|Year : 2021 | Volume
| Issue : 2 | Page : 155-160
Outcomes of infrapopliteal angioplasty in advanced diabetic ischemic foot ulcers
Jithin Jagan Sebastian, MK Ayyappan, Naveen Rajendra, Kapil Mathur, Arun Kumar, Athirath Reddy, Radhakrishnan Raju
Department of Vascular Surgery, Sri Ramachandra Institute of Higher Education and Research, Chennai, Tamil Nadu, India
|Date of Submission||26-May-2020|
|Date of Decision||06-Jun-2020|
|Date of Acceptance||23-Jun-2020|
|Date of Web Publication||13-Apr-2021|
M K Ayyappan
Department of Vascular Surgery, Sri Ramachandra Institute of Higher Education and Research, Chennai, Tamil Nadu
Source of Support: None, Conflict of Interest: None
Aims: Diabetic patients in India present late in advanced stages of tissue loss and isolated occlusive infrapopliteal disease. We aim to determine the outcomes of angioplasty in these patients with SINBAD score >3 and infrapopliteal disease presenting with critical limb-threatening ischemia (CLTI) and tissue loss. Materials and Methods: A prospective, observational, single-center study was carried out of diabetic patients with infrapopliteal occlusive disease who underwent angioplasty for CLTI and tissue loss. Transatlantic society consensus (TASC) - classification was used for staging. Ischemia and Peripheral Artery Calcium Scoring was used to assess peripheral calcium. The patients were followed up till their ulcer healed and then every six months. Results: A total of 73 diabetic patients underwent angioplasty for CLTI. 21.8% (16/73) all-cause mortality was seen during the study. The average age was 68.9 years with 78.9% males. The average time to presentation was 55 days. 61.3% of patients had TASC C or D lesions. Technical success was achieved in 94.5% of patients. 27.4% of patients underwent angioplasty of multiple tibial vessels. The mean duration of follow-up was 2 years. 62.5% of patients had their ulcers completely heal in 6 months. Six patients went on to have major amputation. The amputation-free period was 500 days in this patient group. Ulcer healing was found to be dependent on successful revascularization. Conclusion: Mortality is seen in 1 in 10 and morbidity in 1 in 5 patients. It is difficult to accurately prognosticate healing in these patients. Successful revascularization is the only factor affecting healing in these patients.
Keywords: Diabetic foot, infrapopliteal disease, limb salvage, tibial angioplasty, wound healing
|How to cite this article:|
Sebastian JJ, Ayyappan M K, Rajendra N, Mathur K, Kumar A, Reddy A, Raju R. Outcomes of infrapopliteal angioplasty in advanced diabetic ischemic foot ulcers. Indian J Vasc Endovasc Surg 2021;8:155-60
|How to cite this URL:|
Sebastian JJ, Ayyappan M K, Rajendra N, Mathur K, Kumar A, Reddy A, Raju R. Outcomes of infrapopliteal angioplasty in advanced diabetic ischemic foot ulcers. Indian J Vasc Endovasc Surg [serial online] 2021 [cited 2021 Jun 24];8:155-60. Available from: https://www.indjvascsurg.org/text.asp?2021/8/2/155/313563
| Introduction|| |
India has the second largest diabetic population in the world. 28% of these patients are expected to be suffering from peripheral vascular disease. South India which accounts for majority of this diabetic population has a higher incidence of peripheral vascular disease compared to cardiovascular disease. However, most patients presenting with diabetic foot syndrome with associated vasculopathy present late in advanced stages of tissue loss. These wounds are usually infected and ischemic, and salvage of these limbs is not always possible. Most of these patients on evaluation have infrapopliteal disease. Endovascular treatment in the form of tibial angioplasty has been shown to be effective and comparable to surgical bypass albeit with lesser morbidity. However, data on the outcomes of this procedure on wound healing in the backdrop of critical limb-threatening ischemia (CLTI) are less. This single-center study was conducted to determine the outcomes of tibial angioplasty in these patients and factors which determined ulcer healing.
| Materials and Methods|| |
A prospective, observational study of diabetic patients presenting with tibial disease from October 2015 to December 2018 was carried out. The aim of the study was to study the outcomes after revascularization of diabetic patients with CLTI with tissue loss. Factors which were responsible for delay in wound healing (>2 months) were also determined. The study was undertaken after due clearance from the institutional ethics committee. Informed consent was obtained from all the patients included in the study.
Inclusion and exclusion
Diabetic patients presenting with CLTI to the Outpatient Department of Vascular Surgery, Sri Ramachandra Medical College Hospital, were included. Those patients with a palpable popliteal pulse and absent distal pulses were considered. Patients with CLTI and tissue loss (Rutherford Class 5 and 6) were included. Those patients with superficial femoral artery disease or prior interventions for proximal disease were excluded. Patients who were bedridden or who were not willing for revascularization were excluded. Patients with acute thrombotic occlusion, allergy to iodinated contrast, or bleeding disorders were excluded.
Patients presenting with diabetic foot to the vascular surgery clinic underwent a complete physical examination. Patients with popliteal pulse and absent tibial pulses had their ankle-brachial index (ABI) recorded. Patients with ABI <0.5 were diagnosed to have tibial occlusive disease. In patients with noncompressible vessels, an arterial Doppler was carried out. Patients with stenosis or occlusion of tibial vessels with reduced monophasic flow at the ankle with peak systolic velocity (PSV) <30 cm/s in both AT/PT vessels underwent revascularization. Ischemic wounds were classified into either Rutherford class 5 or class 6 based on the extent of tissue loss/gangrene and ABI. SINBAD classification which has been validated was used for diabetic foot ulcers as per the International Working Group on Diabetic Foot (IWGDF) guidelines. A CT angiogram of the aorta and ipsilateral leg was taken to rule out proximal significant lesions. This group of patients were subjected to digital subtraction angiography with or without angioplasty after appropriate consent. Calcium at the target vessel was calculated by the Peripheral Artery Calcium Scoring (PACSS), which has been validated. If the tissues were infected, it was debrided with minor amputations of the digits simultaneously with angioplasty under local or regional anesthesia. Infection was classified as per the IWGDF guidelines.
Tibial angioplasty was usually carried out under local anesthesia with mild sedation and two standard operators. A renal protection protocol with intravenous fluids and N-acetyl cysteine was followed for all patients with borderline creatinine of 1.2 and above. Anterograde puncture under ultrasound guidance was carried out and a 6 Fr introducer sheath was placed. Contralateral puncture was carried out at the surgeon's discretion in obese patients or diseased puncture site. 5000 IU of unfractionated heparin was given intra-arterially after confirming access. A 0.014 wire and a 4 Fr guiding catheter were used to cross lesions. In one case, retrograde access was necessary. Atherectomy was not carried out for any of the patients. Preferably, direct angiosomal revascularization was attempted otherwise indirect vessels were recanalized. A preliminary angiogram was taken, and the target vessel was classified as per the Trans-Atlantic Society Consensus (TASC) II system. Below the ankle, run-off was noted and the completeness of the arch was noted. Angioplasty was carried out using small-profile balloons selected based on the size of the lesion and the diameter of the artery [Figure 1]. Stenting was not required in any of the patients as a bailout. A completion angiogram was taken, and a procedural success was defined as a straight in line flow to the foot with <30% residual stenosis. Postangioplasty 0.1–0.2 mg of nitroglycerine was injected intra-arterially. At the end of the procedure, hemostasis was achieved by manual compression. Patients were put on a single antiplatelet on discharge
|Figure 1: Angioplasty of a TASC D lesion in posterior tibial artery: preoperative (left), intraoperative (center), and postcompletion angiograms (right)|
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Patients were reviewed weekly till their ulcers healed and then monthly thereafter. Clinical examination and ABI were used for surveillance. If no clinical improvement in ulcer healing or a fall in ABI >0.15 was noted, duplex imaging was carried out. All dressing was done in the outpatient department using saline and hydrocolloid gels. Skin grafting was carried out once the wound had granulated. Offloading of the foot was carried out when indicated once the wound healed to prevent recurrence.
Technical success was defined as the presence of a palpable pulse or improvement in ABI from baseline or a triphasic flow on Doppler with PSV >50 cm/s. Wound healing was defined as complete re-epithelialization of the wound without mortality or major amputation. Delayed healing was taken as wound not healed after 6 months. Limb salvage was defined as the absence of any major amputation. Major amputation was taken as any above the ankle amputation. Wound healing, limb salvage, and amputation-free period were calculated for each patient. Wound healing was taken as the endpoint of treatment in this study rather than patency of the target vessel.
The data were represented as mean and standard deviation for continuous variables and percentages for dichotomous variables. To assess factors for healing, the patients were grouped into two groups and univariate analysis was carried out by the Chi-square and student t-tests. P < 0.05 was considered statistically significant. Cumulative survival was calculated by the life table method of Kaplan and Meier. Kaplan–Meier curves were presented for survival outcomes.
| Results|| |
A total of 88 diabetic patients presented with CLTI to the vascular surgery OPD between 2015 and 2018. Six patients presented with rest pain and no tissue loss and were excluded. A total of 82 patients were followed up for a mean period of 2 years. The maximum follow-up was 4 years and the minimum follow-up was 1 year. Nine patients were lost to follow-up or had incomplete data and were excluded from the analysis. The profile of the study is shown in [Figure 2].
The average age at presentation was 69 years with a predominant male population of 78% ( n = 57). Most patients with advanced stages of diabetic foot syndrome present late with a mean time to presentation of 55 days after onset of tissue loss. All patients had advanced ischemic ulcers with SINBAD score ≥3 with 68.4% (50/73) of patients having a score of ≥5. 15.06% ( n = 11) of patients presented with forefoot and midfoot involvement and tibial disease. 42% of the patients were hypertensive and 6% had chronic kidney disease as shown in [Table 1]. The mean duration of diabetes in these patients was 5.4 years.
The TASC staging showed that 61.3% of the target tibial vessel had advanced disease (TASC C or D). 56.7% had severe calcification of the tibial vessels as per the PACSS scoring system. 63% had a right leg disease. Infection was seen in 73.6% (53/73) of the ischemic diabetic foot. Moderate-to-severe infection was seen in 85% (45/53) of those with infection. Neuropathy was seen in 85% of the cases. Technical success was achieved in 94.5% ( n = 69) of the patients. A patient developed early postoperative rethrombosis of the tibial vessels for which anticoagulation and thrombolysis was carried out. One patient went on to have a distal bypass posttibial angioplasty for acute reocclusion.
The primary endpoint of limb salvage was achieved in 89% ( n = 65) of patients at 1 year. 19 (26.3%) of the 73 patients underwent angioplasty of two or more tibial vessels. Of the patients who had a single tibial vessel revascularization, 32 (58.9%) of 54 patients had an angiosome-directed angioplasty. Six (10%) patients had a major amputation. 30 (62.5%) of 48 patients had their ulcers completely healed by 6 months. Ulcers took an average 2 months to heal. There was an improvement in the SINBAD score to <3 in these ulcers at 2 months. An amputation-free period of average 500 days was achieved. All-cause mortality was seen in 16 (21.9%) of 73 patients. Kaplan–Meier analysis of the patients showed that early healing of ulcer ( P = 0.021) and complications ( P = 0.003) affected overall survival in these patients as shown in [Figure 3]. Complication included major amputation in 6 patients and progression of infection (osteomyelitis) in 2 patients.
Technical success was the only factor that determined early wound healing at 6 months. None of the other factors such as multiple-vessel revascularization, angiosome directed, completeness of the arch, or calcification of tibial vessels determined healing at 6 months in these patients. TASC staging, smoking, and presence or absence of infection did not contribute to ulcer healing. These factors were assessed by Chi-square or Student's t-test and did not show significance as shown in [Table 2].
| Discussion|| |
Infrapopliteal peripheral vascular disease is a common presentation on account of a large diabetic population in South India. Asian Indians have the highest incidence of diabetes as per the CURES study. 51% of diabetic patients present with diabetic foot syndrome of ischemia, infection, and neuropathy as stated by Vibha et al. in a community-based study. 28% of these patients have some form of peripheral vascular disease requiring intervention. Most of these patients present with ischemia associated with some form of neuropathy (85% in our study).
Most of these patients present late in advanced stages of tissue loss and infection secondary to ischemia and hence require some form of intervention for limb salvage. The average time to presentation to the vascular surgeon was 55 days. 70% of these patients travel long distances from rural India for the treatment of the diabetic foot ulcer (average 11 weeks) as observed by Shahi et al. Limb salvage is difficult in this set of patients and entails a challenging revascularization with frequent follow-up and repeated debridements with minor amputations and revisions.
The mean age of presentation of these patients is 69 years similar to the meta-analysis by Mustapha et al. Infrapopliteal angioplasty in diabetic patients has shown to have lesser patency compared to nondiabetic patients. This might be due to the long, multiple, calcified, and complete obstructions seen in diabetics rather than the focal stenotic lesions in nondiabetics. Our study showed that 61.3% had TASC C or D disease and 56.7% of patients had bilateral wall or circumferential (severe, PACSS 3 or 4) calcification.
Ulcer healing is worse in diabetic patients compared to nondiabetics despite obtaining similar patency rates. This may be due to diabetic patients with CLTI having poor collateral distribution and depression of arteriogenic and growth factors in response to ischemia in below the knee arteries as observed by Faglia et al. Ulcer healing seems to be a better clinical outcome than patency in infrapopliteal angioplasty as there is a high rate of restenosis in these patients despite clinical ulcer healing. Increased patency also does not correlate with survival or the risk of amputation.
Limb salvage rates of 89% were higher than the earlier study of infrapopliteal angioplasty by Dayananda et al. (75.8%) probably due to an improvement in hardware and expertise in the field. All-cause mortality of 21.9% was higher in our study compared to the meta-analysis by Mustapha et al. predominantly because of a diabetic population being studied. Ulcer healing rate of 62.5% at 6 months was similar to the recent study by Chaudhari et al. (66.45% at 6 months). At 6 months, technical success was the only factor found to influence wound healing. The concept of angiosome introduced by Taylor and Palmer was not found to help in ulcer healing at 6 months in this group of patients as pointed out in other studies.,,,
Single- versus multiple-vessel revascularization has been shown to improve wound healing rates;, however, these results were not seen in our study probably due to long occlusive, poorly collateralized nature of the tibial vessels. TASC D lesions are more common in diabetic patients than nondiabetics. Multiple-vessel revascularization entails higher contrast volume, longer procedure time, and higher radiation exposure, which might be deleterious in this patient group.
Rashid et al. have shown that it is the pedal arch quality and not angiosomal revascularization, which was responsible for wound healing. However, in our study, below the ankle, run-off or completeness of the arch was not seen to influence wound healing. Severity of the peripheral vascular disease as pointed out by Apelqvist et al. in diabetics seems to be the main criteria affecting wound healing. Success in revascularization seems to be only factor to affect wound healing in these patients despite the long-segment occlusions. We seem to have gone full circle in the aspect of wound healing following infrapopliteal revascularization in diabetics.
Mortality in our study was high at 20% which is higher than the recent meta-analysis, which included nondiabetic patients. The mortality in diabetic patients with peripheral arterial disease is higher than nondiabetic patients (58% vs. 29%, diabetics vs. nondiabetics, 10-year mortality). Amputation which has been found to be a major determinant of mortality is also demonstrated in our study. Healed ulcer is also shown to impact survival from this study.
The study has its share of limitations. The sample size is small and does not include patients without tissue loss, leading to a degree of overestimation. This study however represents a select group of diabetic patients with CLTI and tissue loss. The second limitation was the method of selection and follow-up of patients was based solely on clinical criteria as other objective modalities of TcPo2, toe pressure, and skin perfusion pressure were not available. Third, patency was not established as wound healing was seen to be a better endpoint in these patients. The study highlights the poor morbidity and mortality in this group of patients
| Conclusion|| |
It is difficult to accurately prognosticate healing in patients with diabetic foot ulcer and advanced peripheral vascular disease. Successful revascularization is the only factor affecting outcome in these patients. Wound healing is possible in these patients albeit with high mortality (1 in 10 patients) and morbidity (1 in 5 patients).
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Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2]