Infection Risk from OHS blood temp regulating devices

[dornole]

https://www.washingtonpost.com/news...ew-deadly-heart-surgery-infections/?tid=a_inl

Not to panic, but it seems like something to be aware of if you have had recent OHS - risk of NTM bacterial infection associated with heating/cooling device used during OHS. CDC links are in the attached article. Though, I think they'd be working you up for endocarditis regardless with those symptoms.

​First I'd heard of this.

 

[honeybunny]

How long does it usually take for these infections to show up? It may take months and up to several years after the operation. Virtually all the cases reported so far in Europe and the United States have occurred within four years of surgery.

Well, THAT'S scary!

How did you happen across this article?

 

[epstns]

IIRC, the article actually came out a few months ago. I remember reading the headline and going into panic, until I read the article and saw that it referred to procedures done much more recently than mine.

 

[Paleowoman]

Here's some advice from the FDA for patients: http://www.fda.gov/MedicalDevices/P...larDevices/Heater-CoolerDevices/ucm492585.htm From the Washington Post article Dornole posted it implies that it's the Stockert 3T heater-cooler made by LivaNova PLC which has been linked to those infections and only since 2012. How do patients find out if the hospital where they had surgery used that machine ? I suspect that would be something useful. Weird that no one here has been informed by their hospital as per the CDC's recommendations.

 

[Paleowoman]

I've found this article from 'Public Health England"
https://www.gov.uk/government/uploa...ciated_with_heater_cooler_units_version_1.pdf

It seems rare nonetheless, though obviously anyone getting it would be gutted to know it was from the machine used during surgery. Just quoting some from that pdf:

During 2014-15, PHE were notified of seven European cases of Mycobacteriumchimaera endocarditis or deep infection following cardiac surgery, six cases in Switzerland and one in The Netherlands. Both countries have attributed the infectionsto organisms in the heater cooler unit (HCU) of the cardiopulmonary bypass equipment,transmitted to the surgical site by aerosolisation of contaminated water from within theunit. Germany subsequently reported a further case1,2. It is not clear whether any risk isl imited to a particular model or manufacturer of HCUs. The Swiss publication described the use of heater cooler units manufactured by the Sorin Group (Milan, Italy). The implicated organism, M.chimaera, is a recently described species within the Mycobacterium avium complex, similar to Mycobacteriumintracellulare, and in UK laboratories would usually be identified as M. intracellulare or M. avium complex.

In February 2015, following the report of the Dutch case, PHE convened a multi-agencyincident management team,including MHRA, NHS England, the Department of Health, Society for Cardiothoracic Surgery (SCTS), Association of Cardiothoracic Anaesthetists(ACTA), Society of Clinical Perfusion Scientists (SCPS) and volunteers from NHS trusts, whose aim was to investigate whether patients in the UK were potentially at risk of M. chimaera or other infection from contaminated HCUs, and identify mitigationstrategies for any risk identified. The investigations undertaken were retrospectivenational case finding, environmental microbiological assessment of devices in situ, and aerobiologicalassessment of a device in a laboratory.

Case finding is complete in England and Wales and identified 17 patients with endocarditis, surgical site infection or disseminated infection due to M. avium complexfollowing cardiothoracic surgery in 10 different NHS trusts. All cases were associated with valve replacement or repair. Nine of the 17 patients subsequently died from any cause. The interval between surgery and diagnosis ranged from three months to five years (median one year seven months),which is in keeping with the long incubation period described in the Swiss outbreak report.

Environmental investigation of devices in situ was conducted at five NHS trusts, three of whom had cases of infection believed to be associated with the device and two who did not. All these trusts used Sorin devices, which are the most widely used make of this type of device in the UK. A further investigation was carried out at two trusts using Maquet devices, but the small number of these devices in the UK has made it difficult to conduct a representative study. Investigations continue into these and other devices.


Between 2007 and 31 August 2015, 17 probable cases of Mycobacterium aviumcomplex/M. chimaera infection associated with cardiopulmonary bypass have been identified in the UK. All cases identified are thought to have acquired their infection during surgery involving cardiac valve replacement or repair, sometimes as part of more complex surgery. Our investigation looked for cases diagnosed from 2007 onwards. The earliest casesi dentified were diagnosed in 2008 and the earliest implicated surgery was performed in 2007. The median interval between surgery and diagnosis was 19 months but was up to 5 years. Based on this, the risk to patientswas estimated as follows:

• •  between 2007 and 2014, approximately 100,000 patients underwent valve repair or replacement surgery in the NHS in England according to Hospital Episode Statistics. Assuming each patient undergoing this surgery was theoretically at risk of developing M. chimaera infection for five years after the surgery, we can calculate the combined years of living post operation for all these patients at around 370,000 person-years

• • using this figure and the number of probable cases in England identified among these patients to date, this gives a crude incidence rate of 0.4 (95% confidence interval 0.2 to 0.7) per 10,000 person years of post-operative follow-up

• •  given that patients who underwent surgery between 2011 and 2014 may develop M. chimaera infections at a future date, we can estimate the additional cases that may be diagnosed amongst these patients using the crude risk above applied to the residual period that these patients remain at risk. This suggests an additional 10 to 27 such infections that could manifest themselves over the next five years. This would mean the eventual total number of M. chimaera cases for patients undergoing surgery between 2007 and 2014 will be between 25 and 42

 

[AKAFrench]

I received a notice from my hospital(The Mayo Clinic, Rochester, MN) stating that there was a possibility that I was exposed-OHS April 29, 2016. They stated that the risk on me developing the infection was less than 1%...they did not really give me a plan of action, but rather a list of symptom to look out for. At that percentage of risk, my mind is a little at ease. There are much larger risks associated with OHS that occur during surgery. I'm looking at this with a glass half full attitude and hoping for the best!

 

[AZ Don]

The HeartValveSurgery.com blog had an interview on this recently: http://www.heart-valve-surgery.com/...6/11/08/heater-cooler-machines-infection-cdc/
I read the transcript and receive the letter the next day that the machine was used in my surgery in 2013. There is low risk and nothing to be done unless you have symptoms.

 

[AZ Don]

I recently received a letter as well.

 

[DebbyA]

Consumer Reports has an article about this in the Jan 2017 issue. Most of the article concerns debate among hospitals, CDC and FDA about whether patients should be notified. The concluding section cautions prospective patients to ask whether the device will be used, whether it has been tested for contamination, and whether any cases have been identified. If you've had surgery, be alert for signs of infection like irritation around the incision, " unexplained fevers, night sweats, muscle aches, or weight loss" for up to four years.

I did get a letter from Tucson Medical Center stating that I had been identified as having had the device used during my surgery. It basically said "you may have been exposed to a deadly infection. it's too expensive/too much trouble to test you for infection. Since the infection is hard to track, if you have it, it will probably be serious before identified. Contact your surgeon or primary care physician for more information." I would be astounded to get information from either.

 

[Paleowoman]

Hi Debby - can you post a link to the consumer rights article please ? That's if it's availalbe online. I certainly have irritation around my incision, cardiologist first said it was costocondritis and then that it was the wires irritating ! I'm just now a weeny concerned since my pressure gradient has been steadily rising since surgery - from 33mmHg to 46mmHG in less thatn three years. But I don't want to take this conern about infection back to cardiologist until I know more !

 

[Agian]

It does sound like it's very rare though. Anyone who has had a recent operation is likely to have some irritation around the incision.
That letter Debbie quotes must've been written by a moron.

 

[DebbyA]

Paleogirl--you can link to other Consumer Reports articles from this one: http://www.consumerreports.org/doctors-hospitals/mayo-clinic-warns-patients-of-new-infection-risk/
(Consumer Reports is a paid subscription periodical. We get the hard copy but a separate subscription is needed to get all online content, so you may run into a roadblock with some of the links--I didn't check them out.) I googled "ntm infection" and came up with a boatload of links.

Again--I guess I'm the moron. That was my sarcastic summary of the message I interpreted from the letter. The only real quote was from the Consumer Reports article. I agree that it does sound rare, but also wonder whether it's just un- or mis-diagnosed.

 

[Paleowoman]

Thanks Debby ! I've bookmarked that Mayo Clinic link and will show my cardilogist that and the England public health link after my next echo in six months.....depending on the result !

 

[Agian]

Again--I guess I'm the moron. That was my sarcastic summary of the message I interpreted from the letter. The only real quote was from the Consumer Reports article. I agree that it does sound rare, but also wonder whether it's just un- or mis-diagnosed.

... and here I am thinking it was an official letter

 

[Paleowoman]

I contacted the hospital where I had my AVR and asked them the make of the heater cooler unit in the cardiopulmonary bypass machine. I just had a phone call from them - it was a Sorin T3 - this is one of the ones implicated in this. They assured me that they have indentified no cases of Mycobacterium Chimeara infection....yet - that's me that added the yet snce it's only going back to 2012 that this will have been a problem and it's only since 2015 that the medical establishement have become aware of it.