Needle aspiration should otherwise be avoided because of the risk of introducing skin flora into the pocket and subsequent development of infection. Routine ambulatory care follow-up after CIED place- ment to detect early infectious complications has been performed in many centers. Recent data from 1 investiga- tion92 failed to demonstrate the utility of early follow-up and advocated that instead, patients should be instructed to call their implanting physician for development of fever or incision findings of inflammation. The writing group believes that both early follow-up in a clinic setting and Table 2. Published Case Series That Report Outcomes of CIED Infection Reference Year n Population Treatment Follow-Up, y Outcomes Arber et al13 1994 44 Pacemaker endocarditis categorized as definite (n 25), probable ? ? ? Klug et al34 1997 57 Pacemaker lead endocarditis Plan for initial device removal and parenteral antibiotic therapy removal 2 after removal); 26.9% mortality at end of follow-up O Nunain et al84 1997 21 ICD infection Total system removal in 15; partial system removal in 2; no explantation in 4. All received parenteral antibiotics 1.75 No clinical recurrence of infection; 1 sudden death (1) IV antibiotics without device system removal with 2 weeks of parenteral antimicrobials (n 19); (3) complete removal with 6 weeks of parenteral antimicrobials 0.75 to 5 y 100% Failure and 17% mortality in those treated conservatively; no deaths or recurrent infections in the groups treated with device removal Cacoub et al42 1998 33 Definite pacemaker endocarditis Lead removal and prolonged subsequent antibiotic therapy Chua et al37 2000 123 Patients with either pacemaker (n 87) or ICD (n 36) infections Extraction in 95% with antibiotic therapy (median 28 days) 2001 51 Patients with device-related infections not candidates for surgery (from survey of providers) Long-term suppressive antibiotics (3 mo to 10 y) Not specified 3 Developed relapsing infection del Rio et al40 2003 31 Pacemaker or ICD endocarditis Initial conservative therapy (n 7); surgical removal (n 24) 3.17 Initial conservative therapy: 100% relapse, 1 death; initial surgical therapy: 1 relapse, 3 deaths Rundstrom et al86 episodes in 38 patients) Pacemaker removal in 28 episodes, conservative therapy in Not specified 64% Infection-free in group with pacemaker removal; 19% infection-free in conservative-therapy group Sohail et al37 2007 189 Patients with CDI Initial surgical removal in 183 (96%); removal after failure of medical therapy in 3 (2%); all received parenteral antimicrobial therapy, most for at least 2 wk 0.48 3.7% In-hospital mortality; of those followed up after discharge, 5% relapse or persistent pocket infection; 95% infection-free at end of follow-up Sohail et al87 2008 44 Pacemaker or ICD endocarditis (from 2007 series with CDI) Surgical removal in 43 (98%) with parenteral antimicrobial therapy thorough patient education should be conducted for early identification of CIED-related infectious complications. Currently, there are no data to support the administration of postoperative antibiotic therapy, and it is not recom- mended because of the risk of drug adverse events, selection of drug-resistant organisms, and cost. Recommendations for Antimicrobial Prophylaxis at the Time of CIED Placement Class I 1. Prophylaxis with an antibiotic that has in vitro activity against staphylococci should be administered. If cefazolin is selected for use, then it should be administered intrave- nously within 1 hour before incision; if vancomycin is given, then it should be administered intravenously within 2 hours before incision. (Level of Evidence: A) Antibiotic Prophylaxis for Invasive Procedures Bacterial pathogens commonly gain entrance to the circulation, whether from routine daily activities such as toothbrushing or from invasive procedures.93 There is a general and longstanding focus on secondary antibiotic prophylaxis to prevent hematog- enous infections from invasive procedures in patients with a wide variety of medical devices and conditions. However, controversy surrounds this practice because there are few data to show efficacy, and the risk from prophylaxis likely outweighs any benefit. For example, there is concern about the develop- ment of antibiotic-resistant bacterial pathogens, the possibility of a fatal allergic reaction, and the costs associated with this practice, which include malpractice litigation and, additional medical and dental office visits. Since the original American Heart Association recommen- dations were made more than 50 years ago, there has been a proliferation of purported indications for the use of prophy- lactic antibiotics for patients thought to be at risk for distant site infection from invasive procedures.94 97 There is little, if any, scientific justification for administration of antibiotic prophylaxis for invasive procedures, although there is a wide range of opinions.96 A review of the literature from 1950 to 2007 for publications on cardiac electrophysiological device infections reveals more than 140 articles, none of which report hematologic infection from dental, gastrointestinal, genitourinary, dermatologic, or other procedures. The predominance of staphylococci as pathogens in CIED infections rather than oral flora98 suggests that antibiotic prophylaxis for dental procedures is of little or no value.1,89,99,100 In the rare event of a device infection due to an oral pathogen, it is most likely to have arisen from a bacteremia from a common daily event such as toothbrushing or chewing food.98 Therefore, there is currently no scientific basis for the use of prophylactic antibiotics before routine invasive dental, gastrointestinal, or genitourinary procedures to prevent CIED infection. Recommendations for Antimicrobial Prophylaxis for Invasive Procedures in Patients With CIEDs Class III 1. Antimicrobial prophylaxis is not recommended for dental or other invasive procedures not directly related to device manipulation to prevent CIED infection. (Level of Evidence: C) Emerging Technology Advances in molecular, gene, and cell therapies make the development of a biological pacemaker, a tissue that could be implanted in the heart, a future possibility.101 As pointed out in a recent report,102 our total dependence on a biological pacemaker will have to await the demonstration of the safety and long-term efficacy of the biological tissue. Advancement in the development of gene and cell-transfer therapies to restore myocardial function in a failing heart and to inhibit ventricular arrhythmias103,104 could potentially im- pact the need for ICDs in the future. Technical advances could also impact the risk of infection in cases in which a device, rather than a biological therapy, is required. These include development of a totally subcutaneous ICD and a leadless pacing system. Pediatric Concerns Pediatric and young adult patients with congenital heart disease represent a population with unique medical and surgical issues. These include smaller body size, vascular anomalies, congenital heart defects with and without surgical correction or palliation, and arrhythmias due to congenital disease or surgical repair. The decision to place a CIED in 1 of these patients requires long-term planning with the expec- tation of prolonged survival that will include numerous generator changes and lead replacement due to lead fracture or stress related to somatic growth. In addition, adults with some forms of congenital heart disease that do not allow traditional transvenous access to cardiac chambers will re- quire modified pacemaker/ICD systems. With that in mind, a variety of approaches to implantation of these systems are required. Epicardial implants are frequently preferred or necessary because of a patient s size and growth potential, the presence of intracardiac shunts that allow the possibility of right-to-left shunting, and anatomic or surgical barriers to a transvenous approach. Biventricular pacing often requires epi- cardial placement of a left ventricular lead because of the small size of the coronary sinus. ICD implants are particularly chal- lenging in a patient who weighs less than 15 kg and usually require novel and nonstandard approaches with nonthoracotomy ICD coil arrays, epicardial patches, or shock leads placed in or adjacent to the pericardial space (Figures 3A and 3B). Another technique that is occasionally used to obtain the advantage of an endocardial lead while preserving the integrity of small veins is to perform a thoracotomy with placement of a lead through an atrial wall via a purse-string suture, with the lead connector extended to an abdominal device. Klug et al105 demonstrated that young patients with or without congenital defects have a greater prevalence of PPM lead infections than older ( 40 years of age) individuals. They speculated that several factors could be operative in causing an increased infection rate among younger patients, including a higher rate of reinterventions at the generator site, placement of a relatively larger device based on a higher ratio between the volume of the generator and body size, and the likelihood of local trauma to the generator site in younger, Baddour et al Cardiovascular Device Infections 469 more active individuals. A number of studies86,106 114 of infected PPMs in the pediatric population have demonstrated that congenital heart disease is present in a large percentage (44% to 83%) of young patients, with overall infection rates that ranged between 1% and 8%. Patients with endocardial and epicardial leads composed 70% and 30%, respectively, of reported cases. With the exception of 1 study, there were no differences in rates of epicardial and transvenous pacemaker infections. In the largest review of pediatric pacemaker infections, Cohen et al90 analyzed 385 pacemaker procedures over a 20-year period and identified 30 infections (7.8%). Of these infections, 19 (4.9%) were superficial and were treated successfully with antibiotics only, whereas 9 (2.3%) were deep pocket infections that required removal of the generator and leads. By multivariable analysis, the only risk factors for infection were the presence of Down syndrome and reinter- vention for revision of the pacing system. Although the numbers were small, the authors suggested that a subpectoral placement of a device yielded a reduced infection risk compared with a prepectoral location. No study has compared rates of pacemaker and ICD infec- tions in a pediatric population, although several investigations have examined pediatric and congenital heart disease patients after ICD implantation. Silka et al115 described 125 pediatric patients with 4 ICD wound infections and 2 pocket erosions. A erosions in the first 30 days after device implantation and 13 (2.9%) chronic infections among 443 patients. One study116 compared ICD complications between adults and pediatric patients ( 21 years of age) at the same institution. The infection rate in the pediatric group was 18% (2 of 11) compared with epicardial and 1 transvenous system infection in the pediatric group. There was no specific information provided in the report to indicate how many of the systems in adults were epicardial.117 The authors speculated that pediatric patients may have had a higher infection rate due to returning to activity sooner and less than optimal wound care. The same principles of diagnosis and management of device infections in the general population apply to pediatric and congenital heart disease patients; however, there are some additional considerations. The excellent imaging provided by standard transthoracic echocardiography may supplant the need for a transesophageal study in some pediatric patients. Because of the high prevalence of nontransvenous systems and the unique configurations required to implant CIEDs in some pediatric patients and individuals with congenital heart disease, there must be a thorough evaluation of the need to remove all components of a device. This includes a review of a patient s ongoing need for the device; if the device therapy is no longer required, it should be removed. Epicardial and other nontrans- venous systems in use can necessitate extensive surgical proce- dures for complete device removal, including a full or limited sternotomy or thoracotomy. Therefore, the suspicion of device- component infection must be balanced against the risk of surgical removal. An experienced team of physicians with expertise in cardiac electrophysiology, infectious diseases, pedi- atrics and congenital heart disease, and cardiothoracic surgery is pivotal in CIED infection management. Ethical Considerations Consideration for withdrawal of CIED support in terminally ill patients is common and will become more frequent as the age and accompanying comorbid conditions increase among recipi- ents of these devices. Although a thorough review of related ethical considerations is beyond the scope of the present state- ment, the topic is important to highlight, because the occurrence of a device infection has prompted some patients to refuse implantation of a new device after removal of an infected device. Many of the same ethical concerns that apply to deactivation of a noninfected implanted CIED apply to removal of an infected device without new CIED placement. The American College of Cardiology/American Heart Association/Heart Rhythm Society 2008 guidelines3 for device-based therapy of cardiac rhythm abnormalities outlines specific recommendations regarding terminal Figure 3. A and B, Nonthoracotomy ICD system placed in a 39-year-old man with inoperable pulmonary atresia with ventric- ular septal defect who had ventricular tachycardia with syncope. Note the retrosternal and intrapericardial coil arrays, the epicar- dial pace/sense leads, and the abdominal ICD. Table 3. Summary of Recommendations Recommendation Class and Level of Evidence A. Recommendations for diagnosis of CIED infection and associated complications 1. All patients should have at least 2 sets of blood cultures drawn at the initial evaluation before prompt initiation of antimicrobial therapy for CIED infection. IC 2. Generator-pocket tissue Gram stain and culture and lead-tip culture should be obtained when the CIED is explanted. IC 3. Patients with suspected CIED infection who either have positive blood cultures or have negative blood cultures but have had recent antimicrobial therapy before blood cultures were obtained should undergo TEE for CIED infection or valvular endocarditis. IC 4. All adults suspected of having CIED-related endocarditis should undergo TEE to evaluate the left-sided heart valves, even if transthoracic views have demonstrated lead-adherent masses. In pediatric patients with good views, TTE may be sufficient. IB 5. Patients should seek evaluation for CIED infection by cardiologists or infectious disease specialists if they develop fever or bloodstream infection for which there is no initial explanation. IIaC 6. Percutaneous aspiration of the generator pocket should not be performed as part of the diagnostic evaluation of CIED infection. IIIC B. Recommendations for antimicrobial management of CIED infection 1. Choice of antimicrobial therapy should be based on the identification and in vitro susceptibility results of the infecting pathogen. IB 2. Duration of antimicrobial therapy should be 10 to 14 days after CIED removal for pocket-site infection. 1C 3. Duration of antimicrobial therapy should be at least 14 days after CIED removal for bloodstream infection. 4. Duration of antimicrobial therapy should be at least 4 to 6 weeks for complicated infection (ie, endocarditis, septic thrombophlebitis, or osteomyelitis or if bloodstream infection persists despite device removal and appropriate initial antimicrobial therapy). C. Recommendations for removal of infected CIED 1. Complete device and lead removal is recommended for all patients with definite CIED infection, as evidenced by valvular and/or lead endocarditis or sepsis. IA 2. Complete device and lead removal is recommended for all patients with CIEM pocket infection, as evidenced by abscess formation, device erosion, skin adherence, or chronic draining sinus without clinically evident involvement of the transvenous portion of the lead system. 3. Complete device and lead removal is recommended for all patients with valvular endocarditis without definite involvement of the lead(s) and/or device. 4. Complete device and lead removal is recommended for patients with occult staphylococcal bacteremia. 5. Complete device and lead removal is reasonable in patients with persistent occult Gram-negative bacteremia despite appropriate antibiotic therapy. IIaB 6. CIED removal is not indicated for a superficial or incisional infection without involvement of the device and/or leads. IIIC 7. CIED removal is not indicated for relapsing bloodstream infection due to a source other than a CIED and for which long-term suppressive antimicrobials are required. IIIC D. Recommendations for new CIED implantation after removal of an infected CIED 1. Each patient should be evaluated carefully to determine whether there is a continued need for a new CIED. IC 2. The replacement device implantation should not be ipsilateral to the extraction site. Preferred alternative locations include the contralateral side, the iliac vein, and epicardial implantation. 3. When positive before extraction, blood cultures should be drawn after device removal and should be negative for at least 72 hours before new device placement is performed. IIaC 4. New transvenous lead placement should be delayed for at least 14 days after CIED system removal when there is evidence of valvular infection. IIaC E. Recommendations for use of long-term suppressive antimicrobial therapy 1. Long-term suppressive therapy should be considered for patients who have CIED infection and who are not candidates for complete device removal. IIbC 2. Long-term suppressive therapy should not be administered to patients who are candidates for infected CIED removal. IIIC (Continued) Baddour et al Cardiovascular Device Infections 471 care of dying patients and device deactivation. In addition, there will be a thorough addressing of the ethics of CIED use in a pending statement on CIED extraction from the Heart Rhythm Society. Removal of Noninfected CIEDs Avoidance of Microbiological Studies Noninfectious device-related complications or device malfunc- tion may occur that requires CIED removal with new device placement. At the time of device removal, specimens from the generator pocket or the explanted device should not be routinely sent for microbiological studies unless there are intraoperative findings to suggest concurrent infection. As evidenced in a previous investigation,69 intraoperative culture specimens fre- quently yield bacteria, although there is no other evidence of infection. In these cases, it is presumed that contamination during device explantation and processing of specimens likely account for the majority of positive cultures. In these cases, no antimicrobial therapy has been administered, and the rate of subsequent device infection has been no greater than expected. Thus, cultures should not be obtained routinely, because if positive, they could be misinterpreted as being clinically signif- icant and lead to the inappropriate administration of antimicro- bials, or worse, removal of the newly implanted device. Recommendations to Avoid Microbiological Studies in Cases of CIED Removal for Noninfectious Reasons Class III 1. Routine microbiological studies should not be con- ducted on CIEDs that have been removed for noninfec- tious reasons. (Level of Evidence: B) Areas in Need of Further Research Tremendous gains in our knowledge of CIED infections have occurred over the past 5 years. Because of the increasing rate of these infections among an increasing pool of device recipients, it is imperative that aggressive investigation of all aspects of device infection be conducted. The following topics represent areas that the writing group identified as critical for further study: 1. Determine the safety of 1-stage contralateral device replacement compared with delayed device replace- ment as a management scheme. 2. Define a scoring system that distinguishes patients with S aureus bacteremia and no other evidence of device infection who prove to have CIED infection from those who do not, so that unnecessary device removal can be avoided. 3. Develop CIEDs that are less prone to infection. 4. Develop adjunctive therapies that eliminate biofilm- laden microorganisms. 5. Determine whether there is a floor of vegetation size, among other characteristics, that reliably predicts the occurrence of clinically significant pulmonary embolism with percutaneous extraction of an infected lead. 6. Define more clearly the circumstances in which van- comycin should be used as primary prophylaxis for CIED implantation. 7. Identify risk factors and characterize outcomes of CIED infections in large populations that are represen- tative of those treated in clinical practice. 8. Develop a scoring system to assess the risk of serious complications associated with percutaneous removal that will identify a subset of patients for whom median sternotomy for CIED removal is recommended. 9. Assess implantation strategies in infants and children for CIED with respect to both leads and generators that will reduce both short- and long-term infection rates. 10. Develop gene and cell therapies to obviate the need for CIED devices. 11. Define the current financial cost of CIED infection in the United States. 12. Determine whether generator capsule excision and pocket closure before new device placement are benefi- cial in reducing the likelihood of new CIED infection. 13. Determine the risk of CIED infection among patients with bloodstream infection due to coagulase-negative staphylococci, streptococci, enterococci, and Candida species and no other evidence of device infection. Summary of Recommendations This document has addressed critical aspects of CIED infec- tions. In particular, management strategies have been presented, and a summary of recommendations is outlined in Table 3. Acknowledgments The authors thank Drs John Bradley, Charles Love, Anne Rowley, and Jon Weinstock for their critical review of the manuscript. Table 3. Continued Recommendation Class and Level of Evidence F. Recommendations for antimicrobial prophylaxis at the time of CIED placement 1. Prophylaxis with an antibiotic that has in vitro activity against staphylococci should be administered. If cefazolin is selected for use, then it should be administered intravenously within 1 hour before incision; if vancomycin is given, then it should be administered intravenously within 2 hours before incision. IA G. Recommendations for antimicrobial prophylaxis for invasive procedures in patients with CIEDs 1. Antimicrobial prophylaxis is not recommended for dental or other invasive procedures not directly related to device manipulation to prevent CIED infection. IIIC H. Recommendations to avoid microbiological studies in cases of CIED removal for noninfectious reasons 1. Routine microbiological studies should not be conducted on CIEDs that have been removed for noninfectious reasons. IIIB TTE indicates transthoracic echocardiography. Disclosures Writing Group Disclosures Writing Group Member Employment Research Grant Other Research Support Speakers Bureau/ Honoraria Expert Witness Ownership Interest Consultant/Advisory Board Other Larry M. Baddour Mayo Clinic None None None None None Cardinal Health*; Talecris Biotherapeutics* None Lee B. Beerman University of Pittsburgh None None None Yes; no recent active cases* None None None Ann F. Bolger UCSF None None None None None None None Andrew E. Epstein University of Pennsylvania Biotronik*; Boston Scientific*; Medtronic*; St Jude Medical None Biotronik*; Boston Scientific*; Medtronic*; St Jude Medical Yes, in cases involving ICDs* None None None Christopher C. Erickson University of Nebraska St. Jude Medical None Received honorarium from Medtronic to give a lecture in 2007* None None None None N.A. Mark Estes III Tufts-New England Medical Center None None Boston Scientific*; Medtronic*; St. Jude Medical* None None None None Michael Gewitz New York Medical College None None None None None NDTI*; Jefferson University* None Bradley P. Knight University of Chicago Two of my electrophysiology fellows are supported by industry. One grant from Boston Scientific and 1 from St. Jude None Medtronic, for speaking at fellow educational courses, often exceeds None None None None Matthew E. Levison Drexel University None None None None None None Editor, Infectious Disease Section, Merck Manual Peter B. Lockhart Carolinas Medical Center None None None None None None None Frederick A. Masoudi Denver Health Medical Center AHRQ ; NHLBI None None None None None American College of Cardiology (contract)* Jane W. Newburger Harvard None None None None None None None Eric J. Okum Rush University, Chicago None None Two speaking engagements for training staff of Sanofi-Aventis in the role of Lantus insulin use in cardiac surgery patients (total $1000)* None None None None Eleanor B. Schron Was with NIH but retired None None None None None InCirculation.net Advisory Board, an international educational Web site for dissemination of findings from studies in cardiovascular disease. I have provided advice concerning groups of nurses who may be interested in the Web site and identified nurse researchers with expertise in cardiovascular nursing. Payment zero to no more than $1000 in a particular year* None Kathryn A. Taubert American Heart Association None None None None None None None Walter R. Wilson Mayo Clinic None None None None None None None This table represents the relationships of writing group members that may be perceived as actual or reasonably perceived conflicts of interest as reported on the Disclosure Questionnaire, which all members of the writing group are required to complete and submit. A relationship is considered to be significant if (1) the person receives $10 000 or more during any 12-month period, or 5% or more of the person s gross income; or (2) the person owns 5% or more of the voting stock or share of the entity, or owns $10 000 or more of the fair market value of the entity. A relationship is considered to be modest if it is less than significant under the preceding definition. *Modest. Significant. Baddour et al Cardiovascular Device Infections 473 References 1. 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Page University of Washington None None None None None None None Michael Silka University of Southern California None None None None None None None Bruce Wilkoff Cleveland Clinic None None Medtronic*; St Jude Medical*; Boston Scientific*; LifeWatch None None Medtronic*; St Jude Medical*; Boston Scientific*; LifeWatch None This table represents the relationships of reviewers that may be perceived as actual or reasonably perceived conflicts of interest as reported on the Disclosure Questionnaire, which all reviewers are required to complete and submit. A relationship is considered to be significant if (1) the person receives $10 000 or more during any 12-month period, or 5% or more of the person s gross income; or (2) the person owns 5% or more of the voting stock or share of the entity, or owns $10 000 or more of the fair market value of the entity. A relationship is considered to be modest if it is less than significant under the preceding definition. *Modest. 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