Hemocompatibility related complications in Impella 5+ patients treated with Bivalirudin and dual antiplatelet therapy: a SHEAR score evaluation
Observational published in Cardiovasc Revasc Med (2025)
Abstract
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.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Resumen
Cohort study of 13 cardiogenic-shock patients on Impella 5+ MCS with dual antiplatelet therapy and bivalirudin, evaluating hemocompatibility events using the SHEAR score. No clinically significant hemocompatibility-related adverse events occurred.
Por qué esto importa para la hirudoterapia
This study evaluated hemocompatibility-related complications using the SHEAR score in 13 patients with acute myocardial infarction-related cardiogenic shock who received Impella 5.0 or 5.5 mechanical circulatory support, treated concomitantly with bivalirudin and dual antiplatelet therapy (DAPT). The abstract reports a low rate of thrombotic and hemorrhagic events, with no clinically relevant hemocompatibility-related adverse events, though bleeding events were more frequent than thrombotic events, particularly within the first 48 hours. For ASH, the relevance is indirect, as bivalirudin is a hirudin-derived pharmaceutical rather than a leech therapy or secretome product. The very small sample (13 patients) and lack of a comparison group substantially limit generalizability.
Citación
Hemocompatibility related complications in Impella 5+ patients treated with Bivalirudin and dual antiplatelet therapy: a SHEAR score evaluation.
Bandini M et al. · Cardiovascular revascularization medicine, 2025
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Añadido a la biblioteca ASH: May 27, 2026 · Última actualización del sitio: June 18, 2026