Implanted cardiac electronic devices (CIEDs) play an invaluable and growing role in managing cardiac arrhythmias and preventing sudden death. However, CIED infections (CIED-I) are increasingly common, presenting a significant public health challenge worldwide. In this context, the early extraction of CIED leads may offer an effective solution to minimize the impact of these infections. This updated review examines the impact of CIED-I, provides treatment recommendations, and discusses potential improvements in their implementation:
- Epidemiology of CIED-I and Clinical and Economic Impact
The annual incidence of CIED-I is estimated between 1.2% and 3.4%. Studies like WRAP-IT and registries such as POINTED have significantly demonstrated that CIED-I negatively impacts quality of life and survival. Known risk factors, such as renal failure and immunosuppression, are highlighted, as well as less evident factors, such as being younger or receiving oral anticoagulant treatment.
The economic impact of CIED-I varies significantly depending on the geographic region. Globally, the average cost of a CIED-I can range from 15,000 to 60,000 USD, with most expenses attributable to hospital care.
- Clinical Outcomes
Optimal treatment for CIED-I includes antibiotic therapy and complete extraction of the infected device. Numerous studies have shown a high procedural success rate exceeding 95%, with complication rates below 4% and mortality rates under 1%. Conversely, antibiotic treatment without device extraction increases 30-day mortality sevenfold, and annual mortality nearly triples (40% compared to 14% when extraction is performed).
Furthermore, early device extraction has been associated with higher one-year survival rates compared to delayed extraction following antibiotic treatment failure, with survival rates around 15% for early extraction compared to 35% for delayed extraction. It is essential to note that patient cohorts with delayed extractions often include older individuals, those with frailty, or even those with terminal conditions, potentially complicating result interpretation. Finally, reinfection incidence is substantially lower when a complete system extraction is performed (1% compared to 50%).
- Clinical Guidelines and Real-World Practice Patterns
Current clinical guidelines, including those from the American Heart Association, the British Heart Rhythm Society, the European Society of Cardiology, the Heart Rhythm Society, and EHRA, recommend the complete extraction of the infected device in cases of local or systemic infection, bacteremia, or endocarditis, considering it a Class I indication. Additionally, three of these guidelines explicitly suggest early and complete CIED extraction upon infection diagnosis. However, U.S. Medicare data shows that over 80% of patients do not receive the recommended complete system extraction per Class I indication. Other relevant studies from Europe, covering a four-decade experience, indicate that just over half of patients undergo system extraction upon confirmed CIED infection.
- Barriers to Proper Guideline Adherence
A 2020 survey conducted by EHRA/ESC identified three main barriers limiting proper adherence to clinical guidelines for CIED-I management. First, inadequate identification or diagnosis of device infection, reflecting a lack of knowledge and skills among general practitioners to effectively diagnose this condition. Second, the difficulty of referring patients to appropriate centers due to distance or lack of access to reference centers. Lastly, it is crucial to highlight the barrier of assessing the feasibility of system extraction, especially in patients with multiple comorbidities, advanced age, or leads implanted many years ago. This situation creates an inappropriate perception of both the procedure risk and associated mortality, potentially leading to dismissal of cases that could be eligible for extraction.
- Strategies to Address Challenges in Proper CIED-I Management
One strategy involves incorporating an alert system in the patient’s electronic health record, enabling responsible physicians to activate the necessary mechanisms early and thus comply with guideline recommendations. Additionally, creating expert multidisciplinary teams, including specialists in infectious diseases and trained professionals for device extraction, is essential. This approach allows comprehensive management of CIED-I, enhancing the treatment’s efficacy and safety for these patients.
COMMENTARY:
This article focuses on reviewing the epidemiology, clinical, and economic impact of CIED-I on health systems. Some of the most relevant and clear findings from this review are the high success rate of early extraction procedures, as well as their low mortality and major complication rates, provided that the procedure is performed promptly and with the necessary resources. However, it also highlights the low adherence to guideline recommendations among healthcare professionals involved in CIED-I management. This issue is mainly due to difficulties in diagnosing CIED-I, inadequate patient referral to reference centers, and misconceptions about device extraction. It is crucial for all professionals involved in managing CIED-I to be informed and updated on best practices to ensure patient safety and treatment efficacy.
In Spain’s National Health System, we have solutions to optimize CIED-I management, as mentioned in this review. In most autonomous communities, electronic health records are available to facilitate early diagnosis and expedite referral for prompt extraction. Furthermore, many tertiary hospitals across the country have specialists dedicated to this pathology, facilitating referral from hospitals not equipped to perform extractions with maximum safety.
A previous study conducted at our hospital, published by Mosquera et al. several years ago, demonstrated the remarkable efficacy and safety of excimer laser-assisted transvenous lead extraction in high-risk patients, supporting the outcomes described in this review. This was only possible due to meticulous perioperative patient assessment and joint evaluation by all involved services (cardiologists, infectious disease internists, electrophysiologists, and cardiac surgeons), allowing for early detection and extraction in most cases. Additionally, a strict institutional protocol with a pre-established rescue surgical plan and comprehensive intraoperative invasive monitoring was implemented for each patient to minimize response time in case of major complications. Finally, all procedures were conducted in an operating room equipped for open or endovascular surgery, led by an experienced operator with immediate availability of extracorporeal circulation (ECC) surgery. These aspects are crucial to ensure the safety and effectiveness of the procedure in patients with CIED-I.
Although infected device extraction is a highly effective procedure, we must not overlook that, in some high-risk surgical patients—such as those with leads implanted for over eight years, significant frailty, or limited life expectancy—chronic antibiotic therapy may be an acceptable and effective option. Given the aging population and the projected increase in device implantations in the coming years, careful case-by-case evaluation will be essential, considering all available options before making the drastic and difficult decision not to extract the infected device in certain patients.
REFERENCE:
Lakkireddy DR, Segar DS, Sood A, Wu M, Rao A, Sohail MR, et al. Early Lead Extraction for Infected Implanted Cardiac Electronic Devices: JACC Review Topic of the Week. J Am Coll Cardiol. 2023 Apr 4;81(13):1283-1295. doi: 10.1016/j.jacc.2023.01.038.
Víctor X. Mosquera, Luisa Pérez-Álvarez, Yago Vilela-González, Enrique Ricoy-Martínez, Ignacio Mosquera-Pérez, Carlos Velasco-García, et al. Efficacy, safety, and predictors of complications in excimer laser-assisted cardiac lead extraction. REC CardioClinics 2019;54(1):33-40. doi: 10.1016/j.rccl.2019.01.015.
