The relationship between pocket hematoma and risk of wound infection among patients with a cardiovascular implantable electronic device: An integrative review Jiyoun Song, PhD-c, AGACNP-BC, RN*, Aluem Tark, PhD-c, FNP-BC, RN, CHPN, Elaine L. Larson, PhD, RN, FAAN School of Nursing, Columbia University, 560 W 168th St, New York, NY 10032, USA ARTICLE INFO Article History: Received 16 April 2019 Revised 5 July 2019 Accepted 25 September 2019 Available online xxx ABSTRACT Background: Pocket hematoma is a common adverse event following the insertion of cardiovascular implant- able electronic devices (CIEDs), but the risk of wound infections associated with a pocket hematoma is unclear. Objectives: This integrative review aims to examine the relationship between pocket hematoma and risk of wound infection in a CIED population. Methods: A comprehensive literature search for articles assessing the relationship between pocket hematoma and infection in four electronic databases was conducted in October 2018. Results: After screening and full text review, 7 studies met inclusion criteria (combined sample = 8,177 patients). Most studies (6/7) reported a significant relationship between pocket hematoma and all types of infection (OR = 6.924.98; p < 0.05). The proportion of wound infection among all types of infections was 61.5 - 100%. Conclusions: Pocket hematoma is a significant risk factor for all types of infection, with the most frequent type of infection being wound infection. © 2019 Published by Elsevier Inc. Keywords: Pocket hematoma Wound infection Surgical site infection Pacemaker Implantable cardioverter defibrillator Cardiac resynchronization therapy Introduction The prevalence of cardiovascular diseases including coronary artery disease, arrhythmias and structural heart abnormalities (e.g., valvular stenosis/regurgitation, cardiomyopathy) has increased since the mid-1900s. 1 In fact, cardiac disease is a major cause of mortality, globally accounting for more than 17.3 million deaths per year. 2 As a result, use of cardiovascular implantable electronic devices (CIEDs) has become increasingly prevalent over more than a decade (particu- larly between 2000 and 2010), and a standard of care in the manage- ment of cardiovascular disease. 3 CIEDs include permanent pacemakers (PPM), implantable cardioverter defibrillators (ICD), and cardiac resynchronization therapy (CRT) devices for systolic dysfunc- tion with conduction delays. With the growth in the number of patients with CIEDs aligned with progress in invasive and pharmaco- logical treatment, deaths from cardiovascular disease have decreased. 4,5 However, adverse effects (e.g., infections or hematoma) still remain as threats to individuals with CIEDs. Infections associated with CIEDs are uncommon complications, but they can lead to catastrophic outcomes. The numbers of infec- tions associated with CIEDs have also increased with the increasing demand for the device. 68 Therefore, the negative clinical outcomes observed from infections associated with CIEDs, such as increased mortality, prolonged length of hospital stay, or re-operation caused by implanted cardiac device-related infection are also of concern. A recent United States national study reported a mortality rate of 4.5% due to infections associated with CIEDs. 9 Moreover, when infections occurred, 88% of patients required complete removal of the device and 57.7% of patients underwent re-implantation. 10 A wound or sur- gical site infection is a major infection after surgery which occurs in approximately 3% of post-operative patients, 11 and a pocket infection is one specific type of wound infection of the tissues located directly beneath the tissue where CIEDs are inserted. A pocket hematoma is an accumulation of blood in or near the surgical incision which occurs because of a defect in hemostasis such as injury to blood vessels and/or as a consequence of receiving anti- platelet or anticoagulant therapy. 12 Among patients who are taking antiplatelet or anticoagulant therapy, hematoma formation occurs in 220%. 13,14 In patients who receive CIEDs, antiplatelet or anticoagu- lant therapy are commonly used pre/post operatively to prevent the formation of blood clots. Thus, these patients face greater risk of hav- ing a pocket hematoma. 1517 Abbreviations: CIED, cardiovascular implantable electronic device; PPM, permanent pacemaker; ICD, implantable cardioverter defibrillator; CRT, cardiac resynchronization therapy; LVEF, left ventricular ejection fraction; OR, odds ratio *Corresponding author. E-mail address: js4753@cumc.columbia.edu (J. Song). https://doi.org/10.1016/j.hrtlng.2019.09.009 0147-9563/© 2019 Published by Elsevier Inc. ARTICLE IN PRESS Heart & Lung 000 (2019) 17 Contents lists available at ScienceDirect Heart & Lung journal homepage: www.heartandlung.com