Burst wave lithotripsy and acoustic manipulation of stones.

PURPOSE OF REVIEW: Burst wave lithotripsy and ultrasonic propulsion of kidney stones are novel, noninvasive emerging technologies to separately or synergistically fragment and reposition stones in an office setting. The purpose of this review is to discuss the latest refinements in technology, to update on testing of safety and efficacy, and to review future applications. RECENT FINDINGS: Burst wave lithotripsy produced consistent, small passable fragments through transcutaneous applications in a porcine model, while producing minimal injury and clinical trials are now underway. A more efficient ultrasonic propulsion design that can also deliver burst wave lithotripsy effectively repositioned 95% of stones in 18 human participants (18 of 19 kidneys) and clinical trials continue. Acoustic tractor beam technology is an emerging technology with promising clinical applications through the manipulation of macroscopic objects. SUMMARY: The goal of the reviewed work is an office-based system to image, fragment, and reposition urinary stones to facilitate their natural passage. The review highlights progress in establishing safety, effectiveness, and clinical benefit of these new technologies. The work is also anticipating challenges in clinical trials and developing the next generation of technology to improve on the technology as it is being commercialized today.

Radiation Exposure during the Evaluation and Management of Nephrolithiasis.

PURPOSE: There is rising concern over the increasing amount of patient radiation exposure from diagnostic imaging and medical procedures. Patients with nephrolithiasis are at potentially significant risk for radiation exposure due to the need for imaging to manage recurrent stone disease. We reviewed the literature in an attempt to better characterize actual risks and discussed methods to reduce radiation exposure for adult patients with nephrolithiasis. MATERIALS AND METHODS: A PubMed search was performed using the key words nephrolithiasis, stones, radiation, fluoroscopy, ureteroscopy, percutaneous nephrolithotomy, computerized tomography and shock wave lithotripsy. Additional citations were identified by reviewing reference lists of pertinent articles. RESULTS: A total of 50 relevant articles were included in this review. Patients with a first time acute stone event are exposed to a significant amount of radiation. Most radiation is from computerized tomography. Patients undergoing percutaneous nephrolithotomy are exposed to an equal or greater amount of radiation than they received from computerized tomography. Risk factors for increased exposure during percutaneous nephrolithotomy include obesity, multiple tracts and a larger stone burden. Ureteroscopy exposes patients to approximately the same amount of radiation as plain x-ray of the kidneys, ureters and bladder. Risk factors for increased exposure during ureteroscopy include obesity and ureteral dilation. During shock wave lithotripsy the amount of radiation exposure is not well characterized. Interventions to reduce exposure to patients include using ultrasound when possible and implementing low dose computerized tomography protocols. The as low as reasonably achievable principle of radiation exposure should always be followed when fluoroscopy is performed. The use of an air retrograde pyelogram may also reduce exposure during percutaneous nephrolithotomy. Fluoroscopy time during ureteroscopy may be decreased by a laser guided C-arm, a dedicated C-arm technician, stent placement under direct vision and tactile feedback to help guide wire placement. CONCLUSIONS: Patients with nephrolithiasis are at significant risk for increased radiation exposure from the imaging and fluoroscopy used during treatment. The true risks of low radiation exposure remain uncertain. It is important to be aware of these risks to provide better counseling for patients. Urologists must also be familiar with techniques to decrease radiation exposure for patients with nephrolithiasis.

Determinants of the direction illusion: motion speed and dichoptic presentation interact to reveal systematic individual differences in sign.

When two fields of dots with different directions of movement are presented in tandem, the perceived direction of one is biased by the presence of the other. Although this ''direction illusion'' typically involves repulsion, with an exaggeration of the perceived angular difference in direction between the dot fields, attraction effects, where the perceived difference is reduced, have also been found under certain presentation conditions. Earlier literature has been inconsistent, and there is debate surrounding the nature of the interactions that facilitate the direction illusion, as well as whether they occur at a local or global stage of the motion processing hierarchy. Here we measured the operating characteristics of the direction illusion by parametrically varying inducer contrast and coherence while examining the effects of stimulus speed and dichoptic presentation. It was found that the magnitude and sign of the direction illusion differed substantially from earlier research. Furthermore, there appeared to be significant interindividual variability, with dichoptic presentation producing an attractive rather than repulsive direction illusion in some participants.

Software-Estimated Stone Volume Is Better Predictor of Spontaneous Passage for Acute Nephrolithiasis.

Purpose: To evaluate whether computer program-estimated urolith stone volume (SV) was a better predictor of spontaneous passage (SP) compared with program-estimated stone diameter (PD) or manually measured stone diameter (MD), and whether utilizing SV and MD together provided additional value in SP prediction compared with MD alone. Materials and Methods: Retrospective analysis of patients with acute renal colic and single renal/ureteral stone on CT from July 2017 to April 2020. Diameter obtained from radiology reports or manually measured when report not available. Semiautomated stone analysis software (qSAS) was used to estimate SV and PD. ROC analysis was performed to compare accuracy of SV vs MD vs PD in predicting SP by 2, 4, and 6 weeks. Subgroup analysis was performed by stone size (

Clinical Evaluation of Miniature Flexible Scope for Diagnosis of Ureteroscope Working Channel Defects.

Introduction: To evaluate flexible ureteroscope working channels with a 1.06 mm digital borescope (Clarus Medical, Minneapolis, MN) and identify factors contributing to ureteroscope damage over time. Materials and Methods: We performed a single institutional prospective study of patients undergoing stone surgery using a nondisposable flexible ureteroscope. A 1.06 mm borescope was used to evaluate ureteroscopes before and after surgery. Borescope videos were reviewed by two independent researchers to quantify average pre- and postprocedural damage. Results: Twenty-five procedures were performed with pre- and postprocedural borescope assessment between August 2021 and February 2022. All patients received preoperative CT imaging depicting a mean axial stone size of 14.1 ± 8.4 mm and density of 923.4 ± 458.1 HU. Mean operative time was 63.8 ± 34.0 minutes. The average number an instrument passes through the working channel was 2.1 ± 1.6. Laser was used in 11 cases with mean laser time of 18.8 ± 19.7 minutes and mean total energy of 5.8 ± 4.2 KJ. On preoperative assessment, all ureteroscopes had some form of defect (24% shave, 32% pinhole, 96% dents and scratches, and 28% discolorations). During postoperative assessment, 23/25 (92%) ureteroscopes showed additional damage with an average of 3.7 ± 2.8 imperfections acquired after one use. Significant differences were seen in acquired shavings (p = 0.028) and scratches or dents (p = 0.018). Of the 355 imperfections seen on postoperative evaluation, 0.4% were shave, 3% were pinhole, 85.8% were dents and scratches, and 10.8% were discolorations. Conclusion: The Clarus borescope observed defects after the majority of flexible ureteroscopy procedures for nephrolithiasis. Although such disruptions may not immediately render ureteroscopes nonfunctional, they are more common than previously described and could increase maintenance costs. Further studies are needed to investigate the burden of unit damage per procedure to raise operator awareness and reduce preventable ureteroscope imperfections.

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.

Understanding Causes for Admission in Planned Ambulatory Percutaneous Nephrolithotomy.

Introduction: For treatment of nephrolithiasis, ambulatory percutaneous nephrolithotomy (aPCNL) is growing in popularity for select patients. The aim of this study was to investigate the safety and efficacy of a set of aPCNL selection criteria as well as search for predictors of failed aPCNL resulting in inpatient admission. Materials and Methods: We reviewed all percutaneous nephrolithotomy (PCNL) patients from 2016 to 2020. A total of 175 met selection criteria for aPCNL and were included. Primary outcome was safety and efficacy, and secondary outcome was to identify predictors of inpatient stay. Demographic and perioperative data were analyzed with both descriptive and inferential statistics. Results: In total, between 2016 and 2020, 552 patients underwent PCNL, with 175 of them meeting criteria for aPCNL. One hundred thirty-four of the 175 (76.6%) of these patients were discharged the same day as the surgery and 41 patients were admitted. On univariate analysis, patients who required upper pole access or multiple accesses (p = 0.038) American Society of Anesthesiologists >2 (p = 0.005), or postoperative nephrostomy (PCN) tube (p < 0.001) were more likely to be admitted after surgery. On multivariate analysis, only postoperative PCN was significantly associated with admission (p = 0.015). Regarding reasons for unsuccessful aPCNL, 19.5% of admissions were attributed to intraoperative complications, 7% to social causes, 12.2% to postoperative complications, 14.6% to uncontrolled pain, and 34.1% to unexpected intraoperative procedures. Conclusions: aPCNL using selection criteria is safe and effective, with postoperative PCN predicting the possible necessity for conversion to inpatient admission. Furthermore, our study provides a practical algorithm for those opting to provide aPCNL to patients.

Standardizing Perioperative Medications to Be Used in an Enhanced Recovery After Surgery Program Is Feasible in Percutaneous Nephrolithotomy Patients.

Introduction: The objective of this process improvement project was to determine the effect of enhanced recovery after surgery (ERAS) protocol for percutaneous nephrolithotomy (PCNL) patients with respect to quality of life (QOL) and pain management in the postoperative recovery period. Methods: An electronic-based medical record ERAS orders protocol for PCNL was instituted at an academic medical center in July 2020. The protocol utilized a pain control regimen designed to minimize opioid medication use postoperatively. We prospectively evaluated PCNL patients' QOL through the Wisconsin Stone Quality of Life (WISQOL) survey and Patient-Reported Outcomes Measurement System (PROMIS) at routine perioperative visits. To assess any opioid reduction benefit of the ERAS protocol, we reviewed an age-matched historical cohort n = 66 (before ERAS implementation) to serve as a comparison cohort with respect to opioid usage. Results: After an inception cohort of 95 patients, 55 ERAS patients remained available for assessment with the WISQOL and PROMIS surveys. In comparison with the non-ERAS cohort, the ERAS cohort represented larger stones, more supine positioning, higher blood loss, shorter hospital stay, and more use of access sheath. ERAS patients received a significantly lower amount of opioids compared with non-ERAS patients upon discharge narcotic usage (116.13 morphine milliequivalent [MME] vs 39.57 MME, p = 0.0001). Compared with their preoperative evaluation, the ERAS cohort had significantly improved QOL scores at 1 week, which sustained through 8 weeks postoperatively. Moreover, pain intensity and pain interference scores were improved at 8 weeks postoperatively for ERAS patients compared with their preoperative time point. Conclusions: We demonstrate that standardizing medications in early efforts toward a PCNL ERAS protocol is feasible and allows for reduced opioid use by patients while achieving early and sustained postprocedure QOL.

First In-Human Burst Wave Lithotripsy for Kidney Stone Comminution: Initial Two Case Studies.

Purpose: To test the effectiveness (Participant A) and tolerability (Participant B) of urinary stone comminution in the first-in-human trial of a new technology, burst-wave lithotripsy (BWL). Materials and Methods: An investigational BWL and ultrasonic propulsion system was used to target a 7-mm kidney stone in the operating room before ureteroscopy (Participant A). The same system was used to target a 7.5 mm ureterovesical junction stone in clinic without anesthesia (Participant B). Results: For Participant A, a ureteroscope inserted after 9 minutes of BWL observed fragmentation of the stone to <2 mm fragments. Participant B tolerated the procedure without pain from BWL, required no anesthesia, and passed the stone on day 15. Conclusions: The first-in-human tests of BWL pulses were successful in that a renal stone was comminuted in <10 minutes, and BWL was also tolerated by an awake subject for a distal ureteral stone. Clinical Trial NCT03873259 and NCT02028559.

Retained Digital Flexible Ureteroscope During Percutaneous Nephrolithotomy.

Background: During percutaneous nephrolithotomy, retrograde flexible ureteroscopy can be utilized to facilitate repositioning of stones, enable direct vision percutaneous access, minimize radiation exposure, reduce operating times, and improve stone-free rates. Although advancements in technique and flexible ureteroscope technology for the past decades have rendered complications rare, herein we report a case of a retained ureteroscope during percutaneous nephrolithotomy that was effectively managed endoscopically. Case Presentation: A 59-year-old Caucasian gentleman with a history of recurrent bilateral nephrolithiasis presents for a left-sided percutaneous nephrolithotomy for a large stone burden >4 cm. A ureteral access sheath was used and retrograde ureteroscopy was performed to first reposition several stones into the renal pelvis. During manipulation, we were unexpectedly unable to retract the ureteroscope from the access sheath. We describe procedural details leading up to the event and subsequent intraoperative management using an antegrade approach. Conclusion: A retained flexible ureteroscope is a rare but serious intraoperative complication that may require invasive open surgical management. However, careful endoscopic management may be feasible in select cases, allowing for preservation of ureter and instrument.

In Vitro Evaluation of Urinary Stone Comminution with a Clinical Burst Wave Lithotripsy System.

Objective: Our goals were to validate stone comminution with an investigational burst wave lithotripsy (BWL) system in patient-relevant conditions and to evaluate the use of ultrasonic propulsion to move a stone or fragments to aid in observing the treatment endpoint. Materials and Methods: The Propulse-1 system, used in clinical trials of ultrasonic propulsion and upgraded for BWL trials, was used to fragment 46 human stones (5-7 mm) in either a 15-mm or 4-mm diameter calix phantom in water at either 50% or 75% dissolved oxygen level. Stones were paired by size and composition, and exposed to 20-cycle, 390-kHz bursts at 6-MPa peak negative pressure (PNP) and 13-Hz pulse repetition frequency (PRF) or 7-MPa PNP and 6.5-Hz PRF. Stones were exposed in 5-minute increments and sieved, with fragments >2 mm weighed and returned for additional treatment. Effectiveness for pairs of conditions was compared statistically within a framework of survival data analysis for interval censored data. Three reviewers blinded to the experimental conditions scored ultrasound imaging videos for degree of fragmentation based on stone response to ultrasonic propulsion. Results: Overall, 89% (41/46) and 70% (32/46) of human stones were fully comminuted within 30 and 10 minutes, respectively. Fragments remained after 30 minutes in 4% (1/28) of calcium oxalate monohydrate stones and 40% (4/10) of brushite stones. There were no statistically significant differences in comminution time between the two output settings (p = 0.44), the two dissolved oxygen levels (p = 0.65), or the two calyx diameters (p = 0.58). Inter-rater correlation on endpoint detection was substantial (Fleiss' kappa = 0.638, p < 0.0001), with individual reviewer sensitivities of 95%, 86%, and 100%. Conclusions: Eighty-nine percent of human stones were comminuted with a clinical BWL system within 30 minutes under conditions intended to reflect conditions in vivo. The results demonstrate the advantage of using ultrasonic propulsion to disperse fragments when making a visual determination of breakage endpoint from the real-time ultrasound image.

Comparison of Broad vs Narrow Focal Width Lithotripter Fields.

OBJECTIVE: To investigate the impact of lithotripter focal width on stone fragmentation. MATERIALS AND METHODS: A modified reflector was used to reduce -6 dB beam size of the HM3 lithotripter, while increasing concomitantly peak pressure. Fragmentation in vitro was assessed with modified and original reflectors using BegoStone phantoms. A membrane holder was used to mimic lithotripsy in vivo, and a matrix holder was used to assess variations of fragmentation power in the focal plane of the lithotripter field. Stone fragmentation in vivo produced by the two reflectors was further compared in a swine model. RESULTS: Stone fragmentation in vitro after 500 (or 2000) shocks was ∼60% (or ∼82%) vs ∼40% (or ∼75%) with original and modified reflector, respectively (p ≤ 0.0016). Fragmentation power with the modified reflector was the highest on the lithotripter axis, but dropped rapidly in the lateral direction and became insignificant at radial distances >6.0 mm. Stone fragmentation with the original reflector was lower along the lithotripter axis, but fragmentation power decayed slowly in lateral direction, with appreciable fragmentation produced at 6.0 mm. Stone fragmentation efficiency in vivo after 500 (or 2000) shocks was ∼70% (or ∼90%) vs ∼45% (or ∼80%) with original and modified reflector, respectively (p ≤ 0.04). CONCLUSIONS: A lithotripter field with broad beam size yields superior stone comminution when compared with narrow beam size under comparable effective acoustic pulse energy both in vivo and in vitro. These findings may facilitate future improvements in lithotripter design to maximize comminution efficiency while minimizing tissue injury.

Effects of exercise training on heart rate variability after coronary angioplasty.

BACKGROUND AND PURPOSE: Cardiac autonomic dysfunction is associated with risk of restenosis and cardiovascular mortality in patients after percutaneous transluminal coronary angioplasty (PTCA). Analysis of heart rate variability (HRV) is an important, widely used method for assessing cardiac autonomic regulation. The purpose of this study was to investigate the effect of exercise training on HRV in subjects after PTCA. SUBJECTS AND METHODS: A total of 84 subjects who had undergone PTCA were recruited for this study. The subjects (age [mean+/-SD]=57.0+/-9.3 years) were randomly assigned to either an exercise group to undergo an 8-week outpatient exercise program or a control group to undergo usual care. Heart rate variability was measured for 5 minutes in the supine resting position at baseline and at the end of 8 weeks. RESULTS: The parasympathetically modulated HRV of the subjects in the exercise group increased significantly compared with the HRV of subjects in the control group. The effects of training on HRV were independent of angioplasty type (balloon or stent) and were unrelated to whether the subjects had received previous PTCA. DISCUSSION AND CONCLUSION: Exercise training can increase parasympathetic modulation of cardiac function in people after they have undergone successful PTCA. Our results suggest that analysis of HRV can be extended to assess the effect of exercise training on cardiac autonomic dysfunction in people after coronary angioplasty.

Comparison of the Nanopulse Lithotripter to the Holmium Laser: Stone Fragmentation Efficiency and Impact on Flexible Ureteroscope Deflection and Flow.

INTRODUCTION: The Nanopulse Lithotripter (NPL; Lithotech Medical, Israel) is a novel intracorporeal device that uses a nanosecond duration electrical discharge through a reusable flexible coaxial probe to endoscopically fragment urinary stones. This device was compared with a holmium laser lithotripsy (HoL) with regard to stone fragmentation efficiency (SFE) and its impact on flexible ureteroscope (URS) deflection and flow of irrigation. METHODS: Using a custom bench model, a 6 mm BegoStone cylindrical phantom (mixture 5:2) was confined under 0.9% saline atop sequential mesh sieves. The SFE of two NPL probe sizes (2.0F, 3.6F) and two HoL fibers (200, 365 µm) was evaluated using concordant settings of 1 J and 5 Hz. URS deflection and irrigation flow with NPL probes in the working channel were tested in five new fourth generation flexible URS and compared with other adjunct endourologic instruments. RESULTS: The 2.0F NPL showed improved SFE compared with the 200 µm laser (86 mg/min vs 52 mg/min, p = 0.014) as did the 3.6F NPL vs the 365 µm laser (173 mg/min vs 80 mg/min, p = 0.05). The NPL created more 1 to 2 mm fragments; the laser created more dust. URS deflection reduced by 3.75° with the 2.0 NPL probe. URS irrigation flow reduced from 36.5 to 6.3 mL/min with the 2.0F NPL probe. CONCLUSION: NPL shows improved SFE compared with HoL. Flow with the 2.0F probe is akin to a stone basket. NPL offers an effective alternative to HoL.