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Objective:To evaluate the effectiveness and safety of the home-made umbrella-shaped Octoparms inferior vena cava filter in the prevention of pulmonary embolism.Methods:A multicenter, randomized, positive parallel controlled, non-inferiority clinical trial was conducted in ten hospitals in China from October 2017 to March 2019. A total of 188 subjects were enrolled according to the same inclusion and exclusion criteria in different institutes. The 188 subjects were randomly divided into the trial group or the control group according to 1∶1 by the central randomization system, with 94 cases in each group. Octoparms inferior vena cava filter was used in the trial group, and the Celect inferior vena cava filter in the control group. The primary effective index was clinical success rate,including the clinical success rate of filter placement and filter retrieval. The secondary index included the rate of manual success of the delivery sheath system,incidence of pulmonary embolism(within 6 months), incidence of filter fracture,migration (>20 mm),tilt(>15°) on insertion/retrieval,and the situation of inferior vena cava flow(within 6 months). Safety evaluation included the incidence of filter related complications and device-related adverse events immediately after surgery and during follow-up.Results:The success rate of implantation was 100% in 188 subjects. Filter retrieval was performed in 87 cases (92.55%) in the trial group and 91 cases (96.81%) in the control group. The clinical success rate of the trial group was 97.87%(92/94) and that of the control group 98.94%(93/94). There was no significant difference between the two groups (χ 2=0.77, P=0.380). The success rate of delivery sheath system was 96.81%(91/94) and 98.94%(93/94) in the trail group and the control group,respectively. There was no significant difference between the two groups( P=0.621). There was 1 case (1.22%) of new asymptomatic pulmonary embolism in the trial group after filter placement and 2 cases (2.44%) in the control group. There was no significant difference between the two groups ( P>0.05). No filter fracture or migration (>20 mm) occurred in either group. The tilting of filter (>15°) was found in 1 case (1.06%) in the test group and 1 case (1.06%) in the control group when the filter was placed. The tilting of filter (>15°) was found in 0 case in the test group and 2 cases (2.44%) in the control group when the filter was retrieved. There was no significant difference between the two groups ( P>0.05). Inferior vena cava thrombosis before filter retrieval was found in 5 cases (5.75%) in trial group and 3 cases (3.30%) in control group. There was no significant difference between the two groups ( P=0.489). There were no immediate serious complications during filter placement/removal in either group. No filter obstruction,migration,deformation,penetration and occlusion of inferior vena cava. The incidence of device-related adverse events was low in both group. There was no significant difference between the two groups ( P>0.05). Conclusion:The home-made umbrella-shaped Octoparms inferior vena cava filter is effective and safe in preventing pulmonary embolism, and is not worse than Celect filter.
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Objective@#To investigate the safety and clinical efficacy of comprehensive endovascular treatment for acute deep vein thrombosis(DVT)in elderly patients.@*Methods@#Clinical data of 94 elderly patients who underwent endovascular treatment from June 2013 to June 2016 were retrospectively analyzed.All patients underwent inferior vena cava filter implantation(IVCF). Of them, 57 patients initially underwent thrombectomy and subsequently received the adjunctive catheter-directed thrombolysis(CDT)(Group A)and 37 cases underwent CDT(Group B). Clinical efficacy and safety of treatments in the two groups were examined.@*Results@#Among the 94 patients, 88 cases had retrievable IVCF, and the retrieval rate was 94.3%(83/88). There were significant differences in total infusion time(73.92±31.68 h vs.156.2±30.2 h)and total doses of infused thrombolytic agents(180.71±44.83 million unit vs.355.0±96.0 million unit)between Groups A and B(P<0.05). There was a significant difference in average hospitalized time between Groups A and B(9.4±2.4 d vs.12.8±4.3 d, t=-4.99, P<0.01). There was no significant difference in clinical efficacy between Groups A and B(χ2=1.263, P>0.05). Fifty-six patients were treated with angioplasty(PTA), 34 of them were combined with stent implantation, and there was no difference between the two groups(χ2=1.128, P>0.05). Neither of the two groups saw serious complications.The incidence of minor hemorrhage was 9.6%(9/94), including 2 cases and 7 cases in Group A and Group B respectively, and the difference was statistically significant(χ2=4.503, P=0.034). The average follow-up time was 16.7±8.3 months in the 94 patients, and the stent patency rate was 91.2%(31/34). Doppler ultrasonography results at the last follow-up showed that the reverse flow rate of the valve was 20.2%(19/94), the occurrence rates of post-thrombotic syndrome(PTS)were 24.6%(14/57)and 29.7%(11/37)in Group A and Group B respectively, and the difference was not statistically significant(χ2=0.307, P=0.580). Patients in the mild, moderate and severe stages assessed by Villata scoring were 9 vs.6, 4 vs.5, 0 vs.1 in Group A and Group B respectively, and the differences were not statistically significant(χ2=0.007 and 0.205, P>0.05).@*Conclusions@#It is safe and effective for elderly patients with DVT when timely and appropriate the treatment strategies are chosen and comprehensive approaches including IVCF, anticoagulation, endovascular CDT, thrombectomy, PTA and stent implantation are used.
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Objective To investigate the safety and clinical efficacy of comprehensive endovascular treatment for acute deep vein thrombosis(DVT)in elderly patients.Methods Clinical data of 94 elderly patients who underwent endovascular treatment from June 2013 to June 2016 were retrospectively analyzed.All patients underwent inferior vena cava filter implantation (IVCF).Of them,57 patients initially underwent thrombectomy and subsequently received the adjunctive catheterdirected thrombolysis(CDT)(Group A)and 37 cases underwent CDT(Group B).Clinical efficacy and safety of treatments in the two groups were examined.Results Among the 94 patients,88 cases had retrievable IVCF,and the retrieval rate was 94.3％ (83/88).There were significant differences in total infusion time(73.92 ± 31.68 h vs.156.2 ± 30.2 h) and total doses of infused thrombolytic agents (180.71± 44.83 million unit vs.355.0±96.0 million unit)between Groups A and B(P ＜0.05).There was a significant difference in average hospitalized time between Groups A and B(9.4±2.4 d vs.12.8 ± 4.3 d,t =-4.99,P ＜0.01).There was no significant difference in clinical efficacy between Groups A and B(x2 =1.263,P ＞ 0.05).Fifty-six patients were treated with angioplasty(PTA),34 of them were combined with stent implantation,and there was no difference between the two groups(x2=1.128,P ＞0.05).Neither of the two groups saw serious complications.The incidence of minor hemorrhage was 9.6％ (9/94),including 2 cases and 7 cases in Group A and Group B respectively,and the difference was statistically significant (x2 =4.503,P =0.034).The average follow-up time was 16.7± 8.3 months in the 94 patients,and the stent patency rate was 91.2％ (31/34).Doppler ultrasonography results at the last follow-up showed that the reverse flow rate of the valve was 20.2％ (19/94),the occurrence rates of post-thrombotic syndrome(PTS)were 24.6％ (14/57)and 29.7％(11/37) in Group A and Group B respectively,and the difference was not statistically significant(x2=0.307,P =0.580).Patients in the mild,moderate and severe stages assessed by Villata scoring were 9 vs.6,4 vs.5,0 vs.1 in Group A and Group B respectively,and the differences were not statistically significant(x2 =0.007 and 0.205,P＞0.05).Conclusions It is safe and effective for elderly patients with DVT when timely and appropriate the treatment strategies are chosen and comprehensive approaches including IVCF,anticoagulation,endovascular CDT,thrombectomy,PTA and stent implantation are used.
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Objective@#To investigate the safety and effectiveness of the Celect inferior vena cava filter (IVCF) in the treatment of deep venous thrombosis (DVT).@*Methods@#CT follow-up examinations were performed in 72 patients who underwent Celect inferior vena cava filter placement between August 2015 and September 2017. Forty-five patients (62.5%) presented with DVT alone, 27(37.5%) with DVT and pulmonary embolism (PE). With filters in place, each patient was followed up with CT at least once, to visualize new pulmonary embolism, inferior vena cava occlusion, filter tilting, fracture of struts, migration and penetration of struts through the inferior vena cava. Caval penetration was graded on a five-point scale.@*Results@#All Celect filters were successfully deployed. The interval between the filter placement and the CT was 5.0 to 695.0 days, mean (42.4±84.6)days. No new pulmonary embolism, cava occlusion, filter fracture and migration were found. Forty-two (58.3%) filters tilted, including tilt>15 degrees in 8 (11.1%) and tilt ≤15 degrees in 34 (47.2%). Caval penetration with 0 grade was observed in 47 (65.3%) and beyond grade 1 was observed in 25 (34.7%), including grade Ⅰ in 12 (16.7%), grade Ⅱ in eight (11.1%), grade Ⅲ in four (5.6%) and grade Ⅳ in one (1.4%). No patient presented with symptoms associated with caval penetration. Filter retrieval was attempted in 54(75.0%) patients,the indwell time was 5.0 to 111.0 days, mean(32.0±23.9) days. There were 52 (96.3%) filters successfully removed, including four filters tilted lead retrieval hook embedded the caval wall, which used the adjunctive retrieval techniques. Filter retrieval failure in two (3.7%) cases, including one case retrieval hook embedded the caval wall and the other with retrieval hook penetration.@*Conclusions@#Celect inferior vena cava filter can effectively prevent PE, but had a tendency to tilt and to penetrate caval wall, which affected the filter retrieval, and had the potential risk of serious complications such as abdominal aortic pseudoaneurysm. The filter should be removed as soon as the risk of PE is manageable. We advocate CT follow-up for patients with long-term inferior vena cava filter placement.
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Objective To evaluate the clinical value of percutaneous AngioJet thrombectomy for acute iliofemoral deep venous thrombosis.Methods 50 patients were divided into AngioJet thrombectomy group(25 cases) compared with bolus injection of urokinase through catheter in control group (25 cases).When the thrombosis was completely dissolved,the PTA and stents were implanted in those patients presenting May-Thurner syndrome in both groups.Inferior vena cava filter was retrieved from the patients and the thrombolytic therapy was discontinued.The patency rate of iliofemoral venous was assessed by CTA at 1 and 6 months after the procedure.Results The average dosage of urokinase in AngioJet patients was (880 000 ± 354 000) units.The mean duration time of catheter-directed thrombolysis was (42.2 ± 16.7) hours and the average hospitalization time is (3.8 ± 0.8) days.Grade Ⅲ thrombolysis was achieved in 18 limbs and grade Ⅱ lysis in 6 limbs,grade Ⅰ lysis in 1 limb.The mean duration time of catheter-directed thrombolysis was (129.6 ± 32.2) hours.The average dose of urokinase was (4 100 000 ± 1 060 000) units and the average hospitalization time was (7.9 ± 1.4) days in control group.Grade Ⅲ thrombolysis was achieved in 10 limbs,grade Ⅱ lysis in 9 limbs and grade Ⅰ lysis in 6 limbs.The dosage of urokinase,duration time of catheter-directed thrombolysis,time in hospital and clinical effects were statistically different between the two groups (all P ＜ 0.05).There were no recurrent thrombosis in all the patients after 6 months of treatment.Venous patency was maintained in all patients with implanted stent.Conclusions Percutaneous AngioJet thrombectomy with adjunctive thrombolytic therapy is an effective,safe treatment modality in patients with acute iliofemoral vein thrombosis.
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Objective To discuss the clinical application of mechanical thrombectomy with AngioJet system for acute lower limb arterial ischemia (ALI).Methods A total of 12 ALI patients,who underwent percutaneous mechanical thrombectomy with AngioJet systemn during the period from January 2015 to November 2016,were enrolled in this study.The clinical data were retrospectively analyzed.The blood flow classification score after thrombolysis in myocardial infarction (TIMI) was used to evaluate the blood perfusion condition,and Cooley standard of efficacy score was used to assess the clinical curative effect.Results The technical success rate of mechanical thrombectomy with AngioJet system was 91.7％ (11/12).The average restored perfusion time was (1.5±0.6) hours.The clinical success rate and limb salvage rate were 83.3％ (10/ 12) and 91.7％ (11/12),respectively.The TIMI flow scores were improved from preoperative grade 0 (n=8) and Ⅰ (n=4) to postoperative grade 0 (n=1),Ⅰ (n=3) and Ⅱ (n=8).In 11 patients (91.7％) the symptoms of lower limb arterial ischemia were strikingly improved after mechanical thrombectomy.In one patient,the postoperative TIMI flow score remained 0 as preoperative state and the symptoms of lower limb arterial ischemia were not improved although catheter directed thrombolysis therapy was employed for 24 hours,and above-knee surgical amputation had to be carried out.Cooley efficacy score showed that complete cure was seen in 4 patients (33.3％),good response in 6 patients (50.0％),general improvement in one patient (8.3％) and pool response in one patient (8.3％).No severe bleeding complications occurred.Conclusion Percutaneous mechanical thrombectomy with AngioJet can rapidly recover the blood perfusion in patients with ALI,thus,further deterioration of the disease can be prevented and the limb salvage rate can be improved.Therefore,this technique has good clinical application value.
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Objective To investigate the optimal pressure range produced by two types of air pressure cuff in order to block superficial vein to assist thrombolytic therapy for deep venous thrombosis (DVT) of lower extremity,which can effectively dissolve the thrombus as well as improve the patient's comfort,and to provide useful basis for the implementation of individualized and standard nursing process.Methods A total of 80 patients with lower limb DVT were randomly and equally divided into the modified air pressure cuff group (study group,n=40) and the traditional standard sphygmomanometer cuff group (control group,n=40).Thrombolytic therapy by using continuous intravenous infusion of urokinase via the dorsalis pedis vein with infusion pump was performed in all patients of both groups.The daily dose of urokinase was the same.The pressure value to obstruct lower limb superficial venous blood flow,that was the airbag pressure value when the deep veins of lower limb became visualized on venography,was determined.Leg swelling fade-away rate,mean thrombus clearance rate and patient's comfort degree,etc.were calculated,and the results were compared between the two groups.Results In the study group,the pressure value to block superficial venous blood flow of lower limb was 65-75 mmHg with a mean of (70±5) mmHg;which in the control group was 60-85 mmHg with a mean of (70±10) mmHg.The Leg swelling fade-away rate,the mean thrombus clearance rate determined at different time points,and the patient's comfort degree of the study group were remarkably better than those of the control group (P＜0.05).Conclusion Compared to the use of traditional standard sphygmomanometer cuff,the use of modified air pressure cuff to block the lower limb superficial venous blood flow can obtain better thrombolytic effect,meanwhile,the patients can get high comfort degree in the therapeutic process.
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Objective To explore the clinical features, diagnosis and interventional management of acute deep venous thrombosis of lower extremity (LEDVT)combined with type Ⅱ heparin-induced thrombocytopenia (HITⅡ) and to improve the knowledge of this disease. Methods A retrospective review and analysis of the clinical data of the patients with acute LEDVT combined with HIT Ⅱ enrolled from January 2010 to June 2014. All of them underwent anticoagulation with low molecular weight heparin (LMWH) and the comprehensive interventional therapy at the beginning of treatment.When HIT Ⅱ was identified, all forms of heparin and LMWH were avoided . Alternative anticoagulation was commenced with argatrobam. Adjustments in interventional therapy were taken while the short-term low-dose glucocorticoid treatment were used.The clinical manifestations, changes of PLT, 4Ts score (Warkentin 4T scoring system, 4Ts) , HIT antibody assay (ELISA) and response to therapy of the patients were analyzed and the treatment effect was observed . The efficacy of interventional therapy was evaluated according to the improvement clinical symptoms and venography. Results The incidence of acute LEDVT combined with HIT Ⅱ was 1.9%(8/416). There were 4 males and 4 females with a median age of 24 years in this study. The median time between their initiation exposure to heparin and onset of thrombocytopenia was 5 days (range,3 to 8 days). The median platelet counts prior to HIT Ⅱ was 218 × 109/L( range,122 × 109/L to 254 × 109/L ). Platelet counts decreased to the lowest level range from 20 × 109/L to 51 × 109/L(median 32 × 109/L). After alternative anticoagulation, the interval period which PLT recovered to the basic level was range from 3 to 7 days (median 3.5 days) . According to the score of 4Ts , there were 2 cases score 6 and 6 cases score 8. HIT antibody assay (ELISA) was detected in 6 patients which the results were positive. During heparin anticoagulation treatment, the LEDVT condition of all patients continued to deteriorate. Vein thrombosis extended in 7 patients. Among them, 5 patients occurred new thrombosis in the inferior vena cava and(or) at the vessel of catheter insertion. Another 2 patients complicated with pulmonary embolism. After underwent anticoagulation with argatrobam , with the increased of PLT the treatment efficacy of thrombolysis therapy was ameliorated. At the endpoint of interventional therapy, the curative effect evaluation was excellent in 3 cases, good in 3 cases and medium in 2 cases respectively. All patients were followed up for 12 to 20 months (median 15.5 months) with no evidence of recurrence .Conclusions The study showed that acute LEDVT combined with HITⅡdisplayed the following features:(1)an absolute drop in platelet count below the normal range (PLT ≤100 × 109/L) or as a relative decrease of 30% to 50% from baseline counts. (2) refractory venous thrombosis,during the interventional treatment of acute LEDVT, platelets counts should be monitored regularly in patients who receiving heparin anticoagulation. For patients with strongly suspected HIT Ⅱ, withdrawal of all forms of heparin and early introduction of alternative anticoagulant therapy can improve the effect of interventional therapy.
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Objective To investigate the effect of endovascular treatment to initial and long-term outcomes of postpartum deep venous thrombosis (DVT) . Methods The clinical data, venography and 3-yaer follow up data of 30 female patients with acute or subacute deep vein thrombosis in the postpartum period who received endovascular therapy consisting of catheter-directed thrombolysis with angioplasty (stenting for some patients with iliac vein compression syndrome (IVCS)) were retrospectively evaluated. Clot removal was graded as grade Ⅲ(>95%), grade Ⅱ(50% to 95%), and grade Ⅰ(0.05).For 18 patients with IVCS, there was significant statistical difference between patients implanting stents(initial patency was 100.0%(7/7) and whom not implanting stents(initial patency was 63.6%,7/11) (χ2=5.14, P0.05). Conclusions Endovascular therapy consisting of catheter-directed thrombolysis with angioplasty could be considered as a primary therapeutic procedure in patients with acute or subacute postpartum DVT. Stenting for treatment of iliac compression which contributed to postpartum DVT is very valuable to ensuring higher long-term patency rate.