Presented by: Tom Chi MD
University of California San Francisco

Introduction

Recent studies demonstrated that steerable ureteroscopic renal evacuation (SURE) using the CVAC® Aspiration System is safe and effective, even in complex patients with large stone burden.  ASPiration to Improve Renal Calculi Removal Effectiveness (ASPIRE) is a prospective, randomized, multi-center study to evaluate the safety and efficacy of SURE compared to ureteroscopy with basketing (URS). Herein, we report the 30-day efficacy and safety outcome.

Materials

132 subjects from 11 US institutions were enrolled in the study between June 2021 and February 2023, and 104 subjects qualified for the efficacy analysis. All subjects had baseline CT and post-operative CT. Post-operative CT was standardized to 1.25mm CT slice thickness at 30-days post-op, reviewed by a central lab radiologist, and overread by an endourologist. Three-dimensional volumetric analysis was performed. This data was used for efficacy endpoints including stone clearance, residual stone volume (RSV), and stone free rate (SFR) defined as zero fragments. 

Results

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SURE demonstrated statistically significant higher stone clearance (96.8% vs. 92.9%, p=0.034) and lower RSV (15.0 ± 31.1 vs. 70.2 ± 144.9, p=0.01) than URS. These results were independent of the baseline stone volume, in contrast to that of the standard URS (Figure 1).  SURE also minimized the RSV in the lower pole vs. URS (25.7 ± 37.9 vs. 97.4 ± 147.3, p=0.046). There was no significant difference in SFR or safety between SURE and URS.  There were 3 CVAC-related events that were managed without intervention. 

Conclusion

SURE is safe and delivers higher stone clearance and minimizes residual stone volume, independent of the baseline stone burden. ASPIRE will assess future stone events and retreatments thru the 2-year duration.

Funding

Calyxo

Lead Authors

Brian Matlaga, MD
Johns Hopkins

Co-Authors

Thomas Mueller, MD
Summit Urology

Brett Johnson, MD
University of Texas Southwestern

Jay Page, MD
Arizona Urology

Stuart Wolf, MD
University of Texas

Glenn Preminger, MD
Duke University