Background
Extracorporeal cardiopulmonary resuscitation (ECPR) is an advanced life-saving technique used when standard CPR fails to obtain spontaneous circulation. It involves quickly restoring cerebral blood flow and circulating oxygenated blood throughout the body, while diagnostic interventions such as cardiac catheterization and imaging tests are conducted to treat the underlying cause of the cardiac arrest. While conventional CPR, as outlined in guidelines, is routinely administered to patients with out-of-hospital cardiac arrest, the outcomes frequently remain suboptimal. In contrast, Extracorporeal Cardiopulmonary Resuscitation (ECPR) is associated with improved survival rates and neurological outcomes. Following significant findings like those from the SAVE-J study in 2014, ECPR has been incorporated into both the 2020 Japanese Resuscitation Council Guidelines and the 2023 AHA Guidelines for cases where initial CPR is unsuccessful and specific conditions are met. Recent studies, including randomized controlled trials, indicate ECPR may provide better outcomes than standard ACLS in managing refractory out-of-hospital cardiac arrests. However, the SAVE-J II study, which used data from 2013 to 2018, was not able to fully address the changes in clinical practice that have occurred since 2017, such as the introduction of the left ventricular assist device, IMPELLA, in Japan. This study aims to establish a registry for patients who underwent ECPR for out-of-hospital cardiac arrests, clarify the current state of medical practice in Japan, investigate survival rates and neurological outcomes, and examine factors contributing to the improvement of outcomes and appropriateness of ECPR.
Study title
Multicenter Retrospective Observational Study on Extracorporeal Cardiopulmonary Resuscitation (ECPR) for Out-of-Hospital Cardiac Arrest Patients in Japan.
Acronym
SAVE-J III study.
Design
Multicenter retrospective observational study.
Objective
To establish a registry of patients who underwent ECPR for out-of-hospital cardiac arrest, clarifying the current medical practices in Japan, investigating survival rates and neurological outcomes, and identifying factors contributing to improved outcomes with ECPR.
Study Population and Period
Adults aged 18 and older who underwent ECPR for out-of-hospital cardiac arrest at participating facilities from January 1, 2019, to June 30, 2024.
Outcome
Primary Outcome: Favorable neurological outcome at discharge, defined as good cerebral performance (CPC1) or moderate disability (CPC2), with severe disability (CPC3), coma or vegetative state (CPC4), and death or brain death (CPC5) categorized as poor outcomes.
Secondary Outcomes: Favorable neurological outcomes at one month post-discharge, survival rates at discharge and one month, and complications (bleeding, ischemia, infection).
Funding
- The St. Luke’s Health Sciences Research Fund Kihachiro Arai Research Fund Research Support Program
- SENKO MEDICAL INSTRUMENT Mfg. CO., LTD.
Investigators
Principal Investigator: Toru Hifumi (St. Luke’s International Hospital)
Core members: Akihiko Inoue (Hyogo Prefectural Disaster Medical Center), Jun Nakata (Nippon Medical School Hospital), Toru Takiguchi (Nippon Medical School Hospital), Naofumi Bunya (Sapporo Medical University Hospital), Hiroyuki Ohbe (Tohoku University Hospital), Tasuku Hada (St. Luke’s International Hospital), Yuta Tsunemi (St. Luke’s International Hospital).
Contact
Toru Hifumi
9-1 Akashi-cho, Chuo-ku, Tokyo
TEL: 03-3541-5151
Email: savej3-core@googlegroups.com