UNASSIGNED: Anticoagulation (AC) is the guideline-recommended treatment for intermediate-risk pulmonary embolism (PE); however, it remains unclear whether mechanical thrombectomy provides benefit over AC alone. The PEERLESS II study aims to evaluate outcomes in intermediate-risk PE patients randomized to treatment with large-bore mechanical thrombectomy and AC vs AC alone.
UNASSIGNED: PEERLESS II is an international randomized controlled trial enrolling up to 1200 patients with intermediate-risk PE and additional clinical risk factors from up to 100 sites. Treatment is randomized 1:1 to large-bore mechanical thrombectomy with the FlowTriever System (Inari Medical) and AC or AC alone. Outcomes will be evaluated for up to 3 months, with safety events independently adjudicated. The primary end point is a hierarchical composite win ratio of (1) all-cause mortality by 30 days, (2) clinical deterioration (earlier of discharge or 30 days), (3) all-cause hospital readmission by 30 days, (4) bailout therapy (earlier of discharge or 30 days), and (5) Modified Medical Research Council (mMRC) dyspnea score of ≥1 at the 48-hour visit. Secondary end points include all-cause and PE-related mortality (30-day and 90-day), all-cause and PE-related readmission (30-day and 90-day), major bleeding (30-day and 90-day), clinical deterioration (earlier of discharge or 30 days), bailout (earlier of discharge or 30 days), right ventricle-to-left ventricle diameter ratio (48-hour visit), mMRC dyspnea score (48-hour, 1-month, and 3-month visits), quality of life using Pulmonary Embolism Quality of Life and EuroQol-5 Dimensions-5 Levels (1-month and 3-month visits), 6-minute walk distance (1-month visit), and post-PE impairment diagnosis (3-month visit).
UNASSIGNED: PEERLESS II will inform the understanding of mechanical thrombectomy treatment for intermediate-risk PE and provide evidence for consideration in future treatment guidelines.

暂无摘要。

UNASSIGNED: The relationship between the early hemodynamic consequences of acute pulmonary embolism (PE) and short-term morbidity and mortality has long been recognized. The mortality incidence and other complications after high-risk (massive) PE, the most severe category of the disease, are summarized in this meta-analysis.
UNASSIGNED: A systematic review and meta-analysis of studies reporting on patients with massive PE indexed by PubMed and the Cochrane Library over a 10-year period (2010-2020) was conducted. Studies with adequate information to specify a cohort of patients with high-risk PE defined by the American Heart Association and European Society of Cardiology criteria and their clinical outcomes were included. Incidences were calculated as weighted averages with 95% CIs.
UNASSIGNED: A total of 27 publications spanning 1517 patients were identified that met the search criteria for high-risk PE. In-hospital all-cause mortality averaged 28.3% (95% CI, 20.9%-37.0%) in patients at high risk, comparable to the 30-day all-cause mortality of 30.2% (95% CI, 22.3%-39.6%). In-hospital major bleeding was 13.8% (95% CI, 9.3%-20.0%), and intracranial hemorrhage was reported in 3.6% (95% CI, 2.2%-5.9%). The risk of bias in publications was graded as low-to-moderate, with substantial heterogeneity among the studies.
UNASSIGNED: This systematic review and meta-analysis provided low-quality to moderate-quality evidence documenting mortality, major bleeding, and other complications in patients meeting the American Heart Association and European Society of Cardiology criteria for high-risk PE. This information was used to inform the design of the FLowTriever for Acute Massive Pulmonary Embolism (FLAME) study (NCT04795167), a study evaluating an advanced therapy for patients with high-risk PE.

UNASSIGNED: Residual pulmonary vascular obstruction (RPVO) following pulmonary embolism (PE) is associated with residual dyspnea, recurrent venous thromboembolism, and chronic thromboembolic pulmonary hypertension. Historically, acute PE treated with anticoagulation alone results in high rates of significant RPVO. Contemporary treatment of submassive PE often involves catheter-based interventions, including mechanical thrombectomy (MT), although their relation to RPVO is not characterized. In this study, we aimed to evaluate the rate of ≥10% RPVO in patients treated with MT.
UNASSIGNED: Twenty consecutive patients with submassive PE in a single center underwent MT and subsequent planar ventilation/perfusion scintigraphy scan at a median of 4 months after thrombectomy. A quantitative perfusion score was calculated for each planar ventilation/perfusion scintigraphy study to provide a % perfusion defect. Complete hemodynamic data were collected during the procedure and Miller score was calculated using prepulmonary and postpulmonary angiography. Echocardiographic data were collected prior to, 24 to 48 hours after, and 30 days after the procedure.
UNASSIGNED: Four of 20 patients (20%) had ≥10% RPVO at a median of 4 months follow-up. Following MT, the mean Miller score decreased from 24.5 ± 2.9 to 15.8 ± 3.3 (P < .001) and mean pulmonary artery pressure decreased from 36.1 ± 4.8 mm Hg to 26.8 ± 5.4 mm Hg (P < .001). Right ventricle-to-left ventricle ratio decreased from 1.44 ± 0.2 to 1.05 ± 0.24 by 24 to 48 hours (P < .001) and 0.85 ± 0.1 at 30 days (P < .001) and right ventricular systolic pressure decreased from 63.2 ± 10 mm Hg to 42.1 ± 9.8 mm Hg at 24 to 48 hours (P < .001) and 31.9 ± 10.4 at 30 days (P < .001).
UNASSIGNED: In this prospective study of patients with submassive PE treated with MT, favorable rates of RPVO were noted in comparison to prior studies of anticoagulation alone along with expected acute hemodynamic and echocardiographic improvements. While this study was small in scope, the results suggest the potential for long-term benefits of MT in acute PE in addition to the acute benefits previously described.

UNASSIGNED: Catheter-directed thrombolysis (CDT) and large-bore mechanical thrombectomy (MT) are the leading percutaneous-based therapies for the management of intermediate-risk pulmonary embolism (PE). While previous studies have demonstrated their procedural safety and efficacy, the cost implications of these interventions remain unclear. This study aims to conduct a cost-benefit analysis to evaluate the economic advantages associated with CDT and MT from the perspective of the treating hospital.
UNASSIGNED: A total of 372 consecutive patients with intermediate-risk acute PE who underwent either MT or CDT at 3 academic centers between 2013 and 2021 were included in this analysis. The costs of care incurred during the index hospitalization for the 2 treatment groups were collected and compared using an adjusted cost model.
UNASSIGNED: This study compared the hospital costs of 226 patients who underwent CDT and 146 patients who underwent MT. In the unadjusted overall cohort, the use of CDT was associated with a numerical but nonsignificant increase in costs amounting to $5120 relative to MT (P = .062). This cost difference was primarily driven by the longer length of stay in the intensive care unit and hospital for CDT patients, particularly earlier in the studied timeframe. However, when accounting for confounders including variations between the treating institutions and the timing of treatment during the study period, the adjusted cost differential between CDT and MT narrowed to $1351 (P = .71).
UNASSIGNED: This multicenter cost analysis does not reveal a clear cost advantage of 1 treatment over the other for intermediate-risk PE. The observed cost differences were influenced by variations in practice patterns across the study period and among the 3 participating institutions. Future efforts should also focus on strategies to reduce the length of stay, improve efficiency, and minimize the overall cost of care for intermediate-risk PE patients.

Portal vein thrombosis remains a clinical challenge with limited treatment options. A patient was admitted with decompensated nonalcoholic steatohepatitis and a history of recurrent esophageal and gastric variceal hemorrhages. Contrast-enhanced computed tomography revealed hepatic cirrhosis with concomitant and extensive thrombosis of the portal, splenic, and superior mesenteric veins. The patient was treated with transjugular intrahepatic portosystemic shunt and mechanical thrombectomy with the FlowTriever System (Inari Medical, Irvine, CA). Post-thrombectomy venography and follow-up computed tomography demonstrated patency and brisk flow. This case report shows that mechanical thrombectomy with the FlowTriever System is promising for treating extensive and subacute portal vein thrombosis.

UNASSIGNED: Acute mortality for high-risk, or massive, pulmonary embolism (PE) is almost 30% even when treated using advanced therapies. This analysis assessed the safety and effectiveness of mechanical thrombectomy (MT) for high-risk PE.
UNASSIGNED: The prospective, multicenter FlowTriever All-comer Registry for Patient Safety and Hemodynamics (FLASH) study is designed to evaluate real-world PE patient outcomes after MT with the FlowTriever System (Inari Medical). In this study, acute outcomes through 30 days were evaluated for the subset of patients with high-risk PE as determined by the sites and following European Society of Cardiology guidelines. An independent medical monitor adjudicated adverse events (AEs), including major AEs: device-related mortality, major bleeding, or intraprocedural device-related or procedure-related AEs.
UNASSIGNED: Of the 799 patients in the US cohort, 63 (7.9%) were diagnosed with high-risk PE; 30 (47.6%) patients showed a systolic blood pressure <90 mm Hg, 29 (46.0%) required vasopressors, and 4 (6.3%) experienced cardiac arrest. The mean age of patients with high-risk PE was 59.4 ± 15.6 years, and 34 (54.0%) were women. At baseline, 45 (72.6%) patients were tachycardic, 18 (54.5%) showed elevated lactate levels of ≥2.5 mM, and 21 (42.9%) demonstrated depressed cardiac index of <2 L/min/m2. Immediately after MT, heart rate improved to 93.5 ± 17.9 bpm. Twenty-five (42.4%) patients did not require an overnight stay in the intensive care unit, and no mortalities or major AEs occurred through 48 hours. Moreover, no mortalities occurred in 61 (96.8%) patients followed up through the 30-day visit.
UNASSIGNED: In this cohort of 63 patients with high-risk PE, MT was safe and effective, with no acute mortalities reported. Further prospective data are needed in this population.

暂无摘要。

UNASSIGNED: Mechanical thrombectomy is a promising treatment option for deep vein thrombosis; however, long-term data are lacking. Here, we report for the first time the 1-year clinical outcomes from the completely enrolled ClotTriever Outcomes (CLOUT) registry evaluating mechanical thrombectomy with the ClotTriever System (Inari Medical).
UNASSIGNED: The CLOUT registry (NCT03575364) is a prospective, multicenter, single-arm study that enrolled 500 patients with proximal lower extremity deep vein thrombosis. Prespecified 1-year outcomes include Villalta score and corresponding postthrombotic syndrome (PTS) severity, duplex ultrasound findings of patency (defined as the presence of flow with normal or partial compressibility), Revised Venous Clinical Severity Score, and quality of life (QoL).
UNASSIGNED: In CLOUT, the median age was 61.9 years and 50.5% of patients were women. A total of 310 patients completed the 1-year visit. The 1-year PTS rate (Villalta score ≥ 5) was 19.3% and the moderate-to-severe PTS rate (Villalta score ≥ 10) was 8.8%. Median Villalta score decreased from 9.0 (IQR, 5.0-14.0) at baseline to 1.0 (IQR, 0.0-4.0) at 1 year (P < .0001). Similar rates of PTS and moderate-to-severe PTS were observed among limbs assessed at all study time points. Patency was observed in 94.2% of limbs. Median Revised Venous Clinical Severity Score was 6.0 (IQR, 3.0-9.0) at baseline and 3.0 (IQR, 1.0-4.0) at 1 year (P < .0001). Additionally, 90.4% of patients experienced improvements in QoL.
UNASSIGNED: One-year outcomes from the CLOUT registry demonstrate low PTS rates and preserved patency accompanied by improved symptom relief and QoL. Study follow-up through 2 years is ongoing.

UNASSIGNED: Mechanical thrombectomy provides rapid hemodynamic improvements after acute pulmonary embolism (PE), but long-term benefits are uncertain.
UNASSIGNED: FlowTriever All-comer Registry for Patient Safety and Hemodynamics is a prospective, single-arm, multicenter registry of patients with acute PE treated with the FlowTriever System (Inari Medical). Six-month outcomes including modified Medical Research Council dyspnea scores (MMRCD), right ventricular (RV) function, 6-minute walk test distances, and PE quality-of-life scores (QoL) were assessed.
UNASSIGNED: In total, 799 patients were enrolled and 75% completed the study with a mean follow-up of 204 ± 46 days. Demographic characteristics included 54.1% men, mean age of 61.2 years, 77.1% intermediate-high-risk PE, and 8.0% high-risk PE. All-cause mortality was 4.6% at study completion. The proportion of patients with normal echocardiographic RV function increased from 15.1% at baseline to 95.1% at 6 months (P < .0001). MMRCD score improved from 3.0 at baseline to 0.0 at 6 months (P < .0001). 6-minute walk test distances increased from 180 m at 48 hours to 398 m at 6 months (P < .001). Median PE QoL total scores were 9.38 at 30 days and 4.85 at 6 months (P < .001). Prevalence of site-reported chronic thromboembolic pulmonary hypertension was 1.0% and chronic thromboembolic disease was 1.9%.
UNASSIGNED: In this large diverse group of PE patients, 6-month all-cause mortality, chronic thromboembolic pulmonary hypertension, and chronic thromboembolic disease were low following thrombectomy with the FlowTriever system. Significant improvements in RV function, patient symptoms, exercise capacity, and QoL were observed at 6 months, suggesting that rapid extraction of thrombus may prevent long-term sequelae in patients with PE.