Application of E-coach chronic disease management model in rehabilitation management of patients with arteriosclerosis obliterans.

OBJECTIVE: To explore the effect of a health (E)-coach chronic disease management model on the rehabilitation behaviour management of patients with arteriosclerosis obliterans (ASO). METHODS: The E-coach chronic disease management model was constructed based on a literature review and expert interviews. The effect of the E-coach model on patients with ASO during hospitalisation was analysed by comparing the compliance rates of blood glucose control, blood pressure control, drug compliance, ankle-brachial index, 6-min walking test (6MWT) and pain-free walking distance (PFWD) scores between the E-coach and control groups. RESULTS: In total, 212 patients with ASO were included in this study. After the intervention, the blood pressure compliance rate (44.8% vs. 65.7%) and blood glucose compliance rate (48.6% vs. 66.8%) were higher in the E-coach group than in the control group (p < 0.05). After intervention, compared with the control group, the patients in the E-coach group had better drug compliance (6.8 ± 1.9 vs. 7.9 ± 1.0), and the difference was statistically significant (p < 0.05). The scores for the 6MWT (329.19 ± 5.58 vs. 353.00 ± 9.76; 412.65 ± 12.59 vs. 499.16 ± 18.43) and PFWD (219.15 ± 11.96 vs. 225.36 ± 16.13; 331.62 ± 51.36 vs. 369.42 ± 75.71) tests were significantly higher in the E-coach group than in the control group at 1 and 6 months after intervention (p < 0.05). CONCLUSION: The E-coach chronic disease management model can effectively improve the control rates of blood glucose and blood pressure and the behaviour management of patients with ASO and is thus worthy of clinical reference.

Virtual Reality-Assisted Percutaneous Transluminal Angioplasty for Interventional Treatment of Lower-Extremity Arteriosclerosis Obliterans.

This study was to evaluate the biomechanical characteristics of the vascular wall during virtual reality- (VR-) assisted percutaneous transluminal angioplasty (PTA) and its effect on the treatment of lower-extremity arteriosclerosis obliterans (LEAO). In this study, a three-dimensional (3D) model and a finite-element model of arteries were constructed first, and various fluid mechanics were analyzed. Then, the virtual expansion simulation (VES) of individualized PTA was performed based on the ABAQUS/Explicit module to analyze the interaction between the balloon and the blood vessel at different times and the changes in the vascular shape and structural stress distribution. Finally, an LEAO animal model was constructed. Based on conventional PTA (PTA group) and VR-assisted PTA (VR-PTA) treatment, the morphological changes of vascular lumen of the two animal models were evaluated. The results showed that the normal, stenotic blood vessels and blood models were successfully constructed; the pressure of the stenotic blood vessel at the stenosis decreased obviously and the shear stress of blood vessel wall increased compared with that of the normal blood vessels, and there may be a blood reflux area in the poststenosis stage. The simulation results of the VES showed that the maximum principal stress value at 3 mm of the marginal vessel was much lower than that at 5 mm (about 10% lower), so the maximum principal stress change within 2 mm of the balloon-expanded vessel was the most obvious. The treatment results of the animal model showed that the VR-PTA group showed an obvious increase in the diameter of the vascular lumen, a decrease in the intima and media area, and a decrease in the thickness of the vessel wall in contrast to the PTA group (P < 0.05), which had an important effect on the reconstruction and expansion of the vascular lumen. The VR-PTA treatment on LEAO was realized in this study, which provided critical reference for the follow-up application of VR technology in the evaluation of surgical plan and research on biomechanical mechanisms of restenosis after PTA.

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.

A risk predictor of restenosis after superficial femoral artery stent implantation: relevance of mean platelet volume.

BACKGROUND: To investigate the relationship between an increase in the pre- and post-operative mean platelet volume (MPV) and superficial femoral artery in-stent restenosis (ISR) rate. METHODS AND RESULTS: We recruited patients that underwent superficial femoral artery stenting for lower extremity arteriosclerosis obliterans at our hospital from March 2015 to March 2018. All patients gave venous blood three days before and following implantation. Doppler ultrasound, computed tomography angiography or digital subtraction angiography were used for regular follow-up examination. Logistic regression was used to identify predictors of ISR after superficial femoral artery stenting. We enrolled 173 patients, of which 34 (19.6%) were determined as having ISR for a mean of 8.9 ± 2.7 months (3-12 months). Neutrophil count, neutrophil ratio, lymphocyte ratio and platelet count pre-implantation, and platelet count and MPV after stent implantation, and the pre- and post-operative mean platelet volume difference (MPVD) and mean platelet volume difference ratio (MPVDR) were all statistically different when comparing the ISR and non-restenosis groups (p < 0.05). A positive correlation was found for post-operative MPV and presence of ISR (r = 0.58; P < 0.001). A MPVD not less than 1.5 fL was associated with an odds ratio of 9.17 (95% CI [3.76 to 22.35]; P < 0.001) for presence of ISR. A MPVDR of not less than 17.9% was associated with an odds ratio of 7.68 (95% CI [3.19 to 18.49]; P < 0.001) for occurrence of ISR. CONCLUSIONS: An increase in pre- and post-operative MPV was correlated with the occurrence of superficial femoral artery ISR.

Effects of Valsartan on Restenosis in Patients with Arteriosclerosis Obliterans of the Lower Extremities Undergoing Interventional Therapy: A Prospective, Randomized, Single-Blind Trial.

BACKGROUND The aim of this study was to further clarify the effects of valsartan on restenosis in patients with arteriosclerosis obliterans of the lower extremities. MATERIAL AND METHODS Patients with arteriosclerosis obliterans of the lower extremities undergoing continuous stent implantation in the superficial femoral artery were enrolled and randomly divided into an ARB group and a control group. Patients in the ARB group received valsartan orally in a single-blind manner and were followed up for 6 months. An evaluation was performed based on the criteria for clinical efficacies designed by the Committee of Vascular Disease, Chinese Association of Integrative Medicine. The total clinical effective rate was calculated, and ankle brachial index (ABI) of the patients was assessed. The concentrations of interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hs-CRP) were measured using enzyme-linked immunosorbent assay. The in-stent restenosis of patients was examined by angiography. RESULTS One patient in the control group died due to acute cerebral hemorrhage 4 months after enrollment, and 1 patient was lost to follow-up due to acute myocardial infarction during follow-up 5 months after enrollment. Age, sex, Fontaine stage, and underlying diseases were comparable between the 2 groups. Hs-CRP (3.93±1.43) and IL-6 (11.26±2.29) levels were significant different in the ARB group compared with the control group. The postoperative follow-up showed that ABI was 0.98±0.20 in the ARB group and 0.62±0.48 in the control group. CONCLUSIONS Valsartan inhibited the increase in hs-CRP and IL-6 levels, improved clinical efficacies, increased ABI, and decreased the restenosis rate after the interventional therapy in patients with arteriosclerosis obliterans of the lower extremities.

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.

[Use of enhanced external counterpulsation in the treatment and rehabilitation of patients with atherosclerosis obliterans of the lower extremity]. / Primenenie metoda usilennoi naruzhnoi kontrpul'satsii v lechenii i reabilitatsii patsientov s obliteriruiushchim aterosklerozom sosudov nizhnikh konechnostei.

BACKGROUND: Cardiovascular diseases occupy a leading place in the structure of morbidity in Russia and other developed countries of the world. AIM: To study the efficiency of using enhanced external counterpulsation in the comprehensive rehabilitation treatment of patients with stages I-IIB obliterating atherosclerosis of the lower extremities (OALE). SUBJECTS AND METHODS: A total of 68 patients aged 50 to 78 years with stages I-IIb oale in the presence of clinical symptomatology of arterial insufficiency were examined and treated. According to the method of treatment, the patients were divided into two groups: 1) 32 people received a standard drug therapy (a control group). 2) 36 patients had an enhanced external counterpulsation therapy cycle during the standard therapy (a study group). The frequency of characteristic complaints, pain-free walking distance, peripheral hemodynamics, and the ankle-brachial index (abi) were assessed. RESULTS: Posttreatment leg pain on walking persisted in 11 (30.6%) and 25 (78.1%) patients in the study group and in the control one, respectively; there were leg cramps in 9 (25.0%) and 14 (43.8%) people and cold feet in 5 (13.9%) and 25 (78.1%) patients, respectively (p<0.05). In the study group, the considerable increase in pain-free walking distance as compared to baseline values averaged 250±31.2 m (p<0.05), while that in the control group was only 64.5±25.1 m (p>0.05). The posttreatment increase in the leg and foot rheographic indices averaged 23.9 and 23.2%, respectively, in the study group and 11.9 and 12.3%, respectively, in the control group. The increases in abi in the anterior and posterior tibial arteries were 31.4 and 35.2%, respectively, in the study group (p<0.05), and 16.0 and 13.0%, respectively, in the control group (p>0.05). CONCLUSION: The findings suggest that the use of enhanced external counterpulsation in the combination therapy of patients with stages I-IIb oale is a clinically effective and safe treatment.

[Femoral-popliteal Arteriosclerosis Obliterans:Review of Evidence-based Studies on Drug-eluting Endovascular Treatment].

Atherosclerosis-related diseases have increasingly become health concerns with the increased living conditions and aging.Globally,about 200 million people have suffered from arteriosclerosis obliterans(ASO),which can even be life-threatening in some cases.The past seven decades have witnessed the rapid advances in the treatment of ASO,which has developed from surgery to endovascular interventions including plain balloon angioplasty,bare metal stent placement,drug-coated balloon,and drug-eluting stent.However,the roles of these new techniques for femoral-popliteal lesions,especially their real-world clinical outcomes and indications,remain unclear.This article reviews the latest evidences on the use of drug-eluting devices in treating femoral-popliteal arteriosclerosis obliterans.

[Effect of combined application of ozone therapy and gravitational therapy on the remote results of complex treatment of geriatric patients].

The article presents the remote results of treatment of an obliterating atherosclerosis of arteries of the lower extremities of the II stage at patients of advanced and senile age after the combined use of ozone therapy and gravitational therapy. We performed a prospective randomized study in three parallel groups (139 patients). The 1st group (n=57) received standard medical therapy in combination with ozone therapy; the group was divided into two subgroups: for patients of subgroup 1a (n=28) - intravenous ozonized physiological solution was performed, for patients of subgroup 1b (n=29) - major ozonized autohemotherapy. For patients of the 2nd group (n=62) - a comprehensive treatment, including gravitational therapy in addition to medical ozone, was carried out. In this group were also identified two subgroups: subgroup 2a (n=31) - patients received standard medical therapy in combination with ozonized physiological solution and gravitational therapy, subgroup 2b (n=31) - standard medical therapy in conjunction with major ozonized autohemotherapy and gravitational therapy. The 3rd control group (n=20) included patients, who received only standard medical therapy. Dynamics of changes of a stage of a disease and the number of surgeries in the remote period was estimated (up to 7 years). After 6 months of follow-on stages of the distribution of the disease patients significantly (p>0,05) did not differ from the initial amount. Analysis of survival and probable risk at 7 years of follow-Cox regression method revealed a maximum efficiency in the subgroup 2a where the risk of probability of surgeries and also increases in a stage of a disease effectively decreased.

[Efficacy of drug-coated balloon and common balloon for treatment of superficial femoral artery and popliteal artery arteriosclerosis obliterans: prospective randomized controlled triac].

OBJECTIVE: To compared the efficacy of drug-coated balloon and common balloon for treatment of superficial femoral artery and popliteal artery occlusive disease. METHODS: Forty-six patients were admitted for ipsilateral single or multiple superficial femoral artery and/or popliteal artery lesions (between 3 and 15 cm stenosis or occlusion), Rutherford grades 2 to 5, with or without other accompanying diseases in the Department of Interventional Vascular Therapy of the First Hospital of Nanjing between September, 2015 and December, 2016. The patients were randomly assigned into drug-coated balloon (DCB) group (n=23) and common balloon (CB) group (n=23). None of the patients had stent restenosis, aneurysms, acute thrombosis, pregnancy, life expectancy less than 1 year, or below-the-knee artery occlusion. The late lumen loss (LLL), improvement of the ankle brachial index (ABI), improvement of Rutherford grade, incidence of restenosis, thrombosis rate and amputation rate were compared between the two groups at 6 months after treatment. RESULTS: The two groups of patients were comparable for general conditions, risk factors, and characteristics of the compromised vessels (P>0.05). Six months after treatment, the patients in DCB group showed significantly smaller LLL, more obvious improvement of the ABI and Rutherford grade, and lower restenosis rate and thrombosis rate than those in CB group (P<0.05). The amputation rates were similar between the two groups (P>0.05). CONCLUSIONS: DCB shows obvious advantages over common balloon for treatment of superficial artery and popliteal artery arteriosclerosis obliterans in that it more effectively reduces LLL, restenosis rate and thrombosis rate and improves the ABI and Rutherford grade at 6 months after the treatment.

[POSSIBILITIES OF THE FORCED INTRAARTERIAL INJECTION OF MEDICINAL PREPARATIONS IN A COMPLEX OF TREATMENT FOR THE LOWER EXTREMITIES CHRONIC ISCHEMIA].

The efficacy and prognostic significance of the forced intraarterial injection of medicinal preparations in complex of treatment in patients, suffering chronic ischemia of the lower extremities tissues, was studied. In experimental conditions of the main blood flow blockade the forced intraarterial injection of medicinal preparations have promoted the release of vessels from cellular aggregates and the blood clots; and in the ischemia of degree ІІ - ІІІа ­ has determined more pronounced clinical improvement. Appearance of reactive hyperemia of the foot in terms more than 2 min have witnessed the hopelessness of the extremity saving.

[Standardize the endovascular treatment for arteriosclerosis obliterans].

Endovascular therapy has become the first-line strategy for most peripheral artery disease cases. Currently, many guidelines recommend endovascular therapy as the first choice for arteriosclerosis obliterans. Recently, drug-eluting stent and drug-coated balloon are available. The clinical outcomes have been greatly improved with the evolution of devices. However, the long-term outcomes of endovascular therapy for arteriosclerosis obliterans are still not satisfied. Many centers treat arteriosclerosis obliterans using endovascular therapy in appropriately. In this editorial, an evidence-based approach and some strategies will be discussed to standardize the endovascular treatment and improve the result of endovascular therapy for arteriosclerosis obliterans.

[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.

Imaging Angiogenesis Using 99mTc-Macroaggregated Albumin Scintigraphy in Patients with Peripheral Artery Disease.

UNLABELLED: One problem of vascular angiogenesis therapy is the lack of reliable methods for evaluating blood flow in the microcirculation. We aimed to assess whether (99m)Tc-macroaggregated albumin perfusion scintigraphy ((99m)Tc-MAA) predicts quantitated blood flow after therapeutic angiogenesis in patients with peripheral artery disease. METHODS: Forty-six patients with peripheral artery disease were treated with bone marrow mononuclear cell implantation (BMCI). Before and 4 wk after BMCI, blood flow was evaluated via transcutaneous oxygen tension (TcPO2), ankle-brachial index, intravenous (99m)Tc-tetrofosmin perfusion scintigraphy ((99m)Tc-TF), and intraaortic (99m)Tc-MAA. RESULTS: Four weeks after BMCI, TcPO2 improved significantly (20.4 ± 14.4 to 36.0 ± 20.0 mm Hg, P < 0.01), but ankle-brachial index did not (0.65 ± 0.30 to 0.76 ± 0.24, P = 0.07). Improvement in (99m)Tc-TF count (0.60 ± 0.23 to 0.77 ± 0.29 count ratio/pixel, P < 0.01) and (99m)Tc-MAA count (5.21 ± 3.56 to 10.33 ± 7.18 count ratio/pixel, P = 0.02) was observed in the foot region but not the lower limb region, using both methods. When these data were normalized by subtracting the pixel count of the untreated side, the improvements in (99m)Tc-TF count (-0.04 ± 0.26 to 0.08 ± 0.32 count ratio/pixel, P = 0.04) and (99m)Tc-MAA count (1.49 ± 3.64 to 5.59 ± 4.84 count ratio/pixel, P = 0.03) in the foot remained significant. (99m)Tc-MAA indicated that the newly developed arteries were approximately 25 µm in diameter. CONCLUSION: BMCI induced angiogenesis in the foot, which was detected using (99m)Tc-TF and (99m)Tc-MAA. (99m)Tc-MAA is a useful method to quantitate blood flow, estimate vascular size, and evaluate flow distribution after therapeutic angiogenesis.

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.

[Organizational aspects of managing patients with atherosclerosis obliterans of lower-limb vessels at an ambulatory stage].

The authors describe their first experience of a new approach in dispensary follow up of patients presenting with atherosclerosis obliterans of lower-extremities vessels. The work was based on the municipal system of rendering outpatient medical care in the city of Kemerovo. The patients were subdivided into two groups: one group remained under supervision of the surgeon, the other one was referred to the cardiologist. The mean duration of follow up amounted to 12 ± 1.5 months. The scope of carried out diagnostic, therapeutic and preventive procedures was assessed. The new approach to outpatient follow up, i. e., participation of the cardiologist in the therapeutic process made it possible to improve quality of medical care, also revealing positive alterations in diagnosis, treatment, and prevention of atherosclerosis obliterans of lower-limb vessels.

[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.