Break Wave Lithotripsy for Urolithiasis: Results of the First-in-Human International Multi-Institutional Clinical Trial.

PURPOSE: This study reports on a prospective, multicenter, single-arm, clinical trial utilizing the SonoMotion (San Mateo, California) Break Wave lithotripsy (BWL) device to fragment urinary stones. MATERIALS AND METHODS: Patients with a urinary stone underwent a single treatment of 30 minutes and peak negative pressure of 4.5 to 8 MPa. Subjects were contacted and outcomes assessed at 7, 14, and 35 days after treatment, with clinical follow-up and CT imaging 70 ± 14 days postprocedure. The primary objectives were to assess the safety (hematomas, complications, etc) and effectiveness of BWL (any fragmentation, residual fragments ≤4 mm or ≤2 mm, and completely stone-free rate) as assessed via noncontrast CT-kidneys, ureters, and bladder. RESULTS: Forty-four patients with a ureteral (43%) or renal (57%) stone were treated across 5 centers. Stone fragmentation occurred in 88% of cases; 70% had fragments ≤ 4 and 51% ≤ 2 mm, while 49% were completely stone free on CT; no serious adverse events were reported. Eighty-six percent of patients received either no analgesic medication at all (50%) or minor analgesia (36%). After determining optimal therapy settings, 36 patients were treated and the effectiveness improved exhibiting fragmentation in 92% (33/36), residual fragments ≤ 4 mm in 75% and 58% with fragments ≤ 2 mm with 58% completely stone free. Effectiveness was less in subjects with lower pole stones with 81% fragmentation, 71% having fragments ≤ 4 mm, 29% with fragments ≤ 2 mm, and 29% completely stone free; of distal ureteral stone patients, 89% were completely stone free. CONCLUSIONS: BWL offered safe and effective noninvasive stone therapy requiring little to no anesthesia and was carried out successfully in nonoperative environments. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03811171.

Salvage of Malfunctioning Peritoneal Dialysis Catheters: An Algorithm for Recanalization and Repositioning.

A peritoneal dialysis catheter salvage algorithm was developed and performed for 40 patients with documented catheter malfunction (obstruction and/or malposition) referred to the interventional radiology suite. This procedure utilized a metallic stiffener for repositioning and rotating dual guide wires for recanalization. A retrospective analysis of 35 cases of fluoroscopic manipulation showed that in 83% of the cases, the catheters were successfully repositioned and/or recanalized, and in 59%, they remained patent at 30 days. No major adverse events occurred. The results suggest that this algorithm is a safe and effective approach to salvage malfunctioning peritoneal dialysis catheters and that a trial of fluoroscopic salvage can be considered prior to surgical intervention.

Evaluating the role for renal biopsy in T1 and T2 renal masses: A single-centre study.

INTRODUCTION: Once used primarily in the identification of renal metastasis and lymphomas, various urological bodies are now adopting an expanded role for the renal biopsy. We sought to evaluate the role of the renal biopsy in a Canadian context, focusing on associated adverse events, radiographic burden, and diagnostic accuracy. METHODS: This retrospective review incorporated all patients undergoing ultrasound (US)/computed tomography (CT)-guided biopsies for T1 and T2 renal masses. There were no age or lesion size limitations. The primary outcome of interest was the correlation between initial biopsy and final surgical pathology. A binomial logistic regression analysis was conducted to determine any confounding factors. Secondary outcomes included the accuracy of tumour cell typing, grading, the safety profile, and radiographic burden associated with these patients. RESULTS: A total of 148 patients satisfied inclusion criteria for this study. Mean age and lesions size at detection were 60.9 years (±12.4) and 3.6 cm (±2.0), respectively. Most renal masses were identified with US (52.7%) or CT (44.6%). Three patients (2.0%) experienced adverse events of note. Eighty-six patients (58.1%) proceeded to radical/partial nephrectomy. Our biopsies held a diagnostic accuracy of 90.7% (sensitivity 96.2%, specificity 87.5%, positive predictive value 98.7%, negative predictive value 70.0%, kappa 0.752, p<0.0005). Binomial logistic regression revealed that age, lesion size, number of radiographic tests, time to biopsy, and modality of biopsy (US/CT) had no influence on the diagnostic accuracy of biopsies. CONCLUSIONS: Renal biopsies are safe, feasible, and diagnostic. Their role should be expanded in the routine evaluation of T1 and T2 renal masses.