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Use of a New Bipolar Sealing System to Reduce Blood Loss during Total Knee Arthroplasty: Results of a Prospective Matched-Pair Study M. PFEIFFER, H. BRÄUTIGAM, A. SIGG HELIOS Rosmann Hospital, Department of Orthopaedics, Breisach, Germany This data was originally presented at the Societa Italiana Di Ortopedia e Traumatologia (SIOT) meeting, Naples, Italy, October 2004. Use of a New Bipolar Sealing System to Reduce Blood Loss during Total Knee Arthroplasty: Results of a Prospective Matched-Pair Study M. PFEIFFER, H. BRÄUTIGAM, A. SIGG HELIOS Rosmann Hospital, Department of Orthopaedics, Breisach, Germany BACKGROUND: Minimizing blood loss during total knee arthroplasty (TKA) and maintaining elevated post-operative hemoglobin levels have been shown to reduce the risk of receiving postoperative allogeneic blood transfusions. An innovative new bipolar sealing system (BPS5.0-VT™ bipolar sealer, TissueLink Medical, Dover, NH, USA) designed to reduce blood loss during TKA procedures was compared to conventional electrocautery to determine its effectiveness on reducing blood loss, improving postoperative hemoglobin, and reducing the risk of allogeneic blood transfusions following TKA. STUDY DESIGN AND METHODS: We compared 20 consecutive patients undergoing TKA treated with the BPS5.0-VT bipolar sealer in conjunction with shed blood autotransfusion to a matched-pair control group of 20 patients whose blood management strategy during TKA was standard electrocautery without shed blood autotransfusion. Parameters compared between the two groups included estimated intraoperative and postoperative blood loss, preoperative and discharge hemoglobin, and the number of allogeneic blood transfusions. RESULTS: The estimated total blood loss was significantly less in the BPS5.0-VT group compared to the control group (1,132 mL vs. 1,580 mL; P < 0.003). Mean discharge hemoglobin was higher in the BPS5.0-VT group (10.9 g/dl) compared to the control group (9.6 g/dl) with both groups having similar preoperative hemoglobin levels. Patients in the control group also required 10 allogeneic blood transfusions compared to 2 transfusions for the BPS5.0-VT group. CONCLUSION: The use of the BPS5.0-VT bipolar sealing system results in a reduction in blood loss during TKA and reduces the risk of allogeneic blood transfusions. INTRODUCTION blood vessels on soft tissue and cut bone. This device works by coupling ra d i o f re q u e n cy energy from a standard electrosurgical generator with saline irrigation to conduct thermal energy. The thermal effect shrinks the collagen in the vessel walls of small art e ries effectively stopping bleeding and oozing from these vessels. Reducing intraoperative and postoperative blood loss are important goals for the management of patients receiving a total knee arthroplasty (TKA). Decreasing TKA associated blood loss allows for a faster postoperative recove ry, improved wound healing, and a lower complication rate. As a result of the well documented risks associated with allogeneic blood transfusions, many clinicians are exploring the role of several differing blood conservation strategies for the prevention and management of blood loss in orthopaedic procedures.1 The saline used as a conductive fluid at the tip of the BPS5.0-VT device (Figure 2) also cools the tissue surface and prevents the surface temperature from exceeding 100°C. The use of standard electrocautery results in the tissue surface temperature exceeding 300°C. The use of standard electrocautery also leads to charring of the tissue or bone surface and scar formation. An innovative new approach to prevent blood loss is the use of a bipolar sealing device (BPS5.0-VT™ bipolar sealer, TissueLink Medical, Dover, NH, USA). The BPS5.0-VT bipolar sealer (Figure 1) is designed to reduce blood loss during total knee arthroplasty by intra-operatively sealing The purpose of this study was to evaluate the effectiveness of the BPS5.0-VT bipolar sealer towards reducing blood loss in patients undergoing primary total knee arthroplasty. 1 Use of Bipolar Sealing System for TKA METHODS for the control group for comparative purposes. The study authors were blinded to blood loss and hemoglobin data for the control group prior to matching. Materials The surgical technique utilized for performing the TKA and post-operative management was similar for both groups. Drain removal occurred two days postoperatively for both groups. Patients with known coagulation and peripheral circulation disorders were excluded from the study. All patients obtained a standardized low molecular weight heparin prophylaxis to prevent deep vein thrombosis. No preoperative autologous blood donation was utilized. A torniquet was used in both groups and opened prior to wound closure. Two diffe ring blood management approaches we re compared in this study. Patients in the study group used a blood management strategy consisting of the BPS5.0-VT bipolar sealer in combination with the Solcotrans® Plus Intraoperative Autotransfusion System (Davol, Cranston, RI, USA) to manage blood loss. Patients in the control group were managed with standard electrocautery without shed blood autotransfusion. Figure 1. The BPS5.0-VT™ bipolar sealer. Study Design Figure 2. Saline solution dripping from the tip of the BPS5.0-VT™ bipolar sealer. The BPS5.0-VT bipolar sealer, in combination with the Solcotrans Plus System, was used to manage blood loss in 20 consecutive patients undergoing pri m a ry total knee arthroplasty (BPS group). Estimated blood loss was determined intra o p e rat ively, immediat e ly postoperative, and when the surgical drain was removed. Each patient’s preoperative and discharge hemoglobin were recorded along with their age, gender, and body mass index (BMI). RESULTS Seven males and 13 females were enrolled into both the BPS group and the Control group. The average age f or patients in the BPS group was 72.3 years compared to 72.2 years for the Control group. The above group was compared to 20 age and gender matched control patients who underwent primary total knee arthoplasty using conventional electrocautery to manage intraoperative bleeding. Age and gender were considered as criteria for a matched pair design as a result of previous research by Sigg et al., which indicated that these two parameters independent affect blood loss in patients undergoing TKA.2 A linear stepwise regression analysis of the data from this same study ex cluded preoperat ive hemoglobin concentrations as a predictive factor for total blood loss. Unpublished data from the authors also indicates that body mass index (BMI) does not have a significant predictive effect on postoperative blood loss. As a result of the above, BMI was not used as criteria for the matching the two patient groups. The demographic and clinical data collected for the study group was also obtained Table 1 compares the differences in blood loss between the two groups. The results indicate that the mean estimated total blood loss in the BPS group was significantly lower than the Control group (1,132 mL vs. 1,581 mL; P < 0.003). There was no significant difference between the two groups related to intraoperative blood loss. This is most likely the result of the short time period following the opening of the tourniquet prior to closing. There was a significant difference in the mean post-operative blood loss with the BPS group ex p e riencing signifi c a n t ly less blood loss compared to the control group during this observation period (974 mL vs. 1,406 mL; P < 0.002). There was no significant difference in the preoperative hemoglobin level between the two groups (Figure 3). 2 Use of Bipolar Sealing System for TKA Table 1. Comparison of Estimated Blood Loss BPS Group (BPS5.0™ bipolar sealer + autotransfusion) Control Group (Conventional electrocautery) P value Intraoperative blood loss (mL) 158 175 P < 0.099 Intermediate care blood loss (mL) 573 623 P < 0.055 Drain volume (mL) 402 783 P < 0.001 Total postoperative blood loss (mL) 974 1406 P < 0.002 1,132 1,581 P < 0.003 Total blood loss (mL) No patient from either group re q u i red re o p e ration or experienced postoperative complications. DISCUSSION Blood loss and the risk of re c e iving an allogeneic transfusion remain significant clinical concerns in patients u n d e rgoing TKA. This study demonstrates that the BPS5.0-VT bipolar sealer can significantly reduce total blood loss in patients undergoing TKA. Based on the results of our study, patients treated with the BPS5.0-VT device achieved a 28.4% reduction in total blood loss on average compared to patients in the control group. The combination of the BPS device with postoperat ive shed blood auto-transfusion reduced the risk of receiving an allogeneic transfusion by a factor of five. The ra te of allogeneic transfusions observed in the control group in this series is similar to the rate reported by others.3 Figure 3. Comparison of hemoglobin levels. Patients in the BPS group did, however, have a higher mean discharge hemoglobin level compared to the control group (10.9 g/dL vs. 9.6 g/dL). Although additional postoperative autotransfusion of unwashed 40µ filtered shed blood within 6 hours after surgery was added for the purpose of comprehensive blood salvage management in the study gro u p , the average difference in hemoglobin levels between the two groups at discharge was not significant. This is most likely due to the increased number of postoperat ive blood transfusions allogeniec blood transfusions the Control group received compared to the study group (Figure 4). All patients in the BPS group were able to maintain full suction power of 700 mbar (10.2 lbs/in 2) whereas suction needed to be set to zero in 5 patients in the control group Figure 4. Number of allogeniec transfusions received. due to fast postoperative filling of the suction reservoir. 3 Use of Bipolar Sealing System for TKA There are no contraindications for the use of the BPS5.0-VT bipolar sealer in combination with postoperative autologous retransfusion. While this study was limited to patients undergoing TKA where both of these devices were utilized, we have also had positive clinical outcomes when using the BPS device without an autologous retransfusion system. The results of our study confirm the beneficial impact the BPS5.0-VT bipolar sealer has on reducing blood loss, limiting the drop in postoperative hemoglobin and reducing the risk of allogeneic transfusion. Our experience has shown that the BPS5.0-VT bipolar sealer is easy to set-up and use in our operating room setting. These results sugests that this bipolar sealing system deserves consideration for use as a part of a modern and comprehensive fast-track recovery regimen after total knee arthroplasty. REFERENCES 1. S p e n c e, R.K. Current concepts and issues in blood management. Orthopedics, 2004, 27(6 Suppl), S643-51. 2. Sigg, A., Grosse, H., Henche, R.: Fremdblut-sparende Massnahmen bei knieendopro t h e t i s chen Eingri ffe n durch Ap rotinin. Orthopaedische Praxis.2003, 39:471-473. 3. Bierbaum BE, Callaghan JJ, Galatne JO, Rubash HE, Tooms RE, Welch RB. An analysis of blood management in patients having a total hip or knee arthoplasty. J Bone Joint Surg Am. 1999; 81-2-10. 4 BPS5.O-VT is a trademark of TissueLink Medical, Inc. Additional trademarks are the property of their respective owners. Copyright © 2005 TissueLink Medical, Inc. All rights reserved. 74-82-1024 Rev. A