The real-time intraoperative guidance of the new HIFU Focal-One platform allows to minimize the perioperative adverse events in salvage setting.

Purpose: To assess the use of the new Focal-One HIFU platform in salvage setting to evaluate the occurrence of postoperative complications.

Methods: Patients who underwent salvage HIFU (sHIFU) with Focal-One platform were enrolled prospectively (Candiolo cancer institute-FPO IRCCS; registry number: 258/2018). Perioperative and postoperative outcomes (in terms of oncological and functional ones) were recorded during the first year of follow-up. In particular postoperative complications were classified according to Clavien-Dindo system.

Results: 20 patients were enrolled. No grade 3 complications were recorded. Referring to grade 2 complications, eight patients reported urgency after 3 months of follow-up, and in 4 cases, a low urinary tract infection occurred. Evaluating the impact of sHIFU on patients' sexual potency, micturition and quality of life, no significant deterioration was recorded during the follow-up as proven using the ANOVA analysis for repeated measurements. Only two patient had a biochemical failure after 12 months of follow-up.

Conclusions: The real-time intraoperative guidance with Focal-One platform, allows a continuous monitoring and tailoring of the treatment, with a minimization of the adverse events even in a salvage setting.