Abstract
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.
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Availability of data and materials
Data are available under request.
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Concept and design: EC, SDL; acquisition of data: DG, DA; analysis and interpretation of data: FP, GV, PV; drafting of the manuscript: EC; critical revision: AM, GB, AG, PR, MM; technical or material support: FR, CP; statistical analysis: FP; supervision: CF, FP.
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The study was approved by the local ethics committee (Candiolo cancer institute—FPO—IRCCS; registry number: 258/2018).
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40477_2021_594_MOESM1_ESM.jpg
Supplementary file1 (JPG 189 kb) Supplementary Figure 1: Focal-One platform description. With Focal-One platform the high-intensity ultrasounds are emitted by a robotic endorectal applicator with a Dynamic Focusing transducer. Moreover, aimed to improve the safety of the entire procedure, an infrared external movement detector is located at the level of patient’s iliac crest. The treatment screen allows to plan and execute the treatment, whilst the image screen allows to visualize the prostate and the target area three-dimensionally and to perform the elastic fusion between TRUS and mp-MRI images in case of focal treatment
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Checcucci, E., De Luca, S., Piramide, F. et al. The real-time intraoperative guidance of the new HIFU Focal-One® platform allows to minimize the perioperative adverse events in salvage setting. J Ultrasound 25, 225–232 (2022). https://doi.org/10.1007/s40477-021-00594-8
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DOI: https://doi.org/10.1007/s40477-021-00594-8