The Diagnosis and Treatment of Pacemaker-Associated Infection
Background: Approximately 105 000 cardiac electronic devices are newly implanted in Germany each year. Germany has the highest implantation rate with respect to population of any European country. Infections in cardiac implants are serious complications, with an associated in-hospital mortality of 5–15%. It is thus very important to optimize the diagnostic and therapeutic strategies by which such infections can be detected early and treated effectively.
Methods: This review is based on pertinent publications retrieved by a search in PubMed, with special attention to the current recommendations of international medical specialty societies.
Results: According to the international literature, the incidence of device-associated infection is 1.7% (in six months) for implanted defibrillators and 9.5% (in two years) for resynchronization devices. No absolute figures on infection rates are available for Germany. Infection can involve either the site where the impulse generator is implanted or the intravascular portion of the electrodes. The most important elements of the diagnostic evaluation are: assessment of the local findings; pathogen identification by culture of peripheral blood, swabs of the infected site, or material recovered at surgery; and transesophageal echocardiography to detect endocarditic deposits on the electrodes or cardiac valves. The treatment consists of appropriate antibiotic administration and the complete removal of all foreign material. These special extractions are generally performed via the transvenous route. With the aid of various sheath systems, the procedure can be carried out safely and effectively, with a success rate above 95% and a complication rate below 3%. The indications for the implantation of a new device after eradication of the infection should be critically reassessed.
Conclusion: Untreated infection carries a high mortality. Evaluation and treatment according to a standardized clinical algorithm facilitate correct and timely diagnosis and the choice of an appropriate therapeutic strategy.
Cardiac implantable electronic devices (CIED), such as cardiac pacemakers (CP), implantable cardioverter defibrillators (ICD), and devices for cardiac resynchronization therapy (CRT), play an important role in the treatment of bradycardia arrhythmias, the prevention of sudden cardiac death, as well as in the treatment of heart failure (1). The annual number of new implantations in Germany has remained constant for years at around 105 000; however, at 356 ICD and 922 CP per 1 million inhabitants, more devices are being implanted in Germany than in any other European country (2–4) (eTable). This contrasts with the rising number of device replacements and revision procedures—most recently 50 000 per year—despite the fact that these are associated with a two- to four-fold increased risk of infection compared with primary implantation (3–7). Between 2004 and 2008, an increase was seen in the infection rate in the US from 1.53% to 2.41%, which can be explained by an expansion of ICD indications and an increasing number of implantations in patients with significant comorbidities (8). Furthermore, as a result of more frequent complex CRT implantations, a 57% increase in infections was observed between 2004 and 2006, whereas the rise in the number of devices implanted was only 12% (9). Although absolute numbers on infection rates in Germany are lacking, there too one is seeing a considerable rise in CRT device implantations and patient age, with 42% of CP and 12% of ICD recipients currently aged over 80 years (3–6) (eTable).
As a result of extravascular and intravascular segments, infections can affect the device, the leads, or native cardiac structures. The updated guidelines issued by international specialty societies provide clear recommendations on the diagnosis and treatment of CIED infections; nevertheless, in the authors‘ experience, delayed diagnosis occurs even in specialized hospitals due to the diverse clinical presentation of these infections (10, 11). Unclear inflammatory constellations in CIED wearers should always prompt suspicion of infection, since timely treatment can prevent local infection with a hospital mortality of 2–5% from progressing to a systemic infection with 6–15% mortality. (12–14, e1). A relevant patient history should be taken and local findings assessed as part of the periodic device checks every 4–6 months.
With only a few exceptions, all infections represent an indication to remove the device and all implanted leads, in addition to appropriate antibiotic therapy (10). Due to its high success rate of 96.7% at a complication rate of 1.7–1.8% and an intraprocedural mortality rate of 0.3%–0.4%, interventional transvenous extraction is favored above surgical extraction (15, 16).
The aim of this article is to summarize current standards on the diagnosis and treatment of CIED infections and to formulate recommendations on routine practice for physicians active in the in- and outpatient setting.
This article is based on a selective literature search in PubMed using the search terms “cardiac AND implantable AND electronic AND device AND infection,” “pacemaker AND infection” and “lead AND endocarditis.” Since 2010, 963 articles have been published, 84 of which were evaluated. In addition, recommendations issued by the international specialty societies as well as data from the authors‘ own literature collection are presented.
The risk of infection following implantation of a CP is 0.5%–1% in the first 6–12 months and rises with increasing complexity of the implanted device (17). The infection rate for ICD implantations is 1.7% in the first 6 months and, at 9.5% after 2 years, even higher for CRT implantations (18, 19). Compared with primary implantation, the risk of infection in the case of device replacement or revision procedures is between two- and four-fold higher (7). Infections occurring within the first year following implantation or revision are generally due to bacterial contamination at the time of surgery. It has been shown that 25% of infections occur early (0–28 days postoperatively), 33% late (between 28 days and 1 year postoperatively), and 42% in a delayed manner (>1 year after the initial procedure) (e2). The rising number of device replacements results in complex procedures in older patients, sometimes with considerable comorbidities and a marked increase in infection rates (Table 1) (8, 17, 18, 20, 21).
Presentation and pathogenesis
The clinical picture of device-associated infections is diverse. They may affect the infraclavicular site of device implantation in the form of localized pocket infections, or the intravascular segment of the leads in the form of device-associated endocarditis (Figure 1). According to the authors‘ estimate, localized infections account for the largest proportion (around 60%), and generally exhibit the classic signs of an inflammatory reaction at the implantation site, such as swelling, redness, and warmth. However, they can also follow a relatively mild course, thereby making diagnosis difficult (Figure 1a, Table 2) (22). Any swelling at the implantation site that is not in direct temporal conjunction with a surgical procedure is highly suspicious for infection. Perforation of the device through the skin equates to an infection as a result of subsequent colonization with skin bacteria (Figure 1b). Of the bacteria isolated, coagulase-negative staphylococci (42%–69%) and Staphylococcus aureus (14%–29%) are the most common pathogens; however, streptococci, enterococci, gram-negative bacteria, fungi, and anaerobes can also cause infections in rare cases. At 2.8%, the rate of methicillin-resistant Staphylococcus aureus (MRSA) is extremely low in Germany (25). Bacterial detection is not possible in 12%–21% of clinically diagnosed device-associated infections (14, e3).
Bacterial colonization generally occurs at the time of implantation or revision surgery and goes on to become apparent as an infection within several weeks to months. If pathogens along the leads penetrate the blood stream, device-associated endocarditis involving bacterial colonization of the intravascular segment of the leads can occur (Figure 1c). Secondary infection due to hematogenous spread of bacteria originating from another focus of infection is also possible but rarer. Biofilm formation on the leads makes it difficult for the immunological defense mechanism or administered antibiotics to reach the pathogens and explains why definitive treatment is only possible by removing the entire system (e4).
Systemic infections exhibit non-specific symptoms such as fever, chills, night sweats, malaise, and weight loss; septic shock is seen in less than 10% of patients (Table 2) (26). Infections involving the intravascular segment of the leads account for around 10% of all cases of endocarditis (27). Despite appropriate treatment, lead-related endocarditis is associated with a hospital mortality rate of 6%–15% and a 1-year mortality rate of 15%–23%, although no distinction can be made here between the effects of infection or concomitant comorbidities (12, 13, e5).
Taking blood cultures is essential; at least three sets (aerobic/anaerobic) should be collected at intervals of not less than 30 min prior to initiating antibiotic therapy (28). Wound swabs should be taken, but are sterile in 15% of cases (29). The process of puncturing a closed pacemaker pocket to collect samples is obsolete. Intraoperative swabs from the device pocket and tissue samples should be analyzed along with the tips of the explanted leads (e6).
Echocardiography plays a key role in diagnosis, since it is able to detect electrode or heart valve involvement, determine the size of vegetation, and quantify tricuspid valve insufficiency. Transthoracic echocardiography (TTE) is able to assess prognostic parameters such as reduced left ventricular pump function, increased pulmonary arterial pressure, and the presence of pericardial effusion. Transesophageal echocardiography (TEE), with its sensitivity of 96% and specificity of 90% for the detection of endocarditis vegetation on leads or heart valves, is significantly superior to the transthoracic examination (Figure1c) (e7). Both investigations should be performed in the case of suspected infection (11). Heart valve involvement is not limited to the triscupid valve—vegetation is additionally found on the aortic or mitral valve in 10%–15% of cases of device-associated endocarditis. An echocardiographic examination should be performed as promptly as possible within the first 24 h. Approximately 45% of CIED carriers in whom Staphylococcus aureus is detected in blood cultures have a device-associated infection, meaning that these patients should undergo TEE (e8). Recurrent bacteremia without identification of a clear source of infection also represents an indication for device explantation even in the absence of echocardiographic detection of vegetation (10).
Blood sampling and determination of leukocyte count, C-reactive protein (CRP), and erythrocyte sedimentation rate is mandatory, whereby laboratory inflammatory markers may be normal even if infection has been unequivocally detected. A procalcitonin (PCT) plasma level >0.05 ng/ml can predict localized infection with a sensitivity of 60% and a specificity of 82% (e9).
Positron emission tomography
In the case of clinical suspicion of CIED infection without guidance from echocardiographic or microbiological findings, 18-fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) (18-FDG-PET-CT) can help to establish the diagnosis (30). This examination is also suited to detecting septic embolism in patients with device-associated endocarditis or detecting the primary source in hematogenously infected devices (e10). The routine use of 18-FDG-PET-CT in suspected device-associated infection is not recommended (Figure 1d).
Treatment recommendations can be found in the current guidelines, whereby only a handful of randomized studies are available, meaning that recommendations are largely based on expert opinions (10).
A superficial wound infection that appears less than 30 days postoperatively, does not extend to the device, and shows no signs of systemic infection can be treated with 7- to 10-day antibiotic therapy alone. At 80%, the success rate for this antimicrobial therapy is high (31). Initial empirical antibiotic therapy in superficial infections of this kind, as well as isolated local pocket infections, should be initiated immediately following sample collection, cover the usual bacterial spectrum, and take local resistance into consideration, particularly with regard to MRSA prevalence. The treatment of device-associated endocarditis is based on the recommendations of the European Society of Cardiology (28). It is mandatory to adjust treatment following pathogen identification in swabs, surgical material, or blood cultures. The duration of antibiotic therapy depends on the severity and type of infection, as well as on the causal bacteria (Figure 2).
Transvenous lead extraction
Any infection involving the device and/or intravascular lead segments represents an indication for complete removal of all foreign materials (10, 32). At 38.2%, the 1-year mortality rate in patients receiving antibiotic therapy only for device-related endocarditis is almost twice as high as the rate with device explantation (19.9%) (12). Delayed device explantation following initial unsuccessful antibiotic therapy is also associated with a three-fold higher 1-year mortality rate compared with immediate explantation (13). Transvenous extraction of leads with less than 1 year dwell time is generally possible with simple traction.
When extracting older leads, tools such as locking stylets, a variety of extraction sheaths, and snares are used. Locking stylets are special mandrels coated with a thin wire mesh that are introduced into the central working channel of the lead. Expanding the wire mesh within the lead both stabilizes and lengthens the lead, thereby creating the appropriate conditions for the use of sheath systems (eFigure a). A variety of sheath systems can be used:
- Mechanical polypropylene sheaths that disrupt adhesions in the lead when rotated gently (eFigure b).
- An active extraction sheath with a metal thread and blade at the tip that can be rotated in a controlled manner by pressing a release handle, thereby cutting the lead free (eFigure c).
- Laser sheath: a flexible plastic sheath with optically conductive fibers that is brought over the lead. When activated, the laser cuts the lead on the diode ring at the metal tip of the sheath in a circular fashion
The primary access selected for lead extraction is via the device pocket located in the infraclavicular region. If lead extraction is not possible from the implantation site, a femoral or jugular approach may be helpful (eFigure d) (22). Due to the potential for complications, procedures should only be performed in centers with a cardiac surgery unit, where they can be safely carried out with a high success rate (complete system removal in >95%) and a low surgical complication rate (16, 33). It has been shown that, in hospitals that perform fewer than 30 lead extractions per year, more complications occur (4.1% versus 2.4%; p = 0.0146), the success rate is lower (94.3% versus 97.3%; p = 0.0001), and mortality is higher (2.5% versus 1.2%; p = 0.0088) over the course of the inpatient stay (15).
The most frequent severe complication is myocardial injury (0.9%) followed by cardiac tamponade, which can be treated with pericardial puncture or surgical suturing of the perforation site. The most feared complication, superior vena cava laceration, occurs in 0.6% of cases and is associated with a mortality rate of >40% even in the case of immediate surgical treatment (15, e11). There is evidence that, by using a novel endovascular balloon catheter that occludes the vessel wall lesion, valuable time can be gained and mortality reduced from 50% to 0% (34). The overall perioperative mortality rate for interventional lead extraction is 0.5% (15).
Temporary stimulation in pacemaker-dependent patients by means of an external pacemaker connected to a percutaneously inserted right ventricular lead is required and safe until antibiotic therapy is completed and a new device is implanted (35). Microbiological analysis of lead tips and swabs obtained intraoperatively is absolutely essential in order to be able to initiate targeted antibiotic therapy in the case of pathogen detection.
Due to the risk of fulminant pulmonary embolism, open surgical extraction should be considered in the case of large vegetations (>20 mm) and is indicated if there is already a surgical indication due to valve endocarditis (36). As possible focuses of infection, implanted devices and leads should be removed during surgery for heart valve endocarditis, irrespective of whether they show signs of infection (10).
The indication for renewed implantation needs to be reviewed critically using long-term ECG or telemetry monitoring, since 14%–33% of patients do not require a new device to be implanted following lead extraction. The most frequent reasons for this include: the criteria no longer being met for the original indication, inappropriate initial indication, or patient preference (23, 37). If re-implantation is indicated, this is performed on the contralateral side to the previous explantation. Novel forms of treatment such as subcutaneous defibrillators or intracardiac pacemakers should be considered and used where appropriate. The timing of re-implantation depends on the severity of infection as well as the responsible bacterium and can only be performed once adequate antibiotic therapy has been completed (Figure 2).
Prevention of device-associated infection
Risk factors for the development of device-associated infection (Table 1) need to be minimized preoperatively. Preoperative antibiotic prophylaxis significantly reduces the infection rate and, as such, should be administered in all procedures (31). An absorbable antibacterial envelope that encases the device and extravascular leads and releases antibiotics to the surrounding tissue showed a risk reduction of 71% for the development of infection in a meta-analysis (38). This envelope should be deployed particularly in procedures with high risk of infection, such as device replacement or other revision procedures (e12). Drug prophylaxis for infective endocarditis in procedures bearing a potential risk for bacteremia is not recommended in CIED patients (28).
CIED infections are becoming ever more frequent and, without adequate treatment, are associated with high mortality. Diagnosis can be challenging due to the diverse clinical picture of infections and one always needs to rule out involvement of other cardiac structures. Definitive treatment consists of complete removal of the entire system, which can be performed safely and successfully in specialized centers using a transvenous approach. Device re-implantation is not necessary in all patients; however, when required, it should be carried out on the contralateral side following adequate antibiotic therapy over a sufficiently long period of time
Conflict of interest statement
Prof. Hindricks received consultancy fees from Abbott, Biosense Webster, and Biotronik. He received third-party funding from Biotronik, Boston Scientific, and Abbott.
PD Richter was reimbursed for congress participation fees as well as travel and accommodation costs by Biotronik and Cook Medical. He received third-party funding from Biotronik, Boston Scientific, and Abbott.
Dr. Döring was reimbursed for congress participation fees as well as travel and accommodation costs by Biotronik and Cook Medical. He received third-party funding from Biotronik, Boston Scientific, and Abbott.
Manuscript received on 28 September 2017, revised version accepted on 5 March 2018.
Translated from the original German by Christine Schaefer-Tsorpatzidis.
Dr. med. Michael Döring
Abteilung für Rhythmologie, Klinik für Kardiologie
04289 Leipzig, Germany
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