Hemoglobin Value Reduction and Necessity of Transfusion in Bimaxillary Orthognathic Surgery

J Oral Maxillofac Surg 63:623-628, 2005

Hemoglobin Value Reduction and Necessity of Transfusion in Bimaxillary Orthognathic Surgery Emeka Nkenke, MD, DMD, PhD,* Peter Kessler, MD, DMD, PhD,† Jörg Wiltfang, MD, DMD, PhD,‡ Friedrich Wilhelm Neukam, MD, DMD, PhD,§ and Volker Weisbach, MD, PhD储 Purpose: It has been the aim of the present clinical study to assess the reduction of the hemoglobin

value and the frequency of blood transfusions during bimaxillary orthognathic surgery and to discuss the clinical consequences. Patients and Methods: Fifty-six patients (31 female, 25 male; mean age, 28.6 ⫾ 13.0 years; range, 14 to 66 years) were operated on. Twenty-nine patients predeposited blood before surgery. As a threshold for intraoperative or postoperative transfusion, a hemoglobin value of 7.5 g/100 mL was chosen. Results: Perioperatively, the hemoglobin values of the patients who predeposited blood decreased significantly after blood donation. The hemoglobin value reduced postoperatively by 2.6 ⫾ 1.4 g/100 mL in the non-donors and by 2.6 ⫾ 1.1 g/mL in the donors. None of the patients who did not predeposit blood received homologous blood transfusions intraoperatively or postoperatively. In the group of patients who predeposited blood, 3 were transfused intraoperatively. They received 1 or 2 units of autologous blood. Conclusion: The individual statistics of the department show that there was only a limited reduction of the intraoperative and postoperative hemoglobin values as a consequence of bimaxillary orthognathic surgery. The increased safety of homologous blood and the minimal transfusion rates support abandonment of routine predepositing of autologous blood and the acceptance of homologous blood in the rare case of transfusion in bimaxillary surgery. © 2005 American Association of Oral and Maxillofacial Surgeons J Oral Maxillofac Surg 63:623-628, 2005 until almost 50% red blood cell mass is lost.1 However, today the mandatory blood donor polymerase chain reaction screening in Germany significantly reduces the risk of infections with human immunodeficiency virus (HIV) and hepatitis C virus.2 Autologous blood transfusion has been said to be an effective alternative for the orthognathic surgical patient.3 It demonstrates many advantages when a well-developed self-deposit program is available. The most important reason for an autologous blood donation is the greatly reduced risk of disease transmission.4 Previous reports have shown high rates of blood transfusion in bimaxillary orthognathic surgery, when autologous blood was available. In some studies, up to 50% of the patients have been transfused.4-9 On the other hand, it has been shown that blood transfusion was not necessary, if no autologous blood had been predeposited.10 It was the aim of this study to assess the reduction of the hemoglobin value and the rate of transfusions in patients undergoing bimaxillary orthognathic surgery. Based on these data, the need for autologous

Bimaxillary orthognathic surgery may be complicated by excessive blood loss. Undesirable homologous transfusion reactions have compromised this transfusion technique. Risks associated with transfusion of homologous blood, including the acquisition of infectious disease, have led to clinical guidelines that discourage homologous transfusion in healthy patients

Received from the University of Erlangen-Nuremberg, Erlangen, Germany. *Associate Professor, Department of Oral and Maxillofacial Surgery. †Associate Professor, Department of Oral and Maxillofacial Surgery. ‡Associate Professor, Department of Oral and Maxillofacial Surgery. §Professor and Head, Department of Oral and Maxillofacial Surgery. 储Associate Professor, Department of Transfusion Medicine and Hemostaseology. Address correspondence and reprint requests to Dr Nkenke: Department of Oral and Maxillofacial Surgery, University of Erlangen-Nuremberg, Glueckstr. 11, 91054 Erlangen, Germany; e-mail: [email protected] © 2005 American Association of Oral and Maxillofacial Surgeons

0278-2391/05/6305-0004$30.00/0 doi:10.1016/j.joms.2005.01.005

623

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BLOOD TRANSFUSION IN BIMAXILLARY SURGERY

Table 1. BASIC PATIENT DATA

Non-donors

Age Body weight Body height

Donors

Mean ⫾ SD

Minimum

Maximum

Mean ⫾ SD

Minimum

Maximum

P Value

29.3 ⫾ 14.4 70.7 ⫾ 13.0 173.0 ⫾ 9.6

14 46 153

66 96 188

27.9 ⫾ 11.8 69.7 ⫾ 15.7 172.0 ⫾ 8.6

16 37 154

61 109 183

.993 .538 .761

Nkenke et al. Blood Transfusion in Bimaxillary Surgery. J Oral Maxillofac Surg 2005.

blood donation in light of a reduced risk of infections by homologous blood transfusions is discussed.

Patients and Methods At the Department of Oral and Maxillofacial Surgery of the University of Erlangen-Nuremberg (Erlangen, Germany) 89 consecutive healthy patients underwent bimaxillary orthognathic surgery from October 2000 to July 2002. Of these, 56 agreed to be included in the study (31 female, 25 male; mean age, 28.6 ⫾ 13.0 years; range, 14 to 66 years) (Tables 1 and 2). The follow-up data were assessed prospectively. The patients were invited to join the autologous blood program at the Department of Transfusion Medicine and Hemostaseology of the University of Erlangen-Nuremberg, which is available to all patients undergoing elective surgery who meet the current German and European guidelines for autologous blood donation.11,12 In particular, a hemoglobin value of ⱖ11.5 g/100 mL for women and ⱖ12.0 g/100 mL for men and absence of risk factors for bacteremia are requested. Infectious diseases were excluded by testing for markers of HIV, syphilis, and hepatitis B and C. A frequency of donation not greater than 1 unit per week, beginning 6 to 7 weeks before surgery, is chosen.13 There is no age limit for blood donations.14 A written request from the surgeon was accompanied by a data sheet that included the number of units requested and the prospective date of surgery. At each donation, 450 mL of blood were collected via phlebotomy. Patients received 280 mg of ferrous sulfate (Ferrlecit; Rhône-Polenc Rorer Arzneimittel, Cologne, Germany) 2 times a day beginning several days before phlebotomy and continuing for up to 2 months after surgery, when the initial serum ferritin concentration was below 50 ␮g/L.15 The autologous blood units were cross-matched on the day before the operation. The patients were starved 6 hours before surgery. All patients received routine antibiotics (Penicillin “Grünenthal” 10 Mega; Grünenthal, Aachen, Germany), steroids (Soludecortin H 250 mg; Merck, Darmstadt, Germany), and thrombosis prophylaxis (Monoembolex PEN; Novartis Pharma, Nuremberg, Germany) perioperatively. A standardized

general anesthetic technique with a continuous fluid administration of 10 mL/kg body weight/h was applied. A single-segment Le Fort I osteotomy and a modified bilateral sagittal split ramus osteotomy were carried out.16,17 The stabilization was performed by a rigid fixation with 4 L-shaped 4-hole 2.0-mm titanium miniplates in the maxilla and 2 straight 4-hole 2.0-mm titanium miniplates in the mandible (Champy miniplate osteosynthesis system; Martin Medizintechnik, Tuttlingen, Germany). The duration of the surgery was documented. The venous hemoglobin concentration was assessed preoperatively, intraoperatively after the down-fracture of the maxilla, and on the second day after surgery. As a threshold for transfusion a hemoglobin value of 7.5 g/100 mL was chosen. Postoperatively, symptoms of anemia (lethargy, orthostatic hypotension, tachycardia, and pallor) were documented.

Statistics Mean values were given with standard deviations. The Wilcoxon test was used for comparison of paired samples because normality of the variables could not be assumed because of the small case numbers. The Mann-Whitney-U test was chosen for comparison of unpaired samples. P values ⱕ.05 were considered significant. All calculations were performed using SPSS for Windows, version 11.5 (SPSS Inc, Chicago, IL).

Results Fifty-two patients were operated on because of maxillary deficiency and mandibular excess. Two of

Table 2. BASIC PATIENT DATA

Gender

Donors Non-donors

Female (N)

Male (N)

15 16

12 13

Nkenke et al. Blood Transfusion in Bimaxillary Surgery. J Oral Maxillofac Surg 2005.

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Table 3. FOLLOW-UP DATA

No Predeposit

Hemoglobin before donation (g/100 mL) No. of donated units Preoperative hemoglobin (g/100 mL) Intraoperative hemoglobin (g/100 mL) Duration of surgery (min) Postoperative hemoglobin (g/100 mL)

Predeposit

P Value

Mean ⫾ SD

Minimum

Maximum

Mean ⫾ SD

– –

– –

– –

14.3 ⫾ 1.2 1.6 ⫾ 0.5

12.8 1

17.4 2

– –

14.1 ⫾ 1.3

12.4

16.4

13.5 ⫾ 1.3

10.6

15.4

.228

12.8 ⫾ 1.3 208.1 ⫾ 48.2

10.8 132

15.8 300

11.9 ⫾ 1.9 219.0 ⫾ 54.7

7.3 103

14.2 338

.173 .426

8.3

15.1

11.0 ⫾ 1.6

8.3

13.7

.168

11.5 ⫾ 1.6

Minimum

Maximum

Nkenke et al. Blood Transfusion in Bimaxillary Surgery. J Oral Maxillofac Surg 2005.

these patients suffered from an additional cleft lip and palate malformation. In 4 patients the indication for bimaxillary surgery was an obstructive sleep apnea syndrome. After the autologous blood donation program was explained and recommended to the patients, 35 subjects decided to participate. After the first examination, 6 patients had to be excluded. One patient suffered from an HIV infection, and 1 patient showed a leucocytosis because of a diarrhea. In 2 patients the risk of bacteremia was significantly increased by a piercing of the tongue or potential injuries of the oral mucosa by a special orthodontic device. In 2 patients the drawing of blood was not possible because of extremely fragile venous systems. Results of the analysis of the prospectively assessed data are given in detail in Tables 3 to 5. The age of the 27 patients who did not predeposit autologous blood did not differ statistically from the 29 patients who did predeposit blood. Preoperatively, the hemoglobin levels of the donors and non-donors did not show significant differences. In 12 patients of the donor group 1 unit of blood was collected, while in 17 patients a predeposit of 2 units was carried out. After a regeneration interval of 6 weeks, the hemoglobin values of the patients who predeposited blood were still significantly reduced compared with the hemoglobin levels before donation (P ⫽ .001). Operation times did not differ significantly for the 2 patient groups. The hemoglobin levels decreased sig-

Table 4. P VALUES OF THE STATISTICAL ANALYSIS (NON-DONORS)

Intraoperative hemoglobin Postoperative hemoglobin

Preoperative Hemoglobin

Intraoperative Hemoglobin

⬍.0005 –

– ⬍.0005

Nkenke et al. Blood Transfusion in Bimaxillary Surgery. J Oral Maxillofac Surg 2005.

nificantly compared with the preoperative values for donor and non-donors. Intraoperatively, none of the patients who did not predeposit blood reached the critical hemoglobin value of 7.5 g/100 mL. In the donor group, the hemoglobin value decreased below this level in 3 patients. The preoperative hemoglobin values after a regeneration time of 6 weeks of these patients were below the average value of the donor group. They showed levels of 12.8, 12.5, and 10.6 g/100 mL, respectively. In 1 patient, the operation time (142 minutes) was below the average value, while 2 patients had an operation time longer than the average value (230 and 260 minutes, respectively). All 3 patients had a below-average body weight (37 kg, 48 kg, and 59 kg, respectively). At day 2 after surgery, hemoglobin levels did not differ significantly for donors and non-donors. Again, the values reduced significantly compared with the intraoperative data. The hemoglobin level decreased on average by 2.6 ⫾ 1.4 g/100 mL in the non-donors and by 2.6 ⫾ 1.1 g/100 mL in the donors, respectively. None of the patients showed clinical signs of anemia 2 days after surgery. Table 5. P VALUES OF THE STATISTICAL ANALYSIS (BLOOD DONORS)

Preoperative Preoperative Hemoglobin Hemoglobin Before After Intraoperative Donation Donation Hemoglobin Preoperative hemoglobin after donation Intraoperative hemoglobin Postoperative hemoglobin

.001

–

⬍.0005

–

⬍.0005

–

–

–

⬍.0005

Nkenke et al. Blood Transfusion in Bimaxillary Surgery. J Oral Maxillofac Surg 2005.

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Discussion The conservation of blood is recognized to be a priority in all forms of surgery, especially in elective procedures because of the risks of blood transfusion.18 Clinical guidelines have discouraged homologous transfusion because of the possible acquirement of various infections. Before the polymerase chain reaction tests for HIV and hepatitis C virus were introduced to the screening of homologous blood donors as a standard in Germany, the infection rates were ⬍1:1.000.000 for HIV, 1:200.000 for hepatitis B virus, and 1:100.000 for hepatitis C virus by blood transfusion.19 An additional reduction of the very low transmission risk for HIV, and especially for hepatitis C virus, can be assumed from the introduction of mandatory blood donor polymerase chain reaction screening.2 Before these updated infection data were assessed, it was generally accepted that a necessity for transfusion in more than 10% of the patients undergoing a certain kind of elective surgery represented the indication for preoperative autologous blood donation.20 This threshold level should be raised decisively because only low infection rates have to be expected from homologous transfusion today. To date, it seems that the perioperative risk of infection by hepatitis through blood transfusions becomes less important, while the transmission of the disease by infected surgeons and medical personnel covers a rising percentage of the affected patients.21 An improvement of safety could be achieved by an active vaccination against hepatitis B. It has been the aim of the present study to assess the perioperative reduction of the hemoglobin value and the rate of blood transfusions in bimaxillary orthognathic surgery and to evaluate the need for autologous blood donation in light of a reduced risk of infections by homologous blood transfusions. For standardized elective surgery, every German department performing these operations has to be able to present an individual statistical analysis of the probability of transfusion.22 The decision for or against autologous blood donation should be based on these data. Before the re-evaluation of the transfusion rate in bimaxillary orthognathic surgery was carried out for the Department of Oral and Maxillofacial Surgery of the University of Erlangen-Nuremberg, the autologous blood donation program had been offered to all of the patients of the present study to decrease the risk of transmission of infections by homologous blood transfusions. The disadvantages of autologous blood donation for the elective surgery patient cannot be ignored. Besides several risks of transfusion, the patient has to bear the risks of donation.23 They include the devel-

BLOOD TRANSFUSION IN BIMAXILLARY SURGERY

opment of hypovolemia and anemia.3 The latter may result in an increased rate of intraoperative and postoperative transfusions.24 Moreover, vasovagal reactions in cardiopulmonary compromised patients have to be considered.25,26 When autologous blood has been donated to avoid homologous transfusion, the guidelines for the use of autologous blood do not differ from those of homologous blood. In both cases, the screening of banked blood does not totally eliminate the possibility of disease transmission. Therefore, the indication of transfusion of predeposited autologous blood should be critically reviewed.7 The risk remaining in autologous blood is the possibility that the wrong unit may be transfused as a result of clerical or communication error. It is believed that, although the risk of clerical error resulting in transfusion of blood to the wrong patient is miniscule, this perceived risk outweighs the benefit of transfusion for patients not exhibiting clinical signs of anemia.4,7,27 Moreover, there is a minimal chance that the unit may be contaminated by bacteria at the time of collection. This contamination can be pre-existing as a result of a previous infection or can be related to bacteria from the skin that are brought into the vessels during phlebotomy. Therefore, if there is no decrease of the hemoglobin level below 7.5 g/dL, the predeposited autologous blood units are not returned to their donors.1,13,28 German transfusion guidelines exclude the use of these units as homologous blood. The costs of autologous blood predeposition are substantial. The additional expenses of autologous blood are primarily a function of discarding of units that are donated but not transfused. The hidden costs include time away from work and travel expenses.4 Patients undergoing orthognathic surgery are usually young and in good health. Because of their long life expectancy, the long-range consequences of complications from transfusion of blood can be considerable. Therefore, either autologous or homologous transfusions have to be evaluated critically.7 In the present study, 38 of 56 patients (67.8%) intended to donate blood before surgery. Comparable rates have been found previously, showing the high motivation of the patients to make the surgical procedure safer.10 Only 6 of these patients (13.2%) had to be excluded from autologous blood donation because of different contraindications. The reason for exclusion of an HIV patient was not related to a possible hazard of this patient, but to avoid the transmission of the disease by an erroneous homologous transfusion of the unit. The results of the study show that none of the patients who did not predeposit blood had to be transfused. The analysis of the transfusion rate of the patients who had donated autologous blood show

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that 3 of 31 patients (9.6%) received blood. This rate is considerably lower than described in previous studies, where up to 50% of the patients were transfused with autologous blood.6 The reduced rate of transfusions in the present study can be attributed to the long regeneration interval of 6 weeks between blood donation and surgery. Moreover, previous studies have not defined a certain hemoglobin value as trigger for transfusion like 7.5 g/mL in the present study. With an average decrease of the hemoglobin value of 2.6 ⫾ 1.4 g/100 mL for the non-donors and 2.6 ⫾ 1.1 g/mL for the donors, respectively; the blood loss during the surgery was in the range of previous studies.29,30 Although the use of erythropoietin has been mentioned as an additional measure to increase the hemoglobin value preoperatively,19 some drawbacks and complications have been described in the recent years related to this drug. Hypertension and seizures have been found in chronic renal failure.31 In some of these patients, the use of recombinant human erythropoietin has induced neutralizing antibodies against endogenous erythropoietin leading to red cell aplasia. Moreover and most important, because of the low transfusion rates in orthognathic surgery, the use of erythropoietin is not cost-effective.31 More frequently, advantage should be taken of alternative techniques for the intraoperative conservation of blood.32-34 Hypotensive anesthesia is a wellestablished and effective method that is particularly useful in oral and maxillofacial surgery, reducing blood loss by 50%.32,35-37 The use of drugs like aprotinin to reduce bleeding has also emerged as an additional approach to the conservation of blood.32,38 The placement of the patient in a reverse Trendelenburg position, locating the surgical field above the heart level, as an additional measure has been mentioned to reduce the intraoperative blood loss.6,10 Out of 56 patients undergoing bimaxillary orthognathic surgery, only 3 patients had to be transfused. The improved way of testing homologous blood decreases the risk of transmission of infectious diseases decisively. Therefore, instead of autologous blood homologous blood should be accepted in the scarce cases of transfusion in bimaxillary orthognathic surgery.

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628 28. Neuwirth BR, White RP, Collins ML, et al: Recovery following orthognathic surgery and autologous blood transfusion. Int J Orthod Orthognath Surg 7:221, 1992 29. Toy PT, McVay PA, Strauss RG, et al: Improvement in appropriate autologous donations with local education: 1987 to 1989. Transfusion 32:562, 1992 30. Umstadt HE, Weippert-Kretschmer M, Austermann KH, et al: Transfusion need in orthognathic surgery. Mund Kiefer GesichtsChir 4:228, 2000 31. Cazzola M, Mercuriali F, Brugnara C: Use of recombinant human erythropoietin outside the setting of uremia. Blood 89:4248, 1997 32. Stewart A, Newman L, Sneddon K, et al: Aprotinin reduces blood loss and the need for transfusion in orthognathic surgery. Br J Oral Maxillofac Surg 39:365, 2001

BLOOD TRANSFUSION IN BIMAXILLARY SURGERY 33. Taylor KM: Aprotinin therapy and blood conservation: extending the indications. Br J Surg 92:1258, 1992 34. Welch HG, Meehan KR, Goodnough LT: Prudent strategies for elective red blood cell transfusion. Ann Intern Med 116:393, 1992 35. Anderson JA: Deliberate hypotensive anesthesia for orthognathic surgery: Controlled pharmacologic manipulation of cardiovascular physiology. Int J Adult Orthod Orthognath Surg 1:133, 1986 36. McNulty S, Sharifi-Azad S, Farole A: Induced hypotension with labetalol for orthognathic surgery. J Oral Maxillofac Surg 45:309, 1987 37. Schaberg SJ, Kelly JF, Terry BC, et al: Blood loss and hypotensive anesthesia in oral-facial corrective surgery. J Oral Surg 34:147, 1976 38. Matthey F: Autologous blood transfusion: Indications and potential use in the UK. Br J Hosp Med 22:418, 1988