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A Prospective Study of Steerable Ureteroscopic Renal Evacuation Using the Second-Generation CVAC Aspiration System: Results from the CLEARANCE Study
Brian Eisner, MD1, Niramya Pathak, MD
2, Ravindra Sabnis, MD
2, Arvind Ganpule, MD
2, Abhishek Singh, MD
2, Abhijit Patil, MD
2, Rohan Bahtra, MD
2, Nishanth Shanthin, MD
2, Chaitya Shah, MD
2, Glenn Preminger, MD
3, Mahesh R. Desai, MD
2, Roger L. Sur, MD
4.
1MassGeneralBrigham Urology, Boston, MA, USA,
2Muljibhai Patel Urological Hospital, Nadiad, India,
3Duke University School of Medicine, Durham, NC, USA,
4University of California, San Diego, San Diego, CA, USA.
BACKGROUND: The safety and effectiveness of the second-generation CVAC® Aspiration System that integrates direct vision, laser lithotripsy, microjet irrigation, dynamic aspiration and continuous stone removal and collection was evaluated.
METHODS: A prospective, single-arm study was conducted. Steerable ureteroscopic renal evacuation (SURE) using the CVAC Aspiration System was performed on adult candidates for ureteroscopic laser lithotripsy. Stone clearance (percent stone volume removed), residual stone volume (RSV), residual fragments (RF) and stone-free status at post-operative days (POD) 1 and 30 were assessed using non-contrast CT (NCCT) with 2mm slices and semi-automated segmentation software. Regression analysis was performed to understand whether outcomes degrade with increasing baseline stone volume. Adverse events were recorded.
RESULTS: 30 subjects (32 renal units) were treated by 10 surgeons; 26 subjects (28 renal units) had NCCT available at POD 30. Mean baseline stone volume and density was 703.6mm
3 and 1203 HU respectively. Mean stone clearance increased from 93.8% at POD 1 to 96.2% at POD 30 while average RSV decreased from 36.0mm
3 at POD 1 to 14.1mm
3 at POD 30. SFR (zero RF) increased from 25.0% at POD 1 to 46.4% at POD 30. Stone clearance remained high, and RSV remained low at POD 30 even with increasing baseline stone volume. There were no device-related injuries; adverse events were mild and resolved without issues. No subject required retreatment or hospital readmission for RF.
CONCLUSIONS: The CVAC Aspiration System is safe and efficiently delivers high stone clearance and low RSV even with larger and harder stones and leaves minimal residual stone burden.
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