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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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.
KeywordsPocket 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.
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.
- 2.Trappe HJ, Gummert J. Current pacemaker and defibrillator therapy. Dtsch Arztebl Int. 2011;108(21):372–80.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.CrossRefGoogle 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
- 21.Glueck N. Impact of subcutaneous Redon-drains in visceral surgery: a prospective randomized study [dissertation]. Freiburg, Germany. Albert-Ludwig-University 2006.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, IndiaGoogle Scholar