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.

[Early outcomes of therapy and indirect revascularization surgery in patients with critical ischemia of lower extremities]. / Blizhaishie rezul'taty konservativnogo lecheniya i operatsii nepryamoi revaskulyarizatsii u bol'nykh s kriticheskoi ishemiei nizhnikh konechnostei na fone distal'noi okklyuzii arterii.

OBJECTIVE: To study the immediate results of therapy and indirect revascularization in patients with critical ischemia of the lower limbs. MATERIAL AND METHODS: The results of medication and surgical treatment were analyzed in 210 patients with critical ischemia of the lower limbs. Atherosclerosis obliterans was diagnosed in 142 patients, thromboangiitis obliterans - in 68 patients. Lesion of femoropopliteal segment was observed in 32 (15.2%) cases, popliteal-tibial segment - 68 (32.8%) patients, tibial and foot segment - 62 (29.5%) cases, foot - 31 (14.8%) cases, multiple-level lesion - 17 (8.1%) cases. Survey consisted of Doppler ultrasound, CT angiography, rheovasography with analysis of rheographic index (RI) and pulse oximetry. Circulatory parameters were compared with identical values in 48 almost healthy persons ("reference group"). The results of medication and surgical treatment were evaluated by using of the scale of Rutherford R.B. et al. (1997). RESULTS: Conservative treatment was performed in 48 patients (control group). The following types of indirect revascularization operations were performed to stimulate regional circulation: bone trepanation in 42 patients, lumbar sympathectomy in 51 patients, bone trepanation + lumbar sympathectomy in 38 patients, bone trepanation with intraosseous irradiation in 31 cases. CONCLUSION: Indirect revascularization improves early postoperative outcomes, ensures maintaining support function of the limb and active lifestyle in patients with critical ischemia of the lower limbs. Technical simplicity of these procedures facilitates widespread introduction of indirect revascularization in multi-field hospitals.

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.

Lower extremity CT angiography at 80 kVp using iterative model reconstruction.

PURPOSE: To evaluate the use of 80 kVp and iterative model reconstruction (IMR) in lower extremity computed tomography angiography (CTA). MATERIALS AND METHODS: Sixty patients were randomly assigned to Group A or Group B (both n=30) to further undergo CTA. Group A received Protocol 1 (P1) with 120 kVp, 180mAs, and 100mL of contrast agent with filtered back-projection (FBP). Group B received Protocol 2 (P2) and Protocol 3 (P3) with 80 kVp, 140mAs and 75mL of contrast agent with hybrid iterative reconstruction (P2) and IMR (P3). Mean intravascular attenuation (MIA), image noise, contrast-to-noise ratio (CNR), and signal-to-noise ratio (SNR) were compared. Radiologists assessed image quality on a 5-point scale, and radiation was compared between both groups. RESULTS: Group A had 9 men and 21 women (mean age, 68.2±9.3 years [range: 53-85 years]), and Group B had 20 men and 10 women (mean age, 64.8±10.4 years [range: 37-81 years]). The MIA of P2 and P3 were significantly larger than that of P1 (P<0.01). The CNR and SNR of P3 were significantly higher than those of P1 and P2 (P<0.01). The interobserver agreement had Kappa values of 0.78, 0.77, and 0.81 for P1, P2, P3, respectively. The mean CT volume dose index and dose-length product of Group B were lower than those of Group A (P<0.01). CONCLUSION: Lower extremity CTA using 80 kVp and IMR is useful for lower radiation and contrast agent dose while preserving image quality. IMR can also provide better image quality for small-caliber vessels below the knee than HIR.

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.

[[Impact of plestazol preparation on hyperplasia of inter vascular layer in the patients, suffering obliterating atherosclerosis of the lower extremities arteries after reconstructive operations].]

In the clinic 60 patients were examined, in whom reconstructive operations on the main arteries were performed for obliterating atherosclerosis (OA) of the lower extremities vessels. Efficacy of impact of Plestazol (in a 200 mg/day dose) on neointima hyperpla- sia was studied. Clopidogrel (75 mg/day) was administered to patients of comparative group. Effective criteria for estimation of the migration-proliferation disorders state in endothelial dysfunction are concentration of the intercellular adhesion molecules (ICAM) and the basic factor of the fibroblasts growth (FGFb); morphological disorders in hyperplastic reactions of neointima - determination of thickness of "intima-media" complex in accordance to the ultrasound duplex scanning data. There was established, that Plestazol constitutes an effective disaggregate preparation, positively impacting decelerating reaction of neointima hyperplasia, including, deceleration of the smooth- muscle cells migration into subendotelial layer in the formation zone of the femoro- popliteal shunt distal anastomosis.

[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.

[Low concentration of iodixanol used in CT angiography of lower extremity arteriosclerosis obliterans].

OBJECTIVE: To evaluate the clinical diagnostic value of low concentration of iodixanol used in CT angiography (CTA) of lower extremity arteriosclerosis obliterans (LEASO). METHODS: 42 patients which were suspect diagnosed with LEASO were divided to A group (270 mgI/ml iodixanol, tube voltage 100 kV) and B group (350 mgI/ml iohexol, tube voltage 120 kV), 21 patients in each group. Measure the body mass index (BMI) before the CTA of lower extremity. CTA results were analyzed with the digital subtraction angiography (DSA) as the "gold standard". RESULTS: There were no statistical difference of age, gender, BMI and CT value of the bifurcation of profunda femoral artery and superficial femoral artery, upper segment of anterior tibial artery and posterior tibial artery between A and B group. The diagnostic sensitivity and specificity of A and B groups of CTA were 97.0%, 99.1% and 98.3%, 99.5% for occlusion. Regard artery more than moderate stenosis (include moderate stenosis) as the overall statistics, the diagnostic sensitivity and specificity of A and B groups of CTA were 99.2%, 99.3% and 99.1%, 99.3%, the accuracy were 92.9% and 93.0%, the positive predictive and negative predictive value were 96.9%, 99.3% and 96.6%, 99.3%, respectively. The kappa value of A and B groups of CTA and DSA consistency test were 0.930 and 0.927, respectively. CONCLUSION: The CTA with low concentration of iodixanol combine with low tube voltage can achieve superior conventional scanning imaging features, and has great clinical value in the diagnosis of LEASO, also is an effective method for the inspection, evaluation and follow-up.

[Possibility of operative treatment of geriatric patients with critical lower limb ischemia].

The experience of treating 106 patients of 70+ years shows the possibility of successful vascular reconstructive procedures with good immediate and long-term results, even in the presence of critical limb ischemia and severe comorbidity in geriatric patients, if not guided by the principle of maximum revascularization of the affected limbs, and minimally sufficient, through a wide use of atypical and small renovations. In addition, not only comprehensive assessment of the reserve and compensatory capacities of the patients is important, but also preoperative prevention of cardiac, pulmonary and other complications.

[Ankle brachial pressure index (ABPI): color-Doppler versus ultrasound Doppler correlation study in 98 patients after analysis of interobserver reproducibility]. / Étude de corrélation de mesure des index de pression systolique à la cheville (IPSc) par Doppler couleur versus Doppler continu sur une population de 98 patients après analyse de la reproductibilité interobservateur.

OBJECTIVE: Ankle Brachial Pressure Index (ABPI) by Doppler ultrasound is the gold standard non invasive method for screening of peripheral arterial disease (PAD). This reference method is little used in routine practice, particularly by vascular disease specialists since the most recent ultrasound devices no longer have continuous wave probes. The purpose of our survey was to assess interobserver reproducibility of color-Doppler measurements made in a first population, then second, to assess the correlation between ABPI measurements made with color-Doppler and with ultrasound Doppler in a second population. METHODS: One hundred twenty patients meeting screening criteria for AOMI defined by the French Health Authorities (HAS, 2006) participated in the study between October 2010 and April 2011 in the Echo Doppler and Vascular Medicine unit of the Brest University teaching hospital: 22 patients for interobserver reproducibility and 98 for color-Doppler - continuous Doppler correlation study. Two independent operators measured the ABPI index in each of the 98 patients using color-Doppler and continuous Doppler in random order, producing 353 measurements. Reliability and reproducibility were assessed using the intraclass correlation coefficient of correlation (ICC) determined with Spearman and the Bland-Altman methods. RESULTS: The ABPI was less than 0.90 in 62% of patients. The color-Doppler reproducibility study showed a mean difference of 0.02 [95% CI: -0.02 to 0.17] using the Bland Altman method with ICC equal to 0.89 (P<0.001). For the intermethod correlation study, the mean difference was 0.03 [95% CI: -0.17 to 0.23], with ICC equal to 0.84 (P<0.001). CONCLUSION: Color-Doppler could be an alternative to Doppler ultrasound for PAD screening or follow-up, depending on the results of further evaluations in larger populations.

[The extended endarterectomy from the femoral-popliteal arterial segment].

32 patients with atherosclerosis obliterans of lower limbs stage 2-4 were operated on according to the authorized method of arterial reconstruction in the absence of the suitable autologous transplant vessel (vena saphena magna). The efficacy of the procedure, thrombosis frequency and reocclusion were analyzed. Algorythm of postoperative use of low-molecular heparin in combination with antithrombicytic drugs and desaggregants had been worked out.

Supermicrosurgery in peroneal and soleus perforator-based free flap coverage of foot defects caused by occlusive vascular diseases.

BACKGROUND: Limb salvage rates for lower limbs have improved tremendously for trauma and tumor victims. The optimal solution for coverage of defects caused by ischemic limbs does not exist. The authors believe the use of supermicrosurgery and perforator flap surgery might add a further tool useful to the reconstructive surgeon. METHODS: After excisional débridement of the wound, under loupe magnification, branches of the terminal foot vessels were sought. Once identified and deemed suitable, the thin peroneal flaps were isolated based on perforator vessels. The flaps raised were either peroneal perforator-based or soleus perforator-based flaps. Microanastomosis was performed at the perforator level with 10-0 or 11-0 Ethilon sutures, and the flap was inset. The donor site was closed primarily. RESULTS: A total of 18 such flaps were raised in 17 patients with 15 septocutaneous and three musculocutaneous perforators. Sixteen peroneal perforator-based flaps and two soleus perforator-based flaps were used. There was one major (flap loss) and two minor (wound dehiscence) complications. The rest of the patients healed well, with no recurrence at a mean follow-up of 8.3 months. CONCLUSIONS: Limb salvage in ischemic limbs is now possible with supermicrosurgery and perforator flaps. This method allows contour resurfacing, avoids bulky tissue, is fast, and can be performed under regional anesthesia.

[Development of a prevention of body movement fixation appliance in leg digital subtraction angiography].

In the peripheral angiography to evaluate blood flow below the knee levels in patients with arteriosclerosis obliterans, a motion artifact occurs as a result of body movements of a patient in normal fixation. This sometimes makes a correct evaluation difficult. Therefore, we developed a fixed appliance which can restrain body movement without affecting image quality and blood flow in digital subtraction angiography of a leg. The appliance is filled with the styrofoam of 1 mm diameter in a sealed bag, after air is aspirated from inside the bag. The appliance is stiffened to fit the shape of the crus. We measured signal to noise ratio / contrast to noise ratio / a resolution limit by visual evaluation to examine the influence of the image before and after usage of this appliance. In addition, the blood velocity of the dorsalis artery in ultrasound was measured to examine the effect on the blood flow. As a result, the fixed appliance did not affect blood flow in peripheral angiography to evaluate the clinical significance, the usual 5-point evaluate scale was used. The scale was significantly improved (p <0.01) after usage of this appliance. The newly developed fixed appliance for digital subtraction angiography of a leg is useful to avoid motion artifacts in clinical settings.

[Colour duplex scanning in assessing efficacy of roentgeno-endovascular operations on lower-limb arteries].

The authors analysed efficacy of colour duplex scanning (CDS) in patients after roentgen- assisted endovascular interventions on lower-limb arteries. The study comprised 303 patients presenting with chronic obliterating diseases of lower extremities, who underwent a total of 456 endovascular interventions, including 375 stenting procedures. Efficacy of roentgen-assisted endovascular interventions was assessed l-to-3 days after surgery. We determined the main ultrasonographic criteria for successful balloon angioplasty, i. е., vessel's geometry restoration, haemodynamic alterations in the endovascular intervention site, the presence of residual stenosis less than 25%, accuracy of stent/stents' positioning, commensurability of the diameters of the stent and artery, exclusion of the aneurysm from blood flow. Also studied were ultrasonographic criteria for arterial complications following endovascular interventions, including thromboses of the zone of angioplasty the stent, the presence of less-than-25-percent stenosis, subintimal insertion of the stent, incomplete opening of the stent, incomplete capture of the stenosis area by the stent, and stent dislocation. CDS is an important method to assess evaluating efficacy of roentgen-assisted operations and the state of arteries after angioplasty.

[Possibilities of radionuclide study of lower-limb muscles perfusion in diagnosis of chronic arterial insufficiency].

The authors have hereby proposed a method to diagnose lower-limb muscular ischaemia by means of scintigraphy, used in 35 patients suffering from atherosclerosis obliterans with stage IIB and III A chronic arterial insufficiency of limbs. To do so, administration of the radioactive agent "Myoview" (99m)Tc-tetrophosmine) manufactured by the "Nycomed" Company into a patient's peripheral vein was followed by assessing its accumulation in lower-limb muscles at rest and after standard physical load. Alterations in the parameters studied relative to the norm made it possible to judge on the presence of lower-limb circulatory impairments. The method proved highly efficient, thus making it possible to use it for both therapeutic decision-making and probably in future for dynamic control after the treatment performed. Minimally invasive nature and simplicity in use of the methodology open wide possibilities for its use.

Combined distal venous arterialization and free flap for patients with extensive tissue loss.

BACKGROUND: We evaluated the mid-term outcome of distal venous arterialization (DVA) and the role of a combined free flap as a bridgehead for blood supply. METHODS: In the past 5 years, nine patients with extensive tissue loss and lacking graftable distal arteries underwent DVA. These consisted of four primary DVAs, three combined DVA and free flap procedures, and two adjuvant DVAs for hemodynamically failed distal bypasses. After nine primary DVAs, three redo DVAs were performed for early failure. Etiologies were four Buerger disease and five arteriosclerosis obliterans, including three dialysis patients. RESULTS: Among the nine DVA cases, there were five primary failures: two underwent amputation, two had successful redo DVA, and the remaining one did not require redo DVA. Primary patency, secondary patency, and limb salvage rates were 44.4%, 55.6%, and 77.8%, respectively. The postoperative period was 1-36 months (median 12). Angiography demonstrated DVA was effective in the early period, and development of collaterals or a capillary network from the free flap replaced the DVA function in the intermediate period. CONCLUSION: DVA can be effective as a procedure for limb salvage in patients without graftable distal arteries, and a combined free flap is effective and functions as a bridgehead for blood supply to the ischemic zone.

[Results of femoro-popliteal arterial reconstructions depending on hemodynamic conditions].

The investigation included 205 patients. Reconstructive operations were fulfilled on major arteries of the femoro-popliteal segment (FPS) of lower extremities. An analysis of long-term results showed that the results of surgical treatment of lesions of FPS in obliterating atherosclerosis of the lower extremity vessels depended on the level of the peripheral vascular resistance in the lower extremity arteries, and the formation of the arteriovenous shunt in reconstructions of the FPS allowed considerable improvement of results of surgical treatment of patients with high peripheral vascular resistance.