Lead Management and Extraction
Advay G. Bhatt
Over the previous 20 years, there was a dramatic increase in the rate of cardiac implantable electrophysiologic devices (CIEDs) utilization initially due to the development of implantable cardioverter-defibrillators (ICDs). The rate of implantation accelerated with several large landmark clinical trials showing mortality benefits for primary prevention ICDs and cardiac resynchronization therapy (CRT) in at-risk populations (Fig. 13-1). Moreover, demographic shifts and advances in medical care led to aging and greater life expectancy of the general population.
Between 1993 and 2008, CIED implantation nearly doubled with pacemaker and ICD implantation increasing nearly 50% and 500%, respectively.
Between 1993 and 2008, CIED implantation nearly doubled with pacemaker and ICD implantation increasing nearly 50% and 500%, respectively.
 Figure 13-1 Annual CIED implantation. CIED, cardiac implantable electrophysiologic device; ICD, implantable cardioverter-defibrillator. |
CIED implantation with increasing device complexity and more expansive indications in an aging and increasingly sick population who are living longer have contributed to a confluence of iatrogenic issues associated with a rising rate of device infections, lead or generator malfunction or recalls, and venous occlusion that require lead management and extraction techniques.
The goal of this chapter is to summarize the recommendations for extraction, lead design concepts as they pertain to lead recall advisories, and lead management and extraction techniques.
LEAD INFECTION
EPIDEMIOLOGY
The annual rate of CIED infection remained relatively constant until 2004 after which there was a marked increase from 1.5% in 2004 to 2.4% in 2008 that coincided with the observed increases in ICD utilization. At the same time, the incidence of comorbid conditions increasing the risk of infection such as renal failure, respiratory failure, heart failure, or diabetes mellitus increased dramatically in the CIED population.
RISK FACTORS FOR CIED INFECTION
The risk of CIED infection is related to several host, procedure, and operator-related factors that are shown in Table 13-1.
TABLE 13-1 Risk Factors for CIED Infection | ||||||||||||||||||
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MICROBIOLOGY
The most common pathogen for CIED infection is Staphylococcus, which accounts for greater than two-thirds of all infections (Fig. 13-2).
Coagulase-negative staphylococcal bacteremia was historically thought to be a skin contaminant but in fact accounts for 42% of all CIED infections. Accordingly, any staphylococcal infection should not be underestimated and prompt more detailed evaluation for lead endocarditis or pocket infection.
CLINICAL AND ECONOMIC CONSEQUENCES
CIED infection is associated with higher mortality, both inpatient and long-term, and increased financial costs. The inpatient mortality ranges from 5% to 10% depending on the type of device and long-term mortality is 25% to 35% despite appropriate management of CIED infection.
The treatment costs of a single case of CIED infection approached $150,000 by 2009 with 40% to 50% of the cost due to the need for intensive and critical care.
CLINICAL SIGNS AND SYMPTOMS
The physical examination and laboratory abnormalities associated with CIED infection are less reliable and specific in isolation and therefore any bacteremia in the presence of CIED merits careful evaluation.
The presence of systemic signs of infection such as fever, chills, hypotension, murmur, heart failure, malaise, anorexia, and nausea occur in less than half of reported cases of CIED infection. Local findings at the generator implant site are more
prevalent with erythema, swelling, or deep pocket purulence noted in 67% to 80%; local pain or drainage both occur in half of cases (Fig. 13-3).
prevalent with erythema, swelling, or deep pocket purulence noted in 67% to 80%; local pain or drainage both occur in half of cases (Fig. 13-3).
 Figure 13-2 Microbiology of CIED infections. CIED, cardiac implantable electrophysiologic device. |
 Figure 13-3 Local signs of pocket infection. |
Leukocytosis or positive blood cultures are observed in approximately 40% of cases. Elevated erythrocyte sedimentation rate is seen in only 25% of cases. Anemia is the most frequent lab abnormality and is seen in 50% of cases but is not specific.
INDICATIONS LEAD EXTRACTION FOR CIED INFECTION
Recommendation for Extraction with CIED Infection:
Valvular or lead endocarditis or sepsis with definite CIED infection
Local abscess, device erosion, skin adherence, or chronic draining sinus indicating pocket infection
Valvular endocarditis without definite CIED infection
Occult gram-positive bacteremia
Occult gram-negative bacteremia
MANAGEMENT OF SUSPECTED CIED INFECTION
In cases of suspected CIED infection, the first step is to obtain blood cultures prior to administration of any empiric antibiotics. The duration of antibiotics is counted from the day of device extraction (Fig. 13-4).
If blood cultures are negative and there are signs of pocket infection or erosion, the standard of care is to treat with antibiotics for 7 to 14 days after device extraction.
If blood cultures are positive, then organism-specific antimicrobial therapy should be instituted and a transesophageal echocardiogram performed. The presence of
valvular or lead vegetations necessitates treatment per infective endocarditis guidelines. The absence of vegetations prompts treatment for 2 to 4 weeks with Staphylococcus aureus or 2 weeks for non-S. aureus infections. The duration of treatment may be extended beyond 4 weeks if metastatic infectious complications are present.
valvular or lead vegetations necessitates treatment per infective endocarditis guidelines. The absence of vegetations prompts treatment for 2 to 4 weeks with Staphylococcus aureus or 2 weeks for non-S. aureus infections. The duration of treatment may be extended beyond 4 weeks if metastatic infectious complications are present.
 Figure 13-4 Algorithm for management of CIED infection. CIED, cardiac implantable electrophysiologic device; TEE, transesophageal echocardiography. (Modified from Sohail MR, Uslan DZ, Khan AH, et al. Management and outcome of permanent pacemaker and implantable cardioverter-defibrillator infections. J Am Coll Cardiol. 2007;49(18):1851-1859, with permission.) |
 Figure 13-5 Algorithm to guide timing of CIED reimplantation. CIED, cardiac implantable electrophysiologic device; TEE, transesophageal echocardiography. (Modified from Sohail MR, Uslan DZ, Khan AH, et al. Management and outcome of permanent pacemaker and implantable cardioverter-defibrillator infections. J Am Coll Cardiol. 2007;49(18):1851-1859, with permission.) |
There is divergent opinion regarding the safety of transvenous lead extraction in the presence of vegetations in excess of 2 cm. Many feel that this can be accomplished with an acceptable risk, but others feel that open removal and debridement is safer and more effective. The concern is that any vegetation may embolize during a transvenous extraction procedure causing a large pulmonary embolism or showering innumerable small septic emboli to the lungs causing cardiopulmonary decompensation.
An emerging modality to evaluate for the presence of lead endocarditis or deep versus superficial infection is FDG-PET. The scan is relatively expensive and exposes patients to radiation but may be considered given the importance of establishing an appropriate diagnosis.
Figure 13-5 describes when CIED device reimplantation would be considered appropriate following device extraction.
LEAD DESIGN AND RECALLS
Lead design must factor in significant electrical, thermal, mechanical, and chemical/oxidative stress (Table 13-2). From an engineering, material science, and process
management perspective, these are remarkable devices with relatively low failure rates given the design complexity. Despite extensive preclinical testing, the complexities in lead design limit the ability to anticipate and predict reliability, durability, functional characteristics, and modes of failure until already deployed in widespread clinical use. Therefore, robust postmarket surveillance is of the utmost importance.
management perspective, these are remarkable devices with relatively low failure rates given the design complexity. Despite extensive preclinical testing, the complexities in lead design limit the ability to anticipate and predict reliability, durability, functional characteristics, and modes of failure until already deployed in widespread clinical use. Therefore, robust postmarket surveillance is of the utmost importance.
TABLE 13-2 Lead Design Considerations Impacting Long-Term Durability Due to Complexity | ||||||||||
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