Safety of recombinant activated factor VII for bleeding use post Heart Mate III, left ventricular assist device implantation.

BACKGROUND

Perioperative bleeding is a frequent high-risk complication, especially during Left Ventricular Assist Device (LVAD) implantation, and frequently necessitates reoperation. Bleeding control required many therapeutic options, and in refractory cases, recombinant activated Factor VII (rFVIIa) was considered one of the additional off-label options used. We report our experience with rFVIIa administration during LVAD implantation, particularly with the HeartMate III device, to assess safety outcomes, including pump thrombosis, stroke, and thromboembolic events.

METHODS

This is a retrospective single-center study for patients who developed refractory perioperative bleeding during LVAD, HeartMate III, implantation, and received rFVIIa due to the failure of other therapeutic options. The study was conducted from the first of December 2022-31 July 2025. The primary endpoint was a composite of pump thrombosis, stroke and thromboembolic events.

RESULTS

Among all HeartMate III LVAD implantations during the study period, eight patients received rFVIIa. There was no single recorded case of mortality, major stroke causing disability or device pump thrombosis. One patient (12.5%) experienced a minor stroke. There were a total of three patients (37.5%) identified to have a surgical source of bleeding, and two patients (25%) required operation re-exploration due to continued bleeding.

CONCLUSION

This is a retrospective trial of a single cardiac center experience. rFVIIa use in refractory bleeding during HeartMate III LVAD implantation is safe with no significant additional risk of pump thrombosis or major stroke. A further large-scale investigation is needed to determine its safety and effectiveness.