CDC Update: What Should You Know About Heater Cooler Machines, Infections & Heart Surgery?

By Adam Pick on November 8, 2016

In case you missed it… There was a very important CDC update recently that addressed a potential link between heater cooler machines and infections for heart surgery patients. My goal with this post is not to alarm you. Instead, with the help of Dr. Raymond Singer and the CDC, I want to educate you about this development.

That said, I filmed this video with Dr. Singer to discuss several key points that patients should know about heater cooler units and a potential infection that results from nontuberculous mycobacteria. For more, watch this video…

 

 

In addition to the Dr. Singer’s comments, I also wanted to share this video that was posted by the CDC about heater cooler machines and the potential bacteria that may infect heart valves.

 

 

Again… My goal with this post is not to alarm you or scare you out of having heart surgery. As Dr. Singer suggests, heart surgery remains safe and that many clinicians, companies and agencies are working together to manage this situation appropriately.

Keep on tickin!
Adam

P.S. For the hearing impaired members of our community, I have provided a written transcript of my video with Dr. Singer below.

Adam: Hi, everybody. It’s Adam with heartvalvesurgery.com. We’re coming to you live from the Heart Valve Summit in Chicago, Illinois. I’m thrilled to be here with Dr. Raymond Singer.  Dr. Singer, thanks for being here.

Dr. Singer:  Adam, great to be here.

Adam:  We were just talking, Dr. Singer, about a recent CDC release, and I was hoping you could help educate and make our community aware, all the patients out there, about what you recently learned.

Dr. Singer:  That’s right, Adam. It turns out the CDC, or Centers for Disease Control, released an advisory to patients and to hospitals and doctors, and the FDA has also released recommendations, regarding a somewhat unusual infection that may be related to people who have had open heart surgery. It turns out that there is an organism known as NTM, which stands nontuberculous mycobacteria. That’s different than tuberculosis itself. These organisms may be associated with a machine that is often used in open heart surgery.

Now, it turns out it’s not actually the heart-lung machine, but it’s a machine known as a heater-cooler device. When we do open heart surgery, we often have to lower the patient’s body temperature down and then rewarm them. This is a device that was made in Germany, and this device contains water. It turns out that these organisms are somewhat ubiquitous in all of nature. They’re in the ground; they’re in water. It may be the case that this particular device that was made in Germany may have been contaminated during the production cycle.

Now, what is the risk to you? It turns out that patients who have had open heart surgery may have been exposed to this organism. That doesn’t mean that you necessarily are infected; however, there have been reports of infection. Now, the CDC believes that the infection rate can range from anywhere from 1 in 100 patients to 1 in 1,000. One of the key factors are whether or not the patient has immunocompromised state. Patients who have immunosuppression or immunocompromised for one reason or the other are more at risk for developing an infection.

One of the problems, Adam, is that these infections can be very insidious. It may take months or even years to show up. Sometimes patients may not realize that it’s due to this particular infection. The symptoms can be as simple as fever or malaise, or it can be as serious as infection of a heart valve or even infection of your liver.

What should you do? If you’ve had open heart surgery, it is likely that you’re going to receive a letter from the hospital where you had your open heart surgery. That shouldn’t get you alarmed. It doesn’t mean that you are infected. It turns out that there is not a screening test to determine if you’ve been exposed. However, if you have developed an infection, your doctor can do a test to determine if that infection is due to this nontuberculous mycobacteria infection.

The other thing I want to reassure all of your patients is that having open heart surgery today is very safe, in fact, probably now today more safe than ever because of the FDA recommendations not only on the machine, but how to maintain the machines going forward, and how to do the proper cleaning. There is a lot of other advice that the FDA is giving, and all hospitals around the United States are adhering to this advisory.

The bottom line is it’s a concern. If you have a concern, contact your doctor and/or hospital, and please go forward. Open heart surgery is still safe, and we are paying attention to these developments.

Adam:  Dr. Singer, thank you so much for bringing this very important topic not just to me here at the conference, but to all the patients in our community, and giving us the reassurance to know that open heart surgery is still very safe, and that the FDA, the clinical teams, are working to fix this issue and address this issue. Thank you so much for what you’re doing.

Dr. Singer:  It’s my pleasure, Adam. Thank you for all you do for our community.

Adam: Thanks so much. As we always say here, Dr. Singer, keep on ticking.


Written by Adam Pick
- Patient & Website Founder

Adam Pick is a heart valve patient and author of The Patient's Guide To Heart Valve Surgery. In 2006, Adam founded HeartValveSurgery.com to educate and empower patients. This award-winning website has helped over 10 million people fight heart valve disease. Adam has been featured by the American Heart Association and Medical News Today.

Adam Pick is a heart valve patient and author of The Patient's Guide To Heart Valve Surgery. In 2006, Adam founded HeartValveSurgery.com to educate and empower patients. This award-winning website has helped over 10 million people fight heart valve disease. Adam has been featured by the American Heart Association and Medical News Today.


Gary Stripling says on November 8th, 2016 at 5:00 pm

Thanks for sharing this, Adam. Since I had a mitral valve repair (via open heart surgery) and not a valve replacement, am I still at risk? I guess I need clarification on whether this is pertinent to ONLY those with valve replacements or everyone who underwent OHS, even if for a MV repair.



Adam says on November 8th, 2016 at 6:30 pm

Gary, Great question. I just sent an email to Dr. Singer to get his thoughts. Stay tuned. Best regards, Adam



Adam says on November 8th, 2016 at 11:43 pm

Gary, This just in from Dr. Singer, “It’s all patients who had open heart surgery using a heart-lung machine and the Sorin heater-cooler. It’s the Sorin (now LivaNova) heater-cooler machine, not the heart-lung machine per se. The only open heart procedures not affected would be “off-pump/beating heart” CABG surgery. All open-heart valve procedures would be potentially impacted.”



Gary Stripling says on November 8th, 2016 at 11:49 pm

Thanks Adam! I’ll check with my cardiovascular surgeon about which cooler Florida Hospital uses.



Donna Kowall says on November 12th, 2016 at 6:24 am

Was this machine used in 2011?



barbara gard says on January 17th, 2017 at 11:12 am

Yes, in some hospitals. My surgery was at Robert Wood Johnson University Hospital in NJ. According to the letter they sent to me, they have been using the Sorin 3T since 2009.



Donna Kowall says on January 17th, 2017 at 3:15 pm

I did have open heart surgery in June 2011. Nine months later I ran a continual low grade fever for over two weeks that included night sweats. I went back to my cardiologist who did an echo and pronounced my valve fine. Another week and a half went by with my low-grade fever. I went to my PCP and asked about the possibility of endocarditis. After a TEE they ruled I did have an infection on my heart valve and could not pinpoint the cause. I found a new cardiologist who sent me to an infectious disease doctor who treated me with six weeks of IV antibiotics and they were able to save my valve. This cost me another $5000 deductible— not to mention the emotional stress of wondering whether or not I would have to have an
other open-heart surgery—but they were able to save my valve. I will always wonder if it was because of the heat/ cooler that was used during my AVR which of course I will not be able to prove.



Rebecca Sutphin Reed says on February 12th, 2017 at 8:31 pm

Husband had off pump heart surgery, and 2 sternum nonunion surgeries in hospital that used heater cooler in news. Chest infection last 14 months. He has severe Rheumatoid Arthritis for 20+ years. Is machine ever used or patient at risk if in this situation. Hardly trust hospital to inform. He is still seriously ill 17 months post 1st surgery.


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