Download Nonvalvular Cardiovascular Device

AHA Scientific Statement:
Nonvalvular Cardiovascular
Device–Related Infections
From the Committee on Rheumatic Fever,
Endocarditis and Kawasaki Disease, American Heart
Association
Larry M. Baddour, Michael A. Bettmann, Ann F.
Bolger, Andrew E. Epstein, Patricia Ferrieri,
Michael A. Gerber, Michael H. Gewitz, Alice K.
Jacobs, Matthew E. Levison, Jane W. Newburger,
Thomas J. Pallasch, Walter R. Wilson, Robert S.
Baltimore, Donald A. Falace, Stanford T. Shulman,
Lloyd Y. Tani, Kathryn A. Taubert
Circulation. 2003;108:2015-2031.
Nonvalvular Cardiovascular
Device-Related Infections
•
AHA scientific statement
– Circulation 2003;108:2015-2031

First edition

“Encyclopedic”

Excludes intravascular catheters

Full statement available on the web at
http://circ.ahajournals.org/cgi/content/full/108/
16/2015
Nonvalvular Cardiovascular
Device-Related Infections
Type of Devices
Incidence of Infection %
Intracardiac
Pacemakers…………………………………..
0.13-19.9
Defibrillators………………………………….
0.00-3.2
LVADs………………………………………….
25-70
Total artificial hearts (TAH)……………. To be determined
Ventriculoatrial shunts……………………..
2.4-9.4
Pledgets……………………………………….
Rare
Patent ductus arteriosus (PDA)
occlusion devices………………………….
Rare
Atrial septal defect (ASD) and ventricular
septal defect (VSD) closure devices…….
Rare
Conduits……………………………………….
Rare
Patches…………………………………………
Rare
Circulation 2003;108:2015-2031
Nonvalvular Cardiovascular
Device-Related Infections
Type of Devices
Incidence of Infection %
Intra-arterial
Peripheral vascular stents……………………
Rare
Vascular grafts, including
hemodialysis…………………………………..
1.0-6
Intra-aortic balloon pumps…………………… < 5-26
Angioplasty/angiography-related
bacteremias…………………………………….
< 1*
Coronary artery stents………………………… Rare
Patches……………………………………………
1.8
Intravenous
Vena caval filters……………………………….. Rare
*Closure device use < 1.9%
Circulation 2003;108:2015-2031
Nonvalvular Cardiovascular
Device-Related Infections
AHA Scientific Statement
Two broad sections:
-- General principles
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Clinical
manifestations
Microbiology
Pathogenesis
Diagnosis
Treatment
Prevention
Circulation 2003;108:2015-2031
-- Specific devices
 Intracardiac
 Intra-arterial
 Intravenous
Nonvalvular Cardiovascular DeviceRelated Infections
Pathogenesis
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Pathogen virulence factors
– Adhesions (MSCRAMM)
– Biofilm
Host response to the artificial device
– Abnormal flow
– Immunologic effects
Physical/chemical device characteristics
– Platelet, fibrinogen attachment
Circulation 2003;108:2015-2031
Nonvalvular Cardiovascular
Device-Related Infections
Clinical Manifestations
•
Depend on location of infected portion of
device
– Local
– Systemic
Circulation 2003;108:2015-2031
Nonvalvular Cardiovascular
Device-Related Infections
Microbiology
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Staphylococcal species predominate
– Multidrug resistance, including oxacillin frequent
Aerobic gram-negative bacilli
– Pseudomonas, Acinetobacter, Serratia species
Fungi
– Candida species - most common among fungi
– Aspergillus species - reported
Circulation 2003;108:2015-2031
Vascular graft site infection
in a hemodialysis patient
due to methicillin-resistant
S aureus. The patient
suffered bacteremia
in addition to focal skin and
soft tissue changes at the
graft site, including
erythema, swelling, warmth,
and pain.
Circulation 2003;108:2015-2031
Nonvalvular Cardiovascular DeviceRelated Infections
Diagnosis
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Laboratory
– Specimen (blood, drainage, device)
cultures
Radiologic
– Echocardiographic
Circulation 2003;108:2015-2031
Transesophageal
echocardiographic
view of the left
atrium (LA) and right
atrium (RA). A
pacemaker lead
(filled arrow)
is seen as it crosses
the tricuspid valve.
The lead is thickened
by infective material,
and there is a round
mobile vegetation
(open arrow)
attached to its right
atrial portion.
Circulation 2003;108:2015-2031
Nonvalvular Cardiovascular DeviceRelated Infections
Manifestation of Infection
Initial Imaging Modality
Endocarditis
Pacemakers (temporary and permanent)
Defibrillators
LVADs
Ventriculoatrial shunts
Pledgets
ASD closure devices
Patches
Conduits
PDA occlusion devices
Pericarditis
Coronary artery stents
Pledgets
Circulation 2003;108:2015-2031
TEE
TTE or TEE
TTE or TEE
Nonvalvular Cardiovascular DeviceRelated Infections
Manifestation of Infection
Initial Imaging Modality
Endocarditis
Pacemakers (temporary and permanent)
Defibrillators
LVADs
Ventriculoatrial shunts
Pledgets
ASD closure devices
Patches
Conduits
PDA occlusion devices
Pericarditis
Coronary artery stents
Pledgets
Circulation 2003;108:2015-2031
TEE
TTE or TEE
TTE or TEE
Nonvalvular Cardiovascular
Device-Related Infections
Manifestation of Infection
Initial Imaging Modality
Perivasculitis
CT or MRI
Peripheral vascular stents
Vascular grafts, including hemodialysis
Angioplasty/angiography-related
bacteremias
Coronary artery stents
Patches
Aneurysm or pseudoaneurysm
Angiography
Pledgets
Coronary artery stents
Patches
Angioplasty/angiography-related
bacteremias
Vascular grafts, including hemodialysis
Circulation 2003;108:2015-2031
Nonvalvular Cardiovascular
Device-Related Infections
Manifestation of Infection
Initial Imaging Modality
Infected thrombosis
Vena caval filter
Vascular grafts, including hemodialysis
Ultrasound
Pocket site infections
Pacemakers (permanent)
Defibrillators
LVADs
Total artificial hearts
Ultrasound
Circulation 2003;108:2015-2031
Nonvalvular Cardiovascular
Device-Related Infections
Treatment
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Antimicrobial
– Acute (induction)
– Long-term (lifelong) suppressive
– Device replacement impregnation
Device removal
– “Percutaneous”
– Surgical
Circulation 2003;108:2015-2031
Nonvalvular Cardiovascular
Device-Related Infections
Treatment
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Acute (induction)
– Bactericidal/fungicidal
– Parenteral
– Selection
 Based on pathogen
identification/susceptibility testing
 Host factors
– Duration
 Variable depending on type of device
and location of infection
Circulation 2003;108:2015-2031
Nonvalvular Cardiovascular
Device-Related Infections
Treatment
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Long-term (lifelong) suppressive therapy
– Infected device removal - not an option
– Response to acute treatment - clinically and
microbiologically
– Cardiovascular status - stable
Circulation 2003;108:2015-2031
Nonvalvular Cardiovascular
Device-Related Infections
Primary prophylaxis
• Modeled after surgical site infection
prophylaxis.
• Because of the low incidence of infection for
many of the devices, without evidence-based
data.
• Routinely used: electrophysiological cardiac
devices, VAD, TAH, VA shunts, pledgets,
vascular grafts, and arterial patches.
Circulation 2003;108:2015-2031
Nonvalvular Cardiovascular
Device-Related Infections
Secondary prophylaxis
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Antibiotic prophylaxis is not recommended for
patients who undergo dental, respiratory,
gastrointestinal or genitourinary procedures.
It is recommended for patients if they undergo
incision and drainage of infection at other sites
(eg, abscess) or replacement of an infected
device.
It is recommended for patients with residual
leak after device placement for attempted
closure of the leak associated with PDA, ASD,
or VSD
Circulation 2003;108:2015-2031
Electrophysiologic Devices
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Pacemakers
– Incidence of infection, 0.13%-19.9%
Implantable cardioverter-defibrillators
(ICDs)
– Incidence of infection, 0%-0.8%
Circulation 2003;108:2015-2031
Electrophysiologic Devices
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Generator pocket - most common
infection site
Lead infection
– “Pacemaker endocarditis”
– ~10% of pacemaker infections
– Most often due to generator pocket
infection
Circulation 2003;108:2015-2031
Electrophysiologic Devices
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Infection sources
– Generator pocket contamination at
implantation
– Cutaneous erosion of generator
– Hematogenous seeding
(“late - onset infection”)
Circulation 2003;108:2015-2031
Electrophysiologic Devices
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Treatment
– Duration of therapy
 No evidence-based data
 Limited to generator site - ~ 10 days
 Lead infection - 2 to 6 weeks
– Device removal
 Paramount Reduce risk of infection relapse
and mortality
– Device replacement
 Timing
Varied recommendations - at least wait until
bacteremia/fungemia cleared
Some may not require/want device
replacement
Circulation 2003;108:2015-2031
Electrophysiologic Devices
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Lead removal
– Greater difficulty if prolonged
implantation time
– Techniques (nonsurgical)
 81%-93% successful
 0%-3.3% complications
 0%-0.8% mortality
 Locking stylet
 Telescoping sheath
 Laser sheath
Circulation 2003;108:2015-2031
Left Ventricular Assist Devices
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Incidence of infection; 13%-80%
85% of infections occur > 2 weeks after
LVAD placement
Mean duration of LVAD use = 73 days
– Statistical association - postoperative
hemodialysis
– Clin Infect Dis 2002;34:1295-1300
Circulation 2003;108:2015-2031
Left Ventricular Assist Devices
• Three infection syndromes
– Driveline infection (most common)
– LVAD pocket site infection
– LVAD endocarditis (least common)
– Not mutually exclusive
Circulation 2003;108:2015-2031
Left Ventricular Assist Devices
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Immunologic effects
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Aberrant state of CD4
T-cell activation - apoptosis
Cutaneous anergy - recall antigens
Lower T-cell proliferative responses
Higher surface expression of CD95
B-cell hyperactivity and dysregulated
immunoglobulin synthesis
Circulation 2003;108:2015-2031
Left Ventricular Assist Devices
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Persistent bacteremia/fungemia not a
contraindication to cardiac transplantation
•
Transplantation is life-saving for some
patients with uncontrollable LVAD
infection
Circulation 2003;108:2015-2031
Total Artificial Heart
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1980s - Jarvik-7
– Infectious/noninfectious complications
January 2001 - FDA (USA) approval Abiomed
– Totally implantable except external
battery and lead to electrical inductor coil
– 10 patients (3/10/03)
– Blood clotting problems, CVAs
– No infectious complications, 7 patients
– No data, 3 patients
Circulation 2003;108:2015-2031
Ventriculoatrial (VA) Shunts
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VP > VA use
Incidence of infection < 10%
– Large majority within six months of
placement
– CONS > S. aureus
Clinical manifestations
– Infection site dependent, virulence of
organism, +/- shunt malfunction
– Varied, though meningitis unusual
 Remember immunologic sequelae
Circulation 2003;108:2015-2031
Ventriculoatrial (VA) Shunts
•
Diagnosis of infection
– Findings
 Presence of fever and > 10% PMNs in
ventricular fluid
– Treatment
 Two-staged exchange
Circulation 2003;108:2015-2031
Cardiac Suture Line Pledgets
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Teflon pledgets commonly used
Three infection syndromes
– Chest wall or epigastric involvement
 Draining sinuses, sub-q masses, pain
– Bronchopulmonary infection
 Recurrent hemoptysis,
bronchiectasis, pneumonia with
empyema
– Endocardial infection
 Bacteremia or fungemia
Circulation 2003;108:2015-2031
Occlusion Devices
• Patent ductus arteriosus, atrial septal
•
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defect, and ventricular septal defect
Extremely rare infections (n=2)
Left atrial appendage occluders
– Pending more extensive evaluation
Circulation 2003;108:2015-2031
Prosthetic Vascular Grafts
• Incidence of infection 1%-6% (> 5 yrs)
• Location - related
•
– Aortic < 1%
– Aortofemoral 1.5%-2%
– Infrainguinal < 6% (originate in groin)
Intraoperative or perioperative contamination
– Majority of cases
– Incubation period - < 2 months
– Longer for indolent (CONS) pathogens
Circulation 2003;108:2015-2031
Prosthetic Vascular Grafts
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Purported risk factors
– Groin incisions
– Emergent surgery
– Invasive intervention (local)
 Before/after placement
– Contiguous infection
– Medical conditions (diabetes mellitus,
obesity, chronic renal disease,
immunocompromised host)
Circulation 2003;108:2015-2031
Prosthetic Vascular Grafts
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Clinical presentations
– Distal (extremity) infections
 Focal inflammatory changes
– Intracavitary infections
 Nonspecific, difficult to diagnose
Magnified if years after placement
– GI bleed
Circulation 2003;108:2015-2031
Prosthetic Vascular Grafts
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Diagnostic modalities
– Blood cultures
– Radiologic/nuclear medicine
 CT scanning
Sensitivity/specificity - 94%/95%
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MRI
Sensitivity/specificity - 85%/100%
Indium WBC, gallium - lower
specificity
Circulation 2003;108:2015-2031
Prosthetic Vascular Grafts
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Management
– 4 tenets
 Excision of graft (foreign body)
 Wide/complete debridement of
devitalized, infected tissue
 Maintain or establish vascular flow
 Institute prolonged systemic
antimicrobial therapy
Circulation 2003;108:2015-2031
Hemodialysis Prosthetic
Vascular Grafts
• Epidemiologic factors
•
– Immunocompromised state
– Repetitive needle puncture at graft site
– Increased carriage of S. aureus
3.2 infections/100 patient-months
– CDC national surveillance system
– AV fistulas - 0.56
– Synthetic AV grafts - 1.36
– Cuffed catheters - 8.42
– Non-cuffed catheters - 11.98
Circulation 2003;108:2015-2031
Hemodialysis Prosthetic
Vascular Grafts
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Microbiology
– Access-related bacteremia (fistulas or
grafts)
 S. aureus - 53%
 CONS - 20.3%
– MDR commonplace
 MRSA (VISA, VRSA)
 MRSE
 VRE
Circulation 2003;108:2015-2031
Hemodialysis Prosthetic
Vascular Grafts
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Management
– Complex issues, including available
vascular access
– Old, nonfunctioning AV grafts
 Cause of “delayed” sepsis
Prevention
– Mupirocin
– Increased AV fistula use
– Cryopreserved human femoral vein allograft
– Vaccines
Circulation 2003;108:2015-2031
Endovascular Stents and
Stent-Grafts
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>400,000 patients in US undergo stent
placement annually
Incidence of infection <1/10,000
Early (<4 weeks) presentation
Predominant pathogen
– S. aureus
Circulation 2003;108:2015-2031
Endovascular Stents and
Stent-Grafts
• Complications
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– Pseudoaneurysms
– Others (abscess formation, arterial necrosis,
septic emboli, refractory sepsis, amputation
requirement, death)
Treatment
– Excision with extra-anatomic revascularization
Prevention
– Primary prophylaxis - “selected” patients
Circulation 2003;108:2015-2031
Intra-aortic Balloon
Counterpulsation Catheters (IABP)
•
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Incidence of infection
– Wound infection < 5%
– Bacteremia < 2.2%
Purported risks
– Obesity
– Emergent placement
– Surgical insertion
– Longer duration of use
– Done in areas outside OR or cath lab
– Larger diameter catheters (used in past)
Circulation 2003;108:2015-2031
Coronary Angiography
and PTCA
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~900,000 annually worldwide
– Stents used in 80%-85%
Incidence of infection < 1%
Multiple infectious complications are
described
– Bacteremia
– Mycotic aneurysm, septic arthritis,
endarteritis
Circulation 2003;108:2015-2031
Coronary Angiography
and PTCA
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Risk factors
– Brachial artery access
 Cutdown approach
– Repeat puncture (ipsilateral)
– Prolonged indwelling FA sheath
 Pressurized heparin solution
– Older age
– CHF
Circulation 2003;108:2015-2031
Coronary Angiography
and PTCA
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Microbiology
– Staphylococcus species - Most common
Diagnosis
– CT scan or angiography
 Persistent sepsis, septic emboli, and
abdominal flank pain
Treatment
– Aneurysms require resection or ligation
 Rupture propensity
Circulation 2003;108:2015-2031
Coronary Artery Stents
•
Infection extremely rare
– Only 5 cases described in English
literature
– Acute infection
– Pathogens
 S. aureus - 3; P. aeruginosa - 2
– 3/5 patients died
Circulation 2003;108:2015-2031
Vascular Closure Devices
(VCD)
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FDA (USA) approval - 5 devices
Favored over manual compression or
compression devices
– Decrease time to hemostasis, increased
patient comfort
Incidence of infection < 1.9%
– Two concerns
 VCD > manual compression
 Infections more severe, more difficult to
treat (often surgical intervention)
Circulation 2003;108:2015-2031
Vascular Closure Devices
(VCD)
•
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Microbiology
– S. aureus
 Methicillin-resistant
Risk
– Diabetes mellitus?
 Prophylaxis for this group and for
vascular access per prosthetic graft
Circulation 2003;108:2015-2031
Dacron Carotid Patches
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Incidence of infection = 0.33% - 1.8%
Local (cervical) findings
– Early (< 3 months)
 Cellulitis, abscess, sepsis,
pseudoaneurysm, massive
hemorrhage, patch dehiscence
– Late
 Sinus tracts with drainage,
pseudoaneurysm
Circulation 2003;108:2015-2031
Dacron Carotid Patches
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Microbiology
– Both viridans group streptococci and
S.aureus predominate early; late
infections - coagulase-negative
staphylococci
Treatment
– Surgical
 Usually patch removal
Outcome
– Overall good
Circulation 2003;108:2015-2031
Vena Caval Filters
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•
~30 years in use, 10 filters available (USA)
Infection extremely rare
– 3 proven, 2 suspect
– Staphylococcal species - all 5 cases
– 4 with bacteremia, 2 with spondylodiscitis
– 3 cures with device removal
– 1 sepsis death, 1 long-term suppressive
therapy
Circulation 2003;108:2015-2031
Conclusions
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•
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Medical devices enhance ability to care for
patients with CVD
Device infections complicate patient care
Cure of infection may be difficult to achieve
without device removal
Future developments should be directed toward:
-- devices more resistant to infection
-- antimicrobial agents with enhanced activity
in clearing infection
-- staphylococcal vaccines
Circulation 2003;108:2015-2031