Randomised Clinical Trial of Prostatic Artery Embolisation Versus a Sham Procedure for Benign Prostatic Hyperplasia.

BACKGROUND: Prostatic artery embolisation (PAE) has been associated with an improvement of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH), but conclusive evidence of efficacy from randomised controlled clinical trials has been lacking. OBJECTIVE: To assess the safety and efficacy of PAE compared with a sham procedure in the treatment of LUTS/BPH. DESIGN, SETTING, AND PARTICIPANTS: A randomised, single-blind, sham-controlled superiority clinical trial was conducted in 80 males ≥45yr with severe LUTS/BPH refractory to medical treatment from 2014 to 2019 in a private clinic, with efficacy assessments at 6 and 12 mo after randomisation. One patient in the PAE group and three in the sham group did not complete the study. INTERVENTION: Patients were randomised 1:1 upon successful catheterisation of a prostatic artery to either PAE or a sham PAE procedure without embolisation. After 6 mo, all 38 patients randomised to the sham group who completed the single-blind period underwent PAE, and both groups completed a 6-mo open period. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: An intention-to-treat analysis of all randomised patients was performed. The coprimary outcomes were the change from baseline to 6 mo in the International Prostate Symptom Score (IPSS) and the quality of life (QoL) score at 6 mo, analysed with analysis of covariance and t test, respectively. RESULTS AND LIMITATIONS: Mean age was 63.8±6.0yr, baseline IPSS 26.4±3.87, and QoL score 4.43±0.52. At 6 mo, patients in the PAE arm had a greater improvement in IPSS, with a difference in the change from baseline of 13.2 (95% confidence interval [CI] 10.2-16.2, p<0.0001), and a better QoL score at 6 mo (difference: 2.13; 95% CI 1.57-2.68, p<0.0001) than the patients in the sham arm. The improvements in IPSS and QoL in the sham group 6 mo after they performed PAE were, respectively, 13.6±9.19 (p<0.0001) and 2.05 ± 1.71 (p<0.0001). Adverse events occurred in 14 (35.0%) patients after PAE and in 13 (32.5%) after sham, with one serious adverse event in the sham group during the open period. No treatment failures occurred. Limitations include a single-centre trial, only severe LUTS/BPH, and follow-up limited to 12 mo. CONCLUSIONS: The improvements in subjective and objective variables after PAE are far superior from those due to the placebo effect. PATIENT SUMMARY: Clearly superior efficacy of prostatic artery embolisation (PAE) compared with a sham procedure was found in this study, which supports the use of PAE in patients with typical symptoms associated with benign prostatic hyperplasia.

Correlation between apparent diffusion coefficient values in breast magnetic resonance imaging and prognostic factors of breast invasive ductal carcinoma.

BACKGROUND: We wanted to examine whether the apparent diffusion coefficient values obtained by diffusion-weighted imaging techniques could indicate an early prognostic assessment for patients with Invasive Ductal Carcinoma and, therefore, influence the treatment decision making. OBJECTIVE: The main objective was to evaluate the correlation between the apparent diffusion coefficient values obtained by diffusion-weighted imaging and the key prognostic factors in breast invasive ductal carcinoma. Secondary objectives were to analyze the eventual correlations between magnetic resonance imaging findings and prognostic factors in breast cancer; and to perform a comparison between results in 1.5 and 3.0 T scanners. METHODS: Breast magnetic resonance imaging with diffusion-weighted imaging sequence was performed on 100 patients, who were proven histopathologically to have breast invasive ductal carcinoma. We compared the apparent diffusion coefficient values, obtained previous to biopsy, with the main prognostic factors in breast cancer: tumor size, histologic grade, hormonal receptors, Ki67 index, human epidermal growth factor receptor type 2, and axillary lymph node status. The Mann-Whitney U test and the Kruskal-Wallis analysis were used to establish these correlations. RESULTS: The mean apparent diffusion coefficient value was inferior in the estrogen receptor-positive group than in the estrogen receptor-negative group (1.04 vs 1.17 × 10-3 mm2/s, P = .004). Higher histologic grade related to larger tumor size (P = .002). We found association between spiculated margins and positive axillary lymph node status [odds ratio = 4.35 (1.49-12.71)]. There were no differences in apparent diffusion coefficient measurements between 1.5 and 3.0 T magnetic resonance imaging scanners (P = .513). CONCLUSIONS: Low apparent diffusion coefficient values are related with positive expression of estrogen receptor. Larger tumors and spiculated margins are associated to worse prognosis. Rim enhancement is more frequently observed in estrogen receptor-negative tumors. There are no differences in apparent diffusion coefficient measurements between different magnetic resonance imaging scanners.

Spontaneous Pregnancy with a Live Birth after Conventional and Partial Uterine Fibroid Embolization.

Purpose To determine pregnancy rates after conventional and partial uterine fibroid embolization (UFE). Materials and Methods The study received institutional review board approval and all patients gave written informed consent. A retrospective analysis of data collected prospectively was performed between June 2004 and June 2014 in a cohort of 359 women (mean age, 35.9 years ± 4.8) with uterine fibroids and/or adenomyosis who were unable to conceive. The median follow-up period was 69 months (range, 6-126 months). Under local anesthesia, both uterine arteries were embolized. In 160 patients, partial embolization was intentionally performed to preserve fertility, which may be decreased after conventional UFE. In partial UFE, only the small arterial vessels to the fibroids were embolized, leaving the large vessels of the fibroids patent. The Kaplan-Meier method and Cox regression were used for the statistical analysis. Results During follow-up, 149 women became pregnant, 131 women had live births, and 16 women had several pregnancies, resulting in a total of 150 live newborns. It was the first pregnancy for 85.5% (112 of 131) of women. Spontaneous pregnancy rates at 1 year and 2 years after UFE were 29.5% and 40.1%, respectively. The probability of successful pregnancy with live birth at 1 year and 2 years was 24.4% and 36.7%, respectively. Clinical success for fibroid-related symptoms was 78.6% (282 of 359). A dominant submucosal fibroid and ischemia greater than or equal to 90% had greater likelihood of spontaneous pregnancy. Complication rates in patients treated with partial UFE (14.6%) were not greater than rates in patients treated with conventional UFE (23.1%, P = .04). Conclusion Conventional and partial UFE may be safe and effective outpatient procedures for women with uterine fibroids who want to conceive. © RSNA, 2017.