Dual-layered micromesh stent technology for embolic prevention in carotid revascularization: technical experience and clinical outcomes from a high-volume interventional radiology center.

BACKGROUND: Carotid artery stenting (CAS) has become a cornerstone of carotid revascularization for stroke prevention. Despite the advantages of CAS, large-scale randomized trials involving prior (single-layer) generation of carotid stents demonstrated its higher risk of periprocedural cerebrovascular events compared to carotid endarterectomy (CEA). Dual-layer mesh-covered stents (DLSs) showed promising results in terms of 30-day embolic events. This study aims to evaluate 30-day clinical efficacy of DLS against a closed-cell single-layer stent, based on large-volume data. METHODS: The study center is part of the Italian National Outcomes Evaluation Program (PNE). CAS procedures performed between November 2017 and September 2023 were retrospectively analyzed. Our primary endpoint was 30-day survival free of death, stroke, and myocardial infarction (MI). Periprocedural stroke rate, technical success and restenosis rate of CAS procedures performed with DLSs and first-generation stents (FGSs) were also evaluated. RESULTS: Over a total of 1101 CAS procedures (55 men; 745 males; mean age of 79±7.8 years), 80.2% were treated with DLS and 48.6% were symptomatic. The cumulative stroke-, MI- and death-free 30-day survival was 98.9%, Technical success was achieved in 98.9% of cases. The DLS group showed significantly lower 30-day death, stroke and death+stroke and periprocedural minor stroke rates compared to FGS group (P=0.04; P=0.04; P=0.003 and P=0.0002, respectively). CONCLUSIONS: The use of DLS in patients undergoing CAS in our large-volume center showed a high technical success rate and minimal cerebral embolic complications by 30 days. High volumes and an experienced interventional team may contribute to these favorable outcomes.

The role of post-dilatation in carotid MicroNet-covered stent implantation, evaluated using 3D cone-beam CT angiography.

BACKGROUND: This study aims to assess the role and safety of post-dilatation in protected carotid artery stenting (PCAS) using the new MicroNet-covered 2nd-generation stent assessed by cone beam CT scans. METHODS: From March 2020 to March 2022, patients were enrolled in the study according to CT angiography results based on the following criteria: Evidence of 70% to 99% carotid stenosis in asymptomatic patients and 50% to 99% in symptomatic patients, per the NASCET index. Using a FilterWire EZ™ (Boston Scientific, Natick, MA, USA) embolic protection system (EPS), MicroNet-covered stent PCAS was performed by two interventional radiologists with at least 8 years of experience in endovascular intervention. Each patient underwent post-dilatation following stent placement. Finally, a third radiologist (not participating in the interventional procedures) evaluated the cone beam CT scans and calculated residual stenosis. Major and minor complications were recorded in the 30 days following the procedure. RESULTS: A total of 192 patients (121 male, mean age 73±10 years) were included in the study, and all patients received post-dilatation following stent implantation. Technical successes were achieved in all procedures. Adverse events noted in this study were limited to periprocedural transient ischemic attacks that occurred in three out of 192 patients (1.6%) and showed a swift complete recovery. The post-dilatation balloon diameters used in the study were: 5.0 mm (30.3%), 5.5 mm (39.3%) and 6 mm (30.3%). Optimized postdilatation resulted in a significant increase in the final luminal area. Similar improvements were observed in all subtypes of plaque. CONCLUSIONS: Post-dilatation in protected CAS is safe and induces a significant improvement in the cross-sectional area regardless of the stenotic plaque.

MRI-guided thoraco-abdominal percutaneous needle biopsy: our initial experience.

OBJECTIVE: The aim of this study is to describe the technique and to report early results of thoraco-abdominal biopsies in the Interventional Magnetic Resonance Imaging Suite (IMRIS). MATERIALS AND METHODS: We prospectively evaluated patients with indications for MRI-guided biopsy between January 2021 and May 2022. Exclusion criteria were indication for US-/CT-guided biopsy, contraindication to percutaneous biopsy, inability to lie flat for at least 30 min, claustrophobic, severe obesity, or non-MRI compatible devices. Biopsies were performed by 3 interventional radiologists, with at least 8 years of experience in oncological interventional radiology. Epidemiological, clinical, procedural, and histopathological data were retrospectively collected. RESULTS: From an initial population of 117 patients, 57 patients (32 male, mean age 64 ± 8 y) were finally enrolled. All 57 patients suspected thoraco-abdominal malignant lesions finally underwent MRI-guided percutaneous biopsy. The mean duration of the entire procedure was 37 min (range 28-65 min); the mean duration of the total needle-in-patient time was 10 min (range 6-19 min). Technical and clinical success were obtained for all the biopsies performed. Malignancy was demonstrated in 47/57 (82%) cases and benignancy in the remaining 10/57 (18%) cases. No major complications were detected after the biopsies; two minor compliances (severe pain) occurred and were managed conservatively. CONCLUSION: Our initial experience demonstrated the technical feasibility and the accuracy of MRI-guided biopsies of thoraco-abdominal masses. The reported data associated with the best comfort for the patient and for the operator make the use of MRI a valid alternative to other methods, especially in lesions that are difficult to approach via US or CT. CLINICAL RELEVANCE STATEMENT: Interventional MRI is one of the most important innovations available for interventional radiologists. This method will broaden the diagnostic and therapeutic possibilities, allowing treatment of lesions up to now not approachable percutaneously. For this, it is necessary to start publishing the data of the few groups that are developing the method. KEY POINTS: • To evaluate the use of MRI as a guide for percutaneous biopsies of various districts. • Our preliminary experience confirms experience demonstrated the technical feasibility and the accuracy of MRI-guided biopsies of thoraco-abdominal masses. • Interventional MRI can become the reference method for percutaneous biopsies in particular for lesions with difficult percutaneous approach.

Anatomical Modifications After Stent Implantation: A Comparative Analysis Between CGuard, Wallstent, and Roadsaver Carotid Stents.

PURPOSE: Carotid revascularization can be associated with modifications of the vascular geometry, which may lead to complications. The changes on the vessel angulation before and after a carotid WallStent (WS) implantation are compared against 2 new dual-layer devices, CGuard (CG) and RoadSaver (RS). MATERIALS AND METHODS: The study prospectively recruited 217 consecutive patients (112 GC, 73 WS, and 32 RS, respectively). Angiography projections were explored and the one having a higher arterial angle was selected as a basal view. After stent implantation, a stent control angiography was performed selecting the projection having the maximal angle. The same procedure is followed in all the 3 stent types to guarantee comparable conditions. The angulation changes on the stented segments were quantified from both angiographies. The statistical analysis quantitatively compared the pre-and post-angles for the 3 stent types. The results are qualitatively illustrated using boxplots. Finally, the relation between pre- and post-angles measurements is analyzed using linear regression. RESULTS: For CG, no statistical difference in the axial vessel geometry between the basal and postprocedural angles was found. For WS and RS, statistical difference was found between pre- and post-angles. The regression analysis shows that CG induces lower changes from the original curvature with respect to WS and RS. CONCLUSION: Based on our results, CG determines minor changes over the basal morphology than WS and RS stents. Hence, CG respects better the native vessel anatomy than the other stents.Level of Evidence: Level 4, Case Series.

Interprofessional collaboration between different health care professions in Emilia Romagna.

BACKGROUND: Interprofessional collaboration in the healthcare sector contributes to the delivery of high quality and safe services to patients across different subdivisions of the healthcare system which is faced with constant challenges. The international literature offers a plethora of tools for assessing the collaboration between health workers, but only a few of these have been validated in the Italian language. One that has undergone such validation is the interprofessional collaboration (IPC) scale, which measures the perception of collaboration among health professionals. An advantage of this scale is that is addresses all workers within the system, and is not limited to specific professions. The aim of the present study was to apply the validated Italian version of the IPC scale, to a context different to the one used for its validation, to measure the level of collaboration between different health care workers. METHOD: A questionnaire-based study was conducted on a sample consisting of 329 health professionals working at Azienda USL-IRCCS in Reggio Emilia. The categorical and continuous variables were analysed using descriptive statistics (frequencies, percentages and SD). RESULTS: The IPC scale showed physicians to express the highest level of collaboration with other professionals, in line with the results of other studies in the literature. The values calculated for the factors "accommodation" and "communication" were higher than for "isolation", depicting a good level collaboration. The only case in which the isolation factor, which describes an absence of collaboration, was equal to the other two factors was in relation to the evaluation of midwives by nursing aides/orderlies. CONCLUSIONS: In conclusion, the Italian version of the IPC scale provides a useful instrument for measuring interprofessional collaboration between workers in the healthcare sector. In the present study, it revealed a satisfactory level of collaboration between health professionals in an organization located in Emilia Romagna, Italy.

Intra-procedural dual phase cone beam computed tomography has a better diagnostic accuracy over pre-procedural MRI and MDCT in detection and characterization of HCC in cirrhotic patients undergoing TACE procedure.

PURPOSE: This study was directed to compare diagnostic accuracy of dual-phase cone beam computed tomography (DP-CBCT) vs pre-procedural second line imaging modality (SLIM [multidetector computed tomography and magnetic resonance imaging]) to detect and characterize hepatocellular carcinoma (HCC) in cirrhotic patients with indication for trans-arterial chemoembolization (TACE). METHODS: This is a single centre, retrospective, and observational study. Exclusion criteria were not-assisted DP-CBCT TACE, and unavailable follow-up SLIM. We evaluated 280 consecutive patients (January/2015-Febraury/2019). Seventy-two patients were eligible. Three radiologists in consensus reviewed: pre-procedural SLIM, DP-CBCT, and SLIM at follow-up, with 4 months of interval between each reading. Hyper-vascular foci (HVF) were detected and characterized. Diameter was recorded. Radiological behaviour, according to LI-RADS criteria, of HFV throughout follow-up time was the reference standard. Diagnostic accuracy was calculated for pre-procedural SLIM and DP-CBCT and evaluated through receiver operating characteristic curve. HVF only visible on DP-CBCT (defined as occult) were analysed. Tumour diameters were compared. RESULTS: Median time between pre-procedural SLIM and DP-CBCT and between DP-CBCT and definitive radiological diagnosis of HVF were 46.0 days (95%CI 36.5-55.0) and 30.5 days (95%CI 29.0-33.0), respectively. DP-CBCT had a better diagnostic performance than pre-examination SLIM (sensitivity 99%vs78%; specificity 89%vs85%; PPV 99%vs99%; NPV 92%vs30%; and accuracy 94%vs79%). DP-CBCT diagnosed 63 occult HVF. Occult HCC were 54/243 (22.2%). Six were occult angiomas. Three were false positive. Mean diameter was significantly higher in DP-CBCT vs pre-procedural SLIM (+7.5% [95%CI 3.7-11.3], p < 0.05). CONCLUSIONS: DP-CBCT has a better diagnostic accuracy and NPV than pre-procedural SLIM in cirrhotic patients with indication for TACE.

Sequential dual-phase cone-beam CT is able to intra-procedurally predict the one-month treatment outcome of multi-focal HCC, in course of degradable starch microsphere TACE.

OBJECTIVE: To evaluate the prognostic value of sequential dual-phase CBCT (DP-CBCT) imaging performed during degradable starch microsphere TACE (DSM-TACE) session in predicting the HCC's response to treatment, evaluate with modify response evaluation criteria in solid tumours (mRECIST) at 1-month multi-detector CT (MDCT) follow-up. MATERIALS AND METHODS: Between January and May 2018, 24 patients (68.5 ± 8.5 year [45-85]) with HCC lesions (n = 96 [average 4/patient]) were prospectively enrolled. Imaging assessment included: pre-procedural MDCT, intra-procedural DP-CBCT performed before first and second DSM-TACEs and 1-month follow-up MDCT. Lesions' attenuation/pseudo-attenuation was defined as average value measured on ROIs (HU for MDCT; arbitrary unit called HU* for CBCT). Lesions' attenuation modification was correlated with the post-procedural mRECIST criteria at 1-month MDCT. RESULTS: Eighty-two DSM-TACEs were performed. Lesion's attenuation values were: pre-procedural MDCT arterial phase (AP) 107.00 HU (CI 95% 100.00-115.49), venous phase (VP) 85.00 HU (CI 95% 81.13-91.74); and lesion's pseudo-attenuation were: first CBCT-AP 305.00 HU* (CI 95% 259.77-354.04), CBCT-VP 155.00 HU* (CI 95% 135.00-163.34). For second CBCT were: -AP 210.00 HU* (CI 95% 179.47-228.58), -VP 141.00 HU* (CI 95% 125.47-158.11); and for post-procedural MDCT were: -AP 95.00 HU (CI 95% 81.35-102.00), -VP 83.00 HU (CI 95% 78.00-88.00). ROC curve analysis showed that a higher difference pseudo-attenuation between first and second DP-CBCTs is related to treatment response. The optimal cut-off value of the difference between first and second CBCT-APs to predict complete response, objective response (complete + partial response) and overall disease control (objective response + stable disease) were > 206 HU* (sensitivity 80.0%, specificity 81.7%), > 72 HU* (sensitivity 79.5%, specificity 83.0%) and > - 7 HU* (sensitivity 91.6%, specificity 65.4%), respectively. CONCLUSIONS: DP-CBCT can predict intra-procedurally, by assessing lesion pseudo-attenuation modification, the DSM-TACE 1-month treatment outcome.

Balloon-Occluded Transcatheter Arterial Chemoembolization (b-TACE) for Hepatocellular Carcinoma Performed with Polyethylene-Glycol Epirubicin-Loaded Drug-Eluting Embolics: Safety and Preliminary Results.

PURPOSE: To report technical success, safety profile and oncological results of balloon-occluded transcatheter arterial chemoembolization using a balloon micro-catheter and epirubicin-loaded polyethylene-glycol (PEG) microsphere (100 ± 25 µm and 200 ± 50 µm) in patients with hepatocellular carcinoma (HCC). MATERIALS AND METHODS: This is a single-centre, single-arm, retrospective study with 6-month follow-up. Twenty-two patients (Child-Pugh A 68% [15/22], B in 32% [7/22]; age 67.05 ± 14 years) with 29 HCC were treated in 24 procedures. Technical success is defined: ability to place the balloon micro-catheter within the required vascular segment, balloon-occluded arterial stump pressure drops and assessment of microsphere deposition. Laboratory assessment pre/post-procedural and complications were analysed, respectively, according to Common Terminology Criteria for Adverse Events (CTCAEv5) and CIRSE system. Postembolization syndrome (PES) was defined as fever and/or nausea and/or pain onset. Oncological results were evaluated using m-RECIST criteria with CT/MRI imaging at 1 and 3-6 months. In partial responder patients, pre/post-procedural tumour volume was compared. RESULTS: Pre-planned feeder was reached in all cases. Pressure drop average was 51.1 ± 21.6 mmHg. Exclusive target embolization was achieved in 14/24 procedures (58.3%). Laboratory test modifications were all grade 1. 4/24 adverse events occurred (17%): pseudo-aneurysm of the feeder (grade 3), liver abscess (grade 2) and 2 asymptomatic segmentary biliary tree dilatations (grade 2). PES occurred in 8/24 (33%). The complete response at 1 and 3-6 months was 44.8% (13/29) and 52.9% (9/17), respectively. The partial response at 1 and 3-6 months was 55% (16/29) and 4/17 (23.5%), respectively. Among partial responder patients, the average percentage of tumour volume reduction was 64.9 ± 27.3%. CONCLUSION: Epirubicin-loaded PEG microsphere b-TACE is technically feasible, safe and effective procedure for HCC treatment.

A Steerable Sheath to Deploy Hypogastric Bridging Stent by Contralateral Femoral Approach in an Iliac Branch Procedure after Endovascular Aneurysm Repair.

Aneurysmal degeneration of distal landing zones after endovascular aneurysm repair (EVAR) can be a potential cause of late failure of this technique. Aneurysmal degeneration of common iliac arteries increases the risk of rupture of the iliac aneurysm itself as well as of the abdominal aortic aneurysm owing to aneurysm's reperfusion as a type Ib endoleak. Reoperation consists in plugging and covering the internal iliac artery (IIA), by extension into the external iliac artery, or preservation of antegrade flow in IIA by iliac branch devices (IBDs) or sandwich technique. The management of common iliac aneurysms after EVAR with the purpose of preserving antegrade flow into IIA generally requires a brachial or axillary access. However, this approach may be theoretically associated with local or systemic complications. We report a case of IBD implantation after EVAR, using a steerable sheath for IIA bridging stent deployment via contralateral femoral approach.

Risk Factors for Immediate and Delayed-Onset Fever After Percutaneous Transhepatic Biliary Drainage.

OBJECTIVES: To prospectively investigate the pre and intra-procedural risk factors for immediate (IF) and delayed-onset (DOF) fever development after percutaneous transhepatic biliary drainage (PTBD). METHODS: Institutional review board approval and informed patient consent were obtained. Between February 2013 and February 2014, 97 afebrile patients (77 at the Sapienza University of Rome, Italy and 20 at the Sun Yat-sen University of Guangzhou, China) with benign (n = 31) and malignant (n = 66) indications for a first PTBD were prospectively enrolled. Thirty pre- and intra-procedural clinical/radiological characteristics, including the amount of contrast media injected prior to PTBD placement, were collected in relation to the development of IF (within 24 h) or DOF (after 24 h). Fever was defined as ≥37.5 °C. Binary logistic regression analysis was used to assess independent associations with IF and DOF. RESULTS: Fourteen (14.4%) patients developed IF and 17 (17.5%) developed DOF. At multivariable analysis, IF was associated with pre-procedural absence of intrahepatic bile duct dilatation (OR 63.359; 95% CI 2.658-1510.055; P = 0.010) and low INR (OR 4.7 × 10(-4); 95% CI 0.000-0.376; P = 0.025), while DOF was associated with unsatisfactory biliary drainage at the end of PTBD (OR 4.571; 95% CI 1.161-17.992; P = 0.030). CONCLUSIONS: The amount of contrast injected is not associated with post-PTBD fever development. Unsatisfactory biliary drainage at the end of PTBD is associated with DOF, suggesting that complete biliary tree decompression should be pursued within the first PTBD. Patients with unsatisfactory drainage and those with the absence of pre-procedural intrahepatic bile duct dilatation, which is associated with IF, require tailored post-PTBD management.