Implementation of a standardized Impella-specific management pathway in cardiogenic shock

Abstract Background Device-related complications remain frequent during Impella support. Although coordinated multidisciplinary care and standardized protocols are recommended for cardiogenic shock, Impella-specific management pathways have not been established. We evaluated implementation of a standardized Impella-specific management pathway (SIM) and the accompanying changes in care processes and in-hospital outcomes. Methods This single-center, before-and-after observational study included 190 consecutive patients with cardiogenic shock treated with Impella, 88 before implementation and 102 after SIM introduction. SIM combined multidisciplinary education and implementation support, peri-implant strategy, access-site and limb-perfusion management, hemolysis surveillance, and hemodynamic optimization. The primary endpoint was all-cause in-hospital mortality, and the key secondary endpoint was Impella-related Bleeding Academic Research Consortium type 3 or 5 bleeding. Both were analyzed using overlap-weighted cause-specific Cox models. Results After SIM introduction, pre-PCI Impella use among patients with acute myocardial infarction increased from 36.2 to 76.2%, and 16-Fr sheath use increased from 0 to 80.2%. The rate of detected hemolysis increased progressively, whereas the time spent outside the target ranges for mean arterial pressure and central venous pressure decreased. After overlap weighting, all covariates included in the propensity-score model were balanced (absolute standardized mean difference <0.10). In-hospital death occurred in 58.0% before implementation and 33.3% after SIM introduction (hazard ratio, 0.51; 95% confidence interval, 0.32–0.84; P = 0.009). No significant interaction was observed according to SCAI shock stage, arrest or ECPELLA status at Impella insertion. Impella-related type 3 or 5 bleeding occurred in 30.7 and 12.7%, respectively (hazard ratio, 0.33; 95% confidence interval, 0.16–0.67; P = 0.002). BARC type 5 bleeding, acute limb ischemia, and stroke did not differ significantly. Conclusions SIM was progressively implemented across the catheterization laboratory and ICU, accompanied by measurable changes in care processes and lower rates of major bleeding and in-hospital death. Prospective multicenter studies should assess whether these findings are reproducible.