Effect Of Catheter-directed Thrombolysis Research Articles

Short-term efficacy of endovascular procedures for lower extremity thromboangiitis obliterans (Buerger’s disease)

ABSTRACT Purpose Although thrombolysis obliterans (TAO) has been recognized for more than a century, there is no optimal treatment for this disease. The aim of this report was to compare the short-term efficacies of catheter-directed thrombolysis (CDT), percutaneous transluminal angioplasty (PTA) and CDT+PTA in treating TAO disease. Method Consecutive patients with TAO treated at Ganzhou People’s Hospital between 2012 and 2022 were included in this retrospective study. According to the information provided in the medical records, endovascular procedures included CDT, PTA or CDT+PTA. One-year follow-up outcomes of the patients with TAO who underwent endovascular procedures were compared. The primary outcome was major adverse limb event (MALE) and the secondary outcomes were the technical success, complications, ABI at 1 week after surgery and minor amputation. Results Sixty-nine patients with TAO were assessed for inclusion in our single-center study from 2012 to 2022 and received endovascular procedures. Among them, 22 patients underwent CDT, 21 patients underwent PTA, and 26 patients underwent PTA+CDT. The one-year follow-up revealed significant differences in the MALE-free survival rates among the three groups, particularly between the CDT group and the PTA+CDT group (the hazard ratio (HR) for MALE-free survival was 0.173, 95% CI [0.050–0.599], p = 0.006). The technical success rates of the three groups were 63.6%, 90.5%, and 92.3%, respectively. There were differences in the ABI at one week after surgery among the three groups. Conclusions Endovascular procedures are effective for TAO in the short term. The effectiveness of CDT alone is suboptimal; combining CDT with PTA achieves the most favorable endovascular treatment outcome; while the effectiveness of PTA falls in between these two procedures.

Short-Term Complications and Outcomes in Pharmaco-Mechanical Thrombolysis First and Catheter-Directed Thrombolysis First in Patients with Acute Lower Limb Ischemia

Pharmaco-mechanical thrombolysis (PMT) has emerged as a treatment option in patients with acute lower limb ischemia (ALI), especially Rutherford IIb (motor deficit) for rapid revascularization, but supportive data is scarce. The aim of the present study was to compare the effects of thrombolysis, complications, and outcomes of PMT first versus catheter-directed thrombolysis (CDT) first in a large cohort of patients with ALI. All endovascular thrombolytic/thrombectomy events in patients with ALI performed between January 1st, 2009, and December 31st, 2018 (n=347) were included. Successful thrombolysis/thrombectomy was defined as complete or partial lysis. Reasons for using PMT were described. Complications such as major bleeding, distal embolization, and new onset of renal impairment, and major amputation and mortality at 30days were compared between PMT (AngioJet) first and CDT first groups in a multivariable logistic regression model with adjustment for age, gender, atrial fibrillation, and Rutherford IIb. The most common reason for initial use of PMT was the need for rapid revascularization, and the most common reason for use of PMT after CDT was the insufficient effect of CDT. Presentation of Rutherford IIb ALI was more common in the PMT first group (36.2% vs. 22.5%, respectively, P=0.027). Among the 58 patients receiving PMT first, 36 (62.1%) were terminated within a single session of therapy without need of CDT. The median duration of thrombolysis was shorter (P<0.001) for the PMT first group (n=58) compared to the CDT first group (n=289) (4.0hr vs. 23.0hr, respectively). There was no significant difference in amount of tissue plasminogen activator given, successful thrombolysis/thrombectomy (86.2% and 84.8%), major bleeding (15.5% and 18.7%), distal embolization (25.9% and 16.6%), major amputation or mortality at 30-days (13.8% and 7.7%) in the PMT first compared to the CDT first group, respectively. The proportion of new onset of renal impairment was higher in the PMT first compared to the CDT first group (10.3% vs. 3.8%, respectively), and the increased odds (odds ratio 3.57, 95% confidence interval 1.22-10.41) were maintained in the adjusted model. In Rutherford IIb ALI, no difference in rate of successful thrombolysis/thrombectomy (76.2% and 73.8%), complications or 30-day outcomes was found between PMT first (n=21) and CDT (n=65) first group. PMT first appears to be a good treatment alternative to CDT in patients with ALI, including Rutherford IIb. The found renal function deterioration in the PMT first group needs to be evaluated in a prospective, preferably randomized trial.

Discussion on operation: To compare the curative effect of PMT and CDT in the treatment of middle and high risk stratified APE and the clinical application value of serum BNP, TnI and plasma DFR levelse.

To compare the efficacy of Percutaneous mechanical thrombectomy (PMT) and Catheter directed thrombolysis (CDT) in the treatment of patients with moderate and high-risk ape and explore the clinical application value of biomarkers in the treatment of moderate and high-risk ape. A total of 84 patients with ape were selected from the Department of vascular surgery of the Second Affiliated Hospital of Shandong First Medical University and the Department of vascular surgery of Shanghai Ninth People's Hospital Affiliated with Shanghai Jiao Tong University School of Medicine. According to the relevant guidelines, they were divided into high-risk and medium-risk groups, including PMT groups (35 cases) and CDT groups (49 cases). To detect the changes of serum B-type brain natriuretic peptide (BNP),Troponin I (TnI) and plasma D-dimer/fibrinogen ratio (DFR) levels in different risk stratification before and after PMT and CDT, the correlation and diagnostic value of each index, and compare the thrombus clearance rate, pulmonary artery pressure, average dosage of urokinase, effective thrombolytic time, average hospitalization time and complications of PMT and CDT. Under different treatment methods and risk stratification, there was no statistically significant difference in the clinical data of patients at general baseline;The preoperative BNP, TnI and DFR levels of PMT and CDT in the middle and high risk stratification were significantly lower than those in the other groups (P < 0.005),Compared with the CDT group, PMT has significantly better therapeutic effect on ape than the CDT group in terms of thrombus clearance rate, pulmonary artery pressure, average dosage of urokinase, effective thrombolytic time and average hospitalization time (P < 0.05),meanwhile,there was no significant difference in postoperative complications between the two groups (P < 0.05). After half a year of follow-up, the levels of BNP, TnI and DFR in the cured group were significantly lower than those in the effective group and the ineffective group. The areas under the curve of serum BNP, TnI and plasma DFR were 0.91, 0.87 and 0.93 and the area under the curve DFR has higher diagnostic efficiency than BNP and TnI, while the sensitivity and specificity of TnI are significantly higher than BNP and DFR. Serum BNP, TnI and plasma DFR levels can reflect the risk stratification and better clinical diagnostic value of ape,PMT and CDT are used to treat high-risk ape. For hospitals with medical conditions, PMT is more worthy of clinical recommendation.

Percutaneous thrombectomy or ultrasound-accelerated thrombolysis for initial management of acute limb ischaemia.

Acute limb ischaemia (ALI), the sudden and significant reduction of blood flow to the limb,is considered a vascular emergency. In the general population, the incidence is estimated as 14 per 100,000. Prognosis depends on the time it takes to diagnose the condition and begin appropriate treatment. Standard initial interventional treatments include conventional open surgery and endovascular interventions such as catheter-directed thrombolysis (CDT). Percutaneous interventions, such as percutaneous thrombectomy (PT, including mechanical thrombectomy or pharmomechanical thrombectomy) and ultrasound-accelerated thrombolysis (USAT), are also performed as alternative endovascular techniques. The proposed advantages of PT and USAT include reduced time to revascularisation and when combined with catheter-directed thrombolysis, a reduction in dose of thrombolytic agents and infusion time. The benefits of PT or USAT versus open surgery or thrombolysis alone are still uncertain. In this review, we compared PT or USAT against standard treatment for ALI, in an attempt to determine if any technique is comparatively safer and more effective. To assess the safety and effectiveness of percutaneous thrombectomy or ultrasound-accelerated thrombolysis for the initial management of acute limb ischaemia in adults. The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, the World Health Organization (WHO) International Clinical Trials Registry Platform, and ClinicalTrials.gov to 3 March 2021. We searched reference lists of relevant studies and papers. We included randomised controlled trials (RCTs) that compared PT (any modality, including mechanical thrombectomy (aspiration, rheolysis, rotation) or pharmomechanical thrombectomy) or USAT with open surgery, thrombolysis alone, no treatment, or another PT modality for the treatment of ALI. Two review authors independently selected the studies, assessed risk of bias, extracted data, performed data analysis, and assessed the certainty of evidence according to GRADE. Outcomes of interest were primary patency, amputation rate, major bleeding, clinical success, secondary patency, and adverse effects. We included one RCT in this review. This study had a total of 60 participants and compared USAT with standard treatment (CDT). The study included 32 participants in the CDT group and 28 participants in the USAT group. We found no evidence of a difference between USAT and CDT alone for the following evaluated outcomes: amputation rate (risk ratio (RR) 1.14, 95% confidence interval (CI) 0.17 to 7.59); major bleeding (RR 1.71, 95% CI 0.31 to 9.53); clinical success (RR 1.00, 95% CI 0.94 to 1.07); and adverse effects (RR 5.69, 95% CI 0.28 to 113.72). We rated the certainty of the evidence as very low for these outcomes. We downgraded the certainty of the evidence for amputation rate, major bleeding, clinical success, and adverse effects by two levels due to serious limitations in the design (there was a high risk of bias in critical domains) and by two further levels due to imprecision (a small number of participants and only one study included). The study authors reported 30-day patency, but did not report primary and secondary patency separately. The patency rate in the successfully lysed participants was 71% (15/21) in the USAT group and 82% (22/27)in the CDT group. The study authorsdid not directly report secondary patency, which is patency after secondary procedures, but they did report on secondary procedures. Secondary procedures were subdivided into embolectomy and bypass grafting. Embolectomy was performed on 14% (4/28) of participants in the USAT group versus 3% (1/32) of participants in the CDT group. Bypass grafting was performed on 4% (1/28) of participants in the USAT group versus 0% in the CDT group. As we did not have access to the specific participant data, it was not possible to assess these outcomes further. We did not identify studies comparing the other planned interventions. There is insufficient evidence to assess the safety and effectiveness of USAT versus CDT alone for ALI for our evaluated outcomes: amputation rate, major bleeding, clinical success, and adverse effects. Primary and secondary patency were not reported separately. There was no RCT evidence for PT. Limitations of this systematic review derive from the single included study, small sample size, short clinical follow-up period, and high risk of bias in critical domains. For this reason, the applicability of the results is limited. There is a need for high-quality studies to compare PT or USAT against open surgery, thrombolysis alone, no treatment, or other PT modalities for ALI. Future trials should assess outcomes, such as primary patency, amputation rate, major bleeding, clinical success, secondary patency, and adverse effects.

EP.WE.791Assessing the use and effectiveness of catheter-directed thrombolysis in a single vascular centre

Abstract Aims In the UK, venous thromboembolism remains a leading cause of mortality and morbidity. This audit aimed to assess the use, success and cost of the average patient journey undergoing catheter-directed thrombolysis (CDT) following a diagnosis of a deep vein thrombosis (DVT) within a single vascular centre. Methods A retrospective audit of all procedures (n = 249) between 2010 and 2019 coded as 'angioplasty' were identified; only adults that had CDT for a confirmed iliofemoral DVT were included. Patient anthropological, biochemical and radiological data were collected. Cost of items were confirmed with appropriate hospital departments. Results In ten years, a total of 36 patients (21 female, 15 male, mean age 47 years) started CDT for iliofemoral DVT; one procedure was abandoned due to safety reasons. Almost half of DVTs were provoked. Ultrasound confirmed diagnosis in 92% of patients. CDT was successful in approximately 70% of patients. A quarter of patients developed another DVT following discharge. Average length of stay was 8 days at a cost of £11,235 per patient journey. All patients commenced an anticoagulant regime on discharge. Conclusions This audit supports the use and effectiveness of CDT to treat patients with iliofemoral DVT, however there is a room for improvement regarding long term success given the significant patient and financial costs involved.

In-hospital outcomes of catheter-directed thrombolysis versus anticoagulation in cancer patients with proximal deep venous thrombosis

ObjectiveThe objective of this study was to determine the rate of complications of catheter-directed thrombolysis (CDT) in cancer patients with deep venous thrombosis (DVT) compared with anticoagulation therapy alone. MethodsThis observational study used the National Inpatient Sample database to screen for any cancer patients who were admitted with a principal discharge diagnosis of proximal lower extremity or caval DVT between January 2005 and December 2013. Patients treated with CDT plus anticoagulation were compared with those treated with anticoagulation alone using propensity score matching for comorbidities and demographic characteristics. The primary end point was in-hospital mortality. Secondary end points were acute intracranial hemorrhage, inferior vena cava filter placement, acute renal failure, blood transfusion rates, length of stay, and hospital charges. ResultsWe identified 31,124 cancer patients with lower extremity proximal or caval DVT, and 1290 (4%) patients were treated with CDT. Comparative outcomes as assessed in the two matched groups of 1297 patients showed that there was no significant difference in in-hospital mortality of patients undergoing CDT plus anticoagulation compared with those treated with anticoagulation alone (2.6% vs 1.9%; P = .23). However, CDT was associated with increased risk of intracranial hemorrhage (1.3% vs 0.4%; P = .017), greater blood transfusion rates (18.6% vs 13.1 %; P < .001), and higher rates of procedure-related hematoma (2.4% vs 0.4%; P < .001). The length of stay (6.0 [4.0-10.0] days vs 4.0 [2.0-7.0] days; P < .001) and hospital charges ($81,535 [$50,968-$127,045] vs $22,320 [$11,482-$41,005]; P < .001) were also higher in the CDT group compared with the control group. ConclusionsThere was no significant difference in in-hospital mortality of cancer patients who underwent CDT plus anticoagulation compared with anticoagulation alone. CDT was associated with increased in-hospital morbidity and resource utilization compared with anticoagulation alone. Further studies are needed to examine the effect of CDT on the development of PTS in this population.

Efficacy and Safety of Catheter-directed Thrombolysis in Preventing Post-thrombotic Syndrome: A Meta-analysis.

Post-thrombotic syndrome (PTS) is a complication that can develop after deep vein thrombosis (DVT) of lower extremities. In this meta-analysis, we compare the different modalities for treatment of DVT in reducing the risk of PTS. The primary outcome was the risk of PTS, and the secondary outcome included the risk of bleeding events. Review Manager (version 5.3; Cochrane Collaboration software) was used to analyze the data that are represented as a forest plot. Meta-analysis indicated that catheter-directed thrombolysis (CDT) plus anticoagulation (AC) decreases the likelihood of developing PTS compared with the AC-only group with an odds ratio of 0.28 (0.12-0.64). A subgroup analysis of randomized control trial (RCT) studies was conducted, and findings suggest a slight decrease in the likelihood of PTS incidence in the CDT+AC treatment group compared to the AC treatment group (odds ratio, OR = 0.76; CI = 0.58-0.99). For the secondary outcome, a statistically significant increase in bleeding events in the intervention groups was reported with an OR of 3.38 (1.33-8.61), suggesting that the risk of bleeding was high in the CDT plus AC group. CDT in addition to conventional AC for patients with DVT decreases the likelihood of PTS development. The protective effect of CDT comes at the expense of an increase in bleeding risk by three-fold. The decision to utilize CDT to prevent PTS should be individualized according to patient risk factors for developing PTS and their risk of bleeding.

Administration routes affect thrombolytic effect of catheter-directed thrombolysis with pro-urokinase in treating deep vein thrombosis.

Deep venous thrombosis (DVT) is a common disorder with a significant mortality rate. Catheter-directed thrombolysis (CDT) is a preferred treatment for DVT patients. The aim of this study is to evaluate the thrombolytic effect of CDT with pro-urokinase (pro-UK) in different administration routes. An inferior vena cava (IVC) model was induced in 36 New Zealand white rabbits by catheter injury and placement of IVC filter. The animals were divided into 6 groups with 6 rabbits in each group: group A: systemic thrombolysis with intravenous injection; group B: CDT with pump infusion; group C: CDT with pulse injection; group D: CDT with combination of pump infusion and pulse injection; group E: catheter-directed aspiration thrombectomy; group F: mechanical thrombectomy. The thrombolytic effects were evaluated by color Doppler ultrasound and blood measurement of D-dimer and fibrinogen. The minimum effective concentration of pro-UK solution was identified. Two groups (group A and B) did not achieve successful thrombolysis. Among all catheter-directed administration groups, the rabbit groups that received pro-UK therapy through catheter-directed thrombolytic pump infusion combined with pulse injection (group D) showed the best thrombolysis effect. In contrast, catheter-directed aspiration thrombectomy (group E) is effective but not safe. CDT with combination of pump infusion and pulse injection of pro-UK safely and significantly improves thrombolysis procedure in rabbits, suggesting potential benefits from the use of CDT in proximal DVT.

Catheter-Directed Thrombolysis for Submassive Pulmonary Embolism.

Acute pulmonary embolism (PE) is a leading cause of morbidity and mortality in the United States. PE associated with right ventricular strain, termed submassive or intermediate-risk PE, is associated with an increased rate of clinical deterioration and short-term mortality. Trials have demonstrated systemic thrombolytics may improve patient outcomes, but they carry a risk of major hemorrhage. Catheter-directed thrombolysis (CDT) may offer similar efficacy to and a lower risk of catastrophic hemorrhage than systemic thrombolysis. Three prospective trials have evaluated CDT for submassive PE; ULTIMA, SEATTLE II, and PERFECT. These trials provide evidence that CDT may improve radiographic efficacy endpoints in submassive PE with acceptable rates of major hemorrhage. However, the lack of clinical endpoints, long-term follow-up, and adequate sample size limit their generalizability. Future trials should be adequately powered and controlled so that the short- and long-term effectiveness and safety of CDT can be definitively determined.

Catheter Directed Thrombolysis in Treatment of Acute Iliofemoral Deep Venous Thrombosis : Determinants of Outcome

Background: Acute deep vein thrombosis (DVT) of the lower limbs occurs in about 1.0 person per 1000 population per year and is associated with substantial morbidity. Although anticoagulation effectively prevents thrombus extension, pulmonary embolism, death, and recurrence may occur. Moreover, many patients develop venous dysfunction resulting in post-thrombotic syndrome (PTS). PTS is associated with reduced individual health-related quality of life and a substantially increased economic burden.Hence, additional and more aggressive treatment, including systemic thrombolysis, thrombectomy, and catheter- directed thrombolysis (CDT), has been introduced to accelerate thrombus removal. Numerous studies suggest that additional CDT may provide highly effective clot lysis.There is little doubt that the overall benefit of thrombolysis depends on multiple factors, including predisposing risks, symptom duration, thrombus extension, and technical approaches and interventional success. Aim of the Work: This study aimed to define predictors of immediate and mid-long-term anatomic and clinical failures to guide patient selection and to set a standard for patient and physician expectations. Patients and Methods: This is a prospective observational cohort study that enrolled 20 patients (22 limbs) who presented to the Ain Shams University hospitals in the period from 7/2015 to 7/2017 with acute iliofemoral deep venous thrombosis (IFDVT) and fulfilled the inclusion criteria (mentioned below). Intrathrombus catheter directed thrombolysis (CDT) was done. Assessments of predictors of immediate periprocedural success was based on degree of clot lysis and resolution of symptoms and signs. Incidence of postthrombotic syndrome (PTS) was calculated at 6 months postoperative using Villalta score (≥5 vs <5). Results: During the study duration, 20 patients (22 limbs) were recruited. The mean age was 40.95 ± 12.35 years old, 11 patients (12 limbs) were women. The indication for CDT was severe progressive pain/swelling (18 limbs), and phlegmasia cerulea dolens (4 limbs). 5 patients (7 limbs) had IVC thrombosis at the initial venography. 5 limbs had balloon dilatation only while iliac stenting was done in 12 limbs. 15 patients received CDT for 48 hours while 5 patients (7 limbs) received CDT for 24 hours (mean duration of CDT was 1.68 days). As regards bleeding, only 2 cases of those who had CDT for 24 hours had bleeding, while bleeding occurred in 12 cases of those who had CDT for 48 hours. There were no recurrent DVT, intra or postoperative pulmonary embolism nor death within the study population till the end of the follow up period (6months). 6 months post intervention, 7 limbs were free of PTS (Villalta score < 5), 15 limbs had mild to moderate PTS, and no patients had severe PTS. The mean Villalta score was 5.14 ± 1.859. Conclusion: In our study, determinants of outcome following CDT for acute IFDVT were: 1) access site, 2) dose of thrombolytic agent used, 3) duration of thrombolysis, and 4) thrombus score at the end of the procedure. More studies should be done comparing not only the effect of CDT on incidence of PTS but also its effect on its severity (e.g. Villalta score) on short and long term.

Comparison of Catheter-Directed Thrombolysis vs Systemic Thrombolysis in Pulmonary Embolism: A Propensity Score Match Analysis

SESSION TITLE: Prevention and Treatment of Venous Thromboembolism SESSION TYPE: Original Investigation Slide PRESENTED ON: Tuesday, October 31, 2017 at 11:00 AM - 12:15 PM PURPOSE: In acute pulmonary embolism (PE), systemic thrombolysis(ST) therapy leads to early hemodynamic improvement, but associated with major bleeding, and is withheld in many patients at risk. Whether catheter directed thrombolysis(CDT) is superior to systemic thrombolysis in high risk PE patients is still unclear. We aim to evaluate this in our study. METHODS: The study cohort was derived from the HCUP’s National Readmission Data (NRD) 2013-2014, sponsored by the AHRQ. PE was identified by ICD 9 CM code-415.11/13/19 in primary diagnosis filed. ST and CDT were identified appropriate ICD 9 codes in primary or secondary procedural field. The primary outcome was in hospital mortality and 30-day readmission and secondary outcome was in hospital mortality and/or major bleeding events [Intra cranial hemorrhage(ICH) + Gastrointestinal Bleed (GI bleed)]. The propensity score match (1:2) and hierarchical two level logistic model were used to adjust confounders. RESULTS: Overall 4426 PE patients were identified, of which 1128 matched pairs were taken into consideration (1:2). There was no statistical significance in baseline characteristics after adjusting propensity score match. In-hospital mortality (6.12% vs. 14.94%, p < 0.001), 30-day readmission (7.65% vs 10.58%, p=0.009) and secondary outcomes (8.42% vs 18.13%, <0.001) were lower in propensity matched cohort with CDT as compared to ST. similar results were observed with hierarchical multivariate method (OR, 95 % CI, p value) (Primary:0.29, 0.38- 0.50, p<0.001) and (secondary: 0.44, 0.35-0.55, p<0.001). Discharge to facility (11.79 vs. 14.1, <0.001) was lower with CDT vs. ST in propensity match cohort. GI bleed, blood transfusion and length of stay were also statistically significantly lower among CDT patients after adjusting for propensity score match. CONCLUSIONS: In Pulmonary Embolism treatment, use of CDT is superior compared to systemic thrombolysis in terms of in hospital mortality and major bleeding complications. Further large scale studies are required to further assess the effectiveness of CDT. CLINICAL IMPLICATIONS: This study suggests superior clinical outcomes including major bleeding with use of CDT as compared to ST in patients with PE. Large patient population and robust statistical method was used to analyze clinical outcomes. In this patient population, use of CDT is still underutilized due to various reservations. By publishing our data we hope that CDT will be appropriately utilized in eligible patients. DISCLOSURE: The following authors have nothing to disclose: Abhishek Mishra, Sukriti Kamboj, Purav Shah, Harshil Shah, Shilkumar Arora, Safi Khan, Varun Kumar, Sidakpal Panaich, Apurva Badheka, Navin Subrayappa No Product/Research Disclosure Information

Initial Experiences with Endovascular Management of Submassive Pulmonary Embolism: Is It Safe?

Interventional strategies for massive and submassive pulmonary embolism (smPE) have historically included either systematic intravenous thrombolytic alteplase or surgical embolectomy, both of which are associated with significant morbidity and mortality. However, with the advent of endovascular techniques, recent studies have suggested that an endovascular approach to the treatment of acute smPE may be both safe and effective with excellent outcomes. The purpose of this study was to evaluate the outcomes of patients who have undergone catheter-directed thrombolysis (CDT) for smPE at our institution in an effort to determine the safety of the procedure. A retrospective review was conducted from December 2012 to June 2015 to identify patients whom underwent CDT in the treatment of a smPE at our institution. Primary measure was safety of the procedure. Outcome variables were classified as serious or minor adverse events. Serious events included death, stroke, myocardial infarction, and bleeding complications requiring surgical intervention or transfusion. Minor events included groin hematoma, development of arteriovenous fistula, and bleeding requiring interruption or cessation of CDT. In addition, a secondary measure included effectiveness of CDT based on preinterventional and postinterventional clinical examination and radiographic findings. A total of 27 patients undergoing CDT for smPE at our institution were evaluated. The standard procedure included access via bilateral femoral veins and placement of bilateral EKOS catheters for ultrasound-assisted thrombolysis (USAT), with Activase (alteplase) at 1mg per hour in each catheter for a total of 12hr. There were no serious adverse events and only 4 patients (14.8%) had minor events, of which only 1 patient required premature termination of therapy due to bleeding resulting in a 3.7% clinically relevant bleeding rate. In addition, a reduction in a right-to-left ventricular end-diastolic diameter ratio (RV/LV ratio) on follow-up imaging was observed in each of the 18 patients where preinterventional and postinterventional imaging was available. Likewise, via chart review, all patients reported significant cessation of shortness-of-breath and resolution of chest pain with associated decrease in supplemental oxygen requirement. Current evidence, the majority of which has been industry funded, suggests that CDT should be considered as the first-line therapy for smPE. Our experience, in this single-institution retrospective review, demonstrates that CDT with USAT in the treatment of smPE is safe, while providing immediate resolution of both RV strain and clinical symptoms such as shortness-of-breath and chest pain. We hope that these data will allow other institutions to consider CDT as a plausible option in the treatment of smPE.

GW26-e2507 The Effect of Catheter-directed Thrombolysis with Low-dose Urokinase on Acute Lower Extremity limb Ischemia

To evaluate the safety and effectiveness of catheter-directed thrombolysis therapy with low-dose urokinase for acute lower extremity ischemia limb. Retrospective analysis of clinical data of 50 cases, including 27 males and 23 females, aged 27-81 years old, the onset time of 10 hours to 14 days,

GW25-e1131 Catheter directed thrombolysis along with mechanical thromboaspiration versus anticoagulation alone in the management of lower limb deep venous thrombosis- A comparative study

Catheter-directed thrombolysis (CDT) with assisted mechanical thrombolysis is now considered as the standard of medical care for deep vein thrombosis (DVT). The study was to describe the immediate & long term (six months) safety and effectiveness of CDT in patient with lower limb DVT compared with

Catheter-Directed Thrombolysis Along with Mechanical Thromboaspiration versus Anticoagulation Alone in the Management of Lower Limb Deep Venous Thrombosis-A Comparative Study.

Catheter-directed thrombolysis (CDT) with assisted mechanical thrombolysis is now considered as the standard of medical care for deep vein thrombosis (DVT). The study was conducted to describe the immediate and long-term (6 months) safety and effectiveness of CDT in patient with lower limb DVT compared with the routine anticoagulation alone. All 12 to 85 years old patients with recent (0-8 weeks) DVT were included. In CDT group, thrombus was aspirated mechanically and streptokinase (STK) was given along with unfractionated heparin (UFH). After 6 months, deep venous patency and postthrombotic syndrome (PTS) was assessed by using duplex ultrasound and Villalta scale, respectively. Among 51 patients with completed data, 25 patients were allocated additional CDT given for a mean duration of 108 ± 32 hours and 26 patients were allocated standard treatment alone. Grade III (complete) lysis was achieved in 37% patients and grade II (50-90%) lysis in 63% of patients. Patients with partial lysis underwent percutaneous transluminal angioplasty and/or venous stenting. After 6 months, iliofemoral patency was found in 20 (80%) in the CDT group versus 7 (23%) in anticoagulation alone group (p < 0.01). PTS was seen in 5 (20%) in the CDT group versus 19 (77%) in anticoagulation alone group (p < 0.01). We conclude that CDT and conventional manual aspiration thrombectomy are an effective treatment for lower extremity DVT. STK infusion can be safely given up to 6 days. As addition of UFH can cause thrombocytopenia, so daily monitoring of complete blood counts is needed during CDT.

Catheter-directed Thrombolysis and Stenting in the Treatment of Iliac Vein Compression Syndrome with Acute Iliofemoral Deep Vein Thrombosis: Outcome and Follow-up

The purpose of this study was to evaluate the safety and effectiveness of catheter-directed thrombolysis (CDT) and stenting in the treatment of iliac vein compression syndrome (IVCS) with acute iliofemoral deep vein thrombosis (DVT). A retrospective analysis was conducted in 61 patients (36 women, 25 men, age range 32-90 years, mean 64 years) who had IVCS with acute iliofemoral thrmobosis (≤10 days) and were treated by CDT and stenting between June 2006 and August 2011. All patients presented with IVCS with a median duration of 4.1 days and were treated with CDT (urokinase: initial dose of 125,000-250,000 U followed by 20,000-60,000 U/hr) followed by stent placement. Filters were implanted in those patients with existing pulmonary embolism (PE), inferior caval vein thrombosis, or in accordance with the patients' request. The patency, the pressure gradient crossing the stenosis of the iliac vein, both thigh and calf limb circumferences, and complications were assessed before and after CDT and stenting. A Duplex ultrasound was used to perform follow-up examinations at 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years after the operation. Three patients had PE before CDT as assessed by the computed tomography angiography. A total of 28 patients had a filter implanted (25 patients had a Cordis permanent filter and 3 patients had a Braun temporary filter). A total of 68 stents were implanted in 61 patients. Overall, the 1-month, 6-month, 1-year, 2-year, 3-year, and 5-year primary patency rates were 96.7%, 95.1%, 91.8%, 90.2%, 88.5%, and 85.2%, respectively. The pressure gradient crossing the stenosis of the iliac vein decreased significantly after CDT and stenting (7.22 ± 4.64 vs. 1.82 ± 2.78 cm H2O, P < 0.001). The reductions of thigh and calf circumferences were 66.7% (6.19 ± 2.67 vs. 1.98 ± 1.43 cm) and 61.6% (4.36 ± 2.10 vs. 1.46 ± 1.10 cm), respectively. Reocclusion occurred in 7 patients within 1-27 months. Four patients (7%) experienced minor bleeding and were treated successfully with sandbag compression. One patient felt light pain on the left waist after 3 months of stenting. No large hematoma, stent migration, or acute thrombosis complications occurred during the procedure. Two patients died from nonvascular causes during a follow-up of 2-62 months (mean, 31.0 months). Four patients were found with limb swelling and three patients felt heaviness. The incidence rate of postthrombotic syndrome was 11.5% (7/61). Treatment with CDT for IVCS with acute DVT achieves good patency and vein function after 5 years of follow-up in this study. However, further evidence is required to establish longer term benefits.

Residual rates of reflux and obstruction and their correlation to post-thrombotic syndrome in a randomized study on catheter-directed thrombolysis for deep vein thrombosis.

Deep vein thrombosis (DVT) often results in venous valvular incompetence and incomplete recanalization, followed by post-thrombotic syndrome (PTS). Treatment with additional catheter-directed thrombolysis (CDT) in patients with an iliofemoral DVT has been shown to reduce the frequency of PTS. The objective of this study was to assess the effect of CDT on venous reflux and patency and to identify possible predictors for the development of PTS. Open, multicenter, randomized, controlled clinical trial. Patients (18-75years) with a first-time iliofemoral DVT were randomized to receive conventional treatment with anticoagulation and compression stockings or CDT in addition to conventional treatment. Follow-up after 6 and 24months included ultrasound and air plethysmography for evaluation of venous reflux and patency. PTS was assessed with the Villalta score. Possible predictors of PTS were analyzed in multivariate logistic regression models. Following additional CDT, deep venous reflux was detected in 65.2% (95% confidence interval [CI], 54.8-74.2) of patients at 6months and 66.7% (95% CI, 56.4-75.6) at 24months. The absolute risk reduction of deep venous reflux was 11.9% (95% CI, 1.1-24.9) after 6months and 16.5% (95% CI, 4.2-28.8) after 24months in the CDT arm compared with controls. Correspondingly, venous patency was regained in 65.9% (95% CI, 55.5-75.0) of patients at 6months and 74.7% (95% CI, 64.9-82.6) after 24months. Patency was regained in 18.5% (95% CI, 4.4-32.6) more patients after 6months and 15.1% (95% CI, 1.8-28.5) more patients after 24months compared with controls. Independent of treatment allocation, patients with fully recanalized and competent deep veins at 6-month follow-up had a 40.5% (95% CI, 26.4-54.7) absolute risk reduction of developing PTS compared with patients with abnormal vein assessment. Reflux and lack of patency at 6months were found to be independent predictors of PTS development in patients treated with CDT (odds ratio, 8.3; 95% CI, 2.6-26.8 for patients with reflux, and odds ratio, 0.17; 95% CI, 0.06-0.49 for patients with patency). Additional CDT improved patency and reduced reflux. Both parameters were found to be strong predictors of PTS in patients treated with CDT. Noninvasive vein assessments of patency and reflux may be helpful to identify and monitor patients at high risk of PTS. Our findings provide evidence for the importance of early recanalization with CDT for acute iliofemoral DVT.

Cost-effectiveness of additional catheter-directed thrombolysis for deep vein thrombosis

Additional treatment with catheter-directed thrombolysis (CDT) has recently been shown to reduce post-thrombotic syndrome (PTS). To estimate the cost effectiveness of additional CDT compared with standard treatment alone. Using a Markov decision model, we compared the two treatment strategies in patients with a high proximal deep vein thrombosis (DVT) and a low risk of bleeding. The model captured the development of PTS, recurrent venous thromboembolism and treatment-related adverse events within a lifetime horizon and the perspective of a third-party payer. Uncertainty was assessed with one-way and probabilistic sensitivity analyzes. Model inputs from the CaVenT study included PTS development, major bleeding from CDT and utilities for post DVT states including PTS. The remaining clinical inputs were obtained from the literature. Costs obtained from the CaVenT study, hospital accounts and the literature are expressed in US dollars ($); effects in quality adjusted life years (QALY). In base case analyzes, additional CDT accumulated 32.31 QALYs compared with 31.68 QALYs after standard treatment alone. Direct medical costs were $64,709 for additional CDT and $51,866 for standard treatment. The incremental cost-effectiveness ratio (ICER) was $20,429/QALY gained. One-way sensitivity analysis showed model sensitivity to the clinical efficacy of both strategies, but the ICER remained < $55,000/QALY over the full range of all parameters. The probability that CDT is cost effective was 82% at a willingness to pay threshold of $50,000/QALY gained. Additional CDT is likely to be a cost-effective alternative to the standard treatment for patients with a high proximal DVT and a low risk of bleeding.