Advertisement

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

  • Hassan Awada
  • J. Christoph Geller
  • Michele Brunelli
  • Marc-Alexander OhlowEmail author
Article
  • 86 Downloads

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.

Keywords

Pocket hematoma CIED Premofix Stypro Vacuum drainage Anticoagulation 

Notes

Acknowledgments

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

Compliance with ethical standards

Conflict of interest

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.

References

  1. 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.CrossRefGoogle Scholar
  2. 2.
    Trappe HJ, Gummert J. Current pacemaker and defibrillator therapy. Dtsch Arztebl Int. 2011;108(21):372–80.Google Scholar
  3. 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.CrossRefGoogle Scholar
  4. 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.CrossRefGoogle Scholar
  5. 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.CrossRefGoogle Scholar
  6. 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.CrossRefGoogle Scholar
  7. 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.CrossRefGoogle Scholar
  8. 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.CrossRefGoogle Scholar
  9. 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.CrossRefGoogle Scholar
  10. 10.
    Vogt PM, Andree C, Breuing K, et al. Dry, moist, and wet skin wound repair. Ann Plast Surg. 1995;34(5):493–9.CrossRefGoogle Scholar
  11. 11.
    Belozerskaya B, Makarov V, Zhidkov EA, et al. Local hemostatics—a review. Pharm Chem J. 2006;40:353–9.CrossRefGoogle Scholar
  12. 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.CrossRefGoogle Scholar
  13. 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.CrossRefGoogle Scholar
  14. 14.
    Sensi F, Miracapillo G, Cresti A, et al. Pocket hematoma: a call for definition. PACE. 2015;38(8):909–13.CrossRefGoogle Scholar
  15. 15.
    Baddour L, Bettmann M, Bolger A, et al. Non-valvular device-related infections. Circulation. 2003;108:2015–31.CrossRefGoogle Scholar
  16. 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.CrossRefGoogle Scholar
  17. 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. 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.CrossRefGoogle Scholar
  19. 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.CrossRefGoogle Scholar
  20. 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.CrossRefGoogle Scholar
  21. 21.
    Glueck N. Impact of subcutaneous Redon-drains in visceral surgery: a prospective randomized study [dissertation]. Freiburg, Germany. Albert-Ludwig-University 2006.Google Scholar
  22. 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.CrossRefGoogle Scholar
  23. 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.CrossRefGoogle Scholar
  24. 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.CrossRefGoogle Scholar
  25. 25.
    Tomizawa Y. Clinical benefits and risk analysis of topical hemostats: a review. J Artif Organs. 2005;8:137–42.CrossRefGoogle Scholar
  26. 26.
    Georgieva S, Kokol V. Collagen- vs gelatin-based biomaterial and their biocompatibility: review and perspectives. Intecopencom/pdfs/23617 accessed 24.11.2017.
  27. 27.
    Kokare CR. Pharmaceutical microbiology—principles and applications. Nirali Prakashan 3rd edi: 21; 2008 Pune, IndiaGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2018

Authors and Affiliations

  • Hassan Awada
    • 1
  • J. Christoph Geller
    • 2
  • Michele Brunelli
    • 3
  • Marc-Alexander Ohlow
    • 1
    Email author
  1. 1.Department of CardiologyZentralklinikBad BerkaGermany
  2. 2.Department of invasive and interventional ElectrophysiologyZentralklinikBad BerkaGermany
  3. 3.Department of Cardiology and EndocrinologyStaedtisches KlinikumMagdeburgGermany

Personalised recommendations