Evaluation of margins during radical prostatectomy: confocal microscopy vs frozen section analysis.

OBJECTIVES: To test the performance of ex vivo fluorescence confocal microscopy (FCM; Vivascope 2500M-G4), as compared to intra-operative frozen section (IFS) analysis, to evaluate surgical margins during robot-assisted radical prostatectomy (RARP), with final pathology as the reference standard. METHODS: Overall, 54 margins in 45 patients treated with RARP were analysed with: (1) ex vivo FCM; (2) IFS analysis; and (3) final pathology. FCM margins were evaluated by two different pathologists (experienced [M.I.: 10 years] vs highly experienced [G.R.: >30 years]) as strongly negative, probably negative, doubtful, probably positive, or strongly positive. First, inter-observer agreement (Cohen's κ) between pathologists was tested. Second, we reported the sensitivity, specificity, positive predictive (PPV) and negative predictive value (NPV) of ex vivo FCM. Finally, agreement between ex vivo FCM and IFS analysis (Cohen's κ) was reported. For all analyses, four combinations of FCM results were evaluated. RESULTS: At ex vivo FCM, the inter-observer agreement between pathologists ranged from moderate (κ = 0.74) to almost perfect (κ = 0.90), according to the four categories of results. Indeed, at ex vivo FCM, the highly experienced pathologist reached the best balance between sensitivity (70.5%) specificity (91.8%), PPV (80.0%) and NPV (87.1%). Conversely, on IFS analysis, the sensitivity, specificity, PPV and NPV were, respectively, 88.2% vs 100% vs 100% vs 94.8%. The agreement between the ex vivo FCM and IFS analyses ranged from moderate (κ = 0.62) to strong (κ = 0.86), according to the four categories of results. CONCLUSION: Evaluation of prostate margins at ex vivo FCM appears to be feasible and reliable. The agreement between readers encourages its widespread use in daily practice. Nevertheless, as of today, the performance of FCM seems to be sub-par when compared to the established standard of care (IFS analysis).

A Phase 3 Prospective Randomized Trial to Evaluate the Impact of Augmented Reality During Robot-assisted Radical Prostatectomy on the Rates of Postoperative Surgical Margins: A Clinical Trial Protocol.

We designed a phase 3, prospective, randomized trial to evaluate the impact of augmented reality and augmented reality frozen section analysis in reducing the rates of positive surgical margins after robot-assisted radical prostatectomy.

Artificial Intelligence-Based Hyper Accuracy Three-Dimensional (HA3D®) Models in Surgical Planning of Challenging Robotic Nephron-Sparing Surgery: A Case Report and Snapshot of the State-of-the-Art with Possible Future Implications.

Recently, 3D models (3DM) gained popularity in urology, especially in nephron-sparing interventions (NSI). Up to now, the application of artificial intelligence (AI) techniques alone does not allow us to obtain a 3DM adequate to plan a robot-assisted partial nephrectomy (RAPN). Integration of AI with computer vision algorithms seems promising as it allows to speed up the process. Herein, we present a 3DM realized with the integration of AI and a computer vision approach (CVA), displaying the utility of AI-based Hyper Accuracy Three-dimensional (HA3D®) models in preoperative planning and intraoperative decision-making process of challenging robotic NSI. A 54-year-old Caucasian female with no past medical history was referred to the urologist for incidental detection of the right renal mass. Preoperative contrast-enhanced abdominal CT confirmed a 35 × 25 mm lesion on the anterior surface of the upper pole (PADUA 7), with no signs of distant metastasis. CT images in DICOM format were processed to obtain a HA3D® model. RAPN was performed using Da Vinci Xi surgical system in a three-arm configuration. The enucleation strategy was achieved after selective clamping of the tumor-feeding artery. Overall operative time was 85 min (14 min of warm ischemia time). No intra-, peri- and post-operative complications were recorded. Histopathological examination revealed a ccRCC (stage pT1aNxMx). AI is breaking new ground in medical image analysis panorama, with enormous potential in organ/tissue classification and segmentation, thus obtaining 3DM automatically and repetitively. Realized with the integration of AI and CVA, the results of our 3DM were accurate as demonstrated during NSI, proving the potentialities of this approach for HA3D® models' reconstruction.

Health Information Technology Usability Evaluation Scale (Health-ITUES) and User-Experience Questionnaire (UEQ) for 3D Intraoperative Cognitive Navigation (ICON3DTM) System for Urological Procedures.

Backgound and objectives: In recent years, the adoption of 3D models for surgical planning and intraoperative guidance has gained a wide diffusion. The aim of this study was to evaluate the surgeons' perception and usability of ICON3DTM platform for robotic and laparoscopic urological surgical procedures. Materials and Methods: During the 10th edition of the Techno-Urology Meeting, surgeons and attendees had the opportunity to test the new ICON3DTM platform. The capability of the user to manipulate the model with hands/mouse, the software usability, the quality of the 3D model's reproduction, and the quality of its use during the surgery were evaluated with the Health Information Technology Usability Evaluation Scale (Health-ITUES) and the User-Experience Questionnaire (UEQ). Results: Fifty-three participants responded to the questionnaires. Based on the answers to the Health-ITUES questionnaire, ICON3DTM resulted to have a positive additional value in presurgical/surgical planning with 43.4% and 39.6% of responders that rated 4 (agree) and 5 (strongly agree), respectively. Regarding the UEQ questionnaire, both mouse and infrared hand-tracking system resulted to be easy to use for 99% of the responders, while the software resulted to be easy to use for 93.4% of the responders. Conclusions: In conclusion, ICON3DTM has been widely appreciated by urologists thanks to its various applications, from preoperative planning to its support for intraoperative decision-making in both robot-assisted and laparoscopic settings.

Three-dimensional Augmented Reality-guided Robotic-assisted Kidney Transplantation: Breaking the Limit of Atheromatic Plaques.

BACKGROUND: Robotic-assisted kidney transplantation (RAKT) has shown solid results as a minimally invasive alternative to the standard open approach (open kidney transplantation [OKT]). However, RAKT is still limited in those cases where the recipient's iliac vessels present atherosclerotic plaques, frequently found in elder patients and in those subjected to long-term hemodialysis. Unlike OKT, where the surgeon can palpate the arterial plaques, in minimally invasive surgery the haptic feedback is missing, making the vascular clamping and arteriotomy unsafe. OBJECTIVE: To employ three-dimensional (3D) imaging reconstruction using augmented reality (AR) to intraoperatively locate the plaques during the crucial steps of kidney transplantation. DESIGN, SETTING, AND PARTICIPANTS: Our study was conducted according to the Idea, Development, Exploration, Assessment, and Long-term follow-up (IDEAL) model for surgical innovation. Three-dimensional virtual models were obtained from high-accuracy computed tomography scan imaging and superimposed on the vessels during RAKT using the Da Vinci console software. SURGICAL PROCEDURE: Three-dimensional AR-guided robotic-assisted kidney transplantation. MEASUREMENTS: The correspondence of virtual models with the real anatomy of patients was assessed comparing vessels' and plaques' measures. RESULTS AND LIMITATIONS: We tested the possibility of using the AR in the setting of vascular surgery by checking the correspondence of the virtual models to the real vessels. During the accuracy assessment, we investigated the anatomy of the iliac plaques and the capacity of the virtual models to correctly represent them. Finally, we tested the efficacy of the virtual model superimposition on the real vessels with plaques during RAKT in the recipients of living donor grafts. The main limitation consists in training needed to correctly superimpose virtual models on the real field. CONCLUSIONS: The employment of 3D AR allowed surgeons to overcome one of the main limitations of RAKT, setting the foundation to expand its indications to patients with advanced atheromatic vascular disease. PATIENT SUMMARY: The use of three-dimensional augmented reality guidance during kidney transplantation (KT) has the potential to "navigate" the surgeon during KT, allowing a safer procedure in patients with atheromatic vascular disease.

Technical aspects to maximize the hyperaccuracy three-dimensional (HA3D™) computed tomography reconstruction for kidney stones surgery: a pilot study.

The aim of the current prospective pilot study was to describe a hyperaccuracy three-dimensional (HA3D™) model reconstruction technique, specifically developed to maximize the visualization of the renal collecting system's anatomy, and its relationship with the stones, vessels and renal parenchyma, and to compare the HA3D™ virtual models with the intraoperative findings. The image acquisition was performed using a CT scanner (Toshiba, Aquilion Prime) and included the unenhanced, arterial, venous and excretory phases. The DICOM format CT images were processed by MEDICS Srl ( www.medics3d.com , Turin, Italy). In total, study included three patients with renal stone scheduled for non-papillary prone percutaneous nephrolithotomy (PCNL). The median age and BMI were 51 (range 49-54) and 25.5 (range 25.0-32.7), respectively. The median stone size was 1170 mm2 (range 830-1520) and median stone density was 1130 HU (range 600-1340). In all cases, the quality of the CT images acquired with our protocol was adequate to perform the HA3D™ reconstruction. Median operative and puncture time were 39.4 (range 35.2-44.0) and 1.9 (range 1.8-2.1) mins, respectively. The success rate for the first attempt of the percutaneous puncture was 100%, and only one PCNL tract was sufficient to complete the surgery. All three patients were stone-free on the third postoperative day. A dedicated imaging acquisition protocol and a tailored 3D model reconstruction process specifically developed for kidney stones treatment allow obtaining HA3D™ highly relevant models to greatly match intraoperative findings during PCNL with the potential of minimizing bleeding and organ injury complications.

Three-dimensional Augmented Reality Robot-assisted Partial Nephrectomy in Case of Complex Tumours (PADUA ≥10): A New Intraoperative Tool Overcoming the Ultrasound Guidance.

BACKGROUND: Despite technical improvements introduced with robotic surgery, management of complex tumours (PADUA score ≥10) is still a matter of debate within the field of transperitoneal robot-assisted partial nephrectomy (RAPN). OBJECTIVE: To evaluate the accuracy of our three-dimensional (3D) static and elastic augmented reality (AR) systems based on hyperaccuracy models (HA3D) in identifying tumours and intrarenal structures during transperitoneal RAPN (AR-RAPN), compared with standard ultrasound (US). DESIGN, SETTING, AND PARTICIPANTS: A retrospective study was conducted, including 91 patients who underwent RAPN for complex renal tumours, 48 with 3D AR guidance and 43 with 2D US guidance, from July 2017 to May 2019. SURGICAL PROCEDURE: In patients who underwent 3D AR-RAPN, virtual image overlapping guided the surgeon during resection and suture phases. In the 2D US group, interventions were driven by US only. MEASUREMENTS: Patient characteristics were tested using the Fisher's exact test for categorical variables and the Mann-Whitney test for continuous ones. Intraoperative, postoperative, and surgical outcomes were collected. All results for continuous variables were expressed as medians (range), and frequencies and proportions were reported as percentages. RESULTS AND LIMITATIONS: The use of 3D AR guidance makes it possible to correctly identify the lesion and intraparenchymal structures with a more accurate 3D perception of the location and the nature of the different structures relative to the standard 2D US guidance. This translates to a lower rate of global ischaemia (45.8% in the 3D group vs 69.7% in the US group; p = 0.03), higher rate of enucleation (62.5% vs 37.5% in the 3D and US groups, respectively; p = 0.02), and lower rate of collecting system violation (10.4% vs 45.5%; p = 0.003). Postoperatively, 3D AR guidance use correlates to a low risk of surgery-related complications in 3D AR groups and a lower drop in estimated renal plasma flow at renal scan at 3 mo of follow-up (-12.38 in the 3D group vs -18.14 in the US group; p = 0.01). The main limitations of this study are short follow-up time and small sample size. CONCLUSIONS: HA3D models that overlap in vivo anatomy during AR-RAPN for complex tumours can be useful for identifying the lesion and intraparenchymal structures that are difficult to visualise with US only. This translates to a potential improvement in the quality of the resection phase and a reduction in postoperative complications, with better functional recovery. PATIENT SUMMARY: Based on our findings, three-dimensional augmented reality robot-assisted partial nephrectomy seems to help surgeons in the management of complex renal tumours, with potential early postoperative benefits.

Augmented-reality robot-assisted radical prostatectomy using hyper-accuracy three-dimensional reconstruction (HA3D™) technology: a radiological and pathological study.

OBJECTIVES: To assess the use of hyper-accuracy three-dimensional (HA3D™; MEDICS, Moncalieri, Turin, Italy) reconstruction based on multiparametric magnetic resonance imaging (mpMRI) and superimposed imaging during augmented-reality robot-assisted radical prostatectomy (AR-RARP). PATIENTS AND METHODS: Patients with prostate cancer (clinical stages cT1-3, cN0, cM0) undergoing RARP at our Centre, from June 2017 to April 2018, were enrolled. In all cases, cancer was diagnosed with targeted biopsy at the level of index lesion based on high-resolution (1-mm slices) mpMRI. HA3D reconstruction was created by dedicated software to obtain the 3D virtual model of the prostate and surrounding structures. A specific system was used to overlay virtual data on the endoscopic video displayed by the remote da Vinci® surgical console (Intuitive Surgical Inc., Sunnyvale, CA, USA), and the virtual images were superimposed by the surgeon by the means of the TilePro™ multi-input display technology (Intuitive Surgical Inc.). The AR technology was used in four standardised key steps during RARP. The procedures were modulated differently in cases of prostate cancer without extracapsular extension (ECE) at mpMRI (Group A) or in cases of prostate cancer with ECE (Group B) at mpMRI. In Group A, the virtual image of the prostate was overlaid on the endoscopic view and the intraprostatic lesion was marked on the prostate surface by a metallic clip at the level of the suspicious lesion as identified by the 3D virtual AR image. In Group B, the same step was performed; moreover, a metallic clip was placed at the level of the suspicious ECE on the neurovascular bundles (NVBs) according to the virtual images. Finally, selective biopsies were taken from the NVBs at this level, and then, the entire NVBs were removed for final pathological examination, according to standard clinical indications. For Group A, the pathologist performed a targeted needle biopsy at the level of the metallic clip on the surface of prostate before the sample reduction. For Group B, the presence of tumour was evaluated during the reduction phase, at the level of metallic clip on the prostate surface and at the level of NVBs, sent separately. Finally, an image 3D scanner (Kinect, Microsoft) was used to perform a dimensional comparison between the mpMRI-based 3D virtual reconstruction and the whole-mount specimen. RESULTS: In all, 30 patients were enrolled in the present study, 11 (36.6%) included in Group A and 19 (63.4%) in Group B. In all cases (30/30), final pathology confirmed the location of the index lesion, as cancer was found at the level of the metallic clip. The suspected ECE was confirmed on final pathology in 15/19 cases (79%). The AR-guided selective biopsies at the level of the NVBs confirmed the ECE location, with 11/15 (73.3%) biopsies at the level of NVBs positive for cancer. The mismatch between the 3D virtual reconstruction and the prostate 3D scanning based on the whole-mount specimen was <3 mm in >85% of the gland. CONCLUSION: Our results suggest that a HA3D virtual reconstruction of the prostate based on mpMRI data and real-time superimposed imaging allow performance of an effective AR-RARP. Potentially, this approach translates into better outcomes, as the surgeon can tailor the procedure for each patient.