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Pocket related complications following cardiac electronic device implantation in patients receiving anticoagulation and/or dual antiplatelet therapy: prospective evaluation of different preventive strategies

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Abstract

Purpose

We sought to assess the safety and effectiveness of three different devices: (1) vacuum drainage system, (2) hemostatic gelatin sponge (Stypro®), and (3) compression device (Premofix®) compared to standard of care (control) in patients undergoing cardiac implantable electronic device (CIED) implantation receiving anticoagulation and/or dual antiplatelet therapy (DAPT).

Methods

We enrolled all consecutive patients admitted for first permanent CIED implantation receiving anticoagulation and/or DAPT into a prospective registry. The primary endpoint (1°EP) was a composite of hematoma grade > 1 and pocket infection.

Results

We included 406 patients (median age 73 years, 71% male) of whom 103 (25%) received a vacuum drainage system, 99 (24%) received Stypro®, 103 (25%) received Premofix®, and 101 (25%) were in the control group. One hundred eighty patients (44%) were treated with anticoagulation (median INR 2.0), 176 (43%) received DAPT, and 50 (12%) both. The occurrence of the 1°EP was reduced by Stypro® (hazard ratio (HR) 0.38 (95% confidence interval (CI) 0.16–0.94) and Premofix® (HR: 0.37 (95% CI 0.15–0.90)) compared to controls (p < 0.05 for both). The incidence of hematoma grade 2 or 3 was exclusively lowered by Premofix® compared to control (6% versus 15%; p < 0.05) and was not affected by the type of CIED, INR (≥ 2.5 versus < 2.5), body mass index (≥ 30 versus < 30), or CIED implantation under anticoagulation plus DAPT. The vacuum drainage system did not affect the 1°EP or the incidence of hematoma.

Conclusions

In patients receiving anticoagulation and/or DAPT undergoing CIED implantation, the use of Premofix® and Stypro® significantly lowered the 1°EP occurrence compared to control. Premofix® additionally lowered the frequency of pocket hematomas >grade 1.

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References

  1. Klug D, Balde M, Pavin D, et al. Risk factors related to infections of implanted pacemakers and cardioverter-defibrillators. Circulation. 2007;116:1349–55.

    Article  PubMed  Google Scholar 

  2. Trappe HJ, Gummert J. Current pacemaker and defibrillator therapy. Dtsch Arztebl Int. 2011;108(21):372–80.

    PubMed  PubMed Central  Google Scholar 

  3. Birnie DH, Healey JS, Wells GA, et al. Pacemaker and defibrillator surgery without interruption of anticoagulation (BRUISE CONTROL). N Engl J Med. 2013;368:2084–93.

    Article  CAS  PubMed  Google Scholar 

  4. Udo EO, Zuithoff NP, van Hemel NM, et al. Incidence and predictors of short- and long-term complications in pacemaker therapy: the FOLLOWPACE study. Heart Rhythm. 2012;9(5):728–35.

    Article  PubMed  Google Scholar 

  5. Wiegand U, LeJeune D, Boguschewski F, et al. 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.

    Article  PubMed  Google Scholar 

  6. Essebag V, Verma A, Healey JS, et al. Clinically significant pocket hematoma increases long-term risk of device infection: BRUISE CONTROL INFECTION study. J Am Coll Cardiol. 2016;67(11):1300–8.

    Article  PubMed  Google Scholar 

  7. Reynolds M, Cohen D, Kugelmass A, et al. The frequency and incremental cost of major complications among Medicare beneficiaries receiving implantable cardioverter defibrillators. J Am Coll Cardiol. 2006;47(12):2493–7.

    Article  PubMed  PubMed Central  Google Scholar 

  8. Memon MA, Memon B, Memon MI, et al. The uses and abuses of drains in abdominal surgery. Hosp Med. 2002;63(5):282–8.

    Article  PubMed  Google Scholar 

  9. Ohlow MA, Buchter B, Brunelli M, et al. Prävention von Taschenkomplikationen nach Implantation von Herzrhythmusdevices: D-Stat Hemostat™ im Vergleich mit konventioneller Vakuumdrainage. Herzschrittmacherther Elektrophysiol. 2015;26(1):45–51.

    Article  PubMed  Google Scholar 

  10. Vogt PM, Andree C, Breuing K, et al. Dry, moist, and wet skin wound repair. Ann Plast Surg. 1995;34(5):493–9.

    Article  CAS  PubMed  Google Scholar 

  11. Belozerskaya B, Makarov V, Zhidkov EA, et al. Local hemostatics—a review. Pharm Chem J. 2006;40:353–9.

    Article  CAS  Google Scholar 

  12. Ohlow MA, Lauer B, Buchter B. 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.

    Article  PubMed  Google Scholar 

  13. Chen X, Wan R, Jiang W, et al. Evidence-based study on antithrombotic therapy in patients at risk of a stroke with paroxysmal atrial fibrillation. Exp Ther Med. 2013;6:413–8.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  14. Sensi F, Miracapillo G, Cresti A, et al. Pocket hematoma: a call for definition. PACE. 2015;38(8):909–13.

    Article  Google Scholar 

  15. Baddour L, Bettmann M, Bolger A, et al. Non-valvular device-related infections. Circulation. 2003;108:2015–31.

    Article  PubMed  Google Scholar 

  16. de Oliveira JC, Martinelli M, Nishioka SA, et al. Efficacy of antibiotic prophylaxis before the implantation of pacemakers and cardioverter-defibrillators: results of a large, prospective, randomized, double-blinded, placebo-controlled trial. Circ Arrhythm Electrophysiol. 2009;2:29–34.

    Article  CAS  PubMed  Google Scholar 

  17. Willemen D, Paul J, White SH, et al. Closed suction drainage following knee arthroplasty, effectiveness and risks. Clin Orthop. 1991;15:232–4.

    Google Scholar 

  18. Kiuchi K, Okajima K, Tanaka N, et al. Novel compression tool to prevent hematomas and skin erosions after device implantation. Circ J. 2015;79:1727–32.

    Article  PubMed  Google Scholar 

  19. Turagam M, Nagarajan D, Bartus K, et al. Use of a pocket compression device for the prevention and treatment of pocket hematoma after pacemaker and defibrillator implantation (STOP-HEMATOMA-1). J Interv Card Electrophysiol. 2017;49:197–204.

    Article  PubMed  Google Scholar 

  20. Sairaku A, Nakano Y, Oda N, et al. Rapid hemostasis at the femoral access site using a novel hemostatic pad containing kaolin after atrial fibrillation ablation. J Interv Card Electrophysiol. 2011;31:157–64.

    Article  PubMed  Google Scholar 

  21. Glueck N. Impact of subcutaneous Redon-drains in visceral surgery: a prospective randomized study [dissertation]. Freiburg, Germany. Albert-Ludwig-University 2006.

  22. Xu D, Ren Z, Chen X, et al. A randomized controlled trial on effects of different hemostatic sponges in posterior spinal fusion surgeries. BMC Surg. 2016;16:80–5.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  23. Atreya AR, Cook JR, Lindenauer PK. Complications arising from cardiac implantable electronic devices: review of epidemiology, pathogenesis and prevention for the clinician. Postgrad Med. 2016;128(2):223–30.

    Article  PubMed  Google Scholar 

  24. Greenspon AJ, Patel JD, Lau E, et al. 16-year trends in the infection burden for pacemakers and implantable cardioverter-defibrillators in the USA 1993-2008. J Am Coll Cardiol. 2011;58:1001–6.

    Article  PubMed  Google Scholar 

  25. Tomizawa Y. Clinical benefits and risk analysis of topical hemostats: a review. J Artif Organs. 2005;8:137–42.

    Article  PubMed  Google Scholar 

  26. Georgieva S, Kokol V. Collagen- vs gelatin-based biomaterial and their biocompatibility: review and perspectives. Intecopencom/pdfs/23617 accessed 24.11.2017.

  27. Kokare CR. Pharmaceutical microbiology—principles and applications. Nirali Prakashan 3rd edi: 21; 2008 Pune, India

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Acknowledgments

The authors would like to acknowledge the valuable work of the CIED-nurse team: Christine Feser, Anne Hasch, and Monika Schache.

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Authors and Affiliations

  1. Department of Cardiology, Zentralklinik, Robert-Koch-Allee 9, 99437, Bad Berka, Germany

    Hassan Awada & Marc-Alexander Ohlow

  2. Department of invasive and interventional Electrophysiology, Zentralklinik, Robert-Koch-Allee 9, 99437, Bad Berka, Germany

    J. Christoph Geller

  3. Department of Cardiology and Endocrinology, Staedtisches Klinikum, 39130, Magdeburg, Germany

    Michele Brunelli

Authors
  1. Hassan Awada
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  2. J. Christoph Geller
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  3. Michele Brunelli
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  4. Marc-Alexander Ohlow
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Corresponding author

Correspondence to Marc-Alexander Ohlow.

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The authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Awada, H., Geller, J.C., Brunelli, M. et al. Pocket related complications following cardiac electronic device implantation in patients receiving anticoagulation and/or dual antiplatelet therapy: prospective evaluation of different preventive strategies. J Interv Card Electrophysiol 54, 247–255 (2019). https://doi.org/10.1007/s10840-018-0488-y

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  • DOI: https://doi.org/10.1007/s10840-018-0488-y

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