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CARDIOVASCULAR ANESTHESIA

Does Intraoperative Hetastarch Administration Increase Blood Loss and Transfusion Requirements After Cardiac Surgery?

Jill E. Knutson, BSN, SRNA^*, Jane A. Deering, SRNA, PhD^*, Frank W. Hall, BSN, SRNA^*, Gregory A. Nuttall, MD, Darrell R. Schroeder, MS, Roger D. White, MD, and Charles J. Mullany, MD^§

*Mayo School of Health-Related Sciences; Department of Anesthesiology, Mayo Graduate School of Medicine; Department of Health Sciences Research, Mayo Clinic; §Department of Cardiac Surgery, Mayo Graduate School of Medicine, Rochester, Minnesota

Address correspondence and reprint requests to Gregory A. Nuttall, MD, Department of Anesthesiology, Mayo Clinic, Rochester, MN 55905. Address e-mail to nuttall.gregory{at}mayo.edu

	Abstract

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Hetastarch is used for intravascular volume expansion in cardiac surgery. Studies show conflicting effects of intraoperative hetastarch administration on postoperative bleeding. Hetastarch was routinely used for volume expansion during cardiovascular surgeries at our institution until its use was discontinued intraoperatively. We performed a retrospective chart review on patients undergoing primary coronary artery bypass grafting, valve repair or replacement requiring cardiopulmonary bypass (n = 444), 234 of which received intraoperative hetastarch and 210 did not. There was no difference in demographics, cardiac surgery, or cardiopulmonary bypass duration between the two groups. Blood loss for 0–4 h postoperatively was 377 ± 244 mL in the group not receiving hetastarch compared with 515 ± 336 mL in the group that received hetastarch (P < 0.001). For 0–24 h postoperatively, blood loss was 923 ± 473 mL versus 1,283 ± 686 mL in the absence and presence of hetastarch, respectively (P < 0.001). Allogeneic transfusion requirements (cryoprecipitate, fresh frozen plasma, and platelets) were larger in the hetastarch group (all P < 0.001). Nearly all (99%) patients in the hetastarch group received less than the manufacturer’s recommended dose (20 mL/kg) of hetastarch.

Implications: Our large retrospective study suggests that intraoperative use of hetastarch in primary cardiac surgery with cardiopulmonary bypass may increase bleeding and transfusion requirements. A large prospective study is needed to determine if intraoperative administration of hetastarch should be avoided during cardiovascular surgery.

	Introduction

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Excessive bleeding after cardiopulmonary bypass (CPB) is one of the most common complications of cardiac surgery and can have multiple etiologies (1). Excessive hemorrhage results in the transfusion of allogeneic blood products that may expose the patient to additional risks (HIV, hepatitis, and transfusion reactions) (2–4) and increased expense (5). Postoperative hemorrhage also results in mediastinal reexploration in 3.6%–4.2% of patients (6,7), with a higher incidence noted in certain populations of patients (7). Mediastinal reexploration for excessive bleeding significantly increases patient morbidity, mortality, and hospital costs (7,8).

Hetastarch (6% hydroxyethyl starch), a synthetic colloid with properties similar to those of albumin (9), is widely used in cardiac and noncardiac surgery to increase intravascular volume. Hetastarch is considerably less expensive than albumin, but it may have deleterious effects on coagulation. A retrospective study by Cope et al. (10) demonstrated increased bleeding in cardiac surgical patients who received hetastarch and a correlation between hetastarch infusion and perioperative bleeding. Until this time, hetastarch was routinely used for volume expansion during cardiovascular surgeries at our institution. Based on the findings of Cope et al. (10), the intraoperative use of hetastarch was discontinued by the study surgeon at our institution in January 1997, and crystalloid or albumin was substituted. In the next 18 months, there appeared to be a subjective decrease in perioperative blood loss, transfusion requirements, and the incidence of surgical reexploration of the mediastinum for excessive bleeding. The aim of this large retrospective study was to determine whether hetastarch increases the amount of bleeding and transfusion requirements associated with primary cardiac surgical procedures.

	Methods

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We performed a retrospective chart review on cardiac surgical patients requiring CPB performed by a single surgeon (n = 565) at a large medical center in the midwestern United States between January 1995 and December 1998. Authorization for this study was obtained from the institutional review board, and all included patients provided consent for their medical records to be used for research. The most anesthetics in this study were provided by one anesthesiologist, and his criteria for infusion of intravascular volume expanders were the clinical need for volume expansion based on low blood pressure and/or tachycardia. The minimum dose was that volume required to restore normovolemia. The infusions were given for both acute volume expansion and maintenance. Hetastarch was not used to prime the CPB circuit. Hetastarch was routinely used for intravascular volume expansion during cardiovascular surgeries by the study surgeon at our institution until January 1997. Hetastarch was discontinued, based on the findings of Cope et al. (10). For the current investigation, charts were reviewed for patients undergoing surgery between January 1995 and December 1998 to allow similar numbers in the hetastarch and no hetastarch groups. To reduce variation in patient outcomes based on technique, all cases were performed by the same surgeon; and of the 565 surgeries reviewed, 121 were excluded from the analysis for one or more of these reasons: previous sternotomy (n = 47), use of aprotinin (n = 56), use of tranexamic acid (n = 17), reoperation for surgical bleed (n = 28), and use of hetastarch postoperatively (n = 23). None of our patients received -aminocaproic acid. There were no pregnant or pediatric patients.

Patients were administered anesthesia using moderate dose opioids balanced with benzodiazapines, nondepolarizing muscle relaxants, and inhaled anesthetics. CPB was accomplished with a Sarns 9000 CPB machine (Sarns, Inc., Ann Arbor, MI) and a Univox membrane oxygenator (Bently, Inc., Irvine, CA). The priming solution consisted of 1.5 L plasmalyte, 10 mEq sodium bicarbonate, and 12.5 g mannitol. Patients were initially dosed with porcine heparin at 300 units/kg and an oxygenator prime of 10,000 units. When necessary, an additional 5,000 units of heparin was administered to achieve a celite activated clotting time (ACT) greater than 450 s prior to the initiation of bypass. After bypass, heparin was neutralized with protamine sulfate at a dose of 1.3 mg/kg. If this dose failed to return the ACT to within 10% of the pre-heparin level, additional protamine doses of 20–50 mg were given at the discretion of the anesthesiologist. Intraoperative mediastinal blood loss was salvaged and reinfused in all cases. During CPB, a hemoglobin concentration greater than 7 g/dL was maintained, preferentially by reinfusion of salvaged blood, with allogeneic red blood cells (RBCs) used when autologous blood was not available. After CPB, allogeneic RBCs were transfused to achieve a hemoglobin concentration greater than 8 g/dL. The decision to transfuse allogeneic fresh frozen plasma (FFP), platelets, and cryoprecipitate was based on clinical evidence of bleeding, such as oozing at the surgical site, as well as laboratory studies. The general transfusion criteria for "coagulation blood products" were:

1. Transfusion of platelets with evidence of platelet dysfunction or thrombocytopenia (a platelet count less than 50 x 109/L) in a bleeding patient.

2. Transfusion of FFP, with evidence of coagulation factor deficiencies (prothrombin time or activated partial thromboplastin time [aPTT] > 1.5 times the upper limits of normal).

3. Transfusion of cryoprecipitate for suspected clotting factor deficiency (elevated bleeding time or fibrinogen < 100 mg/dL).

There were no specific transfusion algorithms used during the study period.

The primary outcome variable was postoperative blood loss, which was measured and recorded hourly by the Intensive Care Unit (ICU) staff. Other variables measured included transfusion of allogeneic blood products in the operating room and in the first 24 h in the ICU, and time from end of CPB to exit from operating room. Data are presented as median or mean ± SD. Patients who did versus patients who did not receive hetastarch were compared using the 2 test for discrete variables and the rank sum test for continuous variables.

To assess whether the use of hetastarch was an independent predictor of postoperative blood loss, a multivariate analysis was performed. For this analysis, the dependent variable was 0–4 h postoperative blood loss. Independent variables included continuous variables for age, body mass index, CPB duration, last pulmonary artery catheter temperature in the operating room, total heparin dose, postprotamine ACT, as well as platelet count, international normalization ratio (INR), aPTT, and creatinine level on arrival to the ICU. Categorical variables defining hetastarch use (yes/no), gender (male/female), valve procedure (yes/no), and preoperative anticoagulant use (heparin/coumadin/aspirin/persantine/none) were also included as independent variables in the multivariate analysis. Patients who received multiple preoperative anticoagulants were assigned to the category for the strongest anticoagulant received using the order given previously. The multivariate analysis was performed using a stepwise backward algorithm. All of these independent variables were entered into the model at the first step. The most nonsignificant variable was then removed, and the model was refitted. Again, the most nonsignificant factor was removed, and this stepwise backward process was repeated until all remaining variables were significant (P 0.05).

After identifying the final multivariate model using the stepwise backward procedure, an analysis was performed using a multivariate model that included a continuous independent variable defining date of surgery in addition to the final set of independent variables identified through the backward elimination process. From this model, a significant association between date of surgery and postoperative blood loss would indicate that the multivariate approach did not fully account for temporal changes that may have occurred in other aspects of patients management over the study period. This additional analysis was performed using all patients and also separately for those who did and did not receive hetastarch.

To assess the potential dose relationship between administration of hetastarch and blood loss, we performed a linear regression analysis that included only those patients who received hetastarch. For this analysis, the dependent variable was 0–4 h postoperative blood loss, and the independent variable was hetastarch dose (mL/kg). In all cases, two-sided tests were used with P values 0.05 considered statistically significant.

	Results

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The patient and procedural characteristics of the 444 patients in the study (n = 234 with hetastarch; n = 210 without hetastarch) are presented in Table 1. For the 234 patients receiving hetastarch, the amount given ranged from 250 to 1,500 mL (median 1,000 mL, mean ± SD 795 ± 258 mL) and resulted in doses ranging from 3.1 to 20.6 mL/kg (median 9.8 mL/kg, mean ± SD 9.8 ± 3.8 mL/kg). Nearly all (99%) of the hetastarch patients received less than the manufacturer’s recommended dose (20 mL/kg) of hetastarch. Patients who did and did not receive hetastarch were similar with respect to age, gender, and body mass index. Compared with those who did not receive hetastarch, patients who received hetastarch had a higher frequency of preoperative anticoagulant use (86% vs 79%, P = 0.043). The majority of patients in both groups underwent coronary artery bypass grafting procedures. There was no statistically significant difference in duration of aortic cross-clamp and duration of CPB between the two groups. However, compared with the no hetastarch group, the hetastarch patients experienced lower temperatures during CPB (median 28°C vs 31°C, P = 0.002) and remained in the operating room significantly longer after CPB (median 96 minutes vs 88 minutes, P < 0.001; Table 1).

We repeated the univariate and multivariate analyses, including the patients who were excluded for surgical bleeding, and found no differences in the findings of the study.

	Discussion

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Our study indicates that intraoperative hetastarch administration to patients undergoing primary cardiac surgery with CPB is associated with an increase in postoperative blood loss and allogeneic transfusion requirements in the ICU.

The literature shows conflicting data on the effect of hetastarch on coagulation. Several authors, while examining coagulation factors, demonstrated no effect of hetastarch on coagulation (11,12). Conversely, others (13,14) have found a decrease in several coagulation factors after hetastarch administration. Yet other studies have shown that patients undergoing cardiac surgery who received intraoperative hetastarch had increased chest tube drainage (15), increased transfusion requirements, and reoperations for bleeding (16). A review article on the safety of hetastarch by Warren and Durieux (17) concluded that there were insufficient data available to formulate formal guidelines regarding the use of hetastarch in specific patients, since most of the studies performed have been underpowered (n = 12–127). A power analysis performed in that review article found that 200 patients would be required to detect a 10% increase in postoperative blood loss in hetastarch-treated patients. Our study is currently the largest (n = 444) evaluating these effects of hetastarch. Using both univariate and multivariate analysis, we found that administration of hetastarch was associated with an increase in postoperative blood loss. There was some evidence indicating a dose relationship between the administration of hetastarch and blood loss. However, nearly all (99%) of the patients in the hetastarch group received less than the manufacturer’s recommended dose (20 mL/kg) of hetastarch. We, therefore, question whether there is a specific dose of hetastarch that will not increase bleeding risk when used for intraoperative volume expansion during cardiac surgery with CPB.

As previously noted, hetastarch induces changes in coagulation factor concentrations (13,14) and may reduce platelet function (18). The exact mechanism by which hetastarch is associated with increased bleeding and transfusion requirements in cardiac surgery patients cannot be addressed in this study. However, time appears to be an important factor related to the exposure of the patients’ blood to hetastarch in the period several hours after CPB. During this period, platelet function is at a nadir, and fibrinolytic activity is at a maximum (10).

We identified a significant difference in the use of preoperative anticoagulant therapy and the laboratory indices of coagulation (INR and aPTT) between groups who did and did not receive hetastarch. Dietrich et al. (19) found that preoperative phenprocoumon (a warfarin analog) therapy reduced bleeding after CPB, and preoperative IV heparin therapy increased bleeding. A greater percentage of the hetastarch patients were on preoperative IV heparin therapy. When we performed our multivariate analysis, hetastarch was still shown to have a persistent effect on blood loss.

It should be noted that the patients who received intraoperative hetastarch had significantly lower core temperatures during CPB. Some studies have shown that hypothermia may inhibit coagulation and induce platelet dysfunction, and may then potentiate blood loss, especially if hypothermia is associated with a prolongation in CPB duration (20–22). However, a recent study by Stensrud et al. (23) examined the effect of normothermic and hypothermic CPB on blood loss and transfusion requirements. They demonstrated similar blood loss and transfusion requirements in both normothermic and hypothermic CPB groups.

The retrospective nature of this study is a limitation. As previously noted, changes in practice may have occurred over the time of the study. The multivariate analysis was performed to control for as many of these differences as we could identify, and hetastarch use was still found to be associated with increased bleeding in the ICU. After adjusting for the variables included in the final multivariate model, we did not detect an association between postoperative blood loss and calendar time. However, there may be factors that changed over time for which the multivariate analysis did not correct, which explain the differences in bleeding and transfusion that were found. Patients who received antifibrinolytic therapy, aprotinin and tranexamic acid, and revision sternotomy patients were excluded from the study. This was done to keep possible changes in our antifibrinolytic therapy from affecting the study’s outcome. This limits the broad applicability of our study. Furthermore, our transfusion behavior may have been influenced by our decision to discontinue the use of hetastarch and our opinion prior to starting this study that hetastarch was associated with increased bleeding. However, the personnel in the ICU were generally not aware of whether hetastarch was used, and there was a statistically significant reduction in allogeneic blood transfusions in the ICU. A further limitation of our study is that rigorous transfusion guidelines were not used, nor were rigorous guidelines for the infusion of hetastarch, albumin, or crystalloid. This limits the significance of the transfusion results. All of these limitations are inherent to retrospective studies and temper the strength of our findings. To definitively answer the question of whether intraoperative hetastarch use increases postoperative bleeding, a large prospective study will have to be performed.

In summary, this study is currently the largest investigation of whether postoperative blood loss and transfusion requirements are increased in primary cardiovascular surgery patients who received intraoperative hetastarch. Nearly all (99%) patients in the hetastarch group received less than the manufacturer’s recommended dose (20 mL/kg) of hetastarch. We, therefore, conclude that intraoperative administration of hetastarch to patients undergoing cardiac surgery with CPB is associated with increased bleeding and transfusion of blood products. We recommend that a large prospective study be performed to determine if intraoperative administration of hetastarch should be avoided during cardiovascular surgery.

	Acknowledgments

 
This study was supported by the Mayo Foundation for Medical Education and Research.

	Footnotes

 
Presented at the Society of Cardiovascular Anesthesiologists Annual Meeting, Chicago, IL, April 25, 1999.

	References

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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in ISI Web of Science Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via ISI Web of Science (42) Citing Articles via Google Scholar Google Scholar Articles by Knutson, J. E. Articles by Mullany, C. J. Search for Related Content PubMed PubMed Citation Articles by Knutson, J. E. Articles by Mullany, C. J.

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