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.

[[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.

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.

[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.