Moderate-to-deep sedation technique, using propofol and ketamine, allowing synchronised breathing for magnetic resonance high-intensity focused ultrasound (MR-HIFU) treatment for uterine fibroids : a pilot study

Background: Magnetic resonance high-intensity focused ultrasound (MR-HIFU) treatment for uterine fibroids is rapidly gaining popularity as a treatment modality. This procedure is generally uncomfortable, painful, and requires minimal or absence of movement and an MR-HIFU synchronised breathing pattern of the patient. Procedural sedation and analgesia protocols have become the standard practice in interventional radiology departments worldwide. The aim of this study was to explore if a sedation regimen with low-dose propofol and ketamine performed by trained non-medical sedation practitioners could result in relief of discomfort for the patient and in adequate working conditions for MR-HIFU treatment for uterine fibroids. Methods: In this study, conducted from August 2013 until November 2014, 20 patients were subjected to MR-HIFU treatment of uterine fibroids. Patients were deeply sedated using intravenous propofol and esketamine according to a standardised hospital protocol to allow synchronisation of the breathing pattern to the MR-HIFU. The quality of sedation for MR-HIFU and complications were recorded and analysed. The side effects of the sedation technique, the propofol and esketamine consumption rate, the duration of recovery, and patient satisfaction after 24 h were examined. Results: A total of 20 female patients (mean age 42.4 [range 32–53] years) were enrolled. Mean propofol/esketamine dose was 1309 mg/39.5 mg (range 692–1970 mg/ 23.6–87.9 mg). Mean procedure time was 269 min (range 140–295 min). Application of the sedation protocol resulted in a regular breathing pattern, which could be synchronised with the MRHIFU procedures without delay. The required treatment was completed in all cases. There were no major adverse events. Hypoxemia (oxygen desaturation Conclusions: The use of a specific combination of IV propofol and esketamine for procedural sedation and analgesia reduced the discomfort and pain during MR-guided HIFU treatments of uterine fibroids. The resulting regular breathing pattern allowed for easy synchronisation of the MR-HIFU procedure. Based on our results, esketamine and propofol sedation performed by trained non-medical sedation practitioners is feasible and safe, has a low risk of major adverse events, and has a short recovery time, avoiding a session of general anaesthesia

Volumetric MR-Guided High-Intensity Focused Ultrasound with Direct Skin Cooling for the Treatment of Symptomatic Uterine Fibroids : Proof-of-Concept Study

Objective. To prospectively assess the safety and technical feasibility of volumetric magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) ablation with direct skin cooling (DISC) during treatment of uterine fibroids. Methods. In this proof-of-concept study, eight patients were consecutively selected for clinical MR-HIFU ablation of uterine fibroids with the use of an additional DISC device to maintain a constant temperature (T ≈ 20°C) at the interface between the HIFU table top and the skin. Technical feasibility was verified by successful completion of MR-HIFU ablation. Contrast-enhanced T1-weighted MRI was used to measure the treatment effect (nonperfused volume (NPV) ratio). Safety was evaluated by recording of adverse events (AEs) within 30 days' follow-up. Results. All MR-HIFU treatments were successfully completed in an outpatient setting. The median NPV ratio was 0.56 (IQR [0.27-0.72]). Immediately after treatment, two patients experienced coldness related discomfort which resolved at the same day. No serious (device-related) AEs were reported. Specifically, no skin burns, cold injuries, or subcutaneous edema were observed. Conclusion. This study showed that it is safe and technically feasible to complete a volumetric MR-HIFU ablation with DISC. This technique may reduce the risk of thermal injury to the abdominal wall during MR-HIFU ablation of uterine fibroids. This trial is registered with NTR4189