Contemporary ReviewCurrent strategies to minimize postoperative hematoma formation in patients undergoing cardiac implantable electronic device implantation: A review
Introduction
More than 3 million pacemakers (PMs) and 200,000 implantable cardioverter-defibrillators (ICDs) are implanted annually worldwide.1 As the battery for PM and ICD implants typically last 10–12 and 5–8 years, respectively,2 there is an increasing need for generator change procedures with longer patient life expectancy. The subsequent generator change procedures are associated with a higher risk of postoperative complications. One of the most common is the development of surgical pocket hematoma (PHs; up to 20%–25%).3, 4, 5, 6, 7 One of the most dreaded consequences of PH is the development of device infection.8 The likelihood of developing infections is 20-fold higher in patients with postoperative hematoma as noted in the REPLACE registry.9 Several risk factors for the development of device infection after cardiac implantable electronic device (CIED) implantation procedures are summarized in Figure 1.10, 11, 12, 13, 14, 15, 16, 17 Of note, there are several patient-related factors that are fixed for hematoma development, such as renal dysfunction, thrombocytopenia, body mass index > 25 kg/m2, coagulopathy, diabetes, age, dialysis, and number of prior procedures. Additionally, modifiable factors based on shared decision making that govern whether the implant should be performed, delayed, or deferred; pocket debridement; and type of surgical pocket could heavily influence hematoma incidence, but are beyond the scope of this article.18 As we discuss later, there are no consistent definitions of appropriate CIED wound healing, but on the basis of the surgical literature, we have demonstrated a few examples from our practice using the well-validated Manchester Scar Scale (MSS) and Patient Observer Scar Assessment Scale (POSAS) scales (Figure 2).19, 20, 21, 22
The goal of this review is to outline the current landscape of modifiable mitigation strategies and periprocedural interventions to reduce the development of post–device implant hematomas pre- and periprocedurally. The research reported in this article adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and focuses on physician factors exclusively, as patient risk factors are generally nonmodifiable. This includes management of antiplatelet and anticoagulation agents, prohemostatic intraoperative strategies, and mechanical devices to compress the surgical site postprocedure. This review distinguishes itself as a comprehensive review of factors that can be influenced by nuanced physician discretion.
Section snippets
Periprocedural antithrombotic management in CIED patients
The use of antithrombotic agents has been correlated with the higher risk of hematoma formation in postoperative patients with CIED.3, 4, 5, 6,23, 24, 25 An estimated 14%–35% of patients receiving CIEDs are on anticoagulant medications before the procedure.26 Device hematoma management requires cessation of anticoagulation for prolonged periods of time with the attendant risks of thromboembolic events.27 An important consideration when analyzing optimal periprocedural antithrombotic use is the
Uninterrupted warfarin therapy is superior to heparin bridging strategy
Previously, heparin bridging was a common strategy during CIED implantation procedures. This fell out of favor owing to bridging an increased hematoma risk (up to 31%) with heparin bridging strategy in individual studies.29,30 Several early meta-analyses have also found that the bleeding risk is significantly higher for groups of patients receiving heparin bridging therapy than for those receiving continued warfarin therapy.31,32
The landmark BRUISE CONTROL trial was a randomized single-blinded
Bleeding events with uninterrupted direct oral anticoagulants are similar to uninterrupted warfarin therapy
Two small randomized controlled trials evaluating rivaroxaban vs dabigatran and warfarin vs dabigatran use in patients undergoing CIED implantation procedures similarly showed no significant results in rates of bleeding complications, including hematoma formation, between the groups.38,39 Additionally, a post hoc analysis of 453 patients from the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial
Type of antiplatelet therapy and combination with dual agents drives bleeding risk
Antiplatelet agents are the seventh most prescribed drug class in 2016, and ∼48% of patients making office visits are prescribed antiplatelet agents.43 Therefore, it is no surprise that a large number of patients undergoing CIED implantation procedures are often on antiplatelet agents. We will discuss the studies of different antiplatelet agents below.
An early study of aspirin monotherapy has shown that it does not appear to increase the risk of postoperative hematoma formation in patients
Combination of anticoagulation and antiplatelet agents’ compounds bleeding risk
A meta-analysis from the era of heparin bridging strategy of 5978 patients concluded that the odds of bleeding complications was 8.3 (95% CI 5.5–12.9) for heparin bridging strategy, 5.0 (95% CI 3.0–8.3) for dual antiplatelet therapy, 1.7 (95% CI 1.0–3.1) for withheld anticoagulation, 1.6 (95% CI 0.9–2.6) for continued anticoagulation, and 1.5 (95% CI 0.9–2.3) for aspirin as compared with no therapy. This study suggested that dual antiplatelet agents but not non–heparin-based anticoagulation
Introperative prohemostatic strategies to reduce hematomas during CIED implantation procedures
Various intraoperative strategies have been used to minimize the risk of hematoma formation in patients with CIED. Reverse Trendelenburg is often used in clinical practice to reduce venous bleeding with success, but no studies have systematically studied it. In such cases, head elevation after venous access may circumvent limitations of the table operation. Additionally, head elevation of 30° (if groin access was not performed) postoperatively would assist with hemostasis. To our knowledge, no
Standard pressure dressing and variations
Pressure dressings have been traditionally applied over surgical sites to reduce the risk of hematoma and seroma formation by compressing the dead space. Traditional pressure dressings constitute absorbent bulky layer over the sterile dressing sites, which are compressed using an elastic adhesive bandage that can stretch across the surgical site or circumferentially envelope the torso66 (Figure 6A). A separate regional protocol for hematoma prevention in patients with CIED during the
Conclusion
There is a plethora of strategies to reduce the risk of device-related hematomas. The strongest body of evidence at this time derives from the antiplatelet and anticoagulant literature. Careful scrutiny for the definition of CSH is necessary to determine the true efficacy of different strategies. Additionally, uninterrupted strategies have been used in patients at high thromboembolic risk (defined as >5%/y), so there remains paucity of data for uninterrupted strategies in the lower-risk
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Funding sources: The authors have no funding sources to disclose.
Disclosures: Dr Haines has received honoraria from Biosense Webster, Farapulse, and Sagentia and is a consultant for Affera, Boston Scientific, Integer, Medtronic, Philips Healthcare, and ZOLL Corporation. Dr Mehta has received honoraria from Medtronic and Abbott. The rest of the authors report no conflicts of interest.