Ultrasound-accelerated Catheter-directed Thrombolysis Research Articles

Patency and reflux in relation to postthrombotic syndrome: a subanalysis of the Ultrasound-Accelerated Catheter-Directed Thrombolysis Versus Anticoagulation for the Prevention of Post-Thrombotic Syndrome trial

BackgroundAdjunctive catheter-directed thrombolysis shows variable efficacy in preventing postthrombotic syndrome (PTS), despite restored patency. ObjectivesThis Ultrasound-Accelerated Catheter-Directed Thrombolysis Versus Anticoagulation for the Prevention of Post-Thrombotic Syndrome (CAVA) trial subanalysis investigated the effect of ultrasound-accelerated catheter-directed thrombolysis (UACDT) on patency, reflux, and their relevance in PTS development. MethodsThis multicenter, randomized, single-blind trial enrolled patients (aged 18-85 years) with a first iliofemoral deep vein thrombosis and symptom duration ≤14 days. Patency and reflux were assessed by duplex ultrasound at 12 months (T12) and long-term (LT) follow-up (median, 39.5 months; IQR, 24.0-63.0 months). PTS was diagnosed using the Villalta score. ResultsUACDT significantly improved patency in all vein segments at T12 (60.3% UACDT vs 25.9% standard treatment [ST]; P = .002) and LT (45.2% UACDT vs 11.9% ST; P < .001). Popliteal patency, however, was similar between groups (87.9% UACDT vs 83.3% ST; P = .487). Reflux was similar between groups at T12 and LT; only popliteal reflux was significantly reduced in the UACDT group at LT (22.6% UACDT vs 44.8% ST; P = .010). Absent iliac patency at T12 was associated with increased PTS risk in the ST group only (odds ratio [OR], 10.84; 95% CI, 1.93-60.78; P = .007). In the UACDT group, popliteal reflux at T12 was associated with moderate-to-severe PTS at T12 (OR, 4.88; 95% CI, 1.10-21.57; P = .041) and LT (OR, 5.83; 95% CI, 1.44-23.63; P = .009). Combined popliteal reflux and absent iliac patency significantly amplified PTS risk (OR, 10.79; 95% CI, 2.41-48.42; P < .001). ConclusionUACDT improved patency and reduced popliteal reflux. Iliac patency and popliteal reflux are independently associated with moderate-to-severe PTS and contribute synergistically to its development. However, a proportion of moderate-to-severe PTS cases lacks an evident underlying cause.

Fibrinogen levels and clot properties identify patients who benefit from catheter-directed thrombolysis after DVT

AbstractUltrasound-accelerated catheter–directed thrombolysis (UA-CDT) to improve patency after deep vein thrombosis (DVT) has not conclusively been shown to prevent postthrombotic syndrome (PTS) but might benefit patients who are unlikely to obtain patency with standard treatment. We hypothesized that these patients could be selected based on their fibrin clot properties. To study this, patients with acute iliofemoral DVT from the CAVA (Ultrasound-Accelerated Catheter-Directed Thrombolysis Versus Anticoagulation for the Prevention of Post-thrombotic Syndrome) trial had blood samples taken at inclusion. Fibrin clot properties in plasma were determined by turbidimetric clotting (lag time and maximal turbidity) and lysis assays (time to 50% lysis and lysis rate), permeation assay, and confocal microscopy (fiber density), as well as levels of fibrin clot modifiers fibrinogen and C-reactive protein (CRP). Patency was defined as >90% iliofemoral vein compressibility at 12-month ultrasound. PTS was defined as ≥5 Villalta score at 6 or 12 months. In total, 91 of 152 patients were included, including 43 with additional UA-CDT and 48 with standard treatment. Patients with additional UA-CDT more often obtained patency (55.8 vs 27.1%) Patients who obtained patency had longer lag times and lower maximal turbidity, fibrinogen, and CRP; only maximal turbidity and fibrinogen remained associated when adjusting for treatment, thrombus load, and body mass index. Fibrinogen levels had an optimal cutoff at 4.85 g/L. Low fibrinogen levels best predicted patency. Additional UA-CDT decreased the risk of PTS only in patients with high fibrinogen. Therefore, additional UA-CDT might prevent PTS in selected patients based on routinely measured fibrinogen levels. This study was registered at www.ClinicalTrials.gov as #NCT00970619.

Ultrasound-accelerated catheter-directed thrombolysis: a new tool for the treatment of pulmonary embolism in Brazil

Ultrasound-accelerated catheter-directed thrombolysis: a new tool for the treatment of pulmonary embolism in Brazil

Ultrasound-Accelerated Catheter-Directed Thrombolysis.

Venous thromboembolism is a very common presentation in the hospital setting. In patients with high-risk pulmonary embolism (PE) or PE and hemodynamic instability, systemic thrombolytic treatment is generally indicated. In those with contraindications to systemic thrombolysis, catheter-directed local thrombolytic therapy and surgical embolectomy are currently considered. In particular, catheter-directed thrombolysis (CDT) is a drug delivery system coupling the endovascular drug administration nearby in the thrombus and the local facilitating effect of ultrasounds. The applications of CDT are currently debated. Here we provide a systematic review of the clinical utilization of CDT.

The Safety and Efficacy of Ultrasound-Accelerated Catheter-Directed Thrombolysis in Patients with Intermediate-High-Risk Pulmonary Embolism: Bo-NE-Experience.

Ultrasound-accelerated thrombolysis (USAT) is an advanced interventional therapy for patients with intermediate-high-risk pulmonary embolism (PE) who deteriorated on anticoagulation or for high-risk patients for whom systemic thrombolysis is contraindicated. The aim of this study is to investigate the safety and efficacy of this therapy with a focus on the improvement of vital signs and laboratory parameters. Seventy-nine patients with intermediate-high-risk PE were treated with USAT from August 2020 to November 2022. The therapy significantly decreased the mean RV/LV ratio from 1.2 ± 0.22 to 0.9 ± 0.2 (p < 0.001) as well as the mean PAPs from 48.6 ± 11 to 30.1 ± 9.0 mmHg (p < 0.001). The respiratory and heart rate decreased significantly (p < 0.001). Serum creatinine decreased significantly from 1.0 ± 0.35 to 0.9 ± 0.3 (p < 0.001). There were 12 access-associated complications, which could be treated conservatively. One patient had haemothorax after the therapy and had to be operated on. USAT is an effective therapy for patients with intermediate-high-risk PE, with favourable hemodynamic, clinical, and laboratory outcomes.

EKOSTM in Octogenarians: The Safety and Efficacy of Ultrasound-Accelerated Catheter-Directed Thrombolysis in Elderly Patients with Intermediate-High-Risk Pulmonary Embolism.

Pulmonary embolism (PE) is a common cardiovascular disease. Elderly patients with acute PE have very high mortality rates. Data concerning the safety and effectiveness of ultrasound-accelerated thrombolysis (USAT) in this age group are lacking. Nineteen octogenarians with acute pulmonary embolism underwent USAT between August 2020 and February 2023 at two centres in Germany and were retrospectively analysed. The main efficacy measures were the right ventricle to left ventricle diameter (RV/LV) ratio, systolic right ventricle function, and invasive and echocardiographic measured systolic pulmonary artery pressure (sPAP). The main safety measures were in-hospital death and the bleeding rate according to the GUSTO bleeding score. USAT was associated with an improved RV/LV ratio (0.36 ± 0.29, p < 0.001), systolic right ventricle function (5.0 ± 3.8, p < 0.001), and systolic pulmonary artery pressure (sPAP) at 24 h after therapy (24.2 ± 11.2 mmHg and 19 ± 13.4 mmHg, p < 0.001). No in-hospital deaths or bleeding complications occurred. USAT with EKOSTM may be a safe and effective therapeutic option for octogenarians with acute pulmonary embolism.

Comparison of outcomes and complications in conventional versus ultrasound-accelerated catheter directed thrombolysis for treatment of pulmonary embolism: A systematic review and meta-analysis.

Acute submassive a massive pulmonary embolism are known as leading causes of cardiovascular morbidity and mortality in emergency departments. Choosing the optimal type of catheter directed thrombolysis (CDT) for treatment of pulmonary embolism presents a quandary to the practitioners. To the best of our knowledge, there is no meta-analysis comparing superiority of conventional CDT and ultrasound-accelerated catheter directed thrombolysis (USACDT). Therefore, in this meta-analysis, we aimed to compare conventional CDT with USACDT regarding clinical outcomes and safety profile. A systematic literature search of previous published studies comparing conventional CDT with USACDT regarding clinical outcomes and safety profile was carried out in the electronic databases including MEDLINE, Scopus, EBSCO, Google Scholar, Web of Science, and Cochrane from inception to December 2021. Data were analyzed by comprehensive meta-analysis software (CMA, version 3). The meta-analysis included nine studies with a total of 705 patients. Our meta-analysis showed that there is no significant difference between two groups with respect to pulmonary arterial systolic pressure (SMD: -0.084; 95% CI: -0.287 to 0.12; p: 0.41), RV/LV (SMD: -0.003; 95% CI: -0.277 to 0.270; p: 0.98), and Miller score (SMD: -0.345; 95% CI: -1.376 to 0.686; p: 0.51). Similarly, we found no statistically significant differences between two groups regarding major and minor bleeding (p > .05). Our meta-analysis showed that when compared with USACDT, conventional CDT provides similar clinical and hemodynamic outcomes or safety for treatment of pulmonary embolism without the need for very expensive technologies. However, randomized clinical trials are required to further investigate cost-effectiveness of USACDT in comparison with conventional CDT.

Clinical impact of assessing thrombus age using magnetic resonance venography prior to catheter-directed thrombolysis

ObjectivesMagnetic resonance venography (MRV) is underutilized in the evaluation of thrombus properties prior to endovascular treatment but may improve procedural outcomes. We therefore investigated the clinical impact of using a dedicated MRV scoring system to assess thrombus characteristics prior to endovascular intervention for iliofemoral deep vein thrombosis (DVT).MethodsThis is a post hoc analysis of data from the CAVA trial (Clinicaltrials.gov:NCT00970619). MRV studies of patients receiving ultrasound-accelerated catheter-directed thrombolysis (CDT) for iliofemoral DVT were reviewed. Thrombus age-related imaging characteristics were scored and translated into an overall score (acute, subacute, or old). MRV scores were compared to patient-reported complaints. MRV-scored groups were compared for CDT duration and success rate.ResultsFifty-six patients (29 men; age 50.8 ± 16.4 years) were included. Using MRV, 27 thrombi were classified acute, 17 subacute, and 12 old. Based on patient-reported complaints, 11 (91.7%) of these old thrombi would have been categorized acute or subacute, and one (3.7%) of the acute thrombi as old. Average duration of CDT to > 90% restored patency differed significantly between groups (p < 0.0001): average duration was 23 h for acute thromboses (range: 19–25), 43 h for subacute (range: 41–62), and 85 h for old thromboses (range: 74–96). CDT was almost eleven times more successful in thromboses characterized as acute and subacute compared to old thromboses (OR: 10.7; 95% CI 2.1–55.5).ConclusionA dedicated MRV scoring system can safely discriminate between acute, subacute, and old thromboses. MRV-based selection is predictive of procedural duration and success rate and can help avoid unnecessary complications.Key Points• Thrombus age, characterized by MRV as acute, subacute, and old, can predict CDT duration and probability of success.• Accurate pre-interventional MRV-based thrombus aging has the potential to facilitate identification of eligible patients and may thus prevent CDT-related complications.

Abstract 11701: Ultrasound Acceleration Does Not Provide Detectable Benefit During Catheter-Directed Thrombolysis for Massive or Submassive Pulmonary Embolism: A Meta-Analysis of the Available Evidence

Introduction: Compared with systemic thrombolysis, catheter-directed thrombolysis (CDT) for acute pulmonary embolism (PE) reduces the risk of mortality and major bleeding due to lower thrombolytic doses. The only FDA-approved device for CDT is a more expensive ultrasound-accelerated CDT (USAT) device, which uses high frequency ultrasound waves to disrupt the fibrin mesh of the thrombus. No trials comparing CDT vs USAT exist. We conducted a meta-analysis of all published studies that employed CDT and/or USAT for acute PE, stratified by PE severity. Hypothesis: Ultrasound acceleration will improve mortality, bleeding risk, and right heart strain in acute PE over standard CDT. Methods: We performed a retrospective non-time-limited literature search of PubMed for all studies of either catheter-directed thrombolysis technique. Outcome measures (30-day mortality, major bleeding, RV/LV ratio, pulmonary artery systolic pressure) were extracted. Meta-analyses were performed using RevMan Review Manager 5.3 (Cochrane Collaboration). Random Effects Model was used to calculate proportion, mean difference, and Chi-square with 95% confidence intervals. Results: Of 1260 patients in the 34 identified studies, 311 had massive PE, and 928 underwent USAT. There was no difference between CDT and USAT in 30-day mortality in massive PE (27% [7, 48] vs 30% [-2, 62], Chi2=0.02, p=0.90, I2=40%) or submassive PE (5% [-5, 15] vs 3% [0, 7], Chi2=0.16, p=0.69, I2=0%), in major bleeding in massive PE (21% [0, 43] vs 16% [2, 31], Chi2=0.15, p=0.70, I2=58%), in pulmonary artery systolic pressure in massive PE (md 25.73 [16.06, 35.40] vs 19.75 [5.38, 34.12], Chi2=0.46, p=0.50, I2=89%) or submassive PE (15.71 [10.31, 21.89] vs 15.62 [9.77, 21.47] Chi2=0.01, p=0.91, I2=85%). Conclusions: Both techniques are efficacious in improving mortality, bleeding, and right heart strain. However, few studies report outcomes for standard CDT, and between-study heterogeneity is high. Differences in 30-day mortality, major bleeding events, and markers of right heart strain were not detected between techniques in our met-analysis. Practitioners are left without evidence of benefit for ultrasound acceleration, pending the results of the ongoing randomized-controlled trial .

Ultrasound-accelerated thrombolysis in high-risk perioperative pulmonary embolism: two case reports and review of literature

IntroductionTreatment of high-risk pulmonary embolism (PE) in perioperative patients remains challenging. Systemic thrombolysis is associated with a high risk of major bleedings and intracranial haemorrhage. High mortality rates are reported for open pulmonary embolectomy. Therefore, postoperative surgical patients may benefit substantially from catheter-directed ultrasound-accelerated thrombolysis (USAT).Case presentationWe report two cases of high-risk perioperative PE. Both patients developed severe haemodynamic instability leading to cardiac arrest. After the implantation of a veno-arterial extracorporeal membrane oxygenation (ECMO), they were both successfully treated with USAT. Adequate improvement of right ventricular function was achieved; thus, ECMO could be successfully weaned after 3 and 4 days, respectively. Both patients showed favourable outcomes and could be discharged to rehabilitation.ConclusionCurrent guidelines on treatment of PE offer no specific therapies for perioperative patients with high-risk PE. However, systemic thrombolysis is often excluded due to the perioperative setting and the risk of major bleeding. Catheter-directed thrombolysis was shown to utilise less thrombolytic agent while obtaining comparable thrombolytic effects. The risk for major bleeding (including intracranial haemorrhage) is also significantly lowered. Until further trials determining the value of adopted treatment strategies of high-risk PE in perioperative patients are available, USAT should be considered in similar cases.

Comparison of ultrasound-accelerated versus conventional catheter-directed thrombolysis for deep vein thrombosis: A systematic review and meta-analysis.

Recent in vitro and clinical studies have shown that ultrasound-accelerated catheter-directed thrombolysis (USACDT) can accelerate thrombolysis. Therefore, in this meta-analysis, we aimed to compare the efficacy and safety of USACDT with conventional catheter-directed thrombolysis in patients with deep vein thrombosis. A systematic search of the following electronic databases was performed from their dates of inception to 20 June 2020: MEDLINE, Scopus, Google Scholar, CINAHL, Cochrane Library, and EMBASE. All randomized controlled trials that directly compared the complications and efficacy of USACDT and conventional catheter-directed thrombolysis in patients with deep vein thrombosis were identified. The statistical analysis was performed using comprehensive meta-analysis software. Finally, 18 studies with a total of 597 participants were included in our meta-analysis according to the eligibility criteria. Pooled proportion of USACDT success in patients with deep vein thrombosis was 87.8% (18 studies; 95% CI: 83.1-91.3). Success rate was significantly higher in USACDT treatment than in conventional catheter-directed thrombolysis treatment (seven studies; OR: 2.96; 95% CI: 1.69-5.16; P < 0.01)). Although the mean infusion time was higher in catheter-directed thrombolysis treatment compared to USACDT treatment, this difference was not statistically significant (three studies; MD: -1.46; 95% CI: -3.25-0.32; P = 0.10). Moreover, pooled rate of complications was lower in USACDT than catheter-directed thrombolysis which was not statistically significant (seven studies; OR: 0.49; 95% CI: 0.13-1.76; P = 0.27). This meta-analysis revealed that USACDT significantly increased the success rate of thrombolysis compared to conventional catheter-directed thrombolysis. Furthermore, USACDT was associated with lower rate of complication and infusion time. Taken together, these findings confirm the superiority of this novel intervention over conventional catheter-directed thrombolysis in treatment of patients with deep vein thrombosis.

Ultrasound-accelerated catheter-directed thrombolysis versus anticoagulation for the prevention of post-thrombotic syndrome (CAVA): a single-blind, multicentre, randomised trial

Early thrombus removal might prevent post-thrombotic syndrome by preserving venous function and restoring flow. Previous trials comparing additional catheter-directed thrombolysis to standard treatment showed conflicting outcomes. We aimed to assess the benefit of additional ultrasound-accelerated catheter-directed thrombolysis for the prevention of post-thrombotic syndrome compared with standard therapy in patients with iliofemoral deep-vein thrombosis. We did a multicentre, randomised, single-blind, allocation-concealed, parallel group, superiority trial in 15 hospitals in the Netherlands. Patients aged 18-85 years with a first-time acute iliofemoral deep-vein thrombosis and symptoms for no more than 14 days were randomly assigned (1:1) to either standard treatment with additional ultrasound-accelerated catheter-directed thrombolysis or standard treatment alone. Randomisation was done with a web-based automatic programme and a random varying block size (2-12), stratified by age and centre. Standard treatment included anticoagulant therapy, compression therapy (knee-high elastic compression stockings; 30-40 mmHg), and early ambulation. Additional ultrasound-accelerated catheter-directed thrombolysis was done with urokinase with a starting bolus of 250 000 international units (IU) in 10 mL NaCl followed by a continuous dose of 100 000 IU/h for a maximum of 96 h through the Ekos Endowave-system. Adjunctive percutaneous transluminal angioplasty, thrombosuction, or stenting was performed at the discretion of the physician who performed the intervention. The primary outcome was the proportion of patients with post-thrombotic syndrome at 12 months diagnosed according to the original Villalta criteria-a Villalta-score of at least 5 on two consecutive occasions at least 3 months apart or the occurrence of venous ulceration-and was assessed in a modified intention-to-treat population of all randomly assigned patients who passed screening and started treatment. The safety analysis was assessed in the same modified intention-to-treat population. This study is complete and is registered at ClinicalTrials.gov, NCT00970619. Between May 28, 2010, and Sept 18, 2017, 184 patients were randomly assigned to either additional ultrasound-accelerated catheter-directed thrombolysis (n=91) or standard treatment alone (n=93). Exclusion because of screening failure or early withdrawal of informed consent resulted in 77 patients in the intervention group and 75 in the standard treatment group starting allocated treatment. Median follow-up was 12·0 months (IQR 6·0-12·0). 12-month post-thrombotic syndrome occurred in 22 (29%) patients allocated to additional treatment versus 26 (35%) patients receiving standard treatment alone (odds ratio 0·75 [95% CI 0·38 to 1·50]; p=0·42). Major bleeding occurred in four (5%) patients in the intervention group, with associated neuropraxia or the peroneal nerve in one patient, and no events in the standard treatment group. No serious adverse events occurred. None of the four deaths (one [1%] in the intervention group vs three [4%] in the standard treatment group) were treatment related. This study showed that additional ultrasound-accelerated catheter-directed thrombolysis does not change the risk of post-thrombotic syndrome 1 year after acute iliofemoral deep-vein thrombosis compared with standard therapy alone. Although this trial is inconclusive, the outcome suggests the possibility of a moderate beneficial effect with additional ultrasound-accelerated catheter-directed thrombolysis. Further research is therefore warranted to better understand this outcome in the context of previous trials, preferably by combining the available evidence in an individual patient data meta-analysis. The Netherlands Organisation for Health Research and Development (ZonMw), Maastricht University Medical Centre, BTG-Interventional Medicine.

Popliteal ven tutulumu olmayan akut iliofemoral ven trombozunun ultrasonla hızlandırılmış kateter aracılı trombolitik tedavisi: erken ve orta dönem sonuçlar

Purpose: Deep vein thrombosis is a life-threatening pathology which can lead to long-term morbidity due to post-thrombotic syndrome. The aim of this study was to assess early and midterm results of the patients undergoing ultrasound-accelerated catheter-directed thrombolysis for the treatment of acute iliofemoral deep venous thrombosis without popliteal vein thrombosis.Materials and Methods: A total of 18 patients (11 males, 7 females; mean age: 51.89±16.29 years; range, 16 to 72 years) who were diagnosed with acute iliofemoral deep vein thrombosis between November 2014 and December 2015 were included in this retrospective cross-sectional study. Results: Complete thrombolysis was successful in 88.9% (n=16) and in % 11.1 (n=2) patients with partial clot lysis. No pulmonary embolism was seen, while bleeding at the catheter-insertion site was observed in one patient. In another patient, underlying lesions were successfully treated with balloon angioplasty. No in-hospital mortality or severe complications were observed. The mean follow-up was 31.56±3.35 (range, 25 to 37 months). Ultrasound findings of all the patients were evaluated by a single experienced radiologist. Duplex ultrasound was performed at one month, six months, one year, and two years following intervention and the iliac vein patency rate was found to be 100%, while superficial femoral vein insufficiency was in 5.6% (n=1), 11.1% (n=2), 16.2% (n=3), and 16.2% (n=3), respectively.Conclusion: Based on our findings, ultrasound-accelerated catheter-directed thrombolysis is a safe and effective method for carefully selected patients with acute iliofemoral deep vein thrombosis without popliteal vein thrombosis

Ultrasound-accelerated catheter-assisted thrombolytic therapy applicatıons in deep vein thrombosis.

Ultrasound-accelerated catheter-directed thrombolysis (UCT) increases the invasion of thrombolytic agent into the thrombus using ultrasonic energy, provides less infusion of thrombolytic agent, reduces complication, and post-thrombotic syndrome (PTS) development rates. For these reasons, this procedure is a promising method for the treatment of deep vein thrombosis (DVT). Patients diagnosed with DVT by ultrasonography (USG) who underwent UCT between May 2013 and August 2014 at Gazi University Hospital Cardiovascular Surgery Clinic were included in the study. The demographic characteristics and postoperative acute and long-term patency rates and deep venous insufficiency rates were evaluated retrospectively to determine the efficacy of the UCT procedure. Patients were classified as acute, subacute, and chronical DVT according to the onset of complaints. The efficacy of the UCT procedure was assessed by Doppler USG performed 6 months and 2 years after the procedure, and patients were re-evaluated for deep venous insufficiency and thrombus findings to determine the relationship between UCT procedure and deep venous insufficiency. In acute phase, 57.1% (n = 8) complete and 35.7% (n = 5) partial openings were obtained. No complete patency was obtained in any of the subacute patients. However, partial openness rate was 60%. In patients admitted during the chronic period, complete patency was obtained in 20% (n = 8) and partial openings in 60% (n = 3). Although thrombolysis success was not considered as statistically significant, the success rate was numerically higher in the acute phase. As a result, UCT applications provide thrombolysis especially in acute deep vein thrombosis, preventing deep venous insufficiency and especially post-thrombotic syndrome formation. UCT prevents bleeding complications by keeping thrombolytic amount low and can be used as an endovascular method of high safety in patient population with high bleeding complications such as patients with malignancies.

3:00 PM Abstract No. 351 ■ DISTINGUISHED ABSTRACT ACCESS PTS Study: ACCElerated thrombolySiS for post-thrombotic syndrome using the acoustic pulse thrombolysis EkoSonic® endovascular system: midterm results of a multicenter study

Post thrombotic syndrome (PTS), a potentially devastating long-term outcome of deep vein thrombosis (DVT), develops in >50% of patients following proximal DVT. Unfortunately, treatment options are limited. A multi-center, prospective, single-arm study evaluated the efficacy and safety of endovascular recanalization of venography proven chronic venous-occlusive disease, utilizing venoplasty with ultrasound-accelerated, catheter-directed thrombolysis (USCDT). Inclusion criteria were persistent femoral DVT diagnosed ≥6 months, Villalta Score (VS) ≥8 and failure of 3 months of anticoagulation and compression therapy. Exclusion criteria were isolated iliofemoral DVT, high bleeding risk as assessed by the treating clinician & filling defect ≥3 cm into the IVC. Following standard techniques to cross the venous occlusion, patients underwent venoplasty followed by minimum of 12h USCDT with further venoplasty and venous stenting as needed. Patients will be followed out to 12 months. The primary efficacy endpoint was a reduction in VS ≥ 4 at 30 days post-USCDT in ≥50% of patients. The primary safety endpoints were major bleeding within 72 hours of procedure start and pulmonary embolism (PE) within 30 days post-USCDT. Other measures tracked included the Venous Severity Score (VCSS) and quality of life as assessed by the VEINES-QOL questionnaire. Of 81 patients enrolled, 78 patients (mean age 55, male 68%) received treatment and 77 limbs were evaluable for endpoint assessment. Mean USCDT duration was 22.8 ± 5.4 hours and tPA dose was 18.5 ± 7.6 mg. The Villalta score improved from 15.8 (baseline) to 9.8 and 8.2 at 30 and 180 days, respectively (p<0.0001). The actual primary endpoint was met in 67% (p = 0.003). VCSS improved from 12.3 (baseline) to 8.4 and 7.0 at 30 and 180 days, respectively (p<0.0001). VEINES-QOL improved from 60.6 (baseline) to 70.7 and 80.2 (30 and 180 days, respectively) (p<0.0001). One major bleed occurred within 72 hours post-USCDT. One PE occurred within 30 days of USCDT. In chronic DVT patients with PTS, ACCESS PTS demonstrates intervention utilizing USCDT with venoplasty is safe and effective in achieving clinically relevant improvement in PTS and quality of life.

A systematic review of ultrasound-accelerated catheter-directed thrombolysis in the treatment of deep vein thrombosis.

To review the clinical evidence for ultrasound-accelerated catheter-directed thrombolysis (UACDT) using the EKOS system in the treatment of deep vein thrombosis (DVT) in terms of case selection, procedural outcomes, clinical outcomes and safety outcomes. A systematic literature search strategy was used to identify the use of the EKOS system in the treatment of DVT using the following electronic databases: MEDLINE, EMBASE, the Cochrane databases and the Web of Science. The references in the relevant literature were also screened. Our literature search identified a total of 16 unique clinical studies. Twelve of the sixteen studies were retrospective case series studies. To date, only one randomised controlled trial (RCT) is available. Overall, UACDT using the EKOS system was performed 548 times in 512 patients. Among all cases, 77-100% achieved substantial lysis (> 50%) based on the different definitions of the individual studies. This treatment modality appears to be safe, as there were no reported procedure-related pulmonary embolisms (PE) and only one procedure-related death was reported. Bleeding events were reported in 14 of the 16 studies, and 3.9% (20/512) of the cases of bleeding were considered major. During the follow-up, post-thrombotic syndrome was observed in 17.1% (20/117) of cases. UACDT using the EKOS system is an effective, safe and promising treatment modality for DVT, but the existing clinical evidence is inadequate to make UACDT using the EKOS system the first-line choice for DVT. Additional prospective large-sample RCTs with long-term follow-ups are warranted to define the role of UACDT using the EKOS system in the treatment of DVT.

Echocardiographic assessment with right ventricular function improvement following ultrasound-accelerated catheter-directed thrombolytic therapy in submassive pulmonary embolism

Introduction The objective of this study was to evaluate the efficacy of ultrasound-accelerated catheter-directed thrombolytic therapy in patients with submassive pulmonary embolism. Methods Clinical records of 46 patients with submassive pulmonary embolism who underwent ultrasound-accelerated catheter-directed pulmonary thrombolysis using tissue plasminogen activator, from 2007 to 2017, were analyzed. All patients experienced clinical symptoms with computed tomography evidence of pulmonary thrombus burden. Right ventricular dysfunction was present in all patients by echocardiographic finding of right ventricle-to-left ventricle ratio > 0.9. Treatment outcome, procedural complications, right ventricular pressures, and thrombus clearance were evaluated. Follow-up evaluation included echocardiographic assessment of right ventricle-to-left ventricle ratio at one month, six months, and one year. Results Technical success was achieved in all patients ( n = 46, 100%). Our patients received an average of 18.4 ± 4.7 mg of tissue plasminogen activator using ultrasound-accelerated thrombolytic catheter with an average infusion time of 16.5± 5.4 h. Clinical success was achieved in all patients (100%). Significant reduction of mean pulmonary artery pressure occurred following the treatment, which decreased from 36 ± 8 to 21 ± 5 mmHg ( p < 0.001). There were no major bleeding complications. All-cause mortality at 30 days was 0%. No patient developed recurrent pulmonary embolism during follow-up. During the follow-up period, 43 patients (93%) showed improvement of right ventricular dysfunction based on echocardiographic assessment. The right ventricle-to-left ventricle ratio decreased from 1.32 ± 0.18 to 0.91 ± 0.13 at the time of hospital discharge ( p < 0.01). The right ventricular function remained improved at 6 months and 12 months of follow-up, as right ventricle-to-left ventricle ratio were 0.92 ± 0.14 ( p < 0.01) and 0.91 ± 0.15 ( p < 0.01), respectively. Conclusion Ultrasound-accelerated catheter-directed thrombolysis is a safe and efficacious treatment for submassive pulmonary embolism. It reduces pulmonary hypertension and improves right ventricular function in patients with submassive pulmonary embolism.

Thrombus resolution and right ventricular functional recovery using ultrasound-accelerated thrombolysis in acute massive and submassive pulmonary embolism.

This study aims to evaluate the efficacy and safety of ultrasound-accelerated catheter-directed thrombolysis (UACDT) in the treatment of massive and submassive pulmonary embolism (PE). We conducted a prospective, observational cohort study of consequtive patients with massive or submassive PE treated with low-dose UACDT using EKOS EkoSonic® system at single center from May 2014 until April 2015. Overall, thirty-eight patients (median age, 64.5 years) were included. The primary safety outcomes were change in right ventricular (RV) to left ventricular (LV) diameter ratio within 24 hours of procedure initiation, at 1- and 6-month follow-up and major bleeding within 96 hours of the procedure initiation. BNP, troponin and D-dimer levels were also measured. The ultrasound-accelerated thrombolytic catheters were bilaterally placed in 25 (65.8%) patients. The median tissue plasminogen activator (tPA) dose for all patients in our study was 21.0 mg and the median infusion time was 15 hours. Measurements before and after treatment showed a decrease in pulmonary artery pressure. The median value of RV/LV diameter ratio decreased from 0.9 (0.7-1.1) at baseline to 0.7 (0-0.97) at 6-month follow-up (P=0.001) and pulmonary artery pressure from 61.4 ±16.7 to 37.2±9.1 mmHg (P=0.001). The median BNP level at baseline was 169 (29-721) pg/mL and 45.5 (0-328) pg/mL at 6 month follow-up (P=0.001). Of 38 patients with PE, one had intracranial hemorrage, one gastrointestinal bleeding and two developed puncture site bleeding. This prospective study provides alternative treatment option and an addition to the treatment algorithm for the management of pulmonary embolism.

Pharmacomechanical thrombectomy of upper extremity deep vein thrombosis.

This study aims to evaluate the efficacy and safety of ultrasound-accelerated catheter-directed thrombolysis (UACDT) in the treatment of upper extremity deep vein thrombosis (UEDVT). We conducted a prospective, observational cohort study of consecutive patients with acute UEDVT with low-dose UACDT using the Ekosonic® Endovascular System (EKOS Corporation, Bothell, WA, USA) at a single center from September 2012 until October 2014. Overall, sixteen patients (11 males and 6 females, age range 18 to 70 years, mean age, 45.6 years) were included in the study protocol. The primary efficacy outcome was complete thrombus clearance. The primary safety outcomes were recurrence of thrombosis within the follow-up visit and major bleeding within 96 hours of the procedure initiation. The median tissue plasminogen activator (tPA) dose for all patients in our study was 16.81±2.51 mg (range 15 to 28 mg) and the median infusion time was 15 hours. Complete thrombus clearance was achieved in 11 (68.8%) patients, and partial clearance was detected in 3 (18.8%) patients. Of 16 patients with UEDVT, two had gastrointestinal bleeding, and two had puncture site bleeding. This prospective study demonstrates effectiveness and safety of ultrasound accelerated thrombolysis in patients with UEDVT.

4:03 PMAbstract No. 214 - Improvement of pulmonary hypertension and right ventricular dysfunction after ultrasound-accelerated catheter-directed thrombolysis for submassive pulmonary embolism

4:03 PMAbstract No. 214 - Improvement of pulmonary hypertension and right ventricular dysfunction after ultrasound-accelerated catheter-directed thrombolysis for submassive pulmonary embolism