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CARDIOVASCULAR ANESTHESIA

Institutional Variability in Transfusion Practice for Liver Transplantation

Yves Ozier, MD^*, Fabienne Pessione, MD, Emmanuel Samain, MD, and Françoise Courtois, MD for the French Study Group on Blood Transfusion in Liver Transplantation

*Department of Anesthesiology, Hôpital Cochin (AP-HP), Université René Descartes, Paris, France; Etablissement Français des Greffes, Paris, France; Department of Anesthesiology, Hôpital Beaujon (AP-HP), Clichy, France; Etablissement Français du Sang, Paris, France

Address correspondence and reprint requests to Yves Ozier, MD, Département d’Anesthésie-Réanimation Chirurgicale, Hôpital Cochin, 123 Boulevard de Port Royal, F-75679 Paris Cedex 14. Address e-mail to yves.ozier{at}cch.ap-hop-paris.fr

	Abstract

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We prospectively evaluated the institutional variability in perioperative transfusion therapy in orthotopic liver transplantation (OLT). Adult OLTs completed during a 12-mo period were studied until the 48th postoperative hour at 8 centers. A multivariate analysis using mixed-effects logistic regression included variables predisposing to blood loss and a center random effect. In addition, the influence of the calculated perioperative hemoglobin (Hb) loss on the individual probability of receiving red blood cells (RBCs), fresh frozen plasma (FFP), and platelets in excess of the overall median were explored. The analysis was performed on 301 cases. The overall median numbers transfused were 5 RBC units, 6 FFP units, and the median platelet dose was 5.10¹¹, with significant intercentric differences in the proportions of cases given more than the overall median. Intercentric differences remained significant after adjustment for factors independently associated with a large blood component use. Intercentric differences in RBCs, FFP, and platelet use decreased but persisted after adjustment for the perioperative Hb loss. Intercentric differences in RBC use disappeared after adjustment for the postoperative Hb concentration. The significant heterogeneity in transfusion therapy mandates reassessment of the rational use of blood products in OLT.

IMPLICATIONS: We evaluated transfusion practices in liver transplantation at eight centers. There is a marked heterogeneity in blood component use which is unrelated to differences in the preoperative recipient status and, partly, to differences in blood loss.

	Introduction

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Blood component transfusion in orthotopic liver transplantation (OLT) is attributable to multifactorial perioperative blood loss and to the correction of complex derangements in the coagulation system. Although the amounts of blood transfused have decreased among transplant centers as experience is gained (1–4), OLT surgery still requires extensive blood bank support.

Despite significant efforts being made to ensure the quality, safety, and efficacy of blood usage, persistent residual risks exist. The unnecessary and inappropriate use of blood and blood products increases both risk to the patient and health care costs, and contributes to blood shortages. Wide variations in blood use among hospitals in comparable clinical situations may imply overuse, underuse, or both. Multiinstitutional studies have been performed in coronary artery bypass grafting surgery showing that blood component usage markedly differs among centers (5–7). The Sanguis Study Group (8) has reported striking differences in blood product usage for various types of surgical procedures among teaching hospitals in Europe. In OLT surgery, there are differences in reported blood component requirements among institutions (3). Yet this variability has neither been studied, nor has it even been well documented. It may be attributed to specific patient characteristics or surgical techniques. Moreover, several publications show marked differences among centers with regard to criteria directing blood product transfusion, to the strategies for overcoming a clinical coagulopathy, and to the role of coagulation monitoring techniques (9,10). Differences in institutional practices are likely to influence blood component use. The purposes of the present prospective study are to describe the variability in transfusions among institutions and to determine factors that may account for variability.

	Methods

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All French academic institutions performing >20 adult OLTs a year were asked to participate in the present prospective study. The study was approved by the Institutional Committee on Human Subjects. All consecutive adult (18 yrs) OLTs completed during a 12-mo period in the participating centers were included. Combined liver and kidney transplantations were included, but other types of multiorgan transplantation were excluded. For each individual OLT, the study period lasted from the start of anesthesia until the 48th postoperative hour. Patients who died during the study period were taken into account in the description of the population, but were excluded from the final analysis.

Abstracted perioperative data were prospectively recorded at each site using a standardized study file format. Perioperative blood components taken into account in the present study included allogeneic packed red blood cell (RBC) units, fresh frozen plasma (FFP) units, and platelet concentrates (PCs). Transfusion outcomes for each blood component were characterized in two ways: whether a blood component was transfused, and how much of the component was transfused during the study period. The characteristics of RBCs available at each site were uniform with regard to the hemoglobin (Hb) content. Plasma units were traditional FFP units, solvent/detergent treated plasma, or a combination of both. Platelets were transfused either as pooled PCs or as single donor apheresis platelets, both types of units containing a variable amount of platelets. To simplify the comparative analysis, platelet transfusion data were converted into PC units containing 10¹¹ platelets. All RBCs and platelet units were leukodepleted.

To give an insight into the center effect, perioperative factors that may account for blood component transfusion were considered. A search of the literature was conducted to identify factors that may influence blood loss and blood component transfusion in OLT. Other items were suggested to be of interest by clinical experience. All continuous variables were categorized (Table 1). The liver disease was treated as a dummy variable. For example, a case with carcinoma and liver cirrhosis was considered for both diseases. For serum bilirubin, prothrombin time (PT), and serum albumin, the categorization was derived from the Pugh’s scoring system. According to local practice, PT was expressed as percentage activity (<40% and 60% are approximately equivalent to >20 s and 16 s, respectively). The median values of the ischemia and surgery duration were used as a cut-off point.

The first analysis aimed at documenting intercentric variability in blood component use and at testing the role of patients and surgical conditions known to be associated with a large blood component use in the expected intercentric variability. For that purpose, the center, pre- and intraoperative characteristics indicative of increased surgical risk or of advanced liver failure were tested in a univariate analysis using the ² test and Student’s t-test, for qualitative and quantitative conditions, respectively. A multivariate analysis was performed using mixed-effects logistic regression including all the studied potential prognostic factors with a P value < 0.10 in univariate analysis and a center random effect.

To give further insight into the factors that may account for a possible variability, complementary analyses were conducted that, in addition to the former variables, included blood loss and variables belonging to the institutional behavior regarding blood loss management and transfusion therapy. The individual total Hb loss during the study period was used in place of blood loss, and was calculated using a mathematical model integrating the patient estimated blood volume, the change in Hb concentration, and the allogeneic Hb supply [the model, adapted from (11), is detailed in the Appendix]. A second multivariate analysis was conducted for RBC transfusion that aimed at determining whether variability in RBC use among the institutions could be explained by variations in RBC transfusion triggers or variations in blood loss. For that purpose, the Hb concentration at the end of the 48-h study period and/or the total calculated Hb loss was included in the multivariate analysis. Each center was tested against the others.

Likewise, the total Hb loss was included in a multivariate analysis conducted for FFP and PC transfusion, that aimed at determining whether institutional differences in FFP and PC transfusion were linked to differences in blood loss. In addition, the influences of the median institutional amount of RBCs, FFP, PCs, and aprotinin units on the individual probability of receiving blood products in excess of the median were explored in a complementary analysis. The relation among the three blood components and the median amounts of aprotinin and of the two other blood components (for example, RBCs and FFP in the PC analysis) were included in a mixed-effects logistic regression analysis.

Calculations were made with SAS version 8.2 software (SAS institute, Cary, NC). The macro GLIMMIX was used to perform the mixed-effects logistic regression analysis.

Results
Among the 12 academic institutions usually performing 20 adult OLTs a year, 8 participated in the study. From January 1, 1999 to December 31, 1999, 303 OLTs were performed in 290 recipients. Two recipients died at postoperative day 1; therefore, the blood component use analysis was performed on 301 cases. This represents 47% of the total OLT number performed in France during the same time period. The proportion of cases with a Model for End-Stage Liver Disease score <10, 11–20, and >20 was 30.3%, 50.1%, and 19.5%, respectively. There were 12 combined liver and kidney transplantations, 5 living-donor, and 5 split-liver transplantations. The number of OLTs per center ranged from 18 to 57. The main causes for OLT and characteristics of the recipients are indicated in Table 1. Hemodynamic monitoring was standard, including a pulmonary artery catheter. Aprotinin was the only pharmacologic drug used to decrease blood loss. The proportion of cases given aprotinin ranged from 16% to 100% depending on the center. Different dosing regimens were applied, the largest being a fixed dose of 2 x 10⁶ kallikrein inhibitory units (KIU) after the induction of anesthesia followed by an infusion of 0.5 x 10⁶ KIU/h. None of the cases received vasopressin. In 87% of cases, a technique was used to preserve venous return: inferior vena cava (IVC) conservation with transient porto-caval shunt (49%), IVC conservation alone (40%), or veno-venous bypass (4%). Significant intercentric differences are noted in the proportion of procedures lasting 7 h (P = 0.001).

Allogeneic RBC units were transfused in 86.4% of the cases. The overall median number of RBC units transfused is 5 (75th percentile = 10; maximum = 54). There are intercentric differences in the proportion of OLTs requiring RBC transfusion (P = 0.0015) as well as in the proportion of cases given >5 U (P < 0.001) (Fig. 1a). In center VII, RBCs were transfused in 100% of cases with the largest median value (10 U). In center VIII, RBCs were transfused in 87% of cases but with the smallest median value (4 U) and the smallest percentage of cases given >5 U (13%).

View larger version (39K): [in this window] [in a new window]   Figure 1. Transfusion of blood components in the eight centers: A, red blood cells (RBCs); B, fresh frozen plasma (FFP); and C, platelets. Empty bars are percent of cases with the component transfusion, hatched bars are percent of cases given more than the overall median, and circles the median number of units (excluding cases with no component transfusion). Platelet units represent 1011 platelets.

The statistical relationship between excessive FFP use (>6 U) and the variables listed in Table 1 were tested in univariate and multivariate analyses. In multivariate analysis, 4 characteristics were significantly associated with the use of >6 FFP units and intercentric differences remained statistically significant (Table 2). The use of venous return preserving techniques was related with FFP use in univariate analysis, but not in multivariate analysis (IVC conservation: P = 0.0008 and P = 0.41, respectively; venovenous bypass: P = 0.02 and P = 0.6, respectively).

The inclusion of the total Hb loss in the model did not eliminate the center as a significant predictive factor for FFP use in excess of the median (Table 5). The complementary analysis showed that the individual probability to receive >6 FFP units increased with the institutional median amount of RBC and PC units and significantly decreased with the institutional median amount of aprotinin units administered (Table 4).

The statistical relationship between excessive PC use (>5 U) and the variables listed in Table 1 was tested in univariate and multivariate analyses. In multivariate analysis, 4 characteristics were significantly associated with the use of >5 PC units and intercentric differences remained statistically significant (Table 2). The use of venous return preserving techniques was related to PC use in univariate analysis but not in multivariate analysis (transient portocaval shunt: P = 0.004 and P = 0.32, respectively).

The inclusion of the total Hb loss in the model did not eliminate the center as a significant predictive factor for PC use in excess of the median (Table 5). The complementary analysis showed that the individual probability to receive >5 PC units significantly decreased with the institutional median amount of aprotinin units administered (Table 4).

	Discussion

Top Abstract Introduction Methods Discussion Appendix References

 
This study was designed to prospectively evaluate interinstitutional variability in transfusion therapy in the perioperative care of liver transplant recipients. We found wide hospital-to-hospital differences in blood components usage, and that this heterogeneity could not be explained by differences in patient preoperative and intraoperative characteristics.

The variables that were associated with a large perioperative RBC use, listed in order of explanatory power, were preoperative serum creatinine, duration of surgery, preoperative PT, preoperative Hb level, and previous abdominal surgery. Duration of surgery, preoperative serum creatinine, and PT were associated with large FFP and PC use. Preoperative ascites was associated with FFP use, and preoperative platelet count with PC use. Some of those variables have already been pointed out in earlier retrospective studies on transfusion requirements in adult OLT (12–14). Although the identified characteristics cannot predict intraoperative blood loss and blood requirements on an individual basis because of their poor sensitivity and specificity (2,13,14), they remain statistically significant risk factors that are helpful to an adjusted comparison of centers. Our purpose was not to develop a prediction rule for estimating the blood product requirements, but rather to show that any prediction rule validated in one center cannot be generalized to other institutions. It is possible that factors not measured in this study or unpredictable intraoperative events unrelated to basal patient status might have contributed to perioperative blood component use. However, it is unlikely that these factors can account for such a substantial variability. Although we cannot exclude it, the results were probably not influenced by nonblinding because the average blood component use was in keeping with previous recent consumption in each center.

The main factors usually explaining interhospital variations in the use of blood products for comparable clinical situations are differences in perioperative blood loss and/or differences in transfusion criteria (5,6,8). Our data indicate that both differences in surgical blood loss and different RBC transfusion triggers contribute to the disparity in perioperative RBC use in the present study. The mathematical model used to estimate blood loss assumes a strict isovolemic situation and therefore is open to criticism. However, given the continuous peritoneal fluid transudation, the direct blood loss measurement is difficult in OLT, and likely leads to an inaccurate estimation of the true RBC loss. Taking perioperative Hb loss alone into account reduces the magnitude of the institutional variability without suppressing it all. In the present study, postoperative Hb data indicate that a divergence in transfusion triggers is a contributor to the differences in RBC use, at least regarding two centers. In the different countries where OLT is performed, numerous general guidelines for optimal use of blood components do exist and deliver basically the same message. However, OLT surgery is often regarded as a unique situation that escapes the general rule and deserves a specific approach. Different options for RBC transfusion have been reported. Whereas some authors think it advisable to keep the hematocrit between 0.30–0.35 (15,16), maintaining it at 0.26–0.28 is acceptable to others (17). Yet, taking postoperative Hb alone into account reduces the magnitude of the institutional effect without suppressing it all. The significant variability disappears only when both factors are introduced in the multivariate model.

Differences in blood loss may relate to differences in intraoperative surgical care, intravascular hydrostatic pressures in the surgical field, fluid management strategy, and/or perioperative management of coagulopathies. We are unable to assess the part that each of these factors have played in the variability observed. The role of different surgeons should not be minimized, because we noted large intercentric differences in the proportion of procedures lasting more than seven hours, a factor independently associated with a large blood component use. In the present study, the lack of relationship between the median institutional amount of FFP, PCs, and aprotinin units on the individual probability of receiving RBCs in excess of the median suggests there is no obvious link between a large RBC use and a restrictive institutional policy regarding hemostatic blood product use. Prophylactic aprotinin administration decreased intraoperative blood loss and RBC requirements in a European multicenter randomized study (18). In the present study, the median amount of aprotinin used in the institution was not identified as a factor associated with a decreased individual probability of receiving RBCs in excess of the median. However, aprotinin was used in a selective way in most centers. In many cases, aprotinin was not given prophylactically from the beginning of the procedure, but later administered if blood loss was deemed excessive. Moreover, when aprotinin was administered prophylactically, its use was often restricted to patients considered at high risk of bleeding. Because blood loss could influence aprotinin use, the recognition of an independent effect of the agent on blood transfusion was biased. Therefore, aprotinin could not appear as a blood sparing agent in the present study. For the same reason, an RBC sparing efficacy of the use of a cell saver cannot be detected.

Hospital-specific differences in coagulation management are the most likely explanation to the striking variability in FFP use. This is suggested by the link between a small institutional median amount of aprotinin and the individual probability to receive FFP and/or platelets, but not RBCs, in excess of the median. Moreover, the variability in FFP use persists despite adjustments on perioperative Hb loss, indicating that FFP use does not depend solely on blood loss, but also on local practices. The same findings apply to platelet transfusions. This inconsistency may result from difficulties in assessing the intraoperative hemostatic status during OLT, and from the diversity of attitudes toward abnormal coagulation test results. It is generally admitted that coagulation disorders only need correction if they result in clinical bleeding (19). However, the clinical assessment of an incipient microvascular bleeding may be difficult (20), and laboratory assessment of coagulation takes time. Delays in acquiring the results can be a major problem, even for common tests such as PT and activated partial thromboplastin time.

In this setting, and in the face of a complex procedure in patients with hepatic failure, a wide variability in decision making among physicians can be expected. Many will consider that FFP transfusion while waiting for laboratory results is reasonable and preferable to not giving coagulation factors in time. There is a heterogeneous corpus of reported attitudes regarding the perioperative management of the coagulation system and the role of blood component replacement therapy in OLT. The advised minimal platelet count varies from 30 (21) to 100 G/L (22), a difference that is likely to markedly influence platelet transfusion in the thrombopenic OLT recipients. Many institutions have specific guidelines for FFP transfusion that are based on conventional coagulation tests or on thromboelastographic monitoring (17). In contrast with this careful coagulation testing adjusted use of FFP, some authors have questioned the usefulness of intraoperative coagulation monitoring to guide blood component transfusion and deliberately rely on FFP infusion for volume replacement (10). The indications of FFP infusion vary according to the goal: clotting improvement in some centers, active volume expansion for hemodynamics maintenance in others. Conversely, Dupont et al. (16) support the view that FFP administration is not essential and that OLT may be successfully performed without it. The appropriateness of the reported transfusion thresholds and blood component administration schemes have not been evaluated prospectively in randomized studies.

In conclusion, our study shows a significant heterogeneity in transfusion practice patterns in OLT surgery, even in the same European country. The variability could not be explained by differences in the preoperative recipient status, and only partly by differences in perioperative blood loss. The study underscores that any prediction rule developed and validated in one center cannot be simply generalized to other institutions.

	Appendix

Top Abstract Introduction Methods Discussion Appendix References

 
Total Hb loss was calculated using the following formula:

Where:

The average content in Hb of an RBC unit in France is 54 g (range 40–70).

	Footnotes

 
The French Study Group on Blood Transfusion in Liver Transplantation: F. Courtois, E. Peynaud, Etablissement Français du Sang; F. Pessione, Etablissement Français des Greffes; M. H. Denninger, Laboratoire d’Hémato-Immunologie biologique, Hôpital Beaujon, Clichy; E. Samain, F. Lagneau, Department of Anesthesiology, Hôpital Beaujon, Clichy; N. Declerck, Department of Anesthesiology, Hôpital Huriez, Lille; B. Goubaux, Department of Anesthesiology, Hôpital Larchet, Nice; G. Mahoudeau, G. Freys, J. P. Beller, Department of Anesthesiology, Hôpital Hautepierre, Strasbourg; Y. Ozier, P. Chaussis, Department of Anesthesiology, Hôpital Cochin, Paris; C. Pignal, Department of Anesthesiology, Hôpital Croix-Rousse, Lyon; P. Revel, Department of Anesthesiology, Hôpital Pellegrin, Bordeaux; L. Villalon, Department of Anesthesiology, Hôpital de Pontchaillou, Rennes.

	References

Top Abstract Introduction Methods Discussion Appendix References

 

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Anesthesia & Analgesia® is published for the International Anesthesia Research Society® by Lippincott Williams & Wilkins with the assistance of Stanford University Libraries' HighWire Press®. Copyright 2006 by the International Anesthesia Research Society. Online ISSN: 1526-7598   Print ISSN: 0003-2999