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Surgical Treatment of Pacemaker and Defibrillator Lead Endocarditis^*

The Impact of Electrode Lead Extraction on Outcome

Ana del Río, MD; Ignasi Anguera, MD; José M. Miró, MD, PhD; Lluis Mont, MD, PhD; Vance G. Fowler, Jr, MD, MHS; Manel Azqueta, MD and Carlos A. Mestres, MD; the Hospital Clínic Endocarditis Study Group

^* From the Hospital Clínic (Drs. del Rio, Miró, Mont, Azqueta, and Mestres), Institut d’Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain; Hospital de Sabadell (Dr. Anguera), Barcelona, Spain; and Duke University Medical Center (Dr. Fowler), Durham, NC. A list of participants is given in the ^Appendix.

Correspondence to: José M. Miró, MD, PhD, Division of Infectious Diseases, Hospital Clínic Universitari, Villarroel, 170, 08036, Barcelona, Spain; e-mail: miro{at}medicina.ub.es

	Abstract

TOP Abstract Introduction Materials and Methods Results Discussion Conclusions Appendix References

 
Background: Cardiac device (CD) endocarditis is an infrequent but potentially lethal infectious complication of permanent pacemakers or implantable cardioverter-defibrillators (ICDs), and mortality rates of 30 to 35% have been reported. Medical treatment has been suggested for the treatment of CD endocarditis, but there is increasing evidence that surgical treatment is to be preferred as the best approach to achieve eradication of the infection and reduce mortality.

Objective: To evaluate the following: (1) the clinical and echocardiographic characteristics of patients with pacemaker or ICD endocarditis, (2) the outcome of this population depending on the mode of treatment (medical vs surgical treatment), and (3) the clinical, microbiological, echocardiographic, and therapeutic variables associated with patient outcome.

Design: Prospective cohort study.

Setting: Tertiary referral center in Barcelona, Spain.

Patients: All consecutive patients with infectious endocarditis (IE) admitted to the study institution between 1990 and 2001 were prospectively evaluated by a multidisciplinary treatment team, and a definite diagnosis of CD endocarditis was established when cases met pathologic or clinical criteria according to the Duke criteria.

Results: A total of 31 patients, 25 men and 6 women aged 61 ± 15 years (mean ± SD), with pacemaker or ICD endocarditis were identified among 669 consecutive patients (4.6%) with IE. During the study period, a total of 3,768 pacemakers and 460 ICDs were implanted in the study institution. In 22 cases of pacemaker endocarditis, the pacemaker was implanted in our institution, and 9 cases were referred from other institutions (incidences of endocarditis on pacemaker and ICD implanted in our institution of 0.58% and 0.65%, respectively). Medical treatment without removal of the pacing system was initially performed on seven patients; all of them (100%) had relapses of endocarditis, and one patient died. The remaining 24 patients underwent surgical removal of the pacing system; 1 patient had one relapse, 3 patients died after surgical treatment, and the others were successfully cured with no relapses after a mean follow-up of 38 ± 9 months. Clinical, echocardiographic, microbiological, and therapeutic variables were evaluated in association with prognosis. The only prognostic factor for failure of treatment or mortality was the absence of surgical treatment (p < 0.0001).

Conclusions: Electrode lead endocarditis occurred in < 1% of pacemaker and ICD implants. Conservative treatment without explantation of all hardware failed in all patients, and surgical treatment during antibiotic therapy was effective in eradication of infection but was associated with a 12.5% mortality. The only patient characteristic associated with treatment failure or death was the absence of surgical removal of all infected hardware. Complete extraction of the pacemaker or ICD should be considered as standard therapy for most patients with CD endocarditis.

Key Words: defibrillator • electrode lead • infective endocarditis • pacemaker • treatment

	Introduction

TOP Abstract Introduction Materials and Methods Results Discussion Conclusions Appendix References

 
The clinical use of cardiac devices (CDs) has grown considerably over the past 2 decades.^{1 2} A growing list of indications for permanent pacemakers and implantable cardioverter-defibrillators (ICDs) and the increase in the geriatric population mean that more patients undergo pacemaker and ICD surgery; therefore, there is a larger population at risk of infection.

CD infective endocarditis (IE) is an infrequent but potentially lethal infectious complication of pacemaker and ICD therapy. Infection of the pacemaker pouch and wire may occur in 1 to 7% of implanted pacing systems,^{3 4} and mortality rates in CD endocarditis have been reported to be 30 to 35%.⁵ Risk factors for CD endocarditis include chronic conditions such as diabetes mellitus, malignancies, immunosuppressive therapy, and local factors related to the pacing system such as erosion of the pacemaker pouch, and the number of previously inserted leads, etc.³ Despite advances in diagnostic approaches, treatment of CD endocarditis is still controversial. Medical treatment has been reported to be successful in some cases,^{6 7 8 9 10 11 12} but there is increasing evidence that the entire pacing system should be removed to achieve complete infection eradication.^{13 14 15 16 17} However, most studies have been retrospective and have included few patients, and there are no controlled studies comparing medical vs surgical treatment; therefore, we designed a prospective study to identify all consecutive cases of pacemaker and ICD endocarditis over a decade. The purpose of this study is to describe the following: (1) the clinical and echocardiographic characteristics of pacemaker and ICD endocarditis, (2) the outcome of this population depending on the mode of treatment (conservative therapy vs surgical explantation of all hardware during antimicrobial therapy), and (3) the clinical, microbiological, echocardiographic, and therapeutic variables associated with patient outcome.

	Materials and Methods

TOP Abstract Introduction Materials and Methods Results Discussion Conclusions Appendix References

 
Study Patients
All patients admitted to our tertiary referral center with IE between 1990 and 2001 were prospectively evaluated by a multidisciplinary treatment team. The multidisciplinary team for diagnosis and treatment of IE involves staff members from infectious disease, anatomic pathology, microbiology, and cardiovascular departments (see ^Appendix). Regular meetings of this treatment team served to include all patients who received a diagnosis at the study institution, and served to be certain that no cases were missed. Data were collected prospectively into an institutional protocol using a designed questionnaire for clinical, microbiological, echocardiographic, therapeutic, and follow-up variables; all data were stored in a database. The study institution is a tertiary referral center for complicated endocarditis, including antiarrhythmic device endocarditis, with a catchment area of 750,000 inhabitants. The study was approved by the ethics committee.

Diagnostic Criteria of Endocarditis
Pacemaker or ICD endocarditis were defined according to criteria suggested by Duke investigators,¹⁸ and only definite cases were included in the study. Because pacemakers and transvenous ICDs are structurally similar, patients with infection involving either of these devices were included in the present report. A definite diagnosis of CD endocarditis was established when cases met pathologic or clinical criteria according to the Duke criteria.¹⁸

Early onset endocarditis was defined as infection occurring < 12 months after implantation, and late-onset endocarditis was defined as infection > 12 months from implantation. An infected anatomic site was considered to be the source of bacteremia if consistent focal manifestations preceded the diagnosis of bacteremia and the microorganisms were recovered from adequate site specimens.

Echocardiographic Definitions
Results of two-dimensional transthoracic echocardiography (TTE) [Toshiba SSH-65A; Toshiba Corporation; Tokyo, Japan; and Sonos 1000, 2500, and 5500; Hewlett-Packard; Boston, MA] were routinely evaluated in each patient. Since 1992, transesophageal echocardiography (TEE) using monoplane or multiplane transducers was performed in all cases of suspected antiarrhythmic device endocarditis. Vegetations were defined as circumscribed masses or clumps of echoes that arose from leaflet tips or electrode leads, either as an irregular area of highly reflective leaflet thickening or as more discrete, pedunculated masses in the setting of electrode lead infection confirmed by imaging in more than one echocardiographic plane. Vegetations were measured at the point of maximal thickness in two orthogonal dimensions.¹⁹ To identify valvular involvement, clinical, echocardiographic, operative, and autopsy data were used.

Microorganisms and Antibiotic Therapy
Microorganisms were identified using standard criteria. Antibiotic susceptibility testing was performed by broth microdilution method and interpreted using standard methods.²⁰ All patients received antimicrobial therapy according to the etiologic microorganism and its antimicrobial susceptibility test and the recommended antimicrobial therapy for IE.^{21 22} Decisions regarding medical and surgical therapy were made by the treating physicians independent of the current descriptive investigation. Antibiotics were administered IV for 4 to 6 weeks in all episodes. Treatment of methicillin-susceptible Staphylococcus aureus and coagulase-negative staphylococci infection included cloxacillin (during 4 to 6 weeks) plus gentamicin (during 5 to 7 days); treatment of methicillin-resistant S aureus and coagulase-negative staphylococci infection included vancomycin plus gentamicin and rifampin.

Surgical Treatment
Surgical treatment was not randomized, and the decision to remove the pacing system was based on the judgement of the multidisciplinary treatment team. The indication for surgery during the active phase was considered in all cases with definite diagnosis, following standard recommendations.^{23 24} Percutaneous extraction of the electrodes was achieved by manual traction; when the operator felt a highly fixed electrode in the endocardium, special locking stylets were used. Factors that favored surgical treatment with cardiopulmonary bypass (CPB) were increased vegetation size and the time interval from implantation to diagnosis of definitive endocarditis. Electrode lead extraction under CPB was considered in cases of long-term leads (> 12 months from implantation) or in cases of more than two leads. In cases of large vegetations with possibly higher embolic risk, patients were submitted to surgical removal of the entire pacing or defibrillating system with open-heart surgery and CPB. Temporary transvenous pacemakers were inserted after the operation for pacemaker-dependent patients, and new definitive pacemakers were again implanted approximately 2 weeks after surgery in both dependent and nondependent pacemaker patients.

Statistical Analysis
To preserve the independence of observations, only the initial episodes of CD endocarditis were included in the study. Data were processed with the BMDP statistical package (BMDP Statistical Software; Los Angeles CA). Clinical manifestations, echocardiographic findings, antimicrobic susceptibility, and mode of treatment for patients with and without adverse outcomes were compared with Student t test for continuous variables and the Fisher exact test for categorical variables. Failure of treatment (clinical relapse of CD endocarditis) and mortality were defined as adverse outcomes. The relation of covariates with failure of treatment or mortality was assessed by univariate analysis, and odd ratios (ORs) were then determined with a simple logistic regression model. ORs and 95% confidence intervals (CIs) were calculated with Stata Statistical Software, Release 6 (Stata Corporation; College Station, TX). Differences were considered significant only when two-sided p values were < 0.05. The McNemar test was used to compare TTE and TEE in the detection of cardiac vegetations.

	Results

TOP Abstract Introduction Materials and Methods Results Discussion Conclusions Appendix References

 
Demographic Characteristics
A total of 31 of 669 consecutive patients (4.6%) with IE (6 women and 25 men, aged 61 ± 15 years [mean ± SD]) with bacteriologically proven CD endocarditis were identified over a decade (Table 1 ). Infections of permanent cardiac pacemakers were observed in 28 patients (12 single chamber and 16 dual chamber); in 3 patients, infection was on a single-lead ICD. During the study period, a total of 3,768 pacemakers and 460 ICDs were implanted in our institution. In 22 cases of pacemaker endocarditis, the pacemaker was implanted in our institution and 9 cases were referred from other institutions (incidences of endocarditis on pacemakers and ICDs implanted in our institution were 0.58% and 0.65%, respectively). Cultures of the removed wire yielded the causative pathogen in all but one case. All patients had two or more positive blood culture results. Eleven patients (35%; 2 women and 9 men, aged 62 ± 18 years) had early onset infection (mean, 5 months; range, 1 to 10 months) after implantation; 20 patients (65%) had late-onset infection (4 women and 16 men, aged 60 ± 16 years). Late-onset IE developed after a mean 65 months from primary implantation, and 35% had undergone previous surgical manipulation in the pacing system, principally replacement of an exhausted battery generator (17% < 3 months before endocarditis, 50% between 3 months and 9 months, and 33% > 1 year before endocarditis). All electrode leads had been transvenously implanted, and 17 patients (55%) had two or more electrodes. The mean number of electrodes was 1.7 per patient. Pocket erythema with pain, skin erosion, cutaneous ulcer, or purulent draining sinus from the pocket generator could be determined as a source of infection in seven patients (23%).

	Discussion

TOP Abstract Introduction Materials and Methods Results Discussion Conclusions Appendix References

 
Infections of implantable antiarrhythmic devices may range from 0.2 to 12% and are considered as serious complications of pacing therapy because of the inherent difficulties in the management of CD endocarditis and the adverse outcome. The incidence of pacemaker- and ICD-related infections has been reported as between 0.5% and 12% in the past; in more recent publications, the incidence is < 5%.^{3 25 26} The present investigation found an incidence of endocarditis on pacemakers and ICDs of 0.58% and 0.65%, respectively, which is in the range of reported values.^{3 4}

The Role of Echocardiography
TTE may identify lead vegetations, but it has not been established as a major diagnostic criteria for CD endocarditis due to its low sensitivity.¹⁵ TEE allows the exploration of the entire pacing system from the superior vena cava to the right ventricle. Our study did not differ from previous publications in which detection of lead vegetations increased from sensitivities of TTE in the range of 22 to 30% to sensitivities of approximately 95% with the use of TEE^{14 15 17 27} ; however, TEE appears to be of limited additive value in the detection of tricuspid valve vegetations. We observed no statistical differences between TTE and TEE in the detection of tricuspid valve vegetations (Table 2) . Our results confirm previous observations that TEE does not improve the diagnostic accuracy of TTE in the detection of vegetations associated with right-sided endocarditis.²⁸

Microbiology
Positive blood culture results have been found in 80 to 100% of pacemaker-related endocarditis.^{9 14 27 29} In our study, cultures of the removed wire yielded the causative pathogen in all but one case, and all patients had two or more positive blood culture results. The most frequently detected causative microorganisms were staphylococci (coagulase-negative staphylococci in 48% of cases, and S aureus in 29% of cases). Previous reports^{5 6 9 14 15 17 30 31 32} documented similar microbiologic findings. Early onset infection is associated with infection by S aureus, and the most common portal of entry is the subcutaneous site of implantation of the pacemaker. By contrast, late infections are caused predominantly by coagulase-negative staphylococci, and infection tends to have a more indolent course related to the low virulence of this organism. Staphylococci seem to be particularly capable of adhering to and forming microcolonies on the polyethylene or silicone rubber sheaths covering the electrodes. Infection caused by Gram-negative microorganisms, fungae, anaerobic bacteria, and multiple microorganisms have seldom been reported.^{6 14 30 31 33}

Data^{33 34} suggest the hypothesis that CD endocarditis is mainly caused by local contamination during the implantation procedure. Hematogenous colonization of the pacemaker conducting system during the course of a bacteremia from a distant focus has rarely been demonstrated since the pacing system is rapidly covered by neoendothelium and fibrous tissue, which prevents the foreign surface from being coated by microorganisms. Hematogeneous seeding of the device from distant sites of infection has been reported, but with the exception of S aureus bacteremia appears to be rare.^{3 9} In our study, all patients were bacteremic with fever and positive blood culture results. Among the 65% of patients with late-onset endocarditis, no previous manipulation of the pacing system had been performed, and hematogeneous seeding of the device was presumed to be the mode of colonization of the system. In one study³⁴ of 21 patients with S aureus bacteremia occurring a year or more after device placement, 29% acquired a subsequent device infection. By contrast, 35% of the patients from this study had early onset infection, and 35% of patients with late-onset infection had a previous surgical manipulation of the pacing system (replacement of an exhausted battery generator). This fact has clinical implications for the reduction of the incidence of CD endocarditis and reinforces the value of antibiotic prophylaxis during all types of surgical manipulation of the pacing system (including replacement of generators). In a recent meta-analysis by Da Costa et al,³⁵ systemic antibiotic prophylaxis at the time of insertion of permanent pacemakers or replacements showed a consistent protective effect reducing the incidence of pocket infections and pacemaker endocarditis.

Treatment of CD Endocarditis
Management of CD-related infection is based on a combined approach using both antimicrobial agents with surgical eradication. The results of this investigation demonstrate that patients with CD endocarditis should undergo extraction of the device and leads, followed by a course of IV antibiotics and device reimplantation at another site during a delayed surgical procedure if indication for pacing or defibrillation persists. Our study found a statistically significant difference in successful outcomes with surgical treatment as opposed to medical treatment. Patients treated medically had a mean of 1.6 relapses per patient until they underwent surgical treatment. Patients treated with surgery were more likely to have absence of recurrences or mortality than medically treated patients (p < 0.0001). No other demographic, clinical, echocardiographic, or microbiological variables were associated with adverse outcome (Table 5) . The most widely recommended approach for generator-pocket infection is removal of the entire pacing system, which achieves the highest rates of cure,^{31 32} but electrode infections generally require removal of the system. Following implantation of cardiac antiarrhythmic devices, the generator pocket and intravascular lead become encased in dense layers of endotheliazed fibrous tissue, so that infection is complicated by lack of penetration of antimicrobial agents into the avascular matrix, necessitating removal of some or all of the components to eradicate infection. Attempts at a conservative approach, including combined bactericidal antibiotics and local debridement techniques, not only failed to cure CD-related infections, but were also responsible for higher mortality rates.^{5 6 9 15 16 30 31 34 36} Some authors^{11 12 16} have advocated a conservative approach consisting of antibiotic therapy with hardware in place or partial device removal. Partial device removal is likely to be sufficient only when infection is limited to the removed component, and it is aimed to avoid invasive surgical procedures in debilitated individuals; however, most large studies^{6 9 15 16 17} suggest that complete removal of all parts of an infected device is necessary to achieve a definitive cure in CD endocarditis.

Klug et al¹⁷ suggested that vegetations > 10 mm may be removed by percutaneous lead traction without a significant increase in subsequent pulmonary embolic complications; they also suggested that the indication for percutaneous removal should be expanded to include larger vegetation sizes. In our study, percutaneous removal was performed in vegetations up to 23 mm in length without any associated complications, although these have been reported in the literature.¹⁷ Removal of the material involves technical difficulties. Removal of the leads or electrodes may not be possible by percutaneous traction, and damage of the myocardium or tearing of the tricuspid valve may result as electrodes become imbedded over time. Extraction of the leads remains difficult and may require an invasive surgical approach, including sternotomy with or without extracorporeal circulation.³⁶

Timing from pacemaker implantation to diagnosis of endocarditis is another variable that may favor surgical removal of the electrode system with CPB. Within several months of implantation (usually < 12 months), extraction may be accomplished by simple manual traction; after 12 months from implantation, the use of locking stylets has been proposed be the method of choice.³⁷ Chronic electrode tips are attached to the right ventricular endocardium and are embedded in a dense fibrotic plaque, making electrode removal by direct traction dangerous. In our study, percutaneous traction was carried out in patients with an implantation to diagnosis of endocarditis interval up to 106 months. There were neither deaths nor failures of eradication of the infection among the 12 patients with late-onset endocarditis treated with percutaneous removal of the electrode (mean implantation to diagnosis, 65.5 ± 41 months; range, 21 to 106 months). Five patients in this study underwent surgical removal of the electrode with CPB, with a mean of 99 ± 96 months from implantation to diagnosis of endocarditis (range, 1 to 240 months). Mortality in this subgroup was 40% (two of five patients).

The number of implanted electrodes (recent implants or long-term electrodes) is a further fact that may favor surgical treatment with CPB. In this study, two patients with three and four electrodes, respectively, were treated with surgical excision of the pacing system under CPB, with one of two deaths (50%). Direct counter traction was performed in all but three patients with two or fewer electrodes in patients surgically treated. Mortality in this group was only 1 of 22 patients (4.5%).

Study Limitations
The first limitation of this study is the size of the population studied, its nonrandomized nature, and the low number of patients. Secondly, therapeutic management was based on the judgement of the physicians involved, including the multidisciplinary team for the diagnosis and treatment of endocarditis and varied according to individual patient characteristics. Therefore, comparison of different surgical options is difficult.

	Conclusions

TOP Abstract Introduction Materials and Methods Results Discussion Conclusions Appendix References

 
Electrode lead endocarditis occurred in < 1% of pacemaker and ICD implants. Conservative treatment without explantation of all hardware failed in all patients, and surgical treatment during antibiotic therapy was effective in eradication of infection but was associated with 12.5% mortality. The only patient characteristic associated with treatment failure or death was the absence of surgical removal of all infected hardware. Complete extraction of the pacemaker or ICD should be considered as standard therapy for most patients with CD endocarditis.

	Appendix

TOP Abstract Introduction Materials and Methods Results Discussion Conclusions Appendix References

 
Members of the Hospital Clinic Endocarditis Study Group of the Hospital Clinic, Institut d’Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain include the following: Miró JM, del Río A, de Benito N, Claramonte X, Baraldes MA, Jimenez-Alzate MP, Díaz ME, Soriano A, Moreno A, Gatell JM (Division of Infectious Diseases); Marco F, García de la María C, Armero Y, Almela M, Jiménez de Anta MT (Department of Microbiology); Paré JC, Azqueta M, Mestres CA, Sitges M, Mont LL, Ninot S, Cartañá R, Pomar JL (Cardiovascular Institute); De Lazzari E (Epidemiology and Biostatistics Unit); and Ramírez J, Ribalta T, Pérez N (Department of Anatomical Pathology); and Anguera I, Gumá JR (Hospital de Sabadell).

	Acknowledgements

 
We thank María Antonia Rodríguez Jové for technical assistance, and Fundación Privada Máximo Soriano Jiménez for the grant supporting the Hospital Clínic Endocarditis database.

	Footnotes

 
Abbreviations: CD = cardiac device; CI = confidence intereval; CPB = cardiopulmonary bypass; ICD = implantable cardioverter-defibrillator; IE = infective endocarditis; TEE = transesophageal echocardiography; TTE = transthoracic echocardiography

This work has been supported in part by the Red Española de Investigacíon en Patología Infecciosa (V-2003-REDC14A-0).

Dr. Miró was a recipient of a research grant from the Institut d’Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.

Received for publication October 18, 2002. Accepted for publication February 18, 2003.

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