TissueLink`s HemoSealing™ Technology in Total Joint Reconstruction

TissueLink’s HemoSealing™ Technology in Total
Joint Reconstruction: A Controlled, Randomized
Evaluation of 25 Patients
O. David Taunton, Jr., M.D.
Texas Orthopaedic Specialists, Fort Worth, Texas, USA
TissueLink’s HemoSealing™ Technology in Total
Joint Reconstruction: A Controlled, Randomized
Evaluation of 25 Patients
O. DAVID TAUNTON, JR., M.D.
Texas Orthopaedic Specialists, Fort Worth, Texas, USA
BACKGROUND: Traditional methods for achieving hemostasis during total knee and total hip arthroplasty are inadequate
towards preventing surgical blood loss. An innovative new bipolar HemoSealing™ technology (TissueLink Medical, Dover, NH,
USA) designed to reduce blood loss during orthopaedic pro c e d u res was compared to conventional electro c a u t e ry.
STUDY DESIGN AND METHODS: A series of 25 total hip and total knee arthroplasty patients were enrolled into the study.
Twelve patients underwent arthroplasty using conventional blood management techniques. Thirteen patients were subsequently enrolled into the study and were treated with the HemoSealing technology during the procedure. For the control group, 8
patients had knee arthroplasty and 4 patients had hip arthroplasty. The study group include 9 knee arthroplasty and 4 hip
arthroplasty patients. Parameters compared between the two groups included estimated intraoperative blood loss, percent
change in postoperative hematocrit, percent of patients requiring blood transfusion, and the number of units transfused.
RESULTS: The use of the HemoSealing technology resulted in a reduced drop in postoperative hematocrit versus the control
group following total knee arthoplasty. Additionally, the requirement for transfusion and the mean number of units transfused
was also lower in the study group compared to the control group. The use of HemoSealing technology was also associated with
a reduction in intraoperative blood loss compared to the control group in patients undergoing total hip arthroplasty.
CONCLUSION: The use of TissueLink’s HemoSealing technology reduces blood loss and transfusion requirements in patients
undergoing total hip and total knee arthroplasty.
INTRODUCTION
vessels by shrinking the vascular collagen. By shrinking
vascular collagen, TissueLink's HemoSealing™ technology
p rovides superior cut bone and soft tissue hemostasis
(Figure 1). The use of saline also provides an additional
advantage since it evenly conducts energy to the tissue
enabling the treatment of broad oozing on cut surface areas.
Since this HemoSealing™ technology provides rapid and
thorough hemostasis, the use of this technology during total
joint surgery would be expected to reduce intra- and postoperative blood loss, limit the need for replacement blood
products, and reduce postoperative fluid accumulation, pain,
and swelling.
Traditional techniques for obtaining hemostasis during
orthopaedic surgery, such as conventional electrocautery
(“bovie”) and sealants, have limited clinical effectiveness
towards reducing blood loss and the risk of transfusions. An
innovat ive bipolar sealing tech n o l ogy from TissueLink
Medical (Dover, NH) has recently become available for use
in preventing blood loss in orthopaedic procedures. This
device combines radio-frequency energy with saline irrigation to hemostatically seal both cut bone and soft tissue. The
use of saline with this device prevents tissue temperatures
from rising above 100°C. This prevents the burning and
charring associated with the use of conventional electrocautery where temperatures can exceed 300°C. By operating at a much lower temperature, this bipolar sealing device
changes the mechanism of hemostasis from the creation of
a blood coagulum plug to a mechanical closure of the
METHODS
The use of TissueLink’s HemoSealing technology to reduce
intraoperative blood loss in patients undergoing total knee
arthroplasty and total hip arthroplasty was compared to a
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HemoSealing™ Technology in Total Joint Reconstruction
control group of patients where conventional electrosurgery
was utilized for controlling blood loss. A total of 25 patients
were enrolled into the study. Twelve patients were enrolled
into the control group between February and March 2003
with 8 patients in the control group receiving primary total
knee arthroplasty and 4 patients undergoing primary total
hip arthroplasty. Thirteen patients were enrolled into the
study group between April and June 2003 where TissueLink’s HemoSealing technology was utilized. The study
group consisted of 9 patients receiving a primary total knee
arthoplasty and 4 patients undergoing primary total hip
arthroplasty.
Patients in the HemoSealng group were also heavier with a
mean weight of 190 lbs. versus a mean weight of 164 lbs. for
the the control group. This difference would be expected to
negatively influence the HemoSealing group since heavier
patients normally experience increased blood loss.
Patients in the HemoSealing group experienced a 41%
reduction in the mean ch a n ge in hemat o c rit following
surgery compared to the control group (Figure 2).
Figure 2. Percent change in preoperative vs. postoperative
hematocrit levels in TKA patients.
Consistent with the reduced drop in hematocrit levels for the
HemoSealing group, transfusion requirements were lower
for the study group compared to the control. This included a
62% reduction in the percentage of patients requiring transThe primary objectives of the study were to compare preop- fusion in the HemoSealing group versus the control group
erative versus postoperative hematocrit levels between the (Figure 3) and a 74% reduction in the mean number of units
two groups, the percentage of patients requiring blood trans- transfused for the study group (Figure 4).
fusions and the number of units transfused. Postoperative
hematocrit levels were assessed one day following surgery.
For comparison purposes, the knee and hip patients were
analyzed separately with an emphasis on patient undergoing
total knee arthoplasty due to the larger number of patient
enrolled in this series.
Figure 1. Use of TissueLink’s HemoSealing™
technology for total knee arthroplasty.
RESULTS
Total Knee Arthroplasty
Patients in the HemoSealing g roup were younger than
patients in the control group with a mean age of 65 years
Figure 3. Percent of TKA patients requiring transfusions.
and 73 years respectively.
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HemoSealing™ Technology in Total Joint Reconstruction
DISCUSSION
Orthopaedic surgical procedures can be associated with significant amounts of intraoperative and postoperative blood
loss. As a result, aggressive blood management strategies
can be of benefit towards reducing blood loss and the risk of
receiving postoperative blood transfusions. A promising
new blood management strategy which has recently been
introduced is the use of TissueLink Medical's HemoSealing
technology. This technology provides surgeons with the
ability to deliver superior hemostasis of cut soft tissue and
bone through the shrinkage of vascular collagen.
In our series of 25 patients we observed promising outcomes
with this new technology including a reduction in the drop
in postsurgical hematocrit and a reduced transfusion requirements in patients undergoing total knee arthroplasty. We
also observed a decrease in estimated intraoperative blood
loss in total hip arthroplasty patients.
Figure 4. Mean # of units transfused per TKA patients.
Intraoperative blood loss was not a critical end point
for patients undergoing total knee arthroplasty since a
There is significant variability within patient outcomes assotourniquet was used on all of these procedures.
ciated with blood loss. This variability combined with the
fact that a significant portion of blood loss from arthroplasTotal Hip Arthroplasty
ty occurs postoperatively makes the anecdotal evaluation of
intraoperative blood loss of this HemoSealing technology
Due to the limited number of total hip arthroplasty patients
difficult for surgeons. The variability and difficulty in
in this series, the results reported are limited to differences
predicting which patients are at increased risk of blood loss
in estimated intraoperative blood loss between the two
also make selective use of HemoSealing technology
groups.
sub-optimal. I have found that by incorporating this
HemoSealing technology into all of my arthroplasty proceEstimated intraoperative blood loss was 45% less in the
dures, my blood related outcomes have improved
HemoSealing group compared the control group. Th i s
significantly. A number of significant device improvements
equates to a mean reduction in blood loss of 230 mL for the
have been made since the collection of the data presented
study group versus the control group. (Figure 5).
above. These improves have further enabled the ability for
this technology to deliver a more complete and rapid
hemostatic seal. Additional data is being collected to expand
this series as well as to report on the outcomes
associated with improvements to this technology.
HEMOSEALING is a trademark of TissueLink Medical,Inc.
Copyright © 2004-2005 TissueLink Medical,Inc. All rights reserved.
74-82-0954 Rev. C
Figure 5. Mean estimated bloodloss in THA patients.
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