Changing Trends in Mechanical Circulatory Support Utilization and Outcomes in Patients Undergoing Percutaneous Coronary Interventions for Acute Coronary Syndrome Complicated with Cardiogenic Shock: Insights from a Nationwide Registry in Japan

Background: Temporal trends in the management of acute coronary syndrome (ACS) complicated with cardiogenic shock (CS) after the revision of the guideline recommendations for intra-aortic balloon pump (IABP) use and the approval of the Impella require further investigation as their impact remains uncertain. Methods: Using the Japanese Percutaneous Coronary Intervention (J-PCI) registry database from 2019 to 2021 (734,379 patients from 1,190 hospitals), we extracted 24,516 patients undergoing PCI for ACS complicated with CS. Of those, 12,171 patients (49.6%) used mechanical circulatory support (MCS) during the procedure. The patients were stratified into three groups: (i) IABP alone, (ii) Impella, and (iii) venoarterial extracorporeal membrane oxygenation (VA-ECMO); the VA-ECMO group was further stratified into (iiia) VA-ECMO alone, (iiib) VA-ECMO in combination with the IABP, and (iiic) VA-ECMO in combination with the Impella (ECPella). The quarterly prevalence and outcomes were reported. Results: During the study period, there were notable changes in the prevalence of different MCS modalities and their associated outcomes. The use of an IABP alone and VA-ECMO decreased significantly from 63.5% and 34.4% in the first quarter of 2019 to 58.3% and 33.0% in the fourth quarter of 2021, respectively (P for trend = 0.01 and 0.02, respectively). Among the subset of patients who required VA-ECMO (n = 4,245), the use of VA-ECMO in combination with the IABP decreased significantly from 78.7% to 67.3%, whereas the use of ECPella increased significantly from 4.2% to 17.0% (P for trend <0.001 for both). There was no significant change in the use of VA-ECMO alone. In-hospital mortality decreased significantly over time in both the overall population of patients requiring MCS and those requiring VA-ECMO (P for trend = 0.004 and <0.001, respectively). Conclusions: In conclusion, our study revealed significant changes in the use of different MCS modalities and associated outcomes in ACS complicated with CS, highlighting the evolving patterns of MCS utilization during the study period. ### Competing Interest Statement Dr. Nishimoto received lecture fees from Bayer Healthcare, Bristol-Myers Squibb, Pfizer, and Daiichi-Sankyo. Dr. Kohsaka reported investigator-initiated grant from Novartis and Daiichi Sankyo, and personal fees from Bristol-Myers Squibb. Dr. Sakakura received lecture fees from Abbott Vascular, Boston Scientific, Medtronic Cardiovascular, Terumo, OrbusNeich, Japan Lifeline, Kaneka, and Nipro. Dr. Ishii received lecture fees from Astellas Pharma, AstraZeneca, Bayer, Bristol-Myers Squibb, Chugai Pharma, Daiichi Sankyo, Kowa, Novartis Pharma, Nippon Boehringer Ingelheim, Otsuka Pharma, Pfizer, Mochida Pharma, and Tanabe Mitsubishi. Dr. Amano received lecture fees from Astellas Pharma, AstraZeneca, Bayer, Daiichi Sankyo, and Bristol-Myers Squibb. The remaining authors have no conflicts of interest to declare. ### Clinical Trial N/A ### Funding Statement This work was supported by the Japanese Association of Cardiovascular Intervention. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Not Applicable The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This study was performed in accordance with the amended Declaration of Helsinki, and was approved by the Institutional Review Board Committee of the Network for Promotion of Clinical Studies, a nonprofit organization affiliated with Osaka University Graduate School of Medicine, Osaka, Japan. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Not Applicable I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Not Applicable I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Not Applicable The data, analytic methods, and study materials will not be made publicly available to other researchers for the purpose of reproducing the results or replicating the procedure.