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

Prediction model for extensive ductal carcinoma in situ around early-stage invasive breast cancer

Objectives: Ductal carcinoma in situ (DCIS) is a risk factor for incomplete resection of breast cancer. Especially, extensive DCIS (E-DCIS) or extensive intraductal component often results in positive resection margins. Detecting DCIS around breast cancer before treatment may therefore alter surgery. The purpose of this study was to develop a prediction model for E-DCIS around early-stage invasive breast cancer, using clinicohistopathological and dynamic contrast-enhanced magnetic resonance imaging (MRI) features. Materials and Methods: Dynamic contrast-enhanced MRI and local excision were performed in 322 patients with 326 ductal carcinomas. Tumors were segmented from dynamic contrast-enhanced MRI, followed by 3-dimensional extension of the margins with 10 mm. Amount of fibroglandular tissue (FGT) and enhancement features in these extended margins were automatically extracted from the MRI scans. Clinicohistopathological features were also obtained. Principal component analysis and multivariable logistic regression were used to develop a prediction model for E-DCIS. Discrimination and calibration were assessed, and bootstrapping was applied for internal validation. Results: Extensive DCIS occurred in 48 (14.7%) of 326 tumors. Incomplete resection occurred in 56.3% of these E-DCIS-positive versus 9.0% of E-DCIS-negative tumors (P < 0.001). Five components with eigenvalue exceeding 1 were identified; 2 were significantly associated with E-DCIS. The first, positively associated, component expressed early and overall enhancement in the 10-mm tissue margin surrounding the MRI-visible tumor. The second, positively associated, component expressed human epidermal growth factor receptor 2 and amount of FGT around the MRI-visible tumor. The area under the curve value was 0.79 (0.76 after bootstrapping). Conclusions: Human epidermal growth factor receptor 2 status, early and overall enhancement in the 10-mm margin around the MRI-visible tumor, and amount of FGT in the 10 mm around the MRI-visible tumor were associated with E-DCIS

Prediction Model For Extensive Ductal Carcinoma In Situ Around Early-Stage Invasive Breast Cancer

OBJECTIVES: Ductal carcinoma in situ (DCIS) is a risk factor for incomplete resection of breast cancer. Especially, extensive DCIS (E-DCIS) or extensive intraductal component often results in positive resection margins. Detecting DCIS around breast cancer before treatment may therefore alter surgery. The purpose of this study was to develop a prediction model for E-DCIS around early-stage invasive breast cancer, using clinicohistopathological and dynamic contrast-enhanced magnetic resonance imaging (MRI) features. MATERIALS AND METHODS: Dynamic contrast-enhanced MRI and local excision were performed in 322 patients with 326 ductal carcinomas. Tumors were segmented from dynamic contrast-enhanced MRI, followed by 3-dimensional extension of the margins with 10 mm. Amount of fibroglandular tissue (FGT) and enhancement features in these extended margins were automatically extracted from the MRI scans. Clinicohistopathological features were also obtained. Principal component analysis and multivariable logistic regression were used to develop a prediction model for E-DCIS. Discrimination and calibration were assessed, and bootstrapping was applied for internal validation. RESULTS: Extensive DCIS occurred in 48 (14.7%) of 326 tumors. Incomplete resection occurred in 56.3% of these E-DCIS-positive versus 9.0% of E-DCIS-negative tumors (P < 0.001). Five components with eigenvalue exceeding 1 were identified; 2 were significantly associated with E-DCIS. The first, positively associated, component expressed early and overall enhancement in the 10-mm tissue margin surrounding the MRI-visible tumor. The second, positively associated, component expressed human epidermal growth factor receptor 2 and amount of FGT around the MRI-visible tumor. The area under the curve value was 0.79 (0.76 after bootstrapping). CONCLUSIONS: Human epidermal growth factor receptor 2 status, early and overall enhancement in the 10-mm margin around the MRI-visible tumor, and amount of FGT in the 10 mm around the MRI-visible tumor were associated with E-DCIS

Prediction Model For Extensive Ductal Carcinoma In Situ Around Early-Stage Invasive Breast Cancer

OBJECTIVES: Ductal carcinoma in situ (DCIS) is a risk factor for incomplete resection of breast cancer. Especially, extensive DCIS (E-DCIS) or extensive intraductal component often results in positive resection margins. Detecting DCIS around breast cancer before treatment may therefore alter surgery. The purpose of this study was to develop a prediction model for E-DCIS around early-stage invasive breast cancer, using clinicohistopathological and dynamic contrast-enhanced magnetic resonance imaging (MRI) features. MATERIALS AND METHODS: Dynamic contrast-enhanced MRI and local excision were performed in 322 patients with 326 ductal carcinomas. Tumors were segmented from dynamic contrast-enhanced MRI, followed by 3-dimensional extension of the margins with 10 mm. Amount of fibroglandular tissue (FGT) and enhancement features in these extended margins were automatically extracted from the MRI scans. Clinicohistopathological features were also obtained. Principal component analysis and multivariable logistic regression were used to develop a prediction model for E-DCIS. Discrimination and calibration were assessed, and bootstrapping was applied for internal validation. RESULTS: Extensive DCIS occurred in 48 (14.7%) of 326 tumors. Incomplete resection occurred in 56.3% of these E-DCIS-positive versus 9.0% of E-DCIS-negative tumors (P < 0.001). Five components with eigenvalue exceeding 1 were identified; 2 were significantly associated with E-DCIS. The first, positively associated, component expressed early and overall enhancement in the 10-mm tissue margin surrounding the MRI-visible tumor. The second, positively associated, component expressed human epidermal growth factor receptor 2 and amount of FGT around the MRI-visible tumor. The area under the curve value was 0.79 (0.76 after bootstrapping). CONCLUSIONS: Human epidermal growth factor receptor 2 status, early and overall enhancement in the 10-mm margin around the MRI-visible tumor, and amount of FGT in the 10 mm around the MRI-visible tumor were associated with E-DCIS

Patient Preferences for Minimally Invasive and Open Locoregional Treatment for Early-Stage Breast Cancer

Background Noninvasive or minimally invasive treatments are being developed as alternatives to surgery for patients with early-stage breast cancer. Patients’ preferences with regard to these new treatments have not been investigated. Objectives To assess preferences of patients with breast cancer and of healthy women regarding these new techniques, compared with conventional surgical treatments. Methods Six hypothetical breast cancer treatment-outcome scenarios were developed: three standard surgical scenarios (mastectomy, mastectomy with immediate implant-based reconstruction, and breast-conserving therapy [BCT]) and three minimally invasive or noninvasive scenarios (radiofrequency ablation, magnetic resonance-guided high-intensity focused ultrasound ablation, and single-dose ablative radiotherapy). Participants rated treatment-outcome scenarios by visual analogue scale (VAS) and time trade-off (TTO). The Friedman and post hoc Wilcoxon signed-rank tests were used to test whether scores were significantly different from BCT. Results Seventy-one patients with breast cancer and 50 healthy volunteers participated. Overall, BCT was rated the highest in terms of VAS (0.80) and TTO (0.90) scores. After stratification, BCT ranked the highest in most subgroups, with the exception of healthy individuals, who had given the highest score to ablative boost (VAS, 0.80; TTO, 0.88). Mastectomy with immediate reconstruction was the least preferred in most subgroups. Conclusions This study showed no significant preference for minimally invasive treatment for breast cancer. Using hypothetical scenarios, breast cancer survivors attributed the highest scores to BCT, whereas healthy volunteers showed a slight preference for minimally invasive treatments

Early health technology assessment of magnetic resonance-guided high intensity focused ultrasound ablation for the treatment of early-stage breast cancer

BACKGROUND: Magnetic resonance-guided high intensity focused ultrasound (MR-HIFU) ablation is in development for minimally invasive treatment of breast cancer. Cost-effectiveness has not been assessed yet. An early health technology assessment was performed to estimate costs of MR-HIFU ablation, compared to breast conserving treatment (BCT). METHODS: An MR-HIFU treatment model using the dedicated MR-HIFU breast system (Sonalleve, Philips Healthcare) was developed. Input parameters (treatment steps and duration) were based on the analysis of questionnaire data from an expert panel. MR-HIFU experts assessed face validity of the model. Data collected by questionnaires were compared to published data of an MR-HIFU breast feasibility study. Treatment costs for tumours of 1 to 3 cm were calculated. RESULTS: The model structure was considered of acceptable face validity by consulted experts, and questionnaire data and published data were comparable. Costs of MR-HIFU ablation were higher than BCT costs. MR-HIFU best-case scenario costs exceeded BCT costs with approximately €1000. Cooling times and breathing correction contributed most to treatment costs. CONCLUSIONS: MR-HIFU ablation is currently not a cost-effective alternative for BCT. MR-HIFU experience is limited, increasing uncertainty of estimations. The potential for cost-effectiveness increases if future research reduces treatment durations and might substantiate equal or improved results