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



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).


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.


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.


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.


Pocket hematoma CIED Premofix Stypro Vacuum drainage Anticoagulation 



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.


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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

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