|Year : 2022 | Volume
| Issue : 1 | Page : 37-43
A hospital-based prospective short-term study on efficacy of infrapopliteal angioplasty in critical limb ischaemia in terms of limb salvage and quality of life
Stalin Thomas1, Vimal Iype2, Santhosh John Abraham3
1 Department of Surgery, Lourdes Hospital, Kochi, Kerala, India
2 Department of Vascular Surgery, Lourdes Hospital, Kochi, Kerala, India
3 Department of General Surgery, Lourdes Hospital, Kochi, Kerala, India
|Date of Submission||08-May-2022|
|Date of Decision||15-May-2022|
|Date of Acceptance||17-May-2022|
|Date of Web Publication||14-Jul-2022|
Dr. Stalin Thomas
B S Villa, East Kallada, East Kallada (P. O), Kollam - 691 502, Kerala
Source of Support: None, Conflict of Interest: None
Introduction: Critical limb ischaemia (CLI) refers to chronic ischaemic pain at rest, ulcers or gangrene due to arterial occlusive disease. It is the end stage of peripheral artery disease (PAD). The commonly available treatment is amputation in a low-income family, which is quite disastrous. Aim: This study aimed to find out the efficacy of infrapopliteal angioplasty in tibial lesions of CLI patients. Materials and Methods: A prospective, observational study was conducted on 50 patients with CLI. The patient was taken up for tibial angioplasty and followed up for 4 months. Results: At the end of 4 months, the limb salvage rate was 92% and major amputation rate was 8%. The role of angioplasty in limb salvage is undoubted and has resulted in high levels of limb salvage. Conclusion: CLI lesion if amenable to revascularisation should have angioplasty with regular follow-up. Control of risk factors forms an integral part of the follow-up. Early detection of CLI is the need of the hour.
Keywords: Ambulation, amputation, angioplasty, critical limb ischaemia, limb salvage, revascularisation, ulcer
|How to cite this article:|
Thomas S, Iype V, Abraham SJ. A hospital-based prospective short-term study on efficacy of infrapopliteal angioplasty in critical limb ischaemia in terms of limb salvage and quality of life. Kerala Surg J 2022;28:37-43
|How to cite this URL:|
Thomas S, Iype V, Abraham SJ. A hospital-based prospective short-term study on efficacy of infrapopliteal angioplasty in critical limb ischaemia in terms of limb salvage and quality of life. Kerala Surg J [serial online] 2022 [cited 2022 Sep 24];28:37-43. Available from: http://www.keralasurgj.com/text.asp?2022/28/1/37/350891
| Introduction|| |
Peripheral artery occlusive disease, commonly referred to as peripheral artery disease (PAD) or peripheral vascular disease, refers to the obstruction or deterioration of arteries other than those supplying the heart and within the brain. The term critical limb ischaemia (CLI) refers to a condition characterised by chronic ischaemic pain at rest, ulcers or gangrene in one or both legs attributable to objectively proven arterial occlusive disease. It represents the end stage in the spectrum of peripheral artery disease (PAD).
CLI is a highly morbid disease, causing significant mortality, limb loss, pain and diminished health-related quality of life. There is a general concept that amputation is easier on the patient and cheaper option than revascularisation. Amputation in a low-income male patient is quite disastrous for the entire family. The quality of daily life and the fate of the other limbs and life are not usually considered.
Endovascular intervention for the treatment of lower extremity arterial disease has been widely adopted due to its minimally invasive nature. The aim of this study was to find out the efficacy of infrapopliteal angioplasty in tibial lesions of CLI patients in terms of freedom from major amputations, symptomatic relief of pain and improved quality of life in terms of ambulatory status and ulcer healing of the patient.
| Materials and Methods|| |
This was a prospective, observational study conducted in a tertiary care hospital. Patients with CLI attending the general and vascular surgery outpatient department for 18 months from September 2018 to February 2020 were included in the study. The sample size was 50, as determined by the formula:
where n = sample size
P = rate of prevalence
Q = 1 − P
D = error of estimation
Z = value of standard normal distribution.
By taking P as 6.3% and with a confidence interval of 95%, the minimum sample size as per the above formula worked out to be 47.59 and has been conveniently taken as 50. Simple random sampling was utilised. Statistical tests included Student's independent t-test for comparing demographic variables, Chi-square test for testing the independence of qualitative variables, analysis of variance for comparison of groups and Fisher's exact test for appropriate data.
After obtaining approval from the hospital ethical committee and written and informed consent, 50 adults of either sex of all ages with tibial lesions taken up for angioplasty were included in the study. Patients having tibial lesions with any interventions in the past for the same; those who are having active and ascending infection in the ulcer or limb; those having concurrent suprapopliteal lesions, renal failure with severe renal derangements or wet gangrene proximal to midfoot and those having Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC) D lesion in computed tomography (CT) were excluded.
Patients admitted with diagnosis of CLI were subjected to full history and clinical examination, routine pre-operative investigations like complete blood count, blood sugar level, serum creatinine, chest X-ray and electrocardiography. The patient was classified according to Rutherford classification. Ankle brachial pressure index (ABPI) + toe brachial index (TBI) and arterial Doppler/duplex of the patient were taken, and subjects with isolated tibial lesion were taken up into study. Informed consent was taken regarding participation in the study, and the patient was advised to take CT angiogram/magnetic resonance angiogram/digital subtraction angiography and classified according to TASC (for below-knee arteries – Jaff 2015). The patients were considered for revascularisation by open/endovascular interventions. TASC classification status, patient performance status/comorbidities, financial status, patient preference and treating physicians were all considered in finalising the treatment option. Final decision was made by the vascular surgeon. The patient was taken up for tibial angioplasty in cath lab under fluoroscopic control. Then, the patient was kept under follow-up in immediate post-operative period, at weekly interval for 1 visit and further monthly follow-up of 3 visits, totalling 4-month follow-up. On follow-up, each patient was studied with reference to assessment of ulcer healing if any, ambulatory status, diabetic status, contralateral limb status and handheld Doppler evaluation of tibial vessels. Doppler study or angiogram study was done as and when required.
Postoperatively, the patient was started on low-dose aspirin and statins. Once the wound healed, the patient was given offloading footwears and advised to undergo supervised exercise therapy. Patient's age, sex, risk factors, type of tibial lesions and follow-up findings were analysed to check for statistical significance.
| Results|| |
The majority of patients were in the age group of 70–80 years (64%). The mean age and standard deviation (SD) for our study was 72.66 ± 5.251 (range 60–83), as detailed in [Table 1].
We had a male preponderance, 39 were male (78%) and 11 were female (22%) with a male/female ratio of 3.5/1. Diabetes mellitus in 92% was the highest associated risk factor for CLI. Hypertension was found in 66%. Twenty-three (54%) had a history of coronary artery disease (CAD). Smoking was found in 68%.
Clinical classification of patients was done according to Rutherford classification. We had only 22% and 78% of patients in Rutherford Classes 4 and 5, respectively [Figure 1].
|Figure 1: Bar diagram showing study population classified according to Rutherford classification|
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The patients were classified based on arterial lesion according to TASC criteria. TASC A consisted of 4%, TASC B 86% and TASC C 10% of study population. One primary end point was pain relief and was assessed using the Visual Analogue Scale (VAS) 1–10. Pre-procedure pain score was 8.68 (SD: 0.891), and at the end of the study, pain score was 2.50 (SD: 1.19), as depicted in [Figure 2]. During the study duration of 4 months, VAS 1 (mean for the pre-procedure) was 8.68 ± 0.891, VAS 2 (mean for the immediate post-procedure) 7.58 ± 0.859, VAS 3 (after 1 week post-procedure) 6.14 ± 0.881, VAS 4 (1 month after the procedure) 5.08 ± 1.140, VAS 5 (2 months post-procedure) 3.33 ± 1.375 and VAS 6 (4 months post-procedure) 2.50 ± 1.199.
|Figure 2: Line diagram showing mean of the Visual Analogue Scale during the study period|
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Ulcer healing either by secondary healing or skin grafting was used to quantify ulcer healing. 78% had gangrene which warranted debridement/toe amputation and 22% had rest pain only. After debridement, the study group with active ulcer was 78%. At the end of the study, 58% had complete wound healing (secondary wound healing/skin grafting) and 12% had stable wound and 8% underwent amputation. The study period was classified as area 1 (pre-procedure), area 2 (immediate post-procedure), area 3 (after 1 week post-procedure), area 4 (1 month post-procedure), area 5 (2 months post-procedure) and area 6 (4 months post-procedure). In area 2, there was no ulcer in 22% of the people and 42% had ulcer area between 10.1 and 15. In area 3, 28% had ulcer area between 10.1 and 15. In area 4, 24% had ulcer area between 10.1 and 15. 2% had amputation, 6% had gangrene and 10% wound had been grafted, so the total study population with absent wound is 32%. In area 5, 9% of study population had ulcer area between 10.1 and 15, 8% underwent amputation which denotes failure of therapy and 30% wound was grafted. Hence, the total population with absent wound was 52%. In area 6, 4% of study population had ulcer area between 10.1 and 15, 8% underwent amputation which denotes failure of therapy and 58% wound had been grafted, so the total population with absent wound is 80%, as detailed in [Table 2].
|Table 2: Ulcer area in cm2, amputation status, gangrene and grafted wound from immediate post-procedure (area 2) to end of the study (area 6)|
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In depth 1, 78% of study population were having gangrene of big toe or other parts of forefoot (affecting minor area) and 22% of study population presented with rest pain with no ulcers. In depth 2, 78% had deep ulcers which have resulted from amputation or debridement of gangrenous tissue and 22% were not having any active ulcers. In depth 3, 70% had deep ulcers, 8% had shallow ulcers and 22% had no ulcers. In depth 4, 48% had deep ulcers; 6% had shallow, superficial ulcers and gangrene and 22% had no ulcers. In depth 5, 52% had no active ulcers (including patients who presented with rest pain with no ulcers and grafted wound of patients who presented with gangrene), 24% had deep ulcers, 12% had superficial ulcers, 8% underwent amputation and 4% had shallow ulcers. In depth 6 (end of study), 80% had no ulcer, 8% underwent amputation, 6% had deep ulcers, 2% had shallow ulcers and 4% had superficial ulcers at the end of the study [Table 3].
Our study population had 78% of independent ambulation at the end of 4 months [Table 4]. In AMBU 1 (pre-procedure), 68% were found to be bedridden or wheelchair bound, 20% were prevented by rest pain and 12% required assistance for ambulation. In AMBU 2 (immediate post-procedure), 78% were bedridden or wheelchair bound, 20% were prevented by rest pain and 2% required assistance for ambulation. In AMBU 3 (after 1 week post-procedure), 50% required ambulation for assistance, 40% were bedridden or wheelchair bound, 8% were prevented by rest pain and 2% were having independent ambulation. In AMBU 4 (months after the procedure), 52% required ambulation for assistance, 24% were having independent ambulation, 16% were bedridden or wheelchair bound and 6% were prevented by rest pain. In AMBU 5 (2 months post-procedure), 48% were having independent ambulation, 40% were having ambulation with assistance, 8% underwent amputation and 4% were prevented by rest pain. In AMBU 6 (4 months post-procedure), 78% were having independent ambulation, 12% needed assistance for ambulation, 8% underwent amputation and 2% ambulation was prevented by rest pain.
We monitored ABPI at pre-procedure, immediate post-procedure and at the end of the study as 0.41 ± 0.07, 0.70 ± 0.11 and 0.62 ± 0.11, respectively. TBI observed values were 0.21 ± 0.25, 0.46 ± 0.16 and 0.46 ± 0.13. We found an increase in ABPI and TBI after the procedure and on follow-up. At the end of 4 months, the limb salvage rate was 92% and major amputation rate was 8%, χ2 = 39.10, P < 0.01. The limb salvage rates in the TASC A, B and C groups were 100%, 100% and 20%, respectively. We have not included TASC D population [Table 5].
|Table 5: Relationship between Rutherford Class 4 and ambulatory status, pre-procedure and at the end of the study|
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At the beginning of the study, based on presenting symptoms, patients were classified according to Rutherford class and their ambulatory status at the beginning and end of the study were observed. In the pre-procedure time period, 81.8% had their ambulation prevented with rest pain, 9.1% were getting ambulated with assistance and 9.1% were bedridden or wheelchair bound. At the end of the study in the Rutherford Class 4, 90.9% of patients were having independent ambulation and 9.1% had ambulation prevented by rest pain, χ2 = 18.40 (P < 0.01).
According to the presenting symptom, Rutherford Class 5 represents patients coming with gangrene distal to forefoot. At the pre-procedure period, 84.6% of patients were bedridden or wheelchair bound, 12.8% needed assistance for ambulation and in 2.6% of patients, ambulation was prevented by rest pain [Table 6]. At the end of the study in Rutherford Class 5, 84.6% of patients acquired independent ambulation and 15.4% of study population in Class 5 required assistance for ambulatory support, χ2 = 67.09 (P < 0.01).
|Table 6: Relationship between Rutherford Class 5 and ambulatory status, pre-procedure and at the end of the study|
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When patients were assigned for study, the arterial lesions were classified according to TASC criteria. In the TASC A group, 50% of patients required assistance for ambulation, and in 50% of patients, ambulation was prevented by rest pain. In the TASC B group, 69.8% were bedridden or wheelchair bound. In 18.6%, ambulation was prevented by rest pain and 11.6% required assistance for ambulation. In the TASC C group, 80% were bedridden, and in 20%, ambulation was prevented by rest pain, χ2 = 5.43 (P < 0.01).
In the TASC A group at the end of the study period, 100% had independent ambulation. In the TASC B group, 81.39% had independent ambulation, 11.62% of patients required assistance for ambulation, 4.65% underwent amputation and in 2.32%, ambulation was prevented by rest pain. In the TASC C group, 40% underwent amputation, 40% had independent ambulation and 20% required assistance for ambulation, χ2 = 5.53 (P < 0.01). At the end of the study period in TASC A and B, 100% of the limbs were salvaged. In TASC C, 20% of limbs were salvaged and 80% underwent amputation. At the end of the study, 92% of limb salvage was observed or freedom from major amputation was 92%.
| Discussion|| |
The study included 50 cases of CLI with isolated infrapopliteal disease. They were evaluated, and after satisfying all inclusion criteria and exclusion criteria, the patient was taken up for balloon angioplasty alone for patients with rest pain, followed by debridement or ray amputation for patients with gangrene. They were followed up for a period of 4 months starting from immediate post-procedure, 1 week, 1 month, 2 months and 4 months post-procedure.
Demographic profile of study population including age and sex was studied. Risk factors of CLI such as diabetes mellitus, hypertension and smoking were also studied. Spectrum of arterial disease including prevalence of coronary disease was also studied in the population. After evaluation, the patients were classified clinically according to Rutherford class and angiographically according to TASC II classification for infrapopliteal disease.
Various authors,, have reported mean age from 65 to 74 years. In our study, the mean age was 72.66. The male/female ratio has been reported as 2.5/1, 2/1. 59/41 and 3.2/1 in various studies. We had a male preponderance of 78% when compared to female 22%. The male/female ratio was 3.5/1. All these studies support the fact that CLI mainly affects male population.
Werneck and Lindsay noted that the prevalence of diabetes mellitus is 90%. Janko et al. found that the diabetic population was around 85.5%. In our study, the prevalence of diabetes mellitus was 92% which was consistent with studies quoted in literature. This proved the fact that CLI is strongly associated with diabetes mellitus and it aids in the progression of disease. Kudo et al. identified hypertension in 60%. In our study, the prevalence of hypertension was 66%; this result is consistent with other studies observed denoting the role of hypertension in CLI. Werneck and Lindsay found the prevalence of CAD in the study group as 69%. Ferraresi et al. found it as 38%. Faglia et al. had CAD in 60%. In our study, the prevalence of CAD was found to be 46%. This shows that there is a significant relationship between CLI and CAD. Giles et al. found 50% having habit of smoking. Faglia et al. found a prevalence of 54%. In our study, it was 68%. All other studies have stressed upon the positive correlation between smoking and CLI.
Werneck and Lindsay found that Rutherford Class 5 comprised about 80% of study population. In our study, Rutherford Classes 4 and 5 were 22% and 78%, respectively. From the above studies, it is evident that majority of patients consulting healthcare facilities with CLI will be very symptomatic mostly when the gangrene sets in. Forbes et al. conducted the famous Bypass versus angioplasty in severe ischaemia of the leg (BASIL) trial, in that quality of life was measured in terms of pain also using ED50 questionnaire; pain component was 2.34 (SD: 1.21) in the pre-procedure period; at the end of 3rd month, it was 4.50 (SD: 1.73) and at the end of 1st year, it was 4.65 (SD: 1.72), which denoted pain relief for the patient. In our study, we assessed pain using VAS (1–10), pre-procedure pain score was 8.68 (SD: 0.891) and at the end of the study, pain score was 2.50 (SD: 1.19). Thus, it is evident from the above studies that revascularisation procedures such as angioplasty will provide pain relief for the patient.
Muir et al. found successful wound healing of about 62.5% and 37.5% requiring amputation in their study. In our study, 78% had gangrene which warranted debridement/toe amputation and 22% had rest pain only. After debridement, the study group with active ulcer was 78%. At the end of the study, 58% had complete wound healing (secondary wound healing/grafting) and 12% had stable wound and 8% underwent amputation.
Goodney et al. found ambulatory status after lower extremity revascularisation to be 88% ambulatory 1 year after surgery. In our study, 78% were able to ambulate independently. There is an appreciable increase in ambulatory status after angioplasty.
The efficacy of tibial angioplasty in CLI was to check for ABPI/TBI during the study period. The pre-intervention ABPI was 0.42 ± 0.13 and post-intervention ABPI was 0.90 ± 0.14. There was a significant increase in ABI – pre-procedure ABI was 0.62 ± 0.24 versus a post-intervention ABI of 0.81 ± 0.29 (P = 0.02). In our study, ABPI of the pre-procedure, immediate post-procedure and at the end of the study was 0.41 ± 0.07, 0.70 ± 0.11 and 0.62 ± 0.11, respectively. TBI observed values were 0.21 ± 0.25, 0.46 ± 0.16 and 0.46 ± 0.13. From the above study and from the observation made from the study, it is evident that angioplasty will increase the value of ABPI/TBI; indirectly, it shows that perfusion to lower limb is also getting increased.
Werneck and Lindsay studied the efficacy of angioplasty in limb salvage and concluded that freedom from major amputation was 75.5% at the end of 2 years. Ferraresi et al. in their study with infrageniculate lesions and role of angioplasty in limb salvage noted freedom from major amputation of 93% and amputation of 7% at the end of 1 year. Janko et al. studied 69 patients with CLI of infrageniculate vessels and found to have a limb salvage rate of 88.4%. In our study, at the end of 4 months, the limb salvage rate was 92% and major amputation rate was 8%, χ2 = 39.10, P < 0.01. From the above studies, the role of angioplasty in limb salvage is undoubtful and has resulted in high levels of limb salvage.
In TASC A, B and C, the limb salvage rates were 95%, 87% and 81%, respectively. The TASC D group was associated with poor limb salvage rate. In our study, the limb salvage rate in the TASC A, B and C groups were 100%, 100% and 20%, respectively. We have not included TASC D population. The TASC C group had poor limb salvage rate in our study and it might have due to other comorbidities existing in them.
Recommendations from the study include screening programme in patients above 55 years to detect CLI in high-risk patients, especially with diabetes mellitus, training of general surgeons to do endovascular interventions, introduction of foot clinic for follow-up and supervised exercise programme for post-revascularisation patients, smoking cessation programmes or ban on tobacco products and setting up of angiography suite in public healthcare sector and reduction of price of stent and other endovascular devices.
| Conclusion|| |
CLI generally affects elderly male population. If the lesion is amenable to revascularisation, angioplasty with regular follow-up is ideal. Control of risk factors such as tight glycaemic control, hypertension monitoring, smoking cessation and administration of antiplatelet form an integral part of the follow-up along with ABPI for indirectly measuring perfusion of the limbs. Early detection of CLI is the need of the hour.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]