Comparison of Superpulse Thulium Fiber Laser vs Holmium Laser for Ablation of Renal Calculi in an In Vivo Porcine Model.

Introduction and Objectives: We sought to compare the effectiveness and efficiency of the superpulse thulium fiber laser (sTFL to the holmium: yttrium-aluminum-garnet [Ho:YAG] laser for ureteroscopic "dusting" of implanted renal stones in an in vivo porcine model. Methods: Twenty-four porcine kidneys (12 juvenile female Yorkshire pigs) were randomized to Ho:YAG or sTFL treatment groups. Canine calcium oxalate stones were scanned with computed tomography to calculate stone volume and stone density; the stones were randomized and implanted into each renal pelvis via an open pyelotomy. In all trials, a 14F, 35 cm ureteral access sheath was placed. With a 9.9F dual lumen flexible ureteroscope, laser lithotripsy was performed using dusting settings: Ho:YAG 200 µm laser fiber at 16 W (0.4 J, 40 Hz) or sTFL 200 µm laser fiber at 16 W (0.2 J, 80 Hz). Lithotripsy continued until no fragments over 1 mm were observed. No stone basketing was performed. Throughout the procedures, intrarenal and renal pelvis temperatures were measured using two percutaneously positioned K-type thermocouples, one in the upper pole calyx and one in the renal pelvis. After the lithotripsy, the ureteropelvic junction was occluded, the kidneys were bivalved, and all residual fragments were collected, dried, weighed, and then measured with an optical laser particle sizer. Results: Implanted stones were similar in volume and density in both groups. Intraoperative collecting system temperatures were similar for both groups (all <44°C). Compared to Ho:YAG, sTFL ablated stones faster (9 vs 27 minutes, p < 0.001) with less energy expenditure (8 vs 26 kJ, p < 0.001), and a greater stone clearance rate (73% vs 45%, p = 0.001). After sTFL lithotripsy, 77% of the remaining fragments were ≤1 mm vs 17% of fragments ≤1 mm after Ho:YAG treatment (p < 0.001). Conclusions: In an in vivo porcine kidney, using dusting settings, sTFL lithotripsy resulted in shorter ablation times, higher stone clearance rates, and markedly smaller stone fragments than Ho:YAG lithotripsy.

Porcine Bladder Replacement with a Bilayer Silk Fibroin Enhanced Prosthetic Reservoir: A Feasibility Study.

Introduction: The creation of synthetic reservoirs for bladder replacement has been limited by challenges of interfacing synthetic materials and native tissue. We sought to overcome this challenge by utilizing a novel bilayer silk fibroin scaffold (BLSF) as an intermediary toward the development of an acellular prosthetic reservoir. Methods: Under institutionally approved protocols, 3D-printed reservoirs were implanted in six juvenile female pigs after cystectomy. BLSF was attached to the in situ prosthetic reservoir serving as an intermediary to native ureteral and urethral tissue anastomoses. Our first protocol allowed four pigs to be survived up to 7 days, and the second protocol allowed two pigs to be survived for up to 1 year. At the first sign of functional decline or the end of the study period, the animals were euthanized, and kidneys, ureters, prosthetic bladder, and urethra were harvested en bloc for histopathology analysis. Results: The first two pigs had anastomotic urine leaks because of design flaws resulting in early termination. The third pig had acute renal failure resulting in early termination. The artificial bladder design was modified in subsequent iterations. The fourth pig survived for 7 days and, upon autopsy, had intact urethral and ureteral anastomoses. The fifth and sixth pigs survived for 11 and 12 weeks, respectively, before they were sacrificed because of failure to thrive. One animal developed an enteric fistula. The other animal had an intact anastomosis, and the BLFS was identified at the ureteral and urethral anastomoses on histopathologic analysis. Conclusions: Replacing the porcine bladder with a prosthetic bladder was achieved for up to 3 months, the second longest survival period for a nonbiologic bladder alternative. BLSF was used for the first time to create an interface between synthetic material and biologic tissue by allowing ingrowth of urothelium onto the acellular alloplastic bladder.

The Impact of One Week of Pre-Stenting on Porcine Ureteral Luminal Circumference.

Objectives: Larger ureteral access sheaths (UASs) have the potential to improve ureteroscopic stone removal outcomes but are often avoided by surgeons because of concerns of ureteral injury. Using our novel UAS force sensor and previously defined force thresholds for ureteral injury, we sought to evaluate the impact of 1 week of stenting on the maximum safe dilation of ureteral luminal circumference. Methods: Twelve juvenile female Yorkshire pigs (24 ureters) were evaluated. The inner (i.e., luminal) circumference of each ureter was determined using Cook urethral dilators ranging from 8F to 24F in 2F increments, 37 cm in length. Each dilator was sequentially passed while applying the UAS force sensor to measure insertion force before and after 1 week of stent placement. Each ureter was randomized to receive either a 4.7F or 7.0F stent (20 cm). Maximum ureteral luminal circumference was defined as effective passage of the dilator to the ureteropelvic junction with ≤6 newtons (N) of force (the force threshold previously defined by porcine and clinical studies to avoid ureteral damage). After passage of the largest dilator at 6 N, flexible ureteroscopy was performed and a post-ureteroscopic lesion scale (PULS) was recorded. Results: After 1 week of stent placement, the median ureteral luminal circumference increased to 15F representing a mean increase of 3.8F ± 2.8F (p < 0.001). Twenty-one (88%) of the pre-stented ureters had an increase in luminal circumference, with 12 ureters (50%) dilated to ≥16F (p = 0.032), 6 ureters (25%) dilated to ≥18F, and in 2 cases a maximum size of 24F was recorded. The PULS grade was ≤2 in all cases, indicating no high-grade ureteral injuries. Laterality and stent size did not impact ureteral luminal circumference after pre-stenting (p = 0.232 and p = 0.337, respectively). Conclusions: One week of ureteral stenting resulted in nearly a 4F increase in the luminal circumference of porcine ureters.

Multidisciplinary Approach and Outcomes of Pretreatment Small (cT1a) Renal Mass Biopsy: Single-Center Experience.

Purpose: We evaluated our experience of a multidisciplinary approach to renal mass biopsy (RMB) for small renal masses (SRMs) employing in-office ultrasound (US)-guided biopsy by urology (24%), CT, or US biopsy by interventional radiology (IR) (79%), and endoscopic ultrasound (EUS)-guided biopsy by gastroenterology (GI) (4%). Materials and Methods: A single-institution retrospective review of patients who underwent RMB for SRM from May 2013 to August 2019 was conducted. Data regarding patient demographics, tumor characteristics, biopsy technique, histopathology, and management were collected. Diagnostic rates, concordance with final pathology, complications, and outcomes were analyzed. Results: Of the 192 biopsies reviewed, 63% biopsies were malignant, 20% were benign, and 17% were nondiagnostic. Based on biopsy results, 71 patients (37%) elected active surveillance. Thirty-eight (20%) patients underwent cryoablation, 56 (29%) underwent partial nephrectomy, 14 (7%) underwent radical nephrectomy, and the remaining patients were treated elsewhere. The rate of surgery for benign pathology after pretreatment RMB was 3%. The concordance rate between biopsy and final pathology was 99% for malignancy, 96% for specific pathology subtype, and 85% for renal cell carcinoma grade. Median time from diagnosis to definitive treatment was 97 days (urology: 76, IR: 110 and GI: 54, p = 0.002). Three (1.6%) Clavien I complications were reported. Conclusion: Our multidisciplinary approach to RMB for clinical stage T1a demonstrated favorable safety and diagnostic rates, which effectively directed management strategies and minimized surgery for benign disease. Urologist-performed office biopsies significantly shortened the time from diagnosis to definitive treatment. Our experience with GI EUS biopsy has demonstrated feasibility and safety for tumors that were otherwise not accessible percutaneously.

Ex Vivo Renal Stone Dusting: Impact of Laser Modality, Ureteral Access Sheath, and Suction on Total Stone Clearance.

Introduction and Objectives: Conventional renal stone dusting is challenging; the holmium (Ho:YAG) laser and holmium with MOSES effect (Ho:YAG-MOSES) fail to uniformly produce fragments ≤100 µm (i.e., dust). The superpulse thulium fiber laser (sTFL) may more effectively render uroliths into "dust," and may thus improve stone-free rates. Accordingly, we performed ex vivo evaluations with all three laser modalities, assessing stone fragments and stone clearance. Methods: Seventy-two ex vivo porcine kidney-ureter models were divided into 12 groups of 6: laser type (Ho:YAG, Ho:YAG-MOSES, sTFL), ureteroscope with and without applied suction, and the presence or absence of a 14F ureteral access sheath (UAS). Calcium oxalate stones were preweighed and implanted into each kidney via a pyelotomy. Stones were treated at 16W using dusting settings of 0.4J × 40Hz (Ho:YAG), 0.2J × 80Hz (Ho:YAG-MOSES), and 0.2J × 80Hz (sTFL) for up to 20 minutes. No stone basketing was performed. Kidneys were bivalved and residual fragments were collected, dried, weighed, and sieved to determine fragment size and stone clearance. Results: Initial stone mass (mg), procedure time (seconds), and laser energy expenditure (kJ) were similar in all 12 groups. The greatest stone clearance was seen with sTFL + suction + UAS (94%) compared with a conventional technique (Ho:YAG + no suction + no UAS) (65%, p < 0.01). The use of sTFL provided greater stone clearance than Ho:YAG or Ho:YAG-MOSES. Aspiration improved stone clearance for sTFL (p = 0.01), but not for Ho:YAG or Ho:YAG-MOSES, consistent with the creation of smaller fragments with sTFL. Presence of a 14F UAS improved stone clearance in all scenarios (p < 0.01). Conclusions: In this ex vivo study, stone clearance was optimized under the following conditions: sTFL, 14F UAS, and aspiration. This combination resulted in 94% of stone fragments being cleared; the 6% remaining fragments were all <2 mm. In all scenarios, deployment of a 14F UAS improved stone clearance.

Global Assessments of the Endockscope System: Long-Term Impact of Cyber Endoscopy.

Introduction: The disproportionate costs of state-of-the-art endoscopic equipment prohibit urologists from performing endoscopy in underserved countries. Given the global prevalence of smartphones, we engineered a $45 alternative endoscope utilizing three-dimensional printed attachments, an 8 × lens, and a 1000-lumen light-emitting diode cordless flashlight (Endockscope System [ES]). Materials and Methods: At the 34th World Congress of Endourology in Cape Town, South Africa (WCE 2016; 4-year group), and at the 39th Congress of the Société Internationale d'Urologie (SIU) in Athens, Greece (SIU 2019; 8-month group), a total of 40 ES kits were distributed free of charge to an international group of urologists. Participants were given instructions and a hands-on demonstration of the device. Urologists given an ES were subsequently asked to complete a survey between June and September 2020 that included questions regarding user satisfaction, comfort, and comparability of the ES to standard endoscopic systems. Results: Urologists from 23 countries received ES kits. Overall, 10 of 22 urologists (10/22; 45%) from the 4-year group and 18 of 18 urologists (18/18; 100%) from the 8-month group completed the survey. The ES device was used by 80% (8/10) and 83% (15/18) of urologists from the 4-year and the 8-month groups, respectively. Of note, the greatest impact of ES usage was among urologists from the most impoverished countries. Of those who used the ES, 44% (4/9) of urologists from the 4-year cohort and 47% (8/17) from the 8-month cohort reported they were able to perform more endoscopic procedures directly because of the ES. Moreover, 57% (4/7) of the 4-year participants and 67% (10/15) of the 8-month participants found the ES equal or superior in quality to their standard endoscopic equipment. Conclusion: The ES provided an effective and inexpensive system that enabled urologists in resource-challenged countries to effectively perform and expand their use of urologic endoscopy.

Caveat Emptor: The Heat Is "ON"-An In Vivo Evaluation of the Thulium Fiber Laser and Temperature Changes in the Porcine Kidney During Dusting and Fragmentation Modes.

Introduction: We sought to examine the intrarenal fluid and tissue temperature alterations during dusting and fragmentation with the thulium fiber laser (TFL) in an in vivo porcine kidney. Materials and Methods: In two female Yorkshire pigs, temperature was continuously measured within the upper, interpolar, and lower calices along with the renal pelvis using multipoint thermal sensor probes; another temperature probe was situated at the tip of the ureteroscope. Four experimental protocols were performed for each animal: dual lumen ureteroscope with both warmed (37°C) irrigation and room temperature (20°C-22°C) irrigation and single lumen ureteroscope with warmed and room temperature irrigation. Of note, in each pig, one kidney underwent ureteroscopy (URS) with a 14F ureteral access sheath (UAS) in place, whereas the other kidney had no UAS placed. A 200-µm TFL fiber was fired at three laser settings: (1) dusting at 0.5 J, 80 Hz (40 W) with continuous activation until 5 minutes expired or a temperature of 44°C was reached, (2) low-power fragmentation 1 J, 10 Hz, (10 W), and (3) high-power fragmentation at 1.5 J, 20 Hz (30 W). In all cases, the pulse width was 1 ms. For fragmentation, the laser was activated for 10 seconds with a 2-second intermission for a 1-minute period (five cycles). Results: In the absence of a UAS, in all but one circumstance, temperatures reached or exceeded 44°C at all laser settings with the use of either warm or room temperature irrigation fluid, regardless of the type of ureteroscope used. Of concern, temperatures recorded at the tip of the URS were 4°C to 22°C less than the temperatures recorded in the renal calices. In contrast, with a 14F UAS in place, six distinct groups had temperatures that did not exceed 44°C, specifically at low- and high-power fragmentation settings with room temperature irrigation for both sets of ureteroscopes and at dusting and low-power fragmentation settings with warm temperature irrigation solely for the single lumen ureteroscope. Temperatures recorded at the tip of the ureteroscope with the deployment of a UAS yielded temperature differences ranging from 17°C less to 19°C more than the renal calices. Conclusions: TFL is a novel laser technology for lithotripsy. In the absence of a UAS, high-power TFL fragmentation settings in particular may create temperatures within the collecting system that could result in urothelial tissue injury. Of note, peak temperatures recorded at the tip of the ureteroscope may misrepresent the actual intrarenal temperature during TFL laser lithotripsy.

Evaluation of a Novel Female Gender Flexible Ureteroscope: Comparison of Flow and Deflection to a Standard Flexible Ureteroscope.

Introduction: The advent of single-use disposable flexible ureteroscopes allows for rapid prototyping of novel endoscopes. In this regard, we sought to develop a female-specific ureteroscope, with a shorter working length, to account for the female anatomy. We hypothesized that the shorter, female-specific single-use flexible ureteroscope would engender higher irrigation flow at a given pressure than that of the standard-length ureteroscope. Methods: An in vitro analysis of a standard 65 cm Dornier Axis™ ureteroscope and a shorter, 45 cm female-specific Dornier Axis ureteroscope was performed. All other aspects of the endoscopes were identical. Each ureteroscope was oriented vertically and connected to a Thermedx® irrigation system to provide uniform pressurized flow. The average flow rate was computed over five, 2-minute periods at pressure settings of 50, 100, 150, and 200 mm Hg. Data were collected with the working channel unoccupied, after placement of a 200 µm (0.6F) holmium laser fiber and after passage of a 1.7F stone basket. The procedure was then repeated with the endoscopes at maximum deflection. Results: The female gender ureteroscope had significantly higher irrigation flow rates than the standard-length ureteroscope under all conditions by an average of 11% (p < 0.02). The highest average percent increase, 17% (p < 0.001), was seen with the 1.7F NGage® basket in the working channel with the endoscope straight. The maximum angle of deflection was not significantly different between the female gender and standard ureteroscopes with an open working channel (314° vs 315°, p = 0.86), with the 1.7F NGage basket in place (314° vs 315°, p = 0.15), and with the 200 µm holmium laser in place (316° vs 309°, p = 0.09). Conclusions: A 45 cm female gender ureteroscope allows for a higher irrigation flow rate than the standard-length ureteroscope under all test conditions. There is no added benefit with regard to deflection capabilities.

In Vitro Evaluation of Stone Fragment Evacuation by Suction.

Introduction: Contemporary, flexible stone baskets are unable to extract submillimeter stone fragments at the time of ureteroscopic laser lithotripsy. In this in vitro study, the feasibility of suctioning submillimeter fragments with a standard Luer Lock syringe through the working channel of a flexible ureteroscope was assessed. Materials and Methods: Phantom stones made from industrial plaster were mechanically fragmented into ≤1 and ≤0.5-mm groups. Both stone groups were divided into five preweighed trial samples. Each stone group was then mixed in a beaker filled with normal saline. A standard 10-mL Luer Lock syringe was connected to a fiber-optic ureteroscope with a 1.2-mm working channel. The syringe was then used to suction stone fragments from the beaker. The suctioned stone fragments and the stone fragments remaining in the beaker after removing the overlying solution were separated, centrifuged with supernatant removed, and dried in an incubator set at 33°C for 1 week. Dried weights were recorded. Results: Mean total weights for ≤0.5 and ≤1.0-mm stone groups at baseline were 0.807 and 0.806 g, respectively. The mean percentages of stone fragments suctioned through the ureteroscope for ≤0.5 and ≤1.0-mm groups were 86% and 86%, respectively (p = 0.973). During suctioning, 64% of stones in the ≤0.5-mm group were trapped in either the working channel of the ureteroscope or within the Luer Lock syringe compared with 78% of stones in the ≤1-mm group (p = 0.001) requiring cessation of the procedure to clear the channel. Conclusions: It is feasible to suction submillimeter stone fragments by connecting a Luer Lock syringe to the working channel of a flexible ureteroscope. The limiting factor for removing stone fragments appears to be the small working channel of flexible ureteroscopes as trapping of fragments during suctioning is common and requires time-consuming removal of the endoscope and clearing of the channel.

Characterization of intracalyceal pressure during ureteroscopy.

PURPOSE: To provide the first report of measuring intracalyceal pressures during ureteroscopy (URS). METHODS: A prospective single-center clinical study using a cardiac pressure guidewire to measure intracalyceal pressure during flexible URS was performed. Eight patients (45 calyces) undergoing URS for nephrolithiasis were included. A Verrata® pressure guide wire was passed through the working channel of a dual lumen flexible ureteroscope and into the calyces while irrigation was maintained at 150 mmHg. Pressure was measured in the renal pelvis, upper pole, interpolar, and lower pole calyces both with and without a ureteral access sheath (UAS). The pressure in each location with and without a UAS was compared. The correlation between calyceal pressure and infundibular dimensions (width, length) was determined. RESULTS: Intracalyceal pressure was significantly lower in each region when a UAS was used. Compared to patients with a 12/14Fr UAS, those with a 14/16Fr UAS had significantly lower pressure in the interpolar (25.3 ± 13.1 vs. 44.0 ± 27.5 mmHg, p = 0.03) and lower pole (16.2 ± 3.5 vs. 49.2 ± 40.3 mmHg, p = 0.004) calyces. Interpolar calyceal pressure in the presence of a UAS was significantly higher than the renal pelvis pressure (RPP) (30.8 ± 19.6 vs. 17.9 ± 11.0 mmHg, p = 0.004). CONCLUSIONS: During flexible URS, RPP strongly correlates with, but does not uniformly represent, the intracalyceal pressure. With a 14/16Fr UAS and an inflow pressure of 150 mmHg, RPP and intracalyceal pressure never exceed the threshold for renal backflow.