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Background: Pulmonary embolism is one of the leading causes of morbidity and mortality in the United States. Catheter-directed therapies have emerged as a promising treatment for managing intermediate- and high-risk patients; however, data comparing standard catheter-directed thrombolysis (SCDT) and ultrasound-assisted thrombolysis (USAT) are limited. This study aimed to investigate trends, outcomes, and predictors of mortality of both modalities from a nationally representative sample. Methods: This analysis used data from the National Inpatient Sample years 2016-2020. The primary outcome was in-hospital mortality. A multivariable regression model was used to compare the outcomes. Results: Among 39,430 patients who received catheter-directed thrombolysis, 26,710 (76.8%) received SCDT and 8060 (23.2%) received USAT. The utilization of SCDT and USAT increased during the study years except for 2020. In-hospital mortality was lower among patients who received USAT (2.7% vs 3.8%; P = .04) compared with patients who received SCDT in the unadjusted analysis. On multivariable regression analysis, there was no difference in the incidence of in-hospital mortality between USAT and SCDT (odds ratio, 0.75; 95% CI, 0.52-1.08; P = .13). There were no significant differences between SCDT and USAT groups in the rate of bleeding adverse events including intracranial hemorrhage (0.6% vs 0.4%; P = .47), and nonintracranial major bleeding (4.2% vs 4.1%; P = .72). Conclusions: Ultrasound-assisted thrombolysis was associated with similar in-hospital mortality and bleeding complications compared with SCDT for acute pulmonary embolism. Further studies are warranted to confirm evaluate the long-term outcomes with both modalities.

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Acute pulmonary embolism (PE), often resulting from deep vein thrombosis (DVT), is the third most frequent cause of cardiovascular death and is associated with increasing incidence, causing considerable morbidity and mortality. This review aims to evaluate the efficacy, safety, and outcomes of treatment options in the management of acute PE and DVT, encompassing both established and emerging technologies, such as catheter-directed thrombolysis, aspiration thrombectomy, and other endovascular techniques. A comprehensive literature review was conducted, assessing clinical studies, trials, and case reports that detail the use of percutaneous interventions for PE and DVT and analyzing the advantages and disadvantages of each percutaneous system. Several percutaneous treatments have shown promising results, especially in cases where rapid thrombus resolution is critical, such as in high- and intermediate-high-risk patients. The incidence of major complications, such as bleeding, remains a consideration, though it is generally manageable with proper patient selection and technique. It is fundamentally important to tailor the specific treatment strategy to the clinical and anatomical characteristics of each patient. Percutaneous treatments for acute PE and DVT represent valuable options in the therapeutic arsenal, offering enhanced outcomes in appropriately selected patients. Ongoing advancements in technology and technique, along with comprehensive clinical trials, are essential to further define the role and optimize the use of these interventions.

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OBJECTIVES: We hypothesized that ultrasound-assisted thrombolysis (USAT) is non-inferior to surgical pulmonary embolectomy (SPE) to improve right ventricular (RV) function in patients with acute pulmonary embolism (PE). METHODS: In a single-centre, non-inferiority trial, we randomly assigned 27 patients with intermediate-high or high-risk acute PE to undergo either USAT or SPE stratified by PE risk. Primary and secondary outcomes were the baseline-to-72-h difference in right-to-left ventricular (RV/LV) ratio and the Qanadli pulmonary occlusion score, respectively, by contrast-enhanced chest-computed tomography assessed by a blinded CoreLab. RESULTS: The trial was prematurely terminated due to slow enrolment. Mean age was 62.6 (SD 12.4) years, 26% were women, and 15% had high-risk PE. Mean change in RV/LV ratio was -0.34 (95% CI -0.50 to -0.18) in the USAT and -0.53 (95% CI -0.68 to -0.38) in the SPE group (mean difference: 0.152; 95% CI 0.032-0.271; Pnon-inferiority = 0.80; Psuperiority = 0.013). Mean change in Qanadli pulmonary occlusion score was -7.23 (95% CI -9.58 to -4.88) in the USAT and -11.36 (95% CI -15.27 to -7.44) in the SPE group (mean difference: 5.00; 95% CI 0.44-9.56, P = 0.032). Clinical and functional outcomes were similar between the 2 groups up to 12 months. CONCLUSIONS: In patients with intermediate-high and high-risk acute PE, USAT was not non-inferior when compared with SPE in reducing RV/LV ratio within the first 72 h. In a post hoc superiority analysis, SPE resulted in greater improvement of RV overload and reduction of thrombus burden.

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This analysis aimed to estimate 30-day episode care costs associated with 3 contemporary endovascular therapies indicated for treatment of pulmonary embolism (PE). Systematic literature review was used to identify clinical research reporting costs associated with invasive PE care and outcomes for ultrasound-accelerated thrombolysis (USAT), continuous-aspiration mechanical thrombectomy (CAMT), and volume-controlled-aspiration mechanical thrombectomy (VAMT). Total episode variable care costs were defined as the sum of device costs, variable acute care costs, and contingent costs. Variable acute care costs were estimated using methodology sensitive to periprocedural and postprocedural resource allocation unique to the 3 therapies. Contingent costs included expenses for thrombolytics, postprocedure bleeding events, and readmissions through 30 days. Through February 28, 2023, 70 sources were identified and used to inform estimates of 30-day total episode variable costs. Device costs for USAT, CAMT, and VAMT were the most expensive single component of total episode variable costs, estimated at $5,965, $10,279, and $11,901, respectively. Costs associated with catheterization suite utilization, intensive care, and hospital length of stay, along with contingent costs, were important drivers of total episode costs. Total episode variable care costs through 30 days were $19,146, $20,938, and $17,290 for USAT, CAMT, and VAMT, respectively. In conclusion, estimated total episode care costs after invasive treatment for PE are heavily influenced by device expense, in-hospital care, and postacute care complications. Regardless of device cost, strategies that avoid thrombolytics, reduce the need for intensive care unit care, shorten length of stay, and reduce postprocedure bleeding and 30-day readmissions contributed to the lowest episode costs.

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BACKGROUND: Ultrasound-assisted thrombolysis (USAT) and large-bore-thrombectomy (LBT) are under investigation for the treatment of intermediate-high and high-risk pulmonary embolisms (PE). Comparative studies investigating both devices are scarce. AIMS: This study aimed to compare the safety and efficacy of the two most frequently used devices for treatment of acute PE. METHODS: This multicenter, retrospective study included 125 patients undergoing LBT or USAT for intermediate- or high-risk PE between 2019 and 2023. Nearest neighbor propensity matching with logistic regression was used to achieve balance on potential confounders. The primary outcome was the change in the right to left ventricular (RV/LV) ratio between baseline and 24 h. RESULTS: A total of 125 patients were included. After propensity score matching, 95 patients remained in the sample, of which 69 (73%) underwent USAT and 26 (27%) LBT. The RV/LV ratio decrease between baseline and 24 h was greater in the LBT than in the USAT group (adjusted between-group difference: -0.10, 95% CI: -0.16 to -0.04; p = 0.001). Both procedures were safe and adverse events occurred rarely (10% following USAT vs. 4% following LBT; p = 0.439). CONCLUSION: In acute intermediate-high and high-risk PE, both LBT and USAT were feasible and safe. The reduction in RV/LV ratio was greater following LBT than USAT. Further randomized controlled trials are needed to confirm these findings.

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BACKGROUND: Thromboembolism, which leads to pulmonary embolism and ischemic stroke, remains one of the main causes of death. Ultrasound-assisted thrombolysis (UAT) is an effective thrombolytic method. However, further studies are required to elucidate the mechanism of ultrasound on arterial and venous thrombi. METHODS: We employed the blood-on-a-chip technology to simulate thrombus formation in coronary stenosis and deep vein valves. Subsequently, UAT was conducted on the chip to assess the impact of ultrasound on thrombolysis under varying flow conditions. Real-time fluorescence was used to assess thrombolysis and drug penetration. Finally, scanning electron microscopy and immunofluorescence were used to determine the effect of ultrasound on fibrinolysis. RESULTS: The study revealed that UAT enhanced the thrombolytic rate by 40% in the coronary stenosis chip and by 10% in the deep venous valves chip. This enhancement is attributed to the disruption of crosslinked fibrin fibers by ultrasound, leading to increased urokinase diffusion within the thrombus and accumulation of plasminogen on the fibrinogen α chain. Moreover, the acceleration of the dissolution rate of thrombi in the venous valve chip by ultrasound was not as significant as that in the coronary stenosis chip. CONCLUSION: These findings highlight the differential impact of ultrasound on thrombolysis under various flow conditions and emphasize the valuable role of the blood-on-a-chip technology in exploring thrombolysis mechanisms.

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BACKGROUND: Catheter-directed thrombolysis (CDT) is one of the newest treatment options for submassive pulmonary embolism (sPE). This study will compare the efficacy and safety of catheter-directed thrombolysis (CDT) combine with anticoagulation versus anticoagulation alone (AC) in patients with PE. METHODS: A database search was conducted using PubMed, EMBASE, Cochrane Library, and Clinicaltrials.gov for trials that compared CDT with AC in patients with pulmonary embolism. The primary outcomes was1-year mortality. The secondary outcomes were in-hospital, 30 days, 90 days mortality, in-hospital major and minor bleeding (Thrombolysis in Myocardial Infarction (TIMI) classification), length of hospital stay (LOS), reduction of pulmonary arterial systolic pressure (PASP) and RV/LV diameter ratio. RESULTS: A total of 16 articles (3 RCTs and 13 non-RCTs) and 10595 patients were included in this study. 2237 patients were in the CDT group and 8358 patients were in the AC group. CDT group was associated with significantly lower in-hospital mortality (2.1% vs 6.2%,OR:0.36, 95%CI:0.26-0.51, p < .00001,I2 = 0%), 30 days mortality (3.1% vs 8.6%,OR:0.39,95%CI:0.23-0.66, p = .0005, I2 = 0%), 90 days mortality (3.8% vs 7.7%,OR:0.49,95%CI:0.29-0.80,p = .005,I2 = 7%), 1-year mortality (6.1% vs 11%, OR:0.51, 95%CI:0.35-0.76, p = .0008,I2 = 36%) compared to AC group, especially in ultrasound-assisted thrombolysis (USAT) subgroup. There were no differences on major bleeding between two groups (1.8% vs 2.2%, OR:1.10, 95%CI:0.61-1.98, p = .75, I2 = 0%). Minor bleeding was significantly higher in CDT group than AC group (6.2% vs 3.8%, OR:1.93,95%CI:1.27-2.94.66, p = .002, I2 = 1%). CDT group significantly reduced PASP (WMD:11.90,95%CI:6.45-17.35, p < .0001, I2 = 72%) and RV/LV (WMD:0.17,95%CI:0.04-0.30, p = .009, I2 = 69%) rapidly than AC group after treatment. LOS was similar between two groups (WMD:0.02,95%CI: -0.68-0.73, p = .95, I2 = 51%). CONCLUSION: Results thus confirmed that CDT reduced in-hospital, 30 days, 90 days and 1-year all-cause mortality in patients with sPE compared to AC, particularly in USAT subgroup. Nonetheless, CDT group was associated with a higher risk of minor bleeding.

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PURPOSE: Catheter-directed therapy has been increasingly used in acute pulmonary embolism (PE). Whether ultrasound-assisted thrombolysis (USAT) is superior to standard catheter-directed thrombolysis (SCDT) remains unclear. This is a systemic review and meta-analysis of comparative trials on USAT and SCDT for PE to determine whether either modality yielded better clinical efficacy and safety. MATERIALS AND METHOD: Major databases including PubMed, Embase, Cochrane Central, and Web of Science were searched through March 16, 2023. Studies that reported outcomes of SCDT and USAT for acute PE were included. Studies reported data on therapeutic efficacy (a reduction in the right ventricle [RV]/left ventricle [LV] ratio, a reduction in the systolic pulmonary artery pressure [mm Hg], change in Miller index, length of intensive care unit [ICU] and hospital stay) and safety outcomes (in-hospital mortality, overall and major bleeding events). RESULTS: A total of 9 studies with 2610 patients were included in the meta-analysis. The analysis showed significantly greater improvement in the RV/LV ratio in the SCDT group than in the USAT group (mean difference [MD]: -0.155; 95% confidence interval [CI]: -0.249 to -0.006). No statistically significant differences were found between groups comparing change in systolic pulmonary artery pressure (MD: 0.592 mm Hg; 95% CI: -2.623 to 3.807), change in Miller index (MD: -4.1%; 95% CI: -9.5 to 1.3%), hospital stay (MD: 0.372 days; 95% CI: -0.972 to 1.717), and ICU stay (MD: -0.073.038 days; 95% CI: -1.184 to 1). No significant difference was noted in safety outcomes, including in-hospital mortality (pooled odds ratio: 0.984; 95% CI: 0.597 to 1.622), and major bleeding (pooled odds ratio: 1.162; 95% CI: 0.714 to 1.894). CONCLUSIONS: In our meta-analysis of observational and randomized studies, USAT is not superior to SCDT in patients with acute PE.INSPLAY registration number: INPLASY202240082. CLINICAL IMPACT: This study compared SCDT and USAT in patients with acute pulmonary embolism. We found no additional benefit in PA pressure change, thrombus reduction, hospital stay, mortality and major bleeding rate. Additional study using consistent treatment protocol is necessary for further investigation.

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Background: Early data on use of catheter-directed therapies (CDT) for treatment of Intermediate or High-Risk pulmonary embolism (PE) show improvement in pulmonary artery systolic pressures (PAsP) and RV/LV ratios. Occasionally a paradoxical rise in PAsP was observed with CDT utilizing ultrasound-assisted thrombolysis (USAT). It is unclear whether this pattern is seen with CDT utilizing mechanical aspiration. Objectives: To investigate and compare the changes in PAsP between those who underwent CDT with USAT to those with mechanical aspiration. Methods: A retrospective analysis of those diagnosed with Intermediate or High-Risk PE who underwent CDT using USAT or mechanical aspiration from 7/2013 to 3/2023. The primary outcome was comparison of PAsP changes between the two modalities. Secondary outcomes include length of stay, mortality, and bleeding complications. Results: A total of 142 patients were analyzed, of which 93 underwent USAT and 49 underwent mechanical thrombectomy. The mechanical thrombectomy group had significantly lower post-intervention PAsP than the USAT group (42.2 ± 13.4 mmHg vs 54.5 ± 15.2 mmHg, p < 0.0001) and a greater adjusted mean reduction (-16.5 ± 2.7 vs. -7.7 ± 3.2 mmHg. p < 0.0001). A higher frequency of a paradoxical rise in PAsP was observed in the USAT group (22 % vs 4.1 %, p < 0.001). Conclusions: CDT utilizing mechanical thrombectomy was associated with lower post-interventional PAsP and greater mean negative change compared to USAT. Occasional paradoxical rises in PAsP were observed with both types of CDT, but they were more frequent with USAT. Hemodynamic monitoring should be considered after CDT. Condensed unstructured abstract: We report a retrospective comparison of changes to pulmonary artery systolic pressures (PAsPs) between catheter-directed ultrasound-assisted thrombolysis (USAT) and catheter-directed mechanical thrombectomy in Intermediate and High-Risk pulmonary embolism. Those treated with mechanical thrombectomy compared to USAT had significantly lower post-interventional PAsP (42.2 ± 13.4 mmHg vs 54.5 ± 15.2 mmHg, p < 0.0001) and a greater adjusted mean reduction (-16.2 ± 2.7 vs. -7.5 ± 3.2 mmHg, p < 0.0001). A paradoxical rise in PAsP was observed more frequently in the USAT group than the mechanical thrombectomy group (22 % vs 4.1 %, p < 0.001).

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Background: Pulmonary embolism (PE) outcomes are determined by presentation severity and host-related factors. Limited data exist regarding the association of modified body mass index (mBMI), used as a frailty surrogate, with clinical outcomes after treatment for PE. Therefore, we sought to determine the association of mBMI with mortality and bleeding after treatment for intermediate or high-risk PE. Methods: Patients treated for intermediate-risk or high-risk PE at a large academic center between 2013 and 2019 were studied. PE was characterized as intermediate risk (right ventricular compromise) or high risk (hemodynamic compromise) per European Society of Cardiology guidelines. mBMI was defined as the product of serum albumin concentration and body mass index. Patients were stratified according to mBMI quartiles, with low mBMI defined as ≤79, and evaluated for primary end points of in-hospital mortality and bleeding after treatment. A multivariable logistic regression analysis was performed for primary end points. Results: A total of 843 patients were treated for PE. Low mBMI was associated with increased burden of comorbidities and lower rates of interventional or surgical treatment. mBMI was independently associated with mortality (Q1, 22.8%; Q2, 12.4%; Q3, 10.9%; Q4, 6.6%; P = .005) and bleeding (Q1, 20.1%; Q2, 10.1%; Q3, 13.3%; Q4, 11.0%; P = .006). Compared with the lowest mBMI quartile, the highest mBMI quartile was independently associated with lower rates of mortality (OR, 0.28; 95% CI, 0.13-0.58; P < .001) and bleeding (OR, 0.42; 95% CI, 0.23-0.76; P = .004). Conclusions: Low mBMI is prevalent in patients with intermediate-risk and high-risk PE and is independently associated with in-hospital mortality and bleeding after treatment.

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BACKGROUND: There is limited data on moderate-dose with slow-infusion thrombolytic regimen by ultrasound-asssisted-thrombolysis (USAT) in patients with acute pulmonary embolism (PE). AIMS: In this study, our eight-year experience on USAT with moderate-dose, slow-infusion tissue-type plasminogen activator (t-PA) regimen in patients with PE at intermediate-high- and high-risk was presented, and short-, and long-term effectiveness and safety outcomes were evaluated. METHODS: Our study is based on the retrospective evaluation of 225 patients with PE having multiple comorbidities who underwent USAT. RESULTS: High- and intermediate-high-risk were noted in 14.7% and in 85.3% of patients, respectively. Mean t-PA dosage was 35.4±13.3 mg, and the infusion duration was 26.6±7.7 h. Measures of pulmonary artery (PA) obstruction and right ventricle (RV) dysfunction were improved within days (p<0.0001 for all). During the hospital stay, major and minor bleeding and mortality rates were 6.2%, 12.4%, and 6.2%, respectively. Bleeding and unresolved PE accounted for 50% and 42.8% of in-hospital mortality, respectively. Age, rate, and duration of t-PA were not associated with in-hospital major bleeding and mortality. Oxygen saturation exceeded 90% in 91.2% of patients at discharge. During follow-up of median 962 (610-1894) days, high-risk status related to 30-day mortality, whereas age >65 years was associated with long-term mortality. CONCLUSION: Our real-life experience with USAT with moderate-dose, slow-infusion t-PA regimen in patients with PE at high-and intermediate-high risk demonstrated clinically relevant improvements in PA obstructive burden and RV dysfunction. Age, rate or infusion duration of t-PA was not related to major bleeding or mortality risk, whereas unresolved obstruction remained as a lethal issue.

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Aim: To compare the clinical efficacy of ultrasound-assisted thrombolysis (USAT) vs. standard catheter-directed thrombolysis (SCDT) in patients with acute pulmonary embolism (aPE). Methods: This study analyzed the clinical outcomes of patients with non-low-risk aPE who received USAT or SCDT. The primary outcomes were all-cause death, total bleeding, and major bleeding. Secondary outcomes included pulmonary thrombotic load score (Miller), improvement in right ventricular-to-left ventricular ratio (RV/LV), dose and duration of the thrombolytic drug tissue plasminogen activator (tPA), length of stay (LOS) in the ICU, and total LOS in the hospital. Results: A total of seven articles and 451 patients were included in this study. 241 patients were in the USAT group and 210 patients were in the SCDT group. There were no significant differences in all-cause mortality, total bleeding, and major bleeding between the two groups. Miller scores for pulmonary thrombus also showed no difference between the two groups, but pulmonary artery systolic pressure (PASP) was lower in the SCDT group after-treatment. The reduction of RV/LV from baseline was more pronounced in the SCDT group than in the USAT group (OR: -0.14, 95%CI: -0.20 to 0.07, P < 0.0001, I 2 = 0%). Total dose of tPA and duration of infusion in the USAT group were lower than those in the SCDT group, but there was no significant statistical difference. LOS in the ICU was similar between the two groups, while LOS in the hospital was lower in the SCDT group. Conclusion: This study did not detect any differences in all-cause mortality, total bleeding, and major bleeding between non-low-risk aPE patients treated with USAT or SCDT. Improvement in right ventricular function was better in the SCDT group, and hospital LOS was lower in the SCDT group.

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In the ever-changing landscape of device therapy for pulmonary embolism, it is important to understand the rationale behind the ongoing explosion in the development of new device therapies. There needs to be an in-depth understanding of risk stratification in pulmonary embolism and indications for therapy. Selecting the ideal device for a particular pulmonary embolism subset remains elusive and poorly defined. Knowledge of the risks, benefits, capabilities, and potential limitations of each device is crucial.

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Recent in vitro work has revealed that a forward-viewing intravascular (FVI) transducer has sonothrombolysis applications. However, the safety of this device has yet to be evaluated. In this study, we evaluated the safety of this device in terms of tissue heating, vessel damage and particle debris size during sonothrombolysis using microbubbles or nanodroplets with tissue plasminogen activator, in both retracted and unretracted blood clots. The in vitro and ex vivo sonothrombolysis tests using FVI transducers revealed a temperature rise of less than 1°C, no vessel damage as assessed by histology and no downstream clot particles >500 µm. These in vitro and ex vivo results indicate that the FVI transducer poses minimal risk for sonothrombolysis applications and should be further evaluated in animal models.

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OBJECTIVES: The aim of this trial was to determine whether ultrasound-assisted thrombolysis (USAT) is superior to standard catheter-directed thrombolysis (SCDT) in pulmonary arterial thrombus reduction for patients with submassive pulmonary embolism (sPE). BACKGROUND: Catheter-directed therapy has been increasingly used in sPE and massive pulmonary embolism as a decompensation prevention and potentially lifesaving procedure. It is unproved whether USAT is superior to SCDT using traditional multiple-side-hole catheters in the treatment of patients with pulmonary embolism. METHODS: Adults with sPE were enrolled. Participants were randomized 1:1 to USAT or SCDT. The primary outcome was 48-hour clearance of pulmonary thrombus assessed by pre- and postprocedural computed tomographic angiography using a refined Miller score. Secondary outcomes included improvement in right ventricular-to-left ventricular ratio, intensive care unit and hospital stay, bleeding, and adverse events up to 90 days. RESULTS: Eighty-one patients with acute sPE were randomized and were available for analysis. The mean total dose of alteplase for USAT was 19 ± 7 mg and for SCDT was 18 ± 7 mg (P = 0.53), infused over 14 ± 6 and 14 ± 5 hours, respectively (P = 0.99). In the USAT group, the mean raw pulmonary arterial thrombus score was reduced from 31 ± 4 at baseline to 22 ± 7 (P < 0.001). In the SCDT group, the score was reduced from 33 ± 4 to 23 ± 7 (P < 0.001). There was no significant difference in mean thrombus score reduction between the 2 groups (P = 0.76). The mean reduction in right ventricular/left ventricular ratio from baseline (1.54 ± 0.30 for USAT, 1.69 ± 0.44 for SCDT) to 48 hours was 0.37 ± 0.34 in the USAT group and 0.59 ± 0.42 in the SCDT group (P = 0.01). Major bleeding (1 stroke and 1 vaginal bleed requiring transfusion) occurred in 2 patients, both in the USAT group. CONCLUSIONS: In the SUNSET sPE (Standard vs. Ultrasound-Assisted Catheter Thrombolysis for Submassive Pulmonary Embolism) trial, patients undergoing USAT had similar pulmonary arterial thrombus reduction compared with those undergoing SCDT, using comparable mean lytic doses and durations of lysis.

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Pulmonary embolism (PE) is a significant contributor to morbidity and mortality in the United States. Catheter-directed, ultrasound-assisted thrombolysis (USAT) uses high-frequency, low-energy ultrasound waves to disaggregate uncrosslinked fibrin fibers and increase thrombus penetration of a locally delivered thrombolytic to treat an acute PE. The purpose of this study is to compare the efficacy and safety of catheter-directed USAT versus systemic anticoagulation alone in submassive PE. This was a single-center, retrospective study of patients with a diagnosis of acute submassive PE from April 4, 2014 to May 1, 2019 at a large, academic medical center. Subjects were split into two different groups based on treatment with either USAT with systemic anticoagulation or systemic anticoagulation alone. The primary outcome was the incidence of severe or life-threatening GUSTO bleeding within 72 h or until hospital discharge if sooner. A total of 130 subjects were included (n = 40 in the USAT group and n = 90 in systemic anticoagulation alone group). Significantly fewer subjects in the USAT group had an active diagnosis of cancer at the time of presentation (7.5% vs 28.9%, p = 0.006). There was no difference in severe or life-threatening GUSTO bleeding or any component of the GUSTO bleeding definitions. Administration of USAT with systemic anticoagulation was well-tolerated when compared to systemic anticoagulation alone, but bias may have led to selection of patients for USAT with a lower bleeding risk and higher functional status at baseline.

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OBJECTIVES: Endovascular therapy with ultrasound-assisted catheter-directed thrombolysis (UACDT) theoretically provides higher efficacy while reducing the bleeding risk compared with conventional systemic thrombolysis. The clinical outcomes of UACDT in treating intermediate-to-high-risk pulmonary embolism (PE) are lacking in an Asian population. METHODS: Forty-two patients who presented with intermediate-to-high-risk PE received UACDT. The patients were divided into two groups based on the incidence of procedure-related bleeding events, and baseline demographics were compared between the two groups. A paired-Student's t test was conducted to evaluate the efficacy of UACDT. Univariate and multivariate logistic regression analyses were conducted to identify independent risk factors for significant bleeding events. RESULTS: The average age was 58.93 ± 20.48 years, and 33.33% of the study participants were male. A total of 85.7% of the participants had intermediate-risk PE. Compared with pre-intervention pulmonary artery pressure, the mean pulmonary artery pressure decreased significantly (37.61 ± 9.57 mmHg vs. 25.7 ± 9.84 mmHg, p < 0.01) after UACDT. The cumulative total tissue plasminogen activator dosage and total infusion duration were 44.54 ± 20.55 mg and 39.14 ± 19.06 hours respectively. Overall, 21.43% of the participants had severe bleeding events during the endovascular fibrinolysis treatment period. Forward conditional multivariate logistic regression analysis revealed that the lowest fibrinogen level during thrombolysis was an independent factor associated with moderate-to-severe bleeding (odds ratio: 0.40, 95% confidence interval: 0.19-0.88, p = 0.02). CONCLUSIONS: UACDT exhibited high efficacy, but resulted in a higher-than-expected bleeding rate in this real-world study of an Asian population. The lowest fibrinogen level during thrombolysis was an independent risk factor associated with procedure-related bleeding events.

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Background: Systemic thrombolytic therapy is not recommended for patients with intermediate-risk pulmonary embolism (PE) because of major bleeding and intracranial bleeding overcomes the benefit of reperfusion.Patients and methods: A total of 342 PE patients with intermediate-risk PE from the multicenter Serbian PE registry were involved in the study. Of this group, 227 were not treated with reperfusion therapy (anticoagulation only), 91 were treated with conventional thrombolysis protocols at the discretion of their physicians and 24 patients were treated with ultrasound assisted catheter thrombolysis (USACT) with the EKOS® system. All patients treated with USACT had at least one factor which is associated with an increased risk of bleeding. Other patient characteristics were similar across the treatment groups. All-cause and PE-related mortality at 30 days and rate of major bleeding at 7 days were the main efficacy and safety outcomes of the study.Results: The 30-day all-cause mortality were 11.5% versus 17.6% versus 0.0% for no reperfusion, conventional thrombolysis protocols and USACT groups (p = 0.056), respectively. The difference between the rate of 30-day PE-related mortality was in a favour of EKOS and no reperfusion compare to conventional protocols (0.0% vs. 3.5% vs. 11.0%, p = 0.013, respectively). Major bleeding at 7 days, was presented in 1.8% versus 7.7% versus 8.0% (p = 0.021) in no reperfusion, conventional thrombolysis and USACT groups with no intracranial bleeding.Conclusion: In the patients with intermediate-risk PE and at least one bleeding factor, USACT could be an alternative treatment to anticoagulant therapy only and conventional thrombolytic protocols.

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BACKGROUND: There are increased options to deliver thrombolytic treatment for acute, high-risk pulmonary embolism (PE). The goals of this study were to examine practice patterns of systemic thrombolysis and catheter-directed thrombolysis (CDT) and to compare outcomes following CDT with ultrasound facilitation (CDT-ultrasound) and CDT alone. METHODS: The study analyzed adults aged > 18 years with hospitalizations associated with acute PE and thrombolysis in the 2016 Nationwide Readmissions Database. The study identified characteristics associated with the use of systemic thrombolysis and CDT. Comparisons of CDT-ultrasound vs CDT alone were then made by evaluating in-hospital events and readmissions. The primary outcomes were in-hospital mortality and 30-day readmission rates. RESULTS: Among 5,436 hospitalizations, systemic thrombolysis was used more often (n = 3,376; 62.1%) than CDT (n = 2,060; 37.9%). Compared with CDT, systemic thrombolysis was used more frequently in patients with higher rates of vasopressor use (4.3% vs 1.0%), shock (15.8% vs. 6.9%), cardiac arrest (12.7% vs 3.4%), and mechanical ventilation (19.0% vs 5.9%). Among patients who underwent CDT, 417 (20.2%) received CDT-ultrasound, and 1,643 (79.8%) received CDT alone. Rates of bleeding events, vasopressor use, and mechanical ventilation were similar between therapeutic strategies. Following adjustment, in-hospital mortality (OR, 1.19; 95% CI, 0.63-2.26; P = .59) and 30-day readmission rates (OR, 0.75; 95% CI, 0.47-1.22; P = .25) were not significantly different between CDT-ultrasound and CDT alone. CONCLUSIONS: Systemic thrombolysis is used more often than CDT in patients with acute PE, in particular among those with a greater prevalence of high-risk features. Among patients treated with CDT, there were no differences in events between CDT-ultrasound and CDT alone.

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