Device-related infections

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Device-related infections are associated with surgical implants, e.g., pacemakers or joint prostheses. Clinical presentation ranges from asymptomatic infections resulting from device erosion, to severe systemic illness, sepsis, and septic shock. Diagnosis is generally clinical, supported by laboratory and imaging studies and intraoperative evidence of infection. Diagnosis is confirmed by microorganism growth in cultures taken from or near the device, or by evidence of infection on biopsy samples. Management is multidisciplinary, with assistance from surgical teams and infectious disease services, and it includes antibiotic therapy and invasive treatment of the device (usually removal).

This article provides an overview of the diagnosis and management of common device-related infections. See also “Intravascular catheter-related bloodstream infections” and “Hospital-acquired infections.”

• Approximately 25% of all health care-associated infections are device-associated infections. ^[2]
• Morbidity and mortality: varies according to the device that is infected ^[3]
  • Infection rate is higher for reimplanted devices than for first-time implants.
  • Risk of complications is higher for infections associated with intravascular medical devices (e.g., pacemakers, mechanical heart valves).
  • Mortality is highest in prosthetic valve endocarditis.

Epidemiological data refers to the US, unless otherwise specified.

• Most often due to bacteria
• Infections can result from:
  • Contamination of the device (e.g., during surgery, trauma)
  • Seeding of the device from bacteremia
  • Spread from a contiguous infection (e.g., deep tissue infection)

Patients may present with symptoms localized to the site of the device, systemic symptoms (e.g., fever, chills), and/or bacteremia; see also “Fever” and “Sepsis.”

Cardiac devices ^[11][12]

• Superficial signs (e.g., at the generator site or percutaneous driveline exit site) ^[4][5]
  • Erosion of the device (e.g., pacemaker) or lead through the skin
  • Skin and soft tissue inflammation (e.g., erythema, induration)
  • Purulent drainage
• Systemic illness (e.g., in pacemaker infections with lead vegetation): signs of bacteremia or endocarditis

Neurosurgical devices ^[7]

• Neurological features
  • New headache
  • Lethargy and/or change in mental status
  • Meningismus (rare)
• Local features
  • Erythema and pain at the subcutaneous site
  • Abdominal pain or tenderness (in patients with a ventriculoperitoneal shunt)

Orthopedic hardware ^[7]

• Early onset (< 4 weeks)
  • Local pain
  • Erythema
  • Fever
  • Swelling
  • Poor wound healing
• Late onset (> 10 weeks)
  • Persistent pain
  • Wound drainage or sinus tract
  • Loosening of the implant

Vascular devices ^[10]

Symptoms depend on the location of the vascular graft infection.

• Intracavitary infection
  • Intraabdominal
    • Fever
    • Abdominal pain
    • GI bleeding
  • Intrathoracic
    • Fever and bacteremia
    • Hemorrhage (due to rupture of the anastomosis)
• Extracavitary infection
  • Early onset (< 2 months)
    • Systemic symptoms (e.g., fever)
    • Erythema
    • Sinus tract drainage
    • Abscess
    • Graft occlusion (distal ischemia)
    • Septic emboli
    • Pseudoaneurysm
    • Rupture of the anastomosis with hemorrhage
    • Erosion of the graft through the skin
  • Late onset (≥ 2 months): similar to early onset, but usually without systemic illness

Reproductive and genitourinary devices ^[7]

Breast implants ^[8]

Infections involving breast implants are typically unilateral.

• Acute (≤ 6 weeks)
  • Systemic symptoms (e.g., fever)
  • Erythema
  • Swelling
  • Poor healing
  • Purulent drainage from the surgical site
  • Clinical features of toxic shock syndrome (rare)
• Subacute or chronic (≥ 6 weeks)
  • Breast pain
  • Axillary pain
  • Upper extremity paresthesias
  • Poor aesthetic appearance

Sepsis rarely occurs in breast implant infections. ^[7]

Penile implants ^[7][9][13]

• Acute (< 6 weeks)
  • Erythema
  • Systemic symptoms (e.g., fever)
  • Pain over the area of the prosthesis
  • Induration
  • Drainage
  • Device exposure
• Chronic (≥ 6 weeks)
  • Pain over the area of the prosthesis
  • Device migration

The approach to management varies based on the site of infection. Management should be specialist-guided.

• Order initial diagnostics.
  • General diagnostics:
    • Inflammatory markers including CBC: elevations are nonspecific but may be useful for monitoring infection
    • BMP: Patients with impaired renal function require adjustments to renally dosed antibiotics.
  • Microbiological studies (obtained before initiation of antibiotics if possible)
    • Blood cultures (2 sets) ^[14]
    • Wound or device cultures (preferably from deep tissue or surgical procedure)
  • Imaging studies: often necessary to support the diagnosis and for surgical planning
• Start antibiotics.
  • Empiric antibiotics: based on the infected area and disease severity
  • Targeted antibiotics: once culture and sensitivity results are available
• Provide supportive care, e.g.:
  • IV fluid therapy
  • Specialized nutritional support
  • VTE prophylaxis
  • See also “Supportive therapy” in “Sepsis.”
• Consider the need for device removal: Consult appropriate services (e.g., neurosurgery, vascular surgery).
• Choose an appropriate care setting: e.g., ICU care for patients with severe sepsis or septic shock

If present, start immediate management of sepsis or septic shock (e.g., immediate hemodynamic support with IV fluids and/or vasopressors) and empiric antibiotics.

Management of all device-related infections requires a multidisciplinary approach.

This section covers infections related to cardiac implantable electronic devices (CIEDs), e.g., pacemakers, and ventricular assist devices (VADs). For prosthetic heart valve infections, see “Infective endocarditis.”

Diagnostics ^[4][11][12]

• Laboratory studies
  • Routine studies (e.g., CBC, inflammatory markers): nonspecific, but may further support the diagnosis
  • Microbiological studies
    • Obtain blood cultures and device cultures.
    • Consider obtaining cultures from purulent drainage.
    • Consider fungal and acid-fast bacilli cultures and stains.
• Imaging studies
  • Consider ultrasound of subcutaneous pocket to check for supportive findings, including: ^[4]
    • Septations or heterogeneous fluid collections around the device
    • Septic thrombophlebitis (seen on Doppler)
  • Echocardiography (TEE or TTE): to evaluate for complications
  • Additional imaging (e.g., FDG-PET scan, tagged WBC scan): if other methods are unable to confirm the diagnosis

Duke criteria can be used for suspected cardiac device-associated endocarditis. ^[4]

Diagnostic device pocket needle aspiration should be avoided because of the risk of introducing bacteria. ^[11]

Treatment ^[4][5][11]

Antibiotic therapy ^[4][11]

• Involvement of ICD or pacemaker leads or valves: Follow recommendations for management of infective endocarditis. ^[4]
• No involvement of leads or valves
  • Start empiric antibiotics (after blood culture collection, if possible).
    • Provide gram-positive coverage (e.g., vancomycin ).
    • Consider gram-negative coverage (e.g., meropenem ).
    • Switch to targeted antibiotics; duration of treatment is variable.
• Suppressive antibiotics: may be an alternative for select patients ^[4]

Invasive therapy ^[5][15]

• CIEDs ^[4][11]
  • Unless the infection is superficial, removal is usually required.
  • Indications for removal include:
    • Pocket infections
    • Presence of virulent organisms (e.g., S. aureus or Pseudomonas spp.)
    • Persistent bacteremia or fungemia
    • Patients with prosthetic heart valves
    • Imaging showing vegetations
• VADs ^[5]
  • Drainage, debridement, or explant may be required to control the infection.
  • Indications for removal include:
    • Deep driveline or pump pocket infection
    • Complications such as bacterial mediastinitis, or infective endocarditis

CIED removal is usually not needed in superficial or incisional infections. ^[15]

This section covers infections related to CSF shunts and drains , neurostimulators, and intraspinal pumps.

Diagnostics ^[16][17]

All patients require general blood tests, CSF studies, and neuroimaging.

Laboratory studies

• Blood tests: Obtain CBC, BMP, CRP, procalcitonin, and blood cultures.
• CSF studies
  • ↑ WBC, ↓ glucose, ↑ protein (normal results do not rule out infection)
  • Lactate > 3.5 mmol/L and ↑ procalcitonin further support the diagnosis.
  • Microbiological studies
    • Bacterial cultures (aerobic and anaerobic): Obtain for all patients; if negative, hold for 10 days.
    • Beta-D-glucan and galactomannan: Obtain if fungal infection is suspected.
    • NAATs: Consider initially or if cultures are negative.
  • See also “Cerebrospinal fluid analysis in meningitis.”
• Cultures of device component: Obtain aerobic and anaerobic cultures during device removal.

Negative CSF cultures in patients who have previously received antimicrobial therapy do not rule out health care-associated meningitis or ventriculitis.

An elevated serum procalcitonin may help distinguish bacterial infections from intracranial hemorrhage or surgery as the cause of abnormal CSF studies in patients with negative cultures.

Imaging studies

• Neuroimaging: Obtain for all patients.
  • Modalities: MRI brain (preferred) or CT brain with contrast
  • Supportive findings include:
    • Signs of ventriculitis: e.g., ependymal enhancement
    • Signs of meningitis: e.g., meningeal enhancement
    • Complications: e.g., brain abscess or subdural empyema (both rare), vasculitis, hydrocephalus, or thrombus
• X-ray of CSF shunt (shunt series): for patients with CSF shunts to assess for retained surgical hardware
• Ultrasound or CT abdomen
  • Consider for patients with VP shunts and abdominal pain.
  • Supportive findings include CSF loculations (pseudocysts) at the end of the shunt that may result in shunt obstruction.

Treatment ^[16][17]

• Empiric antibiotics
  • Recommended regimen: vancomycin PLUS antipseudomonal beta-lactam (e.g., cefepime ) ^[16]
  • See also “Empiric antibiotic therapy for bacterial meningitis.”
• Targeted antibiotics: See “Pathogen-specific therapy in meningitis.”
  • Treatment response
    • Assess based on clinical parameters.
    • Repeat CSF studies and cultures in patients with an EVD or without clinical improvement (usually every 1–3 days until negative)
  • Treatment duration
    • Generally 10–14 days
    • Patients with gram-negative bacilli may benefit from antibiotics for up to 21 days.
  • If the response to IV antibiotics is poor, intraventricular antimicrobial therapy may be used.
• Device removal
  • Generally recommended for all patients
  • Patients with an infected CSF shunt: removal and replacement with an EVD

This section covers infection after fracture fixation (IAFF); for prosthetic joint infection (PJI), see “Septic arthritis.”

Diagnostics ^[18][19]

General principles

• A diagnosis can be made in patients with either: ^[18]
  • Characteristic clinical features like presence of wound breakdown, sinus tract, or purulent drainage
  • Confirmatory microbiological study results
• Additional studies (e.g., imaging, ↑ WBC, ↑ ESR, ↑ CRP) further support the diagnosis.

Microbiological studies ^[18]

• Intraoperative samples: for diagnostic confirmation
  • Specimen collection (ideally, no antibiotics should be given for 2 weeks prior to collection)
    • ≥ 5 separate samples from near the fracture or implant for culture
    • Additional samples for histopathology and staining
  • Diagnostic criteria
    • Growth of the same pathogen on ≥ 2 separate culture samples
    • OR microorganisms seen on staining of deep tissue samples
• Cultures from fluid aspirate: may further support the diagnosis ^[20]
  • Obtained from fluid accumulation at the site of infection
  • Synovial fluid analysis from the adjacent joint if joint involvement is suspected

Swab cultures or cultures of sinus tracts should be avoided because of low sensitivity and the risk of contamination by skin flora. ^[19]

Imaging studies ^[21]

• Indications
  • Evaluation of fracture healing and device stability
  • Surgical planning
  • To further support a diagnosis of IAFF
• Modalities: The choice of imaging modality depends on its availability and the clinical concern.
  • X-ray of the extremity ^[21][22]
    • Initial screening study in suspected infection
    • May show widening of the fracture gap or loosening of the implant, bone lysis, nonunion, periosteal bone formation, and sequestration
  • CT of the extremity: used for better visualization or if chronic infection is suspected ^[20][21]
    • Findings are similar to x-ray.
    • Additional findings: bone necrosis, new bone formation, cortical bone reaction, abscess, intraosseous fistula, and details of surrounding tissue
  • MRI of the extremity: for the assessment of soft tissue and intramedullary infection ^[21]
    • Findings are similar to CT.
    • Additional findings: better definition of bone and soft tissue involvement
  • Nuclear imaging (e.g., WBC scintigraphy, FDG-PET): used to precisely localize infection

Treatment ^[19][20]

The goal of treatment is to promote fracture and soft tissue healing, restore limb function, eradicate the infection, and prevent chronic osteomyelitis. ^[20]

Antibiotic therapy ^[19]

• Empiric antibiotics
  • Start after surgical debridement and tissue sampling.
  • Suggested regimen: vancomycin (off-label) PLUS gram-negative coverage (e.g., piperacillin/tazobactam ) ^[19][23]
• Targeted antibiotics
  • Suggested regimens: similar to targeted antimicrobial therapy for adults with septic arthritis and for PJI ^[24]
  • Duration of treatment: variable (e.g., 6–12 weeks after surgery)
• Suppressive antibiotic therapy
  • May be required in patients for whom removal is not initially possible
  • Usually continued until the fracture has healed and the implant has been removed

Start antibiotic therapy after microbiological studies (including intraoperative samples) have been collected.

Invasive treatment ^[19][20]

• Debridement and removal of dead tissue: recommended for all patients
• Management of the device
  • Healed fracture: removal
  • Unhealed fracture: retention, exchange, or external fixation

Surgical debridement with or without device removal is recommended for all infections.

This section covers vascular graft infections. For infections related to intravascular catheters (e.g., central venous lines, arterial lines), see “Intravascular catheter-related bloodstream infections.”

Diagnostics ^[10][25]

Obtain diagnostics early and consult a multidisciplinary specialist team.

• Laboratory studies: nonspecific but useful for monitoring response to therapy
  • CBC: ↑ WBC
  • Inflammatory markers: ↑ ESR, ↑ CRP
• Microbiological studies ^[10][25]
  • Perigraft fluid cultures (preferred): Obtained intraoperatively or via image-guided aspiration
  • Blood cultures: intraabdominal graft erosion into the small intestine or colon can result in polymicrobial enteric bacteremia.
  • Wound swab culture: may grow bacteria that colonize the skin and not reflect the causal organism
• Initial imaging studies: based on the location of the graft ^[10][25]
  • Extracavitary infections
    • Ultrasound (first-line); CT scan (second-line)
    • Supportive findings include pseudoaneurysms, fluid collections, and graft thrombosis or stenosis.
  • Intracavitary infections:
    • CT chest or abdomen
    • Supportive findings include fluid collection or gas around the graft, tissue plane destruction and perigraft stranding, focal thickening of bowel wall in intraabdominal grafts, and pseudoaneurysms.
• Additional imaging studies
  • MRI: Consider as an alternative to CT or if CT results are indeterminate.
  • Echocardiography: Consider for intrathoracic infections to evaluate for complications.
  • Nuclear imaging (e.g., WBC scintigraphy, FDG-PET): Consider if results from other studies are indeterminate.
• EGD: Obtain for patients with GI bleed; may reveal graft-enteric fistula or erosion

CT is the preferred initial imaging for intracavitary infections; ultrasound is preferred for extracavitary infections.

Treatment ^[10][25]

• Empiric antibiotics
  • Should provide MRSA and pseudomonal coverage ^[25]
  • Example regimen: vancomycin PLUS piperacillin/tazobactam
• Targeted antibiotics
  • Tailor to culture and sensitivity results.
  • Duration can range from 4 weeks to 6 months or lifelong suppressive antibiotics.
• Invasive therapy (recommended for most patients) ^[10]
  • Total or partial graft excision (with or without revascularization)
  • Graft preservation techniques (e.g., debridement)

Lifelong suppressive antibiotics may be considered in patients with retained endovascular devices. ^[10]

This section covers infection of breast and penile implants. For information on infections related to indwelling urinary tract devices (e.g., urinary catheters, ureteral stents, nephrostomy tubes), see “Catheter-associated UTI (CAUTI),” and “Complicated pyelonephritis.”

Breast implant infection

Diagnostics ^[7][8][26]

Breast implant-related infection is primarily a clinical diagnosis (see “Clinical features”).

• Ultrasound breast: may reveal periprosthetic fluid; also used to guide fluid aspirate
• Microbiological studies: ideally obtained before starting empiric antibiotics
  • Samples
    • Fluid aspirate (preferred)
    • Blood cultures (in patients with systemic symptoms)
    • Superficial swabs of fluid draining from wounds: potentially contaminated with skin flora (usually not useful)
  • Assess for aerobic and anaerobic bacteria, mycobacteria, and fungi.
• Histopathological studies (from tissue obtained intraoperatively)
  • Consider if the diagnosis remains unclear.
  • E.g., to differentiate subclinical infections from malignancies, or to assess for granulomas or acid-fast bacilli

Treatment ^[8][26]

There is limited evidence regarding the most effective antibiotic therapy for breast and penile implant infections. Decisions should be specialist-guided.

• Antibiotic therapy
  • Start empiric antibiotics: Consider coverage for MRSA, coagulase-negative staphylococcus, and gram-negative bacteria coverage (e.g., vancomycin PLUS piperacillin/tazobactam).
  • Switch to targeted antibiotics.
    • Tailor to culture and sensitivity results.
    • Duration of treatment ranges from 10–14 days to several months.
  • See also “Antibiotic therapy for skin and soft tissue infections.”
• Surgical therapy
  • Implant removal: often required
  • Implant salvage or conservative therapy may be considered in select cases.
  • Reimplantation: may be considered after completion of antibiotic therapy

Penile implant infection ^[7][13][27]

If there is concern for Fournier gangrene, see “Necrotizing soft tissue infections.”

Diagnostics

Penile implant-related infection is primarily a clinical diagnosis (see “Clinical features”).

• Microbiological studies
  • May further support the diagnosis and guide therapy
  • Obtained from intraoperative tissue or implant or from periprosthetic fluid
• Imaging studies: to support the diagnosis and for surgical planning ^[13][28][29]
  • MRI pelvis (preferred modality): Supportive findings include hyperintensity near the device, fluid collection with surrounding rim enhancement, and gas in severe infections.
  • Ultrasound of prosthesis: to assess for fluid collections and edema surrounding the prosthesis
  • CT pelvis: usually reserved for severe infection if MRI might be delayed

An exposed device is always considered infected.

Cultures may be negative, even in patients with clinical signs of infection.

Treatment ^[29]

There is limited evidence regarding the most effective antibiotic therapy for breast or penile implant infections. Decisions should be specialist-guided.

• Antibiotic therapy
  • Start empiric antibiotics: Consider coverage for MRSA, coagulase-negative staphylococcus, gram-negative bacteria (e.g., vancomycin PLUS piperacillin/tazobactam).
  • Switch to targeted antibiotics.
    • Tailor to culture and sensitivity results.
    • Treatment duration is variable.
  • See also “Antibiotic therapy for skin and soft tissue infections.”
• Surgical therapy: Device removal is indicated in most infections.

Device removal is especially important in patients with systemic illness, immunocompromise, and severe infections. ^[7][28]