Real-world efficacy and safety of the CVAC 2.0 ureteroscope: results from a single-center retrospective study

The CVAC 2.0 ureteroscope enables simultaneous lasing and suctioning capabilities under direct visual guidance and received FDA clearance for use in lithotripsy procedures in early 2024. We report real-world clinical efficacy and safety data of this novel device. A retrospective cohort study was conducted at a single center where five urologists offered CVAC 2.0 treatment to their patients. Baseline demographic characteristics, procedure factors, complications, stone factors, and stone-free status based on volumetric and single-dimension analysis were collected through chart review. Stones volumes were calculated using the scalene ellipsoid formula and stone complexity was characterized by the modified S.T.O.N.E. score. A total of 61 cases and 106 stones were identified and eligible for volumetric analysis. Mean age was 60, mean BMI was 32, 28% were anticoagulated, and 73% had an ASA score of 3 or higher. Median total pre-operative linear stone burden was 2.2 cm and median volume was 1,003mm³. Most stones were classified as "complex" with mean S.T.O.N.E. score of 10. Mean stone clearance by volume reached 97%. 52% of patients were stone-free (zero residual fragments) whereas 84% had either zero stone or residual fragments < 4 mm. There were no immediate peri-operative complications, though 11.5% of patients returned to the ED within 30 days for management of stent colic, urinary retention, hematuria, and in one case, urosepsis. In a medically comorbid cohort with large-volume, complex renal and ureteral stones, CVAC 2.0 demonstrated excellent volumetric stone clearance and an acceptable safety profile with stone free rates comparable to or exceeding published ureteroscopy outcomes. Further comparative assessments and cost-effectiveness studies are needed to define the optimal role of CVAC 2.0 in nephrolithiasis management.