Postoperative autologous blood transfusion with blood salvage device in the primary total hip replacement

AHL Wong

Address for Correspondence:
AHL Wong, 87 Trent Bridge Close, Stoke On Trent ST4 8JJ, United Kingdom.
Phone: +44 7593066622
E-mail: hielinwong@doctors.net.uk
 

Abstract:

Aim: The aim of the study was to determine whether post-operative autologous salvage system affects post-operative haemoglobin (Hb) levels and reduces the need for homologous blood transfusion (HBT). 
Methods: A prospective study of 211 patients who had undergone unilateral primary THR with their preoperative, post-operative Hb levels and requirement of homologous banked blood recorded. Cell Saver 5 was used post-operatively for autologous blood transfusion. 
Results: A total 211 patients with mean age of 70 years was enrolled to the study and complete data were obtained perioperatively. The mean pre-operative and post-operative Hb levels were 137.1g/L and 105.1g/L, respectively. Twenty-four units of homologous red blood were transfused to twelve (5.4%) patients, with a mean of 0.109 units per case. There were 65 patients (29.4%) older than 75 years, with 9 patients having pre-operative Hb less than 120 g/L. Patients older than 75 years were associated with a greater use of homologous blood with those equal or under the age of 75 years (chi-squared test, p = 0.001). Mean of in-hospital stay was 6 days. No transfusion-related and wound-related complications were reported.
Discussion: Primary THR can be safely performed without requiring HBT in patients without pre-existing haematological disorder using autologous retransfusion system. This study has shown that use of an autologous retransfusion system for primary THR reduces the necessity for HBT. Post-operative blood salvage also results in lesser patients dropping their post-operative Hb level below 9.0 g/L (15.8%).

J.Orthopaedics 2009;6(1)e10

Keywords:

arthroplasty; total hip replacement; autologous blood transfusion; homologous blood transfusion

Introduction:

Approximately 10% of red blood cell transfusion was used for orthopaedic surgery¹, such as spinal, total joint arthroplasty and revision orthopaedic operations. At present, there is no sound evidence on when to transfuse red cells and how much units of homologous blood to give. Furthermore, no significant measurable evidence was available for the differences in practice that might have on the clinical outcomes. In spite of the protocols and guidelines for red blood cell transfusion, studies have shown that homologous red cell blood transfusion can be as high as 30-57% following THR with mean volume of transfused red blood cell being 1.5 units² per case. 

Homologous blood transfusion (HBT) in hospital is not without risk, even in developed countries. Despites tight regulation and standards, complications from clerical errors, transmission of blood-borne infections, transfusion related acute lung injury (TRALI), transfusion relation allergic reaction and immuno-suppression remain³.  The incidence of hepatitis B and hepatitis C per unit of blood is estimated at 1 in 220,000 and 1 in 1,600,000, respectively, and the risk for Human Immunodeficiency Virus (HIV) transmission is 1 per 1, 800, 000 ⁴.

Risks of transfusion-transmitted disease, such as HIV and hepatitis, can be avoided with the use of autologous blood salvage system perioperatively. Other major risks associated with HBT which include acute haemolytic transfusion reaction, transfusion related allergic reaction, leukocyte, platelet, or red cell alloimmunization, and graft versus host reaction, can also be eliminated. Although some have noted adverse reactions involving fever, chills and tarchycardia in as many as 10 per cent of all patient⁵, no clinical sequelae, such as coagulopathy, electrolyte imbalance, renal insufficiency and abnormalities of oxygen exchange have been recognized.

Conclusive information in relation to the reduction of the rate of HBT with the use of Autologous blood transfusion (ABT) device in primary hip replacement was not available from previous studies because of the design of the study; some included primary and revision cases, others included hip and knee replacement, preoperative autologous blood donation (PABD) or intra-operative salvage was also made available in addition to the ABT device^6-8.

Preoperative donation is not available and intra-operative salvage is not implemented as yet in our unit. Our unit already had a well established autologous blood transfusion programme in place for hip, major spinal and knee operations. Hence, we undertook a prospective study to determine whether post-operative autologous blood transfusion system affects post operative Hb levels and reduces the need for HBT in elective unilateral primary THR. In this study, we used Cell Saver 5 autologous blood retransfusion system (Haemonetics Corp., Braintree, MA, USA).

The purpose of this study is to investigate whether the retrieval and reinfusion of postoperative blood salvage in the recovery room for the patients who had elective unilateral THR reduce the rate of HBT. This is a cost-neutral study in view of the higher costs of the retransfusion system normally offset by savings in homologous transfusion expense. 

Materials and Methods:

Patient population
Patients who were undergoing unilateral primary THR for osteoarthritis on a non emergency basis were eligible for this prospective study. Eligibility criteria for the study were shown in Table 1. 

Table 1: Eligibility criteria for the study

Perioperative management
At pre-operative assessment, all patients are provided with written formal consent and standard patient information for THR. They will be admitted the day before the operation and the pre-operative Hb level recorded. General anaesthesia was administered to all patients and modified posterior approach was used in the unilateral primary THR. A dose of 1.5g of cefuroxime was given routinely at induction and two further doses of cefuroxime (750 mg) at eight-hour intervals as per local prophylactic antibiotics guidelines unless contraindicated.

Predeposited autologous blood or intraoperative blood salvage was not used. All drains were inserted during closure of the wound and then connected to the Cell Saver in the operating room and remained connected in the recovery room. Blood collected in the recovery room was then processed and transfused back to the patient. Adverse effects associated with the use of cell salvage device were recorded. Any significantly serious adverse events will be reported to the hospital transfusion committee and to any appropriate national reporting system.

The modified posterior surgical approach was used for the entire cohort. The capsule and short external rotators are taken in a single continuous layer off the posterior aspect of the greater trochanter preserving the gluteus medius muscle. Then, the capsule is repaired without repairing the piriformis tendon.

The primary hip replacements were performed with an uncemented acetabular cup component and a femoral component (either cemented or uncemented).  All acetabular components were fixed with bone screws. The replacements for the uncemented acetabular component were made using either Trilogy (Zimmer) or Pinnacle (Depuy). The prostheses for femoral component were either cemented C Stem (Depuy) or uncemented Corail (Depuy).

Recruited patients were given identical routine postoperative care. All patients received prophylactic dose 2500mg Fragmin® (dalteparin – low molecular weight heparin) on the evening of surgery until they are fully mobilised or until they were discharged home. Thrombo-embolic deterrent stockings (TED stockings) were used until six weeks following the operation. They were mobilised since the first day following the operation - assisted to stand on the first day and then progressed to walking with a frame on the following day.  

Local blood transfusion practice was to give one or two units of homologous blood if the post-operative Hb was less than 80 g/L or if patients were symptomatic with Hb in the range of 80 g/L to 100 g/L such as hypotensive, tarchcardia, syncope, dizzyness or postural drop. All were monitored for post-operative pyrexia, and wound or other complications. Transfusion related reaction or complications were monitored and recorded as per local practice. Post-operatively, the Hb levels and the number of homologous units required were recorded for each patient. The patients attended outpatient clinic for follow-up at six to eight weeks. All relevant data were recorded separately and completed for each case. 

Ethical Approval
ABT device had been used routinely for complicated orthopaedic procedures such as spine operation, total joint replacements and revision of total joint replacement. This blood salvage device had also been used in the some occasions of elective primary total hip replacement based on the individual preference of Consultant Orthopaedic Surgeon. Local Research Ethical Committee (LREC) approval is not required for this study as autologous transfusion system had been used as part of the clinical care for elective primary THR at the individual’s discretion. This study examined the excellence of the service provided in Trauma and Orthopaedic Unit with the use of postoperative autologous blood transfusion system in relation to the usage of homologous blood units from blood bank. 

Formal consent Specific consent for autologous transfusion procedures carried out in theatre and recovery room is considered to be necessary as ABT device will be used as a routine procedure in this study under the named consultant. The usage of ABT device in the operative procedure will be discussed during the process of obtaining informed consent. The benefits and risks associated with the ABT device will be verbally explained to patients and documented in the consent form. All patients must be given full information about the proposed treatment. General information sheet with regards to the THR was given to the patients prior to the operative procedure. The ABT device was not used by all of the Consultant Orthopaedic Surgeons in their routine practice, additional informed consent for use of ABT device in the study was deemed vital and essential from the ethical point of view. 

End points
The primary end point was the proportion of patients had HBT following unilateral primary hip replacement. Blood bank electronic records were used to examine the accuracy of the number of unit of transfused blood used for each case.

Secondary end point was the adverse effects associated with autologous blood transfusion following the postoperative use of Cell Saver 5 as per local transfusion practice. The following clinical events were recorded: fever (>38 degree Celsius), tarchycardia, transfusion related allergic reaction and hypotension. 

Statistical analysis
The relationship between HBT requirements and categorical variables was examined using the chi-squared test. Comparisons between groups were performed with the student’s t-test for parametric data to establish their relationship with the need for postoperative HBT. Significance was established at p < 0.05. Results were expressed as mean +/- standard deviation (SD), unless stated otherwise.

Results:

Patient population
From 1st July 2005, patients undergoing elective unilateral primary THR for osteoarthritis under the care a single consultant orthopaedic surgeon were eligible and then recruited in this prospective study. Between July 2005 and August 2007, 221 consecutive patients were enrolled at University Hospital of North Staffordshire and their data were completely obtained.

84 males and 137 females had unilateral primary THR operated by one surgeon. The primary THR operations were performed under general anaesthesia through a modified posterior approach with patients in the lateral position. Meticulous haemostasis was obtained prior to wound closure. All drain tubes were placed to drain the joint space deep to the tensor fascia lata. After closure of the wound, the drainage tubes were then connected to the blood salvage device in the operating room and remained connected in the recovery room. Blood collected in the recovery room was then processed and transfused back to the patient. None of the patients who had a malignant lesion or an infection near the site of the operative drain or a coagulation disorder were treated with Cell Saver 5. Their demographics, site of operations and types of anaesthetic were summarized in Table 2. 

Table 2: Patient demographics, diagnosis and anaesthetic type

End points
The Hb level averaged 105.1 g/L following postoperative drainage tubes connecting to Cell Saver 5 for autologous blood transfusion. The patients had an average preoperative hemoglobin of 137.1 g/L (refer to Table 3). Eleven patients (4.98%) had a post-operative Hb level below or equal to 80g/L. Twelve patients (5.4%) were transfused with 24 units of homologous blood postoperatively (refer to Table 4) with no clinical sequelae secondary to HBT. Only three patients out of this group of patients had postoperative Hb of more than 80g/L. 

Table 3: Pre-operative, post-operative and follow-up haemoglobin (Hb) values (mean values and range)

Table 4: Number of units of homologous blood transfusion and number of patients transfused

There were 65 patients (29.4%) older than 75 years, with nineteen patients had pre-operative Hb less than 120 g/L. Patients older than 75 years were associated with a greater use of homologous blood with those equal or under the age of 75 years (chi square, p<0.001). 67 patients had pre-operative haemoglobin of less than 130g/L (Figure 3). Furthermore, patients with pre-operative Hb level of less than 130g/L were associated with a increased risks of using HBT with those more than 130g/L (chi square, p<0.0001).

There were no clinical symptoms, such as fever, hypotension, tachycardia, and dizziness during the reparative period after the operation with the use of Cell Saver 5. No complications such as air or fat embolism, coagulopathy, renal failure, or sepsis were recognized in any of the patients.

None of the patients developed deep vein thrombosis or pulmonary embolism with the provision of TED stocking and prophylactic dose of low molecular weight heparin. The mean time for length of in-hospital stay was 6 days (SD 3.8 days), with the range between 2 – 36 days. No major deep wound complications were recorded in patients enrolled in this study following the provision of antibiotics prophylaxis.

Discussion :

For many years, PABD and intraoperative autotransfusion have become well-established methods for major operations with anticipated massive blood loss, in addition to avoid the risks associated with HBT. Limitations such as storage problems, unexpected delays in operation schedules and multiple preoperative visits to hospital have restricted popularity of PABD in this country. A large proportion of the patients undergoing total joint arthroplasty were elderly and anaemic, and were unable to donate sufficient quantities of blood to satisfy their operative requirements. Furthermore, the cardiorespiratory consequences of moderate postoperative anaemia may be significant in limiting the mobility of patients after primary hip replacement. Such patients may benefit from a prompt return of its preoperative Hb level by using perioperative blood salvage methods. Blood salvage system, either intraoperatively or postoperatively, is not routinely used for primary hip replacement.

Comparison with other studies was not available because some included primary and revision cases as well as patients for whom PABD or intra-operative salvage was made available. Studies that involved primary cases, which included patients for whom PABD and intra-operative salvage were available, have indicated that post-operative salvage does not result in significant haematological, transfusion or clinical benefit in uncomplicated primary THR^7-8. However, other study, which excluded PABD and intra-operative salvage, concluded a reduction in homologous transfusion in primary arthroplasty when post-operative salvage is used^{6, 9}. Our study concluded the latter findings. The most important finding in our study was a substantially reduction in the number of patients requiring homologous transfusion. Twelve patients with post-operative autologous blood transfusion (5.4%) required a total of 24 units of HBT with a transfusion rate of 0.109 per case. Our result is comparable with the recent study conducted by Smith et al., a randomized study that demonstrated a significant reduction transfusion rate in patients with post-operative blood salvage (8%) as compared to those without (21%), with 0.18 units of homologous blood per person in those with post-operative blood salvage⁹. In the same study, which excluded PABD and intra-operative salvage, concluded a significantly higher percentage of patients in the vacuum drain group required homologous blood transfusion compare to those with post-operative blood salvage (21% compared to 8%)⁹. Our study found 15.8% of the cohort had post-operative Hb less than 90 g/L. Without the control, we are unable to demonstrate the significance of this haematological benefit. However, this study revealed the excellence of the service provided in Trauma and Orthopaedic Unit with the use of postoperative autologous blood transfusion system in relation to the usage of homologous blood units from blood bank (0.109 unit of banked blood per case).

Study conducted by Smith et al. did not demonstrate significant association of homologous transfusion with advanced age (> 75 years) or preoperative Hb below 130 g/L9. They claimed that this may be a result of the relatively small number of patients in this group. However, our study, which is comparable to their study, demonstrate the significant association of HBT with advanced age or preoperative Hb below 130 g/L, factors that have been shown to increase the likelihood of homologous transfusion¹⁰. In our group of patients who had HBT, all but one has pre-operative Hb level more than 130g/L. Recent national audit had recommended that preoperative anaemia should be corrected as far as possible in order to minimize the likelihood of a patient receiving a donor blood transfusion¹¹. The chances of requiring HBT following a hip arthroplasty increases as the pre-operative Hb decreases resulting in a 90% risk of requiring HBT when the pre-operative Hb is below 10.5 g/L^{10, 12}. Our unit had considered cross-matched bloods need to be made available and the required units based on our study can be reduced from two to one in patients undergoing primary THR, in view of the higher HBT in patients with a preoperative Hb level of less than 130 g/L. A group and save is then judged to be adequate for patients with a pre-operative Hb level of more than 130 g/L.

The inclusion of a group in which no drain was used may have provided additional information in this study in relation to HBT. Figures from one study showed a higher rate of homologous transfusion for patients with drains (33% with drain versus 26.4% without drain) ¹³, whereas the other study revealed homologous transfusion rate of 21% in those with a vacuum drain⁹.

Post-operative autologous salvage was not associated with an increased risk of early complications. None of transfusion complications was reported for patients with the post-operative autologous salvage. With the high screening standards associated with autologous banked blood, the association between HBT and infection is controversial. Nevertheless, study reported a reduction in transfusion related complications if autologous transfusion is used and this is increased if homologous transfusion is used¹⁴. Long-term follow-up of our cases will continue to determine whether this is the case.

Post-operative homologous blood transfusion is initiated when the serum Hb is 80g/L or lower, unless they are symptomatic as compared to the 70g/L as recommended by the British Committee for Standards in Haematology (BCSH) guidelines15. Trigger serum Hb of 80g/L was selected as most of patients in our centre are older patients as indicated in this study (mean age 70 years). The Hb level is monitored, and the blood pressure, pulse, and preoperative Hb level are also monitored before HBT starts. Twelve patients had HBT with a mean pre-HBT and post-HBT Hb level of 76.3g/L (range=63-92g/L) and 99.3g/L (range 84-122g/L). Three patients were transfused with post-operative Hb of more than 80g/L as they were symptomatic (two with Hb of 80g/L and one with Hb of 85g/L. Only one patient had post-HBT Hb level of more than 120g/L (122g/L) which indicated that one unit of banked blood could be avoided. These data suggest that our transfusion practice for primary THR is closely followed current guidelines for HBT. Patients whose pre-transfusion Hb was <79 should not be transfused to achieve a ‘normal’ Hb concentration (i.e. 120 g/L). It is considered to be appropriate to use a one-unit HBT to exceed the transfusion threshold of 80g/L.

The effect of autologous salvage of blood in the recovery room on the amount of blood that is transfused postoperatively is unknown. The question cannot be answered by this prospective study because a comparator group was not used, which is the major limitation in our study. A historical, retrospective control group would probably be inaccurate and inappropriate, because HBT is now only given in patients who are symptomatic, rather than routinely doing so in all patients whose Hb falls below a certain value (which is relatively higher than the current recommended trigger Hb level). No control group was selected in the design of the study, as ABT device is not used as part of the standard treatment for primary hip replacement. Hence, inclusion of control group in this study inevitably requires ethical approval. Jehovah’s Witnesses were excluded for the same reason.

The experience in our unit supports the feasibility of salvaging blood, which would otherwise be discarded, from drainage tubes as a practical method of autologous transfusion and conservation of a precious resource for blood. We have planned to start to use this device for all patients who have total joint arthroplasty. The use of post-operative blood salvage techniques in elective primary THR has the potential to reduce the use of HBT and the risk for transfusion transmitted diseases by HBT. We believed that the continued use of the Cell Saver post-operatively would be both feasible and useful, bearing in mind the risks of non-autologous blood transfusion and the effectiveness of blood salvage device. This study confirmed the feasibility and safety of transfusing autologous blood that was salvaged post-operatively in the recovery room following THR.

This study confirms that reduced unit per patients who had undergone elective primary THR with post-operative salvage in a University Hospital. We found the Cell Saver autologous re-transfusion system easy to use and safe. The exact costs of HBT are hard to quantify and varied from one region to the other region. Despite this is a cost-neutral study with no added costs were incurred by using the Cell Saver in the recovery room, the cost of banked blood will undoubtedly continue to rise year on year because of the requirement for the National Blood Service (NBS) to screen blood products to ensure their safety. Increasing pressure is on the additional screening for the detection of prion agents in donor blood. Research is in progress to develop prion filter technology and also to develop screening tests for prion agents. In addition, with the declining usage of red cell year on year, the cost of each unit provided is expected to rise to fund the NBS. These considerations favour the continued use of autologous retransfusion systems on economic grounds in our unit.  

Acknowledgements:

I gratefully acknowledge the participation of Philip Roberts and Charles Baker in this study and the support of the clinical staff in the Trauma and Orthopaedic Unit at University Hospital of North Staffordshire NHS Trust for the data collection and validation of clinical data.

Source of funding:

No benefits in any form have been received or will be received for personal or professional use from a commercial party related directly or indirectly to the subject of this article. No funds were received in support of this study.

Disclosure:

No competing interests declared.

Reference :

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2. Helm AT, Karski MT, Parsons SJ, Sampath JS, Bale RS. A strategy for reducing blood-transfusion requirements in elective orthopaedic surgery: audit of an algorithm for arthroplasty of the lower limb. J Bone Joint Surg [Br] 2003; 85-B: 484-9.

3. Hillyer CD, Josephson CD, Blajchman MA, et al. Bacterial contamination of blood components: risks, strategies, and regulation: joint ASH and AABB educational session in transfusion medicine. Haematology Am Soc Haematol Edu Program 2003: 575-89.

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5. Gannon DM, Lombardi AV Jr, Mallory TIC et al. An evaluation of the efficacy of postoperative blood salvage after total joint arthroplasty: a prospective randomized trial. J Arthroplasty 1991; 6: 109

6. Grosvenor D, Goyal V, Goodman S. Efficacy of postoperative blood salvage following total hip arthroplasty in patients with and without deposited autologous units. J Bone Joint Surg [Am] 2000; 82-A: 951-4.

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8. Mauerhan DR, Nussman D, Mokris JG, Beaver WB. Effect of postoperative reinfusion systems on haemoglobin levels in primary total hip and total knee arthroplasties. J Arthroplasty 1993; 8: 523-7.

9. Smith LK, Williams DH, Langkamer VG. Post-operative blood salvage with autologous retransfusion in primary total hip replacement. J Bone Joint Surg [Br] 2007; 89-B: 1092-7.

10. Salido JA, Marin LA, Gomez LA, Zorrilla P, Martinez C. Preoperative haemoglobin levels and the need for transfusion after prosthetic hip and knee surgery. J Bone Joint Surg [Am] 2002; 84-A: 216-20.

11. National Comparative Audit of the use of blood in Primary, Elective, Unilateral Total Hip Replacement. Report prepared by National Comparative Audit of Blood Transfusion Use of blood in Primary, Elective, Unilateral Total Hip Replacement Project Group. July 2007.

12. Hatzidakis AM, Mendlick RM, McKillip T, Reddy RL, Garvin KL. Preoperative autologous donation for total joint arthroplasty. An analysis of risk factors for allogenic transfusion. J Bone Joint Surg 2000; 82-A (1): 89–100.

13. Walmsley PJ, Kelly MB, Hill RMF, Brenkel I. A prospective randomised, controlled trial of the use of drains in total hip arthroplasty. J Bone Joint Surg [Br] 2005; 87-B: 1397-401.

14. Rosencher N, Kerkkamp HEM, Macheras G, et al. Orthopaedic surgery transfusion haemoglobin European overview (OSTHEO) study: blood management in elective knee and hip arthroplasty in Europe. Transfusion 2003; 43: 459-69.

15. Guidelines for the clinical use of red cell transfusion. British Journal of Haematology 2001; 113: 24-31.

This is a peer reviewed paper 

Please cite as: AHL Wong: Postoperative autologous blood transfusion with blood salvage device in the primary total hip replacement.

J.Orthopaedics 2009;6(1)e10

URL: http://www.jortho.org/2009/6/1/e10

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