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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 Clinical manifestations Microbiology Pathogenesis Diagnosis Treatment Prevention Circulation 2003;108:2015-2031 -- Specific devices Intracardiac Intra-arterial Intravenous Nonvalvular Cardiovascular DeviceRelated Infections Pathogenesis • • • 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 • • • 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 • • 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 • • 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 • 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 • 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 • • • 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 • • 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 • • 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 • Infection sources – Generator pocket contamination at implantation – Cutaneous erosion of generator – Hematogenous seeding (“late - onset infection”) Circulation 2003;108:2015-2031 Electrophysiologic Devices • 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 • 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 • • • 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 • Immunologic effects – – – – – – 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 • 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 • • 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 • • • 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 • • 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 • • 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 • 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 • 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 • Diagnostic modalities – Blood cultures – Radiologic/nuclear medicine CT scanning Sensitivity/specificity - 94%/95% MRI Sensitivity/specificity - 85%/100% Indium WBC, gallium - lower specificity Circulation 2003;108:2015-2031 Prosthetic Vascular Grafts • 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 • 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 • • 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 • • • • >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 • • – 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) • • 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 • • • ~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 • 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 • • • 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) • • • 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) • • 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 • • 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 • • • 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 • • ~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 • • • • 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