BACKGROUND The results of a recent pilot study suggest that steerable ureteroscopic renal evacuation (SURE) is safe and more effective in stone removal than basketing following laser lithotripsy. The objective of this retrospective study was to further assess the safety and efficacy of SURE using the CVAC® Aspiration System (Calyxo, Inc., Pleasanton, CA) in patients with large stone burdens. MATERIALS AND METHODS Patients with a baseline stone burden of ≥10 mm who underwent SURE were identified. Subject demographics, secondary procedures, complications, and stone clearance (defined as percent baseline volume reduction) were evaluated. Sub-analyses were performed to explore patients identified as high-risk for percutaneous nephrolithotomy (PCNL) because 1) they were on anticoagulation or antiplatelet therapy at the time of procedure, or 2) they had limited mobility due to neurological conditions. RESULTS Identified patients (N=43) had a mean pre-operative stone burden of 29±12 mm and mean stone volume of 3,092±5,002 mm3. Approximately one-half of patients (n=24, 55.8%) had computerized tomography (CT) imaging at follow-up, and of those, eight (33.3%) had no residual stones, 22 (91.7%) had >90% stone clearance, 23 (95.8%) had >80% stone clearance and 24 (100%) had >60% stone clearance. Stone clearance based on baseline stone burden varied between 93.8% and 98.9%. At baseline, 21 patients were anticipated to require staged ureteroscopy; however, only two of those (9.5%) needed secondary procedures. High-risk patients (n=22) were on anticoagulation or antiplatelet therapy (n=12) or had neurologic conditions (n=10). Stone clearance was 97% among patients in the anticoagulated cohort with postoperative CT imaging, and 83% in patients with neurologic conditions. There were no device-related complications and no post-operative admissions. CONCLUSIONS The CVAC® Aspiration System is safe and effective for treating large stone burdens, including in high-risk patients, and may decrease the need for PCNL or secondary procedures.

中文翻译：

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针对大肾结石的可操纵输尿管镜肾清除术 (SURE)：一项多机构中心研究。

背景最近的一项初步研究结果表明，可操纵输尿管镜肾排石术（SURE）在结石清除方面比激光碎石术后的篮式取石术更安全且更有效。这项回顾性研究的目的是进一步评估使用 CVAC® 抽吸系统（Calyxo, Inc.，普莱森顿，加利福尼亚州）的 SURE 对结石负荷较大的患者的安全性和有效性。材料和方法 确定接受 SURE 治疗的基线结石负荷≥10 毫米的患者。对受试者人口统计、二次手术、并发症和结石清除（定义为基线体积减少百分比）进行了评估。我们进行了亚组分析，以探索被确定为经皮肾镜取石术 (PCNL) 高风险的患者，因为 1) 他们在手术时正在接受抗凝或抗血小板治疗，或 2) 他们由于神经系统疾病而活动受限。结果 确定的患者 (N=43) 术前平均结石负荷为 29±12 mm，平均结石体积为 3,092±5,002 mm3。大约一半的患者 (n=24, 55.8%) 在随访时进行了计算机断层扫描 (CT) 成像，其中 8 名 (33.3%) 没有残留结石，22 名 (91.7%) 结石>90%其中，23 名 (95.8%) 的结石清除率 >80%，24 名 (100%) 的结石清除率 >60%。基于基线结石负荷的结石清除率在 93.8% 至 98.9% 之间变化。基线时，预计有 21 名患者需要分期输尿管镜检查；然而，其中只有两人 (9.5%) 需要进行二次手术。高危患者 (n=22) 正在接受抗凝或抗血小板治疗 (n=12) 或患有神经系统疾病 (n=10)。在接受术后 CT 成像的抗凝队列患者中，结石清除率为 97%，在患有神经系统疾病的患者中，结石清除率为 83%。没有与设备相关的并发症，也没有术后入院。结论 CVAC® 抽吸系统对于治疗大结石负担（包括高危患者）是安全有效的，并且可以减少 PCNL 或二次手术的需要。