Prognostic risk factors for loss of patency after femoropopliteal bailout stenting with dual-component stent: results from the TIGRIS Italian Multicenter Registry.

PURPOSE: To identify the risk factors associated with patency loss after bailout stenting with third-generation hybrid heparin-bonded nitinol stent of the femoropopliteal segment. METHODS: Prospective, multicenter, single-arm registry including 156 patients (50 females, mean age 72 ± 11 years) subjected, from February 2017 to December 2018, to provisional stenting with Gore Tigris vascular stent of the distal superficial femoral artery, with or without involvement of the popliteal artery, in 9 different centers. The 194 lesions, with Rutherford score ≥ 3, were stented in case of recoil, dissection or residual stenosis not responding to percutaneous trans-luminal angioplasty (PTA). The follow-up (FU) was performed with clinical evaluation and duplex ultrasound (DUS) at 1, 6 and 12 months. RESULTS: The primary patency rate was 99(95%CI 98-100)% at 1 month, 86(80-92)% at 6 months and 81(74-88)% at-12 months. After patency loss, 13/23 (56.5%) patients were re-treated, yielding a primary assisted patency of 91(86-96)% at 6 months and 88(82-94)% at 12 months and a secondary patency of 94(90-98)% at 6 months and 90(84-95)% at 12 months. Rutherford score ≥ 4 (p = 0.03) and previous severe treatments (p = 0.01) were identified as risk factors for early patency loss during FU. The involvement of the popliteal artery was not an independent risk factor for loss of patency. CONCLUSIONS: The bailout stenting of the femoropopliteal segment with third-generation nitinol stents is a safe and effective option in case of recoil, dissection or residual stenosis not responding to PTA. Critical limb ischemia and history of previous major treatment at the same level are significant prognostic factors for patency loss during FU.

Mechanical thrombectomy in patients with proximal occlusions and low NIHSS: Results from a large prospective registry.

BACKGROUND: Mechanical thrombectomy is now standard of care for treatment of acute ischemic stroke secondary to large vessel occlusion in the setting of high NIHSS. We analysed a large nationwide registry focusing on patients with large vessel occlusion and low NIHSS on admission to evaluate the efficacy and safety of thrombectomy in this patient population METHODS: 2826 patients treated with mechanical thrombectomy were included in a multicentre registry from January 1, 2011 to December 31, 2015. We included patients with large vessel occlusion and NIHSS ≤ 6 on admission. Baseline characteristics, imaging, clinical outcome, procedure adverse events and positive and negative outcome predictors were analysed. RESULTS: 134 patients were included. 90/134 had an anterior circulation and 44 a posterior circulation stroke. One patient died before treatment. Successful revascularization (mTICI 2b-3) was achieved in 73.7% (98/133) of the patients. Intraprocedural adverse event was observed in 3% (4/133) of cases. Symptomatic intracranial haemorrhage rate was 5.3% (7/133). At three months, 70.9% (95/134) of the patients had mRS score 0-2, 15.7% (21/134) mRS 3-5 and 13.4% (18/134) mRS 6. Age and successful recanalization were significant predictors of a good clinical outcome on both univariate (p= 0.005 and p=0.007) and multivariable (p=0.0018 and p=0.009 [nat log]) analysis. Absence of vessel recanalization and symptomatic intracranial hemorrhage were independent predictors of poor outcome (p=0.021) . CONCLUSIONS: Our study suggests that patients with large vessel occlusion and low NIHSS score on admission can benefit from mechanical thrombectomy. Randomized trials are warranted.

Endovascular repair of popliteal artery aneurysms: an Italian multicenter study.

PURPOSE: The aim of our study is to assess the effectiveness of popliteal artery aneurysm (PAA) endovascular treatment. BASIC PROCEDURES: We retrospectively evaluated 48 high-surgical-risk patients that presented at our three departments with evidence of popliteal artery aneurysms, both symptomatic and asymptomatic, and were therefore treated by deployment of stent graft. Immediate technical success was 100%. No periprocedural complications occurred. MAIN FINDINGS: During a mean follow-up of 24.5 months (range 6-72), 12/48 occlusions of stent graft occurred, five of which occurred in the first 30 days after the procedure while other seven occurred during long-term follow-up. Primary stent patency rate was 70.8% and secondary stent patency rate was 89.6% at 1 year. No limb amputation was witnessed. CONCLUSIONS: According to our experience, endovascular approach appeared as an effective treatment for popliteal artery aneurysms, as it appeared affected by a low rate of peri- and post-procedural complications. It could be proposed as treatment of choice in patients with high surgical risk.

Embo-EVAR: A Technique to Prevent Type II Endoleak? A Single-Center Experience.

BACKGROUND: Intraprocedural aneurysm sac embolization (embo-EVAR) during endovascular abdominal aneurysm repair (EVAR) using coils and fibrin glue is a technique for preventing type II endoleak (EII). Our aim is to evaluate feasibility, safety and clinical outcome of this promising approach. MATERIALS AND METHODS: A retrospective clinical case analysis of 72 patients who underwent EVAR during the period 2011-2014. Two groups were compared at 6 and 12 months follow-up with contrast media computed tomography scan and contrast-enhanced ultrasound (CEUS) imaging: consecutively, 36 patients (group A) treated with classic EVAR and 36 patients (group B) treated with embo-EVAR. Coils were released filling better as possible the aneurysm sac; the embolization was completed by injecting fibrin glue. Device and materials used, differential systemic and sac pressures, presence of any endoleak, and complication were registered. RESULTS: In our experience, we had 100% technical success without surgical conversion. Embo-EVAR was performed, after endograft deployment, in group B patients, all with ratio of Δ-pressures (obtained from Δ-sac pressure/Δ-differential pressure) > 0.16. No early or late complications occurred and mortality was nil. Follow-up was performed with computed tomography-angiography and CEUS at 6 and 12 months. We observed 9 type II and 1 type Ia endoleak in group A and 2 type II and 1 type Ib endoleaks in group B. Mean radiation exposure time was 30.3 min in group A and 43.3 min in group B. EVAR procedure average cost was 9,000 €. The average cost of sac embolization was 1,500€. CONCLUSIONS: Although a randomized study is necessary, embo-EVAR may be a valid approach to prevent type II endoleaks and further complications. Mild costs and exposure-dose increase could be accepted to avoid reinterventions, and in our experience, it could be routinely performed with excellent results.

Radiomics and deep learning models for CT pre-operative lymph node staging in pancreatic ductal adenocarcinoma: A systematic review and meta-analysis.

PURPOSE: To evaluate the diagnostic accuracy of computed tomography (CT)-based radiomic algorithms and deep learning models to preoperatively identify lymph node metastasis (LNM) in patients with pancreatic ductal adenocarcinoma (PDAC). METHODS: PubMed, CENTRAL, Scopus, Web of Science and IEEE databases were searched to identify relevant studies published up until February 11, 2024. Two reviewers screened all papers independently for eligibility. Studies reporting the accuracy of CT-based radiomics or deep learning models for detecting LNM in PDAC, using histopathology as the reference standard, were included. Quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies 2, the Radiomics Quality Score (RQS) and the the METhodological RadiomICs Score (METRICS). Overall sensitivity (SE), specificity (SP), diagnostic odds ratio (DOR), and the area under the curve (AUC) were calculated. RESULTS: Four radiomics studies comprising 213 patients and four deep learning studies with 272 patients were included. The average RQS total score was 12.00 ± 3.89, corresponding to an RQS percentage of 33.33 ± 10.80, while the average METRICS score was 63.60 ± 10.88. A significant and strong positive correlation was found between RQS and METRICS (p = 0.016; r = 0.810). The pooled SE, SP, DOR, and AUC of all the studies were 0.83 (95 %CI = 0.77-0.88), 0.76 (95 %CI = 0.62-0.86), 15.70 (95 %CI = 8.12-27.50) and 0.85 (95 %CI = 0.77-0.88). Meta-regression analysis results indicated that neither the study type (radiomics vs deep learning) nor the dataset size of the studies had a significant effect on the DOR (p = 0.09 and p = 0.26, respectively). CONCLUSION: Based on our meta-analysis findings, preoperative CT-based radiomics algorithms and deep learning models demonstrate favorable performance in predicting LNM in patients with PDAC, with a strong correlation between RQS and METRICS of the included studies.

Effective and organ doses in patient undergoing interventional neuroradiology procedures: A multicentre study.

PURPOSE: Radiation doses to adult patients submitted to cerebral angiography and intracranial aneurysms treatments were assessed by using DICOM Radiation Dose Structured Reports (RDSR) and Monte Carlo simulations. Conversion factors to estimate effective and organ doses from Kerma-Area Product (PKA) values were determined. METHODS: 77 cerebral procedures performed with five angiographic equipment installed in three Italian centres were analyzed. Local settings and acquisition protocols were considered. The geometrical, technical and dosimetric data of 16,244 irradiation events (13305 fluoroscopy, 2811 digital subtraction angiography, 128 cone-beam CT) were extracted from RDSRs by local dose monitoring systems and were input in MonteCarlo PCXMC software to calculate effective and organ doses. Finally, conversion factors to determine effective and organ doses from PKA were determined. Differences between centres were assessed through statistical analysis and accuracy of dose calculation method based on conversion factors was assessed through Bland-Altman analysis. RESULTS: Large variations in PKA (14-561 Gycm2) and effective dose (1.2-73.5 mSv) were observed due to different degrees of complexity in the procedures and angiographic system technology. The most exposed organs were brain, salivary glands, oral mucosa, thyroid and skeleton. The study highlights the importance of recent technology in reducing patient exposure (about fourfold, even more in DSA). No statistically significant difference was observed in conversion factors between centres, except for some organs. A conversion factor of 0.09 ± 0.02 mSv/Gycm2 was obtained for effective dose. CONCLUSIONS: Organ and effective doses were assessed for neuro-interventional procedures. Conversion factors for calculating effective and organ doses from PKA were provided.

Efficacy and safety of MWA versus RFA and CA for renal tumors: A systematic review and meta-analysis of comparison studies.

PURPOSE: Thermal ablation procedures represent an alternative treatment option for patients with T1a renal tumors. Radiofrequency ablation (RFA) and cryoablation (CA) are the most used and studied techniques, while microwave ablation (MWA) has progressively emerged in recent years. Our aim was to assess the effectiveness and safety of MWA in comparison to RFA and CA for the treatment of primary renal tumors. METHOD: Pubmed, CENTRAL, Web of Science and Scopus were searched until March 2023 to identify studies aimed at comparing the efficacy and safety of MWA with those of RFA and CA for the treatment of patients with primary renal tumors. We compared MWA and RFA/CA primary technique efficacy, local recurrences, overall and cancer-specific survival, major and overall complications, and eGFR changes. Moreover, subgroup analyses were conducted (MWA vs RFA; MWA vs CA; MWA vs RFA/CA in T1a renal tumors). RESULTS: Ten retrospective studies with 2258 thermal ablations were included (508 MWA and 1750 RFA /CA). MWA had fewer local recurrences (OR = 0.31; 95% CI, 0.16, 0.62; p = 0.0008) than RFA/CA; the other outcomes were not significantly different. In subgroup analyses, MWA resulted to have fewer overall complications than RFA (OR = 0.60; 95% CI, 0.38, 0.97; p = 0.04) and CA (OR = 0.49; 95% CI, 0.28, 0.85; p = 0.01); moreover, MWA was associated with fewer recurrences than CA (OR = 0.30; 95% CI, 0.11, 0.84; p = 0.02). In T1a renal tumors subgroup analysis, the outcomes were not significantly different. CONCLUSIONS: MWA is an ablative procedure as effective and safe as RFA or CA for the treatment of renal tumors.

Treatment of juxtarenal aortic aneurysm with the Multilayer stent.

PURPOSE: To report the use of a new type of uncovered stent to treat aortic aneurysms. CASE REPORT: Under compassionate use, an 81-year-old man with multiple comorbidities and an expanding 63-mm juxtarenal abdominal aortic aneurysm was treated with a 28×100-mm Multilayer flow-modulating stent. Immediately, the blood flow velocity inside the aneurysm sac appeared reduced on fluoroscopy. All aortic branches covered by the stent (celiac trunk, superior mesenteric artery, and renal arteries) remained patent. Serial computed tomography at up to 12 months has shown excellent stent and visceral artery patency and progressive reduction in the sac diameter (58 mm) and volume (84.9 cm(3) to 82.8 cm(3)). CONCLUSION: This case shows that the use of an uncovered multilayer stent reduces the flow in the aneurysm but preserves perfusion of the branch arteries, which is impossible with covered stents.

Interventional radiology at a single institution over 9 years: a comprehensive evaluation of procedures and an estimation of collective effective dose.

PURPOSE: To investigate the exposure parameters, effective dose, frequency, and collective dose for interventional radiology (IR) procedures performed at a single institution during a 9-year period. MATERIALS AND METHODS: According to the anatomic region imaged, seven diagnostic and 16 therapeutic IR procedures performed between 2002 and 2010 were retrospectively investigated with regard to exposure setting parameters and frequency. Dose-area products (DAPs), cumulative doses (CDs), and irradiation time values were analyzed on a sample of 1,100 examinations. DAP distributions (median, mean, and percentiles) were adjunctively determined by using bootstrap resampling in PCXMC software to estimate patient effective dose. Data provided by the Radiological Information System allowed collective effective and per-capita doses to obtained. RESULTS: The exposure parameters showed widespread variability. The median DAP values for pelvic arteriography and pelvic arterial angioplasty/stent placement were 10,015 and 19,424 cGy·cm(2), respectively. For the 23 procedures studied, the estimated average per-procedure effective dose ranged from 0.34 to 104.9 mSv. The pelvis (37%) was the region most often imaged in diagnostic procedures, and angioplasty/stent treatment of vessels was the most frequently performed therapeutic procedure (44%). During the study period, IR procedures increased in frequency (+137%), with a consequent increase in the per-capita dose (0.172 to 0.461 mSv) and collective dose (21 to 58 man-Sv/y). CONCLUSIONS: A comprehensive Monte Carlo-aided analysis, which allowed evaluation of contributions in terms of per-procedure and collective doses to the population for the practice of IR, showed a significant growth rate during the study period.

Neurovascular Neck-Bridging device in treatment of wide-necked splenic artery aneurysms.

We report the cases of 2 female patients, 45-year-old and 49-year-old, affected by wide-necked splenic aneurysm. We embolized the 2 lesions assisted by a new scaffolding neurovascular device, the Cascade Net, an innovative -occlusive remodeling device for temporary bridging in endovascular coil embolization of intracranial aneurysms. Visceral artery aneurysms are rare with an estimated prevalence of 2%-3% in imaging series and up to 10% in autopsy series. Most are asymptomatic and their diagnosis is occasionally. Aneurysm spontaneous rupture has been demonstrated in 2%-10% of cases and it can result in significant morbidity and mortality. Conservative management and open repair were the preferred treatment options for many years. Endovascular repair has been increasingly used since 2000; and the most widespread method of treatment has been coiling. Because of tortuosity of the parent artery, wide neck, and unfavorable locations at arterial branch points, 6% of Visceral and renal artery aneurysms VRAA cannot be adequately treated by simple coiling and requires parent artery remodeling through balloon occlusion, stent placement or parent vessel occlusion, leading to, in the latter situation, a compromised organ perfusion. Increasingly, balloon-assisted, and stent-assisted approaches as well as novel scaffolding neurovascular devices such as the Cascade Net, have allowed wide necked aneurysms to be bridged during endovascular treatment with smaller delivery system, averting parent artery occlusion and risk of distal embolization.

Endovascular treatment of femoro-popliteal disease with the Supera stent: results of a multicenter study.

BACKGROUND: Even though many types of stents have been tested in superficial femoral artery (SFA) and popliteal artery (PA), most of these devices have provided an unsatisfactory outcome, probably due their unsuitable anatomical and physiological characteristics. The Supera peripheral stent (Abbott Vascular, Santa Rosa, CA, USA) is a braided interwoven nitinol device specifically designed for treating atherosclerotic lesions of the femoro-popliteal segment. The aim of this multicenter retrospective study was to describe the effectiveness of Supera stents in the management of femoral-popliteal atherosclerotic lesions and to critically analyze our findings in the context of current and past literature. DESIGN AND METHODS: In this study we enrolled only patients who satisfied the inclusion criteria: i) patients affected by chronic obstructive arterial disease (COAD) grade II, as per Rutherford classification; ii) patients treated with endovascular revascularization and Supera stent implantation in the femoro-popliteal axis. We retrospectively analyzed the Doppler Ultra-sound (US) follow-up at 12-24 and 36 months to detect the vascular occlusions. The primary patency, primary patency assisted and TLR were described statistically analyzed by survival analysis and the demographic data, clinical data, device safety following stenting were described as frequency and mean value. RESULTS: 105 endovascular procedures on 99 patients for femoro-popliteal stenting with Supera were performed in four Italian hospitals. The median follow-up was 39 months (range 6-72), with primary patency rate of 83.1%, 74.3% and 69.5% at 12, 24 and 36 months after the procedure. The primary patency assisted was 89.9%, 76.8% and 73.4% in the same period, while the freedom from TLR values were 92.7%, 91.5% and 89.5% at 12, 24 and 36 months after the procedure, respectively. The mortality rate recorded at 12 months from the Supera implantation was 2.8% (3 out of 99 patients enrolled). CONCLUSIONS: Our data were in agreement with the current literature, showing the non-inferiority Supera stent in relation to the other stent available. Supera stent showed an excellent safety, effectiveness profile and high durability for the treatment of PAD patients with femoro-popliteal artery disease.

Long-term follow-up of the Derivo® Embolization Device (DED®) for intracranial aneurysms: the Italian Multicentric Registry.

BACKGROUND: The flow-diverter devices (FDDs) safety and effectiveness have been demonstrated by large series and meta-analyses. Due to the high occlusion rates and the acceptable morbidity rates of FDDs, the indications for their use are continuously expanding. We presented our Italian multicentric experience using the second generation of DERIVO® Embolization Device (DED®; Acandis, Pforzheim, Germany) to cure cerebral aneurysms, evaluating both middle and long-term safety and efficacy of this device. METHODS: Between July 2016 and September 2017 we collected 109 consecutive aneurysms in 108 patients treated using DED® during 109 endovascular procedures in 34 Italian centers (100/109 aneurysms were unruptured, 9/109 were ruptured). The collected data included patient demographics, aneurysm location and characteristics, baseline angiography, adverse event and serious adverse event information, morbidity and mortality rates, and pre- and post-treatment modified Rankin Scale scores. Midterm and long-term clinical, angiographic and cross-sectional CT/MR follow-up were recorded and collected until December 2018. RESULTS: In 2/109 cases, DED® placement was classified as technical failures. The overall mortality and morbidity rates were respectively 6.5% and 5.5%. Overall DERIVO® related mortality and morbidity rates were respectively 0% and 4.6% (5 out of 108 patients). Midterm neuroimaging follow-up showed the complete or nearly complete occlusion of the aneurysm in 90% cases, which became 93% at long-term follow-up. Aneurysmal sac shrinking was observed in 65% of assessable aneurysms. CONCLUSIONS: Our multicentric experience using DED® for endovascular treatment of unruptured and ruptured aneurysms showed a high safety and efficacy profile, substantially equivalent or better compared to the other FDDs.