Background: Cardiovascular implantable electronic devices (CIEDs) are frequently inserted while patients are on anticoagulant or anti-aggregant therapy. As a result, the probability for hematoma formation and its consequences is higher.
Aim: To evaluate the effectiveness of TopClosure® System in prevention and management of pocket hematoma following implantation of CIEDs in patients prone to bleeding.
Methods: During 10/2012- 05/2013 we identified 36 patients requiring CIED implantation being prone to bleeding due to anticoagulant treatment. Patients were alternately assigned to TopClosure® system theatment, or to conventional pressure dressings, the latter served as the control group. All patients were on Warfarin treatment. 11+ days following surgery, wound dressings were removed and an independent surgeon evaluated wound healing condition prior to staple removal. Therapy outcome was determined by time being adequate to remove staples, the need to continue antibiotic treatment, or further need for TopClosure® application.
Results: In only two patients of the treatment group (11.8%) suture removal had to be delayed and extended antibiotic therapy was required, compared to 5 patients in the control group (31.3%), who required deferral of staple removal, additional antibiotic administration, or further pressure dressing application. The INR measured in the TopClosure® group and the control group was 1.94±1.05 and 1.14±0.12 respectively.
Conclusions: The use of the TopClosure®, following CIED implantation in cardiac patients on active anticoagulant therapy, proved in this preliminary study to be safe and efficacious.
