A Multicenter International Retrospective Investigation Assessing the Prognostic Role of Inflammation-Based Scores (Neutrophil-to-Lymphocyte, Lymphocyte-to-Monocyte, and Platelet-to-Lymphocyte Ratios) in Patients with Intermediate-Stage Hepatocellular Carcinoma (HCC) Undergoing Chemoembolizations of the Liver.

BACKGROUND: The utilization of inflammation-based scores, such as the Neutrophil-to-Lymphocyte Ratio (NLR), Lymphocyte-to-Monocyte Ratio (LMR), and Platelet-to-Lymphocyte Ratio (PLR), has garnered attention for their potential as prognostic indicators in various cancers. However, their predictive role in patients with intermediate-stage HCC undergoing transcatheter arterial chemoembolization (TACE) remains an area that requires further investigation, as early recognition of TACE refractoriness holds the potential to guide tailored therapeutic interventions. METHODS: This multicenter international retrospective study analyzed data from patients with intermediate-stage HCC undergoing TACE between 2018 and 2024. Inflammation-based scores (NLR, LMR, PLR) were assessed preoperatively to predict treatment outcomes. RESULTS: Two hundred and fourteen patients were enrolled. Preoperative LMR showed the largest area under the curve for the prediction of 6-months PFS, based on the ROC curve analysis. Both high LMR (≥2.24) and low NLR (<4.72) were associated with improved objective response rates and 6-month progression-free survival. Lymphocyte count emerged as a strong predictor of treatment response in both simple (p < 0.001) and multiple (p < 0.001) logistic regression analyses. CONCLUSIONS: This study highlights the prognostic value of inflammation-based scores, particularly LMR and NLR, in predicting the treatment response and short-term outcomes of patients with intermediate-stage HCC undergoing TACE. Future investigations should focus on validating these scores' clinical applicability and assessing their impact on long-term patient survival and therapeutic decision-making.

Role of Flex-Dose Delivery Program in Patients Affected by HCC: Advantages in Management of Tare in Our Experience.

Background: Introduced in the latest BCLC 2022, endovascular trans-arterial radioembolization (TARE) has an important role in the treatment of unresectable hepatocellular carcinoma (HCC) as a "bridge" or "downstaging" of disease. The evolution of TARE technology allows a more flexible and personalized target treatment, based on the anatomy and vascular characteristics of each HCC. The flex-dose delivery program is part of this perspective, which allows us to adjust the dose and its radio-embolizing power in relation to the size and type of cancer and to split the therapeutic dose of Y90 in different injections (split-bolus). Methods: From January 2020 to January 2022, we enrolled 19 patients affected by unresectable HCC and candidates for TARE treatment. Thirteen patients completed the treatment following the flex-dose delivery program. Response to treatment was assessed using the mRECIST criteria with CT performed 6 and 9 months after treatment. Two patients did not complete the radiological follow-up and were not included in this retrospective study. The final cohort of this study counts eleven patients. Results: According to mRECIST criteria, six months of follow-up were reported: five cases of complete response (CR, 45.4% of cases), four cases of partial response (PR, 36.4%), and two cases of progression disease (PD, 18.2%). Nine months follow-up reported five cases of complete response (CR, 45.4%), two cases of partial response (PR, 18.2%), and four cases of progression disease (PD, 36.4%). No intra and post-operative complications were described. The average absorbed doses to the hepatic lesion and to the healthy liver tissue were 319 Gy (range 133-447 Gy) and 9.5 Gy (range 2-19 Gy), respectively. Conclusions: The flex-dose delivery program represents a therapeutic protocol capable of "saving" portions of healthy liver parenchyma by designing a "custom-made" treatment for the patient.

Rotational Mechanical Thrombectomy to Treat Iliac Limb Occlusion after Endovascular Aortic Aneurysm Repair: The Rotational Mechanical Thrombectomy Italian Study.

PURPOSE: To assess the safety and effectiveness of a rotational mechanical atherothrombectomy device in patients with symptomatic iliac limb occlusion after abdominal endovascular aneurysm repair (EVAR). MATERIALS AND METHODS: A retrospective analysis was conducted on patients who underwent rotational mechanical thrombectomy using the Rotarex S device for symptomatic acute, subacute, or chronic graft limb thrombosis at 5 vascular centers between 2017 and 2021. This study comprised 23 male patients with a mean age of 74.5 years (SD ± 7.2) at the time of the procedure. The clinical presentation of the patients varied, with 1 patient experiencing acute limb ischemia and 11 patients (47.8%) experiencing disabling intermittent claudication. The remaining patients developed chronic limb-threatening ischemia after iliac limb occlusion. Early outcomes included technical success, postprocedural complications, and periprocedural mortality. Follow-up evaluations encompassed primary patency, patient survival, freedom from reintervention, and the need for surgical conversion. RESULTS: Technical success was achieved in all cases, with no occurrences of distal embolization during or after the procedure, and no periprocedural deaths were reported. Endograft relining was performed in 82.6% of patients to establish a new, nonthrombogenic surface within the graft. Over a median follow-up period of 8 months (interquartile range, 3-16 months), 2 patients experienced iliac limb reocclusion. No deaths or other reinterventions occurred during the observational follow-up period. CONCLUSIONS: Rotational mechanical thrombectomy for iliac limb occlusion after EVAR appears to be both safe and effective. This technique may uncover intraluminal defects contributing to graft occlusion and enable their resolution within the same procedure.

Clinical Impact of a Protocol Involving Cone-Beam CT (CBCT), Fusion Imaging and Ablation Volume Prediction in Percutaneous Image-Guided Microwave Ablation in Patients with Hepatocellular Carcinoma Unsuitable for Standard Ultrasound (US) Guidance.

PURPOSE: to evaluate the clinical impact of a protocol for the image-guided percutaneous microwave ablation (MWA) of hepatocellular carcinoma (HCC) that includes cone-beam computed tomography (CBCT), fusion imaging and ablation volume prediction in patients with hepatocellular carcinoma unsuitable for standard ultrasound (US) guidance. MATERIALS AND METHODS: this study included all patients with HCC treated with MWA between January 2021 and June 2022 in a tertiary institution. Patients were divided into two groups: Group A, treated following the protocol, and Group B, treated with standard ultrasound (US) guidance. Follow-up images were reviewed to assess residual disease (RD), local tumor progression (LTP) and intrahepatic distant recurrence (IDR). Ablation response at 1 month was also evaluated according to mRECIST. Baseline variables and outcomes were compared between the groups. For 1-month RD, propensity score weighting (PSW) was performed. RESULTS: 80 consecutive patients with 101 HCCs treated with MWA were divided into two groups. Group A had 41 HCCs in 37 patients, and Group B had 60 HCCs in 43 patients. Among all baseline variables, the groups differed regarding their age (mean of 72 years in Group A and 64 years in Group B, respectively), new vs. residual tumor rates (48% Group A vs. 25% Group B, p < 0.05) and number of subcapsular tumors (56.7% Group B vs. 31.7% Group A, p < 0.05) and perivascular tumors (51.7% Group B vs. 17.1% Group A, p < 0.05). The protocol led to repositioning the antenna in 49% of cases. There was a significant difference in 1-month local response between the groups measured as the RD rate and mRECIST outcomes. LTP rates at 3 and 6 months, and IDR rates at 1, 3 and 6 months, showed no significant differences. Among all variables, logistic regression after PSW demonstrated a protective effect of the protocol against 1-month RD. CONCLUSIONS: The use of CBCT, fusion imaging and ablation volume prediction during percutaneous MWA of HCCs provided a better 1-month tumor local control. Further studies with a larger population and longer follow-up are needed.

Transcatheter Arterial Embolization for Bleeding Related to Pelvic Trauma: Comparison of Technical and Clinical Results between Hemodynamically Stable and Unstable Patients.

BACKGROUND: Endovascular intervention is now the primary line of therapy for arterial injury brought on by pelvic trauma since it can significantly reduce considerable morbidity associated with surgery and can swiftly access and control bleeding sites. Despite international guidelines and widespread awareness of the role of angioembolization in clinical practice, robust evidence comparing the outcomes of angioembolization in hemodynamically stable and unstable patients is still lacking. This study aims to directly compare the outcomes of angioembolization for the treatment of pelvic traumatic arterial injury in patients with hemodynamic stability vs. hemodynamic instability. METHODS: In our multicenter retrospective investigation, we analyzed data from consecutive patients who underwent, from January 2020 to May 2023, angioembolization for traumatic pelvic arterial injury. RESULTS: In total, 116 angioembolizations were performed. Gelatin sponges (56.9%) and coils (25.9%) were the most widely used embolic agents. The technical and clinical success rates were 100% and 91.4%, respectively. No statistically significant differences were observed between the two groups in terms of technical success, clinical success, procedure-related complication rate, or 30-day bleeding-related mortality. CONCLUSIONS: Angioembolization is an effective and safe option for the management of traumatic pelvic arterial lesions even in hemodynamically unstable patients, despite technical variations such as greater use of prophylactic angioembolization.

Endovascular Treatment of Visceral Artery Pseudoaneurysms with Ethylene-Vinyl Alcohol (EVOH) Copolymer-Based Non-Adhesive Liquid Embolic Agents (NALEAs).

Background and Objectives: Treatment of visceral artery pseudoaneurysms (VAPs) is always indicated regardless of their diameters, as their risk of rupture is significantly higher than that of visceral artery aneurysms. The invasiveness of surgery and its associated complications have led to a shift in favor of radiological interventions as the initial treatment of choice. However, there are still some unanswered questions on endovascular treatment of VAPs regarding the optimal endovascular technique and the efficacy and safety outcomes. The purpose of this multicenter study was to retrospectively evaluate the effectiveness and safety of endovascular treatment of visceral pseudoaneurysms using Ethylene-Vinyl Alcohol (EVOH) Copolymer-Based Non-Adhesive Liquid Embolic Agents (NALEAs). Materials and Methods: Consecutive patients who underwent endovascular embolization with EVOH-based NALEAs for visceral artery pseudoaneurysms between January 2018 and June 2023 were retrospectively evaluated. Results: 38 embolizations were performed. Technical success was achieved in all patients. The clinical success rate was high (92.1% overall), with no significant differences between ruptured and unruptured VAPs (p = 0.679). Seven patients (18.4%) experienced procedure-related complications, related to one case of non-target embolization, four splenic abscesses due to end-organ infarction, and two femoral pseudoaneurysms. The rates of procedure-related complications, end-organ infarction, and vascular access-site complications did not significantly differ between ruptured and unruptured VAPs (p > 0.05). Conclusions: Both ruptured and unruptured visceral pseudoaneurysms can be effectively and safely treated with NALEA-based endovascular embolization. We suggest considering the use of NALEAs, particularly in specific clinical cases that highlight their advantages, including patients with coagulopathy, fragile vessels, and embolization targets that are located at a considerable distance from the microcatheter tip and are otherwise difficult to reach.

Efficacy and Safety of Transarterial Chemoembolization with DC Beads LUMI in the Treatment of HCC: Experience from a Tertiary Centre.

PURPOSE: The aim of this study was to describe the safety and efficacy profiles of TACE using DC Beads LUMI. MATERIALS AND METHODS: We retrospectively analyzed 90 patients with HCC who underwent TACE with DC Bead LUMI™ between November 2018 and November 2020 at Fondazione IRCCS Cà Granda Policlinico Hospital in Milan, Italy. Patient- and tumour-related factors were registered, including the number of treated lesions, dose of DC Beads LUMI™, dose of Epirubicin, DC Beads LUMI™ target tumour coverage (LC) according to the percentage of target nodule involvement (LC1-0%-25%, LC2-25%-50%, LC3-50%-75%, LC4 75%-100%). Treatment efficacy was obtained through reviewing the follow-up imaging for evidence of response in target lesion(s), according to modified response criteria in solid tumours (mRECIST) criteria with the following outcomes: complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD). Safety assessment was based on the quantitative and qualitative recording of the adverse events, classified according to CIRSE classification. RESULTS: Seventy-two patients were enrolled, and 95 procedures were carried out. We observed a target tumour response rate at 1 month with CR in 68%, PR in 10.3% 11.8%, SD in 13%, PD in 7.2%, and an overall tumour(s) (whole liver) response at 1 month with CR in 58.9%, PR in 12.6%, SD in 10.5% and PD in 18%. We found a significant association (p < 0.01) between tumour response CR or CR + PR and the number of the target lesion(s). CIRSE classification grade I and grade II complications were recorded, respectively, in 11 (11.6%) and 6 (6.3%) procedures. No grade III-IV-V complications occurred. CONCLUSION: TACE using DC Beads LUMI is a safe and effective treatment option for patients with HCC.

Transcatheter Arterial Embolization (TAE) of Cancer-Related Bleeding.

Background and Objectives: Roughly 10% of cancer patients experience an episode of bleeding. The bleeding severity can range from occasional trivial bleeds to major bleeding. The treatment for the bleeding may vary, depending on the clinical condition and anatomical site, and may include various strategies, among which TAE is a cornerstone of major bleeding management. However, the existing literature on tumor hemorrhages is inconsistent. The objective of this multicenter retrospective cohort study was to evaluate the effectiveness and safety of arterial embolization in the treatment of tumor hemorrhages in patients with solid cancers. Materials and Methods: The data for patients with solid cancers undergoing TAE for the management of tumor hemorrhages from January 2020 to May 2023 were gathered. Results: A total of 92 patients with cancer-related bleeding were treated between January 2020 and May 2023. No bleeding was detected by X-ray angiography (XA) in 12 (13%) cases; therefore, a blind embolization was performed. The most common bleeding site was the liver (21.7%). A total of 66 tumor hemorrhages were spontaneous. The most commonly used embolic agent was polyvinyl alcohol (PVA) particles (30.4%). Technical success was achieved in 82 (89.1%) cases, with an 84.8% clinical success rate related to 14 cases of rebleeding. Proximal embolization was performed for 19 (20.7%) patients. Complications were recorded for 10 (10.9%) patients. The 30-day bleeding-related mortality was 15.2%. The technical success, clinical success, proximal embolization rate, and 30-day rebleeding were worse in the subset of patients undergoing TAE with coils. Conclusions: Transcatheter arterial embolization (TAE) represents a viable and potentially life-saving therapeutic approach in the management of tumor hemorrhages, demonstrating a notable effectiveness and safety. The TAE of bleeding tumors using coils resulted in a higher rate of non-superselective proximal embolization, with a trend toward lower clinical success rates and higher rebleeding episodes.

A Multicenter Retrospective Cohort Study Evaluating the Clinical Outcomes of Patients with Coagulopathy Undergoing Transcatheter Arterial Embolization (TAE) for Acute Non-Neurovascular Bleeding.

Background and Objectives: Transcatheter arterial embolization (TAE) is the mainstay of treatment for acute major hemorrhage, even in patients with coagulopathy and spontaneous bleeding. Coagulopathy is associated with worsening bleeding severity and higher mortality and clinical failure rates. Furthermore, some unanswered questions remain, such as the definition of coagulopathy, the indication for TAE or conservative treatment, and the choice of embolic agent. This study aims to assess the efficacy and safety of TAE for spontaneous non-neurovascular acute bleeding in patients with coagulopathy. Materials and Methods: This study is a multicenter analysis of retrospectively collected data of consecutive patients with coagulopathy who had undergone, from January 2018 to May 2023, transcatheter arterial embolization for the management of spontaneous hemorrhages. Results: During the study interval (January 2018-May 2023), 120 patients with coagulopathy underwent TAE for spontaneous non-neurovascular acute bleeding. The abdominal wall was the most common bleeding site (72.5%). The most commonly used embolic agent was polyvinyl alcohol (PVA) particles or microspheres (25.0%), whereas coils and gelatin sponge together accounted for 32.5% of the embolic agents used. Technical success was achieved in all cases, with a 92.5% clinical success rate related to 9 cases of rebleeding. Complications were recorded in 12 (10%) patients. Clinical success was significantly better in the group of patients who underwent correction of the coagulopathy within 24 h of TAE. Conclusions: Transcatheter arterial embolization (TAE) is effective and safe for the management of acute non-neurovascular bleeding in patients with coagulopathy. Correction of coagulopathy should not delay TAE and vice versa, as better clinical outcomes were noted in the subgroup of patients undergoing correction of coagulopathy within 24 h of TAE.

Percutaneous Microwave Ablation of Hepatocellular Carcinoma with "Double Fusion" Technique: Technical Note and Single-Center Preliminary Experience.

Percutaneous image-guided thermal ablation is included in most society guidelines for treatment of hepatocellular carcinoma (HCC). The results of this treatment in terms of efficacy depend on the ability to precisely place the device into the target tumor. Ultrasound (US) is a commonly used imaging guidance modality for its real-time feedback. However, an accurate device deployment remains challenging in some clinical scenarios, including cases of tumors that are undetectable or not clearly visible by US. To overcome this problem, fusion imaging techniques have been developed, which combine images from different modalities. The most widely known technique combines pre-procedural contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) with real-time US scans. Cone beam CT (CBCT) is a technology that can provide intra-procedural cross-sectional images, which can be registered to images from other modalities, including preprocedural CT/MR scans. The aim of our study is to report the preliminary experience on percutaneous microwave ablation (MWA) of patients with HCC that were treated using the "double fusion" technique, which combines the use of US fusion imaging and CBCT fusion imaging. We describe the technical details, feasibility, safety and short-term efficacy of this technique in a small series of eight patients with 11 HCCs.

Vascular Complications following Vacuum-Assisted Breast Biopsy (VABB): A Case Report and Review of the Literature.

INTRODUCTION: Vacuum-assisted breast biopsy (VABB) has been evaluated as a minimally invasive, safe, and accurate procedure with low complication risks; the most frequent one is the mild/moderate hematoma, which occurs with a low-frequency rate, and the majority of patients who experienced it can be treated successfully with only manual compression and dressing. Although cases of uncontrollable catastrophic bleeding are exceedingly rare, local breast vessel involvement is a concrete risk, even in patients with no bleeding propensity. CASE PRESENTATION: In this article, we aimed to describe a 60 years-old woman who, following VABB, experienced a massive hematoma without external bleeding and was successfully treated with embolization. The woman was called back for a cluster of suspicious microcalcifications identified in the left breast's upper-outer quadrant; however, following histopathological analysis, the few samples collected were negative. She had a silent past medical history, 100% performance status, and no active pharmacotherapy. Approximately 15-30 min after VABB, the patient complained of weakness, pain, and lipothymia. A physical examination revealed a massive hematoma without external bleeding. Clinical data reported PaO 65/40 mmHg and blood chemistry Hb < 10 g/dL. The emergency team was alerted to stabilize the patient, and after that, the breast hemorrhage was controlled by endovascular embolization. Despite this being a rare occurrence, it is important to draw up and follow an appropriate protocol to ensure proper patient management and early treatment. DISCUSSION: This case illustrates the prompt and accurate management of a rare complication following VABB. Due to the very high number of patients undergoing this particular procedure, we aim to point out the concrete risk of vascular injury; other similar cases are described to support our thesis and provide different clinical manifestations of this rare occurrence.

Innovation in Acute Ischemic Stroke Patients over 80 y/o-A Retrospective Monocentric Study on Mechanical Thrombectomy of Consecutive Patients: Is Age an Adequate Selection Criterion?

BACKGROUND: Although it is clear that stroke is a time-dependent and age-associated disease, we still need more evidence regarding the efficacy and outcomes in elderly patients who were excluded from the first trials of mechanical thrombectomy. The aim of this study is to highlight patient characteristics, the timing of medical attention and therapy, successful recanalization, and functional outcomes in patients over 80 y/o who underwent mechanical thrombectomy at the Ospedale Maggiore della Carità di Novara (Hub) since endovascular stroke treatment was first started here. METHODS: all 122 consecutive patients over 80 y/o at admission who underwent mechanical thrombectomy between 2017 and 2022 at our Hub center were retrospectively included in our database. A good functional outcome in these elderly patients was considered as the 90 days modified Rankin Scale (mRS) ≤ 3 and/or a decrease in functional status as ∆mRS ≤ 1 in order to interpret the results for patients with intact intellect and basal mRS > 3. Successful recanalization as a score of TICI ≥ 2b (Thrombolysis in Cerebral Infarction) was analyzed as a secondary outcome. RESULTS: Good functional outcome (mRS ≤ 3 and/or ∆mRS ≤ 1) was observed in 45.90% (56/122). The rate of successful recanalization (TICI ≥ 2b) was 65.57% (80/122). CONCLUSION: Our data confirm that a good outcome in the elderly age group has a correlation with age; being younger, with a milder NIHSS (National Institutes of Health Stroke Scale) at the onset and with a lower pre-morbid mRS is statistically associated with a better outcome. However, age should not be a criterion to exclude older patients from mechanical thrombectomy. Decision-making should take into consideration the pre-morbid mRS and the severity of the stroke on the NIHSS scale, especially in the age group over 85 y/o.

Transcatheter Arterial Embolization (TAE) in the Management of Bleeding in the COVID-19 Patient.

Background and Objectives: Increasing attention is being paid to the coagulation disorders associated with SARS-CoV-2 infection. Bleeding accounts for 3-6% of COVID-19 patient deaths, and is often a forgotten part of the disease. The bleeding risk is enhanced by several factors, including spontaneous heparin-induced thrombocytopenia, thrombocytopenia, the hyperfibrinolytic state, the consumption of coagulation factors, and thromboprophylaxis with anticoagulants. This study aims to assess the efficacy and safety of TAE in the management of bleeding in COVID-19 patients. Materials and Methods: This multicenter retrospective study analyzes data from COVID-19 patients subjected to transcatheter arterial embolization for the management of bleeding from February 2020 to January 2023. Results: Transcatheter arterial embolization was performed in 73 COVID-19 patients for acute non-neurovascular bleeding during the study interval (February 2020-January 2023). Coagulopathy was observed in forty-four (60.3%) patients. The primary cause of bleeding was spontaneous soft tissue hematoma (63%). A 100% technical success rate was recorded; six cases of rebleeding resulted in a 91.8% clinical success rate. No cases of non-target embolization were observed. Complications were recorded in 13 (17.8%) patients. The efficacy and safety endpoints did not differ significantly between the coagulopathy and non-coagulopathy groups. Conclusions: Transcatheter Arterial Embolization (TAE) is an effective, safe and potentially life-saving option for the management of acute non-neurovascular bleeding in COVID-19 patients. This approach is effective and safe even in the subgroup of COVID-19 patients with coagulopathy.

Evaluation of operator eye exposure and eye protective devices in interventional radiology: Results on clinical staff and phantom.

PURPOSE: To assess occupational eye lens dose based on clinical monitoring of interventional radiologists and to assess personal protective eyewear (PPE) efficacy through measurements with anthropomorphic phantom. METHODS: Two positions of the operator with respect to X-ray beam were simulated with phantom. Dose reduction factor (DRF) of four PPE was assessed, as well as correlation between eye lens and whole-body doses. Brain dose was also assessed. Five radiologists were monitored for one-year clinical procedures. All subjects were equipped with whole-body dosimeter placed over lead apron at the chest level and eye lens dosimeter placed over the left side of the PPE. Kerma-Area Product (KAP) of procedures performed during the monitoring period was recorded. The correlation of eye lens dose with whole-body dose and KAP was assessed. RESULTS: DRF was 4.3/2.4 for wraparound glasses, 4.8/1.9 for fitover glasses, 9.1/6.8 for full-face visor in radial/femoral geometries. DRF of half-face visor depended on how it is worn (range 1.0-4.9). Statistically significant correlation between dose value over the PPE and chest dose was observed, while there was no correlation between eye lens dose and chest dose. The results on clinical staff showed statistically significant correlation between dose values over the PPE and KAP. CONCLUSIONS: All PPE showed significant DRF in all configurations, provided they were worn correctly. Single DRF value is not applicable to all clinical situations. KAP is a valuable tool for determining appropriate radiation protection measures.

Efficacy and Safety of Axiostat® Hemostatic Dressing in Aiding Manual Compression Closure of the Femoral Arterial Access Site in Patients Undergoing Endovascular Treatments: A Preliminary Clinical Experience in Two Centers.

BACKGROUND: Hemostasis of the femoral arterial access site by manual compression or a vascular closure device is critical to the safe completion of any endovascular procedure. Previous investigations evaluated the hemostatic efficacy at the radial access site of some chitosan-based hemostatic pads. This study aims to assess the efficacy and safety of a new chitosan-based hemostatic dressing, namely Axiostat®, in aiding manual compression closure of the femoral arterial access site in patients undergoing endovascular treatments. Furthermore, the outcomes were compared with evidence on manual compression alone and vascular closure devices. METHODS: This investigation is a two-center retrospective analysis of 120 consecutive patients who had undergone, from July 2022 to February 2023, manual compression closure of the femoral arterial access site aided by the Axiostat® hemostatic dressing. Endovascular procedures performed with introducer sheaths ranging from 4 Fr to 8 Fr were evaluated. RESULTS: Primary technical success was achieved in 110 (91.7%) patients, with adequate hemostasis obtained in all cases of prolonged manual compression requirements. The mean time-to-hemostasis and time-to-ambulation were 8.9 (±3.9) and 462 (±199) minutes, respectively. Clinical success was achieved in 113 (94.2%) patients, with bleeding-related complications noted in 7 (5.8%) patients. CONCLUSIONS: Manual compression aided by the Axiostat® hemostatic dressing is effective and safe in achieving hemostasis of the femoral arterial access site in patients undergoing endovascular treatment with a 4-8 Fr introducer sheath.

Effectiveness and Safety of Different Vascular Closure Devices: Multicentre Prospective Observational study.

AIM: The aim of this prospective, multicentre, observational study was to compare the efficacy and safety of balloon-based and non-balloon-based vascular closure devices (VCDs). MATERIALS AND METHODS: From March 2021 to May 2022, 2373 participants from 10 different centres were enrolled. Among them, 1672 patients with 5-7 Fr accesses were selected. Successful haemostasis, failure and safety were evaluated. Successful haemostasis was defined as the possibility to obtain complete haemostasis with the use of VCDs, without any complication. Failure management was defined as the need of manual compression. Safety was defined as the rate of complications. Cases of haematomas/pseudoaneurysms (PSA) and artero-venous fistula (AVF) were collected. RESULTS: VCDs mechanism of action is statistically significant associated with the outcome. Non-balloon-based VCDs demonstrated a statistically significant better outcome: successful haemostasis was obtained in 96.5% vs. 85.9%, of cases when compared to balloon occluders (p < 0.001). The incidence of AVF was statistically more frequent using non-balloon occluders devices (1.57% vs 0%, p: 0.007). No significant statistical difference was found in comparing haematoma and PSA occurrence. Thrombocytopenia, coagulation deficit, BMI, diabetes mellitus and anti-coagulation were demonstrated to be independent predictors of failure management. CONCLUSION: Our study suggests a better outcome with the same complication rate, except that for AVF incidence for non-balloon collagen plug device if compared to balloon occluders vascular closure devices.

Mechanical thrombectomy in acute limb ischemia: ad Interim results of the INDIAN UP Trial.

BACKGROUND: Penumbra/Indigo aspiration thrombectomy Systems (Penumbra Inc.) in patients with acute lower limb ischemia (ALLI) is becoming a fundamental alternative to surgical and intra-arterial thrombolysis. The INDIAN UP trial represents the second phase of the Italian national multicenter trial evaluating the safety and effectiveness of the device in the treatment of ALLI. METHODS: To assess vessel patency, the TIPI (Thrombo-aspiration In Peripheral Ischemia), is used. The TIPI flow in three different moments: at presentation, immediately after thromboaspiration, and after all adjuvant procedures. The primary outcome is the technical success of the thrombo-aspiration with the investigative system, defined as near complete or complete revascularization TIPI 2 - 3. Safety and clinical success rate were collected at one month follow-up. RESULTS: A total of 250 patients were enrolled. The mean age was 72.2±13.1 years and 72.1% were male. Rutherford grade on enrolment was I in 10.8%, IIa in 34.9%, and IIb in 54.4%. Primary technical success (TIPI 2-3 flow) was achieved in 90.8% of patients. Adjunctive procedures were needed in 158 cases. After all interventions, assisted primary technical success was 96.4%. No systemic bleeding complications or device related serious adverse events were reported. At one month follow up, survival rate was 97.2%, limb salvage was 97.6%. Primary patency was 89.6% and 13 (5.4%) reinterventions were registered. CONCLUSIONS: The updated results of the INDIAN UP trial have confirmed the high value of the mechanical thromboaspiration device Indigo Penumbra in the treatment of ALLI in a large variety of clinical and anatomical settings.

Endovascular treatment of femoro-popliteal occlusions with retrograde tibial access after failure of the antegrade approach.

BACKGROUND: Despite the development in endovascular technologies and the introduction of new tools in clinical practice, the endovascular crossing of femoropopliteal occlusions is not always possible with the antegrade approach, with a failure rate that can be up to 20%. This study aims to assess the feasibility, safety, and efficacy in terms of acute outcome of the endovascular retrograde crossing of femoro-popliteal occlusions with tibial access. METHODS: This study is a single-centre, retrospective analysis of prospectively collected data of 152 consecutive patients, who had undergone, from September 2015 to September 2022, endovascular treatment of femoro-popliteal arterial occlusions with retrograde tibial access after the failure of the antegrade approach. RESULTS: The median lesion length was 25 cm and 66 patients (43.4%) had a calcium grading according to the peripheral arterial calcium scoring system of 4. Angiographically, 44.7% of the lesions were TASC II category D. In all cases, successful cannulation and sheath introduction were performed with an average cannulation time of 150.4 s. Femoropopliteal occlusions were successfully crossed with the retrograde route in 94.1% of cases; the intimal approach was performed in 114 patients (79.7%). The mean time from puncture to retrograde crossing was 20.5 min. Acute vascular access-site complications were noted in 7 (4.6%) patients. Thirty-day major adverse cardiovascular events rate and 30-day major adverse limb events rate of 3.3% and 2%, respectively, were observed. CONCLUSIONS: The results of our study indicate that retrograde crossing of femoro-popliteal occlusions with tibial access is a feasible, effective, and safe approach in case of failed antegrade approach. The results presented represent one of the largest investigations ever published on tibial retrograde access and contribute to the small body of literature present on this topic to date.

Efficacy and Safety of Ethylene-Vinyl Alcohol (EVOH) Copolymer-Based Non-Adhesive Liquid Embolic Agents (NALEAs) in Transcatheter Arterial Embolization (TAE) of Acute Non-Neurovascular Bleeding: A Multicenter Retrospective Cohort Study.

Background and Objectives: Transcatheter arterial embolization (TAE) is part of the daily practice of most interventional radiologists worldwide. The ideal liquid embolic agent is far from being identified. Non-adhesive liquid embolic agents (NALEA) harden from the outside to the inside, resulting in deep penetration, known as "magma-like" progression, which permits a more distal embolization with good control of the embolic material. This multicenter retrospective cohort study aims to assess the efficacy, feasibility and safety of transcatheter arterial embolization (TAE) with ethylene-vinyl alcohol (EVOH)-based NALEAs (Onyx and Squid) in acute bleeding outside of the neurovascular area. Materials and Methods: This study is a multicenter analysis of retrospectively collected data of consecutive patients who had undergone, from January 2015 to December 2022, transcatheter arterial embolization with non-adhesive EVOH-based agents in the setting of acute non-neurovascular bleeding. Results: Fifty-three patients underwent transcatheter arterial embolization for acute non-neurovascular bleeding. Eight (15.1%) procedures were performed in patients with coagulopathy. The most used concentration of EVOH-based NALEAs was 34 (i.e., 8%), with a mean dose of 0.5 (±0.3) mL. The mean CT-to-groin time, the mean procedure time, the mean CT-to-embolization time and the mean fluoroscopy time were 22.9 (±12.4) min, 27.5 (±7) min, 50.3 (±13.1) min and 7.5 (±2.8) min, respectively. Technical success was achieved in all cases with a 96.2% clinical success rate. Complications were recorded in six (11.3%) patients. No statistically significant differences were observed between the group of patients with coagulopathy and the group of patients without coagulopathy in terms of efficacy and safety endpoints. Conclusions: Transcatheter arterial embolization (TAE) performed with non-adhesive EVOH-based embolic agents is an effective, feasible and safe strategy for the management of acute non-neurovascular bleeding, even in the subgroup of patients with coagulopathy.