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Published in: BMC Cardiovascular Disorders 1/2016

Open Access 01-12-2016 | Research article

Bleeding complications during cardiac electronic device implantation in patients receiving antithrombotic therapy: is there any value of local tranexamic acid?

Authors: Osman Beton, Ersin Saricam, Hakki Kaya, Hasan Yucel, Orhan Dogdu, Okan Onur Turgut, Ocal Berkan, Izzet Tandogan, Mehmet Birhan Yilmaz

Published in: BMC Cardiovascular Disorders | Issue 1/2016

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Abstract

Background

The perioperative use of antithrombotic therapy is associated with increased bleeding risk after cardiac implantable electronic device (CIED) implantation. Topical application of tranexamic acid (TXA) is effective in reducing bleeding complications after various surgical operations. However, there is no information regarding local TXA application during CIED procedures. The purpose of our study was to evaluate bleeding complications rates during CIED implantation with and without topical TXA use in patients receiving antithrombotic treatment.

Methods

We conducted a retrospective analysis of consecutive patients undergoing CIED implantation while receiving warfarin or dual antiplatelet (DAPT) or warfarin plus DAPT treatment. Study population was classified in two groups according to presence or absence of topical TXA use during CIED implantation. Pocket hematoma (PH), major bleeding complications (MBC) and thromboembolic events occuring within 90 days were compared.

Results

A total of 135 consecutive patients were identified and included in the analysis. The mean age was 60 ± 11 years old. Topical TXA application during implantation was reported in 52 patients (TXA group). The remaining 83 patients were assigned to the control group. PH occurred in 7.7 % patients in the TXA group and 26.5 % patients in the control group (P = 0.013). The MBC was reported in 5.8 % patients in the TXA and 20.5 % patients in control group (P = 0.024). Univariate logistic regression analysis identified age, history of recent stent implantation, periprocedural spironolactone use, periprocedural warfarin use, perioperative warfarin plus DAPT use, cardiac resynchronization therapy, and topical TXA application during CIED implantation as predicting factors of PH. Multivariate analysis showed that perioperative warfarin plus DAPT use (OR = 10.874, 95 % CI: 2.496–47.365, P = 0.001) and topical TXA application during CIED procedure (OR = 0.059, 95 % CI: 0.012–0.300, P = 0.001) were independent predictors of PH. Perioperative warfarin plus DAPT use and topical TXA application were also found to be independent predictors of MBC in multivariate analyses. No thromboembolic complications was recorded in the study group.

Conclusion

The present study demonstrated that the topical TXA application during CIED implantation is associated with reduced PH and MBC in patients with high bleeding risk.
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Literature
1.
go back to reference Mond HG, Crozier I. The Australian and New Zealand cardiac pacemaker and implantable cardioverter-defibrillator survey: calendar year 2013. Heart Lung Circ. 2015;24:291–7.CrossRefPubMed Mond HG, Crozier I. The Australian and New Zealand cardiac pacemaker and implantable cardioverter-defibrillator survey: calendar year 2013. Heart Lung Circ. 2015;24:291–7.CrossRefPubMed
2.
go back to reference Kusumoto FM, Calkins H, Boehmer J, Buxton AE, Chung MK, Gold MR, Hohnloser SH, et al. HRS/ACC/AHA expert consensus statement on the use of implantable cardioverter-defibrillator therapy in patients who are not included or not well represented in clinical trials. Circulation. 2014;130:94–125.CrossRefPubMed Kusumoto FM, Calkins H, Boehmer J, Buxton AE, Chung MK, Gold MR, Hohnloser SH, et al. HRS/ACC/AHA expert consensus statement on the use of implantable cardioverter-defibrillator therapy in patients who are not included or not well represented in clinical trials. Circulation. 2014;130:94–125.CrossRefPubMed
3.
go back to reference Epstein AE, DiMarco JP, Ellenbogen KA, Estes NA, Freedman RA, Gettes LS, Gillinov AM, et al. 2012 ACCF/AHA/HRS focused update incorporated into the ACCF/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. Circulation. 2013;127:283–352.CrossRef Epstein AE, DiMarco JP, Ellenbogen KA, Estes NA, Freedman RA, Gettes LS, Gillinov AM, et al. 2012 ACCF/AHA/HRS focused update incorporated into the ACCF/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. Circulation. 2013;127:283–352.CrossRef
4.
go back to reference Tompkins C, Cheng A, Dalal D, Brinker JA, Leng CT, Marine JE, Nazarian S, et al. Dual antiplatelet therapy and heparin “bridging” significantly increase the risk of bleeding complications after pacemaker or implantable cardioverter-defibrillator device implantation. J Am Coll Cardiol. 2010;55:2376–82.CrossRefPubMed Tompkins C, Cheng A, Dalal D, Brinker JA, Leng CT, Marine JE, Nazarian S, et al. Dual antiplatelet therapy and heparin “bridging” significantly increase the risk of bleeding complications after pacemaker or implantable cardioverter-defibrillator device implantation. J Am Coll Cardiol. 2010;55:2376–82.CrossRefPubMed
5.
go back to reference Douketis JD, Spyropoulos AC, Spencer FA, Mayr M, Jaffer AK, Eckman MH, Dunn AS, et al. Perioperative management of antithrombotic therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141:326–50.CrossRef Douketis JD, Spyropoulos AC, Spencer FA, Mayr M, Jaffer AK, Eckman MH, Dunn AS, et al. Perioperative management of antithrombotic therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141:326–50.CrossRef
6.
go back to reference Bernard ML, Shotwell M, Nietert PJ, Gold MR. Meta-analysis of bleeding complications associated with cardiac rhythm device implantation. Circ Arrhythm Electrophysiol. 2012;5:468–74.CrossRefPubMedPubMedCentral Bernard ML, Shotwell M, Nietert PJ, Gold MR. Meta-analysis of bleeding complications associated with cardiac rhythm device implantation. Circ Arrhythm Electrophysiol. 2012;5:468–74.CrossRefPubMedPubMedCentral
7.
go back to reference Wiegand UK, LeJeune D, Boguschewski F, Bonnemeier H, Eberhardt F, Schunkert H, Bode F. Pocket hematoma after pacemaker or implantable cardioverter defibrillator surgery: influence of patient morbidity, operation strategy, and perioperative antiplatelet/anticoagulation therapy. Chest. 2004;126:1177–86.CrossRefPubMed Wiegand UK, LeJeune D, Boguschewski F, Bonnemeier H, Eberhardt F, Schunkert H, Bode F. Pocket hematoma after pacemaker or implantable cardioverter defibrillator surgery: influence of patient morbidity, operation strategy, and perioperative antiplatelet/anticoagulation therapy. Chest. 2004;126:1177–86.CrossRefPubMed
8.
go back to reference Boulé S, Marquié C, Vanesson-Bricout C, Kouakam C, Brigadeau F, Guédon-Moreau L, Acheré C. Clopidogrel increases bleeding complications in patients undergoing heart rhythm device procedures. Pacing Clin Electrophysiol. 2012;35:605–11.CrossRefPubMed Boulé S, Marquié C, Vanesson-Bricout C, Kouakam C, Brigadeau F, Guédon-Moreau L, Acheré C. Clopidogrel increases bleeding complications in patients undergoing heart rhythm device procedures. Pacing Clin Electrophysiol. 2012;35:605–11.CrossRefPubMed
9.
go back to reference Thal S, Moukabary T, Boyella R, Shanmugasundaram M, Pierce MK, Thai H, Goldman S. The relationship between warfarin, aspirin, and clopidogrel continuation in the peri-procedural period and the incidence of hematoma formation after device implantation. Pacing Clin Electrophysiol. 2010;33:385–8.CrossRefPubMed Thal S, Moukabary T, Boyella R, Shanmugasundaram M, Pierce MK, Thai H, Goldman S. The relationship between warfarin, aspirin, and clopidogrel continuation in the peri-procedural period and the incidence of hematoma formation after device implantation. Pacing Clin Electrophysiol. 2010;33:385–8.CrossRefPubMed
10.
go back to reference Ohlow MA, Lauer B, Buchter B, Schreiber M, Geller JC. Pocket related complications in 163 patients receiving anticoagulation or dual antiplatelet therapy: D-Stat Hemostat versus standard of care. Int J Cardiol. 2012;159:177–80.CrossRefPubMed Ohlow MA, Lauer B, Buchter B, Schreiber M, Geller JC. Pocket related complications in 163 patients receiving anticoagulation or dual antiplatelet therapy: D-Stat Hemostat versus standard of care. Int J Cardiol. 2012;159:177–80.CrossRefPubMed
11.
go back to reference Ker K, Beecher D, Roberts I. Topical application of tranexamic acid for the reduction of bleeding. Cochrane Database Syst Rev. 2013;7:CD010562. Ker K, Beecher D, Roberts I. Topical application of tranexamic acid for the reduction of bleeding. Cochrane Database Syst Rev. 2013;7:CD010562.
12.
go back to reference Kutinsky IB, Jarandilla R, Jewett M, Haines DE. Risk of hematoma complications after device implant in the clopidogrel era. Circ Arrhythm Electrophysiol. 2010;3:312–8.CrossRefPubMed Kutinsky IB, Jarandilla R, Jewett M, Haines DE. Risk of hematoma complications after device implant in the clopidogrel era. Circ Arrhythm Electrophysiol. 2010;3:312–8.CrossRefPubMed
13.
go back to reference Birnie DH, Healey JS, Wells GA, Verma A, Tang AS, Krahn AD, Simpson CS, et al. Pacemaker or defibrillator surgery without interruption of anticoagulation. N Engl J Med. 2013;368:2084–93.CrossRefPubMed Birnie DH, Healey JS, Wells GA, Verma A, Tang AS, Krahn AD, Simpson CS, et al. Pacemaker or defibrillator surgery without interruption of anticoagulation. N Engl J Med. 2013;368:2084–93.CrossRefPubMed
14.
go back to reference Nammas W, Raatikainen MJ, Korkeila P, Lund J, Ylitalo A, Karjalainen P, Virtanen V, et al. Predictors of pocket hematoma in patients on antithrombotic therapy undergoing cardiac rhythm device implantation: insights from the FinPAC trial. Ann Med. 2014;46:177–81.CrossRefPubMed Nammas W, Raatikainen MJ, Korkeila P, Lund J, Ylitalo A, Karjalainen P, Virtanen V, et al. Predictors of pocket hematoma in patients on antithrombotic therapy undergoing cardiac rhythm device implantation: insights from the FinPAC trial. Ann Med. 2014;46:177–81.CrossRefPubMed
15.
go back to reference McCormack PL. Tranexamic acid: a review of its use in the treatment of hyperfibrinolysis. Drugs. 2012;72:585–617.CrossRefPubMed McCormack PL. Tranexamic acid: a review of its use in the treatment of hyperfibrinolysis. Drugs. 2012;72:585–617.CrossRefPubMed
16.
go back to reference Kashuk JL, Moore EE, Sawyer M, Wohlauer M, Pezold M, Barnett C, Biffl WL, et al. Primary fibrinolysis is integral in the pathogenesis of the acute coagulopathy of trauma. Ann Surg. 2010;252:434–42.PubMed Kashuk JL, Moore EE, Sawyer M, Wohlauer M, Pezold M, Barnett C, Biffl WL, et al. Primary fibrinolysis is integral in the pathogenesis of the acute coagulopathy of trauma. Ann Surg. 2010;252:434–42.PubMed
17.
go back to reference Soares EC, Costa FW, Bezerra TP, Nogueira CB, de Barros Silva PG, Batista SH, Sousa FB. Postoperative hemostatic efficacy of gauze soaked in tranexamic acid, fibrin sponge, and dry gauze compression following dental extractions in anticoagulated patients with cardiovascular disease: a prospective, randomized study. Oral Maxillofac Surg. 2015;19:209–16.CrossRefPubMed Soares EC, Costa FW, Bezerra TP, Nogueira CB, de Barros Silva PG, Batista SH, Sousa FB. Postoperative hemostatic efficacy of gauze soaked in tranexamic acid, fibrin sponge, and dry gauze compression following dental extractions in anticoagulated patients with cardiovascular disease: a prospective, randomized study. Oral Maxillofac Surg. 2015;19:209–16.CrossRefPubMed
18.
go back to reference Shi J, Ji H, Ren F, Wang G, Xu M, Xue Y, Chen M, et al. Protective effects of tranexamic acid on clopidogrel before coronary artery bypass grafting: a multicenter randomized trial. JAMA Surg. 2013;148:538–47.CrossRefPubMed Shi J, Ji H, Ren F, Wang G, Xu M, Xue Y, Chen M, et al. Protective effects of tranexamic acid on clopidogrel before coronary artery bypass grafting: a multicenter randomized trial. JAMA Surg. 2013;148:538–47.CrossRefPubMed
19.
go back to reference Milic DJ, Perisic ZD, Zivic SS, Stanojkovic ZA, Stojkovic AM, Karanovic ND, Krstic NH, et al. Prevention of pocket related complications with fibrin sealant in patients undergoing pacemaker implantation who are receiving anticoagulant treatment. Europace. 2005;7:374–9.CrossRefPubMed Milic DJ, Perisic ZD, Zivic SS, Stanojkovic ZA, Stojkovic AM, Karanovic ND, Krstic NH, et al. Prevention of pocket related complications with fibrin sealant in patients undergoing pacemaker implantation who are receiving anticoagulant treatment. Europace. 2005;7:374–9.CrossRefPubMed
20.
go back to reference Zacà V, Marcucci R, Parodi G, Limbruno U, Notarstefano P, Pieragnoli P, Di Cori A, et al.. Management of antithrombotic therapy in patients undergoing electrophysiological device surgery. Europace. 2015;17:840–54.CrossRefPubMed Zacà V, Marcucci R, Parodi G, Limbruno U, Notarstefano P, Pieragnoli P, Di Cori A, et al.. Management of antithrombotic therapy in patients undergoing electrophysiological device surgery. Europace. 2015;17:840–54.CrossRefPubMed
Metadata
Title
Bleeding complications during cardiac electronic device implantation in patients receiving antithrombotic therapy: is there any value of local tranexamic acid?
Authors
Osman Beton
Ersin Saricam
Hakki Kaya
Hasan Yucel
Orhan Dogdu
Okan Onur Turgut
Ocal Berkan
Izzet Tandogan
Mehmet Birhan Yilmaz
Publication date
01-12-2016
Publisher
BioMed Central
Published in
BMC Cardiovascular Disorders / Issue 1/2016
Electronic ISSN: 1471-2261
DOI
https://doi.org/10.1186/s12872-016-0251-1

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