Journal of Vascular and Interventional Radiology最新文献

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Purpose: To present the results of the Liquid Embolization of Arterial Hemorrhages in Peripheral Vasculature (LAVA) study evaluating safety and efficacy of Lava Liquid Embolic System (Lava LES), an ethylene vinyl alcohol (EVOH), for peripheral arterial hemorrhage (PAH).

Materials and methods: LAVA was a pivotal, prospective, multicenter, single-group, centrally adjudicated study of adults with active PAH. Patients received EVOH at one of two viscosities, administered by experienced physicians. Primary safety endpoint was freedom from 30-day major adverse events (MAE) defined as ischemia/infarction of target territory, non-target embolization, allergic reaction, and catheter breakage/entrapment. Primary efficacy endpoint was 30-day clinical success defined as absence of bleeding from target lesion after embolization without need for emergency surgery, re-embolization, or other target lesion re-interventions. Secondary endpoints included serious adverse events and mortality.

Results: 113 patients (mean age 57.4 years [SD 18.0; range 18.0-93.0]; 63.7% male) with 148 lesions were enrolled at 19 US centers. Targeted areas included non-gastrointestinal (GI) visceral arteries (31.1%), kidneys (26.3%), upper GI (11.5%), lower GI (6.8%) and extremities (6.1%). Empiric embolization was performed for 20.9% of lesions. The primary efficacy endpoint was achieved in 94.3% of lesions (95.3% patients), exceeding the performance goal of 72%. Two target lesions treated with EVOH required subsequent re-embolization. No surgeries were performed for bleeding or ischemia. There were no MAEs reported per study definition. All-cause mortality rate at 30 days was 8.3%.

Conclusions: The LAVA study suggests that EVOH is effective and can be safely used as an embolic agent for treatment of PAH.

Purpose: To assess the safety and efficacy of Y90 radiation segmentectomy (RS) for neuroendocrine tumor liver metastases (NELMs).

Materials and methods: This single-institution retrospective study included 18 patients with 23 liver tumors not amenable to resection or ablation, who underwent RS between 2009 and 2021. Tumor grades by Ki-67/mitotic indices were Grade I (n=9/23, 39%), Grade II (n=10/23, 45%) and Grade III (n=4/23, 17%). Eleven patients (61%) were previously treated with somatostatin analogs, five (28%) with chemotherapy, and two (11%) with peptide receptor radionuclide therapy. Safety was assessed with pre/post liver chemistries, blood counts and clinical adverse events (AEs) using National Cancer Institute Common Terminology Criteria for AEs v5.0. Tumor response was assessed per Response Evaluation Criteria in Solid Tumors 1.1 and modified RECIST criteria. Kaplan-Meier analysis was used to estimate median overall survival (OS), progression-free survival (PFS), and time to progression (TTP) from the date of Y90.

Results: Median follow-up was 31.9 months. Grade 1 fatigue was observed in 13/18 patients (72%), with 1/18 patient (6%) experiencing grade 3 fatigue. Three patients (17%) exhibited grade 3 lymphopenia. No other grade 3 or any grade 4 AE was observed. Tumor objective response was achieved in 83% of patients by RECIST size criteria and 100% by mRECIST enhancement criteria. Median OS was 69.4 months (95% CI, 23.1-99.4) and median PFS was 12.2 months (95% CI, 4.6-28.8). Median overall TTP was 13.0 months (95% CI, 4.6-45.1), with median treated tumor TTP not reached.

Conclusion: Y90 RS demonstrates high rates of antitumor response with a favorable toxicity profile and durable OS in the treatment of NELMs.

Background: To assess the mid to long-term safety and efficacy of Prostatic Artery Embolization (PAE) at a single-center, cohort of 1075 patients.

Methods: This IRB-approved retrospective-study included patients with moderate-to-severe Lower-Urinary-Tract-Symptoms(LUTS) or urinary-retention who underwent PAE from January-2014 to July-2023. Patients were assessed at 1, 3, 6, and 12-months post-PAE and yearly thereafter. International-Prostate-Symptom-Score(IPSS), Quality-of-Life(QoL) score, International-Index of Erectile-Function-5 score(IIEF-5), Prostate-Specific-Antigen(PSA), Prostate-volume(PV), Post-void-Residual(PVR), Benign-Prostatic-Obstruction(BPO)-medication usage, urinary-catheter status, and further prostate-interventions were assessed. Adverse-events were recorded and classified using the Society of Interventional-Radiology Adverse-Events(SIR-AE) severity classification.

Results: The mean follow-up was 458.4±559.5 days. Mean age was 70.4±9.0 years, median(IQR) prostate-volume was 107gm(76-150), median pre-procedure IPSS, QoL, IIEF-5, and PSA were 23(18-28), 5(4-6), 17(10-21), and 4.7(2.6-8), respectively. In the LUTS subgroup, at 1-3, 6-12, and 48-60 months, the median-IPSS was 7(4-12, p<0.001), 6(3-11, p<0.001), and 9(4-15, p<0.001). The QoL was 2(1-2, p<0.001), 1(0-2, p<0.001), 2(0-3, p<0.001) at the same time-points. 119(94%) out of 126-patients in the retention cohort were catheter-free at the 3-month follow-up. Ninety-patients(16% of re-intervention eligible patients) required a second prostatic-intervention upto 60-months post-PAE. 65.5% of patients post-PAE were BPO-medication-free at 1-year. 7 patients (0.65%) had SIR-AE severity-Severe: transient ischemic-attacks:3, Urosepsis-2 (treated in inpatient-setting with IV-antibiotics), prostate-sloughing-2(needing TURP). All adverse events resolved without sequelae.

Conclusion: In a large cohort with long-term longitudinal follow-up, PAE shows significant, sustained long-term relief of LUTS, improved QoL, low re-intervention rate, and high BPO medication-free rates. 94% of catheter-dependent patients at baseline were catheter-free at 3-months.

Purpose: To assess the delivery, function, and patency of a new expanded polytetrafluoroethylene encapsulated TIPS stent- graft ("Liverty") in an animal model.

Materials and methods: TIPS were created in 2 successive groups: 14 single & 10 overlapping devices, in swine weighing 52-64kg. Explants occurred at 30 (n=10) and 60 (n=14) days. These were evaluated by histomorphometry and histopathologic evaluations, and electron microscopy.

Results: Seven 6mm, five 7mm, and twelve 10mm diameter TIPS were created using varied human TIPS access sets without complications; both sheathed and unsheathed advancement and deployment of the devices within liver tracts. One animal was sacrificed at 35d due to encephalopathy; remainder survived to endpoints. 22/24 TIPS were patent at 30 and 60-day endpoints; Mean stenosis at 30 days was 13.3% +/- 10.1%, and for 60 days was 18.44% ± 5.04%. Two shunts were occluded by tissue overgrowth at unstented native hepatic vein end and downgrowth into TIPS. Histology and electron microscopy showed well-apposed, incorporated devices lined with smooth, uniform neointimal tissue averaging 0.48mm (single devices) and 0.74mm thick (overlapped devices) with minimal adventitial inflammation.

Conclusion: The new Liverty TIPS stent graft was straightforward to deploy for TIPS creation and resulted in patent 6,7, and 10mm diameter shunts in both single and overlapping configurations. One- and 2-month histology showed desired tissue healing without in-stent stenosis.