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Ann Thorac Surg 2007;84:161-168
© 2007 The Society of Thoracic Surgeons

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Original Articles: Cardiovascular

Recombinant Factor Seven Therapy for Postoperative Bleeding in Neonatal and Pediatric Cardiac Surgery

^a Department of Pediatrics, Division of Pediatric Critical Care, Vanderbilt University School of Medicine, Nashville, Tennessee
^b Department of Pediatric Cardiothoracic Surgery, Vanderbilt University School of Medicine, Nashville, Tennessee
^c Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, Tennessee

Accepted for publication February 20, 2007.

^_* Address correspondence to Dr Taylor, Vanderbilt Children’s Hospital, 2200 Children’s Way, 5121 B Doctors’ Office Tower, Nashville, TN 37232-9075 (Email: mary.b.taylor{at}vanderbilt.edu).

Background: Severe bleeding is a major complication in the postoperative pediatric cardiac surgery patients. We evaluated the efficacy and safety of recombinant factor seven (rFVIIa) therapy in this patient population.

Methods: A retrospective unmatched case-control study for the previous five years in a single institution was undertaken. Patients with severe bleeding treated with rFVIIa therapy (study group) were compared with patients treated with blood products only (control group) using analysis of variance. Mediastinal bleeding, blood products transfusion, and coagulation studies before and six hours after the first dose of rFVIIa therapy were analyzed using the Student paired t test. The dose, frequency, and side-effects of rFVIIa therapy were studied.

Results: Forty-six patients with severe bleeding were studied. Twenty-three of 24 patients in the study group, including 12 patients placed on extracorporeal membrane oxygenation (ECMO), responded to rFVIIa therapy (mean dose 43 ± 22.9 µg/kg/dose). There was significant reduction in chest tube drainage (from 52.3 ± 36.1 mL/kg/hour to 18.8 ± 20.9 mL/kg/hour, p = 0.0003) along with significant reduction of blood products transfusion (p < 0.001) in the study group patients as compared with control group patients. One patient who failed to respond had surgical bleeding. Two patients developed major thrombotic complications that included clots in the ECMO circuit and thrombosis at bleeding arterial line site resulting in limb ischemia. Four additional patients in the study group developed mediastinal clots. Overall, 25% of patients developed thrombosis after rFVIIa therapy.

Conclusions: The rFVIIa therapy seems to be an effective treatment for severe bleeding in postoperative pediatric cardiac surgery patients in the absence of surgical bleeding. It must be judiciously used in patients bleeding from multiple sites or having preexistent clots in the ECMO circuit to prevent major thrombotic complications.

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Invited commentary

Ian J. Welsby and Thomas L. Ortel
Ann. Thorac. Surg. 2007 84: 168-169. [Extract] [Full Text] [PDF]

This article has been cited by other articles:

				C. D. Mazer, H. Leong-Poi, J. Mahoney, D. Latter, B. H. Strauss, and J. M. Teitel Vascular Injury and Thrombotic Potential: A Note of Caution About Recombinant Factor VIIa Seminars in Cardiothoracic and Vascular Anesthesia, December 1, 2007; 11(4): 261 - 264. [Abstract] [PDF]

				I. J. Welsby and T. L. Ortel Invited commentary Ann. Thorac. Surg., July 1, 2007; 84(1): 168 - 169. [Full Text] [PDF]