Use of recombinant activated Factor VII for refractory after lung transplant bleeding as an effective strategy to restrict blood transfusion and associated complications.
ABSTRACT BACKGROUND: Recombinant activated factor VIIa (rFVIIa) has been increasingly used to stop massive bleeding after cardiothoracic surgical procedures. However, the risk : benefit profile of such a potent hemostatic agent remains unclear in the postsurgical patient, and the cost benefit is even less clear. In patients after lung transplantation, volume of blood transfused is of major concern, and all attempts are made to minimize large blood transfusions in this cohort. We report our experience with rFVIIa in patients with refractory bleeding after lung transplant surgery. STUDY DESIGN AND METHODS: All lung transplant patients who underwent single- or double-lung transplantation who received rFVIIa in the 5-year period, from January 2005 to June 2011, were included. A total of 15 patients were identified from a total of 95 lung transplant cases operated during this study period. Patient demographics, intra- and postoperative records were reviewed to assess the efficacy and safety of rFVIIa treatment. RESULTS: Patients with major bleeding treated with rFVIIa showed improved hemostasis with rapid normalization of coagulation variables. rFVIIa treatment was not associated with an increase in mechanical ventilation time, length of intensive care unit stay, or hospital stay compared to other lung transplant patients. In addition, the use of rFVIIa was associated with reduction in transfusion requirements of red blood cells, fresh-frozen plasma, and platelets (all p < 0.001). No definite thromboembolic-related event was recorded in our cohort. CONCLUSIONS: These data demonstrate that rFVIIa was associated with reduced blood loss, improvement of coagulation variables, and decreased need for transfusions. This reduction in losses led to a reduced requirement for blood transfusion, which may translate to a decrease in transfusion-related complications. Further investigation is needed to determine rFVIIa's safety and its efficacy in improving postoperative morbidity and mortality specifically in the field of post-lung transplantation surgery.
- SourceAvailable from: Gianfranco Gensini[show abstract] [hide abstract]
ABSTRACT: Recombinant activated factor VII (rFVIIa) has been increasingly used to stop life-threatening bleeding following cardiac operations. Nonetheless, the issue of dosing, given the expense and potential for thrombotic complications, is still of major concern. We report our experience with small-dose rFVIIa in patients with refractory bleeding after cardiac surgery. From September 2005 to June 2007, 40 patients (mean age 70.1+/-9.2 years, 52.5 males) received a low dose of rFVIIa (median: 18 microg/kg, interquartile range: 9-16 microg/kg) for refractory bleeding after cardiac surgery. Forty propensity score-based greedy matched controls were compared to the study group. Low dose of rFVIIa significantly reduced the 24-h blood loss: 1610 ml [ 1285-1800 ml] versus 3171 ml [2725-3760 ml] in the study and control groups, respectively (p<0.001). Thus, hourly bleeding was 51.1 ml [34.7-65.4 ml] in patients receiving rFVIIa and 196.2 ml/h [142.1-202.9 ml] in controls (p<0.001). Furthermore, patients receiving rFVIIa showed a lower length of stay in the intensive care unit (p<0.001) and shorter mechanical ventilation time (p<0.001). In addition, the use of rFVIIa was associated with reduction of transfusion requirements of red blood cells, fresh frozen plasma and platelets (all, p<0.001). Finally, treated patients showed improved hemostasis with rapid normalization of coagulation variables (partial thromboplastin time, international normalized ratio, platelet count, p<0.001). In contrast, activated prothrombin time and fibrinogen did not differ between groups (p=ns). No thromboembolic-related event was detected in our cohort. In our experience low-dose rFVIIa was associated with reduced blood loss, improvement of coagulation variables and decreased need for transfusions. Our findings need to be confirmed by further larger studies.European Journal of Cardio-Thoracic Surgery 01/2008; 33(1):64-71. · 2.67 Impact Factor
Article: A decade of lung transplantation.[show abstract] [hide abstract]
ABSTRACT: The experience accrued at the University of Pittsburgh between March 1982 and December 1992 in the various forms of lung transplantation, including heart-lung, double lung, and single lung, is discussed. Heart-lung (n = 97) was the most commonly performed operation followed by double lung (n = 80) and single lung (n = 68). Major indications included primary pulmonary hypertension (n = 76), obstructive lung disease (n = 57), Eisenmenger's syndrome (n = 42), cystic fibrosis (n = 32), and retransplantation (n = 13). Since May 1991, 115 procedures have been performed and heart-lung transplantation has decreased from 61% to 15% of the cases with a corresponding doubling in double lung from 24% to 43% and single lung from 15% to 42%. The 1-, 2-, and 5-year survival rates in all 232 recipients were 61%, 55%, and 44%, respectively. The actuarial survival rate was significantly better for those 107 recent recipients compared to the 125 early recipients (70% vs. 61%). Overall, the 63 single (70%) and 74 double (65%) lung procedures were more successful than heart-lung transplantation (53%). Recently, however, lung transplantation has been associated with an improvement in the survival rate from 48% to 72%. The survival rate has also improved from 53% to 77% for single lung transplant recipients. The causes of death in 106 recipients included infection (n = 40), early allograft dysfunction (n = 23), obliterative bronchiolitis (n = 13), and inoperative bleeding (n = 10). Poor outcomes also included technical problems (n = 6), lymphoma (n = 4), acute rejection (n = 3), diaphragmatic paralysis (n = 2), multisystem organ failure (n = 2), stroke (n = 2), liver failure (n = 1), and airway dehiscence (n = 1). The long-term outlook for lung transplant recipients has improved. There appears to be significant conservation of organs with single lung and double lung transplantation, finding greater acceptance for diseases once exclusively treated by heart-lung transplantation alone. The improved long-term outlook will be dependent upon better treatment for chronic rejection of the airways that histologically is defined by obliterative bronchiolitis.Annals of Surgery 10/1993; 218(3):310-8; discussion 318-20. · 6.33 Impact Factor
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ABSTRACT: To determine if blood transfusion is a consistent risk factor for postinjury multiple organ failure (MOF), independent of other shock indexes. A 55-month inception cohort study ending on August 30, 1995. Data characterizing postinjury MOF were prospectively collected. Multiple logistic regression analysis was performed on 5 sets of data. Set 1 included admission data (age, sex, comorbidity, injury mechanism, Glasgow Coma Scale, Injury Severity Score, and systolic blood pressure determined in the emergency department) plus the amount of blood transfused within the first 12 hours. In the subsequent 4 data sets, other indexes of shock (early base deficit, early lactate level, late base deficit, and late lactate level) were sequentially added. Additionally, the same multiple logistic regression analyses were performed with early MOF and late MOF as the outcome variables. Denver General Hospital, Denver, Colo, is a regional level I trauma center. Five hundred thirteen consecutive trauma patients admitted to the trauma intensive care unit with an Injury Severity Score greater than 15 who were older than 16 years and who survived longer than 48 hours. None. The relationship of blood transfusions and other shock indexes with the outcome variable, MOF. A dose-response relationship between early blood transfusion and the later development of MOF was identified. Despite the inclusion of other indexes of shock, blood transfusion was identified as an independent risk factor in 13 of the 15 multiple logistic regression models tested; the odds ratios were high, especially in the early MOF models. Blood transfusion is an early consistent risk factor for postinjury MOF, independent of other indexes of shock.Archives of Surgery 07/1997; 132(6):620-4; discussion 624-5. · 4.10 Impact Factor