Catheter-directed thrombolysis (CDT) has been associated with rapid recovery of right ventricular (RV) function. The Bashir catheter was developed for enhanced thrombolysis in large vessels such as the pulmonary arteries (PAs) with lower doses of tissue plasminogen activator (tPA). The aim of this study was to evaluate the efficacy and safety of tPA infused using a pharmacomechanical (PM) CDT device called the Bashir endovascular catheter in patients with intermediate-risk acute pulmonary embolism (PE). Patients with symptoms of acute PE with computed tomographic evidence of RV dilatation were enrolled. The Bashir catheter was used to deliver 7 mg tPA into each PA over 5 hours. The primary efficacy endpoint was the core laboratory-assessed change in computed tomographic angiography-derived RV/left ventricular (LV) diameter ratio at 48 hours, and the primary safety endpoint was serious adverse events (SAEs) including major bleeding at 72 hours. At 18 U.S. sites, 109 patients were enrolled. The median device placement time was 15 minutes. At 48 hours after PM-CDT, the RV/LV diameter ratio decreased by 0.56 (33.3%; P < 0.0001). PA obstruction as measured by the refined modified Miller index was reduced by 35.9% (P < 0.0001). One patient (0.92%) had 2 SAEs: a retroperitoneal bleed (procedure related) and iliac vein thrombosis (device related). Two other procedure-related SAEs were epistaxis and non-access site hematoma with anemia. PM-CDT with the Bashir endovascular catheter is associated with a significant reduction in RV/LV diameter ratio and a very low rate of adverse events or major bleeding in patients with intermediate-risk acute PE. The notable finding was a significant reduction in PA obstruction with low-dose tPA. (Recombinant tPA by Endovascular Administration for the Treatment of Submassive PE Using CDT for the Reduction of Thrombus Burden [RESCUE]; NCT04248868).

Superior vena cava (SVC) syndrome is caused by the obstruction of the SVC and can result in significant morbidity and mortality. In contemporary practice, endovascular therapy (ET) has become the standard of care for a majority of these patients. This study is a systematic review and meta-analysis of the available literature to assess technical success, restenosis, and recurrence of SVC syndrome following endovascular intervention. For this meta-analysis, we conducted a systematic literature review of PubMed, Cochrane Library, and Embase databases from inception to April 14, 2021 for studies on ET for SVC syndrome. Studies included full-length journal articles on the use of ET among adults with SVC syndrome. Case reports or case series with fewer than 20 patients were excluded. We evaluated the endpoints of technical success rate, restenosis rate, and recurrence rates in SVC syndrome patients after endovascular stenting. The results of this study were calculated using random-effects models. We identified 6,012 reports, of which 39 studies met our inclusion criteria and were included for analysis. A total of 2200 patients received ET for SVC syndrome. The weighted technical success rate was 98.8% (95% CI 98.2–99.3) with low heterogeneity (I2=17.4%, p = 0.185), restenosis rate was 10.5% (95% CI 8.4–12.6) with moderate heterogeneity (I2=53.5%, p<0.001), and recurrence rate was 10.8% (95% CI 8.1–13.5) with high heterogeneity (I2=75.8%, p<0.001). Total complication rate was 8.6% (95% CI 7.3%-9.9%) with a mean complication rate of 7.5% (95% CI 4.7%-10.3%). Our systematic review revealed high technical success, low restenosis, and low recurrence rates following ET. Collectively, these results support the paradigm of ET as an effective and safe treatment for patients with SVC syndrome. None.

The effectiveness of inferior vena cava filter (IVCF) insertion in reducing venous thromboembolism (VTE)-associated morbidity and mortality is uncertain.¹ Nevertheless, IVCF placement rates in the United States have been rapidly increasing and are 25-fold higher than in Europe.¹ Prompted by the report by Nicholson et al² in this journal of high prevalence of fracture and embolization, with potentially life-threatening sequelae of the Bard Recovery and Bard G2 IVC filters, the US Food and Drug Administration (FDA) issued a device safety warning on August 9, 2010, after reviewing 921 adverse events (ie, device migration, fracture, thrombosis) reported over a 5-year period.³ We sought to assess the nationwide utilization rates of IVCF placement in the United States and the impact of this FDA advisory. We also evaluated VTE-related hospitalization rates during the same period to determine whether any change in IVCF utilization could be accounted for by changes in VTE-related hospitalizations. Temple University waived the requirement for institutional review board approval.