Ryan S. Hsi

Prospective Comparison of Four Laparoscopic Vessel Ligation Devices

PURPOSE The merits of laparoscopic sealing devices have been poorly characterized. The purpose of this study was to compare two bipolar sealing devices [LigaSure V (LS) and Gyrus PK (GP)], an ultrasonic device [Harmonic Scalpel ACE (HS)] and a novel device using nanotechnology [EnSeal PTC (ES)]. MATERIALS AND METHODS The ability of all four 5 mm devices to seal 5 mm bovine arteries was tested under controlled temperature and humidity in accordance with manufacturer specifications. Study endpoints included lateral thermal spread, time to seal, burst pressure, smoke production and subjective (blinded review of video clips) and objective (measured using an aerosol monitor) effect upon visibility. RESULTS The HS demonstrated the least thermal spread. The LS (10.0 secs) and GP (11.1 secs) had the fastest sealing times (p<0.001 for both) when compared to ES (19.2 sec) and HS (14.3 sec). Mean burst pressure values were: LS 385 mm Hg, GP 290 mm Hg, ES 255 mm Hg and HS 204 mm Hg. The HS had the best subjective visibility score and the lowest objective smoke production (2.88 ppm) compared to the GP (74.1 ppm), ES (21.6 ppm) and LS (12.5 ppm), (p<0.01 for all). CONCLUSIONS The LS has the highest burst pressure and fastest sealing time and was the highest rated overall. The HS produced the lowest thermal spread and smoke but had the lowest mean burst pressure. The GP had the highest smoke production, and variable burst pressures. Despite employing nanotechnology, the ES device was the slowest and had variable burst pressures.

Fragmentation of Urinary Calculi In Vitro by Burst Wave Lithotripsy

PURPOSE We developed a new method of lithotripsy that uses short, broadly focused bursts of ultrasound rather than shock waves to fragment stones. We investigated the characteristics of stone comminution by burst wave lithotripsy in vitro. MATERIALS AND METHODS Artificial and natural stones (mean ± SD size 8.2 ± 3.0 mm, range 5 to 15) were treated with ultrasound bursts using a focused transducer in a water bath. Stones were exposed to bursts with focal pressure amplitude of 6.5 MPa or less at a 200 Hz burst repetition rate until completely fragmented. Ultrasound frequencies of 170, 285 and 800 kHz were applied using 3 transducers, respectively. Time to fragmentation for each stone type was recorded and fragment size distribution was measured by sieving. RESULTS Stones exposed to ultrasound bursts were fragmented at focal pressure amplitudes of 2.8 MPa or greater at 170 kHz. Fractures appeared along the stone surface, resulting in fragments that separated at the surface nearest to the transducer until the stone was disintegrated. All natural and artificial stones were fragmented at the highest focal pressure of 6.5 MPa with a mean treatment duration of 36 seconds for uric acid stones to 14.7 minutes for cystine stones. At a frequency of 170 kHz the largest artificial stone fragments were less than 4 mm. Exposure at 285 and 800 kHz produced only fragments less than 2 mm and less than 1 mm, respectively. CONCLUSIONS Stone comminution with burst wave lithotripsy is feasible as a potential noninvasive treatment method for nephrolithiasis. Adjusting the fundamental ultrasound frequency allows for stone fragment size to be controlled.

Focused Ultrasound to Expel Calculi from the Kidney: Safety and Efficacy of a Clinical Prototype Device

PURPOSE Focused ultrasound has the potential to expel small stones or residual stone fragments from the kidney, or move obstructing stones to a nonobstructing location. We evaluated the efficacy and safety of ultrasonic propulsion in a live porcine model. MATERIALS AND METHODS Calcium oxalate monohydrate kidney stones and laboratory model stones (2 to 8 mm) were ureteroscopically implanted in the renal pelvicalyceal system of 12 kidneys in a total of 8 domestic swine. Transcutaneous ultrasonic propulsion was performed using an HDI C5-2 imaging transducer (ATL/Philips, Bothell, Washington) and the Verasonics® diagnostic ultrasound platform. Successful stone relocation was defined as stone movement from the calyx to the renal pelvis, ureteropelvic junction or proximal ureter. Efficacy and procedure time was determined. Three blinded experts evaluated histological injury to the kidney in the control, sham treatment and treatment arms. RESULTS All 26 stones were observed to move during treatment and 17 (65%) were relocated successfully to the renal pelvis (3), ureteropelvic junction (2) or ureter (12). Average ± SD successful procedure time was 14 ± 8 minutes and a mean of 23 ± 16 ultrasound bursts, each about 1 second in duration, were required. There was no evidence of gross or histological injury to the renal parenchyma in kidneys exposed to 20 bursts (1 second in duration at 33-second intervals) at the same output (2,400 W/cm(2)) used to push stones. CONCLUSIONS Noninvasive transcutaneous ultrasonic propulsion is a safe, effective and time efficient means to relocate calyceal stones to the renal pelvis, ureteropelvic junction or ureter. This technology holds promise as a useful adjunct to surgical management for renal calculi.

Dietary Intake of Fiber, Fruit and Vegetables Decreases the Risk of Incident Kidney Stones in Women: A Women's Health Initiative Report

PURPOSE We evaluated the relationship between dietary fiber, fruit and vegetable intake, and the risk of kidney stone formation. MATERIALS AND METHODS Overall 83,922 postmenopausal women from the Womens Health Initiative observational study were included in the analysis and followed prospectively. Cox proportional hazards regression analyses were used to evaluate the associations between total dietary fiber, fruit and vegetable intake, and the risk of incident kidney stone formation, adjusting for nephrolithiasis risk factors (age, race/ethnicity, geographic region, diabetes mellitus, calcium supplementation, hormone therapy use, body mass index and calibrated caloric intake; and dietary water, sodium, animal protein and calcium intake). Women with a history of kidney stones (3,471) were analyzed separately. RESULTS Mean age of the women was 64±7 years, 85% were white and 2,937 (3.5%) experienced a kidney stone in a median followup of 8 years. In women with no history of kidney stones higher total dietary fiber (6% to 26% decreased risk, p <0.001), greater fruit intake (12% to 25% decreased risk, p <0.001) and greater vegetable intake (9% to 22% decreased risk, p=0.002) were associated with a decreased risk of incident kidney stone formation in separate adjusted models. In women with a history of stones there were no significant protective effects of fiber, fruit or vegetable intake on the risk of kidney stone recurrence. CONCLUSIONS Greater dietary intake of fiber, fruits and vegetables was associated with a reduced risk of incident kidney stones in postmenopausal women. The protective effects were independent of other known risk factors for kidney stones. In contrast, there was no reduction in risk in women with a history of stones.

B-mode Ultrasound Versus Color Doppler Twinkling Artifact in Detecting Kidney Stones

PURPOSE To compare color Doppler twinkling artifact and B-mode ultrasonography in detecting kidney stones. PATIENTS AND METHODS Nine patients with recent CT scans prospectively underwent B-mode and twinkling artifact color Doppler ultrasonography on a commercial ultrasound machine. Video segments of the upper pole, interpolar area, and lower pole were created, randomized, and independently reviewed by three radiologists. Receiver operator characteristics were determined. RESULTS There were 32 stones in 18 kidneys with a mean stone size of 8.9±7.5 mm. B-mode ultrasonography had 71% sensitivity, 48% specificity, 52% positive predictive value, and 68% negative predictive value, while twinkling artifact Doppler ultrasonography had 56% sensitivity, 74% specificity, 62% positive predictive value, and 68% negative predictive value. CONCLUSIONS When used alone, B-mode is more sensitive, but twinkling artifact is more specific in detecting kidney stones. This information may help users employ twinkling and B-mode to identify stones and developers to improve signal processing to harness the fundamental acoustic differences to ultimately improve stone detection.

Fluoroless ureteroscopy: zero-dose fluoroscopy during ureteroscopic treatment of urinary-tract calculi.

PURPOSE Fluoroscopy usage during endoscopic procedures exposes the patient and operating room staff to ionizing radiation. Pooled mean fluoroscopy usage time during ureteroscopy reported from recent literature is 144 seconds per case. The purpose of this study was to evaluate radiation exposure using a minimal-use fluoroscopy protocol during ureteroscopic treatment of urinary-tract calculi and determine patient and perioperative factors associated with increased fluoroscopy time. MATERIALS AND METHODS A protocol was developed to access the ureter with the ureteroscope without fluoroscopy usage, and minimize radiation utilization during each portion of the case. Over a 16-month period, fluoroscopy usage and radiation dose for all cases involving retrograde ureteroscopy for a single surgeon were prospectively recorded. A chart review was performed on patient factors and intraoperative events. RESULTS In 162 consecutive ureteroscopic procedures for nephrolithiasis, there were 156 renal units with fluoroscopic usage data, of which total mean and median fluoroscopy time, including stent placement, was 3.3 and 2.0 seconds (0-35 seconds), respectively. Excluding fluoroscopy usage to confirm ureteral stent placement, 75% of all cases did not require any fluoroscopy time (fluoroless), and 85% required 2 seconds or less. Of the 98 renal units with radiation dosage data, the total mean and median radiation dose measured as air kerma was estimated at 1.1 and 0.6 mGy (0.0-17.5 mGy), respectively. Reasons for utilization of total fluoroscopy time more than 5 seconds included stone impaction, ureteral tortuosity or narrowing, collecting system aberrant anatomy, and difficult ureteral stent placement. CONCLUSIONS The reduced fluoroscopy protocol resulted in minimal fluoroscopy time and radiation exposure, significantly lower than reported in the literature. Fluoroless ureteroscopy is safe and feasible in the majority of ureteroscopic cases and lessens exposure to patients and staff.

Focused Ultrasonic Propulsion of Kidney Stones: Review and Update of Preclinical Technology

INTRODUCTION A noninvasive tool to reposition kidney stones could have significant impact in the management of stone disease. Our research group has developed a noninvasive transcutaneous ultrasound device. A review and update of the current status of this technology is provided. DISCUSSION OF TECHNOLOGY: Stone propulsion is achieved through short bursts of focused, ultrasonic pulses. The initial system consisted of an eight-element annular array transducer, computer, and separate ultrasound imager. In the current generation, imaging and therapy are completed with one ultrasound system and a commercial probe. This generation allows real-time ultrasound imaging, targeting, and propulsion. Safety and effectiveness for the relocation of calyceal stones have been demonstrated in the porcine model. ROLE IN ENDOUROLOGY: This technology may have applications in repositioning stones as an adjunct to lithotripsy, facilitating clearance of residual fragments after lithotripsy, expelling de novo stones, and potentially repositioning obstructing stones. Human trials are in preparation.

Quantitative Assessment of Shockwave Lithotripsy Accuracy and the Effect of Respiratory Motion

BACKGROUND AND PURPOSE Effective stone comminution during shockwave lithotripsy (SWL) is dependent on precise three-dimensional targeting of the shockwave. Respiratory motion, imprecise targeting or shockwave alignment, and stone movement may compromise treatment efficacy. The purpose of this study was to evaluate the accuracy of shockwave targeting during SWL treatment and the effect of motion from respiration. PATIENTS AND METHODS Ten patients underwent SWL for the treatment of 13 renal stones. Stones were targeted fluoroscopically using a Healthtronics Lithotron (five cases) or Dornier Compact Delta II (five cases) shockwave lithotripter. Shocks were delivered at a rate of 1 to 2 Hz with ramping shockwave energy settings of 14 to 26 kV or level 1 to 5. After the low energy pretreatment and protective pause, a commercial diagnostic ultrasound (US) imaging system was used to record images of the stone during active SWL treatment. Shockwave accuracy, defined as the proportion of shockwaves that resulted in stone motion with shockwave delivery, and respiratory stone motion were determined by two independent observers who reviewed the ultrasonographic videos. RESULTS Mean age was 51 ± 15 years with 60% men, and mean stone size was 10.5 ± 3.7 mm (range 5-18 mm). A mean of 2675 ± 303 shocks was delivered. Shockwave-induced stone motion was observed with every stone. Accurate targeting of the stone occurred in 60% ± 15% of shockwaves. CONCLUSIONS US imaging during SWL revealed that 40% of shockwaves miss the stone and contribute solely to tissue injury, primarily from movement with respiration. These data support the need for a device to deliver shockwaves only when the stone is in target. US imaging provides real-time assessment of stone targeting and accuracy of shockwave delivery.

First in Human Clinical Trial of Ultrasonic Propulsion of Kidney Stones

PURPOSE Ultrasonic propulsion is a new technology using focused ultrasound energy applied transcutaneously to reposition kidney stones. We report what are to our knowledge the findings from the first human investigational trial of ultrasonic propulsion toward the applications of expelling small stones and dislodging large obstructing stones. MATERIALS AND METHODS Subjects underwent ultrasonic propulsion while awake without sedation in clinic, or during ureteroscopy while anesthetized. Ultrasound and a pain questionnaire were completed before, during and after propulsion. The primary outcome was to reposition stones in the collecting system. Secondary outcomes included safety, controllable movement of stones and movement of stones less than 5 mm and 5 mm or greater. Adverse events were assessed weekly for 3 weeks. RESULTS Kidney stones were repositioned in 14 of 15 subjects. Of the 43 targets 28 (65%) showed some level of movement while 13 (30%) were displaced greater than 3 mm to a new location. Discomfort during the procedure was rare, mild, brief and self-limited. Stones were moved in a controlled direction with more than 30 fragments passed by 4 of the 6 subjects who had previously undergone a lithotripsy procedure. The largest stone moved was 10 mm. One patient experienced pain relief during treatment of a large stone at the ureteropelvic junction. In 4 subjects a seemingly large stone was determined to be a cluster of small passable stones after they were moved. CONCLUSIONS Ultrasonic propulsion was able to successfully reposition stones and facilitate the passage of fragments in humans. No adverse events were associated with the investigational procedure.

Use of the Acoustic Shadow Width to Determine Kidney Stone Size with Ultrasound

PURPOSE Ultrasound is known to overestimate kidney stone size. We explored measuring the acoustic shadow behind kidney stones combined with different ultrasound imaging modalities to improve stone sizing accuracy. MATERIALS AND METHODS A total of 45 calcium oxalate monohydrate stones were imaged in vitro at 3 different depths with the 3 different ultrasound imaging modalities of conventional ray line, spatial compound and harmonic imaging. The width of the stone and the width of the acoustic shadow were measured by 4 operators blinded to the true size of the stone. RESULTS Average error between the measured and true stone width was 1.4 ± 0.8 mm, 1.7 ± 0.9 mm, 0.9 ± 0.8 mm for ray line, spatial compound and harmonic imaging, respectively. Average error between the shadow width and true stone width was 0.2 ± 0.7 mm, 0.4 ± 0.7 mm and 0.0 ± 0.8 mm for ray line, spatial compound and harmonic imaging, respectively. Sizing error based on the stone width worsened with greater depth (p <0.001) while the sizing error based on the shadow width was independent of depth. CONCLUSIONS Shadow width was a more accurate measure of true stone size than a direct measurement of the stone in the ultrasound image (p <0.0001). The ultrasound imaging modality also impacted the measurement accuracy. All methods performed similarly for shadow size while harmonic imaging was the most accurate stone size modality. Overall 78% of the shadow sizes were accurate to within 1 mm, which is similar to the resolution obtained with clinical computerized tomography.