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No Effect of a Bipolar Sealer on Total Blood Loss or Blood Transfusion in Nonseptic Revision Knee Arthroplasty—A Prospective Study With Matched Retrospective Controls
The Journal of Arthroplasty xxx (2016) 1e6
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The Journal of Arthroplasty journal homepage: www.arthroplastyjournal.org
Original Article
No Effect of a Bipolar Sealer on Total Blood Loss or Blood Transfusion in Nonseptic Revision Knee ArthroplastydA Prospective Study With Matched Retrospective Controls Christian Skovgaard Nielsen, MD a, b, *, Kirill Gromov, PhD, MD a, Øivind Jans, PhD, MD c, Anders Troelsen, MD, PhD, DMSc a, Henrik Husted, DMSc, PhD a a b c
Department of Orthopedic Surgery, Copenhagen University Hospital, Hvidovre, Denmark Orthopedic Department, Harris Orthopedic Laboratory, Massachusetts General Hospital, Boston, Massachusetts Section of Surgical Pathophysiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
a r t i c l e i n f o
a b s t r a c t
Article history: Received 17 March 2016 Received in revised form 15 June 2016 Accepted 16 June 2016 Available online xxx
Background: Postoperative anemia is frequent after revision of total knee arthroplasty (TKA) with reported transfusion rates up to 83%. Despite increased efforts of reducing blood loss and enhancing fast recovery within the fast-track setup, a considerable transfusion rate is still evident. The aim of this study was therefore to evaluate the effect of a bipolar sealer on blood loss and transfusion in revision TKA. Methods: In this single-center prospective cohort study with retrospective controls, 51 patients were enrolled in a fast-track setup for revision TKA without the use of a tourniquet. Twenty-five prospectively enrolled patients received treatment with both a bipolar sealer and electrocautery, whereas 26 patients had received treatment with a conventional electrocautery only in the retrospective group. Results: No significant differences were found neither for calculated blood loss, with 1397 (standard deviation, ± 452) mL in the bipolar sealer group vs 1452 (SD, ± 530) mL in the control group (P ¼ .66), nor for blood transfusion rates of 53% and 46% (P ¼ .89), respectively. Four controls were readmitted within 90 days follow-up. Conclusion: The use of a bipolar sealer in a TKA revision setting without the use of a tourniquet did not reduce blood loss or blood transfusion rates. © 2016 Elsevier Inc. All rights reserved.
Keywords: Aquamantys bipolar sealer revision knee arthroplasty blood loss blood transfusion
For patients undergoing primary total knee arthroplasty (TKA), perioperative anemia is highly prevalent and of great concern [1]. In a recent systemic review, postoperative anemia was found in 51% ± 10% of performed TKA procedures [2]. In the TKA revision setting, patients are older and hence experience more comorbidities, surgery lasts longer and has a more extensive character, and the potentially greater blood loss is reflected
One or more of the authors of this paper have disclosed potential or pertinent conflicts of interest, which may include receipt of payment, either direct or indirect, institutional support, or association with an entity in the biomedical field which may be perceived to have potential conflict of interest with this work. For full disclosure statements refer to http://dx.doi.org/10.1016/j.arth.2016.06.037. * Reprint requests: Christian Skovgaard Nielsen, MD, Department of Orthopedic Surgery, Copenhagen University Hospital, Kettegaard Alle 30, 2650 Hvidovre, Copenhagen, Denmark, and Orthopedic Department, Harris Orthopedic Laboratory, Massachusetts General Hospital, 55 Fruit Street, GRJ 1126, Boston, MA. http://dx.doi.org/10.1016/j.arth.2016.06.037 0883-5403/© 2016 Elsevier Inc. All rights reserved.
in high incidences of blood transfusion, from 27% [3] to 82% [4] in the revision setting. Although the ultimate transfusion trigger remains unknown within arthroplasty, restrictive transfusion protocols are recommended and transfusions overall should be avoided if feasible [5]. Modern optimized perioperative treatment (fast-track) includes clinical features in order to reduce blood loss and/or blood transfusion: spinal analgesia due to reduced operating time, reduced need for transfusion, and reduced incidence of thromboembolic disease [6], tranexamic acid (TXA) with proven effect for both primary and revision TKA [7,8], avoiding use of a tourniquet, which otherwise may increase hidden blood loss [9] by activating fibrinolysis [10] and delay functional recovery [11,12], and applying compression bandage at the end of surgery [13]. Despite employing these fast-track measures at our department, including the use of a standardized blood transfusion protocol, transfusion was needed for 27.6% of patients (2-6 units) in the
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revision setting [14], which compared to aforementioned transfusion rates [3,4] is relatively low, however still of great impact and concern. The demands for transfusion and delayed recovery associated with anemia [2] emphasize the need for additional modalities to decrease blood loss in the revision setting. Fibrin sealants and auto transfusion drains have been evaluated, showing various and disappointing effects [15,16]. Lately, local TXA has shown promising results in primary TKA [17], however only efficient in reducing postoperative bleeding due to the time of administration [18,19]. The only nonsystemic modality capable of reducing intraoperative blood loss is theoretically a bipolar sealer. By preincisional treatment of the soft tissue, bleeding (and potentially total blood loss and transfusion) is reduced by transcollation of the tissues without tissue charringdin contrast to the outcomes of conventional electrocautery. Various results for use of a bipolar sealer in primary TKA have been reported [20-24], while a novel meta-analysis suggests that a bipolar sealer might be beneficial in revision TKA [25]. Hence, a bipolar sealer might theoretically benefit the most in a revision setting, without the use of a tourniquet, to prevent blood loss before it actually occurs. The aim of this study is to identify whether the use of a bipolar sealer on top of electrocautery generates less total blood loss and/or less blood transfusion for revision TKA in a fast-track setting without a tourniquet. Materials and Methods This single-center prospective cohort study with retrospective controls was conducted at the Department of Orthopedics, Copenhagen University Hospital, Hvidovre, Denmark. Twenty-five consecutive patients undergoing nonseptic revision TKA accounted for the prospective cohort treated with a bipolar sealer (Aquamantys, Salient Surgical, Portsmouth, NH) on top of electrocautery whereas 26 consecutive patients, undergoing nonseptic revision TKA just before introduction of the bipolar sealer, represented the retrospective control group. The study was performed in a well-established multimodal fast-track setting [14,26], and besides introducing the bipolar sealer, no additional changes were introduced during the time of this trial. The trial was approved by the XXX Data Protection Agency (HvH-2013-037) and registered at ClinicalTrails.Gov under the US National Library of Medicine (NCT02427711). The Regional Ethics Committee of the Capital Region of Denmark waived the need for approval as the study was regarded as a quality assurance study. Participants Patients scheduled for primary unilateral nonseptic TKA revision with an age > 18 years were included; only patients with firsttime revision of both tibial and femoral components were included. Patients receiving oral anticoagulation medication before surgery were excluded. The control group consisted of consecutive unselected nonseptic first-time revisions operated by the same 2 highvolume surgeons who performed the revisions in the prospective group, which met the inclusion criteria and were matched by sex and prevalence of preoperative anemia. Criteria for preoperative anemia were hemoglobin (Hb) < 12 g/dL and Hb < 13 g/dL for women and men, respectively. Anesthesia, Surgery, and Intervention Patients had either spinal anesthesia with 3 mL of 0.5% (15 mg) plain bupivacaine administered via the L2/L3 or L3/L4 vertebral
interspace or combined epidural-spinal anesthesia with 15 mg of bupivacaine initially followed by standardized epidural infusion discontinued at the recovery room, both with additional propofol (0.5-5 mg/kg/h) for sedation if required. A few patients had general anesthesia with intravenous (IV) propofol and remifentanil. All patients received an IV injection of 1.5-g cefuroxime for a body weight below or equal to 80 kg, and if above 80 kg, 3-g cefuroxime during anesthetic induction; all received 1 g of IV TXA before incision. A midline skin incision with a medial parapatellar approach was used without a tourniquet. A conventional electrocautery was used for hemostasis of bleeding vessels in both groups, while a bipolar sealer (Aquamantys) was used to additionally pretreat the tissues in order to perform transcollation in the prospective group. The bipolar sealer was used systematically according to recommendations by the manufacturer with the following areas of treatment after skin incision: deep subcutaneous tissues plus spot treatment of visible vessels, remnants of fat pad/corpus Hoffa, posterior cruciate ligament (if still present) before excision and after, the periphery where the menisci were attached (if remnants of the menisci were still present), scar tissue before excision (including in front of the posterior capsule, behind the femoral condyles, and behind the tibia), and recut bone surfaces on femur and tibia which would not be covered by the revision implants. No attempt was made to pretreat the skin or superficial subcutaneous tissue, near neural tissue (care in the posterolateral corner), bone that was to be covered by an implant, the medial patellar retinaculum, or the patellar/quadriceps tendon. For the arthroplasty revision, 2 types of prostheses were used: the NexGen Legacy Constrained Condylar Knee (LCCK; ZimmerBiomet, Warsaw, IN) and NexGen Rotating Hinge Knee (RHK, Zimmer-Biomet, Warsaw, IN), and the appropriate prosthesis was determined by the surgeon. Local infiltration analgesia with 150 mL of ropivacaine (0.2%) was infiltrated at the end of surgery [27]. No patients received postoperative drains. Fluid therapy was standardized intraoperatively with 10 mL/kg of crystalloid fluid (Ringer) for the first hour, followed by 3 mL/kg/h. For suspected hypovolemia, a bolus of 250 mL of hydroxyethyl starch (Voluven; Fresenius Kabi, Bad Homburg, Germany) was given. Intraoperative hypotension was treated with either ephedrine (5-10 mg) or phenylephrine (0.1-0.2 mg). A standardized blood transfusion protocol was followed during hospitalization with transfusion if Hb decreased to <7.5 g/dL (<10 g/dL in patients with ischemic heart disease) or if postoperative Hb was reduced more than 25% relative to the preoperative level with concomitant clinical symptoms of anemia. For thromboprophylaxis, patients received peroral direct factor Xa inhibitor, Xarelto 10 mg [28] (rivaroxaban; Bayer, Germany) starting 6-8 hours postoperatively and continued once daily until discharged. No prolonged prophylaxis was given. Study Outcomes The primary outcome was blood loss at postoperative day 1 morning, approximately 20-24 h after surgery, calculated by Hb differences using the Gross formula [29] with an estimated total blood volume calculated by Nadler's formula [30]. Secondary outcomes were rate of blood transfusions and readmissions. Demographics in the form of gender, age, body mass index, and American Society of Anesthesiologists score (representing comorbidity) were collected from patient charts. Furthermore, the following data were collected: date of revision, indication for revision, preoperative Hb, surgery time (skin to skin), type of revision (LCCK or RHK), postoperative Hb day 1 (and if possible Hb day 2), number of blood transfusions, Hb at first
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transfusion (trigger), clinical symptoms requiring transfusion, length of stay, readmission <90 days, and reason for readmission. Sample Size Calculation In a retrospective cohort of 33 revision TKA patients in the same setting and department, a mean of 1514 mL (standard deviation [SD], 593 mL) for 24-h blood loss was found. For a clinically relevant difference in blood loss of 500 mL (chosen as an equivalent of approximately 2 blood transfusions to balance the cost of the Aquamantys system resulting in neutral cost), a power of 90% and a P value of .05, 22 patients in each group were needed, and a minimum of 25 were included in each group to account for dropouts.
3
distributed are presented as mean and SD and otherwise presented as the median with interquartile range (IQR). Binomial data are presented as number and percentages. Primary and secondary outcomes were compared between groups by the t test for independent normally distributed data or the Mann-Whitney U test for skewed data while categorical data were compared using the chisquare test. All data were analyzed using SPSS software, version 20.0 (IBM Corp, Troy, MI). A 2-sided P value of <.05 was considered statistically significant. Controls were matched for sex and preoperative anemia on a group level by selecting controls in a consecutive retrospective manner to the number of 26 after which the percentage of women and prevalence of preoperative anemia among controls were comparable.
Statistical Analyses
Source of Funding
Before statistical comparison of outcomes, demographics and outcome were analyzed for normal distribution as assessed by histograms and Q-Q plots. Continuous data that were normally
There was no external funding, and the bipolar sealer component was bought from the manufacturer of Aquamantys: Salient Surgical, Portsmouth, NH.
Fig. 1. Flow diagram.
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Table 1 Demographics. Baseline Data
Prospective Group (AQM)
Retrospective Group
Numbers Age (y), mean (SD) Gender, female, n (%) BMI (kg/m2), mean (SD) BMI (kg/m2), range ASA I ASA II ASA III
25 65.0 (±9.0) 20 (80%) 28.4 (±4.2) 23.4-44.0 6 (24%) 18 (72%) 1 (4%)
26 66.3 (±9.0) 16 (62%) 29.1 (±3.6) 23.8-37.1 6 (23%) 17 (65%) 3 (12%)
P Value
.60 .15 .77 .54 d d
AQM, Aquamantys; SD, standard deviation; BMI, body mass index; ASA, American Society of Anesthesiologists.
Results Patients For the prospective bipolar sealer group, 29 patients were screened for inclusion by the 2 designated surgeons. From May 2013 to June 2015, 3 patients were excluded due to anticoagulation treatment and 1 due to uncertainty regarding the preoperative Hb whereas 25 patients were eligible. Thirty-seven patients were revised from May 2011 to April 2013 by the same 2 surgeons. All of them were screened as potential retrospective controls with groupmatching for gender and prevalence of preoperative anemia. Six were excluded due to multiple revisions, 2 due to bilateral simultaneous revision, 2 due to preoperative anticoagulation treatment, and 1 due to lack of preoperative Hb level, and a total of 26 were eligible as controls (Fig. 1). For all 51 patients, primary and secondary outcomes were assessable. Patients in the 2 groups did not differ with respect to age, gender, body mass index, and American Society of Anesthesiologists score, and baseline characteristics for the 2 groups were comparable (Table 1). Intraoperative Data
or
No differences were found for duration of surgery, preoperative postoperative Hb, prevalence of preoperative anemia,
Table 2 Intraoperative Data. Prospective Group (AQM)
Retrospective Control Group
P Value
Time for surgery (min), 124.2 (±26.5) 122.2 (±29.2) .81 mean (SD) Preoperative HGB (g/dL), 13.5 (±1.6) 13.4 (±1.6) .77 mean (SD) Day 1 HGB (g/dL), mean (SD) 10.2 (±1.3) 10.5 (±1.3) .32 Proportion of preoperative 3 (12%) 6 (23%) .30 anemia Crystalloid fluid (mL), 1364 (±405) 1025 (±413) .005 mean (SD) No. (%) of patients receiving 20 (80%) 26 (100%) .02 HAES HAES (mL), median (IQR) 850 (500-1000) 1000 (750-1000) .11 Intraoperative blood loss (mL), 500 (400-800) 775.0 (500-900) .15 median (IQR) Type of implant, LCCK 22 (85%) 27 (93%) .35 Epi-spinal anesthesia 22 (88%) 24 (92%) .61 Time from preoperative HGB to 20.8 (1.3) 20.5 (1.5) .38 day 1 HGB LOS (d), median (IQR) 4 (3-4) 2 (2-3) <.001 HGB, hemoglobin; HAES, hydroxyethyl; AQM, Aquamantys; SD, standard deviation; IQR, interquartile range; LCCK, Legacy Constrained Condylar Knee; LOS, length of stay.
intraoperative measured blood loss, and time difference from endsurgery to time of Hb sampling at day 1 between the groups (Table 2). A significant difference was found for crystalloid fluid therapy with a mean administrated volume of 1364 (SD, ± 405) mL in the bipolar sealer group and 1025 (SD, ± 413) mL in the control group (P ¼ .005). In the bipolar sealer group, 80% of the patients received colloids with a median volume of 850 (IQR, 500-1000) mL, whereas 100% of the controls received a median of 1000.0 (IQR, 750-1000) mL. The median length of stay in the bipolar sealer group was 4 (3-4) days and 2 (2-3) days in the control group (P < .001). Study Outcome The primary outcome, total blood loss at day 1, was 1397 (SD, ± 452) mL in the prospective bipolar sealer group and 1452 (SD, ± 530) mL in the control group (P ¼ .69; Table 3). The transfusion rate was 53% (1-4 units) in the bipolar sealer group, whereas 46% (2-4 units) in the control group received blood transfusions (P ¼ .89). No readmissions were observed in the prospective bipolar sealer group with a 90-day follow-up. Four patients in the retrospective cohort were readmitted: 1 due to heart incompensation 19 days postoperatively, 1 due to a massive wound effusion 4 days postoperatively, 1 with suspected wound infection 2 weeks postoperatively, and 1 patient with confirmed deep vein thrombosis (DVT) 16 days after surgery. Discussion This study is the first to evaluate whether usage of a bipolar sealer reduces blood loss in revision TKA in a fast-track setting. Despite the theoretical benefit, a bipolar sealer neither reduced calculated total blood loss at day 1 nor reduced transfusion rates when used in nonseptic TKA revisions on top of conventional electrocautery vs treatment with electrocautery alone. Previous studies, which have aimed at clarifying the efficiency of bipolar sealer on bleeding, are mainly conducted in primary arthroplasty and are relatively sparse with divergent results; a novel meta-analysis stated that the bipolar sealer might be of limited use, except for some benefit in primary TKA and revision settings [25]. In a recent randomized, controlled trial for primary TKA, no significant difference was found neither for drain output nor for the postoperative Hb values compared daily and pairwise until the third postoperative day [20], whereas a bipolar sealer in a prospective study for primary TKAs was found to reduce the drain output by 28% [24]. Drains may not be suitable for measurement of blood loss because the hematocrit might decline in the output over time [31], and the total blood loss might actually increase by use of drains [32]. A retrospective cohort study compared the effect of a bipolar sealer with conventional electrocautery in bilaterally operated TKAs and found no difference in calculated blood loss, but patients in the bipolar sealer group were 35% less likely to receive a blood transfusion in the category of <2 units [21]. The overall conclusion was a disadvantageous cost-benefit relation because the marginal savings due to reduced transfusion rates for <2 units did not exceed the additional costs for the bipolar sealer. Two studies, conducted by the same author, in primary TKA, found a favorable effect of the bipolar sealer with a significantly reduced total blood loss (128.4 mL reduction) and a decline in Hb (0.6 g/dL), respectively [22,23]. Although significantly different, the clinical effects were minor compared to the cost of the bipolar sealer. In addition, no significant difference in transfusion rate was observed in neither of the studies [22,23], and a tourniquet was used in both with the risk of changed bleeding kinesthetic [10,17] and an increased risk of DVT [33]. A bipolar sealer has also been investigated in primary hip
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Table 3 Outcomes.
Day 1 blood loss Mean (SD; mL) Blood transfusion Patients transfused
Bipolar Sealer Group (Prospective Group)
Control Group (Retrospective Group)
Difference
95% CI
Test
Significance
1397 (±452)
1452 (±530)
55 (4%)
313 to 223
t Test
P ¼ .66
12 (53%)
12 (46%)
Chi-test
P ¼ .89
15%
CI, confidence interval; SD, standard deviation.
replacement; a meta-analysis and a recent randomized, controlled trial both found a nonsignificant effect on blood loss and transfusion rates [34,35]. Overall, there is a discrepancy of effect, which to some extent may be attributed to a lack of standardized and reliable measurements such as a decline in Hb independently of differences in fluid therapy and total blood volume, as well as use of drains and tourniquets. These parameters were standardized in the present study. For the Hb value on postoperative day 1, no difference was found from end-surgery to time of blood sample with a mean of 20.8 (SD, ± 1.3) hours vs 20.5 (SD, ± 1.5) hours. This eliminates the risk of unequal dilution and equilibrium of the postoperative Hb. Another strength of the present study is that patients were matched by sex, but not by age, as a previous study found women to receive more transfusions (19.2%) as opposed to men (4.2%) but with no influence of age [1]. Matching was likewise done for the prevalence of preoperative anemia because patients with preoperative anemia are more likely to receive blood transfusion [20] with a risk of confounding for comparison of transfusion rates. Matching was performed on group levels by a retrospective consecutive inclusion of patients till comparable values for gender (P ¼ .15) and prevalence of preoperative anemia (P ¼ .30). Despite the theoretical effect, no reduction in blood loss was observed in the bipolar sealer group. It is, however, plausible that time spend on pretreating tissues with the bipolar sealer to reduce a superficial bleeding does not pay off when the major blood loss is hidden and released from the bone marrow and surfaces of cut bone. An actual significant extended surgical time was not observed in the present study; however, this has been pointed out, significantly, in another study [21]. All patients received 1 g of IV TXA preoperatively for which both efficiency (reduction of total blood loss of 25-40%) [7] and safety [36] is evident. Furthermore, preoperative IV TXA facilitates avoidance of the harmful tourniquet that generates increased pain, increased postoperative bleeding, and up to 500% increased risk of DVT [33,37,38]. Despite IV TXA preoperatively, the transfusion rates were 53% and 46% in the bipolar sealer group and retrospective control group, respectively; however, this rate is similar to that described in revision TKA surgery in general [3,4]. With the aim of reducing blood loss, although in primary TKA, use of multiple injections of IV TXA has been investigated to explore a potential and additional effect of repetitive IV TXA [39]. However, in a recent study, a single dose of IV TXA preoperatively was as efficient as continuous infusion with the recommendation of a single preoperative shot [40]. Highly interesting, a future regime might be to inject IV TXA preoperatively to decrease the intraoperative blood loss (with no need of a tourniquet) and supplementary intraarticular injection at end-surgery to decrease the postoperative hidden blood loss proven in primary TKA by a reduction of 37% [41]. An additional 339 mL of administrated crystalloids was observed for patients in the bipolar sealer group. Duration of surgery does not explain this by a prolonged time for infusion. Although the bipolar sealer group received more intraoperative crystalloids, the volume was small and we consider it unlikely that it would have influenced our results significantly.
Bipolar sealer performs the anticoagulation effect on exposed surfaces with no effect on hidden blood loss from bone marrow and deep tissue. Thus, to avoid a potentially skewed hidden blood loss due to unequal distribution of oral anticoagulation for both numbers of patients and types of treatment in the 2 groups, patients treated with oral anticoagulation were excluded. We acknowledge some limitations to our study. Despite the aim of matching the control groups, the nature of this study by a retrospective control group can introduce a risk of bias. There could potentially be a difference in the amount of hemostasis performed in the 2 groupsdas the methodology was obviously not blinded to the surgeon. However, the same 2 experienced surgeons were performing all revisions using their standard routines (except for the bipolar sealer). Four readmissions were observed within the retrospective control group vs 0 for the bipolar sealer group; however, based on literature and clinical experience, we have no reason to believe that the present readmissions (heart incompensation, wound effusion, DVT, and wound infection) were associated with the use of the electrocautery device nor could have been avoided had a bipolar sealer been used as well. In the present study, we aimed for an end point of 500 mL in difference for which it could be argued that the chosen effect measure is fairly large with a considerable risk of a type II error. However, the cost of the applied bipolar sealer, a one-time-use equipment, is equal to the price of 2 units of red blood cells representing a volume of 500-600 mL of red blood cells. The utility of the bipolar sealer would be beneficial, clinically and economically, if the high transfusion rate in the TKA revision setting was reduced radically. Thus, to justify the extra cost, a selected effect measure of 500 mL was used in the power calculation. Conclusion We found no effect of a bipolar sealer on total calculated blood loss or blood transfusion rates in revision TKA without a tourniquet. References 1. Cushner FD, Foley I, Kessler D, et al. Blood management in revision total knee arthroplasty. Clin Orthop Relat Res 2002;(404):247. 2. Spahn DR. Anemia and patient blood management in hip and knee surgery: a systematic review of the literature. Anesthesiology 2010;113:482. 3. Evans S, O'Loughlin E, Bruce J. Retrospective audit of blood transfusion and comparison with haemoglobin concentration in patients undergoing elective primary and revision lower limb arthroplasty. Anaesth Intensive Care 2011;39: 480. 4. Pagnano M, Cushner FD, Hansen A, et al. Blood management in two-stage revision knee arthroplasty for deep prosthetic infection. Clin Orthop Relat Res 1999;(367):238. 5. Spahn DR, Vamvakas EC. Is best transfusion practice alone best clinical practice? Blood Transfus 2013;11:172. 6. Hu S, Zhang Z-Y, Hua Y-Q, et al. A comparison of regional and general anaesthesia for total replacement of the hip or knee: a meta-analysis. J Bone Joint Surg Br 2009;91:935. 7. Alshryda S, Sarda P, Sukeik M, et al. Tranexamic acid in total knee replacement: a systematic review and meta-analysis. J Bone Joint Surg Br 2011;93:1577. 8. Aguilera X, Videla S, Almenara M, et al. Effectiveness of tranexamic acid in revision total knee arthroplasty. Acta Orthop Belg 2012;78:68.
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Original Article
No Effect of a Bipolar Sealer on Total Blood Loss or Blood Transfusion in Nonseptic Revision Knee ArthroplastydA Prospective Study With Matched Retrospective Controls Christian Skovgaard Nielsen, MD a, b, *, Kirill Gromov, PhD, MD a, Øivind Jans, PhD, MD c, Anders Troelsen, MD, PhD, DMSc a, Henrik Husted, DMSc, PhD a a b c
Department of Orthopedic Surgery, Copenhagen University Hospital, Hvidovre, Denmark Orthopedic Department, Harris Orthopedic Laboratory, Massachusetts General Hospital, Boston, Massachusetts Section of Surgical Pathophysiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
a r t i c l e i n f o
a b s t r a c t
Article history: Received 17 March 2016 Received in revised form 15 June 2016 Accepted 16 June 2016 Available online xxx
Background: Postoperative anemia is frequent after revision of total knee arthroplasty (TKA) with reported transfusion rates up to 83%. Despite increased efforts of reducing blood loss and enhancing fast recovery within the fast-track setup, a considerable transfusion rate is still evident. The aim of this study was therefore to evaluate the effect of a bipolar sealer on blood loss and transfusion in revision TKA. Methods: In this single-center prospective cohort study with retrospective controls, 51 patients were enrolled in a fast-track setup for revision TKA without the use of a tourniquet. Twenty-five prospectively enrolled patients received treatment with both a bipolar sealer and electrocautery, whereas 26 patients had received treatment with a conventional electrocautery only in the retrospective group. Results: No significant differences were found neither for calculated blood loss, with 1397 (standard deviation, ± 452) mL in the bipolar sealer group vs 1452 (SD, ± 530) mL in the control group (P ¼ .66), nor for blood transfusion rates of 53% and 46% (P ¼ .89), respectively. Four controls were readmitted within 90 days follow-up. Conclusion: The use of a bipolar sealer in a TKA revision setting without the use of a tourniquet did not reduce blood loss or blood transfusion rates. © 2016 Elsevier Inc. All rights reserved.
Keywords: Aquamantys bipolar sealer revision knee arthroplasty blood loss blood transfusion
For patients undergoing primary total knee arthroplasty (TKA), perioperative anemia is highly prevalent and of great concern [1]. In a recent systemic review, postoperative anemia was found in 51% ± 10% of performed TKA procedures [2]. In the TKA revision setting, patients are older and hence experience more comorbidities, surgery lasts longer and has a more extensive character, and the potentially greater blood loss is reflected
One or more of the authors of this paper have disclosed potential or pertinent conflicts of interest, which may include receipt of payment, either direct or indirect, institutional support, or association with an entity in the biomedical field which may be perceived to have potential conflict of interest with this work. For full disclosure statements refer to http://dx.doi.org/10.1016/j.arth.2016.06.037. * Reprint requests: Christian Skovgaard Nielsen, MD, Department of Orthopedic Surgery, Copenhagen University Hospital, Kettegaard Alle 30, 2650 Hvidovre, Copenhagen, Denmark, and Orthopedic Department, Harris Orthopedic Laboratory, Massachusetts General Hospital, 55 Fruit Street, GRJ 1126, Boston, MA. http://dx.doi.org/10.1016/j.arth.2016.06.037 0883-5403/© 2016 Elsevier Inc. All rights reserved.
in high incidences of blood transfusion, from 27% [3] to 82% [4] in the revision setting. Although the ultimate transfusion trigger remains unknown within arthroplasty, restrictive transfusion protocols are recommended and transfusions overall should be avoided if feasible [5]. Modern optimized perioperative treatment (fast-track) includes clinical features in order to reduce blood loss and/or blood transfusion: spinal analgesia due to reduced operating time, reduced need for transfusion, and reduced incidence of thromboembolic disease [6], tranexamic acid (TXA) with proven effect for both primary and revision TKA [7,8], avoiding use of a tourniquet, which otherwise may increase hidden blood loss [9] by activating fibrinolysis [10] and delay functional recovery [11,12], and applying compression bandage at the end of surgery [13]. Despite employing these fast-track measures at our department, including the use of a standardized blood transfusion protocol, transfusion was needed for 27.6% of patients (2-6 units) in the
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revision setting [14], which compared to aforementioned transfusion rates [3,4] is relatively low, however still of great impact and concern. The demands for transfusion and delayed recovery associated with anemia [2] emphasize the need for additional modalities to decrease blood loss in the revision setting. Fibrin sealants and auto transfusion drains have been evaluated, showing various and disappointing effects [15,16]. Lately, local TXA has shown promising results in primary TKA [17], however only efficient in reducing postoperative bleeding due to the time of administration [18,19]. The only nonsystemic modality capable of reducing intraoperative blood loss is theoretically a bipolar sealer. By preincisional treatment of the soft tissue, bleeding (and potentially total blood loss and transfusion) is reduced by transcollation of the tissues without tissue charringdin contrast to the outcomes of conventional electrocautery. Various results for use of a bipolar sealer in primary TKA have been reported [20-24], while a novel meta-analysis suggests that a bipolar sealer might be beneficial in revision TKA [25]. Hence, a bipolar sealer might theoretically benefit the most in a revision setting, without the use of a tourniquet, to prevent blood loss before it actually occurs. The aim of this study is to identify whether the use of a bipolar sealer on top of electrocautery generates less total blood loss and/or less blood transfusion for revision TKA in a fast-track setting without a tourniquet. Materials and Methods This single-center prospective cohort study with retrospective controls was conducted at the Department of Orthopedics, Copenhagen University Hospital, Hvidovre, Denmark. Twenty-five consecutive patients undergoing nonseptic revision TKA accounted for the prospective cohort treated with a bipolar sealer (Aquamantys, Salient Surgical, Portsmouth, NH) on top of electrocautery whereas 26 consecutive patients, undergoing nonseptic revision TKA just before introduction of the bipolar sealer, represented the retrospective control group. The study was performed in a well-established multimodal fast-track setting [14,26], and besides introducing the bipolar sealer, no additional changes were introduced during the time of this trial. The trial was approved by the XXX Data Protection Agency (HvH-2013-037) and registered at ClinicalTrails.Gov under the US National Library of Medicine (NCT02427711). The Regional Ethics Committee of the Capital Region of Denmark waived the need for approval as the study was regarded as a quality assurance study. Participants Patients scheduled for primary unilateral nonseptic TKA revision with an age > 18 years were included; only patients with firsttime revision of both tibial and femoral components were included. Patients receiving oral anticoagulation medication before surgery were excluded. The control group consisted of consecutive unselected nonseptic first-time revisions operated by the same 2 highvolume surgeons who performed the revisions in the prospective group, which met the inclusion criteria and were matched by sex and prevalence of preoperative anemia. Criteria for preoperative anemia were hemoglobin (Hb) < 12 g/dL and Hb < 13 g/dL for women and men, respectively. Anesthesia, Surgery, and Intervention Patients had either spinal anesthesia with 3 mL of 0.5% (15 mg) plain bupivacaine administered via the L2/L3 or L3/L4 vertebral
interspace or combined epidural-spinal anesthesia with 15 mg of bupivacaine initially followed by standardized epidural infusion discontinued at the recovery room, both with additional propofol (0.5-5 mg/kg/h) for sedation if required. A few patients had general anesthesia with intravenous (IV) propofol and remifentanil. All patients received an IV injection of 1.5-g cefuroxime for a body weight below or equal to 80 kg, and if above 80 kg, 3-g cefuroxime during anesthetic induction; all received 1 g of IV TXA before incision. A midline skin incision with a medial parapatellar approach was used without a tourniquet. A conventional electrocautery was used for hemostasis of bleeding vessels in both groups, while a bipolar sealer (Aquamantys) was used to additionally pretreat the tissues in order to perform transcollation in the prospective group. The bipolar sealer was used systematically according to recommendations by the manufacturer with the following areas of treatment after skin incision: deep subcutaneous tissues plus spot treatment of visible vessels, remnants of fat pad/corpus Hoffa, posterior cruciate ligament (if still present) before excision and after, the periphery where the menisci were attached (if remnants of the menisci were still present), scar tissue before excision (including in front of the posterior capsule, behind the femoral condyles, and behind the tibia), and recut bone surfaces on femur and tibia which would not be covered by the revision implants. No attempt was made to pretreat the skin or superficial subcutaneous tissue, near neural tissue (care in the posterolateral corner), bone that was to be covered by an implant, the medial patellar retinaculum, or the patellar/quadriceps tendon. For the arthroplasty revision, 2 types of prostheses were used: the NexGen Legacy Constrained Condylar Knee (LCCK; ZimmerBiomet, Warsaw, IN) and NexGen Rotating Hinge Knee (RHK, Zimmer-Biomet, Warsaw, IN), and the appropriate prosthesis was determined by the surgeon. Local infiltration analgesia with 150 mL of ropivacaine (0.2%) was infiltrated at the end of surgery [27]. No patients received postoperative drains. Fluid therapy was standardized intraoperatively with 10 mL/kg of crystalloid fluid (Ringer) for the first hour, followed by 3 mL/kg/h. For suspected hypovolemia, a bolus of 250 mL of hydroxyethyl starch (Voluven; Fresenius Kabi, Bad Homburg, Germany) was given. Intraoperative hypotension was treated with either ephedrine (5-10 mg) or phenylephrine (0.1-0.2 mg). A standardized blood transfusion protocol was followed during hospitalization with transfusion if Hb decreased to <7.5 g/dL (<10 g/dL in patients with ischemic heart disease) or if postoperative Hb was reduced more than 25% relative to the preoperative level with concomitant clinical symptoms of anemia. For thromboprophylaxis, patients received peroral direct factor Xa inhibitor, Xarelto 10 mg [28] (rivaroxaban; Bayer, Germany) starting 6-8 hours postoperatively and continued once daily until discharged. No prolonged prophylaxis was given. Study Outcomes The primary outcome was blood loss at postoperative day 1 morning, approximately 20-24 h after surgery, calculated by Hb differences using the Gross formula [29] with an estimated total blood volume calculated by Nadler's formula [30]. Secondary outcomes were rate of blood transfusions and readmissions. Demographics in the form of gender, age, body mass index, and American Society of Anesthesiologists score (representing comorbidity) were collected from patient charts. Furthermore, the following data were collected: date of revision, indication for revision, preoperative Hb, surgery time (skin to skin), type of revision (LCCK or RHK), postoperative Hb day 1 (and if possible Hb day 2), number of blood transfusions, Hb at first
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transfusion (trigger), clinical symptoms requiring transfusion, length of stay, readmission <90 days, and reason for readmission. Sample Size Calculation In a retrospective cohort of 33 revision TKA patients in the same setting and department, a mean of 1514 mL (standard deviation [SD], 593 mL) for 24-h blood loss was found. For a clinically relevant difference in blood loss of 500 mL (chosen as an equivalent of approximately 2 blood transfusions to balance the cost of the Aquamantys system resulting in neutral cost), a power of 90% and a P value of .05, 22 patients in each group were needed, and a minimum of 25 were included in each group to account for dropouts.
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distributed are presented as mean and SD and otherwise presented as the median with interquartile range (IQR). Binomial data are presented as number and percentages. Primary and secondary outcomes were compared between groups by the t test for independent normally distributed data or the Mann-Whitney U test for skewed data while categorical data were compared using the chisquare test. All data were analyzed using SPSS software, version 20.0 (IBM Corp, Troy, MI). A 2-sided P value of <.05 was considered statistically significant. Controls were matched for sex and preoperative anemia on a group level by selecting controls in a consecutive retrospective manner to the number of 26 after which the percentage of women and prevalence of preoperative anemia among controls were comparable.
Statistical Analyses
Source of Funding
Before statistical comparison of outcomes, demographics and outcome were analyzed for normal distribution as assessed by histograms and Q-Q plots. Continuous data that were normally
There was no external funding, and the bipolar sealer component was bought from the manufacturer of Aquamantys: Salient Surgical, Portsmouth, NH.
Fig. 1. Flow diagram.
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Table 1 Demographics. Baseline Data
Prospective Group (AQM)
Retrospective Group
Numbers Age (y), mean (SD) Gender, female, n (%) BMI (kg/m2), mean (SD) BMI (kg/m2), range ASA I ASA II ASA III
25 65.0 (±9.0) 20 (80%) 28.4 (±4.2) 23.4-44.0 6 (24%) 18 (72%) 1 (4%)
26 66.3 (±9.0) 16 (62%) 29.1 (±3.6) 23.8-37.1 6 (23%) 17 (65%) 3 (12%)
P Value
.60 .15 .77 .54 d d
AQM, Aquamantys; SD, standard deviation; BMI, body mass index; ASA, American Society of Anesthesiologists.
Results Patients For the prospective bipolar sealer group, 29 patients were screened for inclusion by the 2 designated surgeons. From May 2013 to June 2015, 3 patients were excluded due to anticoagulation treatment and 1 due to uncertainty regarding the preoperative Hb whereas 25 patients were eligible. Thirty-seven patients were revised from May 2011 to April 2013 by the same 2 surgeons. All of them were screened as potential retrospective controls with groupmatching for gender and prevalence of preoperative anemia. Six were excluded due to multiple revisions, 2 due to bilateral simultaneous revision, 2 due to preoperative anticoagulation treatment, and 1 due to lack of preoperative Hb level, and a total of 26 were eligible as controls (Fig. 1). For all 51 patients, primary and secondary outcomes were assessable. Patients in the 2 groups did not differ with respect to age, gender, body mass index, and American Society of Anesthesiologists score, and baseline characteristics for the 2 groups were comparable (Table 1). Intraoperative Data
or
No differences were found for duration of surgery, preoperative postoperative Hb, prevalence of preoperative anemia,
Table 2 Intraoperative Data. Prospective Group (AQM)
Retrospective Control Group
P Value
Time for surgery (min), 124.2 (±26.5) 122.2 (±29.2) .81 mean (SD) Preoperative HGB (g/dL), 13.5 (±1.6) 13.4 (±1.6) .77 mean (SD) Day 1 HGB (g/dL), mean (SD) 10.2 (±1.3) 10.5 (±1.3) .32 Proportion of preoperative 3 (12%) 6 (23%) .30 anemia Crystalloid fluid (mL), 1364 (±405) 1025 (±413) .005 mean (SD) No. (%) of patients receiving 20 (80%) 26 (100%) .02 HAES HAES (mL), median (IQR) 850 (500-1000) 1000 (750-1000) .11 Intraoperative blood loss (mL), 500 (400-800) 775.0 (500-900) .15 median (IQR) Type of implant, LCCK 22 (85%) 27 (93%) .35 Epi-spinal anesthesia 22 (88%) 24 (92%) .61 Time from preoperative HGB to 20.8 (1.3) 20.5 (1.5) .38 day 1 HGB LOS (d), median (IQR) 4 (3-4) 2 (2-3) <.001 HGB, hemoglobin; HAES, hydroxyethyl; AQM, Aquamantys; SD, standard deviation; IQR, interquartile range; LCCK, Legacy Constrained Condylar Knee; LOS, length of stay.
intraoperative measured blood loss, and time difference from endsurgery to time of Hb sampling at day 1 between the groups (Table 2). A significant difference was found for crystalloid fluid therapy with a mean administrated volume of 1364 (SD, ± 405) mL in the bipolar sealer group and 1025 (SD, ± 413) mL in the control group (P ¼ .005). In the bipolar sealer group, 80% of the patients received colloids with a median volume of 850 (IQR, 500-1000) mL, whereas 100% of the controls received a median of 1000.0 (IQR, 750-1000) mL. The median length of stay in the bipolar sealer group was 4 (3-4) days and 2 (2-3) days in the control group (P < .001). Study Outcome The primary outcome, total blood loss at day 1, was 1397 (SD, ± 452) mL in the prospective bipolar sealer group and 1452 (SD, ± 530) mL in the control group (P ¼ .69; Table 3). The transfusion rate was 53% (1-4 units) in the bipolar sealer group, whereas 46% (2-4 units) in the control group received blood transfusions (P ¼ .89). No readmissions were observed in the prospective bipolar sealer group with a 90-day follow-up. Four patients in the retrospective cohort were readmitted: 1 due to heart incompensation 19 days postoperatively, 1 due to a massive wound effusion 4 days postoperatively, 1 with suspected wound infection 2 weeks postoperatively, and 1 patient with confirmed deep vein thrombosis (DVT) 16 days after surgery. Discussion This study is the first to evaluate whether usage of a bipolar sealer reduces blood loss in revision TKA in a fast-track setting. Despite the theoretical benefit, a bipolar sealer neither reduced calculated total blood loss at day 1 nor reduced transfusion rates when used in nonseptic TKA revisions on top of conventional electrocautery vs treatment with electrocautery alone. Previous studies, which have aimed at clarifying the efficiency of bipolar sealer on bleeding, are mainly conducted in primary arthroplasty and are relatively sparse with divergent results; a novel meta-analysis stated that the bipolar sealer might be of limited use, except for some benefit in primary TKA and revision settings [25]. In a recent randomized, controlled trial for primary TKA, no significant difference was found neither for drain output nor for the postoperative Hb values compared daily and pairwise until the third postoperative day [20], whereas a bipolar sealer in a prospective study for primary TKAs was found to reduce the drain output by 28% [24]. Drains may not be suitable for measurement of blood loss because the hematocrit might decline in the output over time [31], and the total blood loss might actually increase by use of drains [32]. A retrospective cohort study compared the effect of a bipolar sealer with conventional electrocautery in bilaterally operated TKAs and found no difference in calculated blood loss, but patients in the bipolar sealer group were 35% less likely to receive a blood transfusion in the category of <2 units [21]. The overall conclusion was a disadvantageous cost-benefit relation because the marginal savings due to reduced transfusion rates for <2 units did not exceed the additional costs for the bipolar sealer. Two studies, conducted by the same author, in primary TKA, found a favorable effect of the bipolar sealer with a significantly reduced total blood loss (128.4 mL reduction) and a decline in Hb (0.6 g/dL), respectively [22,23]. Although significantly different, the clinical effects were minor compared to the cost of the bipolar sealer. In addition, no significant difference in transfusion rate was observed in neither of the studies [22,23], and a tourniquet was used in both with the risk of changed bleeding kinesthetic [10,17] and an increased risk of DVT [33]. A bipolar sealer has also been investigated in primary hip
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Table 3 Outcomes.
Day 1 blood loss Mean (SD; mL) Blood transfusion Patients transfused
Bipolar Sealer Group (Prospective Group)
Control Group (Retrospective Group)
Difference
95% CI
Test
Significance
1397 (±452)
1452 (±530)
55 (4%)
313 to 223
t Test
P ¼ .66
12 (53%)
12 (46%)
Chi-test
P ¼ .89
15%
CI, confidence interval; SD, standard deviation.
replacement; a meta-analysis and a recent randomized, controlled trial both found a nonsignificant effect on blood loss and transfusion rates [34,35]. Overall, there is a discrepancy of effect, which to some extent may be attributed to a lack of standardized and reliable measurements such as a decline in Hb independently of differences in fluid therapy and total blood volume, as well as use of drains and tourniquets. These parameters were standardized in the present study. For the Hb value on postoperative day 1, no difference was found from end-surgery to time of blood sample with a mean of 20.8 (SD, ± 1.3) hours vs 20.5 (SD, ± 1.5) hours. This eliminates the risk of unequal dilution and equilibrium of the postoperative Hb. Another strength of the present study is that patients were matched by sex, but not by age, as a previous study found women to receive more transfusions (19.2%) as opposed to men (4.2%) but with no influence of age [1]. Matching was likewise done for the prevalence of preoperative anemia because patients with preoperative anemia are more likely to receive blood transfusion [20] with a risk of confounding for comparison of transfusion rates. Matching was performed on group levels by a retrospective consecutive inclusion of patients till comparable values for gender (P ¼ .15) and prevalence of preoperative anemia (P ¼ .30). Despite the theoretical effect, no reduction in blood loss was observed in the bipolar sealer group. It is, however, plausible that time spend on pretreating tissues with the bipolar sealer to reduce a superficial bleeding does not pay off when the major blood loss is hidden and released from the bone marrow and surfaces of cut bone. An actual significant extended surgical time was not observed in the present study; however, this has been pointed out, significantly, in another study [21]. All patients received 1 g of IV TXA preoperatively for which both efficiency (reduction of total blood loss of 25-40%) [7] and safety [36] is evident. Furthermore, preoperative IV TXA facilitates avoidance of the harmful tourniquet that generates increased pain, increased postoperative bleeding, and up to 500% increased risk of DVT [33,37,38]. Despite IV TXA preoperatively, the transfusion rates were 53% and 46% in the bipolar sealer group and retrospective control group, respectively; however, this rate is similar to that described in revision TKA surgery in general [3,4]. With the aim of reducing blood loss, although in primary TKA, use of multiple injections of IV TXA has been investigated to explore a potential and additional effect of repetitive IV TXA [39]. However, in a recent study, a single dose of IV TXA preoperatively was as efficient as continuous infusion with the recommendation of a single preoperative shot [40]. Highly interesting, a future regime might be to inject IV TXA preoperatively to decrease the intraoperative blood loss (with no need of a tourniquet) and supplementary intraarticular injection at end-surgery to decrease the postoperative hidden blood loss proven in primary TKA by a reduction of 37% [41]. An additional 339 mL of administrated crystalloids was observed for patients in the bipolar sealer group. Duration of surgery does not explain this by a prolonged time for infusion. Although the bipolar sealer group received more intraoperative crystalloids, the volume was small and we consider it unlikely that it would have influenced our results significantly.
Bipolar sealer performs the anticoagulation effect on exposed surfaces with no effect on hidden blood loss from bone marrow and deep tissue. Thus, to avoid a potentially skewed hidden blood loss due to unequal distribution of oral anticoagulation for both numbers of patients and types of treatment in the 2 groups, patients treated with oral anticoagulation were excluded. We acknowledge some limitations to our study. Despite the aim of matching the control groups, the nature of this study by a retrospective control group can introduce a risk of bias. There could potentially be a difference in the amount of hemostasis performed in the 2 groupsdas the methodology was obviously not blinded to the surgeon. However, the same 2 experienced surgeons were performing all revisions using their standard routines (except for the bipolar sealer). Four readmissions were observed within the retrospective control group vs 0 for the bipolar sealer group; however, based on literature and clinical experience, we have no reason to believe that the present readmissions (heart incompensation, wound effusion, DVT, and wound infection) were associated with the use of the electrocautery device nor could have been avoided had a bipolar sealer been used as well. In the present study, we aimed for an end point of 500 mL in difference for which it could be argued that the chosen effect measure is fairly large with a considerable risk of a type II error. However, the cost of the applied bipolar sealer, a one-time-use equipment, is equal to the price of 2 units of red blood cells representing a volume of 500-600 mL of red blood cells. The utility of the bipolar sealer would be beneficial, clinically and economically, if the high transfusion rate in the TKA revision setting was reduced radically. Thus, to justify the extra cost, a selected effect measure of 500 mL was used in the power calculation. Conclusion We found no effect of a bipolar sealer on total calculated blood loss or blood transfusion rates in revision TKA without a tourniquet. References 1. Cushner FD, Foley I, Kessler D, et al. Blood management in revision total knee arthroplasty. Clin Orthop Relat Res 2002;(404):247. 2. Spahn DR. Anemia and patient blood management in hip and knee surgery: a systematic review of the literature. Anesthesiology 2010;113:482. 3. Evans S, O'Loughlin E, Bruce J. Retrospective audit of blood transfusion and comparison with haemoglobin concentration in patients undergoing elective primary and revision lower limb arthroplasty. Anaesth Intensive Care 2011;39: 480. 4. Pagnano M, Cushner FD, Hansen A, et al. Blood management in two-stage revision knee arthroplasty for deep prosthetic infection. Clin Orthop Relat Res 1999;(367):238. 5. Spahn DR, Vamvakas EC. Is best transfusion practice alone best clinical practice? Blood Transfus 2013;11:172. 6. Hu S, Zhang Z-Y, Hua Y-Q, et al. A comparison of regional and general anaesthesia for total replacement of the hip or knee: a meta-analysis. J Bone Joint Surg Br 2009;91:935. 7. Alshryda S, Sarda P, Sukeik M, et al. Tranexamic acid in total knee replacement: a systematic review and meta-analysis. J Bone Joint Surg Br 2011;93:1577. 8. Aguilera X, Videla S, Almenara M, et al. Effectiveness of tranexamic acid in revision total knee arthroplasty. Acta Orthop Belg 2012;78:68.
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