Critical Lower Limb Ischemia Research Articles

Gender peculiarities of critical lower limb ischemia

BACKGROUND: Development of critical ischemia of lower limbs in patients with atherosclerosis causes negative consequences due to the high probability of detecting multilevel changes, as well as identifying coronary and carotid pools.
 АIM: The aim of the study was to investigate gender differences in critical lower limb ischemia of atherosclerotic genesis following reconstructive interventions.
 MATERIALS AND METHODS: Arterial reconstructions have been performed in 261 patients with peripheral atherosclerosis (95 women and 166 men). The specific features of reconstructive interventions have been taken into account; complications and the number of amputations have been analyzed in the early period.
 RESULTS: Higher pulse pressure has been registered in the female group; tibial arteries have been affected significantly more frequently (p 0,05). Thrombosis of the operated segment has been observed more frequently in the male patients at the stage of critical ischemia; in the case of claudication the complications were sporadic.
 CONCLUSIONS: The best results of reconstructive care in men and women with peripheral atherosclerosis at the claudication stage determine the vector of active tactics in the absence of conservative treatment results.

Modern principles and prospects of conservative treatment of chronic lower limb ischemia

The article presents an analysis of a review of world literature on the diagnosis and treatment of critical lower limb ischemia (CLLI). The concepts and nature of critical lower limb ischemia are analyzed in detail. The main modern examination methods are described, in particular, the assessment of blood circulation through large and peripheral vessels. The work also reflects the modern principles of complex conservative treatment using vasoconstrictive drugs to a new generation of angioprotectors in combination with intravenous laser blood irradiation (ILBI).

Von Willebrand factor in patients with peripheral artery disease who undergo invasive treatment

AIM: To evaluate the level and activity of von Willebrand factor (vWF) in patients with peripheral artery disease (PAD) who underwent endovascular or open bypass grafting.
 MATERIAL AND METHODS: The study included 115 patients with chronic lower limb ischemia due to PAD, stage IIb-IV according to A.V. PokrovskyFontaine. Fifty-five participants underwent endovascular treatment, while sixty underwent open bypass procedures using synthetic grafts. Peripheral blood samples were collected from all patients at baseline and three months after invasive treatment to determine the vWF antigen and activity. All patients were monitored every three months for a year to detect the development of unfavorable outcomes including disease progression, restenosis, graft thrombosis, oncology, myocardial infarction (MI), limb loss, stroke, and lethal outcomes.
 RESULTS: The highest values of vWF antigen in patients who underwent endovascular treatment were detected in patients with multilevel lesions1.25 g/mL (vs 0.2 g/mL, 95% confidence interval (CI) 0.723.21 mcg/mL p = 0.019); with a similar trend observed after a 3month follow-up. Baseline vWF antigen was higher in endovascular group patients who developed myocardial infarction (MI) within a year following the procedures as compared to those without MI: 1.15 mcg/mL (95% CI 1.051.175 mcg/mL) and 0.9 mcg/mL (95% CI 0.781.01 mcg/mL), respectively (p = 0.015). Moreover, vWF antigen was increased at the 3-month follow-up in patients with lethal outcomes1.06 mcg/mL (95% CI 0.961.18 mcg/mL, р = 0.031). vWF activity in endovascular group patients with developed MI was four times higher than those without MI (р = 0.022); a similar trend was detected in the development of lethal outcomes (р = 0.009). Those who underwent open bypass grafting presented with high activity of vWF with maximum values detected in participants with proximal iliofemoral lesions (1200%, 95% CI 640%1200%) and stage IV disease (770%, 95% CI 320%1200%, p 0.05). ROC analysis revealed that vWF activity at least 6.2 times higher in patients who underwent endovascular treatment associated with the development of lethal outcomes within one year after invasive treatments; sensitivity and specificity of the method were 83.3% and 75.5%, accordingly.
 CONCLUSION: Patients with PAD presented with increased vWF antigen and activity with maximum values detected in patients with multilevel lesions and critical lower limb ischemia. Increased vWF antigen and activity was associated with development of MI and lethal outcomes within one year following endovascular procedures on lower extremity arteries.

Contrast-Induced Nephropathy Following Peripheral Endovascular Intervention and Its Long-Term Morbidity

Background and Objectives: Contrast-induced nephropathy (CIN) is an acute deterioration of renal function seen following the administration of iodinated contrast media for various diagnostic procedures. Although extensive study has been done in various fields, the data on CIN are lacking in peripheral endovascular procedures. This study was conducted to analyze the incidence, risk factors, and long-term renal morbidity of CIN after endovascular procedure for critical limb ischemia (CLI) of lower limbs. Methods: This was a prospective, observational study and the patients undergoing peripheral endovascular procedure for CLI in a referral center were included. The patients were followed up for the development of CIN with serum creatinine levels on the 5th day postprocedure and till 6 months. Results: A total of 211 patients with various comorbidities were included. The incidence of CIN was found to be 7.5%. The risk factors and multiple comorbidities were compared between CIN and non CIN patients. The higher preprocedure creatinine (mean 1.03 mg/dl vs. 0.92 mg/dl, P < 0.045), higher contrast volume (mean 73.8 ml vs. 52.1 ml, P < 0.001), and lower hemoglobin (mean 10.5 g/dl vs. 11.8 g/dl, P < 0.008) were significantly associated with CIN. The follow-up at 6 months showed CIN patients had increased serum creatinine and reduced estimated glomerular filtration rate as compared to non-CIN patients. Conclusion: CIN is a substantial problem in peripheral endovascular procedures with long-term renal morbidity. The strategies to prevent CIN should be included in all patients undergoing endovascular procedures irrespective of risk profile and long-term renal function monitoring of CIN patients is warranted.

Comparative assessment of the quality of life in patients with chronic critical lower limb ischemia after surgical treatment (literature review)

Today, there are several approaches to the treatment of critical lower limb ischemia (KINK). However, despite the high clinical effectiveness achieved, it is not always possible to achieve a high quality of life for the patient after surgery. This article presents modern aspects of surgical treatment of KINK and assesses the quality of life of patients depending on the type of intervention (literature review).

Local intramuscular administration of ANG1 and VEGF genes using plasmid vectors mobilizes CD34+ cells to peripheral tissues and promotes angiogenesis in an animal model

IntroductionPatients with peripheral artery disease have poor prognosis despite advances in vascular surgery. Therefore, attempts have been made at using gene and cell therapy to stimulate angiogenesis in the lower limbs in patients with critical lower limb ischemia (CLI). MethodsThe study included 30 rats divided into 3 groups. An intramuscular injection of a therapeutic gene or cells in the right hind limb was administered in each group: angiopoietin-1 (ANG1) plasmid in group 1, ANG1/vascular endothelial growth factor (ANG1/VEGF) bicistronic construct in group 2, and naked plasmid in group 3 (control). After 3 months of follow-up, tissue samples were harvested, and vessels that stained positively for CD34 cells were quantified. ResultsThe highest CD34+ cell count was noted in the ANG1/VEGF group (98.26 cells), followed by the ANG1 group (80.31) and control group (47.93). The CD34+ cell count was significantly higher in the ANG1/VEGF and ANG1 groups than in the control group. There was no significant difference in the CD34+ cell count between the ANG1/VEGF and ANG1 groups. ConclusionOur study confirmed that therapy with ANG1 plasmid alone or ANG1/VEGF bicistronic construct is safe and effective in a rat model. The therapy resulted in the recruitment of more CD34+ vascular endothelial cells than in the control group receiving naked plasmid.

Combined Correction of Experimental Critical Ischemia of the Lower Extremities in a Rat Model

The purpose of our research was to study the effectiveness of correcting experimental critical ischemia (CI) of the lower extremities with a combination of udenafil, simvastatin, and autologous bone marrow mononuclear cells (ABMMC). Methods and Results: The experiments were carried out on 24-month-old Wistar rats, weighing 220–250g. The animals were randomized by sex and weight. Groups were formed according to the manipulations carried out during the operations. The animals were divided into 7 groups, each with 20 animals: Group 1 included intact animals; Group 2 - falsely operated animals; Group 3 (control group) - animals with simulated CI without treatment; Group 4- animals with CI and monotherapy with udenafil (daily oral administration of 8.6mg/kg for 28 days); Group 5 - animals with CI and simvastatin monotherapy (daily oral administration of 1.71mg/kg for 28 days); Group 6 - animals with CI and monotherapy with ABMMC (parenterally, once on Day 7 after modeling CI, 50μl at 4 points and, paravasally, above the inguinal ligament in the area where the lateral artery leaves the artery enveloping the femur from the internal iliac artery; in the area of the superficial artery that bends around the iliac bone under the inguinal ligament; into the area of origin of the muscular branch of the femoral artery r. muscularis, the place of attachment of the comb and long adductor muscles of the thigh; in the upper third of the gastrocnemius muscle]); Group 7 - animals with CI and combination therapy (udenafil and simvastatin drugs were administered intragastrically 0.86 mg/kg, once a day, for 7 days) and one-time parenteral administration of ABMMC, according to the same scheme as in Group 6. On Days 21 and 28 of the experiment, the level of blood microcirculation was determined in the muscles of the rat leg; for this, laser Doppler flowmetry was used. For further morphometric assessment of the leg muscles, they were removed. Preparations for morphometric analysis were prepared according to the standard technique with Van Gieson staining, as well as H&E. Our study demonstrated the effectiveness of combination therapy with udenafil, simvastatin, and ABMMC to correct critical lower limb ischemia in rats. The severity of morphological changes on the background of this combination was minimal, compared to the findings of other study groups, and the level of blood microcirculation in the ischemic zone on Day 28 was, significantly, 1.9 times higher than in animals of the control group. The results obtained allow us to recommend the use of the investigated combination (udenafil+simvastatin+ABMMC) for the treatment of patients with critical limb ischemia, both in outpatient and inpatient practice.

Состояние антиоксидантной, прооксидантной и эндотелиальной систем у пациентов с хронической критической ишемией нижних конечностей и высоким риском развития реперфузионно-реоксигенационных осложнений

Актуальность. Облитерирующий атеросклероз магистральных периферических сосудов составляет более 20 % случаев всей сердечно­сосудистой патологии, то есть свыше 3 % общей численности населения. Несмотря на большой опыт выполнения оперативных вмешательств на артериях, 3­летняя способность бедренно­подколенных шунтов не превышает 80 %. Частота реокклюзии сосудов аорто­подвздошного сегмента составляет от 6 до 42 %. Целью исследования было изучение особенностей оксидантной, прооксидантной и эндотелиальной систем у пациентов с хронической критической ишемией нижних конечностей. Материалы и методы. В основу работы положен анализ комплексного обследования и хирургического лечения 220 больных облитерирующим атеросклерозом аорты и магистральных артерий нижних конечностей. Больные были распределены на две группы по объему операционной реваскуляризации аорто­бедренно­подколенного сегмента. Операционное вмешательство в первой группе пациентов включало одномоментную реконструкцию аорто­бедренного и бедренно­подколенного сегментов, у пациентов второй группы реконструкция указанных сегментов выполнена в два этапа. Активность составляющих прооксидантно­антиоксидантной системы определяли с помощью спектрофотометрического метода. Результаты. Исследование активности процессов свободного радикального окисления указывает на то, что процессы, происходящие в тканях нижних конечностей, из­за влияния на них свободных радикалов кислорода не только активируют свободнорадикальные процессы, но и могут усиливать процессы повреждающего воздействия на клетки тканей и прежде всего на эндотелиальную систему. Выводы. Риск развития реперфузионных осложнений в послеоперационном периоде у пациентов подтверждается высоким уровнем воспалительного ответа. При реваскуляризации происходит разрушение, отслоение эндотелиальных клеток, расширение эндотелиальных параклеточных контактов, что способствует гиперпроницаемости эндотелиального слоя.

Корекція ендотеліальної дисфункції та порушень мікроциркуляції в пацієнтів із критичною ішемією нижніх кінцівок та високим ризиком розвитку реперфузійно-реоксигенаційних ускладнень

Актуальність. Епідеміологічні дослідження свідчать, що критична ішемія нижніх кінцівок трапляється в 500–1000 пацієнтів на один мільйон населення на рік. В Україні щорічно проводиться близько 10 000 реконструктивних операцій із приводу оклюзійних уражень артерій нижніх кінцівок. Одночасно щорічно виконується близько 8–10 тис. ампутацій нижніх кінцівок на ґрунті атеросклерозу. Метою дослідження було вивчення можливості корекції ендотеліальної дисфункції та порушень мікроциркуляції в пацієнтів із хронічною критичною ішемією нижніх кінцівок та високим ризиком розвитку реперфузійно-реоксигенаційних ускладнень після реконструктивних операцій. Матеріали та методи. В основу роботи покладено аналіз комплексного обстеження та хірургічного лікування 220 хворих на облітеручий атеросклероз аорти та магістральних артерій нижніх кінцівок. Ендотеліальну дисфункцію оцінювали шляхом визначення рівня маркерів: Р-селектину, Е-селектину, тканинного активатора плазміногену, ендотеліну-1, молекули адгезії судинного ендотелію 1-го типу, циркулюючих ендотеліальних клітин. Результати. Порівнюючи рівень ендотеліальної дисфунції та стан мікроциркуляції в ранньому післяопераційному періоді в пацієнтів із спеціальною доопераційною підготовкою й без такої, можна говорити про потребу та ефективність перед­операційного застосування бета-блокатора небівололу, інгібітора АПФ периндоприлу аргініну та L-аргініну. Висновки. Застосування в передопераційному періоді бета-блокатора небівололу, інгібітора АПФ периндоприлу аргініну, L-аргініну та сольового гіперосмотичного гіпертонічного розчину декстрану в пацієнтів із високим ризиком реперфузійно-реоксигенаційних ускладнень дає можливість запобігти значним порушенням при розвитку ендотеліальної дисфункції та погіршенню функціонування мікроциркуляторного русла й забезпечити оксигенацію тканин на рівні 5,04 ± ,37 мм рт.ст. після реваскуляризації нижніх кінцівок.

Aortic Endarterectomy for Aortic Occlusive Disease: An Old Operation With a Re-emerging Role.

Descending aortic complex atheromatous plaques can cause claudication, critical lower limb ischaemia (CLI), and are an independent risk factor for systemic embolization. Current practice involves dealing with most cases using endovascular techniques. However, open repair remains superior in terms of the patency rates and may be the only valid option in a subgroup of patients who are unsuitable for endovascular treatments. Most of the current data investigating open procedures are now historic. The aim of this study is to determine whether it is a feasible option in the current day practice. Ten years data from 2010 to 2020 were collected retrospectively from the hospital records. Clinic letters, radiologic scans, operative records and discharge letters were reviewed. Death records were reviewed to identify patients who survived. Ten cases were identified. The average age was 55 and the mean BMI was 29.4. The mean hospital stay in days was 12 (range: 4 to 22). The mean follow-up period was 147 days (range: 30 to 360days). Four of the patients were TASC B, four were TASC C and two were TASC D. Two cases had to return to theatres. One patient had transient post-op AF and another had transient post-op ileus. One patient was readmitted within 30days of discharge for urosepsis. All cases are alive to date except one case which only survived three years after procedure. AE is a procedure that should be considered in selected cases where endovascular approach is not feasible. There is a trend towards lower mortality than the historic data available in literature. Larger case series or registry data may be required to accurately estimate the current day mortality and morbidity figures.

Early outcomes of novel Temren atherectomy device combined with drug-coated balloon angioplasty for treatment of femoropopliteal lesions.

In this study, perioperative properties and early outcomes of patients who underwent combined Temren rotational atherectomy (RA) and drug-coated balloon (DCB) angioplasty treatment for complex femoropopliteal lesions in a single center were reported. Between June 2019 and February 2020, 40 patients who underwent combined Temren RA and DCB treatment due to critical lower limb ischemia or claudication-limiting daily living activities were retrospectively evaluated. The mean age of patients was 73.2 ± 7.8 years and the majority of the patients were male (65%). Of the patients, 17 had critical limb ischemia and 23 had lifestyle-limiting claudication. Pathologies were total occlusion in 33 limbs and critical stenosis in seven limbs. Nine patients previously underwent endovascular intervention or surgery. The mean total occlusion length was 140.9 ± 100.9 (range, 20-360) mm in patients with chronic total occlusion. There was an additional iliac artery pathology in 5 and below the knee pathology in 8 patients. Rotational atherectomy was possible in all cases. Flow-limiting dissection was seen in six patients (15%). Provisional stent was performed to these patients. Following Temren RA, all patients underwent DCB. Adequate vascular lumen (less than 30% stenosis) was provided in all patients and the symptoms regressed. No distal embolization was encountered. Access site complications (17.5%) were small hematoma in four patients, ecchymosis in two patients, and pseudoaneurysm of the femoral artery in one patient. The mean follow-up was 13.55 ± 4.2 (range, 1-18) months. Re-occlusion was seen in three patients (7.5%) (n = 2 at 2months and n = 1 at 4months). Of these patients, two had required open revascularization via femoropopliteal bypass graft with common, superficial femoral, and popliteal artery endarterectomy and one had required femoro-posterior tibial artery bypass. Four minor toe amputations (10%) were performed to reach complete wound healing in the critical limb ischemia patients. A below-knee amputation was performed in a 94-year-old patient with long segment stenosis at the end of a 1-month follow-up period. There was no mortality after follow-ups. The Kaplan-Meier estimator estimated the rate of freedom from target lesion revascularization (TLR) which was 92.3%. The decrease in the Rutherford levels after the procedure was found to be statistically significant in 36 patients (p < 0.001). The increase in the ankle-brachial index after the procedure was found to be statistically significant in 36 patients (p < 0.001). Combined use of Temren RA with adjunctive DCB is safe and effective method with high rates of primary patency and freedom from TLR and low rates of complication in the treatment of femoropopliteal lesions.

Опыт совместного хирургического лечения пациентов с критической ишемией нижних конечностей на базе Владивостокской клинической больницы № 1

Experience of the joint work of angiosurgeons and surgeons of the purulent surgical department to cure critical lower limb ischemia on the basis of stenotic atherosclerosis/thrombosis of the main arteries in VCH No. 1 was summarized. The results of multidisciplinary work of surgical team for the period from 2018 to 2020 are presened. The reliable decrease of the number of major amputations and lethality was noticed in this group of patients.

Erosive and ulcerative lesions of the gastrointestinal tract and bleeding in patients with critical lower limb ischemia and diabetes mellitus underwent endovascular interventions

The objective was to study the prevalence of erosive and ulcerative gastroduodenal lesions, bleedings of this localization and the relationship with factors predisposing to them in patients with critical lower limb ischemia and type 2 diabetes mellitus who underwent endovascular intervention for limb revascularization.Methods and materials. The study included 81 patients aged 67.5±6.8 years, hospitalized in the department of vascular surgery with critical lower limb ischemia of atherosclerotic genesis and type 2 diabetes mellitus to perform revascularization by means of transluminal balloon angioplasty with stenting when indicated. In the preoperative period, all patients underwent fibrogastroduodenoscopy, according to the results of which a scoring assessment of the lesion of the gastric mucosa and duodenum was presented.Results. All patients participating in the study were diagnosed with pathology of the gastroduodenal zone: in 95.1 % of the inflammatory nature, in 4.9 % of the ulcer. The relationship between the duration of rest pain, the fact of damage to the mucous membrane of the upper gastrointestinal tract and its severity was not revealed, but the relationship of erosive and ulcerative lesions of the stomach and duodenum with the number of taken pain pills was determined. In patients with repeated endovascular intervention and / or amputation, gastrointestinal bleedings were more often recorded compared with study participants who underwent a single revascularization – 11.1 and 1.6 % of patients, respectively.Conclusion. Erosive and ulcerative lesions of varying severity are present in all patients with critical lower limb ischemia on the background of diabetes mellitus. At the same time, patients with repeated endovascular interventions and / or amputations are more susceptible to bleeding. For the prevention of pathology of the stomach and duodenum, an in-depth diagnosis and a differentiated approach are required.

Long-term results of open aorto-femoral reconstructions

The objective was to analyze the long-term results of open aorto-femoral reconstructions in order to optimize the approach to surgical treatment.Methods and materials. The study included 548 patients with reconstructions of the aorto-femoral segment performed between 1999 and 2007. Of these, 293 patients underwent loop endarterectomy of the iliac arteries, 255 – after aorto-femoral bypass with a synthetic prosthesis. All interventions were performed against the critical lower limb ischemia. The superficial femoral arteries remained occluded in all cases. Outflow was carried out only in the deep femoral arteries and collateral vessels. Patients were under clinical supervision for 5 to 20 years. In the long-term period, most patients underwent interventions on the coronary, brachiocephalic arteries, as well as surgery for cancer.Results. Timely correction of concomitant pathology made it possible to increase the survival rate of patients by the 10-year follow-up period to 72 %, and after 20 years this figure reached 63 %. The primary patency of the reconstructed segment after loop endarterectomy was significantly higher than after aorto-femoral bypass surgery. Secondary patency in the groups did not significantly differ and by 20 years of follow-up reached 76 %. A high level of patency of the operated segment was also provided by a large percentage of preserved limbs (80 % after 20 years). A study of the quality of life showed that, despite the persistence of intermittent claudication at the level of 400–800 meters, the vast majority of patients were satisfied with their life. Suppurations in the transplant area and the formation of false aneurysms in the area of anastomoses were found only in the group of aorto-femoral bypass grafts.Conclusion. Open reconstructive operations on the aorto-femoral segment, such as loop endarterectomy and aorto-femoral bypass with adequate postoperative medical examination have good long-term results of survival, patency of the reconstructed segment, percentage of saved limbs and quality of life of patients. Complications in the form of suppuration in the transplant area and the formation of false aneurysms occur only after bypass.

Endovascular treatment of hemodialysis-induced lower limb artery ischemia: retrospective analysis from a single center.

Critical limb artery ischemia is one of common complications after hemodialysis, with endovascular therapy (EVT) having become its first-line treatment. There is no relevant study investigating the relationship between EVT and the prognosis of hemodialysis patients with critical lower limb ischemia, the most common site of vascular dysfunction. This was a retrospective, nonrandomized, single-center study. Hemodialysis patients with critical lower limb ischemia between May 2015 and October 2018 were included in this study. Their demographic and clinical data and the results of laboratory test were collected. The outcomes included all-cause mortality, amputation, and revascularization. Kaplan-Meier analysis and log-rank test were used to assess overall survival and amputation-free survival. Univariable and multivariable hazard Cox regression analyses were performed to determine risk factors of amputation and mortality. In all, 67 hemodialysis patients were finally included in this study. The median age of included patients was 69.8±8.7 years, and the median duration of hemodialysis was 44.1±9.2 months. There was no significant difference between patients receiving and not receiving EVT in collected demographic and clinical data except for the duration of hemodialysis (46.1±9.0 vs. 41.7±9.0 months; P=0.048). The level of high-density lipoprotein cholesterol (HDL-C) in patients receiving EVT was 1.4±0.6 mmol/L, which was significantly lower than the 1.9±0.6 mmol/L in patients not receiving EVT (P<0.001). The results from the Kaplan-Meier curves indicated that the incidences of all-cause mortality and amputation were much lower in patients receiving EVT than in those not receiving EVT (P=0.038 and P=0.020). Hazard Cox regression analysis also indicated that EVT played protective role in all-cause mortality and amputation in hemodialysis patients with lower limb ischemia. Age, nutritional risk, stroke, and C-reactive protein (CRP) were also determined as independent risk factors of all-cause mortality according to multivariable analysis. Additionally, duration of hemodialysis and smoking history were identified as independent risk factors of amputation. EVT could be an efficient treatment for critical lower limb ischemia in hemodialysis patients to reduce all-cause mortality and the incidence of amputation. Moreover, some risk factors, such as malnutritional and stroke, should be avoided to improve the prognosis of hemodialysis patients.

Efficiency of mesenchymal stromal cells (MSCs) in the treatment of patients with critical limb-threatening ischemia

Relevance. The relevance of the study is determined by the fact that hopes are placed in the cell therapy for patients with critical limb-threatening (CLI) ischemia as a method of the restoration of blood circulation in the affected limb in patients who cannot undergo surgical or endovascular intervention. Aim. To evaluate the efficiency of allogeneic MSCs for the treatment of critical lower limb ischemia (randomized placebo-controlled study).Materials and methods. The study included 34 patients with critical lower limb ischemia (grade 4 according to Pokrovsky). There were 18 patients in the MSC group, and 16 patients in the placebo group). The groups were comparable concerning age, disease duration, and comorbidities. Allogeneic MSCs (phenotype CD73+, CD90+, CD105+, CD45–, CD34–, CD14–) were injected into the posterior calf muscles. Clinical outcome, ankle pressure, transcutaneous oxygen tension (tcpO2), and pain-free walking distance (PFWD) were evaluated. The patients were followed-up for 12–36 months. According to the clinical outcome in each group, the patients were divided into subgroups with «effect (+)» or «effect (–)». In 2 patients, there was an «uncertain clinical outcome». When analyzing the results, these patients were assigned to one or another subgroup.Results. In the MSC and placebo groups, the clinical outcome assessed as «effect (+)» or «effect (–)» did not differ (OR 1.5; 95 % CI 0.34–6.7). With different variants of group formation and with the assignment of patients with an «uncertain clinical outcome» to a one or another subgroup, the final results neither differed. According to instrumental research methods (PFWD, tcpO2, ankle pressure, angiography), there were no differences in the MSC and placebo groups. Conclusion. With different variants of analysis and group formation, no convincing evidence that allogeneic MSCs can be effective for the treatment of critical lower limb ischemia have been obtained.

LONG-TERM RESULTS OF REVASCULARIZATION OF THE LOWER EXTREMITIES IN PATIENTS WITH CRITICAL ISCHEMIA AND DIABETES MELLITUS WITH LOCALIZATION OF THE OCCLUSIVE-STENOTIC PROCESS IN THE FEMORAL AND POPLITEAL ARTERIES

Aim: to compare endovascular and open revascularizing interventions in patients with neuro-ischemic form of diabetic foot in order to choose the management tactics for this category of patients, which has the best results in the near and long term. Materials and Methods: The study involved 85 patients with critical lower limb ischemia of atherosclerotic genesis and diabetes mellitus, hospitalized for revascularization in a specialized department. The study participants were divided into two groups: the first group included 38 patients who underwent endovasal revascularization of the affected arterial segment, the second - 47 patients who underwent femoropoplitealautovenous bypass grafting below the knee joint. Results: during the dynamic observation of patients, it was found that the number of reoperations on a previously revascularized limb was significantly higher in the group of endovascular interventions than in the group of open reconstructions: 19 (50 %) and 7 (14,9 %), respectively. In the long-term period, three patients of the second group underwent amputation at the hip level, in contrast to the patients of the first group, in which not a single case of amputation was recorded at the indicated level (p = 0,05). Conclusions: for patients with diabetes mellitus and critical lower limb ischemia, endovasal revascularization can be recommended as the most preferable due to the existing features of arterial lesions, the possibility of repeated surgical intervention and preservation of the limb and its support ability.

Endovascular Treatment for Critical Limb Ischemia in Type II Diabetes Mellitus Involving Femoropopliteal and Infrapopliteal Segments: Revascularization Strategy

PurposeTo determine if further endovascular infrapopliteal angioplasty in combination with femoropopliteal revascularization improves the clinical outcomes regarding major amputation rate, rate of secondary interventions, and mortality in diabetic type-II patients presented with critical lower limb ischemia (CLI).Patients and MethodsThis is a retrospective study in which all type-II diabetic patients with CLI at King Abdullah University Hospital between October 2015 and September 2019 were identified. Patients with concomitant femoropopliteal and infrapopliteal vessels atherosclerotic lesions (total occlusion or more than 50% stenosis) who received successful endovascular treatment were included. Patients were divided into 2 groups. Group-I included patients treated for femoropopliteal segment alone, while Group-II included patients treated for both femoropopliteal and infrapopliteal segments. The outcomes of the two groups were compared regarding major amputation rate, rate of secondary interventions, and mortality. In addition, demographic data, atherosclerotic lesions distributions and cardiovascular risk factors were also collected and analyzed.ResultsIn all, 90 patients (65 males and 25 females) with a mean age of 67.5±12 years were included. In Group-I; 44 patients (48.9%) were included (36 males and 8 females) with a mean age of 67±12 years. In group-II; 46 patients (51.1%) were included (29 males and 17 females) with a mean age of 68±13 years. The major amputation rate was higher and statistically significant in Group-I (38.6% vs 17.4%, p-value = 0.034). However, the secondary interventions and the mortality rates showed no statistically significant differences (56.8% vs 39.1%, p-value = 0.139) and (22.7% vs 28.3%, p-value = 0.632), respectively.ConclusionEndovascular infrapopliteal angioplasty in combination with femoropopliteal revascularization in diabetic type-II patients with CLI improves the clinical outcome regarding major amputation rate. However, there were no significant differences regarding the rate of secondary interventions and the mortality rate.

Hybrid Technique: Common Femoral Artery Endarterectomy and Endovascular Therapy in Critical Lower Limb Ischemia

Introduction: Multilevel arterial occlusive disease in patients with chronic limb threatening ischemia (CLTI) represent a major revascularisation challenge to vascular surgeons. The goal of treatment is a single intervention procedure that results in an excellent technical success without associated complications or the need for further interventions. Methods: Prospective case series study including (30) patients complaining from critical lower limb ischemia (rest pain or tissue loss) and has CFA lesionwith proximal or distal lesions. All patients undergoing common femoral Endarterectomy and endovascular therapy to proximal or distal lesions between May 2018 and December 2020. The study was conducted at the department of vascular and endovascular surgery in Mansoura university hospitals Results: Femoral Endarterectomy was performed in all cases in the current cohort with combined iliac and SFA revascularization in 27% of patients and with separate iliac in 10% and outflow in 63% of cases (SFA 33% and tibial 30%). This study reported a 100% technical success and 96% hemodynamic and clinical success in the current series. And the 2-year patency was 88% Conclusion CFE should remain the treatment of first choice of CFA occlusive disease as it is safe, effective, and durable procedure for common femoral artery disease, and the simultaneous hybrid CFA endarterectomy and endovascular therapy for multilevel occlusive artery disease can provide an immediate satisfactory results, durable midterm patency, and also less invasive therapeutic option in high-risk patients.

Correction of hemostasis and hemorheology with intravenous laser blood irradiation and cytokinotherapy in indirect revascularization at the perioperative period in patients with critical ischemia of their lower extremities

Purpose . To study potentials for correcting hemostasis and hemorheology with intravenous laser blood irradiation (ILBI) and cytokine therapy (CT) in indirect revascularization at the perioperative period in patients with critical ischemia of lower extremities. Material and methods . A prospective controlled clinical trial included 162 patients with critical lower limb ischemia (CLLI) having distal arterial steno-occlusion who had indirect revascularization surgery. CLLI etiological factors were: obliterating atherosclerosis in 108 (66.7%) patients and obliterating thromboangiitis in 54 (33.3%) patients. 56 patients had chronic ischemia of degree III; 106 patients – chronic ischemia of degree IV. All patients were divided into 5 groups who had various curative modalities at their perioperative period: Group I (n = 34) –standard treatment; Group II (n = 32) – standard treatment + ILBI; Group III (n = 32) – standard treatment + CT with Roncoleukin; Group IV (n = 33) – standard treatment + ILBI + CT; patients from Group V (n = 31) in revascularizing osteotrepanation had intraosseous marrow laser irradiation (IOLI) – standard treatment + ILBI + CT. The researchers also studied dynamics of hemostatic parameters (fibrinogen – F, fibrinolytic activity – FA, fibrin degradation products – PDF, activity of antithrombin-III, plasminogen – P) and hemorheology (erythrocyte deformability – DE, von Willebrand factor – WF, ADP induced platelet aggregation). The obtained hemostasis and hemorheology findings were compared with identical parameters of 48 practically healthy subjects («reference group»). Results . On admission, patients with CLLI in distal steno-occlusion had a sharp change in their hemostasis formula shifting towards hypercoagulation and deterioration of hemorheology. ILBI and CT techniques applied either separately or in combination with other therapeutic measures in the perioperative period of indirect revascularization normalized parameters of blood coagulation system (for all parameters – p < 0.05; r = 0.4) and of hemorheology (for DE – p < 0.05; r = 0.4; for WF and ADP-induced platelet aggregation – p < 0.05; r = 0.3). The best results were obtained under the combination of ILBI and CT at the perioperative period of indirect revascularization, especially in revascularizing osteotrepanation with IOLI. Conclusion . ILBI and CT applied in combination with standard treatment at the perioperative period in indirect revascularization reliably correct hemostasis and hemorheology in patients with CLLI and distal arterial steno-occlusion.