PHIL® (precipitating hydrophobic injectable liquid): retrospective multicenter experience on 178 patients in peripheral embolizations.

PURPOSE: This study aims to analyze safety and effectiveness of PHIL® (Microvention, CA-USA) in peripheral endovascular embolization procedures, both in elective and emergent scenarios. MATERIALS AND METHODS: This is a multicenter retrospective study, involving 178 patients from five interventional radiology departments from January 2017 to December 2021. Patients treated by an endovascular embolization with PHIL® were included; different PHIL® viscosities were adopted. Exclusion criteria were: neuroradiological endovascular interventions, other cohesive liquid embolics adopted during the same procedure, follow-up < 30 days. Technical success was intended as definitive target vessel occlusion without the need for other embolics after PHIL® injection. Clinical success was considered as restoration of hemodynamic status in case of emergent embolization and improvement of clinical conditions in case of elective procedures, without additional interventions at 30 days. RESULTS: Sixty-four women and 114 men, mean age 62 years (range 6-91), were evaluated. Sixty-three patients were in elective scenarios (AVMs, type-II endoleaks, tumors, varices, aneurysms, varicoceles) and 115 were in emergent settings (hemorrhage, pseudoaneurysms, hemoptysis, priapism); 190 procedures were performed in 178 patients. Overall technical and clinical success rates were 94.7% and 92.1%, respectively. The complications rate was 7.4% (6 grade-I, 7 grade-III, 1 grade-IV). PHIL®-25 was the more adopted viscosity; totally, 311 vials were injected (rate: 1.64 vial/procedure). CONCLUSION: In this series, PHIL® proved to be a safe and effective liquid embolic in peripheral embolizations, both in elective and emergent scenarios. The pre-filled syringe preparation allowed operators to use it even when unplanned at beginning of the intervention.

Minimally invasive procedure for removal of infected ventriculoatrial shunts.

BACKGROUND: Ventriculoatrial shunts were one of the most common treatments of hydrocephalus in pediatric and adult patients up to about 40 years ago. Thereafter, due to the widespread recognition of the severe cardiac and renal complications associated with ventriculoatrial shunts, they are almost exclusively implanted when other techniques fail. However, late infection or atrial thrombi of previously implanted shunts require removal of the atrial catheter several decades after implantation. Techniques derived from management of central venous access catheters can avoid cardiothoracic surgery in such instances. METHODS: We retrospectively investigated all the patients requiring removal of a VA shunt for complications treated in the last 5 years in our institution. RESULTS: We identified two patients that were implanted 28 and 40 years earlier. Both developed endocarditis with a large atrial thrombus and were successfully treated endovascularly. The successful percutaneous removal was achieved by applying, for the first time in this setting, the endoluminal dilation technique as proposed by Hong. After ventriculoatrial shunt removal and its substitution with an external drainage, both patients where successfully weaned from the need for a shunt and their infection resolved. CONCLUSION: Patients carrying a ventriculoatrial shunt are now rarely seen and awareness of long-term ventriculoatrial shunt complications is decreasing. However, these complications must be recognized and treated by shunt removal. Endovascular techniques are appropriate even in the presence of overt endocarditis, atrial thrombi, and tight adherence to the endocardial wall. Moreover, weaning from shunt dependence is possible even decades after shunting.

The combined use of stent retriever and neuro-aspiration as successful bail-out reperfusion strategy in a patient with embolic myocardial infarction.

Embolic myocardial infarction account for ≈3% of all ST-segment myocardial infarction and represents a challenge often left no-reperfused because current thrombectomy technologies are inefficient to grab thrombus wedged into distal coronary arteries. We present the case of a 34-year-old man who presented with anterior STEMI and a proximal left anterior descending coronary artery ulcerated plaque with a great thrombus burden, which led to distal embolization. Failure of several attempts of manual and rheolytic thrombectomy, led us to use the "Solumbra technique", the combined use of stent retriever and Penumbra catheter was successful in restoring patency and flow.

Under-dilated TIPS Associate With Efficacy and Reduced Encephalopathy in a Prospective, Non-randomized Study of Patients With Cirrhosis.

BACKGROUND & AIMS: Portosystemic encephalopathy (PSE) is a major complication of trans-jugular intrahepatic porto-systemic shunt (TIPS) placement. Most devices are self-expandable polytetrafluoroethylene-covered stent grafts (PTFE-SGs) that are dilated to their nominal diameter (8 or 10 mm). We investigated whether PTFE-SGs dilated to a smaller caliber (under-dilated TIPS) reduce PSE yet maintain clinical and hemodynamic efficacy. We also studied whether under-dilated TIPS self-expand to nominal diameter over time. METHODS: We performed a prospective, non-randomized study of 42 unselected patients with cirrhosis who received under-dilated TIPS (7 and 6 mm) and 53 patients who received PTFE-SGs of 8 mm or more (controls) at referral centers in Italy. After completion of this study, dilation to 6 mm became the standard and 47 patients were included in a validation study. All patients were followed for 6 months; Doppler ultrasonography was performed 2 weeks and 3 months after TIPS placement and every 6 months thereafter. Stability of PTFE-SG diameter was evaluated by computed tomography analysis of 226 patients with cirrhosis whose stent grafts increased to 6, 7, 8, 9, or 10 mm. The primary outcomes were incidence of at least 1 episode of PSE grade 2 or higher during follow up, incidence of recurrent variceal hemorrhage or ascites, incidence of shunt dysfunction requiring TIPS recanalization, and reduction in porto-caval pressure gradient. RESULTS: PSE developed in a significantly lower proportion of patients with under-dilated TIPS (27%) than controls (54%) during the first year after the procedure (P = .015), but the proportions of patients with recurrent variceal hemorrhage or ascites did not differ significantly between groups. No TIPS occlusions were observed. These results were confirmed in the validation cohort. In an analysis of self-expansion of stent grafts, during a mean follow-up period of 252 days after placement, none of the PTFE-SGs self-expanded to the nominal diameter in hemodynamically relevant sites (such as portal and hepatic vein vascular walls). CONCLUSIONS: In prospective, non-randomized study of patients with cirrhosis, we found under-dilation of PTFE-SGs during TIPS placement to be feasible, associated with lower rates of PSE, and effective.

Percutaneous Transanastomotic Stent Graft Deployment to Salvage Dysfunctional Native Forearm Radiocephalic Fistulae: Feasibility and Primary Patency at 12 Months.

PURPOSE: To evaluate feasibility and efficacy of transanastomotic self-expandable polytetrafluoroethylene stent graft placement for salvage of radiocephalic arteriovenous fistulae (RCAVFs). MATERIALS AND METHODS: From 2008 to 2016, 26 patients (21 male; age, 38-80 y) with dysfunctional RCAVFs for juxtaanastomotic lesions that were unresponsive to angioplasty underwent transanastomotic stent graft placement. Stenotic and thrombotic lesions were included. All were deemed unsuitable for surgical revision. Patency rates were calculated per Kaplan-Meier method. A Cox analysis was used to identify influencing factors. RESULTS: Thirty-two stent grafts (6 patients had 2 stents) were deployed. Anatomic and clinical success were achieved in all patients; no major complications occurred. Mechanical and/or pharmacologic thrombolysis was performed in 6 cases before stent graft deployment. During follow-up (median, 34.7 mo; range, 1.9-102.7 mo), 17 repeat interventions were required in 10 patients (43 procedures overall), for an endovascular intervention rate of 0.27 per year. At 3, 6, 12, and 24 months, primary patency (PP) rates were 96% ± 4 (95% CI, 75%-99%), 83% ± 7 (95% CI, 61%-93%), 78% ± 8 (95% CI, 55%-90%), and 69% ± 10 (95% CI, 46%-84%). The corresponding assisted PP rates were 96% ± 4 (95% CI, 76%-99%), 96% ± 4 (95% CI, 76%-99%), 92% ± 5 (95% CI, 71%-98%), and 82% ± 8 (95% CI, 60%-93%). Five AVFs were ultimately abandoned. Per Cox analysis, arterial diameter ≥ 4 mm was associated with better PP (P = .032). CONCLUSIONS: Transanastomotic stent graft placement for RCAVF salvage is feasible and safe, providing patency rates comparable with historical endovascular and surgical data. Its role should be evaluated in larger studies.

Covered stent assisted coil embolization of large Buhler aneurysm in setting of chronic celiac trunk occlusion.

BACKGROUND: The arc of Bühler (AOB) is a residual embryonal anastomosis between the celiac artery (CA) and the superior mesenteric artery (SMA). Although usually asymptomatic, it has clinical relevance when compensatory reverse flow between the SMA and the CA in response to celiac artery obstruction leads to aneurysm formation and bleeding. Endovascular coiling is the mainstay therapy because of the deep AOB retropancreatic location, which hinders open surgery. CASE PRESENTATION: We herein report a case of a 2.8-cm AOB saccular aneurysm and LAM compression of celiac trunk in a 47-year-old man during rehabilitation following motorcycle trauma and vertebral surgery. The patient was considered unsuitable for surgery. Neither conventional coiling nor bare-metal stent and balloon-assisted techniques for coiling were suitable because of the wide necked saccular shape of AOB aneurysm interposed between the SMA and the floor of celiac trunk. To exclude the aneurysm from direct SMA inflow and permit safe and efficient coiling to rule out retrograde sac perfusion, a 9-mm polytetrafluoroethylene stent graft (Viabahn; Gore, Phoenix, AZ, USA) was positioned in the mesenteric artery, followed by antegrade periprosthetic high-density packed coiling of the aneurysm. The AOB remained excluded from mesenteric perfusion. The patient's clinical condition and abdominal contrast-enhanced multislice computed tomographic findings were unremarkable at the 9-year follow-up. CONCLUSION: The 9 year long-term efficacy in our case raises the possibility that perigraft coiling following stent-graft deployment in the SMA may represent a valuable technical option for large Bühler aneurysms that are not amenable to stand-alone coiling.

Endovascular management of KILT syndrome and COVID-19-related extensive deep vein thrombosis in a pregnant patient: A case report.

We report on a 20-year-old pregnant woman who tested positive for SARS-CoV-2 and was diagnosed with KILT syndrome, a rare condition that increases the risk of thrombotic events. The patient showed signs of deep vein thrombosis that extended from the bilateral iliac vein to the inferior vena cava (IVC), which was treated with placement of an IVC filter and endovascular thromboaspiration/thrombolysis. The IVC was successfully recanalized; however, during follow-up, thrombotic restenosis occurred at the filter level, requiring filter removal. This case highlights the potential benefits of endovascular thromboaspiration/thrombolysis and IVC filter placement in patients with KILT syndrome presenting with acute thrombotic events.

Indocyanine green-marked fluorescence-guided off-clamp versus intraoperative ultrasound-guided on-clamp robotic partial nephrectomy: Outcomes on surgical procedure.

Objectives: To compare surgical and functional outcomes between off-clamp robot-assisted partial nephrectomy with indocyanine-green tumour marking through preliminary superselective embolization and on-clamp robot-assisted partial nephrectomy with intraoperative ultrasound identification of the renal mass. Material and methods: One hundred and forty patients with a single renal mass underwent indocyanine-green fluorescence-guided off-clamp robot-assisted partial nephrectomy with preoperative superselective embolization (Group A, 70 patients) versus intraoperative ultrasound-guided on-clamp robot-assisted partial nephrectomy without embolization (Group B, 70 patients). We assessed operative time, intraoperative blood loss, complications, length of stay, renal function, need for ancillary procedures and blood transfusions. Results: Mean tumour size was 24 versus 25 mm in Group A versus Group B (p = 0.19). Mean operative time was 86.5 versus 121.8 min (p = 0.02), mean blood loss was 72.8 versus 214.2 mL (p = 0.02), and mean haemoglobin drop on postoperative day 1 was 1.1 versus 2.6 g/dL (p = 0.04) in Group A versus Group B. One-month creatinine, hospital stay and enucleated tumour volume were comparable. Ten postoperative complications occurred in Group A (13.3%) and 11 in Group B (15.3%). Following superselective embolization, no patients required blood transfusions versus two patients in Group B. Postoperative selective renal embolization was needed in one case per group. Conclusions: Preoperative superselective embolization of a renal mass with indocyanine-green before off-clamp robot-assisted partial nephrectomy significantly reduces operative time and intraoperative blood loss compared to on-clamp intraoperative ultrasound-guided robot-assisted partial nephrectomy. A longer follow-up is needed to establish the effect on renal function.

Transoral percutaneous radiofrequency ablation with a steerable needle and cementoplasty under CBCT and infrared augmented reality navigation system guidance for the treatment of a C1 solitary plasmacytoma: A case report.

We report a case of a 40-year-old female with a solitary plasmacytoma of the right transverse apophysis of C1 who underwent combined transoral ablation using a curved steerable needle and cementoplasty under CBCT and infra-red augmented reality navigation system. An imaging work-up revealed an osteolytic lesion determining partial collapse of the right lateral mass of C1 and involving the vertebral foramen. After a biopsy, that revealed a solid tissue consistent with plasmacytoma, it was decided to proceed with radiation therapy. Subsequent PET-CT restaging scans showed residual tumors treated with a transoral percutaneous approach, combining ablation and cementoplasty. This report evaluates the benefits of this combined procedure and the transoral approach, focusing on the advantages of steerable devices and navigation systems.

Prostate Artery Embolization in the Treatment of Massive Intractable Bleeding from Prostatic Neoplasms: A Case Report and Systematic Review.

Lower urinary tract symptoms (LUTS) and hematuria are common symptoms in men with neoplasms, mainly affecting the elderly population. Prostatic arterial embolization (PAE) is a minimally invasive procedure that has shown promising results in managing LUTS and massive intractable prostatic hematuria in patients with benign prostatic hyperplasia (BPH) and prostate cancer (PCa). A few studies, however, have provided valuable insights into the durability and efficacy of PAE focusing on the long-term effectiveness, quality of life, and cancer-specific control of hemostasis and urinary symptoms. As a result of concomitant cardiovascular conditions, these patients often take anticoagulants or antithrombotics, which can worsen their hematuria and clinical status. Transurethral resection of the prostate (TURP) is considered a very high-risk procedure, even without massive bleeding, and requires discontinuation of vitamin K antagonists and antiplatelet therapies. Such patients usually have their surgery postponed, and PAE should be considered a safe alternative treatment. We aimed to report a narrative review from 1976 to June 2023 of the current state of PAE for massive and intractable hematuria, highlighting recent developments in this technique, including prospective cohort studies, and focusing on long-term outcome, safety, and complication management of patients with prostatic neoplasms who develop significant hemorrhagic symptoms. Additionally, we present a case report and a simple algorithm for treating intractable bleeding in a 92-year-old man with PCa and massive hematuria.

Case of IV Stage Juvenile Nasopharyngeal Angiofibroma Presurgically Treated with a Single ECA Stop-Flow Embolization Technique Using Onyx 18.

Background: Juvenile nasopharyngeal angiofibroma (JNA) is a rare tumor that mainly affects young boys. Its intervention may be complex due to its high vascularity, location, and extension. Preoperative embolization is used to prevent intrasurgical and postsurgical bleeding. Two main kinds of embolization are described in literature: intratumoral and transarterial, and numerous embolic materials are used. Case Presentation. We want to present a case of presurgical embolization of a stage IV JNA, performed using a single stop-flow balloon assisted technique with the balloon cuffed exclusively in the external carotid artery and using Onyx 18 as an embolic agent. Conclusions: The embolization with an exclusive external carotid artery single stop-flow technique using Onyx 18 is a safe, effective, and a definitive approach.

Spontaneous Soft Tissue Hematomas in Patients with Coagulation Impairment: Safety and Efficacy of Transarterial Embolization.

The aim of this study is to report the authors' experience of percutaneous transarterial embolization (TAE) in patients with spontaneous soft tissue hematomas (SSTH) and active bleeding with anticoagulation impairment. The study retrospectively identified 78 patients who received a diagnosis of SSTH by CT scan and underwent TAE between 2010 and 2019 in a single trauma center. The patients were stratified using Popov classification into categories: 2A, 2B, 2C, and 3. The patient's 30-day survival after TAE was considered the primary outcome; immediate technical success, the need for additional TAE, and TAE-related complications were considered secondary outcomes. Immediate technical success, complication rate, and risk factors for death were analyzed. Follow-up stopped on day 30 from TAE. 27 patients (35%) fell into category 2A, 8 (10%) into category 2B, 4 (5%) into category 2C, and 39 (50%) into category 3. Immediate technical success was achieved in 77 patients (98.7%). Complications included damage at the arterial puncture site (2 patients, 2.5%) and acute kidney injury (24 patients, 31%). Only 2 patients (2.5%) had been discharged with a new diagnosis of chronic kidney disease. The 30-day overall mortality rate was 19% (15 patients). The mortality rate was higher in hemodynamically unstable patients, in Popov categories 2B, 2C, and 3, and in patients with an initial eGFR < 30 mL/min × 1.73 m2. The study demonstrated a higher mortality risk for categories 2B, 2C, and 3 compared to category 2A. Nonetheless, TAE has proven effective and safe in type 2A patients. Even though it is unclear whether type 2A patients could benefit from conservative treatment rather than TAE, in the authors' opinion, a TAE endovascular approach should be promptly considered for all patients in ACT with active bleeding demonstrated on CT scans.

Pulmonary Artery Pseudoaneurysms Embolization: Bicentric Experience and Review of the Literature.

The purpose of this bicentric case series was to report the safety, efficacy, and clinical outcome of transcatheter embolization in pulmonary artery pseudoaneurysms (PAPAs). Between January 2016 and June 2021, eight patients with PAPA were subjected to transcatheter embolization. The total number of patients was eight, of which five were female, with a mean age of 62 ± 14 years (average ± standard deviation). Etiology was traumatic in 2/8 cases and iatrogenic in 6/8 cases (after positioning a Swan-Ganz catheter in 5/6 cases and a temporary pacemaker in the latter case). In a single case, the PAPA was incidentally discovered during a routine X-ray, in the remaining 7 cases, the procedure was performed in emergency settings. PAPA embolization was performed using detachable coils alone in 3 cases; coils and glue in 1 case; coils, glue, and vascular plug in 1 case; coils and non-adhesive liquid embolic agents (Onyx and Squid respectively) in 2 cases; and non-adhesive liquid embolic agent alone (Onyx) in 1 case. No peri-procedural or post-procedural complications were recorded. Both the technical and clinical success rates were 100.0%. In conclusion, endovascular embolization is a technically feasible and safe therapeutic option for patients with PAPAs.

The infection risk after transjugular intrahepatic portosystemic shunt: A multiple competing risk analysis from a tertiary care center.

BACKGROUND: Infections following transjugular intrahepatic portosystemic shunt (TIPS) placement have been poorly described. We aim to investigate the rate and the potential predictors of infections occurring after TIPS placement. METHODS: Single center, retrospective, observational study. All patients who had undergone TIPS placement in the last 10 years with a minimum 1-year FU, were considered. Multiple competing risk analyses were performed to identify infection risk factors and a multivariable Cox proportional-hazard regression model to evaluate the predictors of death. RESULTS: Forty-nine patients were considered. Among these, 23 (46%) developed at least 1 infection during the FU, at a median time of 237.7 days (IQR 151.5) from the TIPS placement. We did not find any predictor of infection, while MELD score and cancer were associated with death (p = .04; HR 1.14; CI 1.00- 1.30). CONCLUSION: We found a high rate of all-type infections during the FU times. However, most of these infections occurred as late-onset infections and were caused by Gram-positive microorganisms. Thus, TIPS procedure itself does not seem to be burdened with high infectious perioperative risk.

Safety and Feasibility of Steerable Radiofrequency Ablation in Combination with Cementoplasty for the Treatment of Large Extraspinal Bone Metastases.

Background: Radiofrequency ablation (RFA) and cementoplasty, individually and in concert, has been adopted as palliative interventional strategies to reduce pain caused by bone metastases and prevent skeletal related events. We aim to evaluate the feasibility and safety of a steerable RFA device with an articulating bipolar extensible electrode for the treatment of extraspinal bone metastases. Methods: All data were retrospectively reviewed. All the ablation procedures were performed using a steerable RFA device (STAR, Merit Medical Systems, Inc., South Jordan, UT, USA). The pain was assessed with a VAS score before treatment and at 1-week and 3-, 6-, and 12-month follow-up. The Functional Mobility Scale (FMS) was recorded preoperatively and 1 month after the treatment through a four-point scale (4, bedridden; 3, use of wheelchair; 2, limited painful ambulation; 1, normal ambulation). Technical success was defined as successful intraoperative ablation and cementoplasty without major complications. Results: A statistically significant reduction of the median VAS score before treatment and 1 week after RFA and cementoplasty was observed (p < 0.001). A total of 6/7 patients who used a wheelchair reported normal ambulation 1 month after treatment. All patients with limited painful ambulation reported normal ambulation after the RFA and cementoplasty (p = 0.003). Technical success was achieved in all the combined procedures. Two cement leakages were reported. No local recurrences were observed after 1 year. Conclusions: The combined treatment of RFA with a steerable device and cementoplasty is a safe, feasible, and promising clinical option for the management of painful bone metastases, challenging for morphology and location, resulting in an improvement of the quality of life of patients.

Green Tattoo Pre-Operative Renal Embolization for Robotic-Assisted and Laparoscopic Partial Nephrectomy: A Practical Proof of a New Technique.

(1) Background: Our aim is to describe a new mixed indocyanine-non-adhesive liquid embolic agent (Onyx-18) pre-operative renal embolization technique for assisted-robotic and laparoscopic partial nephrectomy with near-infra-red fluorescence imaging. (2) Methods: Thirteen patients with biopsy-proven renal tumors underwent pre-operative mixed indocyanine-ethylene vinyl alcohol (EVOH) embolization (Green-embo) between June 2021 and August 2022. All pre-operative embolizations were performed with a super selective stop-flow technique using a balloon microcatheter to deliver an indocyanine-EVOH mixture into tertiary order arterial branch feeders and the intra-lesional vascular supply. Efficacy (evaluated as complete embolization, correct tumor mapping on infra-red fluorescence imaging and clamp-off surgery) and safety (evaluated as complication rate and functional outcomes) were primary goals. Clinical and pathological data were also collected. (3) Results: Two male and eleven female patients (mean age 72 years) received pre-operative Green-embo. The median tumor size was 29 mm (range 15-50 mm). Histopathology identified renal cell carcinoma (RCC) in 9 of the 13 (69%) patients, oncocytoma in 3 of the 13 (23%) patients and sarcomatoid RCC in 1 of the 13 (8%) patients. Lesions were equally distributed between polar, meso-renal, endo- and exophytic locations. Complete embolization was achieved in all the procedures. A correct green mapping was identified during all infra-red fluorescence imaging. All patients were discharged on the second day after the surgery. The median blood loss was 145 cc (10-300 cc). No significant differences were observed in serum creatinine levels before and after the embolization procedures. (4) Conclusions: The Green-tattoo technique based on a mixed indocyanine-non-adhesive liquid embolic agent (Onyx-18) is a safe and effective pre-operative embolization technique. The main advantages are the excellent lesion mapping for fluorescence imaging, reduction in surgical time, and definitive, complete and immediate tumor devascularization based on the deep Onyx-18 penetration, leading to a very low intra-operative blood loss.

Combined Trans-Arterial Embolization and Ablation for the Treatment of Large (>3 cm) Liver Metastases: Review of the Literature

(1) Background: The aim of this review was to determine the state of clinical practice in the role of the combined approach of embolization and ablation in patients with secondary liver lesions greater than 3 cm who are not candidates for surgery, and to study its safety and efficacy. (2) Methods: Two reviewers conducted the literature search independently. Eight articles on the combined approach of embolization and ablation in secondary liver lesions were selected. (3) Results: The studies were published between 2009 and 2020. Two studies were prospective in design. The sample size was < 100 patients for all studies. All studies demonstrated the safety of the combined approach based on the low complication rate. Some studies lamented non-uniform systemic chemotherapy regimens and the variability in the sequence of embolization and ablation. (4) Conclusions: This review presents the combined approach of ablation and embolization in liver lesions greater than 3 cm as a safe therapeutic procedure with positive effects on patient survival. Prospective and multicentric studies are needed to further evaluate its efficacy.

Quantib Prostate Compared to an Expert Radiologist for the Diagnosis of Prostate Cancer on mpMRI: A Single-Center Preliminary Study.

Background: To evaluate the clinical utility of an Artificial Intelligence (AI) radiology solution, Quantib Prostate, for prostate cancer (PCa) lesions detection on multiparametric Magnetic Resonance Images (mpMRI). Methods: Prostate mpMRI exams of 108 patients were retrospectively studied. The diagnostic performance of an expert radiologist (>8 years of experience) and of an inexperienced radiologist aided by Quantib software were compared. Three groups of patients were assessed: patients with positive mpMRI, positive target biopsy, and/or at least one positive random biopsy (group A, 73 patients); patients with positive mpMRI and a negative biopsy (group B, 14 patients), and patients with negative mpMRI who did not undergo biopsy (group-C, 21 patients). Results: In group A, the AI-assisted radiologist found new lesions with positive biopsy correlation, increasing the diagnostic PCa performance when compared with the expert radiologist, reaching an SE of 92.3% and a PPV of 90.1% (vs. 71.7% and 84.4%). In group A, the expert radiologist found 96 lesions on 73 mpMRI exams (17.7% PIRADS3, 56.3% PIRADS4, and 26% PIRADS5). The AI-assisted radiologist found 121 lesions (0.8% PIRADS3, 53.7% PIRADS4, and 45.5% PIRADS5). At biopsy, 33.9% of the lesions were ISUP1, 31.4% were ISUP2, 22% were ISUP3, 10.2% were ISUP4, and 2.5% were ISUP5. In group B, where biopsies were negative, the AI-assisted radiologist excluded three lesions but confirmed all the others. In group-C, the AI-assisted radiologist found 37 new lesions, most of them PIRADS 3, with 32.4% localized in the peripherical zone and 67.6% in the transition zone. Conclusions: Quantib software is a very sensitive tool to use specifically in high-risk patients (high PIRADS and high Gleason score).