Uterine Fibroid Embolization (UFE) with Optisphere: A Prospective Study of a New, Spherical, Resorbable Embolic Agent.
用 Optisphere 栓塞子宫肌瘤 (UFE): 一项新的、球形的、可吸收的栓塞剂的前瞻性研究。
- 作者列表："Hacking N","Maclean D","Vigneswaran G","Bryant T","Modi S
INTRODUCTION:Optisphere (Teleflex, Wayne, PA, USA, currently distributed by Medtronic, Minneapolis, MN, USA) is a new, resorbable, calibrated spherical embolic agent. We aimed to evaluate its clinical safety and effectiveness for fibroid embolization through a prospective case series. METHOD:This prospective case series studied patients treated with fibroid embolization using Optisphere between July 2017 and June 2018. The primary outcomes were device-related adverse event assessments and MRI-determined percentage infarct of the dominant fibroid (DF %) and infarct of all fibroids (AF %) at 3 months post-embolization. Secondary outcomes included symptom improvement with the validated Uterine Fibroid Symptom Score and Quality of Life questionnaire (UFS-SS and UFS-QOL) at 3 months and 12 months post-embolization. Statistical analysis was through the Wilcoxon signed-rank test for nonparametric paired data. RESULTS:Twenty-three consecutive patients were treated with Optisphere (median age 44.0, uterine volume 484.0 ml, dominant fibroid volume 167.0 ml). The complete dominant fibroid infarction (DF %) rate was 91.3% (21/23 patients), and the complete all fibroid infarction rate (AF %) was 82.6% (19/23). No adverse device-related safety events were encountered. Significant improvement was demonstrated in 3-month UFS-SS (56 vs 19, p < 0.0001), UFS-QOL (40 vs 88, p = 0.0008), uterine volume (484 ml vs 246 ml, p < 0.0001) and dominant fibroid volume (167 vs 64 ml, p < 0.0001). Symptomatic improvement continued to 12 months (UFS-SS 56 vs 11, p = 0.0008, UFS-QOL 40 vs 98.7, p = 0.0008). CONCLUSION:Optisphere is an effective embolic agent for fibroid embolization with good symptomatic response and percentage fibroid infarct.
简介: Optisphere (Teleflex，Wayne，PA，USA，目前由美敦力公司 (Medtronic，Minneapolis，MN，USA) 分销) 是一种新型的、可吸收的、经过校准的球形栓塞剂。我们旨在通过前瞻性病例系列评价其用于肌瘤栓塞的临床安全性和有效性。 方法: 本前瞻性病例系列研究了 2017年7月至 2018年6月期间使用 Optisphere 进行肌瘤栓塞治疗的患者。主要结局为栓塞后 3 个月器械相关不良事件评估和 MRI 确定的优势肌瘤梗死百分比 (DF %) 和所有肌瘤梗死百分比 (AF %)。次要结局包括栓塞后 3 个月和 12 个月经验证的子宫肌瘤症状评分和生活质量问卷 (UFS-SS 和 UFS-QOL) 的症状改善。统计分析通过非参数配对数据的 Wilcoxon 符号秩检验。 结果: 连续 23 例患者接受 Optisphere 治疗 (中位年龄 44.0，子宫体积 484.0毫升，优势肌瘤体积 167.0毫升)。完全显性肌瘤梗死 (DF %) 率为 91.3% (21/23 例患者)，完全全部肌瘤梗死率 (AF %) 为 82.6% (19/23)。未遇到与器械相关的不良安全事件。3 个月 UFS-SS (56 vs 19，p <0.0001) 、 UFS-QOL (40 vs 88，p = 0.0008) 显著改善,子宫体积 (484毫升 vs 246毫升，p <0.0001) 和优势肌瘤体积 (167 vs 64毫升，p <0.0001)。症状改善持续至 12 个月 (UFS-SS 56 vs 11，p = 0.0008，UFS-QOL 40 vs 98.7，p = 0.0008)。 结论: Optisphere 是一种有效的栓塞剂，具有良好的症状缓解和肌瘤梗死百分比。
METHODS:STUDY OBJECTIVE:To evaluate the differences in perioperative outcomes and immediate complication rates between laparoscopic myomectomy for submucous myomas and laparoscopic myomectomy for myomas in other locations. DESIGN:Retrospective cohort study. SETTING:University-affiliated hospital in London. PATIENTS:A total of 350 patients with symptomatic uterine myomas underwent laparoscopic myomectomy. Thirty-three of these were performed for submucous myomas (group 1), and 317 were for myomas in other uterine locations (group 2). INTERVENTIONS:Analysis of prospectively collected data on patient demographics, myoma characteristics, perioperative outcomes, and immediate complications. MEASUREMENTS AND MAIN RESULTS:Patient demographics, including age, body mass index, and parity, were similar in the 2 groups. No significant differences in myoma characteristics were seen between groups 1 and 2, including the mean dimension of largest myoma (7.1 vs 7.8 cm, respectively; p = .35), mean number of myomas removed (3.8 vs 4.1; p = .665), and mean mass of myomas removed (142.0 g vs 227.3 g; p = .186). There were also no significant between-group differences in any perioperative outcomes, including mean blood loss (226.8 mL vs 266.4 mL; p = .373), duration of surgery (103 minutes vs 113 minutes; p = .264), and duration of hospital stay (1.4 days vs 1.7 days; p = .057). No complications arose from laparoscopic resection of submucous myomas. CONCLUSION:Laparoscopic myomectomy for submucous myomas has similar perioperative outcomes and immediate complications as laparoscopic myomectomy for other myomas and can be considered for large or type 2 submucous myomas.
METHODS:INTRODUCTION:Laparoscopic myomectomy can be difficult when fibroids are large and numerous. This may result in extensive intraoperative bleeding and the need for a conversion to a laparotomy. Medical pretreatment prior to surgery might reduce these risks by decreasing fibroid size and vascularization of the fibroid. We compared pretreatment with ulipristal acetate (UPA) vs gonadotropin-releasing hormone agonists (GnRHa) prior to laparoscopic myomectomy on several intra- and postoperative outcomes. MATERIAL AND METHODS:We performed a non-inferiority double-blind randomized controlled trial in nine hospitals in the Netherlands. Women were randomized between daily oral UPA for 12 weeks and single placebo injection or single intramuscular injection with leuprolide acetate and daily placebo tablets for 12 weeks. The primary outcome was intraoperative blood loss. Secondary outcomes were reduction of fibroid volume, suturing time, total surgery time and surgical ease. RESULTS:Thirty women received UPA and 25 women leuprolide acetate. Non-inferiority of UPA regarding intraoperative blood loss was not demonstrated. When pretreated with UPA, median intraoperative blood loss was statistically significantly higher (525 mL [348-1025] vs 280 mL[100-500]; P = 0.011) and suturing time of the first fibroid was statistically significantly longer (40 minutes [28-48] vs 22 minutes [14-33]; P = 0.003) compared with GnRHa. Pretreatment with UPA showed smaller reduction in fibroid volume preoperatively compared with GnRHa (-7.2% [-35.5 to 54.1] vs -38.4% [-71.5 to -19.3]; P = 0.001). Laparoscopic myomectomies in women pretreated with UPA were subjectively judged more difficult than in women pretreated with GnRHa. CONCLUSIONS:Non-inferiority of UPA in terms of intraoperative blood loss could not be established, possibly due to the preliminary termination of the study. Pretreatment with GnRHa was more favorable than UPA in terms of fibroid volume reduction, intraoperative blood loss, hemoglobin drop directly postoperatively, suturing time of the first fibroid and several subjective surgical ease parameters.
METHODS:AIMS:Hereditary leiomyomatosis and renal cell cancer (HLRCC) syndrome is caused by germline mutations in the Fumarate hydratase (FH) gene. In young women, the syndrome often presents with symptomatic uterine leiomyomas, leading to myomectomy or hysterectomy. In this study, we aimed to investigate the incidence and mutational profiles of FH-negative leiomyomas from young patients, thus allowing for early identification and triage of syndromic patients for surveillance. METHODS AND RESULTS:We evaluated 153 cases of uterine leiomyomas from women aged up to 30 years for loss of FH expression by tissue microarray (TMA)-based immunohistochemical staining. Mutational analysis of tumours with loss of FH was carried out by polymerase chain reaction (PCR) amplification of 10 exons within the FH gene and subsequent Sanger sequencing. The status of promoter methylation was assessed by bisulphite sequencing. Loss of FH protein expression was detected in seven (4.6%) of 153 tested uterine leiomyomas from young patients. All FH-negative leiomyomas displayed staghorn vasculature and fibrillary/neurophil-like cytoplasm. We found that six (86%) of seven FH-negative tumours detected by immunohistochemistry harboured FH mutations, 50% of which contained germline mutations. In particular, the germline mutational rate in FH gene was 2.0% (three of 153 cases). Bisulphite sequencing analysis failed to detect promoter methylation in any of the seven tumours. CONCLUSION:Our study showed a relatively high rate of FH germline mutation in FH-negative uterine leiomyomas from patients aged up to 30 years. While genetic mutations confer protein expression loss, epigenetic regulation of the FH gene appears to be unrelated to this phenotype.