Predictors of Complications After Percutaneous Image-Guided Renal Cryoablation for T1a Renal Cortical Neoplasms.

PURPOSE: To determine the incidence and predictors of major complications in patients undergoing percutaneous cryoablation (PCA) for small renal masses. METHODS: We performed a retrospective analysis of patients undergoing PCA from 2005 to 2012. We analyzed demographic, radiographic, and complication data. We defined complications as any deviation from the expected postoperative course. We determined predictors of complications. RESULTS: A total of 190 patients were included in the study. The mean age was 69 years, and 132 (69%) were males. The mean tumor diameter was 2.2 cm (0.8-4.0 cm). The mean number of probes utilized per procedure was 2.3. We observed 16 (8.4%) complications including 14 Clavien grade I, which includes 6 (2%) large renal/retroperitoneal hematomas, 4 (2%) pneumothoraxes, 2 (1%) urinary tract infections, and 2 (1%) atrial fibrillations. There were two (1%) Clavien grade II complications (intestinal perforations). In univariable analysis, larger tumors and more probes were associated with higher risk of complications (all ps < 0.05). In multivariable analysis, larger tumor dimension (odds ratio [OR] = 2.85; 95% confidence interval [CI] = 1.34, 6.05; p = 0.006) was independently associated with major complications. After multivariable adjustments for patient's characteristics such as age, gender, American Society of Anesthesiologists, year of surgery, and histopathology, larger tumor dimension (OR = 2.85; 95%CI = 1.34, 6.05; p = 0.006) and more cryoablation probes (OR = 1.94; 95%CI = 1.36, 2.75; p < 0.001) were independently associated with higher risk of major complications. CONCLUSIONS: In a cohort of patients undergoing PCA for T1a small renal mass, larger tumor dimension and more cryoablation probes were independently associated with higher risk of complication. Although PCA is relatively safe and the major complications are infrequent, careful patient selection is crucial.

Development and evaluation of a retroperitoneal dialysis porcine model.

OBJECTIVES: We attempted to create a surgical model to evaluate the retroperitoneal space for the ability to transfer solutes through the retroperitoneal membrane. Our dual objectives were to develop a technique to assess the feasibility of retroperitoneal dialysis (RPD) in a porcine model. METHODS: We incorporated two 35-kg Yorkshire pigs for this pilot study. In the first animal, we clamped renal vessels laparoscopically. In the second animal, we embolized renal arteries. In both animals, we dilated the retroperitoneal space bilaterally and deployed dialysis catheters. We measured serum creatinine (Cr), urea, and electrolytes at baseline 6 hours before the dialysis and every 4 hours after. RESULTS: We successfully created retroperitoneal spaces bilaterally and deployed dialysis catheters in both animals. In the first animal, dialysate and plasma Cr ratio (D/P) on the left and right side were 0.43 and 0.3, respectively. Cr clearance by 40 minutes of dialysis treatment was 6.3 mL/min. The ratio of dialysate glucose at 4 hours dwell time to dialysate glucose at 0 dwell time (D/D0) for left/rights sides were 0.02 and 0.02, respectively. kt/Vurea was 0.43. In the second animal, D/P Cr for left/right sides were 0.34 and 0.33, respectively. kt/Vurea was 0.17. We euthanized the pigs due to fluid collection in the peritoneal space and rapid increase of serum Cr, urea, and electrolytes. CONCLUSIONS: We demonstrated the feasibility of creation of a functionally anephric porcine model with successful development of retroperitoneal spaces using balloon inflation. Notwithstanding minimal clearance and limited diffusion capacity in this experiment, additional studies are needed to examine potential use of retroperitoneal space for peritoneal dialysis.

Comparison of Flow Characteristics of Novel Three-Dimensional Printed Ureteral Stents Versus Standard Ureteral Stents in a Porcine Model.

PURPOSE: We compared the flow characteristics of novel three-dimensional (3D) printed ureteral stents with four conventional double-pigtail stents in an ex vivo porcine model. MATERIALS AND METHODS: In six ex vivo porcine urinary systems with kidneys and ureters intact, we deployed a 5F occlusion catheter in an interpolar calix. We tested each system with antegrade irrigation with a 0.9% saline bag placed 35 cm above the renal pelvis. We evaluated four standard stents (6F Universa® Soft, 7F Percuflex,™ 7/10F Applied Endopyelotomy, 8.5F Filiform Double Pigtail) and compared them with a 9F 3D printed prototype stent. For each stent, we measured the total, extraluminal, and intraluminal flow rates. RESULTS: The mean total flow rates for 3D printed stents were significantly higher than the 6F, 7F, and 7/10F stents (P<0.05). No significant difference was seen in the total flow rate for the 3D printed stent and the 8.5F stent. The mean extraluminal flow rates for the 3D stents were similar to those of 7F stents, but significantly lower than 6F stents (P<0.001) and 8.5F stents (P<0.05) and higher than 7/10F stents (P<0.001). The mean intraluminal flow rates for the 3D printed stents were significantly higher than the 6F, 7F, 7/10F, and 8.5F stents (P<0.05). CONCLUSIONS: In this pilot study, 3D printed stents manifested a mean total flow rate comparable to the flow rates of contemporary stents. Continued advances in technology and material may permit functionally feasible 3D printed ureteral stents.

Evaluation of Ignition and Burn Risk Associated with Contemporary Fiberoptic and Distal Sensor Endoscopic Technology.

PURPOSE: To evaluate the ignition and burn risk associated with contemporary fiberoptic and distal sensor endoscopic technologies. MATERIALS AND METHODS: We used new and used SCB Xenon 300 light sources to illuminate a 4.8 mm fiberoptic cable, 10 mm laparoscope, 5 mm laparoscope, rigid cystoscope, semirigid ureteroscope, flexible cystoscope, flexible fiberoptic ureteroscope, distal sensor cystoscope, and a distal sensor ureteroscope (Karl Storz, Inc., Tuttlingen, Germany). We measured peak temperatures at the distal end of each device. We then evaluated each device on a flat and folded surgical drape to establish ignition risk. Finally, we evaluated the effects of all devices on human cadaver skin covered by surgical drape. RESULTS: Peak temperatures recorded for each device ranged from 26.9°C (flexible fiberoptic ureteroscope) to 194.5°C (fiberoptic cable). Drape ignition was noted when the fiberoptic cable was placed against a fold of drape. Contact with the fiberoptic cable, 10 mm laparoscope, 5 mm laparoscope, and distal sensor cystoscope resulted in cadaver skin damage. Cadaver skin damage occurred despite little or no visible change to the surgical drape. Rigid and flexible fiberoptic cystoscopes and flexible fiberoptic ureteroscopes had no effect on surgical drapes or cadaver skin. CONCLUSIONS: Fiberoptic light cables and some endoscopic devices have the potential to cause thermal injury and drape ignition. Thermal injury may occur without visible damage to drapes. Surgeons should remain vigilant regarding the risks associated with these devices and take necessary safety precautions to prevent patient injury.

Evaluation and comparison of urolithiasis scoring systems used in percutaneous kidney stone surgery.

PURPOSE: Contemporary predictive tools for percutaneous nephrolithotomy outcomes include the Guy stone score, S.T.O.N.E. nephrolithometry and the CROES nephrolithometric nomogram. We compared each scoring system in the same cohort to determine which was most predictive of surgical outcomes. METHODS: We retrospectively reviewed the records of patients who underwent percutaneous nephrolithotomy between 2009 and 2012 at a total of 3 academic institutions. We calculated the Guy stone score, the S.T.O.N.E. nephrolithometry score and the CROES nephrolithometric nomogram score based on preoperative computerized tomography images. A single observer at each institution reviewed all images and assigned scores. Univariate and multivariate analysis was done to determine the most predictive scoring system. RESULTS: We enrolled 246 patients in study. In stone-free patients vs those with residual stones the mean Guy score was 2.2 vs 2.7, the mean S.T.O.N.E. score was 8.3 vs 9.5 and the mean CROES nomogram score was 222 vs 187 (each p <0.001). Logistic regression revealed that the Guy, S.T.O.N.E. nephrolithometry and CROES nomogram scores were significantly associated with stone-free status (p = 0.02, 0.004 and <0.001, respectively). The Guy and S.T.O.N.E. nephrolithometry scores were associated with estimated blood loss (p <0.0001 and 0.03) and length of stay (p = 0.03 and 0.009, respectively). The CROES nomogram did not predict estimated blood loss or length of stay. CONCLUSIONS: All scoring systems and the stone burden equally predicted stone-free status. The Guy and S.T.O.N.E. nephrolithometry scores were associated with estimated blood loss and length of stay. A single scoring system should be adopted to unify reporting.

Development of a novel iPad-based laparoscopic trainer and comparison with a standard laparoscopic trainer for basic laparoscopic skills testing.

INTRODUCTION: We developed the iTrainer (iT) as a portable laparoscopic trainer, which incorporates the iPad tablet. We then compared the iT with a standard pelvic trainer (SPT) to assess surgical skills as well as its image quality, resolution, brightness, comfort, and overall performance. MATERIALS AND METHODS: We designed and constructed the iT to be compatible with the Apple iPad 3 and standard laparoscopic instruments. Participants were assigned to perform the thread-the-loops task on both trainers and were prospectively randomized to start on either the iT or the SPT. Each participant was allowed a 2-minute warm-up before the 2-minute testing period. We scored participants using the product of skill quality (0-4 scale) and quantity of loops threaded (0-10 scale). Participants then rated each trainer on image quality, resolution, brightness, comfort, and overall performance on a 5-point Likert scale. RESULTS: A total of 45 subjects including 10 undergraduates, 10 medical students, 10 general surgery and urology residents, and 15 experts (fellows and attending surgeons) participated in this study. There was no significant difference between thread-the-loops task scores completed on the iT when compared with the SPT for all groups tested (p > 0.05) with the exception of the medical student group, who performed better on the SPT (p < 0.05). On evaluation of each trainer, participants rated the iT as having superior image quality and resolution when compared with the SPT (p < 0.05) but rated the SPT higher in overall performance (p < 0.05). Brightness and comfort were rated similarly for both trainers. CONCLUSIONS: We have demonstrated face validity and criterion validity for the thread-the-loops task on the iT. The iT rated superior in image quality and resolution but inferior in overall performance compared with the SPT. The iT provides trainees a unique advantage over SPT as an additional resource to laparoscopic training as it is inexpensive, portable, and can be readily available for training.

Comparison of outcomes in patients undergoing percutaneous renal cryoablation with sedation vs general anesthesia.

OBJECTIVE: To compare the efficacy and safety of local anesthesia with conscious sedation (LACS) with general anesthesia (GA) in patients undergoing percutaneous renal cryoablation (PRC) for renal cortical neoplasms. METHODS: We performed a retrospective review of patients undergoing PRC between 2003 and 2013. Patient demographics, tumor characteristics, and perioperative and postoperative follow-up data were recorded and analyzed. We compared 3 principal outcomes across the GA and LACS groups: anesthesia-related outcomes, treatment failure, and complications. RESULTS: A total of 235 patients with available data were included. Of these, 82 underwent PRC under GA and 153 patients under LACS. The 2 groups were similar with regard to age, gender, body mass index, American Society of Anesthesiologists score, tumor features, preoperative serum creatinine level, and hematocrit value. The GA and LACS groups had a similar percentage of patients with biopsy-proven renal cell carcinoma (68.5% and 64.2%, respectively; P = .62). The mean follow-up time for GA and LACS was 37 and 21 months, respectively (P <.0001). The mean procedure time for GA was significantly longer compared with LACS (133 vs 102 minutes; P <.001), and the mean hospital stay was shorter under LACS (1.08 vs 1.95 days; P <.0001). There was no difference in immediate failure (0% and 1.9%; P = .051) or recurrences (11% and 3.9%, respectively; P = .051) between GA and LACS groups. There was no difference in intraoperative and postoperative treatment-related complications between the 2 groups. CONCLUSION: PRC for small renal masses under LACS is effective and safe. PRC with LACS has the advantage of decreased procedure time and a shorter hospital stay.

Comparison of optics and performance of single channel and a novel dual-channel fiberoptic ureteroscope.

OBJECTIVE: To evaluate performance characteristics and optics of a novel dual-working channel fiberoptic ureteroscope (Wolf Cobra) with 2 single-channel fiberoptic ureteroscopes and to a single-channel distal sensor standard definition digital ureteroscope URF-V (SD-DS). METHODS: Four new ureteroscopes (Cobra, Viper, X(2), and SD-DS) were compared for active deflection, irrigation flow, and optical characteristics. We performed a porcine ureteroscopy and measured the time for cleaning the middle calyx after injection of 10 cc of a standardized bloody solution. RESULTS: The SD-DS showed a higher resolution (7.42 lines/mm; P = .0001) compared with the fiberoptic ureteroscopes; among the fiberoptic ureteroscopes, the Cobra had the highest resolution than the Viper and X(2) (P = .0001). Grayscale distribution and color representation were identical for the fiberoptic ureteroscopes, whereas the SD-DS provided a superior color representation and a significant higher depth of field. The Cobra provided superior flow with empty working channel (86 cc/min vs 68 cc/min [Viper] vs 62.5 cc/min [X(2)] vs 62 cc/min [SD-DS]; P = .0001) and with various accessories (P <.0001). With regard to deflection, the Storz X(2) and the Cobra provided superior deflection up and down (P <.0001). When evacuating a standardized bloody field, the Cobra provided significant shorter evacuation times compared with those of the Viper, X(2), and SD-DS (36.6 vs 72 vs 65.6 vs 72.6 seconds, respectively; P = .0001). CONCLUSION: The additional working channel of the Wolf Cobra may improve vision and performance during challenging ureteroscopic cases by providing an increased flow. The enhanced irrigation capabilities of the Cobra have to be balanced with a larger diameter of this ureteroscope.

Development and initial porcine and cadaver experience with three-dimensional printing of endoscopic and laparoscopic equipment.

INTRODUCTION: Recent advances in three-dimensional (3D) printing technology have made it possible to print surgical devices. We report our initial experience with the printing and deployment of endoscopic and laparoscopic equipment. MATERIALS AND METHODS: We created computer-aided designs for ureteral stents and laparoscopic trocars using SolidWorks. We developed three generations of stents, which were printed with an Objet500 Connex printer, and a fourth generation was printed with an EOSINT P395 printer. The trocars were printed with an Objet30 Pro printer. We deployed the printed stents and trocars in a female cadaver and in vivo porcine model. We compared the printed trocars to two standard trocars for defect area and length using a digital caliper. Paired T-tests and ANOVA were used to test for statistical difference. RESULTS: The first two generations of stents (7F and 9F) were functional failures as their diminutive inner lumen failed to allow the passage of a 0.035 guidewire. The third generation 12F stent allowed passage of a 0.035 guidewire. The 12F diameter limited its deployment, but it was introduced in a cadaver through a ureteral access sheath. The fourth-generation 9F stents were printed and deployed in a porcine model using the standard Seldinger technique. The printed trocars were functional for the maintenance of the pneumoperitoneum and instrument passage. The printed trocars had larger superficial defect areas (p<0.001) and lengths (p=0.001) compared to Karl Storz and Ethicon trocars (29.41, 18.06, and 17.22 mm(2), respectively, and 14.29, 11.39, and 12.15 mm, respectively). CONCLUSIONS: In this pilot study, 3D printing of ureteral stents and trocars is feasible, and these devices can be deployed in the porcine and cadaver models. Three-dimensional printing is rapidly advancing and may be clinically viable in the future.

Comparison of radiation dose from conventional and triple-bolus computed tomography urography protocols in the diagnosis and management of patients with renal cortical neoplasms.

OBJECTIVE: To retrospectively compare the radiation dose of triple-bolus computed tomography (TBCT) and conventional CT (CCT) urography protocols, analyze the effects of body mass index (BMI) on radiation dose in each group, and assess image quality. MATERIALS AND METHODS: We retrospectively reviewed the images of patients who underwent CCT or TBCT imaging in the management of renal cortical neoplasms. We used standard volumetric CT dose index (CTDIvol) and dose length product (DLP) to estimate radiation exposure. In addition, 2 urologists rated the quality of 20 CT images from each group using a survey with a 5-point Likert scale. The survey consisted of 10 questions relating to the ability of the scan to identify relevant renal anatomy. RESULTS: The study included 120 patients. CTDIvol and DLP were 28.7% and 40.4% lower in the TBCT protocol, respectively (both P < .001). Increased BMI was associated with a higher DLP for the CCT group compared with the TBCT group (P < .001). The effect of BMI on CTDIvol did not differ between the CCT and TBCT groups. There was no difference in the urologists' assessments of CT image quality. CONCLUSION: In patients with renal cortical neoplasms, TBCT provides comparable image quality to CCT, with lower ionizing radiation exposure without compromising image quality. Obese patients may benefit more from TBCT scans.

In vitro evaluation of LithAssist: a novel combined holmium laser and suction device.

INTRODUCTION: The aim of this in vitro study was to evaluate and compare a novel intracorporeal lithotripter, LithAssist (LA; Cook Medical, Bloomington, IN), with the Swiss LithoClast Ultra (SLU; Boston Scientific, Boston, MA) for the fragmentation and removal of artificial stones made of gypsum-based cement. MATERIALS AND METHODS: Ten soft and 20 hard ultracal-30 (U-30) stones were fragmented using two lithotripters. We recorded the stone weight (grams) prior to placing them into a 60-mL syringe for fragmentation. We inserted a 30F percutaneous access sheath into the syringe and positioned the stone within its lumen. Next, we inserted the lithotripter into a right-angled nephroscope. We recorded the times required for first and complete stone disintegration, disintegration to 2 mm, and complete stone removal for each device. In addition, we recorded the stone mass following each minute of stone fragmentation. RESULTS: In total, we subjected 5 soft and 10 hard stones to SLU and LA, respectively. All soft stones were completely disintegrated and removed with both the SLU and LA device. For soft stones, disintegration to 2 mm (2.83±0.41 vs. 4.15±0.70 minutes, p=0.049), complete disintegration (3.18±0.20 vs. 6.40±1.95 minutes, p=0.038), and complete removal (3.30±0.22 vs. 8.82±1.05 minutes, p=0.001) were faster for the SLU compared with the LA. For hard stones, fragmentation was not accomplished with the SLU, whereas with the LA, mean time for first disintegration, disintegration to 2 mm, complete disintegration, and complete removal was 3.60±1.36, 7.25±3.33, 7.54±2.94, and 8.64±2.78 minutes, respectively. CONCLUSIONS: In this in vitro study, the SLU was more efficient for softer artificial stones, and the LA was more efficient for harder artificial stones.

Evaluation of a novel trocar-site closure and comparison with a standard Carter-Thomason closure device.

PURPOSE: The aim of this study was to evaluate and compare a novel trocars-site closure device, the WECK EFx™ Endo Fascial Closure System (EFx) with the Carter-Thomason CloseSure System® (CT) for the closure of laparoscopic trocar site defects created by a 12-mm dilating trocar. METHODS: We created standardized laparoscopic trocars-site abdominal wall defects in cadaver models using a standard 12-mm laparoscopic dilating trocar. Trocar defects were closed in a randomized fashion using one of the two closure systems. We recorded time and number of attempts needed for complete defect closure. In addition, we recorded the ability to maintain pneumoperitoneum, endoscopic visualization, safety, security, and facility based on the surgeon's subjective evaluations. We compared outcomes for the EFx and CT closure systems. RESULTS: We created 72 standardized laparoscopic trocars-site abdominal wall defects. The mean time needed for complete defect closure was 98.53 seconds (±28.9) for the EFx compared with 133.61 seconds (±54.61) for the CT (P<0.001). The mean number of attempts needed to achieve complete defect closure were 1.19 (1-3) for the EFx and 1.19 (1-2) for the CT (P=0.50). Mean scores for safety were 2.92 for EFx vs 2.19 for CT (P<0.001). Mean scores for facility were 2.97 vs 1.83 for EFx and CT, respectively (P<0.001). Mean scores for maintenance of pneumoperitoneum were 1.97 for EFx vs 2.33 for CT (P=0.022). No significant difference was observed between the EFx and the CT systems for endoscopic visualization (2.28 vs 2.50, P=0.080). CONCLUSIONS: In this in vitro cadaver trial, the EFx was superior in terms of time needed to complete defect closure, safety, and facility. CT was superior in terms of maintenance of pneumoperitoneum. Both systems were equal in the number of attempts needed to complete the defect closure and endoscopic visualization.