Use of oxidized regenerated cellulose to prevent pocket hematomas after cardiac electronic device implantation in patients on anticoagulants or dual antiplatelet therapy

Abstract

Up to 30% of patients remain on anticoagulants or antiplatelet agents at the time of implantation of cardiac electronic devices [1]. The use of clopidogrel alone, dual antiplatelet therapy (DAPT) or intravenous heparin significantly increases the risk of hematoma post device implantation [2–4]. Then again, withholding anticoagulants or antiplatet therapy peri-operatively may result in thromboembolic complications. Surgicel® FibrillarTM Hemostat (Ethicon Inc. USA) is a form of oxidized regenerated cellulose (ORC), a plant-based topical hemostatic agent that is used adjunctively in surgical procedures to help control capillary, venous and small arterial hemorrhage when conventional methods of hemostasis are impractical [5,6]. It is fully absorbablewithin 14 days and has in-vitro bactericidal properties [6,7]. We describe a pilot series of 42 patients who received Surgicel® FibrillarTM Hemostat during implantation of cardiac pacemakers or defibrillators whilst remaining on anticoagulants or DAPT. We aim to assess the safety and efficacy of ORC in prevention of pocket hematomas in this group of individuals at high risk of bleeding complications postimplant. In our institution, patients on antiplatelet therapy or warfarin remain on these medications when they undergo implantation of cardiac pacemakers or defibrillators. The international normalized ratio (INR) is titrated to less than 3. A pocket hematoma is defined as a palpable mass that protrudes N2 cm (minor hematoma) or N4 cm (significant hematoma). Between 1 April 2012 and 31 January 2013, we identified 42 patients onwarfarin or DAPT inwhom implantation of cardiac electronic devices was indicated (See Table 1). Their mean age was 68 ± 8 years, 28 were males. Eighteen patients were onwarfarinwith a mean INR of 2.5 ± 0.2 peri-operatively. Of these 18 patients, 3 were on both warfarin and clopidogrel 75 mg daily. Twenty-four patients were on DAPT consisting of aspirin 100 mg and clopidogrel 75 mg daily. Each patient received 1 dose of intravenous cephazolin 1 h prior to the procedure. During implantation, a subcutaneous pocket was created in the pre-pectoral region with the use of electrocautery. All visible bleeding sites, especially arterial ones, were meticulously cauterized. Vascular access was obtained through subclavian or axillary venous punctures under fluoroscopy guidance. Each lead was implanted via a separate venous puncture. Following placement of the pulse generator in the pocket, Surgicel® FibrillarTM Hemostat was peeled off in the desired amount and the pieces fitted into the pocket, above and to the sides of the pulse generator. The wound was then closed in 2 layers with absorbable sutures and a sterile dressing applied. Each patient was prescribed a 1-week course of oral cephalexin post-implant. They were examined daily until hospital discharge and they returned for outpatient follow-up on Day 7 and 1 month postimplant for wound inspection and device check. Subsequent follow-up was at 3 to 6 monthly intervals. There was no case of pocket hematoma or infection with a mean follow-up period of 6 ±2.3 months. Despite the continued use of warfarin and DAPT peri-operatively, none of our patients developed pocket hematoma or infection. ORC appeared to be safe and effective in prevention of bleeding complications in high-risk individuals during device implantation. In the setting of anticogulation or DAPT, capillary or venous ooze is common. Conventional methods to achieve hemostasis may prove ineffective, especially in the confined areas of the subcutaneous pocket. The benefit of topical hemostatic agents in such settings is controversial. Milic et al. reported that the administration of fibrin sealant in patients on anticoagulation eliminated post-operative pocket hematomas after pacemaker implantation [8]. Recently, Ohlow et al. published data showing that the use of D-Stat HemostatTM (Vascular Solutions Inc. USA) tended towards a higher incidence of pocket hematoma requiring evacuation and pocket infections [9]. ORC is ready for use straight out of the packaging. It can be cut or peeled into customized sizes and fitted into the subcutaneous pocket. It provides a matrix for platelet adhesion and aggregation by melting into bleeding tissue, thereby serving as a hemostatic adjunct in the control of capillary, venous and small arterial hemorrhage. It is fully absorbed from the sites of implantation within 1 to 2 weeks with no tissue reaction. In-vitro studies highlight its bactericidal properties [7]. Given such features, ORC may potentially be suitable as a topical hemostat during cardiac electronic device implantation. Our study is limited by its small sample size and non-randomized design with no control arm. Large randomized trials comparing ORC versus standard care are necessary to fully evaluate the effectiveness and