Topical versus intravenous tranexamic acid in total knee arthroplasty

Topical versus intravenous tranexamic acid in total knee arthroplasty

The Journal of Arthroplasty xxx (2014) xxx–xxx Contents lists available at ScienceDirect The Journal of Arthroplasty journal homepage: www.arthropla...

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The Journal of Arthroplasty xxx (2014) xxx–xxx

Contents lists available at ScienceDirect

The Journal of Arthroplasty journal homepage: www.arthroplastyjournal.org

Topical versus intravenous tranexamic acid in total knee arthroplasty Brian R. Hamlin, MD, Anthony M. DiGioia, MD, Anton Y. Plakseychuk, MD, PhD, Tim J. Levison, MS The Bone & Joint Center, Magee Womens Hospital of University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

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Article history: Received 7 April 2014 Accepted 8 October 2014 Available online xxxx Keywords: total knee arthroplasty blood management tranexamic acid transfusion complications

a b s t r a c t The objective of this study is to compare the effectiveness of intravenous versus topical application of tranexamic acid in patients undergoing knee arthroplasty. All patients who underwent primary knee arthroplasty at our total joint center over a 12-month period were included in the study. One surgeon utilized 1 g of IV TXA at time of incision in all patients (n = 373) except those with a documented history of venous thromboembolism (VTE). Two surgeons utilized a topical application of TXA for all patients without exception (n = 198) in which the joint was injected after capsular closure with 3 g TXA/100 mL saline. The transfusion rate was 0% in the topical group vs. 2.4% in the IV group and this was statistically significant (P b 0.05). © 2014 Elsevier Inc. All rights reserved.

Total knee arthroplasty is associated with a large amount of perioperative blood loss. Patients may suffer complications/symptoms related to their acute blood loss anemia and often are transfused to try to avoid these complications. The transfusion rate in TKA is reported to be anywhere from 11 to 21% in the literature [1]. Transfusion of allogeneic red cells is known to increase perioperative complications such as surgical site infection [2–5]. The management of blood products has been adopted so to avoid complications, reduce costs, and improve outcomes. Antifibrinolytics have been introduced in TKA as one component of a blood management program. Tranexamic acid (TXA) has been most commonly reported on in the literature. Intravenous use of TXA has resulted in the significant reduction of blood loss and transfusion rates [6–9]. Due to concern over thromboembolic events TXA use in certain patient subsets (recent stroke, recent angioplasty, strong history of VTE) a topical application of TXA has also been adopted. Topical use likewise has been reported to reduce blood loss and transfusion rates [10–15]. Little work has been done directly comparing the effectiveness of topical vs. IV TXA in patients undergoing total knee arthroplasty [16,17]. The objective of this study was to compare the intravenous versus topical use of the antifibrinolytic tranexamic acid in primary unilateral total knee arthroplasty. Methods Following approval of the medical centers institutional review board all patients undergoing primary unilateral cemented TKA over a 12 month period at our total joint center had their charts reviewed and examined as it related to our comprehensive blood management The Conflict of Interest statement associated with this article can be found at http:// dx.doi.org/10.1016/j.arth.2014.10.007. Reprint requests: Brian R. Hamlin, MD, Suite 1601, 300 Halket Street, Pittsburgh, PA 15213.

program. Patient demographics (age, gender) as well as general health (ASA) were collected. Preoperative hemoglobin (Hgb) and Hgb on postoperative day #1 were collected. All transfusions were noted. Complications related to venous thromboembolic events (VTE) were also noted. Two groups of patients were identified and studied as it related to utilization of TXA. Group I (Intravenous TXA) One surgeon (surgeon A) utilized 1 g of IV TXA at time of incision in all patients except those with a documented history of VTE (deep vein thrombosis and/or pulmonary embolus). Group II (Topical TXA) Two surgeons (surgeons B and C) utilized a topical application of TXA consisting of 3 g TXA/100 mL saline. Surgical Technique All total knee arthroplasties were performed through a standard medial parapatellar approach under tourniquet control. The patella was resurfaced in all cases. Intramedullary guides were used for all femoral preparation and extramedullary guides were used for tibial preparation. The posterior cruciate ligament was substituted in all cases. After cementation of all components and placement of final polyethylene, the tourniquet was released. Hemostasis was then achieved followed by placement of a deep drain and closure of the arthrotomy. All drains were removed on the day following the surgery. VTE prophylaxis was titrated based on risk. Patients with a documented history of VTE were bridged from Lovenox to Coumadin (excluded from receiving IV TXA). The remainder of the patients received Coumadin the evening of surgery and dose was adjusted with a goal INR of 2.0.

http://dx.doi.org/10.1016/j.arth.2014.10.007 0883-5403/© 2014 Elsevier Inc. All rights reserved.

Please cite this article as: Hamlin BR, et al, Topical versus intravenous tranexamic acid in total knee arthroplasty, J Arthroplasty (2014), http:// dx.doi.org/10.1016/j.arth.2014.10.007

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B.R. Hamlin et al. / The Journal of Arthroplasty xxx (2014) xxx–xxx

In the topical TXA group the drain was clamped and the knee was injected with 100 mL of the TXA solution (3 g TXA/100 mL saline). The remainder of the wound was then closed in standard fashion. The drain was clamped for 1 hour and then released. All patients were managed with a standard blood management program. This program included a strict transfusion Hgb trigger of 8.0 and the use of 500 mL hetastarch volume expansion for postoperative hypotension, dizziness, and light-headedness prior to consideration of transfusion. The primary outcomes were the drop (or change) in hemoglobin (both absolute and percentage change), transfusion rates, length of stay, and VTE events. Data Analysis All data were reported using summary statistics including means and standard deviations for quantitative data, and frequencies and percentages for qualitative data. The groups of continuous variables were compared using the unpaired two-tailed Student's t-test. P values of b 0.05 were considered significant. A Fisher's exact test was used for categorical variables. Results All patients who underwent primary TKA at our total joint center from April 1 2011 to April 1 2012 were included in our review. Surgeon A (IV TXA) performed a total of 382 knee arthroplasties. Of these nine were excluded because of a history of VTE and did not receive TXA. This left 373 patients undergoing primary TKA with intravenous TXA. Surgeons B and C performed a total of 198 knee arthroplasties with the topical application of TXA with no exclusions. Patient demographics are summarized in Table 1. The patients in the topical group were noted to be younger (62.2 vs. 68.7) than the IV group but otherwise there were no differences between the groups. Primary outcomes are summarized in Table 2. The hemoglobin on postoperative day number one was higher in the topical group (11.4 vs. 11.1) (P b 0.0011). The change in Hgb was significantly lower in the topical group (2.2 vs. 2.8). The average percentage change in hemoglobin was 16.2% in the topical group while it was 20.1% in the IV group (P b 0.0001). The percentage of patients requiring a transfusion was higher in the IV TXA group (2.4%) vs. the topical group (0%) and this was also found to be statistically significant (P = 0.031). There was no difference in the length of stay between the two groups. The rate of clinically significant venous thromboembolic events did not differ between the groups (b1.5%). Discussion In this study the topical use of TXA resulted in no transfusions and less blood loss than patients receiving intravenous TXA. Although the differences were found to be statistically significant the overall transfusion rate in the IV group of 2.4% is still remarkably low in comparison to historical data on rates of transfusion in TKA [1]. Our study groups are dissimilar both in age (IV group was older) and by operating

Table 1 Baseline Demographic and Clinical Characteristics.

Table 2 Primary Outcomes for TKA Patients. Primary Outcomes

Pod#1 Hgb (g/dL) Hgb drop (g/dL) % Hgb change Transfused (%) Length of stay (days) VTE (#/%) *

IV TXA (n = 373)

Topical TXA (n = 198)

*

11.1 ± 1.1 2.8 ± 0.8 20.1 ± 5.3 2.4 2.8 ± 0.9 5/1.3%

11.4 ± 1.3 2.2 ± 0.9 16.2 ± 6.1 0 2.9 ± 1.2 2/1.0%

b0.0011 b0.0001 b0.0001 0.031 0.151 1.000

P value

All t-tests are unpaired two tailed.

surgeon. It is difficult to know if these factors play a role in the differences reported here. It should be noted that antifibrinolytics are only one aspect of this blood management program. It also includes optimizing patients' preoperative hemoglobin, a reasonable transfusion trigger, and the use of volume expanders for symptomatic hypotension. TXA obviously provides additional benefit by stabilizing the bleeding that is occurring within the joint in the perioperative period. TXA is an analog of the amino acid lysine. It competitively inhibits plasminogen activation and plasmin binding to fibrin, thus inhibiting fibrin degradation. Since it works by reducing breakdown of fibrin once formed, it is not procoagulant per se, but rather supportive of coagulation already in progress. There is some concern that patients may be at a greater risk of VTE events with the use of TXA but our study showed no increase risk. To date the orthopedic literature has not shown a significant risk in the total joint arthroplasty population [18–20]. Despite this many surgeons are concerned over VTE and in those patients the topical application has been adopted to provide the benefits without the supposed risk. Although there is some systemic absorption with topical use it is not felt to be clinically significant [10]. Our results are comparable to those reported in the literature for both IV and topical use. We previously reported a greatly reduced transfusion rate (0%) and blood loss for using our topical technique [15]. Wong et al reported a reduction of blood loss by 20 to 25% in comparison to placebo with a topical technique [10]. Fu et al performed a metaanalysis of 22 randomized controlled studies on IV use of TXA and found it's use resulted in a significant reduction in blood loss, transfusion rates, and volume of blood transfused [21]. Wind et al also compared IV to topical TXA and also noted no transfusions in their topical group and only a 0.3% rate in their IV group. Interestingly they reported IV infusion resulted in less blood loss in comparison to historical control without TXA but this did not reach significance with the topical group. There is one prospective study comparing intravenous TXA, intra-articular TXA, and placebo (50 patients each group) by Seo et al. They also report a lower transfusion rate and less blood loss with the use of TXA and like our study; superior results with topical use [22]. In conclusion this study further substantiates the use of antifibrinolytics in the blood management of the total joint arthroplasty patient. This is one of the first studies to directly compare the topical vs. intravenous route and both have proven to be safe and effective. Surgeons may want to choose the route of administration based on their patients underlying clinical profile. Although a randomized trial may allow the further delineation of the true difference between these groups; it is unlikely to show a dramatic difference based on the data presented here.

References

Patient demographics

Gender (M/F) Age ASA Preop Hgb *

IV TXA (n = 373)

Topical TXA (n = 198)

*

(134 M/239 F) 68.7 ± 6.7 2.5 ± 0.5 13.9 ± 1.2

(67 M/131 F) 62.0 ± 9.0 2.6 ± 0.5 13.7 ± 1.3

0.646 b0.0001 0.1175 0.145

All t-tests are unpaired two tailed.

P value

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Please cite this article as: Hamlin BR, et al, Topical versus intravenous tranexamic acid in total knee arthroplasty, J Arthroplasty (2014), http:// dx.doi.org/10.1016/j.arth.2014.10.007

B.R. Hamlin et al. / The Journal of Arthroplasty xxx (2014) xxx–xxx 5. Triulzi DJ, Yazer MH. Clinical studies of the effect of blood storage on patient outcomes. Transfus Apher Sci 2010;43(1):95. 6. Hiippala ST, Strid LJ, Wennerstrand MI, et al. Tranexamic acid radically decreases blood loss and transfusions associated with total knee arthroplasty. Anesth Analg 1997;84(4):839. 7. Veien M, Sorensen JV, Madsen F, et al. Tranexamic acid given intraoperatively reduces blood loss after total knee replacement: a randomized, controlled study. Acta Anaesthesiol Scand 2002;46(10):1206. 8. Ho KM, Ismail H. Use of intravenous tranexamic acid to reduce allogeneic blood transfusion in total hip and knee arthroplasty: a meta-analysis. Anaesth Intensive Care 2003;31(5):529. 9. Charoencholvanich K, Siriwattanasakul P. Tranexamic acid reduces blood loss and blood transfusion after TKA: a prospective randomized controlled trial. Clin Orthop Relat Res 2011;469(10):2874. 10. Wong J, Abrishami A, El Beheiry H, et al. Topical application of tranexamic acid reduces postoperative blood loss in total knee arthroplasty: a randomized, controlled trial. J Bone Joint Surg Am 2010;92(15):2503. 11. Chareancholvanich K, Siriwattanasakul P, Narkbunnam R, et al. Temporary clamping of drain combined with tranexamic acid reduce blood loss after total knee arthroplasty: a prospective randomized controlled trial. BMC Musculoskelet Disord 2012;13:124. 12. Mutsuzaki H, Ikeda K. Intra-articular injection of tranexamic acid via a drain plus drain-clamping to reduce blood loss in cementless total knee arthroplasty. J Orthop Surg Res 2012;7:32.

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Please cite this article as: Hamlin BR, et al, Topical versus intravenous tranexamic acid in total knee arthroplasty, J Arthroplasty (2014), http:// dx.doi.org/10.1016/j.arth.2014.10.007