Infection control is key
comment & analysis by Michael Edmonds
What must not be overlooked is that the control of infection in diabetic foot disease is an important consideration for the whole diabetic foot care team. Diabetes, arterial insufficiency and renal failure all increase the risk of developing ulceration and make infection more likely, so the team needs to acknowledge the risk.
The team has to be aware of three distinct pathologies in the diabetic foot: neuropathy, ischaemia and infection. This is why diagnosing and treating diabetic feet is such a complex challenge.
Early diagnosis and treatment of infection to prevent necrosis can only be accomplished by an interdisciplinary diabetic foot service that pays attention to all aspect of the ulcer, including wound care, revascularisation, treatment of infection, protecting the foot from abnormal mechanical forces, and achieving good metabolic control. An infection expert should be included in the team.
In diabetic patients, the recognition of an ulcer developing in the high-risk foot is crucial. It is important to get the ulcer healed at this stage before infection develops, which may lead to necrosis and difficulty in limb salvage. In the event of infection supervening, it is important to diagnose it early and treat it aggressively. It is imperative to acknowledge, however, that in many diabetic patients, the classical signs of infection may not be present. There may be no fever, and there may be a normal white blood count. The absence of these indicators is not enough to rule out severe infection in diabetic patients. When diagnosed, severe infections often need intravenous antibiotic therapy and assessment of the need for surgical drainage and debridement.
In addition, the patient has an extremely important role in taking care of his feet, because the best infection control is to avoid infection by preventing an ulcer. In 2010, the ilegx meeting will focus on the important topic of infection control.
Combine antibiotics and revascularisation for infected, ischaemic feet
"For diabetic patients with a foot infection and severe limb ischaemia. combining antibiotic therapy and appropriate revascularisation is most likely to lead to a good outcome," Benjamin A Lipsky, professor of medicine, University of Washington and Director of the Antibiotic Research Clinic, VA Puget Sound, Seattle, USA, told delegates at ilegx on Tuesday 13 October 2009.
The focus of his presentation was the combination of infected tissue in the presence of foot ischaemia; a combination he termed a "sinister synergy".
Lipsky told delegates, "When one has this combination, which Mike Edmonds has referred to this as 'double trouble', it requires a combined approach. With infection, there is persistent inflammation, progressive necrosis, increased compartment pressure, and worsening circulation, the last of which is already a problem in so many diabetic patients. On the ischaemia side of the equation, this causes impaired delivery of oxygen, impaired white blood cell migration, inability to deliver antibiotics, and development of acidosis and toxin build-up, and pressure. Clearly the combination of the two is worse than either alone".
Diagnosing infection is also more difficult in the ischaemic foot, Lipsky said. There are a variety of ways to diagnose infection, but the most accepted is the presence of two or more of the well-known signs of inflammation. "Each of these classical findings, however, can be either lessened or mimicked by the presence of ischaemia, making a diagnosis of infection even more difficult. There may be a decrease, rather than an increase in pain caused by ischaemia; erythema may be caused, or blunted, by ischaemia, warmth may be reduced by ischaemia, and induration may be reduced by ischaemia," Lipsky told delegates.
Lipsky referred to a number of investigations, including the EURODIALE studies which enrolled 1,229 consecutive diabetic patients with a new foot ulcer. Overall, peripheral arterial disease was present in 49%, and infection in 58% of these patients at presentation. "Both peripheral arterial disease and infection were present in 31% of patients; resource utilisation, hospital use and costs were much higher in this group (67%)," Lipsky said.
In the EURODIALE study, a disturbing finding was that among the patients who were uninfected, nearly half received antibiotic therapy, only somewhat lower than in the group who had evidence of infection, where antibiotics were given to about two-thirds of patients. Lipsky asked, "Why were half of the patients who were uninfected receiving antibiotic therapy? Certainly as a specialist in infectious disease I would not condone the use of such therapy, with it's attendant potential for adverse effects, development of antibiotic resistance and increased cost. A big part of the problems we see with multidrug resistant organisms results from patients being treated with antimicrobials unnecessarily".
The results of EURIODIALE also showed that, analysed by peripheral arterial disease status, infection was a specific predictor of non-healing only if peripheral arterial disease is also present. "Infection, therefore, seems to be associated with poor outcomes only if peripheral arterial disease is pre-existing in the patient," Lipsky said.
Lipsky then looked a studies investigating factors associated with wound healing. In a study reported by Richard and colleagues, 188 of 1,222 patients hospitalised from a foot unit had an infected foot wound, Lipsky told delegates. Neuroischaemia was present in 71%. Interestingly, Lipsky said, multi-drug-resistant organisms were isolated from 22%. Healing time for these patients was significantly longer, and it was longer for patients with moderate/severe infections and neuroischaemic ulcers. So, presence of ischaemia makes it more difficult to heal infected diabetic foot wounds. Furthermore, the presence of both ischaemia and infection increases the risk of lower extremity amputation, as shown in a study by Nather and colleagues. The results of these studies, Lipsky told delegates, indicate that more hospitalisations, higher costs, less healing and more amputations are a result of a combination of these two factors.
Lipsky presented recommendations from a surgeon's point of view, on how to treat this "sinister synergy". On the infection side, he said, the surgeon needs to clean and debride the wound, obtain blood and wound cultures, to start empiric antibiotic therapy (which should later be modified if necessary based on the culture results) which should usually be parenteral to ensure good delivery. If revascularisation is not possible, or must be delayed, consider topical or instillation antimicrobial therapy. On the ischaemia side, the patient should have a vascular evaluation and the need for revascularisation should be considered.
In conclusion, Lipsky said that perhaps half of diabetic foot infections are complicated by limb ischaemia; the presence of ischaemia makes successful treatment more difficult. Antibiotic penetration is usually diminished by ischaemia, he said, but studies show that except in critical ischaemia it is often adequate. With critical ischaemia, revascularisation is usually necessary, and revascularisation can and should be done early, rather than being delayed for some duration of antibiotic therapy.
Correct diagnosis is paramount to successful control of infection
Simply applying antimicrobial dressings and using antiseptics is not enough, Robert Strohal, associate professor of dermatology, Feldkirch, Austria, told delegates at the 2009 ilegx meeting, on 13 October. "You need a clear goal for management," he said.
"Guidelines speak a clear language: interdisciplinary clinical networks are needed to optimise the metabolic condition, we need specialists to care for feet and nails often special shoes and, most importantly, we need to educate the patient," Strohal said during a satellite symposium sponsored by Boston Scientific.
Starting with diagnosis, Strohal pointed delegates to the PEDIS (perfusion, extent, depth, infection and sensation) classification system.
"Our major problem is at stages 1 and 2 - here we are talking about infection prevention and control". Strohal looked at current non-clinical diagnostic procedures such as include swapping, which is the European standard, needle aspiration, and biopsy. In PEDIS 3 and 4 acute action is needed, Strohal emphasised, to control infection especially in Europe quick action is needed.
Strohal then looked at various treatments, starting with systemic antibiotics, for which studies do not support specific antibiotics or combinations. Start with standard antibiotics, he advised and, in the case of deterioration, engage microbiologic diagnostics (blood cultures, etc.) for a more specific targeted anti-microbial therapy.
Strohal stressed the point strongly that systemic antibiotics are a big "no" (in local infected wounds) because they are not specific enough and they induce methicillin-resistant Staphylococcus aureus (MRSA).
In a chronic wound with local signs of infection, Strohal told delegates, you need to prepare the wound bed and the next step is antimicrobial dressing. "It is essential that after every dressing change you look to see if the signs of local infection are gone and if they are gone stop it. If there is still local infection at 21 days you need to step back and consider new regimen, but do not use antimicrobial dressings for more than 21 days," he advised.
Speaking on current antimicrobial agent options, Strohal said, "We have silver and Polyhexamethylene biguanide PHMB as options. A must when you treat your patients is the active release of the anti-microbial agent".
Strohal then presented results of a study which showed that Suprasorb X is faster at removing local infection compared to silver, "but both are efficient," he said.
If wound is colonised with bacteria, Strohal said, automatic use of antiseptics is not right. "You need a clear goal and management and then you can use antiseptics and anti-microbial dressing".
Turn patients every two hours to prevent pressure ulcers
Delegates were astonished to hear that patients need to be turned every two hours in order to prevent pressure ulcers. This was the recommendation made by Friedhelm Baisch, from the Institute of Aerospace Medicine, Cologne, Germany, at ilegx 2009.
"Without position changing performed by a nurse in hospital or at home, you will not prevent pressure ulcers. That is one clear-cut statement I want to make," Baisch told delegates during the panel discussion session following his presentation, "Influencing the regional blood flow - fact or fiction?"
Baisch explained that, in weightlessness the factor gravity (G) comes close to zero (μG), and thus weight disappears (FWeight= m* μG => 0 Newton). Hence it follows that no contact pressure (p=FWeigh/Area) can develop. This means that in weightlessness pressure ulcers cannot develop. Blood supply is dependent on movements, he continued; this applies for the muscles and the red blood cells in the capillaries. However, Baisch explained, if weight compresses tissues, the capillary vessels collapse and the blood flow stops. If the perfusion is interrupted for too long, a deficit of oxygen arises. The cells suffocate, break down, and poison their environment. The damage gets out of hand.
Baisch explained that pressure, or decubitus ulcers are to be found at those skin areas where skin touches the surface and where an inner skeletal structure is on the direct opposite of these areas (e.g. back of the head, scapula, sacrum, ischium, and heel). However, a decubitus develops only if the pressure is continuously persisting over a certain period of time. If this is the case, it results in a cellular breakdown.
Baisch demonstrated how the flow behaviour in the capillary bed can be shown in an experiment. "We compressed the tissue up to a level that the movements of red cells stopped. Oxygen then is still available in a certain amount by trapped red cells. In this way load periods in tissues are being bridged. However, the tolerance periods are limited," Baisch said.
Constant movements allow us to cope with the consequences of gravity, Baisch told delegates. In a constant change, areas being compressed before are relieved again by shifting the weight. This explains also why pressure ulcers are not often found at the back of the head and heels but are found in the gluteal region most frequently.
The so-called alternating pressure systems - a common pressure ulcer therapeutic applicant in Germany - will also not do the job completely. Artificial movements substitute only less than 15% of the movement activities healthy subjects perform regularly even during relaxation, Baisch showed in a second experiment scenario.
Weight shifting movements are always performed at regular intervals naturally when we move. When this activity stops, due to sensor failures in the skin, a diabetic neuropathy, pain rigour etc, and the time and target-oriented shifting of weight ceases, a cellular breakdown occurs.
Baisch addressed the practicalities of implementing weight shifting to prevent decubitus ulcers. Nursing care, in this case treatment care, he said, means that "this breakdown needs to be compensated by regular change of position. Thus, the treatment of pressure ulcers becomes a question of staff." The nursing shortage is a (politically intended?) supply shortfall in healthcare, Baisch said.
In the next 25 years, Baisch warned, the share of the population having a high decubitus risk will grow by more than 40%. Only the right combination of nursing care and technical tools can help to reduce the number of decubitus ulcer cases. It cannot be done without well-trained nursing staff. In the panel discussion following Baisch's presentation, he said"you need political pressure ... If we are not able to put pressure on the system to improve nursing it will affect all of us".
Non-invasive application of dressings benefits wound healing
"I would like to introduce the concept of soft debridement by means of non-invasive application of dressings to improve the surrounding skin," Marco Romanelli, consultant dermatologist, University of Pisa, Italy, told delegates at the ilegx 2009 meeting. He was speaking during the scientific symposium, sponsored by Sorbion, on Tuesday 13 October.
The topic of the session was "Biofilm and the role of debridement in chronic wounds". Romanelli spoke on slough and soft debridement using Sachet S (Sorbion). He presented the results of a study which aimed to investigate the role of the dressing in exudate management using non-invasive dermatological methods on untreated lower leg venous ulcers before, during and after treatment. "We investigated patients with moderate to high exuding venous leg ulcers. Standard compression treatment was applied," Romanelli said. The investigators also analysed the pH of the wound bed, Romanelli told delegates, because to control the bacteria the wound bed needs to be made as acidic as possible.
In the study, ten patients were followed for four weeks (four visits). Romanelli then illustrated with a case of a moderate exuding wound. After four weeks of treatment, the wound bed size reduced, there was wound bed granulation in 80% of the area, and the exudate was under control, Romanelli told delegates. There was also a reduction in pH. Other patients showed similar good results, he said. In conclusion, he said that, overall there was a reduction in pH in the Sachet S group, and water loss was under control. Romanelli finished by saying that he and the other investigators would like to introduce the concept of soft debridement by means of non-invasive application of dressings to improve the surrounding skin.
In addition to reduction in pH and other benefits, the number of dressing changes was reduced and wound progress was good. After Romanelli's conclusion finished, Mayer commented that he was still sceptical of soft debridement alone but acknowledged the good results and said that more investigation was needed.
Endovascular therapy and surgery complement each other
Debate: 'Endovascular therapy is better than surgery'
In the debate between Dierk Scheinert, Leipzig, Germany, and Gerhard Rümenapf, Speyer, Germany, on the topic"Endovascular therapy is better than surgery," delegates at the 2009 ilegx meeting in Munich, Germany, on 13 October got to know first-hand how while results from historical studies and the idea that surgery and endovascular procedures were exclusive were one thing, reality on the ground is quite another.
FOR
Scheinert said that while"My opponent will say that surgery is the only viable and durable option for patients with long lesions and long total occlusions, as shown in some past studies, but in reality decisions are based on many factors. Comorbidities often need to be considered, " he said.
He put the results of past trials like BASIL which showed that outcomes and advantages of surgery were similar to endovascular therapy in terms of patients remaining asymptomatic inperspective. Scheinert told delegates that at the time of BASIL, "We had no appropriate stents and we had to use coronary stents off-label." Nowadays we have a wide choice of self-expanding and balloon-expandable stents, but the restenosis rate is still too high, he admitted.
"Less is definitely more in the treatment of critical limb ischaemia," said Scheinert referring to any less-invasive treatment options compared with the invasive nature of bypass. "New devices have helped to improve success rates of endovascular therapy and we are attempting to achieve what we must achieve, which is avoiding amputations," he said.
AGAINST
On the opposing side of the debate, Rümenapf said, "I think endovascular therapies and surgery should complement one another, not replace one another".
He continued, "Treatment of lesions should be interdisciplinary, and if the short-term and long-term symptomatic improvement is expected to be equivalent, endovascular techniques should be used first. It is difficult to talk against this".
The results of BASIL undoubtedly place surgery as the most durable option, however, Rümenapf argued, vascular surgeons need to expand their skill-sets in order to be able to offer patients the best treatment options. Since the results of BASIL were published, new devices and techniques have evolved and treatment choices have expanded. Vascular surgeons need to be educated to offer the best endovascular therapies as well as performing open surgery, Rümenapf said.
He told delegates, "I cannot say anything against endovascular therapy if it is reasonably done. So before asking what remains for vascular surgeons or what is better, consider that the vascular surgeon can offer both techniques".
Endovascular therapy and surgery complement each other: A vascular surgeon's view
The future will allow for greater choices as vascular surgeons acquire a growing number of devices and techniques for revascularisation. Thomas Umscheid, vascular surgeon, Bad Nauheim, Germany, shared his perspective on complete and durable revascularisation during a satellite symposium sponsored by Cordis.
"As a vascular surgeon I am familiar with aneursyms but also with feet. I had the opportunity to learn a lot about endovascular techniques as a vascular surgeon, so I think the ideal approach is to combine the best of two technologies: open surgery with endovascular techniques, as necessary", Umscheid told delegates. Umschied told delegates that he was motivated by a very high amputation rate at Bad Nauheim to attempt to change things and lower this rate.
"The vascular surgeon of the future will not only use the knife for bypass, thrombectomy, and debridement procedures," Umscheid predicted, "but will also use catheter interventions and procedures such as vaccuum dressings, meshgraft transplantation, and flap transfers".
Bypass surgery is not declining, but in the Transatlantic Inter-Society Consensus (TASC) guidelines and other guidelines, more and more emphasis is on interventional technologies.
Many patients aged 55-74 suffer claudication, Umscheid told delegates, and 5% of these develop critical limb ischaemia. Most are high risk with with coronary artery disease, hypertension, chronic obstructive pulmonary disease, and old age. The natural history is that many patients die within a few years; there is a marked decrease in survival. So we have to be durable for 5 to 10 years. "This means in patients with claudication cumulative five-year mortality is 30% and in patients with acute limb ischaemia cumulative five-year mortality is 70%". There are good data on vascular procedures and there is a good patency rate for femoral popliteal reconstructions over five years and there are good results for limb salvage and graft patency, Umscheid told delegates.
BASIL is the only trial that is randomised and controlled and compares percutaneous transluminal angioplasty with surgery. There is no real difference in mortality, or in morbidity and no difference in costs over the years, Umscheid said. However, In the early years results are similar, but after four or five years the curve spreads and survival rate is better for surgical group and all-cause mortality.
BASIL concludes that surgical repair is more durable, the symptoms and haemodynamics are better corrected and there were fewer readmissions, Umscheid said. He also told delegates that another 2005 study comparing grafts and percutaneous transluminal angioplasty showed that there is no evidence that stents are better than percutaneous transluminal angioplasty alone.
"You have to respect the comorbidities of the patient and their life expectancy. It is better to choose the best of two worlds," Umscheid told delegates. "Combine open surgery with intervention. For iliacs, intervention is the first choice, for femorals TASC A and B we use intervention, but usually without stents - percutaneous transluminal angioplasty alone is usually sufficient. The vascular specialist should be able to use both methods. We need an angiosuite in the operating room".
Now angioplasty can treat femoral lesions once considered "impossible"
In an ilegx session that left interventionalists gasping at how far you could go with angioplasty, Lanfroi Graziani succeeded in demonstrating how exactly to push the boundaries with this endovascular procedure.
How far can you really go with angioplasty? How do you go where no interventionalists usually go? These were the questions Lanfroi Graziani, Brescia, Italy addressed in a session titled"Angioplasty pushed to its limits".
He told ilegx delegates, "Transluminal balloon angioplasty remains our best option in treating patients with critical limb ischaemia. Due to improvements in techniques and devices, we can now treat femoral lesions once considered impossible to treat - but specific training is required".
Graziani highlighted that the use of sophisticated instruments has enabled achieving good results in patients, even in the treatment of extreme lesions in dialysed subjects with critical peripheral ischaemia.
Angioplasty is a well-established technique in peripheral arterial disease and critical ischaemia, particularly in the case of the lower limb arteries and extremely calcified femoral popliteal segments," he said.
Graziani said that in his institution, psoralen with long wavelength ultra violet radiation after balloon angioplasty is the first line treatment. "We believe in transluminal balloon angioplasty as it is a minimally-invasive, repeatable technique and a low-cost procedure," he said.
In integrated extreme intervention, the lesion is usually approached from the femoral artery going down to the foot. "This kind of technique represents 90% of procedures used in critical limb ischaemia cases," Graziani stated. "Stenting in the femoro-popliteal segment and balloon angioplasty are combined together for the best revascularisation".
Graziani has said that three tips to optimise the result of balloon angioplasty would be to ensure that 1) there is prolonged balloon inflation (>180 sec), 2) gradual high-pressure balloon dilatation and 3) dilatation using a correct balloon size.
Distal bypass is favourable for diabetic renal failure patients
For diabetic patients with renal failure, distal bypass has favourable outcomes, according to Hisham Rashid, consultant vascular surgeon, King's College Hospital, London, UK. Rashid was speaking at the ilegx 2009 meeting in Munich, on 13 October.
"There is always something in the diabetic foot that we can bypass, however, the pedal arch is usually poor." Treatment options, he said, are either angioplasty or bypass. With renal failure comes increased calcification and atherosclerosis, Rashid told delegates. "It is well-known that in the renal failure patient the amputation and mortality rates are higher," he said. "You need an aggressive management strategy, with defined pathways and a multidisciplinary approach".
Rashid showed an example of a hybrid technique. "I define hybrid technique as a planned angioplasty and a bypass". He added, "There is enough evidence in the literature to support this technique so that is why I think it is a useful tool, especially when you are dealing with patients who have got a limited vein conduit". Of the 125 distal bypasses for critical limb ischaemia performed by Rashid and colleagues, the majority were elderly men, 79% were diabetic and almost a third had renal failure (28%). After performing the procedures, Rashid said, "At one year, our primary patency rate is quite low (54%), we have a low threshold for offering these patients angioplasty, however, the assisted primary and secondary patency rates are 81 and 82% respectively. Major amputation rate is 6% and amputation-free survival is 83%. Mortality rate is 11%". For amputation free survival there was no significant difference between the two groups, he said.
Looking back to see how the arterial pedal arch had any impact on outcomes, Rashid said that, surprisingly, only 6% had a complete pedal arch. Renal failure did not impact significantly on presence or absence of the pedal arch and absent pedal arch was the same in both groups (23%). Again the amputation-free survival in patients with normal renal function with different arch quality did not impact amputation-free survival - there was no significant difference between any of the groups.
Looking at mortality in both groups at one-year, mortality was almost doubled (9% for normal renal function and 17% in chronic renal failure).
In conclusion, Rashid told delegates that distal bypass in diabetic patients with renal failure has a favourable outcome, however, one-year mortality is higher.
Angioplasty expertise is pivotal for the long-term success, he said. Poor or absent pedal arch is not a contraindication for distal bypass.
To stent or not to stent remains open to question
Debate: 'Balloon angioplasty is enough'
FOR
"Even the industry has recognised that no stent is a good stent for the leg," said Gunnar Tepe, interventional radiologist, Rosenheim, Germany. He was alluding to bioabsorbable stents, which are still in early development and conceded that these may be the future of stenting
technology.
Speaking for the motion, Tepe said, "Stents coverage of long lesions is very expensive, for technical reasons only short spot stenting is feasible, there are no randomised data available showing that there is increased patency with stenting and if there is, it usually has no clinical relevance," he said. On balloon angioplasty as a sole treatment option, Tepe said that it showed"excellent" results. He also said that with stenting, there was often a new problem created, that of in-stent restenosis.
Overall, Tepe argued that it is "much too early to say stents have to be used as first-line strategy".
AGAINST
Thomas Zeller, associate professor of vascular medicine, Heart Centre Bad Krozingen, Germany, said, "Balloon angioplasty alone is not enough in below-the-knee revascularisation, especially in lesions smaller than 10cm. For example, in a bended, focal lesion below the knee, plain balloon angioplasty might be associated with insufficient primary success and high restenosis rate; atherectomy could be potentially associated with an increased risk of perforation and so a self-expanding low profile nitinol stent, might be the answer," he said.
Zeller quoted Tepe's paper "Self-expanding stents for treatment of infragenicular arteries following unsuccessfull balloon angioplasty". He said data showed that when 24 stents were implanted in 20 such arteries, at six months follow-up of all patients, there was 100% technical success, 88% clinical improvement and an 18% restenosis rate. Tepe said that this study had a small cohort, and had showed a lot of restenosis.
DEFINITIVE aims to address unmet needs
Calcification is an unmet need, it cannot be treated by percutaneous transluminal angioplasty and stents are not strong enough, Gunnar Tepe said, so atherectomy may be the correct choice. The DEFINITIVE trial programme aims to create a solid database and address unmet needs in super femoral artery disease, Tepe, interventional radiologist, Rosenheim, Germany, told delegates the ilegx 2009 meeting in Munich, Germany.
He was speaking during an ev3 satellite symposium, on 13 October. Tepe said that data collected on the SilverHawk atherectomy device so far have included large sample sizes of 60 to 600 patients, and both patency and limb salvage rates are fairly high. The DEFINITIVE trial strategy is threefold, he explained. First the problem of calcium will be addressed, followed by the problem of the lower extremity and finally, looking into the future, the problem of arterial restenosis.
The purpose of the calcium study is to evaluate the safety and effectiveness of SilverHawk and SpiderFX for the treatment of moderate to severely calcified peripheral arterial disease in the superficial femoral and/or the popliteal arteries, Tepe told delegates. It will also acquire data to support marketing application to the Food and Drug Administration for approval of percutaneous peripheral indication for both devices.
Currently the devices are indicated for use in a surgical cut down approach (SilverHawk) and for use in carotid stenting with the PROTÉGÉ RX Stent and in coronary saphenous vein graft interventions (SpiderFX), Tepe said.
The aim of the next phase of the programme is also to increase to develop a robust database for lower extremity data. An 800-patient registry is planned with 50 US and European sites involved. Interestingly, Tepe pointed out that, "There will be a sub-analysis of diabetic and non-diabetic outcomes because we know that diabetic patients with peripheral arterial disease are at increased risk for poor outcomes".
Summarising, Tepe told delegates that the DEFINITIVE trial aims to support the use of the atherectomy device. "New devices are available right now," he said, "for example TurboHawk, which specifically addresses very calcified lesions". The DEFINITIVE programme addresses unmet needs in super femoral artery disease and will create a solid database. It will also address the future with the arterial restenosis strategy.
Overcoming reimbursement and health system obstacles - the German perspective
On the second day of the 2009 ilegx meeting, for the first time, a section of the programme was devoted to the issue of reimbursement and health system obstacles. A number of speakers gave their views on the situation as it stands in Germany.
In Germany, the healthcare system silos prevent effective care for leg/foot tissue loss. At the ilegx meeting international experts agreed that giving patients flexible access to both community and acute care is mandatory for best clinical outcomes. Given that the diagnosis of leg and foot tissue loss is so complex this is critical for saving legs.
Unfortunately, in Germany this flexible access is traditionally prevented by an artificial divide between in-patient care and out-patient care. Acute healthcare professionals traditionally were not allowed to treat out-patients. Only in the last two to three years have individual clinics been able to negotiate to care for patients in a more integrated way, either by an integrated care contract for diabetic patients or by special permission for acute professionals to work part-time in out-patient services.
Andreas Liebl, head of metabolic disorders, Centre for Diabetes and Metabolism, Fachklinik, Bad Heilbrunn, Germany claimed that he presented the only example of integrated diabetes care in southern Germany. He presented the integrated care concept from Bad Heilbrunn, which allows out-patient centres to send patients to the specialised diabetes clinic without having to cross the usual difficulties of silo partitions. The out-patient centre, upon identifying diabetic foot syndrome, sends the patient to the specialist clinic, Liebl told delegates. The specialist clinic diagnoses and develops an individual therapy concept.
"Many patients who take up the integrated care concept are rewarded by their insurers for doing so, for example by reimbursements or added money to their payment," Liebl said. "When we introduced quality control, we could prove that all risk factors decreased significantly, and quality of life for patients has also been increased; complications and long-term treatment costs have been reduced." Liebl said. Eight patients suffered diabetic foot syndrome in the year after integrated care, but none had amputations, Liebl reported. He also said that integrated diabetes care has increased the average profit per patient for the clinic for nearly 50%, diabetologists receive extra honorarium for quality assessment, and help for their most complicated patients.
The problem with diabetes is that it is linked to many complications, Liebl said. Every 19 minutes in Germany there is a major amputation (See Figure 1). The costs involved are considerable, Liebl told delegates. Quoting figures from the Code 2 study, he said, "A diabetic patient who does not have any complications creates 1.3 times the amount of costs to regular health insurers as an non-diabetic insured patient".
Maximillian Spraul, Diabetic Department, Mathias-Spital, Rheine, Germany said that in Germany for a long time the diabetic foot was a neglected disease because of the organisation of the German healthcare system. But despite these problems, Spraul has been able to run an out-patient clinic for the last 25 years, with different organisation patterns. In 1984 the diabetic foot clinic at the University of Dusseldorf was established with a minimal model to start with.
In his current position in Mathias-Spital, an out-patient clinic has also been established and, in a good example of how interdisciplinary teams can work together on an equal setting, he said that his co-worker is his senior doctor in the out-patient clinic but that Spraul is senior in the in-patient setting. The integrated contract means that Spraul is able to treat in and out patients and is fully reimbursed by the outpatient system. But this is very rarely done in Germany, he emphasised.
A benchmarking system similar to that in Belgium is in place, he said, and a contract with insurance companies who are paid for coordination of multidisciplinary team has been negotiated. Documentation and follow-up data must be provided and for this additional payment is made. Money matters without that you have unstructured care, Spraul said. Strict quality control and benchmarking is also needed. This is necessary to avoid misuse of money. Only by these programmes will a real multidisciplinary approach be possible.
The panel discussants whole-heartedly agreed that a massive restructuring in the healthcare system is required before a success, such as in Belgium, can be achieved. In Belgium (see below), the government embraced the creation of certified centres. They were financially rewarded and were clearly told how to treat and thereby a consensus was able to be reached. But without a supportive system, how can individuals successfully implement an international consensus which asks for a different set-up?
Benchmarking is essential
Kristien van Acker, endocrinologist, Willebroek, Belgium, showed that the establishment of an individually successful clinic should only ever be the beginning. She argued that national centres of excellence have an obligation to train smaller centres as well as community professionals. As an example, her hospital run 100 hands-on workshops in the north of Belgium to train community professionals, like podiatrists, community nurses and even pharmacists. She also stressed that on-going quality control is key to improving diabetic foot care. The results of the tracking are made available to each individual centre who thereby not only learns about the patients but also about their clinical performance relative to other clinics, serving as a basis for necessary adjustments. Building a national diabetic foot programme should be a step-by-step process, with benchmarking as standard to measure quality, van Acker said.
Inevitably, she told delegates, the team will start small, even in an academic centre. "In my experience we started in 1989 with two nurses", van Acker said. "It was what we would call a minimal model - which means the staff consists of just a doctor and a nurse or podiatrist in a small regional hospital or health centre. The aim is for prevention and basic curative care for perhaps just your own patients. "
Fourteen years later, she told delegates however, there was a big team in place. "The team includes a vascular surgeon, orthopaedic surgeon, the secretary, the microbiologist, the radiologist, the assistant of the vascular surgeon, myself and the nurse, " she said. This is the maximal model or centre of excellence. Once the maximal model is in place, the responsibility is to develop referral pathways.
By challenging policy-makers and healthcare professionals, the Belgian government began to establish diabetic foot clinics. The clinics were required to fulfill special criteria: They had to show experience of 52 new diabetic ulcers with Wagner grade 2 or Charcot foot, van Acker explained. In addition, there must be specialised centres with 24-hour availability, and the interdisciplinary team must be present at the out-patient clinic at least 48 weeks a year, and a minimum of half a day a week. Minimum members of the team must include a diabetologist, a surgeon, a podiatrist, a nurse/educator and an orthotist.
In addition, van Acker said, "We learned that perhaps just having these centres is not enough, so we developed a kind of benchmarking system, " she told delegates. The established centres were assessed according to factors such as revascularisation, infection control and offloading.
One result of benchmarking was that they found that "some centres were doing very well and they stated that they did off-loading in all patients, but in other centres recognised as good centres this was not the case. For that reason we decided to have a meeting together with the centres and to workshop on off loading techniques so that we could improve this problem".
In summary, van Acker told delegates that "This can be an example of how to progress in the future," however, she reminded delegates, "but it has taken four years to get to this point", highlighting that implementation is a challenge, but one that can be overcome.
More cost-benefit studies for wound care are needed
Clinical decision-making must consider patient outcomes and treatment effectiveness particularly when discussing economic issues, argued Matthias Augustin, University Medical Centre, Hamburg, Germany, told delegates at the 2009 ilegx meeting in Munich, Germany, on 14 October.
Speaking during a satellite symposium sponsored by Systagenix, Augustin said that, in general, health economic studies in wound therapy evaluate costs derived from chronic wound treatment. Only a few studies relate costs derived from treatment with the corresponding clinical results, he said. "It is well known that any economic analysis should involve both costs and benefits of treatment. Data on effectiveness and costs in wound care are required for reimbursment decisions". The number of authorities regulating the market is growing, Augustin told delegates. However, a recent report on criteria for reimbursement showed that almost all countries were required to provide data on cost effectiveness before reimbursement would be considered.
Undoubtedly, Augustin told delegates, there is a need for cost-benefit studies for wound treatment. In wound care, three main groups of benefits are measured. One thing to note, Augustin said is a fundamental economic principle that short-term higher costs can be balanced by long-term benefits. "For example, we may incur large costs at the beginning of treatment but then costs will go down over time becasue of better healing rates.This is called the investment principle, " he told delegates. "Early intervention pays economically".
"We know from clinical experience that there are benefits from using Promogran Prisma Matrix treatment in venous leg ulcers," Augustin said. Preliminary results presented at the European Wound Management Association (EWMA) conference 2008 showed that, compared to controls, those patients in the Prisma group had significantly higher reduction of ulcer size and a better index of healing. Augustin then outlined details of an ongoing study, which hypothesises that Promogran Prisma leads to significantly better granulation and shows superior incremental cost-effectiveness ratio. Health economic data were collected by patient needs questionnaires, patient benefit questionnaires and questionnaires on related costs from a societal perspective.
In conclusion, Augustin said that use and reimbursement of wound devices is based on medical and economic considerations. Clinical research in chronic wounds needs to include pharmacoeconomic parameters to evaluate the cost of treatment compared to the benefits to patients and pharmaeconomic evaluation should be based on international standards such as the International Society for Pharmacoeconomics and Outcomes Research consensus document 2007 and Hannover guidelines 1998/2007.
