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Prospective Randomized Evaluation of the Need for Blood Transfusion During Primary Total Hip Arthroplasty with Use of a Bipolar Sealer
Wael K. Barsoum, MD1; Alison K. Klika, MS1; Trevor G. Murray, MD1; Carlos Higuera, MD1; Ho H. Lee, MD, PhD1; Viktor E. Krebs, MD1
1 Department of Orthopaedic Surgery – A41, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195. E-mail address for A.K. Klika: klikaa@ccf.org
View Disclosures and Other Information
Disclosure: In support of their research for or preparation of this work, one or more of the authors received, in any one year, outside funding or grants in excess of $10,000 from TissueLink (Salient Surgical Technologies). In addition, one or more of the authors or a member of his or her immediate family received, in any one year, payments or other benefits in excess of $10,000 or a commitment or agreement to provide such benefits from commercial entities (Stryker, Shukla Medical, Exactech, Wright Medical, and OtisMed).

Investigation performed at the Department of Orthopaedic Surgery, Cleveland Clinic, Cleveland, Ohio

Copyright © 2011 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2011 Mar 16;93(6):513-518. doi: 10.2106/JBJS.J.00036
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Abstract

Background: 

Blood loss during total hip arthroplasty can be substantial and may lead to adverse patient outcomes and increased health-care costs. Many blood-management options are available for these procedures. The purpose of the present study was to test the hemostatic efficacy of a bipolar sealer used during total hip arthroplasty in order to determine whether its use results in significantly lower transfusion requirements and/or improved clinical, functional, and health-related quality-of-life outcomes in healthy patients.

Methods: 

This prospective, single-center, randomized, double-blinded study was designed to enroll a total of 140 patients. Patients with a low preoperative hemoglobin level or a history of bleeding abnormalities and other medical conditions were excluded. Patients were randomized to either the treatment arm (radiofrequency energy with use of the Aquamantys 6.0 bipolar sealer) or control arm (standard Bovie electrocautery). The primary outcome measure was the transfusion requirement, and the secondary outcome measures were intraoperative estimated blood loss, postoperative hemoglobin levels, perioperative narcotic usage, length of hospital stay, postoperative pain scores, and postoperative function as measured with the Harris hip score and the Short Form-12 quality-of-life score.

Results: 

Seventy-one patients were assigned to the treatment arm, and sixty-nine were assigned to the control arm. The mean number of units of blood transfused for all patients in the study and control arms were 0.38 and 0.44, respectively (p = 0.72). The transfusion requirements were similar in the two groups, with fifteen of seventy-one patients in the treatment arm and fourteen of sixty-nine patients in the control arm requiring a transfusion (p = 0.9). No significant differences were detected between the groups in terms of estimated blood loss, postoperative hemoglobin levels, perioperative narcotic usage, length of hospital stay, postoperative pain scores, Harris hip scores, or Short Form-12 scores.

Conclusions: 

In this patient population, there were no significant differences between the treatment and control groups in terms of the need for blood transfusions or overall blood loss. Given these findings, we have discontinued the use of this bipolar sealing device in uncomplicated primary total hip arthroplasty patients at our institution.

Level of Evidence: 

Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.

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    References

    Accreditation Statement
    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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    Alison K. Klika, MS
    Posted on May 20, 2011
    Dr. Klika and colleagues respond to Dr. Keggi
    Cleveland Clinic, Cleveland, Ohio

    Thank you to Dr. Keggi for his letter and interest in our research. We appreciate the opportunity to respond to the points he has raised.

    First, we would like to address the report generated by Salient Surgical Technologies and shared with Dr. Keggi in his consulting role with the company. We appreciate that he has disclosed this relationship in his letter, and feel that it is important to the readers to understand when interpreting his comments. He has quoted a portion of the report which questions temporal variability in patient characteristics, and highlights a difference in the transfusion requirements by study enrollment quartile. This same independent review concluded that it could not disagree with our results. We do not completely follow the rationale that temporal variability in terms of patient characteristics, transfusion requirements, etc. confounds the study. This is a prospective, randomized, double-blinded trial which enrolled consecutive patients meeting our inclusion criteria. No changes were made to the protocol which defined the techniques followed by the operator in an effort to standardize the study procedure as much as possible. Patient cohorts were not significantly different in terms of age, BMI, gender, baseline hemoglobin, operative time, incision length, type of anesthesia, etc.

    The comments by Dr. Keggi suggest that the study was underpowered, based on large standard deviations observed in both groups for units transfused (standard deviation of 0.83 units for study arm and 0.98 units for control). The study was powered (as described in our paper) using a standard deviation of 1.7 units as determined from our retrospective pilot study data (1) and a difference to detect of <0.85 unit difference. We believe that the study was adequately powered.

    Dr. Keggi anecdotally refers to his experience with the device, and states that its use in hip arthroplasty results in time savings, lower blood utilization, fewer transfusions, and lower cost per case. We do agree that the device may have utility in arthroplasty procedures, but in our selected study patient population the level I data do not support his clinical observations. Additionally, an article published prior to ours presents data that also do not support an overall reduction in blood loss utilizing this device in hip arthroplasty surgery (2). As we all are looking for and researching ways to improve arthroplasty patient outcomes, we look forward to reading his report once it has gone through the process of peer review and publication. His information may help better define the patient population in which this device is effective.

    References

    1. Rosneck J, Klika AK, Barsoum EK. The effectiveness of TissueLink’s hemosealing technology during total hip arthroplasty. European Federation of National Associations of Orthopaedics and Traumatology, Florence, Italy, May 2007.

    2. Zeh A, Messer J, Davis J, Vasarhelyi A, Wohlrab D. The Aquamantys System – an alternative to reduce blood loss in primary total hip arthroplasty? J Arthroplasty. 2010;25:1072-7.

    John M. Keggi, MD
    Posted on May 20, 2011
    Bipolar Sealer Study Inconclusive
    Orthopaedic Surgeon, Orthopaedics New England, Middlebury, Connecticut

    To the Editor:

    I wish to thank Barsoum et al. (2011;93:513-8) for investigating the matter of blood loss reduction in THA. Their study regarding the use of a bipolar sealer in THA finds no difference from standard electrocautery when assessing for the primary outcome measure of units of blood transfused and for other secondary parameters. This study's conclusions are not determinative of the utility of the study device or of its inutility, however, as several flaws render it unable to answer this question.

    The overall impact of the study is limited by its small size of 140 total patients (71 patients in the study arm). This becomes evident in the data tables where several trends in the data are overshadowed by large standard deviations, as is the case for the primary measure, Units Transfused. The study arm was 0.38 +/- 0.83 while the control group was 0.44 +/- 0.98 units. EBL, a secondary measure (in mls.) was 315.2 +/-203.4 and 368.5 +/- 277.8, respectively, as well. EBL, while measured carefully in irrigation and sponges, took no account of the drapes, gowns or the floor – all of which could unpredictably affect outcome.

    Table II also reports an average operative time of 107 minutes for primary, unilateral THA in patients with typical BMI's of 29. This seems somewhat longer than expected and could give higher than usual blood losses in both arms of the study. While the average of 107 minutes was consistent overall between the groups, the ranges were notably different with the control group between 48 and 188 minutes while the study group was 53 to 283 minutes. The longest case in the study group lasted more than an hour and a half longer than the lengthiest control case, likely with greater blood loss due to open wound time alone, regardless of any device effect or not. In a small study, even this single case difference is sufficient to cause error.

    Other statistical errors are revealed in a separate, independent analysis of the raw data, commissioned by the device manufacturer, Salient Surgical, who as sponsor of the study also had access to the results as they became available prior to publication. I have reviewed this report in the course of my consulting work with Salient. Consistency of the data was examined in enrollment quartile subgroups in order to ascertain the validity of the statistical methods. The key summary points are as follows:

    "No difference between treatments in any variable was found to exist in the study. However, due to the number of enrollment period confounds, differences that were found to exist with VAS scores, patient reported outcome (SF-36), estimated blood loss, transfusions, hemoglobin and hematocrit, it is impossible to accurately interpret the results of the study for these variables. Confounds of this type indicate that the patients enrolled over the course of the study differed in terms of their characteristics and the validity of pooling the entire trial enrollment cohort for analysis is questionable. "

    As an example, the primary measure of Units Transfused varied greatly among enrollment quartiles with a statistically significant difference between the 2nd and 4th quartiles (p=0.02) as shown in Figure 1.


    Fig. 1

    The cause of the temporal variability seen in Figure 1 is unclear. The performance of the device should remain relatively constant throughout the study, suggesting either significant variability in the patient demographics and/or the operators' technique as a function of the study enrollment period.

    We have used the study device for several years and are reporting our initial experience with it in 127 study patients vs 126 controls (manuscript in preparation). Our experience indicates a time saving in each case as well as lower blood utilization per patient, fewer patients transfused and overall lower cost per case. Every new technology requires close scrutiny and thorough evaluation. The Barsoum study does not provide us with guidance one way or another for this particular device.

    Alison K. Klika
    Posted on April 29, 2011
    Dr. Barsoum and colleagues respond to Drs. Mont and Johnson
    Research Program Coordinator, Cleveland Clinic

    We would like to thank Dr. Mont for his comments and discussion prompted by our prospective, randomized study comparing the blood transfusion requirements of primary total hip arthroplasty patients treated with and without a bipolar sealer. He raises some good discussion points and we are happy to have the opportunity to provide clarification. We are in complete agreement with the statement that this device may be efficacious for complicated patients, including revision surgeries and those most at risk for blood loss and transfusion(s). The key point here is that these patients were specifically not included in our study, as we chose to exclude those at risk patients and test the use of the device in a relatively healthy, straightforward, primary total hip population of patients. Theoretical advantages of such a device include reduced pain, reduced swelling, and a quicker recovery and return to function, secondary to reductions in hemarthrosis. The research question is whether or not this type of technology is warranted for everyday use in typical cases. Based on our results, the answer is no, and we have stopped using the device in routine patients. The bipolar sealer is available to our surgeons to use at his/her discretion, and it continues to be used in complex procedures/patients.

    As we discussed in our paper, our study did not corroborate the results published by Marulanda et al. (1), who reported a significant difference in blood loss and As he described in his Letter to the Editor, the operative protocols used differed substantially between the two studies in terms of duration of use of the device. Dr. Mont’s group used the sealer for an average of 12 minutes (range, 9 to 17), compared with a 3 minute average in our study. First, it is worth noting that the sponsor was consulted in terms of defining a pre-set protocol for the use of the product, and was agreed upon by all parties. Second, with all due respect to Dr. Mont and his group, we do not agree that this amount of time is inconsequential in terms of additional operative time. In addition, a recent report warns that overuse of the sealer may be deleterious to the surrounding tissues (2). These are certainly both topics that require further investigation to fully understand the risk of complication based on duration of use.

    The results of our study were consistent with those recently reported by Zeh et al. (3), who conducted a prospective, randomized study of 105 primary total hip patients to evaluate the same bipolar sealer. No statistically significant difference was found in intraoperative and postoperative blood loss between the two groups (control 1846 mL; bipolar sealer 1740 mL). Exclusion criteria were any history of bleeding disorders, laboratory signs of bleeding disorders, malignancy, and rheumatic joint disease. This group also concluded that there was no advantage over conventional cautery, and use of the device is not recommended for primary total hip arthroplasty.

    Dr. Mont questioned the results reported at an international conference (4), in which we did find a significant difference in estimated blood loss. This was a separate study from the prospective, randomized clinical trial. In the Rosneck et al. (4) study, a simple retrospective study was conducted on 40 total hip arthroplasty patients managed with and without the bipolar sealer. The only exclusion criteria considered was any previous surgical procedure to the operative hip. Patients treated with the bipolar sealer had significantly lower EBL (mean = 242.1 mL; range, 150-450) than patients in the control group (mean = 305.2 mL; range, 150-500; p<0.05). The percentage of patients requiring transfusion was the same in both groups (47%). The mean number of units transfused was higher for patients in the control group (1.4) than patients treated with the device (1.0), although this was not statistically significant (p=0.52).

    Again, we thank Dr. Mont for his interest in our study and hope that we have adequately addressed his questions. Our conclusion remains that this device is not necessary in the typical primary total hip patient, but acknowledge that other at risk patient populations may benefit.

    References

    1. Marulanda GA, Ulrich SD, Seyler TS, Delanois RE, Mont AM. Reductions in blood loss with a bipolar sealer in total hip arthroplasty. Expert Rev Med Devices. 2008;5:125-31.

    2. Ng VY, Arnott L, McShane M. Periprosthetic femoral condyle fracture after total knee arthroplasty and saline-coupled bipolar sealing technology. Orthopedics. 2011;43:53.

    3. Zeh A, Messer J, Davis J, Vasarhelyi A, Wohlrab D. The Aquamantys System – an alternative to reduce blood loss in primary total hip arthroplasty? J Arthroplasty. 2010;25:1072-7.

    4. Rosneck J, Klika AK, Barsoum EK. The effectiveness of TissueLink’s hemosealing technology during total hip arthroplasty. European Federation of National Associations of Orthopaedics and Traumatology; Florence; Italy. 2007 May.

    Michael A. Mont, MD
    Posted on April 29, 2011
    Efficacy of the Bipolar Sealer
    Orthopaedic Surgeon, Rubin Institute for Advanced Orthopedics, Center for Joint Preservation and Replacement, Maryland

    Dear Drs. Barsoum and Co-authors:

    We read with interest your study entitled, “Prospective Randomized Evaluation of the Need for Blood Transfusion During Primary Total Hip Arthroplasty with Use of a Bipolar Sealer”, published in the March issue of Journal of Bone and Joint Surgery (2011;93:513-8). We applaud you on your efforts as we appreciate the involvement necessary to perform any prospective randomized study. You did not find any significant reductions in overall blood loss between a bipolar sealing device (TissueLink, Salient Surgical Technologies, Portsmouth, New Hampshire) and electrocautery in your carefully selected patient population. However, despite the apparent high quality of your study, we still have certain questions concerning the methodologies which lead us to question some of your conclusions about the use of this device.

    According to the operative procedure section, the bipolar sealing device was only used for a possible average of sixty seconds x 3, or 180 seconds per case. This is in contradistinction to a study published by one of us where the device was used for a mean of 12 minutes (range, nine to seventeen minutes) per case (1). To effectuate blood conservation, we believe that the device needs to be used in a rigorous manner by a pre-set protocol and it should be used continuously throughout the case by assistants (not necessarily the primary operating surgeon) without adding operative time to the procedure.

    In the study by Marulanda et al., which was a similar prospective study of total hip arthroplasties comparing this bipolar sealer to a standard electrocautery device, a statistically significant reduction in blood loss and transfusions was found. Fifty consecutive patients were studied with none excluded as compared to the present study where only 140 out of 394 potential subjects (35%) were enrolled. This selectivity of subjects might have created various study biases that decreased the ability to separate the efficacy of this device; for example in the study by Marulanda et al. the mean starting hemoglobin for both groups was 12.7 and 12.8, which was almost two points lower than the present study, and might have accounted for the transfusion rate differences found.

    It is surprising that these same authors presented preliminary pilot data where the device was actually conserving blood and effective (2), and presented initial efficacy of the TissueLink device from this study at national meetings. Why did this change? Was someone monitoring the usage time of the bipolar sealer? Perhaps the decreased efficacy could have been due to a less effective utilization of the sealer for the latter cases which made the two groups similar? For the device usage to save blood, it must be used consistently throughout the study.

    We also believe that the patient population in which the device was utilized (straightforward primary procedures) included the least appropriate cases to prove the efficacy of this type of blood conservation method. Although we believe that this device can be used with efficacy compared to standard electrocautery in any joint replacement, it would be most efficacious in conserving blood in patient populations that include difficult primaries, revision procedures, or in cases where blood conservation is critical (Jehovah’s witnesses, low hematocrit patients). It is not surprising, however, that there were no differences in transfusion rates for these healthy, uncomplicated cases where the device was used for less than three minutes.

    In summary, we believe that this device can be efficacious for a large portion of these complicated patients, especially when used for an appropriate duration throughout the case, and it is still being used at our institution.

    References

    1. Marulanda GA, Ulrich SD, Seyler TS, Delanois RE, Mont, MA. Reductions in blood loss with a bipolar sealer in total hip arthroplasty. Expert Rev Med Devices. 2008;5:125-31.

    2. Rosneck J, Klika A, Barsoum W. The effectiveness of TissueLink’s hemosealing technology during THA. European Federation of National Associations of Orthopaedics and Traumatology, 2007, Florence, Italy.

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