Download Use of a New Bipolar Sealing System to Reduce Blood Loss during

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.
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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).
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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.
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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.
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