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J Knee Surg 2022; 35(12): 1378-1384
DOI: 10.1055/s-0041-1723972
Original Article

Clinical Outcomes and Experience of a Multiyear Consecutive Case Series of Total Knee Arthroplasty Procedures Conducted with a Bipolar Sealer System for Hemostasis

Alexander P. Sah 
1   Sah Orthopaedic Associates, Institute for Joint Restoration, Center for Joint Replacement Bldg, Fremont, California
› Institutsangaben Funding Database support for this study was provided by Medtronic.
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Abstract

Maximizing hemostasis during total knee replacement procedures remains a key challenge in current practice. Bipolar sealer technology achieves intraoperative hemostasis through tissue sealing and coagulation with adjustable radio frequency energy and a saline-irrigated tip. Optimal surgical site hemostasis is important to avoid potential complications such as hemarthrosis, wound drainage, increased pain, delayed discharge, and readmissions. The aim of this study is to evaluate the safety and effectiveness of the bipolar sealer device in primary knee replacement in the largest consecutive series to date. A consecutive, treatment-control series of subjects who underwent a primary total knee arthroplasty (TKA) utilizing a bipolar sealer for hemostasis, one subgroup with concomitant tranexamic acid (TXA) administration (n = 1599) and one subgroup without TXA administration (n = 3582), compared with a control group of primary TKA under tourniquet only (n = 667). Statistical analyses were performed through two-tailed unpaired t-tests. There was less total postoperative drain output and a lower overall transfusion rate in the bipolar sealer group (807ml ± 428) (2.5%) than the tourniquet only group (1290 ± 658, p = 0.001) (8.4%, p = 0.0001), respectively. Drainage output in bipolar sealer + TXA (450 ± 297 ml) was lower than the other two groups (bipolar sealer 807 ± 428 mL, p = 0.0001; tourniquet only 1290 ± 658 ml, p = 0.0001). The bipolar sealer group had a higher hematocrit at postoperative day 1 (POD1) (bipolar sealer: 33.1 ± 4.3 cc, tourniquet only: 32.5 ± 4.3 cc, p = 0.001) and at discharge (POD2, bipolar sealer: 31.5 ± 3.7 cc, tourniquet only: 30.2 ± 3.9 cc, p = 0.0001). There were zero reported serious adverse events related to hemostasis management in any group. The bipolar sealer system is a safe and effective instrument to achieve intraoperative hemostasis during primary TKA. The bipolar sealer group required significantly fewer postoperative blood product transfusions and maintained a higher hematocrit concentration at the time of discharge compared with subjects treated solely with tourniquet mediated hemostasis. Addition of TXA to local hemostasis methods may further reduce blood loss and transfusion requirements.

Level of Evidence This is a Level III study.

Keywords

knee arthroplasty - hemostasis - blood transfusion - bipolar sealer - blood loss

Ethical Approval

This work was exempt from IRB approval.


Note

Surgical treatments, data collection, and data analysis were performed at Sah Orthopaedic Associates Institute for Joint Restoration.




Publikationsverlauf

Eingereicht: 23. Oktober 2020

Angenommen: 02. Januar 2021

Artikel online veröffentlicht:
19. Februar 2021

© 2021. Thieme. All rights reserved.

Thieme Medical Publishers, Inc.
333 Seventh Avenue, 18th Floor, New York, NY 10001, USA

 

  • References

  • 1 Elders MJ. The increasing impact of arthritis on public health. J Rheumatol Suppl 2000; 60: 6-8
    PubMedGoogle Scholar
  • 2 Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am 2007; 89 (04) 780-785
    Google Scholar
  • 3 Losina E, Walensky RP, Kessler CL. et al. Cost-effectiveness of total knee arthroplasty in the United States: patient risk and hospital volume. Arch Intern Med 2009; 169 (12) 1113-1121 , discussion 1121–1122
    CrossrefPubMedGoogle Scholar
  • 4 Parks ML. CORR insights: comorbidities in patients undergoing total knee arthroplasty: do they influence hospital costs and length of stay?. Clin Orthop Relat Res 2014; 472 (12) 3951-3952
    CrossrefPubMedGoogle Scholar
  • 5 Bierbaum B, Callaghan J, Galante J, Rubash H, Tooms R, Welch RB. An analysis of blood management in patients having a total hip or knee arthroplasty. J Bone Jt Surg Am. 1999; 81: 2-10
    CrossrefPubMedGoogle Scholar
  • 6 Robinson S, McGonigle O, Volin S. et al. Comprehensive look at blood transfusion utilization in total joint arthroplasty at a single academic medical center under a single surgeon. J Blood Transfus 2013; 2013: 983250
    CrossrefPubMedGoogle Scholar
  • 7 Meybohm P, Kohlhof H, Wirtz DC. et al. Preoperative anaemia in primary hip and knee arthroplasty. Z Orthop Unfall 2020; 158 (02) 194-200
    Artikel in Thieme ConnectPubMedGoogle Scholar
  • 8 Boutsiadis A, Reynolds RJ, Saffarini M, Panisset JC. Factors that influence blood loss and need for transfusion following total knee arthroplasty. Ann Transl Med 2017; 5 (21) 418
    CrossrefPubMedGoogle Scholar
  • 9 Prasad N, Padmanabhan V, Mullaji A. Blood loss in total knee arthroplasty: an analysis of risk factors. Int Orthop 2007; 31 (01) 39-44
    CrossrefPubMedGoogle Scholar
  • 10 Nichols CI, Vose JG. Clinical outcomes and costs within 90 days of primary or revision total joint arthroplasty. J Arthroplasty 2016; 31 (07) 1400-1406.e3
    CrossrefPubMedGoogle Scholar
  • 11 Goodnough LT, Shuck JM. Risks, options, and informed consent for blood transfusion in elective surgery. Am J Surg 1990; 159 (06) 602-609
    CrossrefPubMedGoogle Scholar
  • 12 Lu Q, Peng H, Zhou GJ, Yin D. Perioperative blood management strategies for total knee arthroplasty. Orthop Surg 2018; 10 (01) 8-16
    CrossrefPubMedGoogle Scholar
  • 13 Guild III GN, Runner RP, Castilleja GM, Smith MJ, Vu CL. Efficacy of hybrid plasma scalpel in reducing blood loss and transfusions in direct anterior total hip arthroplasty. J Arthroplasty 2017; 32 (02) 458-462
    CrossrefPubMedGoogle Scholar
  • 14 Liu D, Dan M, Martinez Martos S, Beller E. Blood management strategies in total knee arthroplasty. Knee Surg Relat Res 2016; 28 (03) 179-187
    CrossrefPubMedGoogle Scholar
  • 15 Rosenthal BD, Haughom BD, Levine BR. A retrospective analysis of hemostatic techniques in primary total knee arthroplasty: traditional electrocautery, bipolar sealer, and argon beam coagulation. Am J Orthop 2016; 45 (04) E187-E191
    PubMedGoogle Scholar
  • 16 Ulrich SD, Kyle B, Johnson AJ, Zywiel MG, Mont MA. Strategies to reduce blood loss in lower extremity total joint arthroplasty. Surg Technol Int 2010; 20: 341-347
    PubMedGoogle Scholar
  • 17 Berry DJ, Bozic KJ. Current practice patterns in primary hip and knee arthroplasty among members of the American Association of Hip and Knee Surgeons. J Arthroplasty 2010; 25 (6, Suppl): 2-4
    CrossrefPubMedGoogle Scholar
  • 18 Hernandez AJ, Almeida AM, Fávaro E, Sguizzato GT. The influence of tourniquet use and operative time on the incidence of deep vein thrombosis in total knee arthroplasty. Clinics (São Paulo) 2012; 67 (09) 1053-1057
    CrossrefPubMedGoogle Scholar
  • 19 Olivecrona C, Blomfeldt R, Ponzer S, Stanford BR, Nilsson BY. Tourniquet cuff pressure and nerve injury in knee arthroplasty in a bloodless field: a neurophysiological study. Acta Orthop 2013; 84 (02) 159-164
    CrossrefPubMedGoogle Scholar
  • 20 Olivecrona C, Lapidus LJ, Benson L, Blomfeldt R. Tourniquet time affects postoperative complications after knee arthroplasty. Int Orthop 2013; 37 (05) 827-832
    CrossrefPubMedGoogle Scholar
  • 21 Tie K, Hu D, Qi Y, Wang H, Chen L. Effects of tourniquet release on total knee arthroplasty. Orthopedics 2016; 39 (04) e642-e650
    PubMedGoogle Scholar
  • 22 Jiang J, Yue Y, Li B, Zhou R. Deliberate hypotension for orthopaedic surgery. Cochrane Database Syst Rev 2017
    PubMedGoogle Scholar
  • 23 Aken H. Deliberated hypotension. In: Miller's Anesthesia, R. Miller, ed. Tokyo: Churchill Livingstone; 2000: 1470-1486
    Google Scholar
  • 24 Kuppurao L, Wee M. Perioperative cell salvage. Contin Educ Anaesth Crit Care Pain 2010; 10: 104-108
    CrossrefPubMedGoogle Scholar
  • 25 Wang H, Shan L, Zeng H, Sun M, Hua Y, Cai Z. Is fibrin sealant effective and safe in total knee arthroplasty? A meta-analysis of randomized trials. J Orthop Surg Res 2014; 9: 36
    CrossrefPubMedGoogle Scholar
  • 26 Steuten L, Vallejo-Torres L, Bastide P, Buxton M. Analysing uncertainty around costs of innovative medical technologies: the case of fibrin sealant (QUIXIL) for total knee replacement. Health Policy 2009; 89 (01) 46-57
    CrossrefPubMedGoogle Scholar
  • 27 Caruana EJ, Kadlec J, Iyer S, Mani A, Solli P, Scarci M. The Aquamantys(®) system improves haemostasis and pneumostasis in open decortication for thoracic empyema. J Thorac Dis 2016; 8 (07) 1540-1545
    CrossrefPubMedGoogle Scholar
  • 28 Currò G, Lazzara S, Barbera A. et al. The Aquamantys® system as alternative for parenchymal division and hemostasis in liver resection for hepatocellular carcinoma: a preliminary study. Eur Rev Med Pharmacol Sci 2014; 18 (2, Suppl): 2-5
    PubMedGoogle Scholar
  • 29 Suarez JC, Slotkin EM, Szubski CR, Barsoum WK, Patel PD. Prospective, randomized trial to evaluate efficacy of a bipolar sealer in direct anterior approach total hip arthroplasty. J Arthroplasty 2015; 30 (11) 1953-1958
    CrossrefPubMedGoogle Scholar
  • 30 Derman PB, Kamath AF, Lee G-C. Saline-coupled bipolar sealing in revision total knee arthroplasty for infection. Am J Orthop 2013; 42 (09) 407-411
    PubMedGoogle Scholar
  • 31 Frank SM, Wasey JO, Dwyer IM, Gokaslan ZL, Ness PM, Kebaish KM. Radiofrequency bipolar hemostatic sealer reduces blood loss, transfusion requirements, and cost for patients undergoing multilevel spinal fusion surgery: a case control study. J Orthop Surg Res 2014; 9: 50
    CrossrefPubMedGoogle Scholar
  • 32 Fukui D, Kawakami M, Nakao SI. et al. Reduced blood loss and operation time in lumbar posterolateral fusion using a bipolar sealer. Eur Spine J 2017; 26 (03) 726-732
    CrossrefPubMedGoogle Scholar
  • 33 Grasso G, Giambartino F, Iacopino DG. Hemostasis in brain tumor surgery using the Aquamantys system. Med Sci Monit 2014; 20: 538-543
    CrossrefPubMedGoogle Scholar
  • 34 Huang Z, Ma J, Shen B. et al. Use of a bipolar blood-sealing system during total joint arthroplasty. Orthopedics 2015; 38 (12) 757-763
    CrossrefPubMedGoogle Scholar
  • 35 Kamath AF, Austin DC, Derman PB, Clement RC, Garino JP, Lee G-C. Saline-coupled bipolar sealing in simultaneous bilateral total knee arthroplasty. Clin Orthop Surg 2014; 6 (03) 298-304
    CrossrefPubMedGoogle Scholar
  • 36 Marulanda GA, Ulrich SD, Seyler TM, Delanois RE, Mont MA. Reductions in blood loss with a bipolar sealer in total hip arthroplasty. Expert Rev Med Devices 2008; 5 (02) 125-131
    CrossrefPubMedGoogle Scholar
  • 37 Plymale MF, Capogna BM, Lovy AJ, Adler ML, Hirsh DM, Kim SJ. Unipolar vs bipolar hemostasis in total knee arthroplasty: a prospective randomized trial. J Arthroplasty 2012; 27 (06) 1133-7.e1
    CrossrefPubMedGoogle Scholar
  • 38 Ackerman SJ, Tapia CI, Baik R, Pivec R, Mont MA. Use of a bipolar sealer in total hip arthroplasty: medical resource use and costs using a hospital administrative database. Orthopedics 2014; 37 (05) e472-e481
    CrossrefPubMedGoogle Scholar
  • 39 Kuznietsova V, Woodward RS. Estimating the learning curve of a novel medical device: bipolar sealer use in unilateral total knee arthroplasties. Value Health 2018; 21 (03) 283-294
    CrossrefPubMedGoogle Scholar
  • 40 Saltzman BM, Oni JK. A review of bipolar sealer use in modern total joint arthroplasty. Ann. Orthop. Rheumatol. 2014; k 2: 1015
    PubMedGoogle Scholar
  • 41 Fechisin J, Scuderi G. The efficacy of bipolar transcollation in managing blood loss in total knee arthroplasty. Tech Knee Surg 2011; 10: 206-210
    CrossrefPubMedGoogle Scholar
  • 42 Wang Z, Tian A, Feng K, Wang Q, Wang Y. Bipolar sealer can reduce intraoperative blood loss and transfusion in major orthopedic surgery: a meta-analysis and trial sequence analysis. 2018 . Available at: https://www.oncotarget.com/article/23980/text/
    PubMedGoogle Scholar
  • 43 Isabell G, Weeden S. Hemodynamic efficacy of a bipolar sealing device in primary total knee arthroplasty. In Annual Meeting of the Texas Orthopaedic Association; 2006
    PubMedGoogle Scholar
  • 44 Marulanda G, Ragland P, Mont M. Use of a bipolar sealer device for hemostasis in total hip arthroplasty. In Am Acad Ortho Surg; 2006
    Google Scholar
  • 45 Pfeiffer M, Bräutigam H, Draws D, Sigg A. A new bipolar blood sealing system embedded in perioperative strategies vs. a conventional regimen for total knee arthroplasty: results of a matched-pair study Ein neues bipolares Blutstillungssystem zur Ergänzung perioperativer herkömmlichen Verfahren. Ger Med Sci 2005; 3: 3-7
    PubMedGoogle Scholar
  • 46 Pierson J, Hellman E, Earles D. Randomized, prospective trial to examine the hemostatic efficacy of a bipolar sealing device in TKA. In Am Acad Ortho Surg; Presented at Annual Meeting AAOS 2006
    Google Scholar
  • 47 Morris MJ, Barrett M, Lombardi Jr AV, Tucker TL, Berend KR. Randomized blinded study comparing a bipolar sealer and standard electrocautery in reducing transfusion requirements in anterior supine intermuscular total hip arthroplasty. J Arthroplasty 2013; 28 (09) 1614-1617
    CrossrefPubMedGoogle Scholar
  • 48 Bert JM, Hooper J, Moen S. Outpatient total joint arthroplasty. Curr Rev Musculoskelet Med 2017; 10 (04) 567-574
    CrossrefPubMedGoogle Scholar
  • 49 Falez F, Meo A, Panegrossi G, Favetti F, La Cava F, Casella F. Blood loss reduction in cementless total hip replacement with fibrin spray or bipolar sealer: a randomised controlled trial on ninety five patients. Int Orthop 2013; 37 (07) 1213-1217
    CrossrefPubMedGoogle Scholar
  • 50 Nielsen CS, Gromov K, Jans Ø, Troelsen A, Husted H. 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. J Arthroplasty 2017; 32 (01) 177-182
    CrossrefPubMedGoogle Scholar
  • 51 Barsoum WK, Klika AK, Murray TG, Higuera C, Lee HH, Krebs VE. Prospective randomized evaluation of the need for blood transfusion during primary total hip arthroplasty with use of a bipolar sealer. J Bone Joint Surg Am 2011; 93 (06) 513-518
    CrossrefPubMedGoogle Scholar
  • 52 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 (07) 1072-1077
    CrossrefPubMedGoogle Scholar
  • 53 Yang Y, Zhang LC, Xu F, Li J, Lv YM. Bipolar sealer not superior to standard electrocautery in primary total hip arthroplasty: a meta-analysis. J Orthop Surg Res 2014; 9: 92
    CrossrefPubMedGoogle Scholar
  • 54 Min J-K, Zhang Q-H, Li H-D, Li H, Guo P. The efficacy of bipolar sealer on blood loss in primary total hip arthroplasty: a meta-analysis. Medicine (Baltimore) 2016; 95 (19) e3435
    CrossrefPubMedGoogle Scholar
  • 55 Walker RH. Special report: transfusion risks. Am J Clin Pathol 1987; 88 (03) 374-378
    CrossrefPubMedGoogle Scholar
  • 56 Roberts I, Shakur H, Afolabi A. et al; CRASH-2 collaborators. The importance of early treatment with tranexamic acid in bleeding trauma patients: an exploratory analysis of the CRASH-2 randomised controlled trial. Lancet 2011; 377 (9771): 1101.e1–1101.e2 1096-1101
    CrossrefPubMedGoogle Scholar
  • 57 Sekhavat L, Tabatabaii A, Dalili M, Farajkhoda T, Tafti AD. Efficacy of tranexamic acid in reducing blood loss after cesarean section. J Matern Fetal Neonatal Med 2009; 22 (01) 72-75
    CrossrefPubMedGoogle Scholar
  • 58 Seviciu A, Gross I, Fathima S, Walsh SM. Effects of tranexamic acid and bipolar sealer alone or in combination in primary total knee arthroplasty: a prospective, randomized, controlled trial. Arthroplast Today 2016; 2 (02) 77-82
    CrossrefPubMedGoogle Scholar
  • 59 Richter F, Schnorr D, Deger S. et al. Improvement of hemostasis in open and laparoscopically performed partial nephrectomy using a gelatin matrix-thrombin tissue sealant (FloSeal). Urology 2003; 61 (01) 73-77
    CrossrefPubMedGoogle Scholar
  • 60 Achneck HE, Sileshi B, Jamiolkowski RM, Albala DM, Shapiro ML, Lawson JH. A comprehensive review of topical hemostatic agents: efficacy and recommendations for use. Ann Surg 2010; 251 (02) 217-228
    CrossrefPubMedGoogle Scholar
  • 61 Fletcher IR, Healy TEJ. The arterial tourniquet. Ann R Coll Surg Engl 1983; 65 (06) 409-417
    PubMedGoogle Scholar
  • 62 McEwen JA. Complications of and improvements in pneumatic tourniquets used in surgery. Med Instrum 1981; 15 (04) 253-257
    PubMedGoogle Scholar
  • 63 Smith AG, Capobianco R, Cher D. et al. Open versus minimally invasive sacroiliac joint fusion: a multi-center comparison of perioperative measures and clinical outcomes. Ann Surg Innov Res 2013; 7 (01) 14
    CrossrefPubMedGoogle Scholar