Multicenter Registry Analysis of Bivalirudin for Primary Anticoagulation in Pediatric HeartMate 3 Recipients: ACTION Analysis
Multicenter registry analysis published in ASAIO Journal (2026)
Abstract
Bivalirudin, a direct thrombin inhibitor, is increasingly used as an alternative to heparin in pediatric mechanical circulatory support (MCS) and has resulted in improved stroke-free survival in children supported by paracorporeal pulsatile devices. However, for those supported by implanted continuous-flow devices, such as HeartMate 3, significant practice variation exists in agents used as early intravenous anticoagulation. Leveraging ACTION VAD registry data, we sought to compare early hemocompatibility-related adverse events (<14 days) in pediatric HeartMate 3 patients on bivalirudin versus heparin (unfractionated heparin [UFH]). A total of 234 patients, aged under 25 years, with a median age of 15 years and a median weight of 60 kg, at the time of HeartMate 3 implant, were included in the study cohort. Of these, 100 (42.7%) received bivalirudin as initial intravenous anticoagulation agent and 134 (57.2%) received UFH. With data censored at change of agent, there was no significant difference between the groups for freedom from stroke (96.9% vs. 96.3%, p = 0.77) or bleeding (94.8% vs. 89.9% %, p = 0.21), but time to transition to oral anticoagulation was longer for the bivalirudin group. Survival at 1 year after implant was also not different between groups. These data suggest that bivalirudin is a reasonable alternative to UFH for early thromboprophylaxis after HeartMate 3 implantation.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Resumen
ACTION registry analysis of 234 pediatric HeartMate 3 implants showed no significant difference between bivalirudin (42.7%) and heparin (57.2%) groups for freedom from stroke or bleeding, supporting bivalirudin as a reasonable alternative for early thromboprophylaxis.
Por qué esto importa para la hirudoterapia
Este análisis de registro empleó datos del registro ACTION VAD para comparar los eventos adversos tempranos (<14 días) relacionados con hemocompatibilidad entre bivalirudina (42,7%, n=100) y heparina no fraccionada (57,2%, n=134) como anticoagulación intravenosa inicial en 234 receptores pediátricos de HeartMate 3. No se hallaron diferencias significativas en la supervivencia libre de ictus (96,9% vs. 96,3%), sangrado (94,8% vs. 89,9%) ni en la supervivencia a 1 año, aunque el grupo de bivalirudina presentó un tiempo más prolongado hasta la transición a anticoagulación oral. El resumen identifica la bivalirudina como un inhibidor directo de la trombina, pero no menciona hirudina, saliva de sanguijuela, terapia con sanguijuelas ni ningún origen derivado de sanguijuelas de la bivalirudina. Los datos sugieren que la bivalirudina constituye una alternativa razonable a la HNF para la tromboprofilaxis temprana tras el implante del HeartMate 3, pero no puede establecerse a partir del resumen ninguna conexión defendible con el dominio de la hirudoterapia de la ASH ni con el secretoma de la sanguijuela.
Citación
Multicenter Registry Analysis of Bivalirudin for Primary Anticoagulation in Pediatric HeartMate 3 Recipients: ACTION Analysis.
Lynch A et al. · ASAIO Journal, 2026
Contexto clínico relacionado
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Añadido a la biblioteca ASH: May 27, 2026 · Última actualización del sitio: 18 de junio de 2026