Complications of temporary mechanical circulatory support in cardiogenic shock: a systematic review and meta-analysis

Introduction Temporary mechanical circulatory support (tMCS) devices, including intra-aortic balloon pump (IABP), microaxial flow pump (mAFP) and venoarterial extracorporeal membrane oxygenation (VA-ECMO) are therapeutic strategies to stabilise patients with cardiogenic shock (CS) when inotropic support fails. While these devices could offer haemodynamic stabilization, their use is associated with significant ischaemic and bleeding complications. Purpose This systematic review aims to assess the incidence of stroke, bleeding and major vascular complications associated with tMCS in CS. Methods This systematic review was performed according to the methodology described in the PRISMA (Preferred Reporting Items for Systematic Review and Meta- Analysis) 2020 guidelines(1). A systematic search was performed in PubMed, Embase, Web of Science, and Cochrane CENTRAL. Studies including adult CS patients receiving short-term MCS and reporting device-specific complications were eligible. Random-effects Mantel-Haenszel method was used to calculate pooled incidences with 95% confidence intervals (CI). Results A total of 67 studies (9 RCTs, 59 observational) were included. The pooled incidence of stroke across all tMCS devices was 7% (95% CI, -1%–14%; p = 0.07), with no statistically significant difference overall or between devices. The incidence of stroke ranged from 4% for IABP and mAFP to 11% for VA-ECMO. The overall pooled incidence for bleeding was 25% (95% CI 18%–32%; p < 0.00001). Device-specific analyses showed that patients supported with VA-ECMO + mAFP exhibited the highest bleeding incidence (45%; 95% CI 22%–69%; p = 0.0001). Bleeding was also significantly elevated in the VA-ECMO-only group (34%; 95% CI 21%–47%; p < 0.00001) and the mAFP-only group (17%; 95% CI 6%–29%; p = 0.003). However, bleeding incidence was not significantly elevated for IABP-only, VA-ECMO + IABP or VA-ECMO + IABP/mAFP. In other MCS combinations, a high incidence of 44% was found and borderline significant (p = 0.05). For major vascular complications the pooled incidence was 10% (95% CI 3%–18%; p = 0.004). A high incidence of 19% was observed among VA-ECMO-supported patients (95% CI, 5%– 33%; p = 0.009). A higher incidence of major vascular complications was noticed in combinations of MCS devices. Up to 26% for ECMO + IABP/mAFP versus 2% for IABP-only, 7% for mAFP-only and 19% for VA-ECMO-only. However, these pooled incidences were not statistically significant. Risk of bias analysis showed overall a moderate risk of bias, mainly due to confounding bias. Heterogeneity was low. Conclusions This meta-analysis demonstrates that bleeding and vascular complications in tMCS-supported patients are frequent and increase significantly when devices are combined.Pooled incidences of tMCS complications