Efficacy and Safety of a Novel Helical Self-Expanding Nitinol Stent for Femoropopliteal Artery Obliterans Disease.

BACKGROUND: The aim of this study was to evaluate the efficacy and safety of a novel self-expanding nitinol stent (Smartflex stent) in femoropopliteal artery obliterans disease. METHODS: From June 2016 to May 2019, patients with atherosclerotic occlusion disease of the superficial femoral and popliteal arteries using the Smartflex stents were retrospectively analyzed in our institution. Patients were monitored at 1, 3, 6, and 12 months and annually thereafter. The main characteristics of the diseased vessels, perioperative and follow-up outcome were evaluated. Kaplan-Meier method was used to assess patency rate and the rate of freedom from clinically driven target lesion revascularization (CD-TLR). RESULTS: A total of 50 limbs from 48 patients (mean age 69.4 ± 8.95 years; 38 men) were included. Eighty-eight Smartflex stents (1.76 stents per limb) were deployed successfully. Of the study patients, 82% had claudication (Rutherford III), 10% had rest pain (Rutherford IV), and 8% had tissue loss (Rutherford V). Trans-Atlantic Inter-Society Consensus II C and D lesions were 26% and 42%, respectively. The mean lesion length was 18.2 ± 8.5 cm and the mean stented length was 22.3 ± 9.9 cm. The average follow-up time was 16.4 ± 8.2 months. Of these lesions, 42 (94%) were chronic total occlusions and 16 (32%) were severely calcified. The primary patency rate at 1 year per Kaplan-Meier estimating, the rate of freedom from CD-TLR at 1 year, and the second patency rate was 83.3%, 88.1%, and 94%, respectively. Among them, 90% patients had improved ankle-brachial indexes (0.47 ± 0.13 before and 0.84 ± 0.16 after). No stent fractures and kinking were identified. CONCLUSIONS: Stenting of the femoropopliteal artery diseases using the Smartflex stent appeared to be safe and effective. It performed well in long-segment and above knee joint lesions.

Midterm Outcome of Directional Atherectomy Combined with Drug-Coated Balloon Angioplasty Versus Drug-Coated Balloon Angioplasty Alone for Femoropopliteal Arteriosclerosis Obliterans.

BACKGROUND: The "leave nothing behind" strategies have been becoming a popular treatment for femoropopliteal arteriosclerosis obliterans. Atherectomy before drug-coated balloon (DCB) angioplasty may have an advantage in improving the efficiency of drug delivery into the blood vessel wall. This study aimed to compare the therapeutic effects of directional atherectomy combined with DCB angioplasty with DCB angioplasty alone in the treatment of femoropopliteal arteriosclerosis obliterans. METHODS: Patients with femoropopliteal arteriosclerosis obliterans who received endovascular therapy from June 2016 to June 2018 in our hospital and presented with life-limiting claudication or severe chronic limb ischemia comprised the study cohort. The patients were randomized to receive directional atherectomy combined with DCB angioplasty (n = 45) or DCB alone (n = 49). Ninety-four patients were enrolled in our study with 72 males, and the mean age was 67 ± 10 years. The mean lesion length was 112 ± 64 mm. RESULTS: There were no significant differences in the baseline characteristics of patients and lesions between the 2 randomized groups (P > 0.05). Flow-limiting dissections occurred more frequently in the DCB group (n = 12; 24.5%) than in the DA-DCB group (n = 2; 4.4%; P = 0.006). The technical success rate in the DA-DCB group was superior to that in the DCB group (95.6% vs. 75.5%, P = 0.006). The mean follow-up duration was 16.7 ± 6.1 months in the DCB group and 15.3 ± 5.8 months in the DA-DCB group. No amputations were performed. The overall mortality in the DCB group was 4.1% (2/49), while all patients survived in the DA-DCB group. The 12-month and 24-month primary patencies in the DA-DCB group were greater than those in the DCB group (80.5% vs. 75.7% and 67.1% vs. 55.1%, respectively); however, using all available patency data, no significant differences over time were observed (P = 0.377). CONCLUSIONS: In this study, directional atherectomy combined with DCB angioplasty can decrease the flow-limiting dissection rate in the treatment of femoropopliteal arteriosclerosis obliterans compared with DCB angioplasty alone. There was no significant difference between the 2 groups in terms of primary patency rate which was needed to be further clarified.

Cilostazol Improves Wound Healing in Patients Undergoing Open Bypass for Ischemic Tissue Loss: A Propensity Score Matching Analysis.

BACKGROUND: Few reports have described the effects of medication on the wound healing of ischemic ulcers after revascularization. This study was conducted to investigate the effects of cilostazol on wound healing in patients who underwent infrainguinal bypass for ischemic tissue loss. METHODS: Two hundred sixty-three limbs undergoing de novo infrainguinal bypass for tissue loss from January 2004 to December 2015 were divided into 2 groups based on whether or not cilostazol was administered after surgery. The end point was wound healing. The 1-year outcomes of the groups were analyzed using the Kaplan-Meier method, and a propensity score matching analysis was performed to examine the effects of cilostazol on wound healing. In addition, the significant predictors were determined using a Cox proportional hazards regression analysis. RESULTS: Sixty-one and 202 limbs were included in the cilostazol and non-cilostazol group, respectively. The cilostazol group showed superior wound healing to the non-cilostazol group (cilostazol versus non-cilostazol, 1-year wound healing rate: 92% vs. 81%; median wound healing time: 45 vs. 78 days, P = 0.002). The results of the cilostazol group remained superior after a propensity score matching (cilostazol versus non-cilostazol, 1-year wound healing rate: 95% vs. 83%; median wound healing time: 45.5 vs. 57 days, P = 0.048). A Cox proportional hazards regression analysis indicated that foot infection, Rutherford classification, diabetes mellitus, coronary artery disease, angiosome, the administration of cilostazol, and graft patency were significant factors that influenced wound healing. CONCLUSIONS: The postoperative use of cilostazol help to promote wound healing after open surgery.

Evaluation of paramalleolar and inframalleolar bypasses in dialysis- and nondialysis-dependent patients with critical limb ischemia.

OBJECTIVE: The aim of this study was to elucidate the efficacy of paramalleolar or inframalleolar bypass (PIMB) in hemodialysis-dependent (HD) patients with critical limb ischemia (CLI) and nonhemodialysis-dependent (NHD) patients in terms of clinical outcomes. METHODS: Between January 2000 and December 2013, there were 333 consecutive arteriosclerosis obliterans patients with CLI who underwent 401 PIMB procedures for limb salvage (LS). Of the 333 patients, 188 (56.5%) were HD patients. Vein grafts were exclusively used, and 172 paramalleolar and 229 inframalleolar bypasses were performed. Five-year primary and secondary cumulative graft patency, LS, and amputation-free survival (AFS) rates were compared between the two groups, and the independent determinants of these outcomes were identified in each group. RESULTS: The 5-year primary and secondary cumulative graft patency rates were 53% and 82% in HD patients and 69% and 92% in NHD patients (primary cumulative graft patency, P < .05; secondary cumulative graft patency, nonsignificant), respectively. The LS rates were 87% and 99% (P < .01) in HD patients and NHD patients, respectively. Overall, 48% and 70% of HD and NHD patients were ambulatory before PIMB (P < .01), and 73% and 85% of HD and NHD patients were ambulatory 12 months after PIMB (including 1-year survivors; nonsignificant), respectively, demonstrating drastic post-PIMB improvement in HD patients. The 5-year AFS rates in the HD and NHD groups were 27% and 69% (P < .01), respectively, demonstrating very poor AFS rates in HD patients. In HD patients, factors negatively associated with AFS were female gender (hazard ratio [HR], 2.102; 95% confidence interval [CI], 1.254-3.524), history of congestive heart failure (HR, 2.075; 95% CI, 1.395-3.085), and preoperative nonambulatory status (HR, 1.974; 95% CI, 1.305-2.986), whereas older age (HR, 2.601; 95% CI, 1.372-4.931) and history of congestive heart failure (HR, 2.928; 95% CI, 1.496-5.731) were identified as independent factors negatively associated with AFS in NHD patients. CONCLUSIONS: The use of PIMB for CLI was associated with excellent LS rates in both HD and NHD patients with low operative mortality and complications. However, the AFS rate observed in HD patients was significantly lower than that observed in NHD patients, indicating the necessity of a specific management program to improve AFS after LS in HD patients.

[Use of drug-free methods of treatment in comprehensive therapy of patients with stage II chronic lower limb ischaemia].

Analysed herein are the results of treating a total of 139 patients presenting with stage II chronic lower limb ischaemia. The patients were subdivided into three groups, depending on the variant of treatment performed. Group One patients (n=57) received standard conservative therapy combined with ozone therapy, with the Group being further subdivided into two subgroups: patients of subgroup 1a (n=28) were subjected to intravenous administration of ozonated physiological solution (OPS), subgroup 1b patients (n=29) were given big autohemoozonetherapy (BAT). Group Two patients (n=62) underwent complex treatment including beside medical ozone gravitation therapy (GT). Group Two patients were also subdivided into two subgroups: subgroup 2a patients (n=31) received standard conservative therapy combined with OPS and GT, subgroup 2b patients (n=31) received standard conservative therapy in combination with BAT and GT. Group Three (Control Group) was composed of 20 patients receiving standard conservative therapy alone. The highest efficacy was observed in the subgroup of patients receiving OPS and GT, with the patients of this subgroup showing a statistically significant increase in the pain-free walking distance by 116.5% and in the ankle-brachial index by 49.2%, also demonstrating the most pronounced positive dynamics of lipid metabolism parameters: a decrease in total cholesterol by 21.3%, low density lipoproteins by 25.4%, very low density lipoproteins by 24.2% and triglycerides by 18.5%. Besides, a tendency was observed towards normalization of the haemostasis system indices: fibrinogen decreased by 21.8%, prothrombin index by 13%, fibrin monomer complexes retraction by 18.2%, and the clotting time increased by 20.7%. Hence, combined use of ozonated physiological solution and gravitation therapy in treatment of patients with stage II chronic lower limb ischaemia promotes a considerable increase in the pain-free walking distance and ankle-brachial index, as well as contributes to correction of lipid metabolic disorders and haemocoagulation.

[FUNCTIONAL STATE OF PERIPHERAL VESSELS OF THE LOWER EXTREMITIES AND INTRAOSSEOUS PRESSURE IN PATIENTS, SUFFERING OBLITERATING ATHEROSCLEROSIS ON BACKGROUND OF DIABETES MELLITUS].

Results of examination of 46 patients, suffering obliterating atherosclerosis of the lower extremities arteries solely or in combination with diabetes mellitus (DM), were analyzed. The malleolar pressure index (MPI), regional systolic pressure (RSP), velocity of the volume blood flow (VVBF), rheographic index (RI), using test with nitroglycerine, postocclusion venous pressure (POVP) and intaosseous pressure (IOP) in tibiae were studied. The RI reduction, parallel to the arterial ischemia progression, was established. The test indices with nitroglycerine in patients with obliterating atherosclerosis have reduced step by step. With coexistent DM the efficacy of nitroglycerine was practically absent. POVP is upgraded in patients of all the groups and it have lowered step by step in a laying position of the patient, and while transition into standing position--it have upgraded progressively with a progress of arterial ischemia. IOP have upgraded significantly in isolated obliterating atherosclerosis in ischemia stage 3a and have lowered--in stage 3b. In coexistent DM IOP is upgraded in ischemia stage 3b also.

Lower limb ischaemia in patients with diabetic foot ulcers and gangrene: recognition, anatomic patterns and revascularization strategies.

The confluence of several chronic conditions--in particular ageing, peripheral artery disease, diabetes, and chronic kidney disease--has created a global wave of lower limbs at risk for major amputation. While frequently asymptomatic or not lifestyle limiting, at least 1% of the population has peripheral artery disease of sufficient severity to be limb threatening. To avoid the critical error of failing to diagnose ischaemia, all patients with diabetic foot ulcers and gangrene should routinely undergo physiologic evaluation of foot perfusion. Ankle brachial index is useful when measurable, but may be falsely elevated or not obtainable in as many as 30% of patients with diabetic foot ulcers primarily because of medial calcinosis. Toe pressures and skin perfusion pressures are applicable to such patients.

Beraprost Sodium Protects Against Diabetic Nephropathy in Patients with Arteriosclerosis Obliterans: A Prospective, Randomized, Open-label Study.

BACKGROUND: Inhibition of the renin-angiotensin system (RAS) has been used to treat diabetic nephropathy. However, RAS inhibition increases the risk of renal complications. In this study, we evaluated the effect of combining RAS inhibitor treatment with beraprost sodium (BPS), a prostaglandin I2 analog, in diabetic nephropathy with arteriosclerosis obliterans. METHODS: This study was a prospective, randomized, open-label study. Twenty-six Japanese patients (age >30 years) with diabetic nephropathy and arteriosclerosis obliterans were randomly assigned to the BPS group (n=13), which received the combination of an RAS inhibitor and BPS (120 µg/day) therapy, or the control group (n=13), which received only an RAS inhibitor. Patients were followed up for 1 year. The primary endpoint was the effect of BPS on renal function. RESULTS: In the control group, serum creatinine (1.64±0.87 to 2.34±1.53 mg/dL, p<0.001), 1/creatinine (0.82±0.47 to 0.65±0.47, p=0.003) cystatin C (1.77±0.61 to 2.18±0.86 mg/L, p<0.001), and the estimated glomerular filtration rate (43.9±26.1 to 34.0±24.6 mL/min/1.73 m(2), p=0.004) were significantly worsened 48 weeks after the start of treatment. Conversely, in the BPS group, serum creatinine (1.71±0.75 to 1.66±0.81 mg/dL, p=0.850), 1/creatinine (0.66±0.19 to 0.71±0.25, p=0.577), cystatin C (1.79±0.55 to 1.80±0.57 mg/L, p=0.999), and the estimated glomerular filtration rate (35.8±10.8 to 38.7±14.4 mL/min/1.73 m(2), p=0.613) were unchanged. CONCLUSIONS: Combination treatment with BPS and an RAS inhibitor prevented the progression of diabetic nephropathy. These observations should be confirmed in large-scale studies with long-term follow-up.

[Functional methods of assessment of the blood flow in the lower limbs of the patients with obliterating atherosclerosis during complex conservative treatment].

Have been studied the changes of tissue blood flow in the distal parts of the lower limbs at the capillary level under the influence of the different complexes of rehabilitation. Were obtained the objective results of advantages of the combined use of physical therapy and drug therapy. The study showed that for evaluation of tissue blood flow is preferable to to use the laser flowmetry, and for registration of quantitative indicators of regional blood flow changes--Doppler ultrasound.

Factors affecting primary patency of stenting for TransAtlantic Inter-Society (TASC II) type B, C, and D iliac occlusive disease.

BACKGROUND AND OBJECTIVE: The purpose of our study was to evaluate 1- and 2-year results and the influence of risk factors on the outcome in the patients undergoing iliac artery stenting for TASC II type B, C, and D iliac lesions. MATERIALS AND METHODS: In this prospective nonrandomized study conducted between April 15, 2011, and April 15, 2013, 316 patients underwent angiography with a diagnosis of aortoiliac atherosclerotic disease. Of these, 62 iliac endovascular procedures (87 stents) were performed in 54 patients. RESULTS: The indications for revascularization were disabling claudication (Rutherford 2, 5.9%; Rutherford 3, 35.2%), rest pain (Rutherford 4, 22.2%), and gangrene (Rutherford 5, 16.7%). The overall complication rate was 9.2%. The cumulative primary stent patency at 1 and 2 years was 83.0%±5.2% and 79.9%±5.8%, respectively. Early stent thrombosis in ≤30 days was detected in two patients (3.7%). The primary patency rates for the stents ≤61mm at 12 and 24 months were 90.6%±4.5% and 86.6%±5.8%, respectively; those for the stents >61mm were 67.7%±10.9% and 60.2%±12.0%, respectively (P=0.016). The multivariate Cox regression analysis enabled the localization of a stent in both the CIA and the EIA (hazard ratio [HR], 3.3; 95% confidence interval [CI], 1.1-9.5; P=0.021) and poor runoff (HR, 3.2; 95%, CI 1.0-10.0; P=0.047) as independent predictors of decreased stent primary patency. CONCLUSIONS: The localization of a stent in both iliac (CIA and EIA) arteries and poor runoff significantly reduce the primary stent patency. Patients with stents >61mm have a higher risk of stent thrombosis or in-stent restenosis development.

[Use of gravity therapy and discrete plasmapheresis in treatment of atherosclerosis obliterans].

The authors carried out a comparative analysis of the results of management of patients presenting with stage II lower-limb atherosclerosis obliterans according to the classification of A.V. Pokrovsky (1973) in three clinical groups. Group One patients (n=118) were subjected to conventional conservative therapy combined with gravitational therapy, Group Two patients (n=28) underwent plasmapheresis on the background of standard conservative therapy, and Group Three patients (n=40) in the composition of the combined therapy received gravity therapy and plasmapheresis. Prior to treatment, the patients were found to have alterations in the lipid spectrum mainly at the expense of an increase in the level of triglycerides, elevated concentration of C-reactive protein, and pronounced circulatory impairments in the lower extremities on ultrasound Doppler examination. After treatment, the most effective correction of the levels of C-reactive protein, fibrinogen and triglycerides appeared to be in those groups where patients received plasmapheresis. The use of gravitational therapy ensured a considerable increase in the regional blood flow. A combination of plasmapheresis and gravitational therapy in the composition of comprehensive therapy made it possible to act upon various links of pathogenesis of atherosclerosis obliterans and to substantially improve the treatment outcomes in this cohort of patients.

[Efficiency of bioprosthesis in case of axillary-femoral bypass in patients with high operative risk].

It was analyzed the treatment results of 60 male patients with critical limb ischemia in case of atherosclerotic lesions of the aorta-iliac segment and severe somatic diseases. All patients were divided into 2 groups. Every group consisted 30 patients. The first group included axillary-femoral bypass by using of synthetic polytetrafluoroethylene prosthesis. The second group - by using of bioprosthesis of bull's internal thoracic arteries. Using of bioprosthesis allows to reduce early postoperative complications in intermediate postoperative period on 13.3%, late bypass thrombosis on 30%. Also there was elongation of average time of bypasses functioning in 1.8 times. Physical health was increased on 12.8%, mental - on 9.1%.

[Hybrid operative interventions in patients with multi-level atherosclerotic lesions of lower-limb arteries].

The authors share their experience gained in hybrid surgical interventions for multi-level steno-occlusive lesions of the aortoiliac and infrainguinal segments in a total of 96 patients presenting with chronic ischaemia of the lower limbs. The postoperative-period complications included haematomas observed in 9 (9.4%) cases and 6 (6.3%) instances of lymphorrhea occurring in the area of the postoperative wound. There were no lethal outcomes in the immediate postoperative period. The remote results were assessed at follow-up terms varying from 6 to 53 months in 75 (79.7%) patients. Thrombosis of the bypass graft was registered in 6 cases and thrombosis of the stented iliac segment was encountered in 3 cases, which required amputation of the lower limb in 5 (6.7%) patients.

[Cardiosynchronized sequential antegrade pneumocompression in treatment of patients with multifocal atherosclerosis].

The work was aimed at assessing efficacy and safety of indications for and contraindications to a promising method of treatment for multifocal atherosclerosis - enforced external counterpulsation, suggesting a new noninvasive method of treatment of chronic obliterating diseases of lower-limb arteries - cardiosynchronized sequential antegrade pneumocompression.

[Ankle brachial index: motivations, training, and practices among 165 general practitioners in Île-de-France]. / Index de pression systolique et médecine de ville : motivation, formation, mesure et valorisation de l'acte. Enquête auprès d'un échantillon de 165 médecins généralistes d'Île-de-France.

UNLABELLED: Peripheral arterial disease (PAD) is under-diagnosed despite its predictive value for cardiovascular mortality. The ankle brachial index (ABI), a simple reliable measure recommended by the French health authorities to detect and evaluate the severity of PAD, is used by too few general practitioners (GPs). OBJECTIVE: This study aimed at identifying motivations and barriers for using ABI in general practice. METHOD: A representative, descriptive, cross-sectional survey was conducted amongst 165 GPs practicing in Île-de-France who were interviewed using stratified quotas. RESULTS: Although 1 out of 5 GPs considered ABI to be an irrelevant indicator, most had a favorable opinion about its use (OR: 4.9 [CI 95 %: 4.2-5.7]). Only 42 % (CI 95 %: 34 %-49 %) of GPs knew ABI was recommended by the health authorities. This information had a critical impact on the acceptance of ABI relevancy (OR: 3.7 [CI 95 %: 3.2-4.2]). Training reinforced acceptance (OR: 5.0 [CI 95 %: 4.4-5.6]) and pre-residency education provided a better understanding of ABI (OR: 2.8 [CI 95 %: 2.3-3.4]). Time needed to measure ABI was the main barrier (OR: 0.6 [CI 95 %: 0.6-0.7]). A Doppler-calculation kit (OR: 11.8 [CI 95 %: 8.9-15.6]), equipment cost≤300Euros (OR: 3.4 [CI 99 %: 3.0-3.9]), a specific fee in addition to the regular consultation fee (OR: 2.6 [CI 95 %: 2.3-3.0]) and inclusion of ABI in the GP's evaluation scheme (OR: 2.6 [CI 95 %: 2.3-2.9]) would motivate more GPs. Seven out of 10 GPs agreed that ABI has a positive impact on patient adherence to treatment and follow-up, but ABI remained underexploited for symptomatic patients (OR: 0.4 [CI 95 %: 0.3-0.4]). CONCLUSION: Better communication and training together with an upgraded status for ABI would provide motivation for GPs to measure ABI.

[Treatment for chronic obliterating diseases of lower limb arteries].

The work is dedicated to a new method of treatment for chronic obliterating diseases of lower limb arteries - cardiosynchronized sequential antegrade pneumocompression. The author describes the basic principles of the method, its physiological effects, and the results of treatment on volunteers.

Prospective study of sarpogrelate hydrochloride on patients with arteriosclerosis obliterans.

OBJECTIVE: To evaluate the effect of sarpogrelate for patients with atherosclerotic obliterans (ASO). PATIENTS AND METHODS: Patients with ASO were randomly divided into sarpogrelate group (n = 92) and control group (n = 84). The patients in sarpogrelate group received sarpogrelate (100 mg, tid), whereas in control group aspirin (100 mg, qd) was administered orally. The patients were followed up monthly to observe any side effect of medication. Clinical manifestation, painless walking distance, Rutherford type and ankle brachial Index (ABI) were studied. RESULTS: In comparison with control group, the severity of pain, Rutherford type 0 and 1 were improved with statistic significance. Incidence of patients with intermittent claudication decreased from 56.6% before treatment to 28.3% after treatment; the painless walking distance was prolonged (116.3 ± 72.3m vs. 243.5 ± 175.3m, P <0.001); ABI values were increased (0.74 ± 0.17 vs. 0.86 ± 0.18; p <0.001). No side effect of medication was observed. CONCLUSION: Sarpogrelate has a therapeutic effect on patients with atherosclerotic obliterans.

[Therapeutic angiogenesis in treatment of patients with chronic obliterating diseases of lower limb arteries].

The authors share their experience gained in realization of the concept of "therapeutic angiogenesis" by means of the first Russian gene therapeutic agent Neovasculogen in comprehensive treatment of patients with stage II-III chronic obliterating disease of lower limb arteries (CODLLA) according to the Pokrovsky-Fontain classification. A total of 45 patients were treated. The findings were assessed and analyzed depending on the stage of chronic lower limb ischaemia. The clinical results including such measures such as the pain-free walk (PFW), ankle/brachial index (ABI), transcutaneously determined oxygen tension (TDOT), linear blood velocity (LBV) were followed up for 2 years. All patients were found to have good tolerance and at terms up to 2 years, and no side effect or complications were revealed. Patients with stage IIB of the disease after one year demonstrated statistically significant results suggesting improved blood circulation in the ischemized lower limbs after using the agent according to the indices of PFW, TDOT, LBV (p<0.05). In stage III of the disease? significant results were observed for PFD and TODT (p<0.05). Considerable part of patients with stage IIB and III CODDLLA (84.4%) showed increased physical capabilities for ambulation at the expense of considerably increased PFW (p<0.01). It was observed that using the agent was enough for obtaining a persistent satisfactory result preserving for not less than one year, with 50% of patients from stage IIB and 16.7% from stage III transferred to stage IIA of the disease. The effect of treatment persisted during the second year of follow up.