Impact on postoperative bleeding and cost of recombinant activated factor VII in patients undergoing heart transplantation.

BACKGROUND: Cardiac transplantation can be complicated by refractory hemorrhage particularly in cases where explantation of a ventricular assist device is necessary. Recombinant activated factor VII (rFVIIa) has been used to treat refractory bleeding in cardiac surgery patients, but little information is available on its efficacy or cost in heart transplant patients. METHODS: Patients who had orthotopic heart transplantation between January 2009 and December 2014 at a single center were reviewed. Postoperative bleeding and the total costs of hemostatic therapies were compared between patients who received rFVIIa and those who did not. Propensity scores were created and used to control for the likelihood of receiving rFVIIa in order to reduce bias in our risk estimates. RESULTS: Seventy-six patients underwent heart transplantation during the study period. Twenty-one patients (27.6%) received rFVIIa for refractory intraoperative bleeding. There was no difference in postoperative red blood cell transfusion, chest tube output, or surgical re-exploration between patients who received rFVIIa and those who did not, even after adjusting with the propensity score (P = 0.94, P = 0.60, and P = 0.10, respectively). The total cost for hemostatic therapies was significantly higher in the rFVIIa group (median $10,819 vs. $1,985; P < 0.0001). Subgroup analysis of patients who underwent redo-sternotomy with left ventricular assist device explantation did not show any benefit for rFVIIa either. CONCLUSIONS: In this relatively small cohort, rFVIIa use was not associated with decreased postoperative bleeding in patients undergoing heart transplantation; however, it led to significantly higher cost.

Validation of a Dosing Strategy for Cefazolin for Surgery Requiring Cardiopulmonary Bypass.

BACKGROUND: A prospective, single center, open-label study was conducted to determine if the standard practice for surgical prophylaxis, which includes standardized dosing of cefazolin, at the University of Maryland Medical Center (UMMC) is adequate for patients placed on bypass during cardiac surgery. METHODS: All patients were given the same standard dosing regimen regardless of weight: two grams of cefazolin administered within 1 h of incision, an additional one gram injected into the bypass circuit at the onset of bypass, and two grams every 3 h after the initial dose. Cefazolin serum concentrations were collected immediately after incision, after the start of bypass, each hour of bypass, at the end of bypass and at sternal closure. RESULTS: Ten patients were consented and completed the study with an average age of 62 y, average weight of 84.7 kg and average cardiopulmonary bypass time of 116 min. The free serum concentrations of cefazolin stayed above the pre-defined inhibitory threshold of 16 mcg/mL throughout the procedure for 100% of participants. The mean total serum concentration in the blood throughout surgery was 160 mcg/mL. No patients were found to have surgical site infections using standard criteria and no adverse events were observed. CONCLUSIONS: For patients undergoing cardiac surgery with cardiopulmonary bypass, the UMMC dosing regimen surpassed targeted cefazolin concentrations during the entire surgical procedure for all patients regardless of weight or time on bypass.