Efficacy and safety of Impella 5.0 in cardiogenic shock: an updated systematic review

Aim: The impact on safety and efficacy outcomes of Impella 5.0 in cardiogenic shock (CS) has not been systematically assessed. Materials & methods: We conducted a systematic review of the literature (PROSPERO protocol: CRD42020164680) to critically appraise available evidence on Impella 5.0 comparative safety, efficacy and effectiveness. Results: Of 244 retrieved citations, 17 original articles met the a priori defined inclusion criteria. All included studies had a retrospective study design and, overall, reported on, respectively, 52 and 67 different safety and efficacy/effectiveness outcomes. Thirty-day survival rates ranged from 40 to 94%, myocardial recovery from 18 to 93%. Conclusion: Impella 5.0 provides a full cardiac support, it is associated with a lower rate of vascular complications, it represents a valuable bridge-to-decision and allows for resolution of intercurrent clinical conditions. As available data suggest Impella 5.0 good performance in CS of various etiologies, more solid evidence will come from much-needed large-scale all-comer registries and prospective multicenter randomized trials. Lay abstract: Cardiogenic shock (CS) is a life-threatening condition in which the heart cannot pump enough blood to meet the body's needs. Despite advances in biomedical research and technology, CS is still associated with high mortality. Some devices (Intra-aortic balloon pump (IABP), Impella, Venoarterial Extracorporeal Membrane Oxygenation (VA-ECMO), placed through vascular accesses, can support the heart in the failing phase. The aim of this systematic review of the scientific literature is to evaluate safety, efficacy and effectiveness of Impella 5.0 in