https://www.uptodate.com/contents/infections-involving-cardiac-implantable-electronic-devices-treatment-and-prevention/print 11/37 7/6/23, 10:53 AM Infections involving cardiac implantable electronic devices: Treatment and prevention - UpToDate inflammation or device exposure due to erosion, same-day reimplantation on the contralateral side place has been performed in small numbers of pacer dependent patients [1,46]; however, published experience with this approach is limited, and the severity of infection and other clinical factors (eg, pacemaker dependence) should be considered carefully in deciding on timing of reimplantation. The new CIED should not be placed at the site of the previously infected device if any alternative exists. Contralateral CIED implant is reasonable in many scenarios. In addition to intravascular CIEDs, subcutaneous ICDs or leadless pacemakers, when clinically appropriate, pose a lower risk of intravascular infection [47-49]. (See "Subcutaneous implantable cardioverter defibrillators", section on 'When to consider the S-ICD' and "Permanent cardiac pacing: Overview of devices and indications", section on 'Leadless systems'.) PREVENTION Implantation of CIEDs (ie, pacemakers or implantable cardioverter-defibrillators [ICDs]) should be performed with assiduous aseptic and surgical techniques in a controlled environment; the same is true of changing pulse-generator units [2,5,50]. CIED implantation should be deferred in the setting of active infection elsewhere [1]. Efforts to prevent CIED infection have been reviewed in detail; the major considerations are noted below [51]. Operator experience affects outcome; ideally, the procedure should be performed by an individual who has done many CIED implantations [5,52,53]. (See "Cardiac implantable electronic devices: Periprocedural complications", section on 'Operator characteristics' and "Infections involving cardiac implantable electronic devices: Epidemiology, microbiology, clinical manifestations, and diagnosis", section on 'Risk factors'.) Anticoagulation or antiplatelet therapy Pocket hematomas are associated with a significantly increased risk of CIED infection. Accordingly, careful attention should be directed to current anticoagulation or antiplatelet therapy. For patients with CHA DS -VASc <4 (calculator 1) 2 2 (eg, those not at high risk for embolic events), anticoagulation should be held prior to the procedure. Bridging anticoagulation with heparin is not recommended. Ideally, antiplatelet therapy should be held for 5 to 10 days before the procedure [5]. (See "Cardiac implantable electronic devices: Periprocedural complications", section on 'Bleeding'.) Antibiotic prophylaxis at device implantation Systemic antibiotic prophylaxis is warranted for surgical implantation of foreign devices. We are in agreement with the American Heart Association and the Heart Rhythm Society, which recommend prophylaxis with antistaphylococcal antimicrobial drugs at the time CIEDs are implanted or generator units https://www.uptodate.com/contents/infections-involving-cardiac-implantable-electronic-devices-treatment-and-prevention/print 12/37 7/6/23, 10:53 AM Infections involving cardiac implantable electronic devices: Treatment and prevention - UpToDate exchanged [1,2,5]. The dosing regimens are similar to those used for cardiac surgery (eg, cefazolin 2 g [3 g for those weighing >120 kg] intravenously within 60 minutes of surgical incision or, if there is concern about cephalosporin allergy or colonization by methicillin-resistant staphylococci, vancomycin 1 g intravenously within 90 to 120 minutes before the incision) ( table 3) [2,54]. For patients who cannot tolerate beta-lactam antibiotics or vancomycin, daptomycin or linezolid are alternatives [2]. (See "Antimicrobial prophylaxis for prevention of surgical site infection in adults", section on 'Antibiotic selection'.) Contamination with skin flora is responsible for a significant proportion of CIED infections; antibiotic prophylaxis reduces risk for device infection [55-59]. In a randomized trial including 1000 patients randomized to receive either cefazolin or placebo prior to CIED implantation, those who received cefazolin had a lower infection rate than those who received placebo (0.6 versus 3.3 percent) [58]. Administration of incremental perioperative antibiotics does not appear to confer benefit over conventional administration of preoperative antibiotic therapy for prevention of CIED infection. In the PADIT (Prevention of Arrhythmia Device Infection Trial) trial, a cluster randomized trial including 19,603 patients undergoing CIED procedures at 28 centers (including 12,842 "high risk" patients undergoing any repeat CIED procedure or cardiac resynchronization therapy procedure), patients were randomized to incremental treatment (which included preprocedural cefazolin plus vancomycin, intraprocedural bacitracin pocket wash, and oral cephalexin for two days following the procedure) or conventional therapy (preprocedural cefazolin) [59]. Compared with cefazolin prior to the procedure, there was no significant difference in the hospitalization rate for CIED infection within one year overall (odds ratio [OR] 0.77, 95% CI 0.56-1.05) or within the risk-related subpopulations (high-risk patients: OR 0.82, 95% CI 0.59-1.15; low-risk patients: OR 0.77, 95% CI 0.56-1.05). Antibiotic prophylaxis for other clinical procedures There is no role for routine prophylaxis at times of mucosal trauma or manipulation for patients with CIEDs, unless there is another independent indication for endocarditis prophylaxis [2,60]. Transient bacteremia associated with mucosal trauma rarely results in CIED infection. (See "Prevention of endocarditis: Antibiotic prophylaxis and other measures".) Some experts favor deferring elective procedures that pose a risk for bacteremia (such as colonoscopy or dental work) for 8 to 12 weeks following CIED implantation if possible; however, there are no data regarding the benefit of this practice. Use of antibiotic-impregnated envelopes We suggest using an antibiotic-impregnated absorbable envelope at the time of CIED implantation or generator replacement in patients at increased risk for CIED infection wherein benefit has been established in a prospective https://www.uptodate.com/contents/infections-involving-cardiac-implantable-electronic-devices-treatment-and-prevention/print 13/37 7/6/23, 10:53 AM Infections involving cardiac implantable electronic devices: Treatment and prevention - UpToDate randomized trial [5,61]. This approach is based on the reduction in major CIED infections in certain higher-risk populations in the WRAP-IT trial [62]. Utilizing an antibiotic-impregnated absorbable envelope consists of placing the CIED pulse generator in an absorbable mesh envelope that is impregnated with minocycline and rifampin such that these antibiotics are slowly released in the generator pocket. All CIED recipients, including those whose device is placed in an envelope, should still receive preprocedure systemic antibiotic prophylaxis. Data regarding the efficacy of antibiotic-impregnated envelopes are derived from one randomized trial and nonrandomized cohort studies [62-65]. Published in 2019, the WRAP-IT trial randomized 6983 patients who were considered at increased risk for major CIED infection to either have the device encased in an antibiotic- impregnated absorbable envelope or not (control group) [62]. The study population was comprised of patients undergoing CIED generator replacement, system upgrade, pocket or lead revision, or those undergoing initial cardiac resynchronization-defibrillator (CRT-D). Standard-of-care infection prevention was provided to all patients. During the 12-month postprocedure follow-up, the primary end point of a major device infection (defined as infection causing CIED removal or revision without removal, prolonged antibiotic therapy in lieu of removal, or death) occurred in 25 (0.7 percent) of envelope recipients and 42 patients (1.2 percent) in the control group (hazard ratio [HR] 0.60, 95% CI 0.36-0.95). Among the major infections, pocket infections were the predominant clinical event (occurring in 14 [0.4 percent] of the envelope patients and 35 patients [1.0 percent] in the control patients [HR 0.30, 95% CI 0.21-0.72]); the rate of bacteremia or endocarditis did not differ significantly between the groups. In subgroup analyses, the only significant difference in major infections was noted among the ICD or CRT-D recipients. An in-depth analysis of the microbiology of infections in the WRAP-IT trial demonstrated that patients who received an envelope had a 76 percent reduction in staphylococcus- related pocket infection (HR 0.24, 95% CI 0.08-0.71) with no major difference in staphylococcal systemic infections (HR 4.0, 95% CI 0.87-19.32) [66]. Subsequent publication of longer-term follow-up (mean 21 months) demonstrated a sustained reduction in major CIED infections (HR 0.66) among recipients of the antibiotic-impregnated envelope, an effect that was driven mostly by a reduction in major pocket infections [67]. Further support of the WRAP-IT trial is seen in systematic reviews and meta-analyses. In a meta-analysis of six studies including 11,899 patients, the 5844 who underwent implantations with an antibiotic-impregnated envelope experienced significantly fewer major CIED infections in both the pooled and propensity matched analyses (OR 0.34 [95% https://www.uptodate.com/contents/infections-involving-cardiac-implantable-electronic-devices-treatment-and-prevention/print 14/37 7/6/23, 10:53 AM Infections involving cardiac implantable electronic devices: Treatment and prevention - UpToDate CI 0.13-0.86] and OR 0.29 [95% CI 0.10-0.82], respectively) [61]. Mortality rates were not significantly reduced in envelope recipients. The efficacy of antibiotic-impregnated envelopes accrues in high infection risk patients; in fact, there is no benefit in subgroup analyses when envelope recipients are compared to a low-risk population. Cost considerations have prompted further efforts to better define the patient population at greatest likelihood of benefit from these envelopes [68]. In addition to the device- related factors mentioned above, some of highest risks for CIED infection include end-stage kidney disease, prior CIED infection, fever prior to implantation, and immune suppression [68]. It is not fully known if antibiotic envelopes would reduce infection in all of these scenarios, particularly those in which the infection is bloodborne rather than via the skin or surgical site. SOCIETY GUIDELINE LINKS Links to society and government-sponsored guidelines from selected countries and regions around the world are provided separately. (See "Society guideline links: Infections involving cardiac implantable electronic devices".) SUMMARY AND RECOMMENDATIONS Cardiac implantable electronic devices (CIEDs) include pacemakers and implantable cardioverter-defibrillators (ICDs). Management of CIED infection includes antibiotic therapy, CIED explantation (leads and pulse generator), and, if indication for CIED persists, CIED reimplantation (through an uninfected route) ( algorithm 4 and algorithm 1 and algorithm 2 and algorithm 3). (See 'General principles' above.) Antibiotic therapy In general, initial empiric antibiotic therapy assumes systemic infection and utilizes regimens designed to treat endocarditis. Subsequently, antibiotic therapy should be tailored to the extent and etiology of infection once defined (via blood and/or pocket wound cultures). (See 'Antibiotic therapy' above.) Empiric antibiotic therapy for patients with suspected CIED infection should consist of antistaphylococcal therapy. Given the high incidence of methicillin resistant Staphylococcus aureus (MRSA) and Staphylococcus epidermidis, initial therapy with vancomycin is reasonable. In patients presenting with hemodynamic instability, broadening of therapy to include gram-negative bacteria is appropriate. (See 'Empiric therapy' above.) https://www.uptodate.com/contents/infections-involving-cardiac-implantable-electronic-devices-treatment-and-prevention/print 15/37 7/6/23, 10:53 AM Infections involving cardiac implantable electronic devices: Treatment and prevention - UpToDate Once a causative organism is identified (via blood and/or pocket wound cultures), the antibiotic regimen should be tailored accordingly. Definitive antibiotic therapy is based on the recovered pathogen and its antibiotic susceptibility. The antibiotic selection and duration (generally four to six weeks) are based on pathogen-specific regimens for treatment of endocarditis ( algorithm 4 and algorithm 1 and algorithm 3). (See 'Definitive therapy' above.) We favor four to six weeks of parenteral antibiotic therapy for definitive or presumptive endocarditis in the following circumstances (see "Antimicrobial therapy of left-sided native valve endocarditis" and "Antimicrobial therapy of prosthetic valve endocarditis"): Patients with transesophageal echocardiography (TEE) or other imaging demonstrating a valve or lead vegetation. Patients with bacteremia due to S. aureus, coagulase-negative Staphylococcus (high grade), Cutibacterium (formerly Propionibacterium) species (high grade), Candida species; high-grade bacteremia is defined as multiple (two or more) separate blood cultures positive for the same organism, drawn 1 hour apart. Patients with bacteremia due to alpha-hemolytic streptococci, non-Group A beta- hemolytic streptococci, or enterococcus (high grade and/or no clear alternative source). A two-week course of antibiotic therapy is reasonable in the following circumstances (see 'Definitive therapy' above): Patients with no lead or valve vegetation on TEE and bacteremia due to a gram-negative organism, Streptococcus pneumoniae, or transient bacteremia from a clear alternative source due to an organism that does not commonly cause endocarditis Patients with CIED pocket infection only (no lead or valve vegetation on TEE, sterile blood cultures, and no clinical evidence suggesting systemic infection) Device management We recommend CIED removal (leads, including residual non-functional leads, and pulse generator ( algorithm 4 and algorithm 1 and algorithm 3) (Grade 1B) (see 'Device removal versus retention' above). These include: Patients with TEE or other imaging demonstrating valve or lead vegetation with suspicion or confirmation of bloodstream infection https://www.uptodate.com/contents/infections-involving-cardiac-implantable-electronic-devices-treatment-and-prevention/print 16/37 7/6/23, 10:53 AM Infections involving cardiac implantable electronic devices: Treatment and prevention - UpToDate Patients with bacteremia due to S. aureus, coagulase-negative Staphylococcus (high grade), Cutibacterium (formerly Propionibacterium) species (high grade), Candida species, or high-grade bacteremia due to another organism with propensity to cause endocarditis Patients with CIED pocket infection (based on clinical manifestations of pain or tenderness, erythema, swelling, purulent drainage, pocket deformation, and/or percutaneous exposure/erosion of the generator and/or leads) or imaging studies Device retention may be reasonably attempted in a few limited circumstances. These include absence of vegetation on TEE in the setting of bacteremia due to a gram-negative organism or S. pneumoniae, or transient bacteremia from a clear alternative source due to an organism that does not commonly cause endocarditis. (See 'Retention criteria' above.) An approach to device reimplantation is summarized in the algorithm ( algorithm 2). (See 'Device reimplantation' above.) Prevention At the time of all CIED implantations, generator exchanges, or upgrades, we recommend systemic preprocedure antimicrobial prophylaxis ( table 3) (Grade 1A). Additionally, in patients at increased risk of CIED infection (eg, patients undergoing CIED generator replacement, lead revision, system upgrade, or CRT-D placement), we suggest using an antibiotic-impregnated absorbable envelope at the time of CIED implantation (Grade 2B). (See 'Antibiotic prophylaxis at device implantation' above and 'Use of antibiotic- impregnated envelopes' above.) 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The World-wide Randomized Antibiotic Envelope Infection Prevention (WRAP-IT) trial: Long-term follow-up. Heart Rhythm 2020; 17:1115. 68. Traykov V, Blomstr m-Lundqvist C. Antibiotic-Eluting Envelopes for the Prevention of Cardiac Implantable Electronic Device Infections: Rationale, Efficacy, and Cost-Effectiveness. Front Cardiovasc Med 2022; 9:855233. Topic 116021 Version 18.0 https://www.uptodate.com/contents/infections-involving-cardiac-implantable-electronic-devices-treatment-and-prevention/print 23/37 7/6/23, 10:53 AM Infections involving cardiac implantable electronic devices: Treatment and prevention - UpToDate GRAPHICS Approach to evaluation and management of suspected infection limited to cardiac implantable electronic device (CIED) pocket in adults https://www.uptodate.com/contents/infections-involving-cardiac-implantable-electronic-devices-treatment-and-prevention/print 24/37 7/6/23, 10:53 AM Infections involving cardiac implantable electronic devices: Treatment and prevention - UpToDate TEE: transesophageal echocardiogram; FDG PET/CT: fluorine-18 fluorodeoxyglucose positron emission tomography/computed tomography; SPECT/CT: radiolabeled autologous white blood cell single-photon emission computed tomography with computed tomography; MRSA: methicillin- resistant Staphylococcus aureus. https://www.uptodate.com/contents/infections-involving-cardiac-implantable-electronic-devices-treatment-and-prevention/print 25/37 7/6/23, 10:53 AM Infections involving cardiac implantable electronic devices: Treatment and prevention - UpToDate Refer to separate UpToDate algorithm for approach to patients with systemic symptoms, positive blood cultures, and/or vegetation on TEE. FDG PET/CT may be useful to distinguish between CIED pocket infection and superficial site infection in some circumstances; refer to the UpToDate topic on diagnosis of CIED infection for further discussion. Oral antibiotic dosing as follows: Cephalexin 500 mg orally 4 times daily Clindamycin 300 to 450 mg orally 4 times daily (use higher dose for patients with weight >120 kg) Dicloxacillin 500 mg orally 4 times daily Doxycycline 100 mg orally twice daily Linezolid 600 mg orally twice daily Minocycline 200 mg orally once, then 100 mg orally every 12 hours Trimethoprim-sulfamethoxazole 1 to 2 double-strength tablets orally every 12 hours We favor initial therapy with vancomycin (15 to 20 mg/kg/dose intravenously every 8 to 12 hours [not to exceed 2 g per dose]); refer to UpToDate text for discussion of alternative agents. Graphic 117258 Version 5.0 https://www.uptodate.com/contents/infections-involving-cardiac-implantable-electronic-devices-treatment-and-prevention/print 26/37 7/6/23, 10:53 AM Infections involving cardiac implantable electronic devices: Treatment and prevention - UpToDate Approach to reimplantation of cardiac implanted electronic device (CIED) following removal of an infected device (for patients who require CIED reimplantation) TEE: transesophageal echocardiogram. Refer to separate UpToDate algorithms for approach to diagnosis and antibiotic therapy for management of CIED infection. Temporary pacing may be required; refer to the UpToDate text for further discussion. Graphic 117259 Version 1.0 https://www.uptodate.com/contents/infections-involving-cardiac-implantable-electronic-devices-treatment-and-prevention/print 27/37 7/6/23, 10:53 AM Infections involving cardiac implantable electronic devices: Treatment and prevention - UpToDate Approach to management of adults with suspected CIED infection and negative UpToDate algorithm for approach to initial diagnostic evaluation) CIED: cardiac implantable electronic device; TEE: transesophageal echocardiogram; FDG PET/CT: fluorine-18 f tomography/computed tomography; SPECT/CT: single photon emission computed tomography/computed to High-grade bacteremia is defined as multiple (2 or more) separate blood cultures positive for the same orga for coagulase-negative staphylococci or Cutibacterium species may represent skin contamination. In such cas grade bacteremia. If repeat cultures are confounded by antibiotic therapy and clinical suspicion for CIED infec PET/CT) if available; further management should be guided by consultation with infectious disease expertise. Clinical suspicion is increased for organisms that commonly cause endocarditis. FDG PET/CT may be useful to establish a diagnosis of CIED infection in some circumstances. Other potentia https://www.uptodate.com/contents/infections-involving-cardiac-implantable-electronic-devices-treatment-and-prevention/print 28/37 7/6/23, 10:53 AM Infections involving cardiac implantable electronic devices: Treatment and prevention - UpToDate The choice and duration of antibiotic therapy is based on regimens for treatment of endocarditis caused by implicated (refer to UpToDate text and related topics). The duration of antibiotic therapy (usually 4 to 6 weeks warranted. The choice of antibiotic therapy is guided by culture results. Graphic 131691 Version 2.0 https://www.uptodate.com/contents/infections-involving-cardiac-implantable-electronic-devices-treatment-and-prevention/print 29/37 7/6/23, 10:53 AM Infections involving cardiac implantable electronic devices: Treatment and prevention - UpToDate Approach to evaluation and management of suspected infection of a cardiac implantable electronic device (CIED) in adults TTE: transthoracic echocardiogram; TEE: transesophageal echocardiogram. Signs and symptoms of an isolated CIED pocket infection include pocket erythema, discomfort, swelling, incision dehiscence, deformation, and erosion. Signs and symptoms of endocarditis include new murmur, new regurgitation, vegetation, paravalvular leak, evidence of pulmonary or systemic emboli, and immune phenomena. https://www.uptodate.com/contents/infections-involving-cardiac-implantable-electronic-devices-treatment-and-prevention/print 30/37 7/6/23, 10:53 AM Infections involving cardiac implantable electronic devices: Treatment and prevention - UpToDate Vancomycin dosing consists of 15 to 20 mg/kg/dose intravenously every 8 to 12 hours (not to exceed 2 g per dose); in patients presenting with severe sepsis, broadening of parenteral therapy to include gram-negative bacteria is appropriate. Refer to UpToDate text for further discussion. The choice of antibiotic regimen is guided by blood culture results (refer to UpToDate text). The duration of antibiotic therapy (4 to 6 weeks) should be counted from the day of device explantation, if warranted. Graphic 117257 Version 7.0 https://www.uptodate.com/contents/infections-involving-cardiac-implantable-electronic-devices-treatment-and-prevention/print 31/37 7/6/23, 10:53 AM Infections involving cardiac implantable electronic devices: Treatment and prevention - UpToDate Approach to vancomycin dosing for adults with normal kidney function* Loading dose (for patients with known or Load 20 to 35 mg/kg (based on actual body suspected severe Staphylococcus aureus weight, rounded to the nearest 250 mg infection) increment; not to exceed 3000 mg). Within this range, we use a higher dose for critically ill patients; we use a lower dose for patients who are obese and/or are receiving vancomycin via continuous infusion. Initial maintenance dose and interval Typically 15 to 20 mg/kg every 8 to 12 hours for most patients (based on actual body weight, rounded to the nearest 250 mg increment). In general, the approach to establishing the vancomycin dose/interval is guided by a nomogram. Subsequent dose and interval adjustments Based on AUC-guided (preferred for severe [1]