Sociedad Americana de Hirudoterapia

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)

Última actualización: 18 de junio de 2026Revisado por: ASH Editorial Board
Artículo de investigación — revisión de evidenciaReferencia del artículo
Evidence: Research reportDesarrollo de fármacosSeguridad y control de infeccionesBandini M et al. · Cardiovascular revascularization medicine, 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.

Publication typeJournal Article
Indexed MeSH termsHumansHirudinsPeptide FragmentsMaleRecombinant ProteinsFemaleHeart-Assist DevicesAgedMiddle AgedTreatment OutcomePercutaneous Coronary InterventionHemorrhage

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

Este estudio evaluó complicaciones relacionadas con la hemocompatibilidad mediante la puntuación SHEAR en 13 pacientes con shock cardiogénico asociado a infarto agudo de miocardio que recibieron soporte circulatorio mecánico Impella 5.0 o 5.5, tratados concomitantemente con bivalirudina y doble terapia antiagregante plaquetaria (DAPT). El resumen informa una baja tasa de eventos trombóticos y hemorrágicos, sin eventos adversos clínicamente relevantes relacionados con la hemocompatibilidad, aunque los eventos hemorrágicos fueron más frecuentes que los trombóticos, particularmente dentro de las primeras 48 horas. Para la ASH, la relevancia es indirecta, dado que la bivalirudina es un fármaco derivado de la hirudina, y no una terapia con sanguijuelas ni un producto del secretoma. El tamaño muestral muy pequeño (13 pacientes) y la ausencia de un grupo de comparación limitan sustancialmente la generalizabilidad.

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

Contexto clínico relacionado

Añadido a la biblioteca ASH: May 27, 2026 · Última actualización del sitio: 18 de junio de 2026

Este sitio web proporciona información educativa y no constituye consejo médico, diagnóstico ni recomendaciones de tratamiento. La terapia con sanguijuelas medicinales conlleva riesgos clínicamente significativos y debe ser realizada únicamente por profesionales calificados bajo protocolos aprobados institucionalmente. La autorización 510(k) de la FDA para sanguijuelas medicinales se limita a indicaciones específicas; las discusiones sobre uso investigativo y fuera de indicación se señalan correspondientemente. Para orientación médica específica, consulte a un profesional de salud calificado.