Skip to main content

Use of a pocket compression device for the prevention and treatment of pocket hematoma after pacemaker and defibrillator implantation (STOP-HEMATOMA-I)



Pocket hematoma is a recognized complication after placement of cardiac implantable electronic devices and is associated with increased device infection, length of hospitalization, and morbidity especially with uninterrupted antiplatelet agents and anticoagulants. We assessed the use of a post-surgical vest to decrease the incidence of pocket hematoma in patients undergoing device implantation with uninterrupted antiplatelet and anticoagulants.


In this observational study, a vest was used by 20 consecutive patients who were compared to 20 age-, gender-, procedure-matched patients who received standard care. All patients were continued on antiplatelet and anticoagulants in the perioperative period. The pocket was assessed at post procedure day 0, 2, and 7, respectively.


There were no significant differences in the baseline characteristics between both groups. Baseline mean international normalized ratio (INR) was significantly higher in the vest group when compared with the control group (2.7 ± 0.4 vs. 2.2 ± 0.3 = <0.001). The incidence of pocket hematoma was significantly lower in the vest group than the control group (0 vs 30%, p = 0.02) at the end of 7 days. Control group had a total of six hematomas with one patient requiring evacuation and blood transfusion. The vest group had three hematomas on day 2 that resolved by day 7.


The risk of moderate or large pocket hematoma is significantly reduced with the use of this vest in high-risk patients undergoing implantable devices on uninterrupted antiplatelet and anticoagulants.

This is a preview of subscription content, access via your institution.

Fig. 1
Fig. 2


  1. Tracy CM, Epstein AE, Darbar D, et al. 2012 ACCF/AHA/HRS focused update incorporated into the ACCF/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm AbnormalitiesA report of the American College of Cardiology Foundation/American Heart Association task force on practice guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2013;61:e6–e75.

    Article  PubMed  Google Scholar 

  2. Brignole M, Auricchio A, Baron-Esquivias G, et al. 2013 ESC guidelines on cardiac pacing and cardiac resynchronization therapy. The Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC) Developed in collaboration with the European Heart Rhythm Association (EHRA). 2013;34:2281–329.

    Google Scholar 

  3. Mond HG, Proclemer A. The 11th world survey of cardiac pacing and implantable cardioverter-defibrillators: calendar year 2009--a world Society of Arrhythmia’s project. Pacing and clinical electrophysiology : PACE. 2011;34:1013–27.

    Article  PubMed  Google Scholar 

  4. Sridhar AR, Yarlagadda V, Yeruva MR, et al. Impact of haematoma after pacemaker and CRT device implantation on hospitalization costs, length of stay, and mortality: a population-based study. Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology. 2015;17:1548–54.

    Article  Google Scholar 

  5. Wiegand UK, 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. Palmisano P, Accogli M, Zaccaria M, et al. Rate, causes, and impact on patient outcome of implantable device complications requiring surgical revision: large population survey from two centres in Italy. Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology. 2013;15:531–40.

    Article  Google Scholar 

  7. Krahn AD, Lee DS, Birnie D, et al. Predictors of short-term complications after implantable cardioverter-defibrillator replacement: results from the Ontario ICD database. Circulation Arrhythmia and electrophysiology. 2011;4:136–42.

    Article  PubMed  Google Scholar 

  8. Kutinsky IB, Jarandilla R, Jewett M, Haines DE. Risk of hematoma complications after device implant in the clopidogrel era. Circulation Arrhythmia and electrophysiology. 2010;3:312–8.

    Article  PubMed  Google Scholar 

  9. Nielsen JC, Thomsen PEB, Højberg S, et al. A comparison of single-lead atrial pacing with dual-chamber pacing in sick sinus syndrome. Eur Heart J. 2011;32:686–96.

    Article  PubMed  Google Scholar 

  10. Tang AS, Wells GA, Talajic M, et al. Cardiac-resynchronization therapy for mild-to-moderate heart failure. N Engl J Med. 2010;363:2385–95.

    CAS  Article  PubMed  Google Scholar 

  11. Flaker GC, Theriot P, Binder LG, Dobesh PP, Cuker A, Doherty JU. Management of Periprocedural Anticoagulation: a survey of contemporary practice. J Am Coll Cardiol. 2016;68:217–26.

    Article  PubMed  Google Scholar 

  12. Douketis JD, Spyropoulos AC, Spencer FA, 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:e326S–50S.

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  13. Healey JS, Eikelboom J, Douketis J, et al. Periprocedural bleeding and thromboembolic events with dabigatran compared with warfarin: results from the randomized evaluation of long-term anticoagulation therapy (RE-LY) randomized trial. Circulation. 2012;126:343–8.

    CAS  Article  PubMed  Google Scholar 

  14. Ferguson Jr TB, Ferguson CL, Crites K, Crimmins-Reda P. The additional hospital costs generated in the management of complications of pacemaker and defibrillator implantations. J Thorac Cardiovasc Surg. 1996;111:742–51. discussion 751-2.

    Article  PubMed  Google Scholar 

  15. Reynolds MR, Cohen DJ, Kugelmass AD, et al. The frequency and incremental cost of major complications among medicare beneficiaries receiving implantable cardioverter-defibrillators. J Am Coll Cardiol. 2006;47:2493–7.

    Article  PubMed  PubMed Central  Google Scholar 

  16. Swindle JP, Rich MW, McCann P, Burroughs TE, Hauptman PJ. Implantable cardiac device procedures in older patients: use and in-hospital outcomes. Arch Intern Med. 2010;170:631–7.

    Article  PubMed  Google Scholar 

  17. Sohail MR, Hussain S, Le KY, et al. Risk factors associated with early- versus late-onset implantable cardioverter-defibrillator infections. Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing. 2011;31:171–83.

    Article  Google Scholar 

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

    Article  PubMed  Google Scholar 

  19. Airaksinen KE, Korkeila P, Lund J, et al. Safety of pacemaker and implantable cardioverter-defibrillator implantation during uninterrupted warfarin treatment--the FinPAC study. Int J Cardiol. 2013;168:3679–82.

    Article  PubMed  Google Scholar 

  20. Birnie DH, Healey JS, Wells GA, et al. Pacemaker or defibrillator surgery without interruption of anticoagulation. N Engl J Med. 2013;368:2084–93.

    CAS  Article  PubMed  Google Scholar 

  21. Thal S, Moukabary T, Boyella R, et al. The relationship between warfarin, aspirin, and clopidogrel continuation in the peri-procedural period and the incidence of hematoma formation after device implantation. Pacing and clinical electrophysiology : PACE. 2010;33:385–8.

    Article  PubMed  Google Scholar 

  22. Tompkins C, Cheng A, Dalal D, 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.

    Article  PubMed  Google Scholar 

  23. Kiviniemi MS, Pirnes MA, Eranen HJ, Kettunen RV, Hartikainen JE. Complications related to permanent pacemaker therapy. Pacing and clinical electrophysiology : PACE. 1999;22:711–20.

    CAS  Article  PubMed  Google Scholar 

  24. Kirkfeldt RE, Johansen JB, Nohr EA, Jorgensen OD, Nielsen JC. Complications after cardiac implantable electronic device implantations: an analysis of a complete, nationwide cohort in Denmark. Eur Heart J. 2014;35:1186–94.

    Article  PubMed  Google Scholar 

  25. Polyzos KA, Konstantelias AA, Falagas ME. Risk factors for cardiac implantable electronic device infection: a systematic review and meta-analysis. Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology. 2015;17:767–77.

    Article  Google Scholar 

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

    Article  PubMed  Google Scholar 

  27. Uslan DZ, Gleva MJ, Warren DK, et al. Cardiovascular implantable electronic device replacement infections and prevention: results from the REPLACE registry. Pacing and clinical electrophysiology : PACE. 2012;35:81–7.

    Article  PubMed  Google Scholar 

  28. Raad D, Irani J, Akl EG, et al. Implantable electrophysiologic cardiac device infections: a risk factor analysis. European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology. 2012;31:3015–21.

    CAS  Article  Google Scholar 

  29. Poole JE, Gleva MJ, Mela T, et al. Complication rates associated with pacemaker or implantable cardioverter-defibrillator generator replacements and upgrade procedures: results from the REPLACE registry. Circulation. 2010;122:1553–61.

    Article  PubMed  Google Scholar 

  30. Ruff CT, Giugliano RP, Braunwald E, et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet (London, England). 2014;383:955–62.

    CAS  Article  Google Scholar 

Download references

Author information

Authors and Affiliations


Corresponding author

Correspondence to Vijay Swarup.

Ethics declarations

Conflict of interest

All authors declare that they have no conflict of interest.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Turagam, M.K., Nagarajan, D.V., 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-I). J Interv Card Electrophysiol 49, 197–204 (2017).

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI:


  • Cardiac implantable electronic device
  • Pocket hematoma
  • Device complications
  • Hospital outcomes
  • Compression vest