CX NEWS

The CX ilegx Collaboration Day course has been designed to update attendees on the latest treatment strategies developed to avoid the increasing number of unnecessary lower limb amputations—flagship principles of the ilegx initiative. Delegates will learn about the King’s College Hospital open access vascular diabetic foot care pathway—an effective approach which incorporates early diabetic foot referral and interdisciplinary work—which is showing promising results saving limbs.

Delegates will also hear about revascularisation strategies of the ischaemic foot with the latest data in the field; and will have the opportunity to discuss in more detail, in two roundtables led by experts, the controversy of “Leaving something in” or “Leaving nothing behind” in the superficial femoral artery. This subject will be exposed in the CX Main Programme – Peripheral Arterial Controversies (two days before ilegx).

In the commentary below, Michael Edmonds (King’s College Hospital, London, UK), who is one of the founders of ilegx and co-director of the CX ilegx Collaboration Day course, explains the King’s College Hospital pathway. He also writes about the value of endovascular techniques for diabetic foot care and critical limb ischaemia treatment.

This is followed by an interview with Cliff Shearman (University of Southampton, Southampton, UK), co-director of the ilegx Collaboration Day. He talks about what he believes the take-home message from this year’s CX ilegx Collaboration Day will be.

Commentary by Michael Edmonds, ilegx course director

Early referral, fast track care and multidisciplinary work: Key approach to save limbs

The ilegx Collaboration Day will include an account of a modern successful approach to the diabetic ischaemic foot in the King’s College Hospital (London, UK) open access vascular diabetic foot care pathway, which has resulted in greater than 90% limb salvage rate.

This approach is based on a new understanding of the natural history that has led to a novel classification of the ischaemic diabetic foot, emphasising the importance of the diabetic neuroischaemic foot as well as the critically ischaemic foot. This pathway is operated by an interdisciplinary team comprising surgeon, physician, podiatrist, nurse and orthotist and provides integrated care focused on a diabetic foot clinic. The diabetic foot can deteriorate with alarming speed and for this reason the clinic provides open rapid access to accelerate urgent assessment and to proceed quickly to state-of-the-art interventions in the revascularisation of not only the critically ischaemic foot but also the neuroischaemic foot. This includes prompt decision making within the interdisciplinary team as to proceed to endovascular or open vascular surgery (or both in a hybrid technique), involving revascularisation of both legs and increasingly, pedal arteries. The diabetic neuroischaemic foot is particularly characterised by ulceration and complicating infection and within this interdisciplinary diabetic foot service, modern techniques in wound care and aggressive treatment of infection with surgical debridement and parenteral antibiotics are also important. 

The value of endovascular techniques for diabetic foot care and critical limb ischaemia treatment
There is a crucial role for endovascular techniques to revascularise the foot, whether it is to restore blood flow in order to help diabetic ulcers to heal, or longer-term as a treatment for critical limb ischaemia.

It is agreed that the critically ischaemic foot should be urgently revascularised so as to save the limb either by endovascular procedures or open vascular surgery. However, controversy exists when there is a diabetic patient with a neuroischaemic foot ulcer that is not healing in a moderately ischaemic limb. These patients are often not getting the benefit of endovascular procedures in a timely fashion.

Although the neuroischaemic foot would not have got into trouble unless it had been subjected to minor trauma—which is often unsensed because of nerve damage—it is important to understand that, having got into trouble, the ulcer cannot be healed because the blood supply to the foot  cannot be increased. Thus there is a crucial role for below-the-knee endovascular procedures to improve the blood supply, even if it is a temporary increase, to get such ulcers healed. Once such ulcers are healed it will not matter if subsequently there is restenosis.

Interview with Cliff Shearman, ilegx course director

In this year’s CX iLegx Collaboration Day, what do you think the take home message will be?

Shearman: Avoiding amputation is relatively easy; it is about early treatment and not ignoring the problem. The biggest barrier to success is poor organisation and lack of awareness of the seriousness of the problem. Solving the problem improves outcomes, improves quality of care and saves a lot of money.

This year’s ilegx roundtables will discuss revascularisation strategies in the superficial femoral artery; do you believe you should “Leave nothing behind” or “Leave something in”?  

Shearman: Better understanding of the biology of diabetic vascular disease will lead to better therapies. While it is appealing to consider therapies, which do not leave anything behind, we have to understand what the main effect (short- and medium-term) of an intervention is on the plaque to design the optimum therapy.

About ilegx

The ilegx initiative, launched in 2008, was created in response to the increasing number of lower limb amputations which are mostly due to type II diabetes.

ilegx is a collaboration of like-minded health professionals, patients and care workers who share the view that too many legs are amputated and many of these are completely unnecessary.

The ilegx mission is to attract attention and draw awareness to the need for an improvement in health care in order to lower unnecessary major amputation of legs.

The CX ilegx Collaboration Day will take place at the Charing Cross Symposium on Thursday 30 April – Grey Learning Centre, Olympia Grand, London, UK

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This year, the Charing Cross Symposium is launching the CX Live Case method. Thomas Zeller (Universitäts-Herzzentrum Freiburg – Bad Krozingen, Bad Krozingen, Germany), course director of the CX Live Peripheral Arterial Cases, will link the live case demonstrations from Bad Krozingen with topics to be discussed in the CX Main Programme – Peripheral Arterial Controversies at the Charing Cross Symposium 2015.

 

Starting with shorter and simpler lesions, Zeller and his team will aim to demonstrate the value of drug-coated balloons against plain old balloon angioplasty. Beyond this, longer and also calcified arterial stenoses will be tackled. The audience will see which stents are selected, and whether atherectomy pre-stent is thought to be beneficial. Zeller will show which stent devices can reach longer lesions and into the popliteal artery, and which require pre-treatment with adjunctive therapies. The value of drug-eluting stents will also be demonstrated, and the management of in-stent restenosis and its correction by mechanical means will be shown.

In this interview, he explains the value of live case presentations at conferences and the importance of relating the CX Live Peripheral Arterial Cases to the topics of the CX Main Programme – Peripheral Arterial Controversies, and encourages audience interaction in this session.

What are the benefits of including live case presentations in medical conferences?

Live case presentations—provided they are unbiased—support the transfer of clinical science into clinical practice. New technologies and treatment algorithms can be demonstrated (supplementing talks and roundtable discussions) and the potential limitations and advantages in daily routine can be highlighted. With live case presentations; conference audience gets a better and practical impression of how new technologies can be implemented in the interventionalist’s routine.

What are the benefits of having the CX Live Peripheral Arterial Cases relate to what is discussed in the CX Main Programme – Peripheral Arterial Controversies?

The attendee gets immediate insights into the clinical application and potential pitfalls of new interventional strategies, which have been discussed in the CX Main Peripheral Programme (The CX Main Programme – Peripheral Arterial Controversies will take place on 28 April 2015, a day before the CX Live Peripheral Arterial Cases). Every new technology imposes a learning curve which might become shortened if the attendee gets advice from experienced operators who have already gained experience in the application of interventional strategies or use of those new technologies.

The live cases for the Charing Cross Symposium have been selected based on the topic of a given session to enable the panel and audience to discuss these topics with the operators.

The CX Main Programme – Peripheral Arterial Controversies dedicates a session to the discussion of revascularisation strategies in the superficial femoral artery; which key controversies will you try to shed light on with the CX Live Peripheral Arterial Cases session in this field?

In the CX Peripheral Live Cases, the main issue of controversy to discuss is the potential role of drug-coated balloons and drug-eluting stents for the treatment of the superficial femoral artery. We will analyse whether (or not) these devices are worth the costs compared to standard treatment (plain old balloon angioplasty and bare metal stenting). Moreover, the role of spot stenting in a drug-coated balloon setting will be discussed and finally the potential role of vessel preparation prior to the use of drug-eluting technologies.

What techniques and technologies will be demonstrated at the CX Live Peripheral Arterial Cases session?  

We will show interventions dealing with drug-coated balloons and provisional stenting, stenting of kink zones, vessel preparation with debulking devices, how to treat in-stent reocclusions, etc.

The CX Symposium advocates strong audience interaction; how will you encourage participants’ interaction in the CX Live Peripheral Arterial Cases session?

Audience interaction has to be pushed by the moderators and panellists. We as operators will be open to questions from the audience and we will also invite the audience to express their own experiences with the interventional techniques, which will be shown during the live case transmissions.

The CX Live Peripheral Arterial Cases session will take place at the Charing Cross Symposium on Wednesday 29 April – Grey Learning Centre, Olympia Grand, London, UK

Click here to see the CX Main Programme Sessions

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Benjamin Starnes (Seattle, USA) told the audience attending yesterday’s mini symposium on acute aortic transection that intravascular ultrasound (IVUS) was an important tool in the management of patients with blunt aortic injury undergoing thoracic endovascular aortic repair (TEVAR) because it helps to ensure accurate sizing of the endograft and prevent rupture. The session also reviewed the differences between image-based classifications of blunt aortic injury.

Starnes reported that, over the past decade, endovascular repair of patients with blunt traumatic aortic injury has become the “predominant approach to fixing these injuries”, but added that there were “unique challenges” to using the endovascular approach. He said: “One of challenges is the dynamic nature of the aorta. There are some interesting data from blood-letting studies in Yorkshire pigs that show significant decrease in aortic diameter accompanying induced haemorrhagic shock, with a dose-dependent effect.”

According to Starnes, aortic diameter is also known to increase after resuscitation and the area with the greatest change in size is the area that is most commonly injured in blunt trauma (ie. the isthmus and descending aorta). He added: “CT angiography is used for diagnosis of these injuries and axial slices from the initial scan are often used for planning and sizing of the repair. While using IVUS at the time of repair to better characterise the injury, we noticed a difference in the aortic diameter with systolic variation [compared with the diameter observed on the initial CT angiography]. This then begs the questions “Is initial CT angiography appropriate for sizing the endograft in these patients?” and “Is that endograft going to be undersized once that patient is fully resuscitated?”

Starnes and colleagues, therefore, conducted a retrospective chart review of patients with blunt aortic injury who underwent TEVAR at their level-one trauma centre to determine if there was a difference between the aortic diameter observed on diagnostic CT angiography and that observed on IVUS at the time of the repair. The inclusion criteria were initial admission or pre-admission CT angiography, IVUS at the time of repair, and a post-implant CT angiography. Of the 26 patients who were treated at the centre during the study period (July 2007–July 2011), three patients did not have post-implant CT angiography information, one patient was converted to surgery, and six patients did not receive IVUS—leaving 16 patients available for assessment.

There was a significant difference of 2.4mm between mean aortic diameter with initial CT angiography and mean aortic diameter with IVUS: 21.7mm vs. 24mm, respectively (p=0.004). Starnes noted: “When we look at post-implant CT angiography compared with initial CT angiography, there is again a highly significant difference of 3mm (p=0.0001). But, when we compared post-implant CT angiography with IVUS, there was no difference.” He added that when they reviewed theoretical graft diameters, there was a significant difference of 2.4mm (p=0.003) between the size of the graft that would be chosen based on the initial CT angiography and that based on IVUS at time of repair. There was also a significant difference in graft size between post-implant CT angiography and initial CT angiography (3mm; p=0.0002), but no difference in size between post-implant CT angiography and IVUS.

“I believe IVUS is a critical and important tool for the management of patients with blunt aortic injury,” Starnes concluded.

Ali Azizzadeh (Houston, USA) also presented data at the mini symposium, reviewing the long-term effects of intentional stent graft coverage of the left subclavian artery (in patients with blunt aortic injury undergoing TEVAR). He said that in a review of 82 patients undergoing TEVAR at his centre between September 2005 and July 2012, 50 received intentional stent graft coverage of their left subclavian artery. Azizzadeh reported: “Intentional coverage of the left subclavian artery during TEVAR for blunt aortic injury appears safe without compromising mental or physical health outcomes. Furthermore, left artery stent coverage does not increase the long-term risk of upper extremity symptoms or impairment of normal activities.”

Does intramural haematoma exist?

As well as presenting data for the role of IVUS in the management of patients with aortic, Starnes also reviewed the classification of the injury. He reported that he and his colleagues developed a new image-based classification system for these types of injury because they believed the current classification system, by the Society for Vascular Surgery (SVS), was “lacking”. Starnes explained: “The SVS system has four grades of injury—grade one, intimal tear; grade two, intramural haematoma; grade three, pseudoaneurysm; and grade four, rupture—but does not provide for any treatment recommendations because grades one to three are treated the same and we do not believe grade two exists. In a review of 140 aortic transections at our centre, we did not see a single case of intramural haematoma.”

Therefore, they developed a new classification system based on the presence or absence of an aortic external contour abnormality. Under this new system, intimal tear (intimal defect and/or thrombus of

However, Michael Dake (Stanford, USA) commented that there was a lack of consensus surrounding intramural haematoma as unlike Starnes and colleagues, Rabin and colleagues did recognise the existence of intramural haematoma and classified it as being a “grade one” injury (in contrast to the SVS classification). He added that Osgood and colleagues, in an another system, classed intramural haematoma as being “grade 1B” but he noted that they did not find any patients with that type of injury in their series. Dake reported, regardless of how it was classified, recent publications have suggested that: “Intramural haematoma without associated peri-aortic component, contour abnormality, or pseudoaneurysm may be conservatively managed with appropriate follow-up imaging.”

The CX Great Debate saw Peter Taylor, London, UK, and Richard Gibbs, Imperial College, London, UK, persuaded 71% of the audience at the Charing Cross International Symposium yesterday to vote for their position against the motion “For uncomplicated type B dissections, early intervention is indicated”.

Their opponents in the debate, Christoph Nienaber, Rostock, Germany, and Jan Brunkwall, Köln, Germany, had the support of 29% of the audience. Audience discussion at the end of the session identified a need for a larger randomised trial with long-term follow-up that had clinically meaningful endpoints.

Nienaber and Brunkwall set out to persuade the audience that placing a stent graft early was important in order to heal the aorta. “Rupture, malperfusion, hypertension and down the line, aneurysm formation are some of the risks of type B dissection,” Brunkwall said.

Nienaber made the point that scaffolding was the only way to stabilise the progression of the dissection as data available so far showed that the disease is characterised by a downhill evolution over time. “If there is no scaffold, and the aorta is not remodelled, you are confronted with ongoing attrition rate in terms of cardiovascular death and progression of the disease. This is beneficial for even in so called stable or clinically silent patients,” he said. He made his views clear that no dissection was ever uncomplicated.

“Only pre-emptive stenting will ensure long-term remodelling and stability. Only remodelling stabilises the aorta and no drug that induces remodelling, only the likelihood of rupture, so supportive scaffolding should be offered to any type B dissection,” Nienaber said.

“What do we achieve with TEVAR in the setting of type B acute dissections? Fewer later interventions and lower mortality after five years,” Brunkwall said. The five-year long-term follow-up of the INSTEAD XL showed a statistically significant reduction in aorta-specific mortality and a statistically significant reduction in disease progression in favour of the combined TEVAR plus medical therapy arm.

Brunkwall also made the point that the ADSORB trial with false lumen thrombosis as an endpoint, had shown that patients receiving TEVAR have significantly more complete and partial thrombosis than the ones getting best medical therapy.

The ADSORB trial was a prospective randomised trial to compare TEVAR with best medical therapy in patients with acute uncomplicated type B aortic dissection. At the follow-up for one year, there was no death stroke or paraplegia in either group at 30 days and aortic remodelling at one year favoured the intervention but it did not reach statistical significance.

Taylor and Gibbs based their arguments around the fact that medical treatment is getting better. Briggs noted that a recent study (Fattori et al. J Am Coll Cardiol 2013;61:1661-78) had shown that survival at five years without intervention is 70–89%. They also highlighted the fact that TEVAR carries risks including retrograde dissection; stroke (3%); paraplegia (2.5%) and other complications. The team stated that all current endografts used in dissection are designed for use in aneurysms.

“There is no adequate evidence to recommend early intervention in all but a few patients with uncomplicated type B dissection. Only a small subgroup at high risk of aortic expansion will benefit from early intervention and these patients can be identified using techniques such as functional imaging,” Briggs said

Taylor also attacked the quality of evidence from randomised controlled trials that supported early intervention. “The ADSORB trial had only 61 patients in total. It was underpowered and stopped at one year and was therefore too short and small to answer questions about survival and efficacy. The INSTEAD trial had only 140 patients in total and underpowered for survival. In total, there have been only 201 dissection patients ever randomised,” he said.

Taylor made the point that drug therapy was getting better and that the available evidence showed that the majority of patients are alive with medical treatment; there is 80% survival at five years and that therefore, medical treatment was safe for the majority of patients with uncomplicated type B dissection. They do not need early intervention and there is an early mortality associated with TEVAR that cannot be ignored, he said.

A member of the audience noted that in order to make a clinical difference, all-cause mortality has to be the only endpoint at five years and the trial should be designed to show superiority. Martin Bjorck, Uppsala, Sweden, also commented on the difficulty faced in every day clinical practice. “There is a problem because we know from the data from the two randomised trials that it is rather safe to do TEVAR, but that there is a 3–5% risk of  very serious neurological complications that cannot be discounted. We know from the long-term results of the INSTEAD trial that if you do not treat, you have many patients developing dilatations and needing treatment later on that is more complicated. We need a larger randomised trial with long-term follow-up.”

CX voting results

Earlier in the session, 65% of the CX audience had voted that registry data is now irrelevant and that it was time that randomised trial evidence for TEVAR dissection became available. Nearly 80% also believed that aortic intervention for acute dissection should only be performed in recognised vascular centres with cardiothoracic surgery on site.

Michael Dake, Stanford, USA, outlined the first experiences with the Gore TAG (W L Gore) thoracic branch endoprosthesis and Frank R Arko, Charlotte, USA, presented on the MONA LSA (Medtronic) branched device results at a session yesterday. Both speakers shared early cases and their results.

Thoracic aortic aneurysms that involve the left subclavian artery often leave physicians no choice but to use surgical techniques or to cover the branch vessel. “Although reports from single-centre experience with the hybrid approach have been positive, a single branch thoracic endograft specifically designed for treatment of the aortic arch (Zone 0–2) could be useful in extending the advantages of endovascular repair to the aortic arch.  As such, the Gore TAG Thoracic Branch Endoprosthesis is designed as a modular system which allows for treatment of aortic arch pathologies using a less invasive hybrid endovascular approach,” Dake said.

He presented on the Zone 2 US investigational device exemption feasibility trial that will enrol 20 to 40 patients at six sites. Patients will be followed for five years. The study will evaluate the device for the treatment zone 2 aneurysms.

The Gore TAG thoracic branch endoprosthesis has a modular construction design with off-the-shelf components. It has an inner lumen for anchoring and sealing the branch component. The complete system consists of aortic and branch components designed for the use in the arch, and also the accompanying accessory devices to facilitate delivery.

“The system is easy to use with a single femoral access and requires minimal catheter manoeuvres. It is safe with zero ischaemic time and has low risk of branch vessel coverage. After the first four cases, successful access and deployment of the endoprosthesis was seen in all cases. There was one procedural type 1 endoleak that resolved without re-intervention at one month. There were no device-related endoleaks, but one type 2 endoleak was seen at one month. There were no deaths or neurological events. There were no site reported serious adverse events related to the device,” he said.

Dake explained that the procedure to deploy the device included inserting the guidewires in aorta and branch vessel; introducing the aortic component over both guidewires into position within the arch; deploying aortic component and withdrawing catheter; advancing the introducer sheath and dilator and advancing and deploying branch component.

In order to be enrolled, patients had to have descending thoracic aortic aneurysms requiring placement of the proximal extent of the aortic stent graft in Zone 2. The primary endpoints of the study were: successful access and deployment of the thoracic branched endograft and the primary patency of the side branch assessed by angiography when the procedure finishes. The secondary endpoints included a one-month core lab analysis, assessing the side branch primary patency and device-related endoleaks.

Arko told delegates that there was a clinical need for left subclavian artery preservation in association with encroaching thoracic artery aneurysm. He presented the current status of an early feasibility trial in the FDA’s new innovation pathway testing the Valiant Mona LSA device.

The key goals of the trial are to validate the procedure in humans; assess the safety and performance acutely and at 30 days and collect imaging data to augment the current understanding.

Arko told delegates that the Valiant Mona LSA Thoracic Stent Graft consisted of a flexible cuff “volcano” on the main body. The system is a two-graft system and the main graft system comes in diameters between 30 and 46mm and in the single length of 15cm. It is a two-wire system as well and the secondary wire can be snared and then the second branch is brought up and deployed. The branch graft itself is made of a nitinol helical wire and polyester fabric. It has a proximal flare. The branch graft is always 40mm in length and a 15F profile, femoral access system.

The early feasibility trial is a prospective, non-randomised, three-centre, premarket clinical study that has enrolled nine patients. The primary safety and effectiveness objectives were measured acutely and at 30 days. “The follow-up schedule will be at 0-30 days, six months, 12 months and annually through five years,” Arko said.

The principal investigators are Eric E Roselli, Cleveland, USA, Frank R Arko, Charlotte, USA and Matt Thompson, London, UK.

Arko revealed that the current status of the early feasibility trial had seven patients enrolled as part of the US cohort and two enrolled as part of the cohort outside the US. One emergent case had been enrolled in the USA, outside of trial. Acute procedure results from all seven patients revealed 100% technical success and 100% patency in both main and branch stent graft. There were no type I or III endoleaks.

“All current devices need a healthy landing zone to seal. To achieve sufficient landing zone, the left subclavian artery may be sacrificed with resulting complications, such as 6% arm ischaemia, 4% spinal cord ischaemia, 2% vertebrobasilar ischaemia, 5% anterior circulation stroke and 6% death. Left subclavian artery preservation is recommended in the literature. 17–43% of patients undergoing TEVAR have planned coverage of the left subclavian artery to achieve an adequate proximal seal and the coverage of the left subclavian artery without revascularisation is the single most important predictor of post-TEVAR stroke,” Arko said.

At the ilegx Collaboration Day, attendees learnt about the best management therapies for diabetic foot care and vascular reconstruction in critical limb ischaemia patients and for the second year running, the symposium broadcast edited live cases treating superficial femoral artery lesions to the Far East and North America in an event named Endovascular Electronic Education, sponsored by Abbott Vascular.

In the morning, three edited live cases were showcased to the Far East. The first case was performed by Andrej Schmidt in Leipzig, Germany, the second procedure was carried out by Peter Goverde in Antwerp, Belgium, and the third case was performed by Josef Tacke in Passau, Germany. The Abbott Supera stent system was used to treat occlusion and total occlusion of the superficial femoral artery and proximal popliteal artery.

Schmidt, Goverde and Tacke were present to answer questions from the audience at CX and those watching the live broadcast in the Far East.

Responding to questions about how a physician chooses a stent, Schmidt said: “In some cases it is clear—if it is a calcified lesion, for me it is clear that a drug-eluting balloon might not be so good, we know this from our data, and the Supera stent is the stent of choice.” He added that more data are required to make the stent selection process more comprehensive.

In the afternoon, edited live cases were broadcast to North America.

Early referral, fast track care and multidisciplinary work: key approach to save limbs

The ilegx initiative, launched in 2008, was created in response to the increasing number of lower limb amputations which are mostly due to type II diabetes. Michael Edmonds (London, UK) who is one of the founders of ilegx, introduced the “diabetic foot care” session, which was organised in conjunction with the King’s College Hospital Open Access System, with a presentation which highlighted the importance of early diabetic foot referral and interdisciplinary work as an effective approach to reduce the number of lower limb amputations, flagship principles of the ilegx initiative. He said: “Up until recently, the diabetic ischaemic foot has defeated every health care system in the world. However, a strategy which combines early referral and interdisciplinary working has led to improvements in care.” With this in mind, he commented, “ulcers can now be healed and amputations can be prevented.”

Edmonds also referred to the importance of organising a “fast-track” service in a “one-stop” visit, comprising clinical assessment, same-day investigations and urgent management to treat infection and revascularise the foot, when dealing with cases of “diabetic foot attack.” “This is best carried out in a diabetic foot clinic which can see the ischaemic patient in an open access system without delay and has rapid availability of debridement and intravenous antibiotics to treat infection and control the septic vasculitis.” He also said that diabetic foot patients who experience repeated crises from the rapid onset of infection need a special form of such easily accessible care provided by the diabetic foot clinic. “Such integrated fast track care can rapidly restore the circulation, limit tissue necrosis, save the limb from amputation and provide complete recovery from the foot attack,” he commented.

An interdisciplinary team including podiatrists, nurses, orthotists, microbiologists, interventional radiologists and surgeons—including vascular surgeons, orthopaedic surgeons and plastic surgeons—is the ideal team required in the management of diabetic foot, Edmonds noted.

He also mentioned that to complete an effective management of diabetic foot, follow-up and rehabilitation are required.

Interdisciplinary views on diabetic foot care

A vascular surgeon, an interventional radiologist and a podiatrist from King’s College Hospital, London, UK, shared with CX delegates their best practices treating diabetic foot.

Vascular surgeon Hisham Rashid, said that “the incidence of type II diabetes mellitus is increasing across the world with an expected rise in 2030 to more than 12% in a large population of the world.”
This is a worrying figure taking into account that “a major amputation rate is significantly higher in diabetic patients,” he noted.

Rashid told CX delegates that aggressive revascularisation with angioplasty, bypass or hybrid techniques is essential for limb salvage and reduction of major amputation rate. He mentioned that at King’s College Hospital, 77% of cases are treated with angioplasty and 23% with distal bypass. He said that distal bypass surgery “plays a major role in revascularisation, especially in patients presenting with significant tissue loss and when angioplasty is not feasible.” Hybrid techniques in “no-option” critical leg ischaemia have also proven very effective in preventing major amputation in this challenging group of patients, he commented.

 
At King’s, Rashid noted, revascularisation using distal and ultra-distal bypass has a very good outcome with a one-year amputation rate of 3.4% and 30-days mortality rate of 1.5–1.7%. At one-year, “mortality is significantly influenced by end-stage renal failure and age rather than diabetes mellitus,” he said.

Interventional radiologist Dean Huang, said that the concept of “foot attack” and “time is tissue” in diabetic patients means that treatment of an infected ulcer should be handled as an emergency with the management of a multidisciplinary team. At King’s College Hospital, “we follow this approach; we work on the basis of rapid access to diagnosis, rapid access to intervention and follow-up of interventional and surgical procedures.” From the interventional radiologist perspective, he said, “rapid access to imaging diagnostics enables the selection and planning of the optimal strategy.” Ultrasound, CTA and MRA have their place and angiography remains the gold standard, he commented. “Prompt definitive treatment with radiological intervention and/or surgical bypass to revascularisation for healing in conjunction with wound care and antibiotics is the key to achieve prevention of amputation,” Huang noted. “The threshold of what can be treated with endovascular procedures is shifting as more sophisticated devices appear on the market.”

Podiatrist Jennifer Tremlet, spoke about the different techniques used at King’s College Hospital to heal diabetic foot wounds. “Diabetic foot patients are complex cases, they experience extensive tissue loss and infection. In order to achieve successful wound healing, they require intensive wound care and rigorous monitoring.” She said that, depending on the complexity of the wound and the type of patient, they use different multi-modal techniques including debridement, larvae therapy, hydrosurgery therapy topical negative pressure therapy, split skin grafts and pressure relief. 

Foot care and arterial reconstruction

At a session on foot care and arterial reconstruction, Christopher Attinger (Washington, USA) said that using the angiosome principle to guide revascularisation is a critical component for optimising wound healing. He explained that the angiosome concept divides anatomic regions into three-dimensional blocks of tissue fed by source arteries and creates a framework for understanding tissue perfusion, predicting wound healing, and planning surgical interventions. Therefore, “understanding the boundaries of an angiosome and the vascular connections between source arteries provides the basis for limb salvage to optimise revascularisation to ischaemic areas and promote wound healing.”

Mauro Gargiulo (Bologna, Italy) spoke on the need to have multidisciplinary guidelines to support the treatment of critical limb ischaemia. He referred to a consensus document that has been recently published on the treatment of peripheral arterial disease in diabetes written by the Italian Societies of Diabetes (SID, AMD), Radiology (SIRM) and Vascular Endovascular Surgery (SICVE). The consensus, published in Nutrition, Metabolism & Cardiovascular Disease (Aiello A et al, 2014; 24: 355–369), higlights that “the prevalence of peripheral arterial disease is high in diabetic patients and, associated or not with peripheral neuropathy, can be found in 50% of cases of diabetic foot.” Gargiulo said that the document summarises indications for revascularisation, revascularisation techniques and details on follow-up of revascularised patients, among other topics.

In the same session, Bijan Modarai spoke about effective cell therapies for revascularisation of critical limb ischaemia and Roberto Ferraresi discussed patient-centric revascularisation strategies.

At the end of the ilegx Collaboration Day a roundtable consensus on the role of drug-eluting balloons for the treatment of superficial femoral artery including data from the IN.PACT SFA, ILLUMINATE, Levant 2 and BIOLUX-PI studies was held. Vascular News will be reporting on the outcomes of this discussion.