Eisenstein David, Shukr Ghadear H, Carlow John J, Kemp Laura, Yu Steve
Department of Urology, Trinity/IHA Medical Group, Detroit, MI, USA.
Department of Obstetrics and Gynecology, University of South Florida Morsani College of Medicine, Tampa Bay, FL, USA.
Clinicoecon Outcomes Res. 2024 Jul 29;16:523-536. doi: 10.2147/CEOR.S437353. eCollection 2024.
To describe two-year post-operative outcomes, and healthcare utilization of three uterus-sparing interventions used to treat women with intramural and/or subserosal uterine fibroids.
This was a post-market, randomized, prospective, multi-center, longitudinal, interventional, and comparative clinical study to evaluate the costs and health outcomes of LAP-RFA vs the standard uterine conserving technologies (myomectomy and UAE) for the treatment of symptomatic uterine fibroids in women who desire uterine conservation. For this RCT study, 54 subjects were randomized on a 1:1 ratio across the three procedures and followed out to two years. Their results were compared to retrospective US insurance claims from the IBM MarketScan Commercial Database from 2017-2020 for 96,854 women who underwent a uterus-sparing procedure for fibroids.
Mean ambulatory surgical center costs and the mean out-patient hospital costs were lowest for LAP-RFA ($13,134 and $14,428) and highest for UAE ($28,214 and $19,131). The total two-year re-intervention rate of any subsequent procedure (AM, LM, LAP-RFA, or UAE) was lowest in AM group (0%) followed by LM (4.2%), LAP-RFA (11%), and UAE (33%). Mean peri-operative reintervention costs and the mean reintervention total costs were $2429 and $5939 for LAP-RFA, $2122 and $8368 for LM, $4410 and $11,942 for AM, and $8113 and $46,692 for UAE subjects. In the RCT study, the average length of hospital stay was significantly less for the LAP-RFA group subjects (8.2 hours) in contrast to both the laparoscopic myomectomy group subjects (16.0 hours) and the abdominal myomectomy group subjects (33.6 hours). Despite the small numbers, two-year reintervention rates followed a similar pattern as the IBM MarketScan data.
In comparing these three non-invasive approaches, LAP-RFA was associated with the lowest peri-operative cost, and UAE was associated with the highest peri-operative cost. Further studies are needed to assess the cost, effectiveness, and subject satisfaction with each procedure.
描述用于治疗肌壁间和/或浆膜下子宫肌瘤女性的三种保留子宫干预措施的术后两年结果及医疗资源利用情况。
这是一项上市后、随机、前瞻性、多中心、纵向、干预性和对比性临床研究，旨在评估腹腔镜射频消融术（LAP-RFA）与标准子宫保留技术（肌瘤切除术和子宫动脉栓塞术（UAE））治疗希望保留子宫的有症状子宫肌瘤女性的成本和健康结果。在这项随机对照试验（RCT）研究中，54名受试者按1:1比例随机分配至三种手术中，并随访两年。将他们的结果与2017年至2020年来自IBM MarketScan商业数据库的96,854名接受保留子宫肌瘤手术女性的回顾性美国保险理赔数据进行比较。
LAP-RFA的平均门诊手术中心成本（13,134美元）和平均门诊医院成本（14,428美元）最低，UAE最高（28,214美元和19,131美元）。任何后续手术（消融术（AM）、肌瘤切除术（LM）、LAP-RFA或UAE）的两年再次干预率在AM组最低（0%），其次是LM组（4.2%） 、LAP-RFA组（11%）和UAE组（33%）。LAP-RFA的平均围手术期再次干预成本和平均再次干预总成本分别为2429美元和5939美元，LM组为2122美元和8368美元，AM组为4410美元和11,942美元，UAE组受试者为8113美元和46,692美元。在RCT研究中，LAP-RFA组受试者的平均住院时间显著短于腹腔镜肌瘤切除术组受试者（16.0小时）和开腹肌瘤切除术组受试者（33.6小时）。尽管样本量较小，但两年再次干预率与IBM MarketScan数据呈现相似模式。
在比较这三种非侵入性方法时，LAP-RFA的围手术期成本最低，UAE的围手术期成本最高。需要进一步研究来评估每种手术的成本、有效性和受试者满意度。
