A Safe Framework for Quantitative In Vivo Human Evaluation of Image Guidance.

Goal: We present a new framework for in vivo image guidance evaluation and provide a case study on robotic partial nephrectomy. Methods: This framework (called the "bystander protocol") involves two surgeons, one who solely performs the therapeutic process without image guidance, and another who solely periodically collects data to evaluate image guidance. This isolates the evaluation from the therapy, so that in-development image guidance systems can be tested without risk of negatively impacting the standard of care. We provide a case study applying this protocol in clinical cases during robotic partial nephrectomy surgery. Results: The bystander protocol was performed successfully in 6 patient cases. We find average lesion centroid localization error with our IGS system to be 6.5 mm in vivo compared to our prior result of 3.0 mm in phantoms. Conclusions: The bystander protocol is a safe, effective method for testing in-development image guidance systems in human subjects.

A contemporary comparison of laparoscopic versus open partial nephrectomy for renal cell carcinoma.

PURPOSE: To analyze surgical and oncologic outcomes of patients undergoing open partial nephrectomy (OPN) versus laparoscopic partial nephrectomy (LPN) for treatment of renal cell carcinoma (RCC). METHODS: We retrospectively investigated our institutional RCC database for patients who underwent PN for RCC from 1997 to 2018. Decision for technique was at the discretion of the operating urologist, following practice patterns and training history. Outcomes analyzed included pre/peri/post-operative parameters, pathologic outcomes, and disease recurrence rates. RESULTS: 1088 patients underwent PN from 1997 to 2018. After exclusionary criteria, 631 patients who underwent 647 unique PNs for a total of 162 OPN and 485 LPN remained. Baseline, pre-op, and pathologic characteristics were not statistically different. Surgical time was lower in laparoscopic cases [185 vs. 205 min] (p = 0.013). Margin involvement was not statistically different; LPN had lower estimated blood loss (EBL) [150 vs. 250 mL] (p < 0.001) and longer ischemia time [21 vs. 19 min] (p = 0.005). LPN had shorter length of stay [2 vs. 4 days] (p < 0.001), fewer overall complications (p < 0.001), and no significant difference in high-grade complications [2.89 vs. 4.32%] (p = 0.379). Fewer LPN patients developed metastases [1.65 vs. 4.94%] (p = 0.0499). Local recurrence rates were not statistically different [1.24 vs. 3.09%] (p = 0.193). Renal function was equivalent between cohorts post-operatively. CONCLUSION: Long-term oncologic outcomes were not significantly different between LPN versus OPN, with no statistical difference in patient and tumor characteristics. LPN was associated with lower EBL, shorter length of stay, and lower overall complication risk. Renal function was not significantly different between cohorts.

Factors Affecting Holmium Laser Efficiency: Comparison of Laryngeal Mask Airway and Endotracheal Intubation During Ureteroscopy for Renal Stones.

Introduction: Holmium laser lithotripsy is a standard energy source used for treatment of kidney stones during flexible ureteroscopy. Efficiency of laser surgery may be affected by patient and operator characteristics or perioperative management. Here, we sought to examine intraoperative data from patients undergoing high frequency dusting with high-powered holmium laser lithotripsy to evaluate surgical and demographic factors associated with lasing efficiency (LE). Methods: A total of 82 intraoperative reports were analyzed from an ongoing laser lithotripsy clinical trial evaluating the Lumenis Pulse™ 120H holmium laser with renal stones up to 20 mm in diameter with and without Moses 2.0 technology. For each case, the total pause time between lasing activations was corrected to remove lengthy pauses and divided by the total lasing time to calculate an efficiency percentage. This was then compared with patient demographics, anesthesia administration, stone burden, postoperative complications, and stone-free rates using both univariate and multivariate analyses. Results: Of the 82 included patients, 36 received endotracheal tube (ETT) intubation and 46 had a laryngeal mask airway (LMA). Patients with ETT had significantly higher LE (78.7%) compared to those with an LMA (73.3%) in our univariate analysis (p < 0.01) as well as in the multivariate model that adjusted for maximum stone size, number of stones, stone density, and patient body mass index (p < 0.05). There was also significantly higher mean LE in patients with no postoperative complications (76.3%) compared to those with any grade (I-V) Clavien-Dindo complication within 30 days after surgery (70.0%) (p < 0.05). Conclusions: Flexible ureteroscopy and laser lithotripsy cases with higher LE are associated with lower rates of postoperative complications. The data also support the use of ETT over LMA to improve overall LE; however, this remains one consideration among many for choosing anesthesia administration. Clinical Trial Registration number: NCT04505956.

Quick Sequential Organ Failure Assessment Score Is a Better Predictor of Septic Shock After Percutaneous Nephrolithotomy: A Secondary Analysis of Two Multicenter Prospective Trials.

Introduction: Recent retrospective literature suggests that the quick sequential organ failure assessment (qSOFA) scoring tool is a potentially superior tool over use of the systemic inflammatory response syndrome (SIRS) criteria to predict septic shock after percutaneous nephrolithotomy (PCNL) surgery. Here we examine use of qSOFA and SIRS to predict septic shock within data series collected prospectively on PCNL patients as part of a greater study of infectious complications. Materials and Methods: We performed a secondary analysis of two prospective multicenter studies including PCNL patients across nine institutions. Clinical signs informing SIRS and qSOFA scores were collected no later than postoperative day 1. The primary outcome was sensitivity and specificity of SIRS and qSOFA (high-risk score of greater-or-equal to two points) in predicting admission to the intensive care unit (ICU) for vasopressor support. Results: A total of 218 cases at 9 institutions were analyzed. One patient required vasopressor support in the ICU. The sensitivity/specificity was 100%/72.4% (McNemar's test p < 0.001) for SIRS and was 100%/90.8% (McNemar's test p < 0.001) for qSOFA. Conclusion: Although positive predictive value for both qSOFA and SIRS in prediction of post-PCNL septic shock is low, prospectively collected data demonstrate use of qSOFA may offer greater specificity than SIRS criteria when predicting post-PCNL septic shock.

The Fate of Residual Fragments After Percutaneous Nephrolithotomy: Results from the Endourologic Disease Group for Excellence Research Consortium.

Background: Residual fragments (RFs) after percutaneous nephrolithotomy (PCNL) have a significant impact on patients' quality of life and clinical course. There is a paucity of studies that evaluate the natural history of RFs after PCNL. The objective of this study is to compare rates of reintervention, complications, stone growth, and passage in patients with RFs >4, ≤4, and ≤2 mm after PCNL. Methods: Sites from the Endourologic Disease Group for Excellence (EDGE) research consortium examined data of PCNL patients from 2015 to 2019 with at least 1-year follow-up. RF passage, regrowth, reintervention, and complications were recorded and RFs were stratified into >4 and ≤4 mm groups, as well as >2 and ≤2 mm groups. Potential predictors for stone-related events after PCNL were determined using multivariable logistic regression analysis. It was hypothesized that larger RF thresholds would result in lower passage rates, faster regrowth, and greater clinically significant events (complications and reinterventions) than smaller RF thresholds. Results: A total of 439 patients with RFs >1 mm on CT postoperative day 1 were included in this study. For RFs >4 mm, rates of reintervention were found to be significantly higher and Kaplan-Meier curve analysis showed significantly higher rates of stone-related events. Passage and RF regrowth were not found to be significantly different compared with RFs ≤4 mm. However, RFs ≤2 mm had significantly higher rates of passage, and significantly lower rates of fragment regrowth (>1 mm), complications, and reintervention compared with RFs >2 mm. On multivariable analysis, older age, body mass index, and RF size were found to be predictive of stone-related events. Conclusions: With the largest cohort to date, this study by the EDGE research consortium further confirms that clinically insignificant residual fragment is problematic for patients after PCNL, particularly in older more obese patients with larger RFs. Our study underscores the importance of complete stone clearance post-PCNL and challenges the use of Clinically insignificant residual fragment (CIFR).

Kidney Stone Prevalence Based on Self-Report and Electronic Health Records: Insight into the Prevalence of Active Medical Care for Kidney Stones.

OBJECTIVE: To compare rates of patient-reported kidney stone disease to Electronic Health Records (EHR) kidney stone diagnosis using a common dataset to evaluate for socio-demographic differences, including between those with and without active care. METHODS: From the All of Us research database, we identified 21,687 adult participants with both patient-reported and EHR data. We compared differences in age, sex, race, education, employment status and healthcare access between patients with self-reported kidney stone history without EHR data to those with EHR-based diagnoses. RESULTS: In this population, the self-reported prevalence of kidney stones was 8.6% overall (n = 1877), including 4.6% (n = 1004) who had self-reported diagnoses but no EHR data. Among those with self-reported kidney stone diagnoses only, the median age was 66. The EHR-based prevalence of kidney stones was 5.7% (n = 1231), median age 67. No differences were observed in age, sex, education, employment status, rural/urban status, or ability to afford healthcare between groups with EHR diagnosis or self-reported diagnosis only. Of patients who had a self-reported history of kidney stones, 24% reported actively seeing a provider for kidney stones. CONCLUSION: Kidney stone prevalence by self-report is higher than EHR-based prevalence in this national dataset. Using either method alone to estimate kidney stone prevalence may exclude some patients with the condition, although the demographic profile of both groups is similar. Approximately 1 in 4 patients report actively seeing a provider for stone disease.

Patient-specific, touch-based registration during robotic, image-guided partial nephrectomy.

Image-guidance during partial nephrectomy enables navigation within the operative field alongside a 3-dimensional roadmap of renal anatomy generated from patient-specific imaging. Once a process is performed by the human mind, the technology will allow standardization of the task for the benefit of all patients undergoing robot-assisted partial nephrectomy. Any surgeon will be able to visualize the kidney and key subsurface landmarks in real-time within a 3-dimensional simulation, with the goals of improving operative efficiency, decreasing surgical complications, and improving oncologic outcomes. For similar purposes, image-guidance has already been adopted as a standard of care in other surgical fields; we are now at the brink of this in urology. This review summarizes touch-based approaches to image-guidance during partial nephrectomy, as the technology begins to enter in vivo human evaluation. The processes of segmentation, localization, registration, and re-registration are all described with seamless integration into the da Vinci surgical system; this will facilitate clinical adoption sooner.

MOSESTM Technology for Holmium Laser Enucleation of the Prostate: A Prospective Double-Blind Randomized Controlled Trial.

PURPOSE: Holmium laser enucleation of the prostate has proven to be efficacious and safe for the treatment of benign prostatic hyperplasia. New laser technologies, such as the MOSES™ pulse laser system, improve energy delivery and may improve operative times. We sought to prospectively evaluate holmium laser enucleation of the prostate using MOSES technology in a double-blind randomized controlled trial. MATERIALS AND METHODS: This is a single-center, prospective, double-blind, randomized controlled trial comparing holmium laser enucleation of the prostate using MOSES technology to holmium laser enucleation of the prostate. Patients were randomized in a 1:1 fashion. The study was powered to evaluate for a difference in operative time. Secondary end points included enucleation, morcellation, and hemostasis times, as well as blood loss, functional outcomes and complications 6 weeks postoperatively. RESULTS: A total of 60 patients were analyzed without difference in preoperative characteristics in either group (holmium laser enucleation of the prostate using MOSES technology: 30/60, 50%, holmium laser enucleation of the prostate: 30/60, 50%). Shorter total operative time was seen in the holmium laser enucleation of the prostate using MOSES technology group compared to the holmium laser enucleation of the prostate group (mean: 101 vs. 126 minutes, p <0.01). This difference remained significant on multiple linear regression. Additionally, the holmium laser enucleation of the prostate using MOSES technology group had shorter enucleation times (mean: 68 vs. 80 minutes, p=0.03), hemostasis time (mean: 18 vs. 29 minutes, p <0.01), and less blood loss (mean: -6.3 vs. -9.0%, p=0.03), measured by a smaller change in hematocrit postoperatively, compared to the traditional holmium laser enucleation of the prostate. There was no difference in functional or safety outcomes at followup. CONCLUSIONS: We report the results of a prospective, double-blind, randomized controlled trial comparing holmium laser enucleation of the prostate using MOSES technology to traditional holmium laser enucleation of the prostate. MOSES technology resulted in an improvement in operative time and a reduction in blood loss with comparable functional outcomes and complications compared to traditional holmium laser enucleation of the prostate.

Accuracy of Touch-Based Registration During Robotic Image-Guided Partial Nephrectomy Before and After Tumor Resection in Validated Phantoms.

Aim: Image-guided surgery (IGS) allows for accurate, real-time localization of subsurface critical structures during surgery. No prior IGS systems have described a feasible method of intraoperative reregistration after manipulation of the kidney during robotic partial nephrectomy (PN). We present a method for seamless reregistration during IGS and evaluate accuracy before and after tumor resection in two validated kidney phantoms. Materials and Methods: We performed robotic PN on two validated kidney phantoms-one with an endophytic tumor and one with an exophytic tumor-with our IGS system utilizing the da Vinci Xi robot. Intraoperatively, the kidney phantoms' surfaces were digitized with the da Vinci robotic manipulator via a touch-based method and registered to a three-dimensional segmented model created from cross-sectional CT imaging of the phantoms. Fiducial points were marked with a surgical marking pen and identified after the initial registration using the robotic manipulator. Segmented images were displayed via picture-in-picture in the surgeon console as tumor resection was performed. After resection, reregistration was performed by reidentifying the fiducial points. The accuracy of the initial registration and reregistration was compared. Results: The root mean square (RMS) averages of target registration error (TRE) were 2.53 and 4.88 mm for the endophytic and exophytic phantoms, respectively. IGS enabled resection along preplanned contours. Specifically, the RMS averages of the normal TRE over the entire resection surface were 0.75 and 2.15 mm for the endophytic and exophytic phantoms, respectively. Both tumors were resected with grossly negative margins. Point-based reregistration enabled instantaneous reregistration with minimal impact on RMS TRE compared with the initial registration (from 1.34 to 1.70 mm preresection and from 1.60 to 2.10 mm postresection). Conclusions: We present a novel and accurate registration and reregistration framework for use during IGS for PN with the da Vinci Xi surgical system. The technology is easily integrated into the surgical workflow and does not require additional hardware.

Transurethral Anastomosis after Transurethral Radical Prostatectomy: A Phantom Study on Intraluminal Suturing With Concentric Tube Robots.

Current surgical approaches to radical prostatectomy are associated with high rates of erectile dysfunction and incontinence. These complications occur secondary to the disruption of surrounding healthy tissue, which is required to expose the prostate. The urethra offers the least invasive access to the prostate, and feasibility has been demonstrated of enucleating the prostate with an endoscope using Holmium laser, which can itself be aimed by concentric tube robots. However, the transurethral approach to radical prostatectomy has thus far been limited by the lack of a suitable means to perform an anastomosis of the urethra to the bladder after prostate removal. Only a few intraluminal anastomotic devices currently exist, and none are small enough to pass through the urethra. In this paper we describe a new way to perform an anastomosis in the small luminal space of the urethra, harnessing the dexterity and customizability of concentric tube manipulators. We demonstrate a successful initial proof-of-concept anastomosis in an anthropomorphic phantom of the urethra and bladder.

Comparing the accuracy of the da Vinci Xi and da Vinci Si for image guidance and automation.

BACKGROUND: Current laparoscopic surgical robots are teleoperated, which requires high fidelity differential motions but does not require absolute accuracy. Emerging applications, including image guidance and automation, require absolute accuracy. The absolute accuracy of the da Vinci Xi robot has not yet been characterized or compared to the Si system, which is now being phased out. This study compares the accuracy of the two. METHODS: We measure robot tip positions and encoder values assessing accuracy with and without robot calibration. RESULTS: The Si is accurate if the setup joints are not moved but loses accuracy otherwise. The Xi is always accurate. CONCLUSION: The Xi can achieve submillimetric average error. Calibration improves accuracy, but excellent baseline accuracy of the Xi means that calibration may not be needed for some applications. Importantly, the external tracking systems needed to account for setup joint error in the Si are no longer required with the Xi.

Capacitive coupling reduces instrumentation-related infection in rabbit spines: a pilot study.

BACKGROUND: Postoperative spine infections cause considerable morbidity. Patients are subjected to long-term antibiotic regimens and may require further surgery. Delivery of electric current through instrumentation can detach biofilm, allowing better antibiotic penetration and assisting in eradicating infection. QUESTION/PURPOSES: We asked (1) whether capacitive coupling treatment in combination with a single dose of antibiotics would reduce infection rates when compared with antibiotics alone in a rabbit spine infection model, (2) whether it would decrease the overall bacterial burden, and (3) whether there was a time-dependent response based on days treated with capacitive coupling. METHODS: Thirty rabbits were subjected to a well-established spine infection model with a single dose of intravenously administered systemic ceftriaxone (20 mg/kg of body weight) prophylaxis. Two noncontiguous rods were implanted inside dead space defects at L3 and L6 challenged with 10(6) colony-forming units of Staphylococcus aureus. Rabbits were randomly treated with a capacitive coupling or control device. Instrumentation and soft tissue bacterial growth were assessed after 7 days. RESULTS: Sites treated with capacitive coupling showed a decrease in the incidence of positive culture: 36% versus 81% in the control group. We observed no difference in the soft tissue's infectious burden. Overall bacterial load was not decreased with capacitive coupling. CONCLUSIONS: Capacitive coupling in conjunction with antibiotics reduced the instrumentation-related infection rate compared with antibiotics alone. CLINICAL RELEVANCE: Capacitive coupling noninvasively delivers an alternating current that may detach biofilm from instrumentation. Treatment of infection may be successful without removal of instrumentation, allowing for improved stability and overall decreased morbidity.