Ureteroscopy-assisted Percutaneous Kidney Access Made Easy: First Clinical Experience with a Novel Navigation System Using Electromagnetic Guidance (IDEAL Stage 1)

Abstract Background Puncture of the renal collecting system represents a challenging step in percutaneous nephrolithotomy (PCNL). Limitations related to the use of standard fluoroscopic-based and ultrasound-based maneuvers have been recognized. Objectives To describe the technique and early clinical outcomes of a novel navigation system for percutaneous kidney access. Design, setting, and participants This was a proof-of-concept study (IDEAL phase 1) conducted at a single academic center. Ten PCNL procedures were performed for patients with kidney stones. Surgical procedure Flexible ureterorenoscopy was performed to determine the optimal renal calyx for access. An electromagnetic sensor was inserted through the working channel. Then the selected calyx was punctured with a needle with a sensor on the tip guided by real-time three-dimensional images observed on the monitor. Outcome measurements and statistical analysis The primary endpoints were the accuracy and clinical applicability of the system in clinical use. Secondary endpoints were the time to successful puncture, the number of attempts for successful puncture, and complications. Results and limitations Ten patients were enrolled in the study. The median age was 47.1 yr (30–63), median body mass index was 22.85kg/m 2 (19–28.3), and median stone size was 2.13cm (1.5–2.5cm). All stones were in the renal pelvis. The Guy's stone score was 1 in nine cases and 2 in one case. All 10 punctures of the collecting system were successfully completed at the first attempt without X-ray exposure. The median time to successful puncture starting from insertion of the needle was 20 s (range 15–35). No complications occurred. Conclusions We describe the first clinical application of a novel navigation system using real-time electromagnetic sensors for percutaneous kidney access. This new technology overcomes the intrinsic limitations of traditional methods of kidney access, allowing safe, precise, fast, and effective puncture of the renal collecting system. Patient summary We describe a new technology allowing safe and easy puncture of the kidney without radiation exposure. This could significantly facilitate one of the most challenging steps in percutaneous removal of kidney stones.