as a therapeutic option for severe heart failure, and its outcomes have been improving due to advancements in devices and management techniques. In particular, percutaneous cardiopulmonary support (PCPS) and extracorporeal membrane oxygenation (ECMO) have contributed to both expanding the range of conditions that can be treated and improving survival rates through the accumulation of knowledge on the clinical introduction, indications, and management of these novel devices in recent years. Additionally, the intracardiac implantable pump catheter for circulatory support, known as IMPELLA (the only such device available in Japan as of 2022), which was introduced for clinical use in Japan from October 2017, is a minimally invasive and rapidly deployable device that has demonstrated significant therapeutic effects, bringing about a paradigm shift in the management strategy for severe heart failure. MCS devices have been introduced at many institutions and are now used for many patients in daily practice. However, the evidence for the indications, management methods, and device selection is still insufficient, and each physician and facility is still accumulating experience in the treatment of patients. In Japan, continuous efforts are being made to overcome this situation, and new insights, such as those gained via the analysis of treatment outcomes using registry data for IMPELLA, are being compiled.In order to establish appropriate use and standardization of implantable ventricular assist device (VAD) therapy for severe heart failure patients in Japan, the Guidelines for device therapy: implantable left ventricular assist device for patients with severe heart failure were published in 2013 with the aim of achieving benefits from VAD therapy equivalent to or greater than those in Europe and the USA.2 The role of MCS in the overall management of heart failure is also mentioned in the Guidelines for diagnosis and treatment of acute and chronic heart failure (revised in 2017) published in 2018.3 Furthermore, the Revised 2021 Guideline on implantable left ventricular assist device for patients with advanced heart failure was published in 2021, and incorporates the latest evidence, including expanded indications for new devices and long-term destination therapy (DT).4 The main purpose of this Focus Update is to provide guidelines for the appropriate use and safe management of MCS, especially PCPS, ECMO, and IMPELLA, in the treatment of severe heart failure. Currently, much of the knowledge in this field in Japan is based on analysis of a few relatively small case series in individual facilities. Therefore, in this Focus Update, specific classes or levels of evidence are not strictly mandatory, but rather they are presented as expert consensus. However, we strongly hope that this Focus Update will (1) serve as a guideline for the standardization of PCPS, ECMO, and IMPELLA therapy within Japan, (2) be widely used by various healthcare professionals including physicians, nurses, clinical engineers, and other professionals involved in this treatment, and (3) be continuously revised in the future.