Infection of a cardiac electronic implantable device (CIED) is a rare, but serious complication. We now know that, because of the appearance of biofilm on implants, these infections cannot be treated by antibiotics alone. As such, Worldwide Cardiac Society guidelines recommend complete system removal of all hardware, including the leads, when an infection is present. Although the guidelines are clear, too many patients continue to not get the appropriate treatment. Why is that? Mauro Biffi and Carina Blomström-Lundqvist, both experts in the field of lead extraction, see a lot of patients fall through the cracks. They discuss why and what the consequences are of not extracting in time but also: what is the recommended care pathway to improve the outcomes.
This series is supported by Philips.
- Oh, thank you Mauro, for this very nice introduction of this very important subject.
- Several patients are treated by antibiotics, because this is meant to be the cure for an infection. On the contrary, CIED infection is best managed by complete device removal. There are recommendations, not to say guidelines. What do they say Carina?
- Yes, they are very clear. There is only one answer, which is early and complete system removal, both for pocket infection and for systemic infection. And this is a Class I recommendation in the consensus document.
- So, this is a clear message. In case of doubt, when I see a patient, what should I do to confirm that the CIED infection is there?
- I think it's, the best is to refer the patient as soon as possible to an expert centre, or discuss with an expert colleague of yours, or if you feel comfortable, you can do the assessment yourself. And refer to the guidelines because they describe both the diagnostics and the management of CIED infection.
- Perfect. This is very helpful. Having a process that takes you to the diagnosis is the key step. What are the exams that I should do to confirm that CIED infection is present?
- It's mandatory to perform a transesophageal echocardiography, and at least three blood cultures. These two are mandatory. However, you may recover other investigations, such as PET-scan, CT, ICE, or SPECT. And without going too much into detail about this investigation, please go to the consensus document, and there are many more investigations that may be needed. Another thing, and is team approach, consult an infection specialist, and also, a thoracic surgeon about the suspected or confirmed infection. Extraction is always mandatory, as I said earlier, for both pocket infection and systemic infection. And the only thing that differs between those types of infection is the duration of the antibiotic therapy and the type of antibiotic therapy. And these recommendations are supported by major cardiac societies worldwide.
- Recently, the American College of Cardiology meeting saw the report of the Duke data, and they showed that only minority of patient with ICE, CIED infections were treated adequately. This is quite striking. What is causing this in your opinion?
- Yeah, this is indeed very striking. Well, patient is not aware of the device infection. They may ignore symptoms, or may not even be aware of that, a certain symptom is associated with a device infection. Physicians are not aware of the adequate treatment of device infections. So, these two problems, patient unawareness and physician unawareness.
- Are there barriers for referral of the patient to a centre who is capable to perform lead extraction?
- Yes, mentioned in previous podcast, it may be a real detective work to find, and to diagnose an infection. And it's very difficult, if you don't exactly know what tools to use. Another barrier may be the difficulty to find a, or identifying access to extraction centre, physicians perception. I find that it's not so infrequent, that physician often give repeated courses of antibiotics, and use a wait and see approach. For device infection, there is no such thing, wait and see. Physicians may also have low confidence in doing an assessment themselves. We know that from several European surveys. So, it's very important to implement the consensus document, and acquire more knowledge.
- This is quite important, because I believe that the consensus document fills the gap, that is, we can deliver widespread knowledge and avoid that, this suboptimal management occurs across Europe as well. Do you think that, what is actually happening in Europe is similar to the Duke University data?
- I would certainly suspect so. Even though there are no such reports in Europe, we know that there definitely certain under-reporting of device infection. In our centre, we studied this situation in Sweden. And we reviewed the infection rates, the electronic medical records, and to our surprise, the infection rate was quite high and there was a significant under-reporting to the device registry. So, if the infections are not reported, it would not be surprising to me, that the level of awareness on device infection treatment is comparable to the US data.
- Okay, got it. This is important. One thing that, it happens in my practise is that the patient is referred late in his clinical history. After several courses of antibiotics, as you've mentioned, because there is a perception of high risk in the extraction procedure. Is this true? Is really consistently a high risk in this procedure?
- Yeah, your perception is, in my experience also, and we have to break this perception, but there is more risk for the patient in waiting, than referring early. The risk for lead extraction or system, device infection extraction is lower if you compare the complication rate for PCI or TAVR. So, the complications are lower for lead extraction, as compared to these two procedures.
- This is a very strong message, because we normally accept to have a patient undergoing PCIs, or TAVR, or cardiac surgery, without even telling them the risk of mortality using the procedures. So here, we are in a lower range, and we should be comforted by this data. Can you tell me whether there is any difference in the management of patient who are treated with complete removal, versus those patients that are treated without device removal?
- Yeah, certainly, we know, first of all that the clinical success ranges to about over 95%, up to 97% with a very low procedure mortality, less than 0.5% according to recent registries. And most important, if you do nothing, the one year mortality is very high, 30 to 60% mortality. And you can also reduce the mortality by referring the patient in time. Early lead extraction is crucial. There are many studies, the crucial time, we have studies supporting a three day waiting time, and you should at least not wait longer than 10 days.
- Thank you very much. This is another important message. Be timely in your treatment. It just like as an acute aortic syndrome, we cannot delay treatment longer than 48 hours, because the majority of patient may be already dead. So, as always, we are not forcing generic widespread rush into a procedure, but everything shall be discussed in a multidisciplinary team, as you've mentioned, just for being timely in the patient management, and the patient shall be informed himself as well. I though say that it was a very nice talk with you. Because, indeed you led us through understanding why timely extraction is the optimal treatment in CIED infection. We have learned at least two very important things. One is, extraction is the only Class I indicator treatment in CIED infection. Two, extraction shall be timely. Today, I learned a lot, and probably the audience will want to know more about the details of the extraction procedure, but this is subject of another podcast, that I invite you to listen to, or visit the website deviceinfection.com. While thanking Professor Carina Blomstrom-Lundqvist, I'm wishing you a very nice day. Thank you so much to everyone.
- Thank you.