Adverse events related to accessory devices used during ureteroscopy: Findings from a 10-year analysis of the Manufacturer and User Facility Device Experience (MAUDE) database.

Objectives: The objective of this study was to evaluate adverse events and device events related to accessories used during ureteroscopy (URS). Materials and methods: Analysis was performed of the records available in the Manufacturer and User Facility Device Experience database in the United States. Information was collected on characteristics of problem, timing, manufacturer verdict, successful completion of planned surgery, prolonged anaesthesia and injury to patient or staff. Results: Five-hundred seventy-one events related to URS accessories were recorded. These were associated with the following devices: baskets (n = 347), access sheath (n = 86), guidewires (n = 78), balloon dilators (n = 27), ARDs (n = 17) and ureteral catheters (n = 16). Of the events, 12.7% resulted in patient injuries. Forty-eight per cent of the events resulted in prolonged anaesthesia, but the planned surgery was successfully completed in 78.4% of all cases. Collectively, the manufacturers accepted responsibility due to actual device failure in only 0.5% of cases. Common problems for baskets were failure to deploy (39.5%) and complete detachment of basket head (34.6%) and partial breakage of the basket head (12.4%). Of the basket group, 4.3% required open or percutaneous surgery to remove stuck basket. Full break of the body of the access sheath occurred in 41.9% and complete ureteral avulsion in 3.5%. For balloon dilators, there was a burst in 37% of cases. Broken guidewires were associated with 11.5% requiring repeat intervention for retrieval and 6.4% required JJ stent due to perforation to the collecting system. No injuries to operating staff were recorded with accessory usage. Conclusion: Accessories used during URS are fragile. Potential for serious injury does exist as a direct result of their use. Surgeons should familiarise themselves with these events and how they can be prevented.

Single use flexible ureteroscopes: Current status and future directions.

Introduction: Single use ureteroscopes are a technological innovation that have become available in the past decade and gained increased popularity. To this end, there are now an increasing number of both benchside and clinical studies reporting outcomes associated with their use. Our aim was to deliver a narrative review in order to provide an overview of this new technology. Methods: A narrative review was performed to gain overview of the history of the technology's development, equipment specifications and to highlight potential advantages and disadvantages. Results: Findings from preclinical studies highlight potenial advantages in terms of the design of single use ureteroscopes such as the lower weight and more recent modifications such as pressure control. However, concerns regarding plastic waste and environmental impact still remain unanswered. Clinical studies reveal them to have a non inferior status for outcomes such as stone free rate. However, the volume of evidence, especially in terms of randomised trials remains limited. From a cost perspective, study conclusions are still conflicting and centres are recommended to perform their own micro cost analyses. Conclusions: Most clinical outcomes for single use ureteroscopes currently match those achieved by reusable ureteroscopes but the data pool is still limited. Areas of continued debate include their environmental impact and cost efficiency.

Ureteroscopy during pregnancy: Outcomes and lessons learned over 4 decades at a tertiary center in Norway.

Background: The management of suspected kidney stone disease in pregnancy is challenging. In cases of persistent flank pain and where investigations may have rendered equivocal results, ureteroscopy (URS) is a recognized diagnostic and therapeutic intervention. This study aimed to investigate the safety and outcomes associated with performing URS during pregnancy, as the technique has evolved over the past 4 decades at our center. Materials and Methods: We performed a retrospective analysis of pregnant patients who underwent URS at our tertiary center between 1984 and 2022. Outcomes of interest included anesthetic approach, operative time, hospital stay, and complications. Results: Eighty-seven pregnant patients underwent 96 URS procedures, and 60% (n = 57) of these procedures were performed during the third trimester. Overall, 58% (n = 56) of the procedures were achieved with local anesthesia and light sedation. During the most recent decade, the latter was successfully carried out in 97% of the procedures, with the remainder occurring under spinal anesthesia as per patient choice. Overall, 57% (n = 50) of the whole study group had ureteral calculi found at the time of surgery and in 88% (n = 44) of these cases, fragmentation/extraction was performed. The remainder had insertion of ureteral stent with definitive clearance deferred until postpartum. Mean operative time and postprocedure hospital stay was 33 minutes (range, 7-100 minutes) and 2.2 days (range, 0-16 days), respectively. The overall intraoperative and postoperative complication rates were 2% and 11%, respectively. During the final decade, the latter improved to 6% and all adverse events were minor (Clavien I/II), with the exception of a single case. Regarding exit strategy, ureteral stent was placed in 42% (n = 40) of the procedures, 23% (n = 22) had ureteral catheter inserted, and the remainder (35%, n = 34) had none. Conclusions: Ureteroscopy can be safely performed during pregnancy using anesthetic approach with local anesthesia and light sedation. Development of a local protocol and multidisciplinary management algorithm are instrumental in enabling the delivery of such a service.

Ureteroscopy during pregnancy under local anesthesia and light sedation: Technique and video.

Ureteroscopy during pregnancy has become increasingly recognized as a safe intervention. Performing it under local anesthesia and light sedation reduces the risks associated with general or regional anesthesia, such as difficult airway scenarios, hypothermia, and hypotension. In addition, this approach reduces the total amount of fetal exposure to medications and anesthetic agents. Performing ureteroscopy in this manner requires a number of adjustments and modifications to the standard technique. This article provides a summary in a step-by-step format, as well as an accompanying video demonstration.

Mortality due to urolithiasis in England and Wales: updated findings from a national database over a 23-year period.

Introduction: Urolithiasis is a recognised disease of prevalence, and although not common, fatal sequelae can occur. There are few studies with population-based data that provide an overview of the mortality burden associated with this condition. Our aim was to perform an update based on national data from England and Wales. Material and methods: A search was performed of the database available through the Office of National Statistics (ONS), which collates relevant information from all death certificates in England and Wales. The cause of death is classified according to the conditions listed in the International Classification of Diseases, Tenth Revision (ICD-10). The codes N 20-23 were utilised. Data were collected on gender, location in the upper or lower urinary tract, and age. Results: Over the 23-year period, 3717 deaths caused by urolithiasis were recorded. The male-to-female ratio was 1:1.4. However, this gender gap steadily closed over time. The mean number of deaths per year was 161 (range: 98-308 year), and this gradually increased over the study period. By 2021, urolithiasis accounted for 0.1% of deaths in England and Wales. Over half of the deaths (64.9%) were in persons aged ≥75 years, while the mortality rate in persons under 50 years old was less than 4%. 0.1% of the deaths occurred in children under 15 years of age, and these were all females. Conclusions: The number of deaths caused by urolithiasis has increased in England and Wales. Although mortality is higher among females, this gender gap is narrowing.

Holmium and Thulium Fiber Laser Safety in Endourological Practice: What Does the Clinician Need to Know?

PURPOSE OF REVIEW: To summarise the literature on laser safety during endourological practice. RECENT FINDINGS: Holmium and Thulium Fiber laser are the two main energy sources in the current clinical practice. The latter may have superior properties, but more clinical studies are needed to formally establish this. Laser injury to urothelium is more dependent on user experience rather than laser type. Smaller laser fibres allow for lower intra-renal temperature profiles. Operators should pay close attention to laser technique including maintaining the safety distance concept and only firing the laser when tip is clearly in view. When adjusting laser settings, pay close attention to resultant power given the associated heat changes. Prolonged periods of laser activation are to be avoided for the same reason. Outflow can be manipulated such as with access sheath to mitigate temperature and pressure changes. There is still limited evidence to support the mandate for compulsory use of eye protection wear during laser lithotripsy. Lasers are the gold standard energy source for stone lithotripsy. However, the safe clinical application of this technology requires an understanding of core principles as well as awareness of the safety and technical aspects that can help in protecting patient, surgeon and operating staff.

Ureteroscopy in Patients with Urinary Diversion: Outcomes and Lessons Learned from Two European Centres.

Background: Ureteroscopy (URS) in patients with urinary diversion is technically challenging. Common difficulties include anastomotic strictures, tortuosity, and failure to cannulate the ureteric orifice. There are few studies reporting outcomes in this special population. Objective: Our aim was to report outcomes at two tertiary centres in Europe. Design setting and participants: A multicentre retrospective cohort study was conducted between 2010 and 2022. Intervention: URS (antegrade and retrograde) procedures carried out in patients with urinary diversions. Outcome measurements and statistical analysis: Outcomes of interest included success at cannulating the ureteric orifice, stone-free rate (SFR), and complications. A logistic regression analysis was performed to identify potential predictors for success at cannulating the ureteric orifice and success at completing the intended procedure in a single session. Results and limitations: Fifty patients underwent 72 URS procedures, with most (86%) undergoing a retrograde approach. The majority (82%) of patients had undergone ileal conduit. Wallace was the commonest anastomosis type (64%). Ureteric anastomosis was cannulated successfully in 81% of cases. The most common reason for cannulation failure was the inability to identify the ureteric orifice (11%). A multivariable analysis revealed that an endourologist performing the case was associated with a significantly greater likelihood of cannulation success compared with consultants (odds ratio 25.9, p < 0.001). The mean operative time and hospital stay were 49 min (range: 11-126) and 1 d (range: 0-10), respectively. SFRs were 75% (zero fragments) and 81% (residual fragments ≤2 mm). No intraoperative complications were recorded. The overall postoperative complication rate was 6%. This study is limited by its retrospective status. Conclusions: Endourological experience increases the likelihood of successful ureteric cannulation and procedural success. A low complication rate can be achieved despite this being a population with often multiple comorbidities. Patient summary: Patients with previous bladder reconstructive surgery can undergo ureteroscopy with good outcomes. Surgeon experience increases the likelihood of treatment success.

Device Failure and Adverse Events Related to Single-use and Reusable Flexible Ureteroscopes: Findings and New Insights From an 11-Year Analysis of the Manufacturer and User Facility Device Experience Database.

OBJECTIVE: To catalog and characterize device failures and adverse events related to flexible ureteroscopes from a national database. METHODS: Search of the Manufacturer User and Facility Device Experience database was performed for all recorded events related to flexible ureteroscopes between 2012 and 2022. The following information was collected: Problem and cause, timing, complications and injury, prolonged anesthesia, and early termination of procedure. Event severity was graded using a validated tool. RESULTS: A total of 206 events were identified (reusable/single use ratio, 2.5:1). There were 20 different problem categories reported, which included image loss (26.7%), difficulty removing scope (13.6%), scope damage from basket (4.4%), detachment of scope tip (5.8%) and contamination (4.9%). Faulty device was the predominant cause for an event related to single-use scopes (86.4%); this was seldom the case for reusable (2%). Patient injury occurred in 21.8%, but these were all in reusable scopes. No deaths were reported, but major complications included complete avulsion of the ureter (3.4%) and fully entrapped scope necessitating open surgery (2.9%). While the safety profile for single-use scopes was superior, they were significantly more likely to result in early termination (71.1% vs 37.3%, P < .001). This was related to 76.3% of the single-use scopes experiencing sudden image loss. CONCLUSION: Flexible ureteroscopes are fragile, and a multitude of problems can occur. Many of these can be avoided through correct surgeon technique and robust maintenance services.

Paediatric kidney stone surgery: state-of-the-art review.

While urolithiasis in children is rare, the global incidence is rising, and the volume of minimally invasive surgeries being performed reflects this. There have been many developments in the technology, which have supported the advancement of these interventions. However, innovation of this kind has also resulted in wide-ranging practice patterns and debate regarding how they should be best implemented. This is in addition to the extra challenges faced when treating stone disease in children where the patient population often has a higher number of comorbidities and for example, the need to avoid risk such as ionising exposure is higher. The overall result is a number of challenges and controversies surrounding many facets of paediatric stone surgery such as imaging choice, follow-up and different treatment options, for example, medical expulsive therapy, shockwave lithotripsy, ureteroscopy, and percutaneous nephrolithotomy. This article provides an overview of the current status of paediatric stone surgery and discussion on the key topics of debate.

Ureteroscopy for Stone Disease in Extremely Elderly Patients (≥85 Years): Outcomes and Lessons Learned.

Introduction: The volume of surgeries including ureteroscopy (URS) performed for urolithiasis is increasing. This includes for the elderly population. The aim of this study was to evaluate the outcomes of URS in extremely elderly patients and identify any lessons that could be learned for clinical practice and treatment planning. Materials and Methods: Retrospective analysis was performed of consecutive patients aged 85 years and older undergoing URS between 2010 and 2022 at our tertiary center. Uni- and multivariable logistic regression analyses were performed to identify possible risk factors for complications. Survival analysis, stratified by age-adjusted Charlson Comorbidity index (ACCI), was performed using the Kaplan-Meier method as well as the log-rank test. Results: Sixty-four URS procedures were performed on 51 patients (mean age 88 years, range 85-97). Mean ACCI score was 7 (range 4-13) and most patients were American Society Anesthesiologists 3 (78%). Mean operative time and hospital stay were 60 minutes (range 15-120) and 2 days (range 0-6), respectively. At 3-month follow-up imaging, 92% were stone free (zero fragments). Intraoperative complication rate was 14% and in three cases (5%), early termination of the procedure was necessary. Eight patients (13%) suffered a complication before discharge. Eighteen patients (28%) had documented late complications after their surgery. The complication rate when combining early and late adverse events was 41%. One year mortality rate was 23%. Multivariable regression analysis revealed that operation time and ACCI >7 were significant predictors of complications after surgery. Survival probability was significantly worse in those patients with ACCI >7 (p = 0.0083). Conclusion: The morbidity burden of URS in the extremely elderly is higher than for other population groups. Risk should be considered carefully and implementation of ACCI can aid this process. High scores should prompt strong consideration of a conservative approach. Operation time should be kept to a minimum wherever possible.

Ureteroscopy for stone disease in the paediatric population: lessons learned and outcomes in a Nordic setting.

Introduction: Paediatric stone disease is rare in the Nordic communities. Still, the condition can require surgical intervention in the form of ureteroscopy (URS). Here, we report outcomes achieved at a regional (tertiary) centre. Patients and methods: Retrospective analysis was performed of consecutive patients (<18 years of age) undergoing URS for stone disease between 2010 and 2021. Outcomes of interest included stone-free rate (SFR) determined using a definition of no residual fragments ⩾ 3 mm on imaging and complications classified according to Clavien-Dindo system. Results: In total, 23 patients underwent 47 URS procedures for a total of 31 stone episodes. Mean age was 9 (range 1-17) years and male-to-female ratio was 6:17. Overall, 35% had at least one medical comorbidity. Ultrasound determined preoperative stone status in 87%. Mean largest index and cumulative stone sizes were 9 (range 3-40) and 12 (range 3-40) mm, respectively. Overall, 32% had multiple stones. Lower pole was the commonest stone location (39%). No patients underwent elective pre-operative stenting. Ureteral access sheaths were not used in any cases. Access to upper urinary tract at first procedure was successful in 94%. Initial and final SFR was 61% and 90%, respectively. No intra-operative complications were recorded. Overall post-operative complication rate was 17.5%. Urinary tract infection (CD II) was the commonest adverse event (12.5%). Conclusion: Paediatric URS can be delivered in the setting of a regional centre without compromising outcomes. This includes when carried out by adult endourologists, without routine pre-stenting and omitting use of ureteric access sheath.

Thulium Fibre Laser versus Holmium:YAG for Ureteroscopic Lithotripsy: Outcomes from a Prospective Randomised Clinical Trial.

BACKGROUND: Holmium:yttrium-aluminium-garnet (Ho:YAG) laser is the gold standard for ureterorenoscopic (URS) lithotripsy. Thulium fibre laser (TFL) has recently been introduced as a new technology and may challenge Ho:YAG as the preferred laser owing to favourable properties as demonstrated in preclinical studies. OBJECTIVE: To evaluate and compare outcomes after URS lithotripsy with Ho:YAG and TFL. DESIGN, SETTING, AND PARTICIPANTS: In a prospective randomised trial, patients aged ≥18 yr with ureteral and/or renal stones (≥5 mm) scheduled to undergo day-case URS lithotripsy were invited to participate. In total, 120 consecutively admitted patients with signed consent were included for randomisation. INTERVENTION: URS lithotripsy with Ho:YAG or TFL. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was the stone-free rate (SFR) assessed on noncontrast computed tomography at 3-mo follow-up. Secondary outcomes were the operative time and complications. Outcomes were compared between the groups using the t test and χ2 test. RESULTS AND LIMITATIONS: After a single session, the SFR was 67% in the Ho:YAG group and 92% in the TFL group, p = 0.001. For ureteral stones, the SFR was 100% in both groups, and for renal stones; 49% (Ho:YAG) and 86% (TFL), p = 0.001. Operative time was shorter using TFL (49 min) compared to Ho:YAG (57 min), p = 0.008. Bleeding that impaired the endoscopic view was the most frequent intraoperative adverse event and occurred in 13 patients (22%) in the Ho:YAG group and three (5%) in the TFL group, p = 0.014. CONCLUSIONS: In this study, significantly more patients with renal stones achieved stone-free status and fewer experienced intraoperative complications using TFL compared to Ho:YAG. TFL is the emerging laser of choice for stone lithotripsy. PATIENT SUMMARY: We compared outcomes after ureterorenoscopic treatment of kidney and ureteral stones using two different lasers. Our results show that the new thulium fibre laser technology is superior to the current standard laser (holmium:YAG) in clearing kidney stones and reducing operative complications.

Serum miR371 in testicular germ cell cancer before and after orchiectomy, assessed by digital-droplet PCR in a prospective study.

MicroRNA-371a-3p (miR371) has been suggested as a sensitive biomarker in testicular germ cell cancer (TGCC). We aimed to compare miR371 with the classical biomarkers α-fetoprotein (AFP) and ß-human chorionic gonadotropin (hCGß). Overall, 180 patients were prospectively enrolled in the study, with serum samples collected before and after orchiectomy. We compared the use of digital droplet PCR (RT-ddPCR) with the quantitative PCR used by others for detection of miR371. The novel RT-ddPCR protocol showed high performance in detection of miR371 in serum samples. In the study cohort, miR371 was measured using RT-ddPCR. MiR371 detected CS1 of the seminoma and the non-seminoma sub-types with a sensitivity of 87% and 89%, respectively. The total sensitivity was 89%. After orchiectomy, miR371 levels declined in 154 of 159 TGCC cases. The ratio of miR371 pre- and post-orchiectomy was 20.5 in CS1 compared to 6.5 in systemic disease. AFP and hCGß had sensitivities of 52% and 51% in the non-seminomas. MiR371 is a sensitive marker that performs better than the classical markers in all sub-types and clinical stages. Especially for the seminomas CS1, the high sensitivity of miR371 in detecting TGCC cells may have clinical implications.