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“Leads are the weakest part of any device. They cause most device failures and all risk from extractions, and, hence, eradicating leads would be a very good thing.” Amir Zaidi speaks to Caroline Telfer, Assistant Commissioning Editor. Amir Zaidi qualified in 1989 from Manchester University (UK) and undertook postgraduate training in London and in the northwest of England. Dr Zaidi worked as a consultant cardiologist at Royal Bolton Hospital (Lancashire, UK) from 2002 until 2009 before moving to his current position of consultant at the Manchester Royal Infirmary (Manchester, UK). Dr Zaidi is currently the training program director for cardiology in North-Western Deanery and a member of the Cardiology Specialist Advisory Committee. What inspired you to undertake a career in cardiology?
Cardiology has a lot of attractions from a personal and a professional point of view. It’s very fast paced and constantly evolving, and I wanted a career that would develop over time, so I could gain new skills and learn new procedures throughout my consultant career. I think from a personal point of view, it is a specialty in which you can make a dramatic impact on patients’ lives with interventions; for example, we get very sick patients and can perform procedures on them, which can immediately produce dramatic improvements in their conditions, both in the short-term and long-term. We feel like we are having a worthwhile impact on patients’ lives. What is your career background?
I’m from Manchester (UK). I trained at Manchester Medical School (UK), did most of my training in the northwest of England, spent some time in London (UK), and became a consultant at the Royal Bolton Hospital (Lancashire, UK) in 2002. I then moved to the Manchester Royal Infirmary (Manchester, UK) in 2009. I’m now the lead consultant for devices and extraction at Manchester Royal Infirmary (UK). You were talking about the lead extraction devices. Why is there a need for cardiac device lead extraction?
Well, it used to be a relatively uncommon procedure when I was training, but there has been a huge explosion in the need for extraction in 10.2217/FCA.13.72 © 2013 Future Medicine Ltd
Interview
Amir Zaidi
Future Cardiology
Advances in cardiac lead extraction
the last 2 or 3 years. I think it is because patients are living for much longer with devices now. It used to be the case that they were largely put in elderly patients, and one pacemaker would last them the rest of their life. These days, we are doing a lot more repeat procedures in patients because they are living so much longer with devices, and, unfortunately, changing devices and revising devices brings a particularly high risk of causing complications that will lead to extraction. We are doing much more complex procedures on patients. The sort of devices we have put in take much longer to implant and are more likely to develop problems that need repeat procedures and, unfortunately, the main reason for extraction is because of infection. About 70% of the extractions that are performed worldwide are because of infection. The other reason for the rapid rise in extraction numbers is that defibrillator leads are more prone to failure than pacemaker leads and there have been a number of high profile recalls of leads recently because of premature failure. Cook Medical (Limerick, Ireland) has recently launched an advanced platform lead extraction technology, which has been trialed in various centers including Manchester, where you work. What technology was previously available for this procedure?
There were many different tools available. The problem with extraction is that leads are much more difficult to take out than they are to put in. The reason for that is that they get fibrosed, in a number of areas, particularly the Future Cardiol. (2013) 9(6), 775–777
part of
ISSN 1479-6678
775
Interview
Zaidi
lead tip, the superior vena cava and the insertion site under the clavicle, and what you need to do to effectively and safely remove leads is to cut the fibrous connections that hold the leads in place, without damaging the vessels or the heart. There are various cutting tools that are used to do that. Some people use electrocautery to go over the lead and divide the lesions to allow the lead to come out, some people use laser but I, and many other people, use various Cook Medical (Limerick, Ireland) tools, which have a rotating cutting edge that goes over the lead, divides the adhesions and allows the lead to come out. They are very good, but as with any technology, they are not perfect. The new technology that Cook Medical has introduced allows us to extract more effectively and safely. There are four new tools; two are improvements in the cutting tools: the Evolution® and the Evolution Shortie (Cook Medical). In the older models, the cutting edge rotated in only one direction and that worked pretty well, but what it tended to do was cause wrapping of the lead. Now the cutting tool can rotate in both directions sequentially, avoiding lead wrap, which allows the leads to be extracted more easily. There is also the SteadySheath™ (Cook Medical), which is an outer sheath that holds the cutting edge more securely and allows more effective extractions, and the One Tie™ (Cook Medical) that allows you to tie the end of the lead, particularly defibrillator leads, which gives a much more secure rail for the extraction tools to go over. In your personal experience with these devices, how long did you tend to monitor the patients for after the procedures?
Normally, it depends on the patient. Very often with extraction where we take the whole system – either the pacemaker or the defibrillator – the patients have to stay in hospital afterwards, waiting for the new device to be implanted. That’s usually for treatment of infection. If a single lead is being removed and a new one being implanted for lead failure, then often, the patients are able to go home the following day. What sort of end points are you looking for in these sorts of trials?
The key is efficacy with safety, as with any procedure. So using the modern tools, the clinical success of extraction should be in the high 90%. The mortality and serious morbidity of extraction should be very low. In the largest 776
Future Cardiol. (2013) 9(6)
trial, mortality was around 0.4% and major complications were around 1%, so those are the levels of complications that we are looking for as individual centers. Although it remains a complex and potentially dangerous procedure, I think these tools are definitely putting us in a better position to get leads out more safely and effectively. What do you think will be the next steps for these particular devices?
I think that one of the challenges is that we are moving into an age where we are going to see a lot more extractions because of patients living much longer with devices, and a lot more extractions of defibrillator leads, which is a particular challenge. The highest risk extractions come with defibrillator leads because of tissue growing into the coils in the superior vena cava, causing damage to the vessel when we do the extraction. I think we will have new extraction tools that will allow us to remove leads through alternative routes. Normally we take them out of the same vein in which they were implanted, but I think we are going to see a lot more extractions through other veins, particularly the jugular vein and femoral vein, and we definitely need better tools for achieving that safely. In your opinion, what have been the most significant advances in the field of interventional cardiology in the last 5 years?
The thing that has excited me the most on the interventional side is probably the development of transcatheter aortic valve implantation. I think that has been a huge development, which potentially means that a lot of the patients who were previously thought to be unfit for surgery for aortic valve disease or were forced to have very high-risk open heart surgery for aortic valve disease can now be treated effectively and much more safely with transc atheter aortic valve implantation. Hopefully, it is going to lead on to routine percutaneous valve replacement for the aortic and mitral valve in the future. What we are most excited about in the device world is the development of leadless pacemakers that are implanted directly into the heart, which is something that hopefully will be available in the next 6–12 months. I think that would certainly be the biggest development in the device world for decades. In terms of extraction, I think probably the biggest changes have been the development of new extraction tools such as Evolution, which have allowed us to perform extraction more safely and effectively. future science group
Advances in cardiac lead extraction
Where do you see the field in general in 5 years time? What sort of advances do you think will be made?
I think we are going to be a seeing a lot more of the procedures that previously have been the province of surgeons performed by cardiologists in hybrid laboratories. I think we are going to see a lot more routine valve work done percutaneously, rather than with open heart surgery. I think that the developments such as bioabsorbable stents will hopefully lead to even more effective percutaneous coronary intervention therapy. I hope that we are going to be able to do more complex device work without having to use leads. Leads are the weakest part of any device. They cause most device failures and all risk from extractions, and, hence, eradicating leads would be a very good thing.
future science group
Interview
Disclaimer
The opinions expressed in this interview are those of the interviewee and do not necessarily reflect the views of Future Medicine Ltd. Financial & competing interests disclosure
A Zaidi has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this manuscript.
www.futuremedicine.com
777
Manchester Royal Infirmary, Oxford Road, Manchester, Greater Manchester, M13 9WL, UK n [email protected]
“Leads are the weakest part of any device. They cause most device failures and all risk from extractions, and, hence, eradicating leads would be a very good thing.” Amir Zaidi speaks to Caroline Telfer, Assistant Commissioning Editor. Amir Zaidi qualified in 1989 from Manchester University (UK) and undertook postgraduate training in London and in the northwest of England. Dr Zaidi worked as a consultant cardiologist at Royal Bolton Hospital (Lancashire, UK) from 2002 until 2009 before moving to his current position of consultant at the Manchester Royal Infirmary (Manchester, UK). Dr Zaidi is currently the training program director for cardiology in North-Western Deanery and a member of the Cardiology Specialist Advisory Committee. What inspired you to undertake a career in cardiology?
Cardiology has a lot of attractions from a personal and a professional point of view. It’s very fast paced and constantly evolving, and I wanted a career that would develop over time, so I could gain new skills and learn new procedures throughout my consultant career. I think from a personal point of view, it is a specialty in which you can make a dramatic impact on patients’ lives with interventions; for example, we get very sick patients and can perform procedures on them, which can immediately produce dramatic improvements in their conditions, both in the short-term and long-term. We feel like we are having a worthwhile impact on patients’ lives. What is your career background?
I’m from Manchester (UK). I trained at Manchester Medical School (UK), did most of my training in the northwest of England, spent some time in London (UK), and became a consultant at the Royal Bolton Hospital (Lancashire, UK) in 2002. I then moved to the Manchester Royal Infirmary (Manchester, UK) in 2009. I’m now the lead consultant for devices and extraction at Manchester Royal Infirmary (UK). You were talking about the lead extraction devices. Why is there a need for cardiac device lead extraction?
Well, it used to be a relatively uncommon procedure when I was training, but there has been a huge explosion in the need for extraction in 10.2217/FCA.13.72 © 2013 Future Medicine Ltd
Interview
Amir Zaidi
Future Cardiology
Advances in cardiac lead extraction
the last 2 or 3 years. I think it is because patients are living for much longer with devices now. It used to be the case that they were largely put in elderly patients, and one pacemaker would last them the rest of their life. These days, we are doing a lot more repeat procedures in patients because they are living so much longer with devices, and, unfortunately, changing devices and revising devices brings a particularly high risk of causing complications that will lead to extraction. We are doing much more complex procedures on patients. The sort of devices we have put in take much longer to implant and are more likely to develop problems that need repeat procedures and, unfortunately, the main reason for extraction is because of infection. About 70% of the extractions that are performed worldwide are because of infection. The other reason for the rapid rise in extraction numbers is that defibrillator leads are more prone to failure than pacemaker leads and there have been a number of high profile recalls of leads recently because of premature failure. Cook Medical (Limerick, Ireland) has recently launched an advanced platform lead extraction technology, which has been trialed in various centers including Manchester, where you work. What technology was previously available for this procedure?
There were many different tools available. The problem with extraction is that leads are much more difficult to take out than they are to put in. The reason for that is that they get fibrosed, in a number of areas, particularly the Future Cardiol. (2013) 9(6), 775–777
part of
ISSN 1479-6678
775
Interview
Zaidi
lead tip, the superior vena cava and the insertion site under the clavicle, and what you need to do to effectively and safely remove leads is to cut the fibrous connections that hold the leads in place, without damaging the vessels or the heart. There are various cutting tools that are used to do that. Some people use electrocautery to go over the lead and divide the lesions to allow the lead to come out, some people use laser but I, and many other people, use various Cook Medical (Limerick, Ireland) tools, which have a rotating cutting edge that goes over the lead, divides the adhesions and allows the lead to come out. They are very good, but as with any technology, they are not perfect. The new technology that Cook Medical has introduced allows us to extract more effectively and safely. There are four new tools; two are improvements in the cutting tools: the Evolution® and the Evolution Shortie (Cook Medical). In the older models, the cutting edge rotated in only one direction and that worked pretty well, but what it tended to do was cause wrapping of the lead. Now the cutting tool can rotate in both directions sequentially, avoiding lead wrap, which allows the leads to be extracted more easily. There is also the SteadySheath™ (Cook Medical), which is an outer sheath that holds the cutting edge more securely and allows more effective extractions, and the One Tie™ (Cook Medical) that allows you to tie the end of the lead, particularly defibrillator leads, which gives a much more secure rail for the extraction tools to go over. In your personal experience with these devices, how long did you tend to monitor the patients for after the procedures?
Normally, it depends on the patient. Very often with extraction where we take the whole system – either the pacemaker or the defibrillator – the patients have to stay in hospital afterwards, waiting for the new device to be implanted. That’s usually for treatment of infection. If a single lead is being removed and a new one being implanted for lead failure, then often, the patients are able to go home the following day. What sort of end points are you looking for in these sorts of trials?
The key is efficacy with safety, as with any procedure. So using the modern tools, the clinical success of extraction should be in the high 90%. The mortality and serious morbidity of extraction should be very low. In the largest 776
Future Cardiol. (2013) 9(6)
trial, mortality was around 0.4% and major complications were around 1%, so those are the levels of complications that we are looking for as individual centers. Although it remains a complex and potentially dangerous procedure, I think these tools are definitely putting us in a better position to get leads out more safely and effectively. What do you think will be the next steps for these particular devices?
I think that one of the challenges is that we are moving into an age where we are going to see a lot more extractions because of patients living much longer with devices, and a lot more extractions of defibrillator leads, which is a particular challenge. The highest risk extractions come with defibrillator leads because of tissue growing into the coils in the superior vena cava, causing damage to the vessel when we do the extraction. I think we will have new extraction tools that will allow us to remove leads through alternative routes. Normally we take them out of the same vein in which they were implanted, but I think we are going to see a lot more extractions through other veins, particularly the jugular vein and femoral vein, and we definitely need better tools for achieving that safely. In your opinion, what have been the most significant advances in the field of interventional cardiology in the last 5 years?
The thing that has excited me the most on the interventional side is probably the development of transcatheter aortic valve implantation. I think that has been a huge development, which potentially means that a lot of the patients who were previously thought to be unfit for surgery for aortic valve disease or were forced to have very high-risk open heart surgery for aortic valve disease can now be treated effectively and much more safely with transc atheter aortic valve implantation. Hopefully, it is going to lead on to routine percutaneous valve replacement for the aortic and mitral valve in the future. What we are most excited about in the device world is the development of leadless pacemakers that are implanted directly into the heart, which is something that hopefully will be available in the next 6–12 months. I think that would certainly be the biggest development in the device world for decades. In terms of extraction, I think probably the biggest changes have been the development of new extraction tools such as Evolution, which have allowed us to perform extraction more safely and effectively. future science group
Advances in cardiac lead extraction
Where do you see the field in general in 5 years time? What sort of advances do you think will be made?
I think we are going to be a seeing a lot more of the procedures that previously have been the province of surgeons performed by cardiologists in hybrid laboratories. I think we are going to see a lot more routine valve work done percutaneously, rather than with open heart surgery. I think that the developments such as bioabsorbable stents will hopefully lead to even more effective percutaneous coronary intervention therapy. I hope that we are going to be able to do more complex device work without having to use leads. Leads are the weakest part of any device. They cause most device failures and all risk from extractions, and, hence, eradicating leads would be a very good thing.
future science group
Interview
Disclaimer
The opinions expressed in this interview are those of the interviewee and do not necessarily reflect the views of Future Medicine Ltd. Financial & competing interests disclosure
A Zaidi has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this manuscript.
www.futuremedicine.com
777
