Journal of Thrombosis and Haemostasis, 6: 1615–1621

DOI: 10.1111/j.1538-7836.2008.03080.x

REVIEW ARTICLE

Perioperative anticoagulation in patients having implantation of a cardiac pacemaker or defibrillator: a systematic review and practical management guide E . J A M U L A , J . D . D O U K E T I S and S . S C H U L M A N Department of Medicine, McMaster University, Hamilton, ON, Canada

To cite this article: Jamula E, Douketis JD, Schulman S. Perioperative anticoagulation in patients having implantation of a cardiac pacemaker or defibrillator: a systematic review and practical management guide. J Thromb Haemost 2008; 6: 1615–21.

Introduction Summary. Background: The perioperative management of anticoagulation in patients who are having implantation of a pacemaker or implantable cardioverter defibrillator (ICD) is a common clinical problem in which best clinical practise is not established. Methods: We performed a systematic review of the literature to assess the safety (pocket hematoma risk) and efficacy (thromboembolism risk) of different management strategies. We included studies involving patients who were having pacemaker or ICD implantation whenever a portion of these patients were receiving a coumarin and also assessed pocket hematoma or thromboembolism. Results: We identified eight studies that assessed two strategies used for perioperative anticoagulation management: interruption of a coumarin and use of bridging anticoagulation with a short-acting heparin; and perioperative continuation of a coumarin. A strategy involving bridging anticoagulation with therapeutic-dose heparin was associated with an incidence of pocket hematoma of 12–20%. A strategy involving perioperative continuation of a coumarin was associated with an incidence of pocket bleeding of 1.9– 6.6%. The incidence of thromboembolic events was 0–1%, irrespective of the perioperative anticoagulation strategy used. Conclusion: The perioperative anticoagulation management of patients who require pacemaker or ICD implantation is not established but a strategy involving postoperative bridging with intravenous heparin confers a high risk for bleeding whereas perioperative continuation of a coumarin appears to confer a lower risk for bleeding. Keywords: anticoagulation, bleeding, implantable cardioverter defibrillator, pacemaker, pacemaker pocket hematoma.

Correspondence: James D. Douketis, St JosephÕs Healthcare, Room F-544, 50 Charlton Ave, Hamilton, ON L8N 4A6, Canada. Tel.: +1 905 521 6178; fax: +1 905 521 6068. E-mail: [email protected] Received 11 May 2008, accepted 20 June 2008  2008 International Society on Thrombosis and Haemostasis

Approximately 176 000 patients undergo surgery for a permanent pacemaker or implantable cardioverter defibrillator (ICD) annually in North America [1], and up to 45% of such patients are receiving a coumarin because of atrial fibrillation or a mechanical heart valve [2]. The perioperative anticoagulant management of such patients is challenging because interruption of coumarin therapy may increase the risk for embolic stroke, which can be fatal or associated with major disability in 70% of patients [3]. Patients who have pacemaker or ICD implantation are susceptible to bleeding within the pacemaker pocket because the fascial layers are not sutured and remain unopposed. Pocket hematomas can become infected, increase the risk of bacterial endocarditis and may require surgical drainage [4,5]. In managing the perioperative anticoagulation of patients who are having pacemaker or ICD implantation, one approach is to stop the coumarin approximately 5 days before surgery and to administer bridging anticoagulation with intravenous heparin or low-molecular-weight heparin (LMWH) before and after surgery when the international normalized ratio (INR) is sub-therapeutic [6]. This approach aims to minimize the time patients are not therapeutically anticoagulated and the risk for thromboembolism. Another approach is to continue the coumarin during the perioperative period, thereby mitigating the risk for thromboembolism, and provide close attention to local hemostasis. Although minor procedures, such as dental extractions, can be safely carried out in anticoagulated patients [7], the safety of this approach in patients is not established for surgical procedures. We systematically reviewed studies assessing perioperative anticoagulation of patients requiring pacemaker or ICD implantation. We aimed to assess the safety (pocket hematoma and non-pocket bleeding risk) and efficacy (thromboembolism risk) of different management strategies and, based on this evidence, to provide practical guidelines for the perioperative anticoagulation management of such patients.

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Methods Data sources

We identified all English language articles that assessed perioperative anticoagulation management in patients having pacemaker or ICD implantation. Databases used were MEDLINE (1966–April 2008, week 4), EMBASE (1997–2008, week 18) and the Cochrane Library (1999–2008, issue 2). The search strategy is detailed in Appendix 1. In addition, reference lists were reviewed by a manual search. Study selection

A study was included if it assessed patients who were having pacemaker or ICD implantation and if at least a portion of these patients were receiving a coumarin. Included studies also assessed at least one of these outcomes: pocket hematoma; thromboembolism. Case reports and commentaries were excluded. Data extraction

Due to the heterogeneity of study outcomes, pooling of data was not possible, thereby precluding any statistical analyses. Instead, our findings are presented in a narrative format. The outcomes of interest were: pocket hematoma bleeding and thromboembolic events. Results Study selection

A search of the MEDLINE database identified 288 potentially relevant articles, of which eight satisfied our selection criteria and were included in this review [8–15]. Manual searches of reference lists yielded no additional studies. Searches of the EMBASE and Cochrane databases did not yield any additional articles. Data extraction

The characteristics of included studies and the incidence of clinical outcomes associated with different perioperative anticoagulation strategies are shown in Table 1. Perioperative anticoagulation strategies

In the articles that satisfied the study selection criteria, we identified two strategies used for perioperative anticoagulation management: (i) interruption of the coumarin and use of bridging anticoagulation, either with intravenous heparin or subcutaneous LMWH [8–11]; and (ii) continuation of the coumarin in the perioperative period [12–15]. We did not identify any studies assessing perioperative management with partial anticoagulation (INR 1.5–1.9) at the time of pacemaker or ICD implantation.

Perioperative interruption of the coumarin and use of bridging anticoagulation Wiegand et al. [8], in a retrospective cohort study, assessed the incidence of pocket hematoma in 3164 patients who had pacemaker implantation, which included 1069 phenprocoumon-treated patients. Phenprocoumon was stopped 1–5 days before surgery and bridging with therapeutic-dose heparin or LMWH was administered when the INR was