A randomized controlled trial of standard vs customized graduated elastic compression stockings in patients with chronic venous disease.

OBJECTIVE: This study aimed to compare the efficacy of customized graduated elastic compression stockings (c-GECSs) based on lower leg parameter models with standard GECSs (s-GECSs) in patients with chronic venous disease (CVD). METHODS: In this randomized, single-blind, controlled trial, 79 patients with stage C2 or C3 CVD were assigned to one of two groups: c-GECSs or s-GECSs. The primary outcome was change to Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) scores at months 1, 3, and 6 as compared with baseline. Secondary outcomes included compliance with wearing ECSs, interface pressure at the smallest circumference of the ankle (point B) and the largest circumference of the calf (point C), and calf volume (CV). RESULTS: There were 13 pairs of s-GECS and 2 pairs of c-GECS that showed pressure values higher than the standard at either point B or C. The c-GECSs were significantly superior to s-GECSs in terms of score improvement at all three time points (month 1, 8.47 [95% confidence interval (CI), 7.47-9.45] vs 5.89 [95% CI, 5.00-6.78]; month 3, 9.60 [95% CI, 8.47-10.72] vs 6.72 [95% CI, 5.62-7.83]; month 6, 7.09 [95% CI, 5.93-8.24] vs 3.92 [95% CI, 2.67-5.18]; P < .0001). Besides, at month 1, the mean daily use time of the c-GECS and s-GECS groups was 10.7 and 9.5 hours, respectively (P < .05). Correlation analysis indicated a negative relationship between local high pressure and daily duration in the s-GECS group (rpb = -0.388; n = 38; P < .05). Variances in pressure were greater in the s-GECSs group. The c-GECSs showed advantage in maintaining pressure. Both c-GECSs and s-GECSs effectively reduced CV (mL), with no significant differences between groups (month 1, 90.0 [95% CI, 71.4-108.5] vs 85.0 [95% CI, 65.6-104.2]; month 3, 93.8 [95% CI, 69.7-117.8] vs 85.9 [95% CI, 65.5-106.2]; month 6, 70.8 [95% CI, 46.5-95.2]) vs 60.8 [95% CI, 44.1-77.5]). CONCLUSIONS: The c-GECSs based on individual leg parameter models significantly improved VEINES-QOL scores and provided stable and enduring pressure as compared with s-GECSs for patients with stage C2 or C3 CVD. Although both c-GECSs and s-GECSs effectively reduced CV, the superior fit and comfort of c-GECSs improved patient compliance. Hence, c-GECSs are a viable alternative for patients who have difficulty tolerating s-GECSs.

Three-dimensional laser scanner as a new tool for measuring lower limb volume in patients with chronic venous diseases.

OBJECTIVE: Measurement of lower limb volume in patients with chronic venous disease (CVD) is necessary for assessing severity at the time of diagnosis and evaluating response to therapy administered. Existing methods have some limitations in clinical application and accuracy. The study aimed to investigate the reliability and validity of a three-dimensional laser scanner (3DLS) in measuring the lower limb volume of patients with CVD. METHODS: A total of 30 patients with CVD (mean age, 55.6 ± 8.07 years; mean body mass index, 24.61 ± 1.87) were recruited in a vascular surgery clinic. The lower limb volumes of all participants were measured using the 3DLS and circumferential method (CM). Statistical analysis was conducted to compare the 3DLS and CM. RESULTS: There was a strong correlation between the CM and 3DLS method (r2 = 0.9065). The 3DLS had a high intraoperator and interoperator reliability. A Bland-Altman plot showed satisfactory agreement between the two methods. The 3DLS demonstrated greater bilateral limb differences than CM. CONCLUSIONS: There was satisfactory agreement between the two investigated methods. The 3DLS method was confirmed to be accurate, repeatable, and rapid in measuring the lower limb volume in patients with CVD and is, therefore, suitable for clinical use.

Compression syndromes of the popliteal artery due to intramuscular ganglion cyst of the biceps femoris: A case report and literature review.

Intramuscular ganglion cyst (IMGC) is a very rare lesion with an unidentified pathogeny that originates within the muscle. We encountered a case of 49-year-old man who complained of intermittent claudication in the right lower limb for 2 months. An intramuscular ganglion cyst in the biceps femoris muscle was diagnosed and located by Computed tomography angiography (CTA) and magnetic resonance imaging (MRI), which compressed the popliteal artery and resulted in ischemia in the right lower limb. Six months after surgical resection, there was no recurrence of the cyst and the popliteal artery was patency. We describe this case with a review of the relevant literature.

Randomized clinical trial of radiofrequency-induced thermotherapy combined with transilluminated powered phlebectomy versus high ligation and stripping for the treatment of lower limb varicose veins.

OBJECTIVE: The objective of this study was to evaluate the efficacy and safety of radiofrequency-induced thermotherapy (RFiTT) combined with transilluminated powered phlebectomy (TIPP) in the treatment of lower limb varicose veins (VVs) in comparison with high ligation and stripping (HLS) combined with TIPP. METHODS: The patients with lower limb VVs were randomly assigned to RFiTT combined with TIPP or HLS combined with TIPP. The primary end point was total closure rate of the great saphenous vein at 12 months. Secondary end points included Venous Clinical Severity Score and 14-item Chronic Venous Insufficiency Questionnaire score changes at 12 months and perioperative complications. RESULTS: The total closure rate of the great saphenous vein at 12 months was slightly lower in the RFiTT group (90.9% [90/99]) than in the HLS group (97.0% [98/101]) but not statistically significant (χ2 = 0.068; P = .08). Operation time, intraoperative blood loss, duration in hospital, duration in bed, and resumption of activities were statistically significantly better with RFiTT than with HLS. There were no significant differences between the groups in deep venous thrombosis, phlebitis, hematomas, pain, and infection. However, skin pigmentation and paresthesia were statistically significantly better with RFiTT than with HLS. At 12 months, both groups showed similar improvement from baseline in Venous Clinical Severity Score (1.28 ± 0.57 in the RFiTT group vs 1.33 ± 0.61 in the HLS group) and 14-item Chronic Venous Insufficiency Questionnaire score (67.32 ± 1.29 in the RFiTT group vs 67.45 ± 1.32 in the HLS group); however, neither group was superior to the other. CONCLUSIONS: RFiTT combined with TIPP is an effective treatment method for lower limb VVs and had a more satisfactory clinical outcome in surgical data, skin pigmentation, and paresthesia than HLS at the 12-month follow-up.

Once-daily vs. twice-daily dosing of enoxaparin for the management of venous thromboembolism: A systematic review and meta-analysis.

The present study aimed to determine whether there is any difference in the efficacy and safety of once-daily vs. twice-daily enoxaparin when used for the initial treatment of venous thromboembolism (VTE). The PubMed, Embase, Cochrane Central Register of Controlled Trials, Science Direct and Google Scholar databases were searched for studies comparing once-daily and twice-daily enoxaparin for the initial treatment of VTE added from inception up to 1st October 2019. Studies utilizing any other low-molecular-weight heparin and using enoxaparin for VTE prophylaxis were excluded. A total of 6 studies were included in the systematic review and 5 in the meta-analysis. Only one study was a randomized controlled trial (RCT). Pooled analysis of 460 patients receiving once-daily enoxaparin and 464 patients receiving twice-daily enoxaparin indicated no significant difference between the two dosing regimens regarding VTE recurrence [odds ratio (OR)=1.48, 95%CI: 0.75-2.89, P=0.26; I2=0%]. No significant difference in major hemorrhagic complications was noted (OR=1.21, 95%CI: 0.52-2.81, P=0.66; I2=0%). Sub-group analysis based on study type and use of enoxaparin for bridging therapy did not change the overall results. In cancer patients, no statistically significant difference in the recurrence of VTE was obtained between once-daily and twice-daily enoxaparin, but the confidence intervals were wide with a tendency to favor twice-daily dosing (OR=2.28, 95%CI: 0.91-5.75, P=0.08; I2=0%). The overall quality of the studies was determined to be average. To conclude, while the present results suggested no significant difference in efficacy and safety of once-daily vs. twice-daily enoxaparin when used for the initial treatment of VTE, the quality of the evidence may not have been sufficiently high to support the conclusions with confidence. Further high-quality and adequately powered RCTs are required to corroborate the present results.

Combination of Rotarex Thrombectomy and Drug-Coated Balloon for the Treatment of Femoropopliteal Artery In-Stent Restenosis.

BACKGROUND: The optimal treatment method for femoropopliteal (FP) artery in-stent restenosis (ISR) remains controversial. We assess the efficacy and safety of combination of Rotarex thrombectomy and drug-coated balloon (DCB) for the treatment of FP ISR. METHODS: From June 2016 to July 2017, 32 patients with FP ISR who underwent combination of Rotarex thrombectomy and DCB angioplasty were included in a prospective registry. The primary end point was primary patency of the target lesion defined as a peak systolic velocity ratio <2.4 documented by duplex ultrasound at 12 months without clinically driven target lesion revascularization (CD-TLR). The secondary outcome measure was the rate of major adverse limb events. The primary functional end point was assessed using the Walking Impairment Questionnaire (WIQ). RESULTS: Twenty-nine (90.6%) patients completed 12-month follow-up. Mean ankle-brachial index was 0.45 ± 0.14 at baseline and 0.84 ± 0.12 at 12 months (P < 0.05). The WIQ score was 30.45 ± 21.14 at baseline and 52.68 ± 29.75 at 12 months (P < 0.05). The Kaplan-Meier estimate of the primary patency rate at 12 months was 86.2% (25/29), and freedom from CD-TLR rate at 12 months was 89.7% (26/29). CONCLUSIONS: The data suggest that combination of Rotarex thrombectomy and DCB for treatment of FP ISR is safe and effective with satisfying primary patency rate and freedom from CD-TLR rate at 12-month follow-up.

WITHDRAWN: Drug Coated Balloon vs. Standard Percutaneous Transluminal Angioplasty for the Treatment of Femoropopliteal Artery Disease: 12 - Month Results of the LEGFLOW OTW China Randomised Controlled Trial.

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Effects of delivering recombinant tissue plasminogen activator on a new infusion system during endovascular intervention in patients with lower limb ischemia.

BACKGROUND: To evaluate the feasibility and effects of recombinant tissue plasminogen activator (rt-PA) delivered by a new infusion system during endovascular intervention therapy in patients who had limb ischemia within 6 months. METHODS: From November 2006 to December 2010, 103 consecutive patients were randomly distributed in two groups. 10 mg (group A) and 5 mg (group B) bolus of rt-PA was respectively injected into the proximal occlusive lesion by a new infusion system. Subsequently, additional rt-PA of 10 mg (group A) and 5 mg (group B) was injected into the thrombotic occlusion, respectively. Significant underlying lesions were treated by endovascular intervention or surgery. Rates of major and minor complication, procedural success, and clinical success were evaluated statistically. RESULTS: Rates of complete lysis and partial lysis success were 12.6% (13 of 103) and 87.4% (90 of 103), respectively. To treat underlying lesions, 84.5% (84 of 103) patients received balloon angioplasty/stent implantation and 4.9% (5 of 103) patients received surgical correction. After final definitive treatment, procedural success rate was up to 99% (102 of 103) and clinical success rate was 100%. Comorbidity conditions and patient characteristics did not statistically influence the rates of success and complication. During the follow-up period of 30-day, 6-, 12- month, there was no statistical difference in the amputation-free survival rates between these two groups. CONCLUSION: It is safe and effective to treat lower limb ischemia by combining adjunctive endovascular intervention with bolus of rt-PA (10 to 20 mg) given by a new infusion system. But long-term effects of thrombolysoangioplasty therapy in treating lower limb ischemia must be confirmed by large-scale population studies before routine use.

[Surgical treatment of 154 patients with non-traumatic acute lower limb ischemia].

OBJECTIVE: To analyze the surgical treatment and prognosis of non-traumatic acute lower limb ischemia, and compare the morbidity and prognosis of acute arterial embolism and acute arterial thrombosis. METHODS: The clinical data of 154 acute lower limb ischemia patients surgically treated from July 1999 to December 2007 were retrospectively analyzed. Fogarty catheter embolectomy was used in all patients; in which, 128 cases underwent Fogarty catheter embolectomy only, 8 cases Fogarty catheter embolectomy combined with endarterectomy, 13 cases Fogarty catheter embolectomy combined with vascular reconstruction with prosthetic graft or great saphenous vein, 5 cases Fogarty catheter embolectomy combined with amputation. The patients were divided into two groups according to pathogenesis: acute arterial embolism group (99 cases) and acute arterial thrombosis group (55 cases). The morbidity, amputation, perioperative mortality rates and high risk factors of amputation in the two groups were compared. RESULTS: Female experienced acute arterial embolism more often than man (60.6% vs 39.4%, P < 0.05), and more acute arterial thrombosis occurred in man (72.7% vs 27.3%, P < 0.05). The amputation rate of all cases was 9.7%, and perioperative mortality rate was 11.7%. The amputation rate in acute arterial embolism group was lower than acute arterial thrombosis group (5.1% vs 18.2%, P < 0.05). The perioperative mortality rates in the two groups were equal (11.1% vs 12.7%, P > 0.05). The statistically high risk factor of amputation for two groups was ischemic time, and smoking and diabetes were high risk factors for acute arterial thrombosis. CONCLUSIONS: Men experiences acute arterial thrombosis more often, and women experiences acute arterial embolism more often. The amputation rate of acute arterial embolism is lower than acute arterial thrombosis, and acute arterial thrombosis has more high risk factors of amputation.

[Endovascular therapy and arterial bypass for subclavian artery occlusion].

OBJECTIVE: To investigate the effect of endovascular therapy and artery bypass for subclavian artery occlusion disease and to explore a suitable therapeutic procedure. METHODS: Thirty-nine patients with subclavian artery occlusive disease received endovascular therapy or arterial bypass from June 1997 to May 2004. Twenty-seven endovascular stenting were performed on 26 patients through the femoral artery (n = 14) or combined brachial artery (n = 12). Retrograde endovascular balloon angioplasty and stent placement were performed on 12 patients. Eight subclavian arteries were punctured with ultrasound localization. On account of unsuccessful stenting, 13 cases received arterial bypass. In addition, endovascular stenting were performed on 9 cases with carotid or vertebrarterial stenoses. RESULTS: The blood pressure difference was less than 10 mm Hg between the treated and the healthy arms in all 39 patients. The ratio of healthy/diseased side of the mean blood pressure index increased from 0.62 +/- 0.11 preoperatively to 0.98 +/- 0.04 postoperatively (P < 0.01). The mean patency time for endovascular therapy and arterial bypass was (57.6 +/- 3.7) and (60.2 +/- 7.2) months, respectively. CONCLUSIONS: Both endovascular therapy and arterial bypass have good curative effect for subclavian artery occlusion. Endovascular therapy is the preferred treatment for subclavian artery occlusion with mini-trauma and safety.

[Clinical analysis on treatment for superficial varicosities of low limbs with minimally invasive rotary varicotomy].

OBJECTIVE: To evaluate therapeutic efficacy of minimally invasive rotary varicotomy (TriVex) for superficial varicosities of low limbs and summarize our therapeutic experiences. METHODS: One hundred and eighty-two cases (totally 216 lower limbs) were applied minimally invasive rotary varicotomy (TriVex) and relative clinical data was analyzed. RESULTS: The average operation time for each limb was 48 min. Discomfort and pain of lower limbs disappeared in all of patients after operation. There was no residual of superficial varicosities. There was no severe complication and recurrence of varicosities. The postoperative complication rate was 21.3%. CONCLUSIONS: For treatment of superficial varicosities of low limbs, minimally invasive rotary varicotomy (TriVex) have many advantages including minimal invasion, quick recovery, safety and cosmetic effect. In addition, it has extensive indications and satisfactory therapeutic efficacy. It would be beneficial to master the operative techniques of key procedures. It could decrease complications and get better curative effects.

[Follow-up study in endovascular therapy for the renal artery stenosis].

OBJECTIVE: To evaluate the safety and efficacy of endovascular therapy for renal artery stenosis. METHODS: Percutaneous transluminal renal angioplasty with stent (PTRAS) was performed on 33 consecutive patients with severe renal artery stenosis who suffered from poorly controlled hypertension or renal dysfunction. They were subsequently underwent 7 to 49 months clinical follow up for the effect of the procedure on renal function, blood pressure control, mortality. RESULTS: Angiographic success was obtained in 32 (97.0%) of the 33 patients. The mortality was 18.2%. After PTRAS, two (6.1%) died of myocardial infarction within 4 months. Four (12.1%) patients with preoperative serum creatinine (Scr) > or = 177 micromol/L died of uraemia within 17 approximately 28 months. Twelve and twenty-four months after the procedure, systolic and diastolic blood pressure of 26 (78.8%) cases with preoperative Scr < 177 micromol/L significantly decreased (P < 0.05), with less antihypertensive medications taken and satisfactory renal function. CONCLUSION: For patients without serious cardiorenal disease, PTRAS has a beneficial effect on blood pressure and renal function. For patients with serious cardiorenal disease or preoperative Scr > or = 177 micromol/L, the mortality is higher. PTRAS should be performed prudently. The preservation of renal function may be enhance by using renal protection device.

[Stenting for carotid artery stenosis of 55 cases].

OBJECTIVE: To introduce the procedure of carotid stenting, and to summary experiences of 55 cases. To study the theory and clinical significance of carotid stenting for carotid artery stenosis. METHODS: Fifty-five patients with severe carotid atheromatous stenoses were treated by stent implantation. Fifty-eight stents were implanted. Forty-one of these stents were Wallstent, 14 were Smart stents and 3 were OptiMed stents. Cerebral protection device was furnished for 18 patients. RESULTS: During operation, there were 2 cases of small stroke and 2 cases of major stroke. One patient suffered from left eye area deficit, who had a little signs after 3 months. Another patient had consciousness loss and right-side paralysis and had a recovery in consciousness after salvage. The incidence of nervous system complications was 6.9%. Serious stroke rate was 3.5%. The incidence of circulatory system complications was 10.3%. Those patients who received cerebral protection device did not have nervous complication. CONCLUSION: Carotid stenting is effective for the treatment of carotid artery stenosis. The experienced surgeon can make this procedure safe. The procedure's safety is enhanced by using cerebral protection device.