Impella device in fulminant myocarditis: Japanese Registry for Percutaneous Ventricular Assist Device (J-PVAD) registry analysis on outcomes and adverse events

Abstract

Abstract Aims Given that fulminant myocarditis, characterized by unstable haemodynamics, is a significant clinical challenge and that traditional pharmacological treatments have limitations, evaluating alternatives such as the Impella device is a crucial focus of this study. Further, this study presents pioneering large-scale registry data on its use in managing fulminant myocarditis. Methods and results Data from the Japanese Registry for Percutaneous Ventricular Assist Devices (J-PVAD) were analysed to assess Impella’s role in managing fulminant myocarditis from February 2020 to December 2021. The primary outcome was 30-day mortality for those treated with Impella. Of the 269 patients treated with Impella, 107 used Impella standalone, and 162 used ECPELLA (Impella combined with extracorporeal membrane oxygenation). The average age was 54 years, with 42.8% females. Overall, 74.3% survived at 30 days. Specifically, the success rate was 68.5% for the ECPELLA group and 83.2% for the Impella standalone group. Cox regression highlighted that lower estimated glomerular filtration rate and pre-Impella systolic blood pressure increased adverse event risk, while Swan–Ganz catheterization use reduced it. Adverse events were noted in 48.7% of patients, such as bleeding (32.0%) and deteriorating renal function (8.6%). Conclusion Impella’s use in fulminant myocarditis demonstrates encouraging short-term outcomes, albeit with significant adverse events. These findings align with previous mechanical circulatory support studies, emphasizing caution regarding haemorrhagic issues. Further studies are essential to enhance patient selection and treatment approaches.