Christoffel Ladina, Römer Thomas, Schiermeier Sven
Spital Oberengadin, Samedan, Switzerland.
Evangelisches Klinikum Köln-Weyertal, Köln, Germany.
Med Devices (Auckl). 2021 Mar 3;14:77-84. doi: 10.2147/MDER.S301166. eCollection 2021.
Transcervical fibroid ablation (TFA) is a minimally invasive, effective treatment of symptomatic uterine fibroids that utilizes intrauterine ultrasound for imaging and radiofrequency energy for ablation. Outcomes reported with TFA have been positive, with significant reductions in fibroid volume, improvements in symptom severity and health-related quality of life, and low complication and surgical reintervention rates. The SAGE registry characterizes the long-term (5-year) outcomes of TFA when used to treat symptomatic uterine fibroids in real-world usage.
METHODS/DESIGN: SAGE is an ongoing postmarket global registry involving up to 50 sites and up to 500 women who select TFA with the Sonata system for treatment of symptomatic uterine fibroids. Patients are followed for 5 years. Main outcomes include symptom severity score and health-related quality of life subscales of the UFS-QoL, general health status on the EQ-5D, perceived treatment benefit, treatment satisfaction, work and activity patterns, overall patient treatment outcome, adverse events, pregnancy incidence and outcomes, and surgical reinterventions for heavy menstrual bleeding.
The SAGE registry represents the largest known study of TFA for uterine fibroids and will generate up to 2500 patient-years of outcome data. Preliminary results from the first 160 treated women suggest broad applicability of TFA to a wide range of fibroid types and sizes and an excellent safety profile, with a device-related adverse event rate of 0.6% and a serious procedure-related adverse event rate of 0.6%. Of the 241 fibroids treated, 10% were submucous, 52% transmural, 28% intramural, and 10% subserous. Ablated fibroid diameters ranged from <1 cm to >10 cm, with 27% of fibroids having maximum diameters >5 cm. The real-world experience from SAGE will strengthen the existing evidence on the durability of TFA in providing meaningful relief from uterine fibroid symptoms and will have important clinical and economic implications for patients, physicians, and healthcare payers.
https://clinicaltrials.gov, NCT03118037. Registered on 18 April 2017.
经宫颈肌瘤消融术（TFA）是一种治疗有症状子宫肌瘤的微创有效方法，它利用宫内超声进行成像，并用射频能量进行消融。TFA报告的结果是积极的，肌瘤体积显著减小，症状严重程度和健康相关生活质量得到改善，并发症和手术再次干预率较低。SAGE注册研究描述了TFA在实际应用中治疗有症状子宫肌瘤的长期（5年）结果。
方法/设计：SAGE是一项正在进行的上市后全球注册研究，涉及多达50个地点和多达500名选择使用索纳塔系统进行TFA治疗有症状子宫肌瘤的女性。对患者进行5年随访。主要结局包括UFS-QoL的症状严重程度评分和健康相关生活质量子量表、EQ-5D上的总体健康状况、感知治疗益处、治疗满意度、工作和活动模式、患者总体治疗结局、不良事件、妊娠发生率和结局，以及因月经过多进行的手术再次干预。
SAGE注册研究是已知最大规模的关于TFA治疗子宫肌瘤的研究，将产生多达2500患者年的结局数据。前160例接受治疗女性的初步结果表明，TFA对广泛的肌瘤类型和大小具有广泛适用性，且安全性良好，器械相关不良事件发生率为0.6%，严重手术相关不良事件发生率为0.6%。在治疗的241个肌瘤中，10%为黏膜下肌瘤，52%为壁间肌瘤，28%为肌壁间肌瘤，10%为浆膜下肌瘤。消融肌瘤直径范围从<1厘米到>10厘米，27%的肌瘤最大直径>5厘米。SAGE的实际经验将加强现有关于TFA在有效缓解子宫肌瘤症状方面的持久性的证据，并将对患者、医生和医疗保健支付方产生重要的临床和经济影响。
