Contemporary Management of Cardiac Implantable Electronic Device Infection

Background Cardiac implantable electronic devices (CIEDs) infection remains a serious complication, causing increased morbidity and mortality. Early recognition and escalation to definitive therapy including extraction of the infected device often pose challenges. Objectives The purpose of this study was to assess U.S.-based physicians current practices in diagnosing and managing CIED infections and explore potential extraction barriers. Methods An observational survey was performed by the American College of Cardiology including U.S. physicians managing CIEDs from February to March 2022. Sampling techniques and screener questions determined eligibility. The survey featured questions on knowledge and experience with CIED infection patients and case scenarios. Results Of 387 physicians completing the survey (20% response rate), 49% indicated familiarity with current guidelines regarding CIED infection. Electrophysiologists (EPs) (91%) were more familiar with these guidelines, compared to non-EP cardiologists (29%) and primary care physicians (23%). Only 30% of physicians specified that their institution had guideline-based protocols in place for managing patients with CIED infection. When presented with pocket infection cases, approximately 89% of EPs and 50% of non-EP cardiologists would follow guideline recommendation to do complete CIED system removal, while 70% of primary care physicians did not recommend guideline-directed treatment. Conclusions There are gaps in familiarity of guidelines as well as the knowledge in practical management of CIED infection with non-extracting physicians. Most institutions lack a definite pathway. Addressing discrepancies, including guideline education and streamlining care or referral pathways, will be a key factor to bridging the gap and improving CIED infection patient outcomes.

C ardiac implantable electronic de- vices (CIEDs) play an important role in contemporary management of cardiac arrhythmias and reduce the risk of sudden cardiac death.Clinical indications for CIEDs have expanded, leading to a gradual yet significant increase in implantation rates over the past 2 decades. 1 This rise in CIED implantation rates has also led to a parallel increase in CIED infection rates. 2 CIED infection can be a serious and lifethreatening condition which is associated with significant morbidity, mortality, and health care burden. 3,4though CIED infections are a resource-intensive clinical burden, they are often underdiagnosed and associated with significant heterogeneity in clinical management.Inexperience with CIED infection recognition and management could increase the likelihood of missed infection, resulting in delayed and suboptimal management with poor outcomes.Therefore, adequate knowledge and skills regarding CIED infection management are needed among health care providers involved in the clinical care pathway to ensure timely identification and optimal management.6][7][8] However, major gaps in knowledge and insufficient adherence to guidelines continue to remain an important hurdle to overcome.A recent analysis of Centers for Medicare & Medicaid Services data demonstrated that more than 8 in 10 patients are not treated according to Class I guidelines. 9A comparable pattern is seen in a separate, extensive nationwide database of 25,000þ patients with CIEDs systemic infection revealed that only a small proportion of patients (12%) underwent transvenous lead extraction. 10This evidence underscores the critical need for a more indepth exploration of the potential barriers to extraction and the gaps that currently exist in the timely management of CIED infection.Lakkireddy et al Contemporary Management of CIED Infection  compared to 44% of non-EP cardiologists and 24% of PCPs.However, 60% of PCPs and 40% of non-EP cardiologists reported that they were unsure of the infection rate or it was not applicable to their facility.
Three-fifths of clinicians (62%) reported that the risk level of major complications resulting from a lead extraction procedure was moderate (1%-5% risk), while 20% indicated that it was high risk (6%-10% risk) or very high risk (>10% risk).EPs (76%) and cardiologists (non-EPs) (62%) were more likely to report that the risk of major complications was moderate as compared to 37% of PCPs (P < 0.001).Almost all EPs (93%) associated a higher rate of CIED infection with the generator change and upgrade scenario as compared to non-EP cardiologists (50%) and PCPs (45%) (P < 0.001).
The top 2 decision factors to consider lead extraction or referral for extraction were the patient's comorbidity (87%) and risk of lead extraction procedure (86%), followed by the age of the lead (80%) and the age of the patient (79%).Ease of access to extraction center had a much lower level of influence (55%).The least influential factor is the fear of losing the patient to the extraction physician (11%), although 25% of PCPs surveyed felt that this was an influence.
After diagnosing a patient with CIED pocket infection, 69% of respondents would refer to a device specialist with expertise in lead management, including 31% of EPs, 89% non-EPs, and 89% PCPs as shown in Table 2. Less than one-half (44%) would EPs believed that generator change and upgrade is a scenario that is typically associated with a high rate of CIED infection.There was a significant difference among the 3 specialties in their understandings of scenarios associated with CIED infections (multi-response question, P < 0.001 for every answer, chi-squared test).In case 2, a patient with a pacemaker implanted 7 years prior presented with a fever and pocket site swelling and erythema.Most EPs (83%), while only 61% of non-EPs and 37% of PCPs reported antibiotic treatment and complete CIED system removal as the next step (P < 0.001).Guidelines recommend that for a patient with signs of systemic infection, blood cultures should be ordered to determine the type of bacteria and transesophageal echocardiogram should be performed to examine valve vegetation.Complete CIED system should be removed, and antibiotics should be administered for 4 to 6 weeks.When blood cultures are negative for at least 72 hours and CIED remains indicated, reimplant CIED.

Lakkireddy et al
In case 3, a patient presented with a pacemaker pocket erosion.Patient was afebrile with normal white blood cell count.Most EPs (93%) reported that the next step for this patient is complete CIED system removal and 6 weeks of antibiotics, compared to 51% of non-EP cardiologists and 32% of PCPs (P < 0.001).

Scale bar
Values are %.
Lakkireddy et al  for complete system extraction in these scenarios. 7wever, a great divide exists between recommendations and current clinical practice patterns. 10The surveyed clinical cases highlight a critical low level of awareness with clinical practice guidelines for management of CIED infections among non-EP cardiologists and PCPs, who are often the first point of contact for patients with device-related issues.In addition,
Lakkireddy et al

Lakkireddy et al
The COGNITO (COGNITO: Latin for awareness of Knowledge; ContempOrary manaGemeNt of cardiac ImplanTable electrOnic device infection) study was a survey conducted by the American College of Cardiology (ACC) to gain insights from the U.S. fellows of ACC members.The purpose of the survey was to capture and understand clinical perspectives related to the challenges in care and overall awareness of CIED infection.METHODS The ACC conducted an online survey designed to understand and assess the current practice of U.S.based electrophysiologists (EPs), cardiologists (non-EPs), and primary care physicians (PCPs) related to the diagnosis and management of CIED infections from February 11, 2022, to March 10, 2022.The survey was based on a previous survey undertaken by European Heart Rhythm Association (EHRA) to explore the gaps in knowledge around CIED management and modified to suit the American health care system. 11The 10-to 15-minute questionnaire is provided in the Supplemental Appendix.The demographic section had 8 questions, and the main survey section included 17 questions.The survey was anonymized with no identifiable personal or patient data so specific ethical approval was not required.Participants were first asked to identify as an EP, non-EP cardiologist, or PCP, and also type of practice (hospital, university, multispecialty/physician group).Participants were also asked to select multiple-choice responses to the following: years of experience managing CIED, experience with device implantations and extractions, estimates of annual device infection at respective centers, familiarity with device extraction guidelines, whether institution has guidelines or protocols in place for the management of CIED infections, along with several management questions.Furthermore, 3 patient case scenarios involving CIED infections were provided with multiple questions.RECRUITMENT.Four different sample sources were used when fielding the survey.Email invitations and 3 reminders were sent to ACC CardioSurve panelists.The CardioSurve Panel consists of 492 U.S.-based fellows of the ACC who have voluntarily agreed to participate in monthly research surveys for a 2-year term.Panelists were selected using a stratified random sampling technique to ensure accurate demographic representation of the U.S. cardiologists.For the EP audience, email invitations and 2 reminders were sent to 933 EP members of the ACC.For the PCP audience, email invitations and 2 reminders were sent to 500 PCP panel members of the Dynata research group.Twitter was also used as a channel for survey distribution.The survey was distributed on this channel via the ACC X handle (@ACCIntouch) and survey sponsor accounts.Three patient case scenarios were provided in the survey to assess competency regarding identification and management of CIED infections.

FIGURE 1
FIGURE 1 Familiarity With Guidelines, Institution for Protocols, and Perception of CIED Infection Risk

J
A C C : A D V A N C E S , V O L . 3 , N O . 2 , 2 0 2 4 Contemporary Management of CIED Infection F E B R U A R Y 2 0 2 4 : 1 0 0 7 7 3 refer to an infectious disease specialist.Almost threefourths of EPs who perform lead extraction (73%) would manage the patient on their own as compared to 39% of EPs who do not perform lead extractions.Approximately 22% would manage the patient on their own, including 54% EPs, 3% non-EPs, and 11% PCPs.After diagnosing a patient with a CIED with bacteremia, 61% would refer to an infectious disease specialist and 58% would refer to a device specialist with expertise in lead management.PATIENT CASE SCENARIOS.Case scenarios are provided in the Figure2.In case 1, a 63-year-old male with a CIED implanted 8 years ago presented with recurrent fever and found to have a pocket infection and methicillin-resistant Staphylococcus aureus.Most EPs (91%) reported that a complete CIED system removal and 4 weeks of antibiotics were the optimal therapy for this patient, as compared only 65% non-EPs and 33% PCPs (P < 0.001).Guidelines recommend that for a patient with suspected CIED pocket infection and positive blood cultures of S aureus, complete CIED system should be removed, and IV antibiotics should be administered for 4 to 6 weeks depending on the transesophageal echocardiogram findings.CIED should be reimplanted when blood cultures are negative for at least 72 hours and CIED remains indicated.
part of the CIED should imply contamination of the entire system, complete system removal should be performed.Patients should also be treated with 7 to 10 days of antibiotics before reimplantation of a new CIED with specific timing dependent on clinical scenario and if CIED remains indicated.DISCUSSION The COGNITO study is the largest professional society-based survey of practicing physicians in assessing approaches to management of CIED infection.The survey represents a broad range of practicing clinicians including EPs, non-EP cardiologists, and PCPs.The main findings of the survey are as follows.First, familiarity with identification and management of CIED infections was very low among non-EP cardiologists and PCPs, as shown in the Central Illustration.Second, fewer than one-third of respondents had knowledge of local institutional CIED management protocols.Even among EPs who routinely implant CIEDs, only 42% reported being aware of institutional CIED infection protocols.Third, for a patient with CIED infection, approximately 40% of EPs who do not perform lead extraction reported managing the patient themselves without a referral to a lead extraction specialist.Additionally, 11% of PCPs reported managing CIED infections themselves.Onefourth (24%) of PCPs and one-fourth (24%) of non-EP cardiologists perceived lead extraction as a procedure with high (6%-10%) or very high (>10%) risk of major complications.Finally, perceived risk of lead extraction was a major determinant of referral practices in 86% of respondents.

2 0 2 4 : 1 0 0 7 7 3
Contemporary Management of CIED InfectionA 2020 EHRA survey identified substantial gaps in the knowledge and skills of European physicians across all phases of CIED care.Comparing to the EHRA survey, our study shifts focus to U.S. physician groups to identify knowledge and skill gaps in an effort to understand the educational needs of both referring physicians and lead extractors in the United States.Although our survey from the ACC received responses from a slightly broader range of physicians (386 participants vs 336 EHRA survey participants), it mirrors the EHRA survey's overall results, highlighting similar deficiencies in guideline adherence and discrepancies between real-world management and guideline recommendations.Both surveys

FIGURE 2
FIGURE 2 Physician Responses to 3 Case Scenarios

J 4 Contemporary
A C C : A D V A N C E S , V O L . 3 , N O . 2 , 2 0 2 Management of CIED Infection F E B R U A R Y 2 0 2 4 : 1 0 0 7 7 3