Major bleeding complication in patients with CS on Impella and undergoing Impella assisted high risk percutaneous coronary intervention. Results of IMPELLA PL registry

Abstract Background Percutaneous microaxial flow pump, Impella CP, is one of the most efficient mechanical circulatory devices used to support patients with cardiogenic shock (CS) and undergoing high-risk percutaneous coronary interventions (HR PCI). However, Impella use is associated with an increase in bleeding events due to large bore access, anticoagulation, device-, procedure- and patient- related risk factors, which remain not clear. Aims To determine the predictive factors of major bleeding complications in patients supported with Impella CP in the CS and HR PCI setting. Methods Univariable and multivariable logistic regression analysis were performed to predict severe bleeding complications among patients included in the multicenter, retrospective Impella -PL registry. Results Of 308 patients, 55 had CS and 253 received Impella for HR PCI. Severe bleeding complication according to the Bleeding Academic Research Consortium (BARC) definition were reported in 34.5% patients in the CS and 6.4% HR-PCI groups, respectively. In the CS cohort, the use of intravascular ultrasound was associated with increased odds of major bleeding complications (OR = 7.62; 95% CI: 1.12–51.85; p = 0.038), while manual compression of the vascular access site demonstrated a trend towards a protective effect (OR = 0.075; 95% CI: 0.005–1.04; p = 0.053). In the HR-PCI group, severe calcification (OR 2.75 ; 95% CI:1.094 –7.26; p =0.042), angioplasty of left main coronary artery (OR 8.46; 95% CI:1.56 –46.02; p = 0.013) or left circumflex artery (OR 6.63; 95% CI: 1.97–22.32; p =0.002), contrast volume (OR 1.005; 95% CI: 1.002–1.008; p = 0.002) and ultrasound guided vascular access (OR 3.30; 95% CI: 1.24 –8.77; p =0.017) were the predictors of major bleeding complication. In turn, the removal of Impella directly after the PCI procedure had a protective effect (OR 0.15; 95% CI: 0.03 –0.67; p = 0.013). Conclusion The frequency of major bleeding complications is substantially higher in CS patient supported with Impella, compared to HR-PCI. Careful patient selection, procedural planning, and post-procedure monitoring is crucial to minimize the risk of bleeding complications, especially in patients with severe calcifications and undergoing left main PCI.