Short-term outcomes of impella support in japanese patients with cardiogenic shock due to non-ischemic cardiomyopathy

Background/Introduction The Impella percutaneous left ventricular assist device has been available in Japan since 2017. This is the first large-scale registry study to analyze the efficacy and safety of Impella in Japanese patients with non-ischemic cardiomyopathy with cardiogenic shock. Methods and Results The Japanese registry for Percutaneous Ventricular Device (J-PVAD) has registered all consecutive Japanese patients treated with Impella. We extracted data for 339 patients with non-ischemic cardiomyopathy from J-PVAD and analyzed 30-day survival and safety profiles. The average age was 56 years old, with 74.0% males. Overall-30-day survival was 72.9%. The 30-day survival of Impella alone and Impella plus venoarterial extracorporeal membrane oxygenation (ECPELLA) group was 78.2% and 66.2% (p=0.013), respectively. The Impella alone group was older and had a lower rate of in-hospital and out-hospital cardiac arrest, lower serum lactate concentrations compared with ECPELLA group. Cox regression analysis revealed that in-hospital cardiac arrest (hazard ratio [HR] 2.445, 95%-confidence interval [CI] 1.311-4.558, p=0.005), low eGFR (<60mL/min/1.73m2, HR 3.554, 95%-CI 1.204-9.345, p=0.021) and high serum lactate concentration (>2.0mmol/L, HR 3.005, 95%-CI 1.451-6.225, p=0.003) were risk factors affecting 30-day mortality in overall cohort. Major adverse events were hemorrhage/hematoma (20.9%), hemolysis (20.4%), Stroke (6.2%), peripheral ischemia (2.7%), and thrombosis (1.8%). ECPELLA group had a higher rate of hemorrhage/hematoma compared with Impella alone group (32.5% vs 11.7%, p<0.001). Conclusions Non-ischemic cardiomyopathy with cardiogenic shock treatment with Impella showed favorable 30-days survival. The survival rate of patients treated with Impella alone was particularly high. Hemorrhage/hematoma is an important complication especially in ECPELLA group.