Nontuberculous mycobacteria (NTM)

Mycobacterium spp. that do not cause TB

M. avium complex (MAC) among most common NTM
MAC: Slow-growing, ubiquitous in environment
Surface water, tap water, and soil

Very low virulence, opportunistic pathogens

Disseminated disease only with extreme immune
compromise (e.g. AIDS with low CD4 count)
Lung disease among those with airway abnormalities

Rarely considered a healthcare-associated threat

Special methods needed for culture detection
No person-to-person transmission

 Invasive M. chimaera infection in 6 patients

M. chimaera is one species of MAC (ID by DNA sequencing)

All six patients had cardiac implants (2008-2012)

Time from surgery to diagnosis: 1.7-3.6 years
Endocarditis, graft material, bloodstream
Two of six patients died

Investigation of water sources revealed:

Water in heater-cooler units grew outbreak strain
Air samples grew outbreak strain when units ran
Clin Infect Dis 2015 (July 1);61:67

Additional outbreaks and cases

detected in multiple countries
Netherlands (1), England (7), Germany (1),
Switzerland (6)
US: First major recognized outbreak in PA
WellSpan, York, PA: 8 probable cases, 4 deaths
Investigation confirmed heater-cooler unit source

FDA alert and CDC guidance issued 10/2015

More rigorous cleaning and disinfection
Assess for NTM infection in those with symptoms
who had cardiac surgery in prior 4 years
Mycobacterial cultures from blood or affected site
http://www.cdc.gov/HAI/pdfs/outbreaks/CDC-Notice-Heater-Cooler-Units-final-clean.pdf

Clinical Manifestations
Prosthetic valve endocarditis
Vascular graft infection
Disseminated infection
Splenomegaly
Arthritis
Osteomyelitis
Cytopenias (bone marrow involvement)
Chorioretinitis
Lung involvement
Hepatitis
Nephritis
Myocarditis

Kohler et al. Eur Heart J 2015;36:2745

M. chimaera detected in heatercooler unit water and in air

samples, but only while the unit
was running

Clin Infect Dis 2015 (July 1);61:67

Although water from heater-cooler unit

never contacts patients directly, the
ventilation fan can aerosolize
contaminated water from the circuit
15: Fan

16: Ventilation

FDA safety communication

For all heater-cooler devices:
Adhere to manufacturer instructions
Use only sterile or filtered water (0.2 micron)
Direct unit exhaust away from operative field
Remove units with signs of contamination
Report any case of NTM infection after device
use

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm466963.htm
10/15/15.

CDC Guidance
The most important action to protect
patients will be to remove contaminated
heater-coolers from operating rooms, and
ensure that those in service are correctly
maintained.

http://www.cdc.gov/HAI/pdfs/outbreaks/CDC-Notice-Heater-Cooler-Units-final-clean.pdf.
10/27/15.

PA DOH Advisory
Risk: approximately 1:10,000 to possibly 1:100 among
patients undergoing open heart surgery on CPB.
Patients and providers should not delay cardiac
surgeries after appropriate informed consent.
Several important unknowns:
Whether the risk of NTM infection can be completely
eliminated
The degree to which only certain models of HCUs will
aerosolize bacteria or whether all HCUs have the potential to
aerosolize bacteria
The ability of stated disinfection procedures to adequately
decontaminate a colonized machine
Pennsylvania Department of Health, Advisory #322, 12/11/15.

Challenges
Case finding: Many patients receive follow-up care
locally, not at UIHC
Symptoms can be very nonspecific (fever, fatigue,
arthralgias, myalgias)
Symptoms can present up to 4 years after the
exposure (long incubation period)
Mycobacterial cultures are not routinely performed,
but are required for diagnosis
For above reasons, the true extent of this
problem is not currently known
Very difficult to treat (multiple drug therapy, surgical
removal of involved devices)