- Welcome. This is Nicola Montano, professor of internal medicine at the University of Milan, Italy. After having heard the need for extraction in the previous podcast, you are probably curious to know more about this procedure. So here I am with Brigitte Osswald, head of the Electrophysiological Surgical Programme at Johanniter Hospital in Duisburg, Germany. She has done over 3,500 extractions so far. Quite an impressive number. Hello, Brigitte.

- Hello, Nicola.

- Thank to you to be here and to share your time with us. So let me ask you, when a patient needs an extraction, what do you say to your patient to explain the procedure?

- Well, I explain the fact that we perform the operation from the CIED incision side and that we use dedicated high-tech tools for this procedure. Furthermore, I describe the tools and draw some sketches of each tool to give some idea how it looks like and how it works. Another important part is the fact of being prepared at all times for the unlikely, but possible event of a complication. At the end, I ask whether there are further questions. I really take my time to explain and I find this very important.

- I fully agree with you, Brigitte. This is the most important part. I have to say that we did a small study here looking at the difference of saying and not saying to the patients everything that is related to all the possible complication and effects. And I have to tell you that the compliance and also the relationship with the patient becomes even more stronger, more trustable. Patient like physician who explain exactly what are the good and the bad of our procedure. So I really think that it's important. So to move on, when we talk about extraction, what is done in the procedure?

- Well, in case of infection, either pocket or systemic infection, all foreign CIED material must be completely removed. This means the generator box, all wires, or lead that go into the heart, used sutures, and so on. The reason for this radical treatment is the high risk close to or equal 100% of reinfection if some part related to the infected device is left behind.

- Interesting. And who is involved in the procedure?

- Well, this procedure is done by either a cardiac surgeon like me or by a cardiologist or electrophysiologist. Best, the procedures are performed by a whole team where we have well-trained persons for minimal invasive lead extractions and open heart procedures as well.

- Thanks May I ask you in easy terms, what are the main step in the lead extraction procedure?

- Well, to be honest, I put every patient on a general anaesthesia for any lead extraction. It doesn't matter about the dwell time or whatever. So we prepare the patient for safety measures and constantly monitor the heart rate but also blood pressure and central venous pressure. If needed, we imply a temporary wire to ensure a stable heart rhythm during and also after the procedure. We also create a femoral access and place a safety wire for the rare occasion of a complication. Then we have the steps of the procedure itself. It consists of three. First, we remove the generator, then we extract the leads, and finally we check the wounds and close the skin.

- Well, thank you. And you mentioned that this is a minimally invasive surgery. But with the electrodes sitting in the heart, how do you exactly extract them?

- Well, first we prepare the leads for removal which means we use a dedicated device to grab the lead from the inside. This device locks the lead completely over the whole length. When leads are adhered to the vessel wall, we use extraction sheath which go over the leads and are able to cut through the adhesions. It depends on the amount of and the type of adhesion which of the tools we need. In the most easy case, we just can take the leads out by gentle pulling. In fact, in one of three leads about this will work. But when the leads are more adhered to the surface, then we need additional tools. Depending on the case, we start either with the laser or a rotational mechanical rotational sheath. When we have these dedicated instruments available for a procedure, we achieve in more than about 97% the complete removal of the system. And if required, remaining lead fragments can be removed by femoral or other techniques.

- Thank you. That's interesting. And so what happens when the device and the leads are taken out?

- Well, when there is an infection, the pocket is cleaned. If necessary, a temporary external pacemaker is used and so the heart of the patient continues to receive the support which is necessary. Antibiotics are given to cure the infection and if the related blood samples indicate very low or absent infection levels, a new device can be implanted at the contralateral site.

- Thanks. And what about the patient? How long is the recovery time for the patient?

- Well, the extraction recovery is rather quick because it's a minimal invasive procedure. But in patients with severe sepsis or a severe infection, the recovery may be prolonged. As usual, hospitalisation duration depends on the status of the patient.

- Good, thanks. And is there any follow-up needed for the patient when is discharged?

- Well, it's best to follow the patient on a regular basis. This can be done in the local HCP network or by general practitioners. Nevertheless, the patient should always go back to the recurring physician because they know their patients best.

- And let's talk very briefly about the safety profile. As mentioned in the previous podcast, there is the living perception that extraction is dangerous and there is something taken out of the heart. And I have some experience of patient actually and also physician just referring to me with this word. But in fact, the contrary is true. Is they're more dangerous for my patient to leave the leads in the body. And I also saw recent data that this procedure is even safer than other common procedures such as PCI. Would you mind to comment on that?

- Yes, sure. Because I did also make the same experience as you and we have indeed to break this perception of a high-risk procedure. As mentioned between previous podcast, there is more risk for the patient in waiting than referring and extracting early. Most importantly, when we do nothing, one in three patients will die within the first year. This is amazing. And with the modern tools we currently have available, we can do this procedure very safely with a very low procedural mortality which is less than 0.5%. This is even lower going to compared to other standards and standard procedures like PCI.

- Thank you very much, Dr. Osswald for giving insights on how extraction are performed. And I would like to summarise the three more important evidence. First in that in the case of infection, everything needs to be taken out, the box and the leads. Second, that lead extraction is done by minimal invasive surgery and specialised tool are available to the operator. And third, the patient recover well, and after discharge, they can continue the normal way of living. So putting ourself in the shoes of the patient, how do they feel about CIED infection, about extraction. So if you want to know more about it, go and check our next podcast or visit the website, deviceinfection.com. Thank you very much.

- Thank you.