Dr Amit Kumar C Jain*, Dr Ajit Kumar Varma**,Dr Mangalanandan***, Dr Harish Kumar****
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1 The Journal of Diabetic Foot Complications REVASCULARIZATION IN THE DIABETIC LOWER LIMB Authors: Dr Amit Kumar C Jain*, Dr Ajit Kumar Varma**,Dr Mangalanandan***, Dr Harish Kumar**** The Journal of Diabetic Foot Complications, 2013; Volume 5, Issue 1, No. 3, Pages All rights reserved. Abstract: Peripheral vascular disease is an important risk factor for lower extremity amputation in diabetic patients with chronic foot ulcers. There is a geographic difference in the prevalence of peripheral arterial disease in diabetes. Successful revascularization reduces the major amputation rate in diabetic patients. This can be achieved either by peripheral bypass or by percutaneous transluminal angioplasty. Recent studies are favouring peripheral angioplasty over traditional bypass surgery in diabetic lower limb. This article surveys the literature on the current role of percutaneous transluminal angioplasty and peripheral vascular bypass in lower limb revascularization in diabetic patients. The article also provides an insight on our own experience with revascularization. The literature shows that only 5% of non diabetic persons with peripheral vascular disease require vascular reconstruction. There has been a 50% reduction in the annual number of infrainguinal bypass surgeries with the advent of percutaneous transluminal angioplasty (PTA). Data from our institute in India reveals that only 3.32% of patients with diabetic foot ischemia require vascular bypass procedures. This article provides for the first time data on the revascularization procedures required in diabetic foot patients at a diabetic limb salvage centre in India, a country known to have the highest number of diabetic individuals in the world. Key words: diabetes, foot ulcer, lower limb, revascularization Corresponding author: Dr Ajit Kumar Varma Professor Department of Endocrinology, Diabetic Lower Limb and Podiatric Surgery Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham University Ponekara P.O, Kochi , Kerala, India. ajitkumarvarma@aims.amrita.edu Affiliations: *MBBS, DNB[Gen Surgery],[Postdoctoral Fellow in Diabetic Lower Limb and Podiatric Surgery] **MBBS, MS[Gen Surgery],(Professor) ***MBBS, F. Diab(Associate Professor) ****MBBS, MRCP(Professor and HOD) Department of Endocrinology, Diabetic Lower Limb and Podiatric Surgery Amrita Institute of Medical Sciences, Ponekara P.O,Kochi,Kerala,India INTRODUCTION India, with a population greater than 1.1 billion, has the dubious distinction of having a larger number of people with diabetes than any other country in the world, after China. It was estimated in 2000 that there were 32 million people with diabetes in India, a number that is predicted to increase to nearly 80 million by The global burden of diabetes is projected to increase from 246 million people to over 380 million people by the year The lifetime risk for foot ulcers in people with diabetes is estimated to be 15 %. 3 Diabetic patients are at higher risk for limb loss owing to neuropathy, infection and presence of arterial occlusive disease. However, the distribution of peripheral vascular disease in diabetics has regional differences. Arterial disease was present in 48% of foot ulcers in Germany but only 11% in Tanzania and 10% in India 4. The basic aim of any successful revascularization is to achieve pulsatile flow to the foot. The two methods currently available are peripheral bypass surgery and peripheral angioplasty. 18
2 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) The objective of the angioplasty was to Dayananda et al reported a high limb achieve straight line flow from the aorta down salvage rate of 75.8% at the end of one year to either a patent dorsalis pedis or plantar arch. by using infrapopliteal angioplasties in diabetic The aim of treatment is limb salvage. Percutaneous transluminal angioplasty (PTA) is today success rate of 58.75% in a general population patients 5. Saab et al also reported a clinical considered the first choice revascularization comprising of diabetic and non-diabetic patients 6. procedure in many cases. It is feasible, safe and In another study, Faglia et al achieved a 5 year cost affective for limb salvage in a high percentage of diabetic patients [Table 1]. dergoing peripheral angioplasty 7 primary patency of 88% in diabetic patients un-. TABLE 1 - ADVANTAGES AND DISADVANTAGES OF PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY [PTA] ADVANTAGES DISADVANTAGES 1. Economical 1. Not feasible in completely calcified occlusion of vessel 2. Safe 2. Five year patency of vessel is inferior to bypass. 3. Low morbidity 4. Repeatability Currently, many promising novel endovascular techniques such as cryoplasty, drug eluting stenting, plaque debulking lasers and excision atherectomy are being investigated and are potentially useful adjuncts to PTA. Zhu et al showed that subintimal angioplasty for arterial lesions below the ankle in diabetic patients could achieve a limb salvage rate of 94.6% Dose not require general or spinal anaesthesia 6. Complications are infrequent 7. Can be performed in inframalleolar arterial occlusion PERIPHERAL BYPASS SURGERY For more than 50 years, the standard procedure performed for lower limb arterial revascularization has been vascular bypass surgery using reversed saphenous vein 9. Various methods were developed to render valves incompetent in order to allow the vein to be used non-reversed or in situ. Vascular surgeons began to employ in situ bypass and reporting improved results with this technique. In 1980s, Ascer et al reported the first series of bypass grafts with inflow taken from the popliteal artery 10. This procedure has proved to be another important advance in arterial reconstruction for patients with diabetes. Because atherosclerotic occlusive disease often spares the superficial femoral artery in diabetic patients, the popliteal artery can be readily used as a source of inflow for a distal vein graft. Only the most experienced vascular surgery centers in the world perform extreme distal arterial reconstructions. In one study, limb salvage was achieved in nearly 70% at 5 years when pedal bypasses were performed 11. In one centre, bypass to the dorsalis pedis artery constitute approximately 25% of all the lower limb arterial reconstructions in diabetic patients 9. Since the introduction of endovascular interventions, most vascular surgical units have seen at least a 50% reduction in the annual number of infrainguinal bypass operations 12. However, there are still a few subsets of patients who require peripheral vascular bypass to salvage a diabetic foot. 19
3 AMRITA S EXPERIENCE Our centre in India is a large tertiary, superspecialty referral hospital with 1450 inpatients beds. The division of diabetic lower limb and podiatric surgery is integrated with the Department of Endocrinology. Currently, it is the only medical college in India offering postdoctoral training in podiatric surgery and it is one of the largest diabetic lower limb salvage centres in India. Nearly 50 inpatients beds are dedicated to patients with diabetic foot problems and our daily outpatient census is around patients. Peripheral angiograms and angioplasties are performed by a dedicated interventional radiologist and peripheral bypass surgeries are performed by vascular surgeons. The decision regarding the need for the diagnostic angiogram and subsequent revascularization is taken by our diabetic limb salvage and podiatric surgeons in order to obtain a scientific and biomechanically acceptable functional foot [Figure 1]. Post revascularization foot care and surgeries are done by our podiatric surgeons to achieve a favorable outcome. In order to analyze the revascularization procedures in our patients, we retrospectively reviewed our data on 1083 patients admitted for diabetic foot complications. Of these, 769 (71%) were males and 314 (29%) were females. Six hundred and nine patients (56.2%) with diabetic foot complications had some form of peripheral arterial disease (PAD). Patients were considered to have PAD when distal pulses were absent, hand held Doppler showed monophasic flow signals or when ankle-brachial indices (ABI) was less than Only 180 patients (16.6%) with diabetic foot problems had undergone peripheral angiogram. Angiograms are performed only in those patients in whom wounds fail to heal with customary care. Thirty-six patients (3.32%) underwent peripheral vascular bypass surgeries whereas seventy three patients (6.73%) underwent peripheral angioplasty. Seventy-one of our patients (6.55%) with diabetic foot problems had non-revascularizable lesions. Figure 1. Midfoot amputated stump at the end of 1 year with therapeutic foot wear. The ultimate goal of a podiatric surgeon after any revascularisation or reconstructive procedure is to provide a scientific and biomechanically acceptable functional foot. Only then should a limb be considered as salvaged. 20
4 DISCUSSION Lower extremity arterial disease is clinically identified by intermittent claudication and absence of peripheral pulses in the lower legs and feet. Chronic limb ischemia (CLI) represents the most severe stage of peripheral vascular disease, with limb loss being a feared complication. In Western society, the prevalence of symptomatic peripheral arterial occlusive disease (PAOD) producing intermittent claudication in men and women aged years is 45%. 12 People with diabetes are twice as susceptible as non-diabetic persons. In non diabetics with PAD and claudication, the natural history of PAOD usually follows a benign course with only 23% deteriorating over a 5-year period; 5% requiring vascular reconstruction and only 2% progressing to amputation 12. In the diabetic population, the onset of PAOD is particularly sinister, as the risk of progression to amputation increases tenfold to 20%. In diabetic patients, PAOD is characterized by distal, multiple obstructions with a higher percentage of occlusions with respect to stenosis 14. The aim of the revascularization procedure is to provide sufficient blood flow to relieve rest pain and heal skin lesions. The ideal revascularization procedure is one that avoids general anesthesia, poses a lesser systemic stress and has fewer serious complications. Both surgical bypass and endovascular revascularization are currently accepted forms of treatment. Arterial bypass surgery has traditionally been the main treatment with a well-documented long-term patency and limb salvage rate. However, technical and anatomical limitations such as the availability of the long vein graft and the presence of infection near the site of planned distal anastomosis often make surgery technically challenging and difficult [Table 2]. Additionally, patients often have multiple comorbidities such as cardiovascular disease, TABLE 2 - ADVANTAGES AND DISADVANTAGES OF SURGICAL BYPASS ADVANTAGES 1. It can be considered when angioplasty fails or is technically not feasable 2. Longer 5 year patency of vessel compared to PTA 3. Long segment occlusion of large vessels like femoral artery benefits from bypass DISADVANTAGES 1. Costly 2. Technically challenging especially inframallelor bypass 3. Mortality is higher 4. Complications higher 5. Presence of infection at site of planned distal anastomosis makes procedure difficult 6. Anaesthesia complications failure, and other pathologies associated with diabetes. Their co-morbidities increase general anesthesia risk and lead to poor tolerance for prolonged surgery. PTA is thus an attractive alternative in this subset of patients. Today, PTA has become a feasible, safe, effective and first choice procedure for the treatment of diabetic lower limb ischemia. At our institute, all patients whose wounds do not heal with underlying ischemia are referred for peripheral angiogram, which is done by our interventional radiologist. After evaluating the angiogram and local wound, the patient s systemic condition is assessed and the podiatric surgeons subject the patients for angioplasty. In cases where angioplasty cannot be completed or when angioplasty fails, a vascular surgeon s opinion is sought and peripheral arterial bypass is done if possible. In one of the earlier studies from our institute, Dayanand et al showed a reasonably good ulcer healing rate of 58.62% and a limb salvage rate of 75.8% at the end of one year following infrapopliteal percutaneous transluminal angioplasties. 5 21
5 The overall lower limb salvage rate in diabetic patients has been improving in our CONCLUSION Lower limb ischemia in patients with diabetic foot problems imposes a huge social impact on the cost as well as a major economic burden on health and social care, not only in developed countries, but also increasingly in developing countries. In India, only 10% of patients with diabetic foot ulcers have underlying peripheral arterial disease. Current literature shows that percutaneous transluminal angioplasty (PTA) is the first choice of procedures in institute over the years from 89.5% in to 91.5% in revascularization of the lower limb. Data from our institute (Amrita), the largest diabetic limb salvage center in India, reveals that around 6.73% of the patients with diabetic foot problems require peripheral angioplasty whereas only 3.32% of the patients require peripheral vascular bypass. The overall diabetic limb salvage rate at our institute is 91.5% which is comparable to the best centres in the world. References 1] Wild S, Roglic G, Green A, et al : Global prevalence of diabetes: Estimates for 2000 and projection for Diabetes Care 2004;27: ] Reiber GE, Lemaster JW. Epidemiology and economic impact of foot ulcers and amputation in people with diabetes. In: Levin and O Neals The diabetic foot.7th edition.mosby.2008:pg ] Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA 2005; 293: ] Morbachs S, Lutale JK, Viswanathan V, et al : Regional differences in risk factors and clinical presentation of diabetic foot lesions. Diabet Med 2004;21(1): ] Dayananda L et al. Infrapopliteal Angioplasties for limb salvage in diabetic patients : Does clinical outcome justify its use. Indian J Radio Imaging 2008;18(2): ] Saab MH, Smith DC, Aka PK, Brownlee RW, Killeen JD. Percutaneous transluminal angioplasty of tibial arteries for limb salvage. Cardiovasc Intervent Radiol 1992;15: ] Faglia E, Mantero M, et al. Extensive use of peripheral angioplasty, particularly infrapopliteal, in the treatment of ischaemic diabetic foot ulcers: clinical results of a multicentric study of 221 consecutive diabetic subjects. J Intern Med 2002;252(3): ] Zhu et al. Subintimal Angioplasty for Below the ankle arterial occlusions in diabetic patients with Chronic Critical Limb Ischaemia. Journal of Endovascular Therapy 2010; 16(5): ] Allen D Hamdan, Frank B Pomposelli. Lower limb arterial reconstruction in patients with diabetes mellitus: Principles of treatment. Levin and O Neals The Diabetic Foot 2008;21:
6 10] Ascer E, Veith FJ, Gupta SK, et al : Short vein grafts : A superior option for arterial reconstructions to poor or compromised outflow tracts. J Vasc Surg 1998;7: ]Hughes K, Domenig CM, Hamdan AD, et al : Bypass to plantar and tarsal arteries : An acceptable approach to Limb Salvage. J Vasc Surg 2004; 40: ]Malcolm Simms. Peripheral vascular diseases and reconstruction. In:The foot in Diabetes.4th edition.wiley.2006;21(4): ] Howard IM. The prevention of foot ulceration in diabetic patients. Phys Med Rehabil Clin N Am 2009;20: ] Jude EB, Oyibo SO, Chalmers N, Boulton AJ. Peripheral arterial disease in diabetic and non diabetic patients. A comparison of severity and outcome. Diabetes Care 2001;24: ] Jain AKC, Varma AK, Mangalanandan, Kumar H. Major amputationin diabetes. An experience from diabetic limb salvage centre In india. J Diab Foot Comp 2012;4(3): ] Varma AK. Reconstructive foot and ankle surgery in diabetic patients. Ind J Plast Surg 2011;44(3):
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