Hemocompatibility related complications in Impella 5+ patients treated with Bivalirudin and dual antiplatelet therapy: a SHEAR score evaluation.

Background: The surgical Impella 5.0 and 5.5 (5+) provide greater and more durable hemodynamic support than Impella CP in patients with cardiogenic shock. The concomitant need for DAPT on top of systemic anticoagulation might increase the risk for hemocompatibility-related adverse events.

Methods: 13 patients who underwent primary PCI and Impella 5+ support and were treated with DAPT and Bivalirudin. We evaluated adverse events (AEs) and hemocompatibility-related complications according to the SHEAR score.

Results: Median duration of Impella 5+ support was 14 ± 32 days. At baseline, all patients had risk for bleeding because of DAPT (SHEAR A); moreover, 2 patients suffered from thrombocytopenia. None presented risk factors for thrombosis. The highest total SHEAR score was 6 in 2 patients, three patients had a total SHEAR score of 3, three patients had a total SHEAR score of 2, 5 patients had a total SHEAR score of 1. Both bleeding and thrombotic events were most frequent within the first 48 h of support, and bleeding events had a greater role in determining the hemocompatibilty score. No patient suffered from clinically relevant hemocompatibility-related adverse events.

Conclusions: In conclusion, we report a low rate of thrombotic and hemorrhagic events in a cohort of AMI-CS patients requiring Impella 5+ support and treated with bivalirudin and DAPT, according to the SHEAR score classification. This is further confirmed by the ability of the SHEAR score to add multiple events that can occur during prolonged support. Further studies are urgently needed to confirm this new approach in tMCS.