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In this randomized trial, patients undergoing hemodialysis who had native upper-extremity arteriovenous fistula stenosis received drug-coated or standard balloon angioplasty after initial successful transluminal angioplasty. The drug-coated balloon was superior to the standard balloon and was noninferior with respect to access circuit-related serious adverse events.

•STORM-PE is an RCT evaluating CAVT in PE.•STORM-PE includes intermediate high-risk acute PE patients.•The primary endpoint is a change in RV/LV ratio at 48 hours.•Other endpoints are 7-day MAEs, 90-day mortality, and symptomatic PE recurrence.•STORM-PE will also assess patient-centered 90-day functional and QoL outcomes. Therapeutic anticoagulation (AC) is standard care for pulmonary embolism (PE). Endovascular therapy with mechanical thrombectomy (MT) is commonly performed for PE and well-studied in single-arm trials. The efficacy benefit of MT over AC alone in a randomized fashion remains unstudied. STORM-PE (ClinicalTrials.gov Identifier: NCT05684796) is a post-market, international, open-label trial conducted in partnership with The Pulmonary Embolism Response Team Consortium. Up to 100 patients with confirmed acute intermediate-high-risk PE demonstrated by right ventricular (RV) dysfunction with a right-to-left ventricular (RV/LV) ratio ≥1.0 and elevated cardiac biomarkers will be randomized 1:1 to receive AC alone or AC plus computer assisted vacuum thrombectomy (CAVT) with the Indigo Aspiration System (Penumbra Inc.). The primary outcome is a mean change in RV/LV ratio at 48 hours, assessed by computed tomographic pulmonary angiography (CTPA) and adjudicated by a blinded, independent imaging Core Lab. Additional endpoints are composite major adverse events, functional outcomes (6-minute walk test, New York Heart Association classification, post-venous thromboembolism functional status scale, modified Medical Research Council Dyspnea Scale, Borg Scale), quality of life (Pulmonary Embolism Quality of Life Questionnaire and EQ-5D-5L), mortality, and symptomatic PE recurrence through 90 days. A Clinical Events Committee will adjudicate adverse events for causality and attribution and an independent Data Safety Monitoring Board will oversee the study. STORM-PE is funded by Penumbra Inc. The STORM-PE trial will help inform future guidelines and standards of care related to frontline treatment using mechanical thrombectomy with CAVT for patients with acute intermediate-high-risk PE. STORM-PE, NCT05684796, is registered at https://clinicaltrials.gov/study/NCT05684796.

Background Management of PE has become streamlined with the implementation of PE Response Teams (PERT). Race, ethnicity and insurance status are known to influence the outcomes of patients with acute PE. However, whether the implementation of PERT-based care mitigates these racial and ethnic disparities remains unknown. Our aim was to assess the association of race, ethnicity and insurance with outcomes for patients with acute PE managed by PERT. Methods We performed a retrospective chart review of 290 patients with acute PE, who were admitted to one of three urban teaching hospitals in the Mount Sinai Health System (New York, NY) from January 2021 to October 2023. A propensity score-weighted analysis was performed to explore the association of race, ethnicity and insurance status with overall outcomes. Results Median age of included patients was 65.5 years and 149 (51.4%) were female. White, Black and Asian patients constituted 56.2% (163), 39.6% (115) and 3.5% [ 10 ] of the cohort respectively. Patients of Hispanic or Latino ethnicity accounted for 8.3% [ 24 ] of the sample. The 30-day rates of mortality, major bleeding and 30-day re-admission were 10.3%, 2.1% and 12.8% respectively. Black patients had higher odds of major bleeding (odds ratio [OR]: 1.445; p  < 0.0001) when compared to White patients. Patients of Hispanic or Latino ethnicity had lower odds of receiving catheter-directed thrombolysis (OR: 0.966; p  = 0.0003) and catheter-directed or surgical embolectomy (OR: 0.906; p  < 0.0001) when compared to non-Hispanic/Latino patients. Uninsured patients had higher odds of receiving systemic thrombolysis (OR: 1.034; p  = 0.0008) and catheter-directed thrombolysis (OR: 1.059; p  < 0.0001), and lower odds of receiving catheter-directed or surgical embolectomy (OR: 0.956; p  = 0.015) when compared to insured patients, although the odds of 30-day mortality and 30-day major bleeding were not significantly different. Conclusion Within a cohort of PE patients managed by PERT, there were significant associations between race, ethnicity and overall outcomes. Hispanic or Latino ethnicity and uninsured status were associated with lower odds of receiving catheter-directed or surgical embolectomy. These results suggest that disparities related to ethnicity and insurance status persist despite PERT-based care of patients with acute PE.

PurposeTo describe the feasibility, safety and short-term results of prostatic artery embolization (PAE) performed with adjunctive coil embolization of the main prostatic arteries (PA) following particle embolization.Materials and MethodsA total of 95 patients who underwent PAE with adjunctive bilateral coil embolization of the PAs following particle embolization between September 2018 and May 2021 were included. The patients had a mean prostate size of 115 ± 64 ml, 18/95 with hematuria symptoms, and 16/95 with indwelling urinary catheters. Coil embolization was performed in the main PAs prior to the bifurcation into the anteromedial and posterolateral branches using detachable microcoils. International Prostate Symptoms Score (IPSS), quality of life (QOL), maximum flow rate (Qmax) and adverse events were recorded.ResultsIPSS were improved by − 11.2 ± 7.9 (n = 49, P < 0.001) and QOL by − 2.4 ± 1.8 (n = 49, P < 0.001) over a mean follow-up of 10.7 ± 7.9 weeks. Qmax did not demonstrate statistical significance. Twelve patients with hematuria (67%) showed improvement or resolution and twelve patients with indwelling or intermittent catheters (75%) were no longer catheter dependent. Two patients underwent a repeat PAE. There were no adverse events which were attributable to coil embolization.ConclusionAdjunctive coil embolization of the main PAs following particle embolization is a technically feasible technique with similar short-term clinical outcomes compared to prior studies. This novel technique warrants further prospective investigation with controls.

Purpose We describe the anatomic characteristics on preoperative CT angiography (CTA) that predispose to type-2 endoleaks after endovascular aneurysm repair (EVAR) for an abdominal aortic aneurysms (AAA). Methods Between 1999 and 2010, 326 patients had a CTA before and after EVAR. CTAs were reviewed for maximal sac diameter, >50 % circumferential luminal thrombus, and patency of the infrarenal aortic side branches, including the inferior mesenteric artery (IMA) and L2-L5 lumbar arteries. Postoperative CTAs were reviewed for a persistent type-2 endoleak. Results Of 326 patients, 30.4 % had a type-2 endoleak on CTA. Univariate analysis demonstrated a patent IMA, increased patent individual L2, L3, and L4 lumbar arteries, and an increased number of total patent lumbar arteries in patients with type-2 endoleak compared to those without ( p  < 0.001, 0.002, <0.001, <0.001, and <0.001 respectively). Sac diameter, patent L5 lumbar arteries, and >50 % circumferential mural thrombus were not significantly different ( p  = 0.652, 0.617, and 0.16). Univariate logistic regression demonstrated increased risk of endoleak with each additional patent lumbar artery (odds ratio (OR) 1.26, p  < 0.001). Multivariate analysis of the 326 patients resulted in the delineation of the optimal anatomic variables that predicted a type-2 endoleak: occluded L3 lumbar arteries (OR 0.1, p  = 0.002), occluded L4 lumbar vertebral arteries (OR 0.31, p  = 0.034), and IMA occlusion (OR 0.38, p  = 0.008). Conclusions Univariate analysis demonstrated total patent lumbar arteries as a significant predictor of type-2 endoleak. Multivariate analysis demonstrated IMA occlusion, L3 lumbar artery occlusion, and L4 lumbar artery occlusion as independently protective against type-2 endoleak after EVAR.

Background Mesenteric metastases from small-bowel neuroendocrine tumors (SBNETs) present a surgical challenge due to encasement of mesenteric vessels. In this study, we evaluate the feasibility and safety of a new, hybrid surgical approach to these mesenteric masses, EndoVascular Occlusion and Tumor Excision (EVOTE). Methods From 2014 to 2018, 13 patients underwent the EVOTE procedure after being referred to our institution for primary SBNETs with “unresectable” mesenteric metastases. During stage 1 of the hybrid EVOTE procedure, angiographic evaluation of the mesenteric mass is performed. If adequate collateralization is demonstrated, the encased mesenteric vessel(s) is embolized. Mass excision is performed the following day during stage 2 of the EVOTE procedure. Results Preoperative embolization was successful in 86% of cases; 2 cases were aborted for persistent abdominal pain following occlusion testing. Complete surgical excision of the mesenteric mass was achieved in 86% of cases. The 30-day overall morbidity and mortality rate was 29% and 0%, respectively. There was one local recurrence at 31.8 months post-op; this patient underwent a repeat EVOTE procedure with successful complete excision. Discussion EVOTE represents a new technique that aids in preoperative planning and surgical resection of SBNETs with mesenteric metastases.

Background High venous thromboembolism (VTE) rates have been described in critically ill patients with COVID-19. We hypothesized that specific clinical characteristics may help differentiate hypoxic COVID-19 patients with and without a diagnosed pulmonary embolism (PE). Methods We performed a retrospective observational case-control study of 158 consecutive patients hospitalized in one of four Mount Sinai Hospitals with COVID-19 between March 1 and May 8, 2020, who received a Chest CT Pulmonary Angiogram (CTA) to diagnose a PE. We analyzed demographic, clinical, laboratory, radiological, treatment characteristics, and outcomes in COVID-19 patients with and without PE. Results 92 patients were negative (CTA-), and 66 patients were positive for PE (CTA+). CTA + had a longer time from symptom onset to admission (7 days vs. 4 days, p = 0.05), higher admission biomarkers, notably D-dimer (6.87 vs. 1.59, p < 0.0001), troponin (0.015 vs. 0.01, p = 0.01), and peak D-dimer (9.26 vs. 3.8, p = 0.0008). Predictors of PE included time from symptom onset to admission (OR = 1.11, 95% CI 1.03–1.20, p = 0.008), and PESI score at the time of CTA (OR = 1.02, 95% CI 1.01–1.04, p = 0.008). Predictors of mortality included age (HR 1.13, 95% CI 1.04–1.22, p = 0.006), chronic anticoagulation (13.81, 95% CI 1.24–154, p = 0.03), and admission ferritin (1.001, 95% CI 1-1.001, p = 0.01). Conclusions In 158 hospitalized COVID-19 patients with respiratory failure evaluated for suspected PE, 40.8% patients had a positive CTA. We identified clinical predictors of PE and mortality from PE, which may help with early identification and reduction of PE-related mortality in patients with COVID-19.