Podcast Episode 6: From Guidelines to Registries: Strategies for Better PAD Care

Peripheral arterial disease (PAD) remains a pressing issue both clinically and in terms of health policy. This is partly because, in everyday clinical practice, it is often diagnosed too late, treated inconsistently and not adequately addressed at a structural level

In this episode, PD Dr Barbara Rantner speaks with PD Dr Ulrich Rother, senior consultant at Erlangen University Hospital, head of the PAD Commission of the German Society for Vascular Surgery and a key contributor to the new S3 guideline on PAD.

The discussion covers the enormous relevance of the condition, the work of the Commission, the establishment of a much-needed registry, the most important updates in the guidelines – and the question of how walking training, revascularisation and lifestyle changes can be implemented in practice.

Which treatment takes priority? How do we manage the very elderly patient group? And why must vascular medicine create better structures for walking training and prevention?

A practical yet forward-looking discussion about an underestimated widespread disease – very much in keeping with the DGG motto: “We think ahead when it comes to blood vessels.”

Topics in this episode:

• The work of the DGG’s PAD Commission
• Why a nationwide PAD register is crucial
• The new S3 guideline: conservative therapy, walking training, revascularisation
• Endovascular or open surgery? A nuanced look at Best-CLI and BASIL-2
• The importance of structured walking programmes and the challenges of implementing them
• Geriatric patients: individual treatment goals, frailty and quality of life
• Where the greatest gaps in care lie – and what needs to change

Questions or feedback? Would
you like to get in touch with the editorial team or the experts? We look forward to hearing from you at: podcasts(at)medizinkommunikation.org

Rantner: Welcome to a new episode of “Focus on Vessels”! 

My name is Barbara Rantner; I am a vascular surgeon and senior consultant in Munich.

This podcast is designed to offer you, our listeners, a platform to delve deeply into the topics that shape and advance our field. Together with our guests, we’ll explore the latest developments in surgical, endovascular and preventive vascular medicine and discuss current issues from the worlds of science, teaching, clinical practice and the clinic. True to our motto: “We’re taking vascular medicine further!”

Today we are focusing on peripheral arterial disease, the most prevalent vascular condition when looking at prevalence and incidence figures.

To this end, I am speaking today with Senior Registrar Dr Ulrich Rother. He works as a senior registrar at Erlangen University Hospital and chairs the PAD Commission of the German Society for Vascular Surgery. He is a recognised expert in the field of PAD and played a leading role in the development of the current S3 guideline on PAD. 

That is why I am particularly pleased to be able to discuss this important topic with him. Dear Uli, it’s great to have you here today; I’m really looking forward to our conversation.

Rother: Yes, dear Barbara, thank you very much for inviting me today and for the opportunity to focus on this topic.

Rantner: Uli, as I mentioned briefly, you chair the PAD Commission of the DGG, our professional association. The very fact that there is a dedicated commission for this condition underscores its relevance to the general population and, of course, to us in vascular medicine. Perhaps you could give our listeners a brief insight into what the commission’s work involves, what you focus on and where your priorities lie.

Rother: Peripheral arterial disease (PAD) is the main focus of our committee; after all, it is the widespread condition that we, as vascular specialists, deal with. 

If we are to believe current studies, approximately 237 million people worldwide suffer from PAD. In Germany, the figure is around 4.5–5 million people. A very recent Danish study also forecasts the trend, attempting to calculate and predict it using various models, and we expect to see a rising prevalence right up to the years 2030 and 2040. 

We, as the Commission for PAD and Diabetic Foot Syndrome, have ultimately set ourselves the goal of raising awareness of this widespread condition and improving the care system. What we are trying to achieve here is quite multifaceted; on the one hand, we are trying to raise awareness, for example through a Vascular Health Day. This is organised once a year by our professional association – the German Society for Vascular Surgery and Vascular Medicine – and most recently, PAD was the focus of this event. We played a very supportive role in this as a commission. Then, another point is that we would like to collect more data on what is happening in Germany in the field of PAD care and the outcomes associated with it. One key aspect here is the registry, which we are trying to support and get off the ground as a committee. Another area in which we are involved as a committee is supporting the development of a guideline; the new one has just been published. I think, Barbara, we’ll be coming round to that in a moment.

Rantner: Thank you very much, Uli. You’ve given us a great insight into PAD across its various severity levels and have clearly highlighted the relevance of the very widespread condition of atherosclerosis. I’d now like to briefly revisit the topic of registries. The relevance of care registries is, of course, a subject of frequent critical debate. If we’re honest, everyone is already stretched to the limit in their daily clinical practice by bureaucracy, documentation requirements and these obligations, and the motivation to then also deal with registries is, in some cases, very low. We need to think carefully about what is recorded in a registry so that we can actually provide really good analyses, and that’s why I’d be interested to hear where you see the benefits – and perhaps also the necessity – of a nationwide registry, and whether you believe the advantages would outweigh the effort involved. 

Rother: Yes, Barbara, I think you’ve really hit on a critical point. Anyone among us who hears the word ‘register’ in day-to-day life probably immediately has major concerns and reservations about all the work and additional documentation it entails. Everyone is certainly already sufficiently confronted with this in their daily work. Nevertheless, we need to consider the pros and cons of such a register. I think one important point is that, through our professional association, we have the German Institute for Vascular Medical Health Research (DIGG) at our disposal, which is now under the new, highly motivated leadership of Mr Behrens, who can simply provide support in collecting such data and establishing such a registry. 

I believe the registry itself clearly has many advantages from my perspective; we must realise that we are ultimately the largest professional association of vascular surgeons in Europe, with well over 3,000 members, and this naturally gives us enormous potential to actually enter all the treatments we perform into this registry. We can thus really contribute a relevant registry, even in a European comparison, and this will certainly be well received at an international level.

If you look at what current publications, including those in the European Journal of Vascular and Endovascular Surgery, are ultimately focusing on, these are often registry studies that are being featured, and at present these registry studies are predominantly coming from Scandinavian countries. However, this has resulted in truly outstanding publications and the collection of very good data. If, for example, we wish to participate in the Europe-wide Vasconet consortium – which is essentially a network of existing European registries – then we must, of course, also submit a German registry in order to ultimately access this data and contribute to it. 

If we have such a registry, however, I believe it also presents an opportunity for young researchers who ultimately input data into these registries to access this data, develop studies based on it, and ultimately generate impact for their own research and careers. 

And a completely different point which, I think, could certainly be relevant for our professional association and for the DIGG is that we can, of course, perhaps also consider a collaboration with industry. We can input and include the wide variety of treatment strategies and the diverse range of devices we use into these registries, thereby analysing the results of the various devices. This is, of course, of interest to industry and, in turn, can secure funding for us if we enter into such a collaboration under these conditions.

What I think is clear is that registers always mean extra work; ultimately, they mean additional effort for each individual, but for me the advantages that arise here clearly outweigh the disadvantages – on the one hand for individuals personally, because ultimately we are producing scientific output, but also for our professional association itself, because we can simply be perceived much better on an international level.

Rantner: I’m keeping my fingers crossed that the pAVK registry can finally get off the ground. Well, we’re currently focusing on the aorta; the carotid artery is in a slightly better position because it’s simply a legal requirement that quality documentation must be carried out there. On the subject of registries, perhaps a personal word from me: the idea that ‘we could network with industry’ is, of course, a bit of a double-edged sword, as I’m sure you’ve experienced yourself. There are always these industry-sponsored efforts to bring certain devices to the attention of users in the first place, and if you imagine that now combined with registry data, then you naturally have to assess the data quality somewhat critically, if I may put it that way. Because if it’s industry-sponsored or industry-supported, and then it’s only ‘register data’ in inverted commas rather than randomised data, then it probably loses a bit of its value – or how do you see it?

Rother: No, absolutely, I’m one hundred per cent on your side there. I think it’s more about the fact that we can, so to speak, collect the data and look at devices; these are, of course, a far cry from an industry-sponsored study. So I believe the point and the difference lie quite clearly here. What shouldn’t be carried out here is an industry-sponsored study, which we’ve been dealing with very frequently in everyday life across all the recent publications, which is why we simply don’t yet have large datasets for many of these devices either. The advantage is simply that devices currently in use can step in here and thus generate independent data for this purpose.

Rantner: ‘Independent data’ is the perfect cue for my next question. I’ve been incredibly busy of late, and I can still see a few lingering wrinkles on your forehead from updating the AWMF S3 guideline. That’s the highest-level evidence guideline on peripheral arterial disease. It’s an interdisciplinary document. I had a quick read through it whilst preparing for our conversation and noticed it’s exactly the same number of pages as the carotid guideline – so it’s a very substantial piece of work. Why don’t you tell us a bit about how the guideline came about? Perhaps you could share a few highlights with us. There’s been quite a lot happening recently in the field of PAD, and there are a few critical or much-discussed publications – perhaps you could give us a brief summary of those.

Rother: Yes, I think the wrinkles are gradually smoothing out; especially as my upcoming holiday approaches, I’ll look perfect again. Still, I think you’re right – it’s true, of course, that the AVK guideline has turned into quite a mammoth undertaking. I think anyone who has taken the trouble to read through all the pages can see that we have put a great deal of effort into it and the workload was considerable; and as I believe is the case at the outset of any such guideline, the expectations of the individual professional societies involved are always enormously high. Naturally, everyone believes that the technique they themselves are best at is actually the one that is undoubtedly best for the patients too. And as such a guideline develops, you increasingly realise how you grow closer together, critically discuss viewpoints, come to an agreement, and then perhaps, after a beer at the bar in the evening, can simply discuss these matters again the next morning with a fresh perspective and new insights. I think the critical points are particularly obvious in the field of PAD treatment. Ultimately, these are conservative therapy, including drug therapy, and then the question of revascularisation – a major point of contention, or rather, I would call it a major point of discussion: should it be endovascular therapy or open surgery? 

We have also placed a few key focuses on other areas, namely geriatrics. Firstly, there is a chapter that deals with geriatric patients holistically and is dedicated to them. I think this is clearly a growing group within our patient base, and we have also critically examined the relevance of lifestyle changes and the influence of lifestyle on outcomes, whilst clearly identifying gaps in care. 

If we go through the series step by step, it is the case that a very significant emphasis has been placed on conservative therapy. Ultimately, this refers to exercise therapy, and quite clearly to walking training. We know from a great many studies, including prospective controlled randomised trials, that walking training is simply the first-line treatment for intermittent claudication. And this is how we have addressed and recommended it in the guideline. Ultimately, all patients suffering from intermittent claudication should initially receive walking training. This should ideally be structured and last for 3–6 months. And then, if this proves ineffective, interventional or surgical treatment should only be considered at that stage. It is also crucial that, even if this walking training ultimately proves ineffective and we have carried out open surgery or interventional treatment, walking training must continue afterwards, so that it is, so to speak, provided alongside the interventional or surgical therapy.

Rantner: May I just jump in here briefly? We discussed walking training recently at the DGG board meeting, because vascular exercise groups are somewhat neglected, or simply because setting up such groups is very difficult. It is poorly remunerated. Hardly anyone can be found who wants to dedicate themselves to the subject. Now, of course, it is a major challenge when even the guidelines state that this should be made available and applied as the first-line therapy for PAD patients and those with claudication. Is unaccompanied walking training sufficient, or should it actually now be structured, supervised walking training? What is the evidence on this?

Rother: Well, ideally, walking training should take place at all. There are all sorts of variations; ideally, of course, there is structured walking training, but ultimately the other forms available can also be used, and these are just as effective in the long term. So the crucial thing is that walking training takes place at all. We have, in fact, recently investigated together with Mr Behrend what the actual possibilities are for offering walking training at all. And there we see that, ultimately, on the healthcare provider side – that is, those who actually make the recommendation to undertake walking training – there is a clear need for improvement. Specifically, we as vascular surgeons. And the situation is actually even worse when it comes to healthcare infrastructure – where does such structured walking training actually take place? Ultimately, there are no walking groups that patients can turn to. This is a major focus of our commission as well, as we are trying to address this problem. I can report from personal experience that here in Erlangen, for example, we have ultimately managed to set up such a walking group. Ideally, this can be achieved by consulting local sports clubs. There are often coaches here who either have training in cardiac rehabilitation and can undertake additional training in walking exercise, for example, and then offer a walking exercise group. This is also funded by health insurance providers, so I think that if we make use of the existing local structures, there is certainly an opportunity for each and every one of us to get something off the ground here, and that is something which I believe our professional association should also support.

Rantner: Well, that’s great that you’ve had such good experiences with this yourself. We’ll gladly take that on board. And anyone listening who’s interested might then get in touch with you to get a bit of support on how to implement this in their own hospitals. Because the need is actually very high and implementation isn’t always that straightforward. 

Rother: Exactly, absolutely. Another point that was highly relevant in the guideline and, I think, was among the most hotly debated was the question of the revascularisation strategy. The very specific question is rather: endovascular first or open surgery first? That’s the key message the guideline is meant to convey in the end and the principle it should stand for. And here, one might need to look a little at the development history of the guideline. We’ve been on quite a journey with the guideline. We spent about two and a half years getting this work off the ground, and that period was very turbulent in terms of what was happening internationally on the scientific front. So when we started, the reality was that we actually only had a single randomised controlled trial on how revascularisation should be carried out in the stage of chronic critical limb ischaemia. That was essentially what this question was all about, namely the BASIL 1 study, which is, after all, quite old and which essentially concluded that the benefit of open-surgery bypass revascularisation is present after two years if a vein is available, but otherwise the endovascular revascularisation strategy may well have advantages. 

We then began work on the guideline with these considerations and this knowledge in mind. Next came the major Best-CLI study from America, which was published, and all the surgeons involved in this guideline were delighted, because for the first time, what we had all essentially felt in our hearts was finally published: that bypass is quite clearly the best revascularisation strategy. The key message ultimately conveyed here was that, provided a suitable vein is available for the bypass, bypass surgery is beneficial. This was primarily driven by the reintervention rate from the endovascular side, but also by the hard outcome of amputation rates. 

Then, after we had discussed this area very intensively, the setback for the advocates of bypass surgery finally arrived: the BASIL 2 study. At first glance, this actually conveyed exactly the opposite, namely that bypass surgery is responsible for and leads to a 35% higher risk of amputation and death. So ideally, we should avoid performing bypass surgery wherever possible and instead favour endovascular therapy. And against the backdrop of these study findings, we met to discuss the matter, and I think, as listeners can imagine, this discussion was certainly not entirely unbiased or easy to conduct.

The key point was that we basically had to delve into the studies and examine them more closely: what are the inclusion criteria, what are the limitations of the individual studies, what are they comparing with one another, and are these studies comparable with one another? And if you look at it a bit more closely, the fact is that, ultimately, both studies actually have problems, if we’re honest. On the one hand, Best-CLI had to be stopped prematurely – or rather, the randomisation or patient recruitment had to be halted – because funding ran out, even though they had actually secured millions for it. 

Then BASIL 2 also failed to reach its target patient number, mainly because the COVID-19 pandemic threw a spanner in the works of patient recruitment. Furthermore, the severity of AVC was defined rather poorly in both studies – that is, the underlying angiomorphological basis. Furthermore, in Best-CLI the interventions were performed mainly by vascular surgeons, whereas in BASIL 2 they were performed mainly by interventional radiologists. That, of course, was a major point of discussion. And then there is the fact that the mortality rate in BASIL 2 tended to occur after 2 or 3 years and was not actually associated with the procedure, so the question then arose: were sick patients perhaps included here? So, it must be said that, ultimately, both studies are simply the first prospective, randomised, large-scale controlled studies we have on this topic, but they both clearly have weaknesses. And based on these points, I think we were able to reach a relatively good consensus in the end on what we should actually recommend. We were then able to define decision-making criteria that can simply be consulted and used as a guide. 

A major question here is: is there a donor vein available that can be used for bypass grafting? What is the patient’s surgical risk? What is the complexity of the vascular pattern, the occlusion pattern – in other words, how long are the occlusion segments? What is the condition of the tissue; is there an infection? But also, what are the technical resources like? Who can do what in a hospital? And above all, what is the expertise of the treating team? These are ultimately the decision-making parameters that we have listed and defined here. And so, in the end, the conclusion was that we have moved away from an ‘Endo First’ or ‘Open Surgery First’ approach; instead, one must consider the patient and the circumstances in which they find themselves. 

Rantner: Yes, well, it’s a bit of a ‘same same but different’ situation. Personally, I found it a bit unfortunate that the publications were somehow fired off in such quick succession. Because, as you say, there wasn’t really that much comparability between the patient groups and the research questions, and there were certainly relevant differences; naturally, everyone then picked out what suited their own interpretation, based on their own skills. And, as you say, in line with their own preferences and capabilities. The topic of technology in PAD also interests me, because, alongside the aorta, PAD is certainly the most material-intensive – or perhaps even more so – area of vascular surgery, and it’s incredibly fast-moving. I grew up with the very traditional Fogarty catheter for treating cardio-embolic ischaemia of the leg. Nowadays, it is expected that clinics wishing to treat peripheral circulatory disorders will keep certain materials in stock. Where do you think this is heading? I’m asking this quite deliberately against the backdrop of the Hospital Structure Improvement Act, because PAD is, of course, a relevant field that everyone would like to continue with as far as possible. But perhaps, in reality, they won’t be able to meet the demands at some point. What’s your view on this, Uli?

Rother: Yes, I think that is a key, critical point, which also came up during the development of the guideline. The question was, after all, that nowadays you really need a whole array of wires, stents, drills, catheters and other devices for the optimal treatment of AVC. The question was, to what extent should we actually make recommendations for individual devices? And if you look more closely at the literature, the reality is that there isn’t really any robust long-term data with clear recommendations for the guidelines regarding the individual devices. The situation is this: we naturally have a great many 6-month and 1-year results for the individual devices – such as rates of restenosis, for example, or reintervention rates – but genuine long-term data are simply rare. And if you now look more closely at the recommendations for action provided in the guideline, they cover plain old balloon angioplasty, simply the oldest procedure, then stent angioplasty, either with self-expanding or balloon-expandable stents; covered stents are also mentioned, and drug-eluting balloon angioplasty. All other devices are briefly mentioned in the main text, but are not accompanied by clear recommendations for action, simply because the evidence for them is still too limited. I think what becomes clear, however, is that if we wish to successfully perform PAVK treatments in the future – perhaps against the backdrop of the Hospital Structure Improvement Act – it is important that we have clear treatment pathways in our clinics and that we are ultimately able to offer both methods, i.e. open surgical procedures and endovascular procedures, with a high level of expertise. To achieve this, it may be that the vascular surgeon themselves is highly proficient in both; however, it may also be that these procedures, as is the case in our hospital, can simply be carried out to a very high standard and with perfection through interdisciplinary collaboration. Ultimately, this means that we must ensure we can provide endovascular care, but also open surgery at a high standard. That is ultimately what we must guarantee in order to treat patients adequately. I think it is less about a single device and more about ensuring both options are available at a high standard. And this can be demonstrated, for example, within the framework of vascular centres, where it is examined and analysed whether clinics can provide this, or indeed in well-established facilities that are capable of carrying out the whole procedure. I think what is important, and what we have also expressed in the guideline, is that if another method is clearly better and cannot be performed on-site at a clinic, then it would certainly be worth considering transporting and transferring patients to a centre for that purpose, for example.

Rantner: Uli, the final topic, the last section I’d like to discuss with you – you’ve already mentioned it – is the issue of geriatric patients. We’ve already had a podcast on age-related regulations in carotid surgery. Do there need to be regulations regarding indications in this regard? Peripheral arterial disease (PAD) can, of course, also affect the very elderly; I mean, it’s also quite common among younger patients. What have you included in the guidelines regarding this? I’ve been aware of this and was also able to contribute to the book that has now been published on the subject. Why don’t you tell us what you’ve specifically outlined in the guidelines for geriatric patients? 

Rother: Yes, I think for geriatric patients it is crucial that we simply consider what, so to speak, is the goal – the therapeutic goal – for a geriatric patient? The key is that we do not look at chronological age, but rather biological age, often expressed through frailty. If we keep that in mind, so to speak, it may well be that for an 80-year-old, for example, claudication is extremely debilitating because they are simply very mobile; yet in the majority of cases, there is likely to be a different goal behind treatment for an 80-year-old or a 90-year-old patient than there might be for a 60-year-old patient. And I think the crucial point is that we set individual treatment goals here and achieve them with as minimally invasive an approach as possible. It may be, for example, that the focus is on freedom from pain, meaning that major reconstruction may not be essential, but in my view, the priority must always be – or the decisive factor must always be – that we ultimately focus on limb preservation. In some cases, the aim may simply be pain management in the sense of basic palliative care, which may well be the patient’s goal for a treatment regimen.

Rantner: And the treatment options should, of course, always be adapted somewhat to the patient’s expectations, so to speak. I mean, there are plenty of patients who’ve already become so fixated on a particular treatment by the time they enter the hospital that urgent guidance is often needed to somehow convince them of the medically most sensible course of action. Have you documented anything on this, or how do you see it?

Rother: No, I absolutely agree; you have to talk to the patient. Just because it might have been written somewhere that major bypass surgery is actually the best option, that doesn’t mean it’s necessarily the best in an individual case. I think we need to decide together with the patient what our treatment goal is, what such an intervention means for the patient individually, and what kind of immobility or morbidity might come with it. And then decide together what’s right. I think that, particularly with a geriatric patient population, it’s simply not a black-and-white situation, but rather there are many shades of grey in between. This decision simply has to be reached together with the relatives, but also with the patient. 

Rantner: Yes, Uli, thank you very much for this fascinating exploration of PAD. I think it has become very clear why PAD must be regarded as a widespread condition. And that we should continue to invest a great deal of energy and effort into the care of affected patients. Perhaps just a very brief summary and a final question from me: where do you currently see the most pressing issues in the care of PAD patients, and where does the most work lie – perhaps for the DGG as a society, but also for all disciplines involved in vascular medicine?

Rother: Yes, I think the key point is what has already been mentioned today: we must view PAD as a widespread disease that incurs enormous costs for our healthcare system. It is a condition that ultimately affects more than just the legs and must be viewed holistically. PAOD is a risk factor that increases morbidity and mortality; therefore, drug therapy and secondary prevention are clearly crucial for improving the long-term outcomes of our patients. For me, it is crucial that treatment should be interdisciplinary; this is not the sole responsibility of a single specialist discipline. What is important to me – and what we have also formulated in the guideline – is that we should move away from an ‘endovascular-first’ or ‘open surgery-first’ strategy. In my view, that is obsolete. We should find and select the best procedure for the patient. What is absolutely crucial here is that we achieve lifestyle changes in our patients. And I think this is also the greatest task facing our professional association. We should create more opportunities and raise awareness. We should, in particular, set up walking groups that promote and support this. Each and every one of us certainly has a role to play in helping to establish and develop such groups.

Rantner: Yes, I couldn’t agree more. Uli, once again, thank you very much for the lovely chat today. It was great fun. I think we’ll see each other soon at the annual congress in Lucerne.

Rother: Yes, dear Barbara, thank you very much, I’ve thoroughly enjoyed it too. Thank you for the invitation and the opportunity to focus on the AVK today.

Rantner: And to you too, dear listeners, thank you very much for your continued support. If you have any questions or feedback, please feel free to write to us at podcasts(at)medizinkommunikation.org. I’m already looking forward to the next episode. Until then, I wish you all the best; stay curious and stay healthy.