Presentation Authors: Alberto Saita*, Rozzano, Italy, Luca Villa, Milano, Italy, Marco Paciotti, Vittorio Fasulo, Paolo Casale, Giovanni Lughezzani, NicoloMaria Buffi, Rodolfo Hurle, Luigi Domanico, Giulio Bevilacqua, Roberto Peschechera, Massimo Lazzeri, Giorgio Guazzoni, Rozzano, Italy
Introduction: Stone extraction devices have become a routine tool after RIRS. Basketing increases the surgical duration and can lead to serious complications such as perforation and avulsion of the ureter wall. Furthermore, obtaining a complete stone fragment removal is still a challenging issue. In this video we present in vitro experiment for a new conception of FlexorÂ® Vue Deflecting Endoscopic System (FVDES) use and its in vivo application/implementation.The aim of our study is to create and test a new system that is able to routinely, effectively clear the fragments remaining after RIRS.
Methods: FVDES includes a disposable sheath and a visualization source, originally designed as a flexible endoscope.We placed an irrigator within optical channel so to have the flexor carry out a new function.We created an in vitro study that modelled the lithic fragments remaining post-RIRS.The device was implemented in vivo on 11 consecutive patients treated for primary or recurrent renal stones of medium size (1,5-2,5 cm). All the procedures were performed using a 200 Âµm holmium fiber using a flexible ureterorenoscope (Olympus URF-V2) and standard UAS. The FVDES was positioned at the end of procedure in order to improve SFR. The outcomes of interest are feasibility, safety and efficacy. Feasibility was defined as the capacity of positioning and favouring fragment removal according to the Bernulli's principle by the Flexor device. Safety was defined by complication analysis. Efficacy outcomes measured operative time, SFR, hospital stay, re-treatment and rehospitalization. SFR was defined as fragments less than 4 mm assessed by ultrasound and CT. Descriptive statistical analysis was applied.
Results: The experimental in vitro model showed the efficacy of the device, allowing the removal of about 90% of fragments. In vivo, 11 patients (M/F ratio: 7/4, mean age 63.5 Â± 8.3) were treated. The stones were located in the lower calyces, and the renal pelvis in 3 and 8 patients, respectively. Medium stone size was 1.8 mm Â± 3.2. The procedure with FVDES was feasible in all the patients. Eight patients underwent preoperative ureteral stent. Mean operative time was 82 min Â± 13.7 and median hospital stay was of 1.5 day. The SFR after 30 days was 81% (9/11). Post-operatively we had no significant bleeding. 1 patient had fever and required antibiotic treatment for 5 days. No cost/effectiveness study was performed.
Conclusions: Our in vitro results confirmed the rationale for new conception of FVDES use.In vivo results showed it to be feasible, safe and effective for patients with medium size (1.5 to 2.5 cm) renal stones. The technique we described could allow to avoid the basketing whilst increasing the SFR after RIRS.The removal of the residual stones could lead to a reduction of the risk of disease reoccurrence and also lower the chances of patients requiring re-treatments. The positive impact may extend to include a reduction in the costs of the procedure.Further studies with larger population are mandatory before the introduction of this technique in our clinical practice.