Clinical application value of intravascular long balloon angioplasty in the treatment of diabetic foot

by lkts1ji2kod on 2011-04-07 12:21:24

【Abstract】 Objective To observe the clinical efficacy of endovascular long balloon angioplasty in patients with severe diabetic lower limb vascular lesions combined with diabetic foot. Methods Thirty-seven patients with type 2 diabetes, severe lower limb vascular lesions, and diabetic foot were randomly divided into a treatment group (18 cases) and a control group (19 cases). Both groups received conventional drug therapy. The treatment group additionally underwent lower limb angiography + long balloon angioplasty. Results In the treatment group, there were 18 patients with 24 affected limbs, and among the total of 33 target lesions, 26 were successfully treated, achieving an intraoperative patency rate of 78.8%. The clinical efficacy, ulcer healing status, and amputation rate in the treatment group were significantly better than those in the control group (P0.05), making them comparable.

1.2 Treatment Methods Both groups received treatments including blood glucose control, anti-infection, anticoagulation, promoting blood circulation, nourishing nerves, and local dressing changes. On this basis, the treatment group underwent lower limb angiography + balloon angioplasty. Using the Seldinger technique, either the contralateral or ipsilateral femoral artery was punctured, an arterial sheath was placed, and 2,000 U of heparin was injected. Angiography was performed on the iliac artery, femoral artery, superficial femoral artery, popliteal artery, anterior tibial artery, posterior tibial artery, fibular artery, and dorsalis pedis artery of the affected limb to determine the scope, degree, and collateral circulation situation of the lesioned vessels. Selective catheterization was performed at the site of arterial occlusion or stenosis, and a guidewire was passed through the occluded or narrowed segment of the vessel. After exchanging the catheter, a balloon catheter was introduced. An Italian Invatec company Deep long balloon (100±20)mm was used to perform PTA treatment for a long time (120±60)s under low pressure (405±203)kPa. A follow-up angiography was immediately performed after PTA. The success criteria were as follows [2]: (1) Residual stenosis of the target lesion vessel <30%; (2) Distal blood flow TIMI grading at level 3.

1.3 Observation Indicators and Efficacy Determination The clinical symptoms, foot ulcer healing condition, and prognosis of diabetic foot were observed and evaluated at 1 week, 4 weeks, 12 weeks, and 24 weeks post-treatment. Effective: Improvement in clinical symptoms, improvement in the diameter of the lower limb vessels shown by lower limb vascular ultrasound, improvement in the color of the foot skin, abundant blood supply in the ulcer area, granulation tissue growth, and reduction in the size of the ulcer. Ineffective: No improvement in clinical symptoms, no change in the diameter of the lower limb vessels shown by lower limb vascular ultrasound before and after treatment, no change in the color of the foot skin, and basically the same blood supply and size of the ulcer as before treatment. Deteriorated: Aggravation of clinical symptoms, reduction in the diameter of the lower limb vessels shown by lower limb vascular ultrasound after treatment, darkening of the foot skin color, and enlargement of the ulcer.

1.4 Statistical Methods SPSS 13.0 statistical software was used for data processing. Measurement data were expressed as ±s and analyzed using t-tests. Count data were expressed as rates and analyzed using χ² tests. Efficacy evaluation was conducted using Ridit analysis. P<0.05 was considered statistically significant.

2 Results

2.1 Evaluation of PTA Treatment In the treatment group, there were 18 patients with 24 affected limbs and a total of 33 target lesions. The pre-treatment degree of stenosis of the target lesions was (95.8±4.1)%, which decreased to (28.6±9.5)% after treatment. The difference in the degree of stenosis of the target lesions before and after treatment was statistically significant (P<0.01). The success rate of PTA treatment for target vessels was 78.8% (26/33).

2.2 Comparison of Foot Ulcer Healing Between the Two Groups There were statistically significant differences in the healing of foot ulcers at 4 weeks, 12 weeks, and 24 weeks post-treatment between the two groups (P<0.05). See Table 1.

2.3 Comparison of Clinical Efficacy All 18 patients in the treatment group were effective (100%), with no amputations. In the control group, 14 patients were effective (73.7%), 2 patients were ineffective (10.5%), and 3 patients deteriorated and required amputation (15.8%). The difference in efficacy between the two groups, as determined by Ridit analysis, was statistically significant (P<0.01). See Table 1 for the comparison of foot ulcer healing after treatment in the two groups. Note: Compared with the control group, *P<0.05.

3 Discussion Diabetic foot is one of the important chronic complications of diabetes, with its pathogenesis involving neuropathy, vascular disease, and infection. The most common manifestation is lower limb skin ulcers, and severe cases may lead to lower limb gangrene requiring amputation, or even death. Traditional treatment methods include controlling blood glucose, anti-infection, improving blood circulation, and local dressing changes as symptomatic supportive treatments. These methods result in slow wound healing and unsatisfactory treatment outcomes. They cannot re-open already occluded large vessels, and most patients ultimately require amputation. In recent years, PTA technology has developed rapidly and has been applied to the treatment of diabetic lower limb vascular diseases [3]. Early PTA treatment used regular balloons and high-pressure short-time expansion methods to treat lower limb vascular diseases. However, due to the different pathological changes and characteristics of diabetes compared to coronary artery atherosclerosis, this method did not show significant efficacy in diabetic lower limb vascular diseases and could easily cause intimal tears, leading to impaired blood flow after expansion, directly affecting the interventional effect and long-term outcomes [4,5]. With the continuous update of treatment techniques, PTA treatment for diabetic lower limb vascular diseases has fundamentally improved. This study used a new type of long balloon that is less prone to deformation, and through prolonged low-pressure expansion, it significantly reduced intimal tears, allowing sufficient expansion of the narrowed lesion sites and markedly increasing the speed of distal blood flow. Within half a year after successful PTA treatment, the limb preservation rate reached 100%, consistent with the research results of Wang Shan et al. [6].

However, PTA treatment also has certain applicability and limitations. Balloon expansion is effective for large and medium arteries, and even if restenosis occurs, it can be expanded again. However, it is often difficult to perform on completely occluded arterial lesions. Diabetic arteriosclerosis often affects small arteries and microcirculation. Small artery and microcirculation lesions cannot be resolved by catheters or guidewires alone and must be combined with drug therapy, such as vasodilators and anticoagulants administered via catheters or orally to improve microcirculation. The occurrence of lower limb vascular diseases in diabetes is mainly related to hyperinsulinemia, insulin resistance, lipid metabolism disorders, hypertension, hyperglycemia, and the resulting endothelial cell dysfunction and abnormal coagulation mechanisms. Once lower limb vascular disease appears, the distal tissues may experience ischemia and hypoxia, leading to the onset of diabetic neuropathy. The appearance of lower limb vascular disease and neuropathy forms the "high-risk foot" in diabetes. High-risk foot patients develop ulcers and infections under certain factors, leading to diabetic lower limb ulcers. Therefore, lower limb vascular disease plays a crucial role in the occurrence and development of diabetic lower limb ulcers. Diabetic foot is a long-term, chronic disease. Besides interventional treatment, postoperative long-term use of vasodilators, hypoglycemic agents, antihypertensive drugs, lipid-lowering drugs, etc., is necessary to control various harmful factors related to diabetic foot. Additionally, neurotrophic drugs should be included [7]. In this study, the treatment group received both PTA and conventional drug therapy, achieving good therapeutic effects. However, due to the limited number of observed cases, strict comparative statistics could not be performed, and further sample expansion is needed for verification.

In conclusion, under the conditions of comprehensive internal medicine treatment, including blood glucose control, anti-infection, anticoagulation, promoting blood circulation, and neurotrophic drugs, the use of long balloons for PTA in treating diabetic foot is reliable, with few complications, high feasibility and safety [8], capable of saving the patient's limbs, and having obvious advantages over traditional drug therapy, worthy of further clinical research.

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