Abstract

BackgroundVentricular assist devices(VAD) implantation/removal is a complex surgical procedure with perioperative bleeding complications occurring in nearly half of the cases. Recombinant activated factor VII (rFVIIa) has been used off-label to control severe hemorrhage in surgery and trauma. We report here our experience with rFVIIa as a rescue therapy to achieve hemostasis in patients undergoing orthotopic heart transplant (OHT) and/or VAD implantation.MethodsA retrospective review was conducted from Jan 03 to Aug 05 for patients who received rFVIIa for the management of intractable bleeding unresponsive to standard hemostatic blood component therapy. Blood loss and the quantity of blood products, prior to, and for at least 12 hours after, administration of rFVIIa were recorded.ResultsMean patient age was 53, (38–64 yrs), mean dose of rFVIIa administered was 78.3 μg/kg (24–189 μg/kg) in 1–3 doses. All patients received the drug either intraoperatively or within 6 hours of arrival in ICU. Mean transfusion requirements and blood loss were significantly reduced after rFVIIa administration (PRBC's; 16.9 ± 13.3 to 7.1 ± 6.9 units, FFP; 13.1 ± 8.2 to 4.1 ± 4.9 units, platelets; 4.0 ± 2.8 to 2.1 ± 2.2 units, p < 0.04 for all). 5 patients expired including 3 with thromboembolic cause. One patient developed a lower extremity arterial thrombus, and another deep vein thrombosis.ConclusionIn this review, there was a significant decrease in transfusion requirement and blood loss after rFVIIa administration. Although, 5/17 developed thromboembolic complications, these patients may have been at higher risk based on the multiple modality therapy used to manage intractable bleeding. Nevertheless, the exact role of rFVIIa with respect to development of thromboembolic complications cannot be clearly determined. Further investigation is needed to determine rFVIIa's safety and its effectiveness in improving postoperative morbidity and mortality.

Highlights

  • Ventricular assist devices(VAD) implantation/removal is a complex surgical procedure with perioperative bleeding complications occurring in nearly half of the cases

  • In our retrospective case series, we report our experience with the use of rFVIIa in the treatment of refractory bleeding in patients with VAD implantation or explantation and orthotopic heart transplant (OHT)

  • Two patients had heparin-induced thrombocytopenia (HIT); one with a known history and another diagnosed subsequent to thrombocytopenia following the left VAD (LVAD) implantation

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Summary

Introduction

Ventricular assist devices(VAD) implantation/removal is a complex surgical procedure with perioperative bleeding complications occurring in nearly half of the cases. Ventricular assist devices (VADs) have been in widespread clinical use for long-term support of patients with endstage heart failure as a bridge to transplantation. These devices are compatible with low long term morbidity, hemodynamic stability along with significant metabolic and physical rehabilitation. VAD implantation and explantation are complex surgical procedures with perioperative bleeding occurring in nearly half of the cases [1,2]. Recently published analysis, excessive bleeding requiring more than four units of PRBC transfusion was the strongest (odds ratio = 5) independent predictor with respect to perioperative stroke [10]. Massive blood loss (receiving at least five units of PRBC within 24 hours of surgery) in cardiac surgery was associated with an 8.1-fold (95% confidence interval, 3.9–17.0) increase in the odds of death [9]

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