Determination of Whole Blood Loss From Minimally Invasive Myomectomy Using a Standardized Formula: A Pilot Study.

STUDY OBJECTIVE: To determine the median perioperative blood loss (PBL) during minimally invasive surgical (MIS) myomectomy. DESIGN: Prospective pilot study. SETTING: Large academic teaching hospital. PATIENTS: Thirty-one patients underwent laparoscopic or robotic myomectomy and completed a postoperative complete blood count (CBC) from November 2020 to August 2022. Patients had to have at least one fibroid greater than or equal to 3 cm on preoperative imaging. INTERVENTIONS: A CBC was collected preoperatively within 7 days of surgery. Estimated blood loss (EBL) was determined by the surgeon intraoperatively. A repeat CBC was drawn between postoperative days 2 through 4. PBL was calculated using the equation PBL = (patient weight in kg × 65 cc/kg) × (preoperative hematocrit - postoperative hematocrit)/preoperative hematocrit. MEASUREMENTS AND MAIN RESULTS: Median PBL (536.3 cc [270.0, 909.3]) was greater than median EBL (200.0 cc [75.0, 500.0]). PBL ranged from a net gain of 191.5 cc to net loss of 2362.5 cc. Median size of the largest fibroid on preoperative imaging was 8.8 cm (6.6, 11.5), and median weight of fibroids removed was 321 g (115, 519). About half of patients (51.6%) had one fibroid removed, and 48.4% had 2 or more fibroids removed. Five patients were converted to laparotomy, 4 from robotic approaches. Two patients required a blood transfusion. CONCLUSION: Calculated PBL was greater than intraoperative EBL. This suggests there is continued blood loss post myometrial bed closure. Blood loss should be evaluated both during and after myomectomy, as intraoperative EBL underestimates total PBL.

Pregnancy Outcomes After Laparoscopic Radiofrequency Ablation of Uterine Leiomyomas Compared With Myomectomy.

OBJECTIVE: To compare pregnancy outcomes after laparoscopic radiofrequency ablation and myomectomy. METHODS: The ULTRA (Uterine Leiomyoma Treatment With Radiofrequency Ablation) study is an ongoing multicenter prospective cohort study with longitudinal follow-up up to 5 years comparing outcomes of radiofrequency ablation with myomectomy in premenopausal women older than age 21 years with symptomatic uterine leiomyomas. Participants were queried every 6 months after surgery to assess the incidence of pregnancy and pregnancy outcomes. RESULTS: Among 539 women enrolled in ULTRA, a total of 37 participants (mean age at first pregnancy 35.0±4.7 years) conceived 43 times as of March 2023 (22 radiofrequency ablation, 21 myomectomy). The average length of follow-up time after all procedures was 2.5±1.0 years. The baseline miscarriage rate in the study population was 33.3%. In participants who underwent radiofrequency ablation, 9 of 22 pregnancies (40.9%, 95% CI, 20.3-61.5%) ended in first-trimester miscarriage, 11 resulted in live births (50.0%, 95% CI, 29.1-70.9%), one resulted fetal death at 30 weeks of gestation, and one resulted in uterine rupture during miscarriage treatment with misoprostol 10 weeks after radiofrequency ablation. Among the live births in the radiofrequency ablation group, 45.5% were by vaginal delivery. In the myomectomy group, 9 of 21 pregnancies (42.9%, 95% CI, 21.7-64.0%) ended in first-trimester miscarriage and 12 resulted in live births (57.1%, 95% CI, 36.0-78.3%). There were no significant differences in the likelihood of live birth or miscarriage between the study groups. CONCLUSION: Full-term pregnancy and vaginal delivery are achievable after radiofrequency ablation of leiomyomas. However, in this interim analysis, the miscarriage rate in both radiofrequency ablation and myomectomy groups was higher than expected for women in this age group. Long-term data collection in the ongoing ULTRA study aims to further understand pregnancy outcomes after radiofrequency ablation compared with myomectomy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT0210094.

The Role of Preprocedure Genetic Counseling in Pregnancies Interrupted for Fetal Abnormalities.

OBJECTIVE: Congenital birth defects affect 3 to 5% of pregnancies. Genetic counseling can help patients navigate the testing process and understand results. The study objective was to identify predictors and utility of genetic counseling at the time of pregnancy termination. Additionally, we aimed to see what proportion of patients would benefit from additional testing based on the results of the genetic testing. STUDY DESIGN: This was a retrospective cohort review of all terminations performed for fetal anomalies by an academic center from July 2016 to May 2020. Indications were stratified by abnormal serum screening or types of abnormal ultrasound findings. Data were abstracted regarding uptake of genetic counseling and testing results. Abnormal results that warranted additional testing regarding recurrence risks were noted. Multivariable logistic regression was performed to identify predictors of receipt of genetic counseling and testing. RESULTS: Of 387 patients, 57% (n = 220) received preprocedure genetic counseling and 43% (n = 167) did not. Among patients who received diagnostic testing, 62% (n = 194) had genetic counseling compared with 38% (n = 121) without counseling (adjusted odds ratio 2.46, 95% confidence interval [1.41-4.29], p < 0.001). Among the entire cohort, 38% (n = 148) had suspected aneuploidy based on serum screening. Of these, 89% (n = 132/148) had definitive testing, 92% (n = 122/132) confirming the aneuploidy. Among the other 68% (n = 239) with structural anomalies, 76% (n = 183) had diagnostic testing with 29% (n = 53) yielding an abnormal result. Among those fetuses with structural anomalies, 36% (n = 19/53) of genetic diagnoses warranted additional parental testing because of risk of recurrence compared with only 2% (n = 2/122) of patients with abnormal serum screening results alone. CONCLUSION: Genetic counseling was associated with increased uptake of diagnostic testing, which yielded useful information and prompted additional testing. This is important for determining etiology and recurrence risk and should be offered to patients presenting for termination for fetal indications, as well as providing diagnostic closure for patients. KEY POINTS: · Genetic counseling increases the uptake of diagnostic testing in patients with fetal anomalies.. · Patients with ultrasound anomalies received less diagnostic testing despite actionable results 36% of the time.. · Genetic testing is invaluable for recurrence risk counseling even if patients chose to terminate..

Complementary and Alternative Medicine Use Among Women with Symptomatic Uterine Fibroids.

Objective: The aim of this study is to examine complementary and alternative medicine (CAM) use among women with symptomatic uterine fibroids in the United States. Materials and Methods: In this cross-sectional analysis of baseline data from a multicenter, prospective cohort study of premenopausal women undergoing surgery for symptomatic fibroids and who enrolled in the Uterine Leiomyoma Treatment with Radiofrequency Ablation study from 2017 to 2019, we contrast women indicating use of at least one CAM modality specifically for fibroid symptoms against women using CAM for other reasons and CAM nonusers. Multivariable logistic regression models were performed to identify participant characteristics independently associated with CAM use for fibroids. Results: Among 204 women, 55% were Black/African American and the mean age was 42 (standard deviation 6.6) years. CAM use was common (67%), with 42% (95% confidence interval [CI]: 35%-49%) reporting use of CAM specifically to treat fibroid symptoms. Most commonly, CAM treatments used for fibroids were diet (62%) and herbs (52%), while CAM treatments for other reasons were exercise (80%) and massage (43%). On average, each participant who reported CAM use utilized three different types of CAM modalities. In a multivariable model, participants were more likely to use CAM for fibroids if they had pelvic pressure (odds ratio [OR] 2.50, 95% CI: 1.07-5.87, p = 0.04), a body-mass index lower than average (OR 0.76, 95% CI: 0.60-0.97, p = 0.03), and a lower health-related quality of life score (OR 0.61, 95% CI: 0.46-0.81, p = 0.001). Conclusions: In this diverse sample of women with symptomatic fibroids, CAM use was highly prevalent. Our findings highlight the need for providers to query patients about CAM use and understand the role of CAM in fibroid management. ClinicalTrials.gov Identifier: NCT02100904.

Transcervical Ultrasound-guided Radiofrequency Ablation of Adenomyosis: A Case Report.

Transcervical, ultrasound-guided radiofrequency ablation with the Sonata System was performed on a patient with symptomatic localized adenomyosis. Six-month postoperative follow-up demonstrated subjective improvement of heavy and painful menstrual bleeding and objective decreases in the volume of the adenomyosis lesion (66.3%) and the uterine corpus (40.8%) as determined by magnetic resonance imaging. This is the first known case of successful use of the Sonata System for treating adenomyosis.

Impact of Pregnancy on Hidradenitis Suppurativa Disease Course: A Systematic Review and Meta-Analysis.

BACKGROUND: Hormones are thought to play a role in hidradenitis suppurativa (HS). However, data on the HS disease course during pregnancy and the postpartum period has not been well established. The objective of this study is to analyze the available literature to determine HS disease activity during pregnancy and the postpartum period. METHODS: The PubMed and Embase databases were systematically searched for relevant articles from database inception until November 22, 2020. The inclusion criteria were a study population with the diagnosis of HS and discussion of pregnancy impact on the HS disease course or postpartum flare. Study characteristics, patient demographics, HS severity, and HS disease course during pregnancy and the postpartum period were extracted by 2 independent reviewers. The quality of included studies was assessed using the Newcastle-Ottawa Scale for observational studies. Heterogeneity was assessed using Cochran's Q statistic and I2 index. The random-effects meta-analytical model was used. The primary study outcome was the pooled odds ratio of improvement or of worsening of HS disease activity during pregnancy. RESULTS: The systematic search identified 8 studies for analysis. There was a total of 672 cases for which data on the patient-reported HS disease course during pregnancy were available, and 164 cases for which data on patient-reported postpartum flare were available. In the meta-analyses, the rate of HS disease improvement was 24% (95% CI 0.13-0.40) and the rate of HS disease worsening was 20% (95% CI 0.11-0.34). Sixty percent (99/164) of patients experienced a postpartum flare. CONCLUSION: While about a quarter of women will experience an improvement in HS during pregnancy, the majority will have a stable or worsened disease course, and over half of patients will experience a postpartum flare. Close monitoring of HS patients is needed during pregnancy and postpartum periods, as patients may need continued, or even escalated, disease management.

Diagnosis and management of hidradenitis suppurativa in women.

Hidradenitis suppurativa is a chronic inflammatory disease that disproportionately affects women of childbearing age. Hidradenitis suppurativa is characterized by painful nodules, abscesses, draining dermal tunnels, and scarring with a predilection for intertriginous sites, such as the axilla, groin, and breast regions. Delay in diagnosis and treatment of hidradenitis suppurativa often results in long-term sequelae leading to significant morbidity, and rarely mortality, in these patients. This clinical opinion suggests that obstetrician-gynecologists are uniquely poised to recognize early signs of hidradenitis suppurativa during routine well-woman examinations and initiate treatment or referral to dermatology. Herein, we provide clinical pearls for obstetrician-gynecologists caring for female patients with hidradenitis suppurativa, including strategies for comprehensive management and recommendations to improve the comfort of patients with hidradenitis suppurativa during examinations.

Special considerations for women with hidradenitis suppurativa.

Hidradenitis suppurativa (HS) is a chronic, debilitating disease that manifests as painful nodules, abscesses, sinus tracts, and scars with a predilection for intertriginous sites. HS disproportionately affects women of childbearing age and often leads to impairments in patients' health-related quality of life. Women with HS face unique challenges related to menstruation, pregnancy, and lactation that require additional strategies for optimization of management. Practical interventions include lifestyle modifications, treatment of premenstrual HS flares, enhancing HS management during pregnancy, and creating optimal delivery plans in collaboration with obstetricians. This discussion is based on expert recommendations and aims to highlight the special challenges for women with HS, as well as provide a practical discourse on optimizing care of female patients with HS.

Laparoscopic Radiofrequency Ablation of Uterine Leiomyomas: Clinical Outcomes during Early Adoption into Surgical Practice.

STUDY OBJECTIVE: To assess surgical outcomes, clinical effectiveness, and gynecologist experience of introducing laparoscopic radiofrequency ablation (RFA) of leiomyomas into surgical practice. DESIGN: Uncontrolled clinical trial. SETTING: Five academic medical centers across California. PATIENTS: Premenopausal women with symptomatic uterine leiomyomas, uterus size ≤16 weeks size, and all leiomyomas ≤10 cm with no more than 6 total leiomyomas. INTERVENTIONS: Laparoscopic RFA of leiomyomas. MEASUREMENTS AND MAIN RESULTS: We assessed intraoperative complications, blood loss, operative time, and adverse events. Gynecologists reported the operative difficulty and need for further training after each case. Participants reported leiomyoma symptoms preoperatively and at 6 and 12 weeks after surgery. We analyzed all outcome data from the first case performed by gynecologists with no previous RFA experience. Patient demand for RFA was high, but poor insurance authorization prevented 74% of eligible women from trial participation; 26 women underwent surgery and were enrolled. The mean age of the participants was 41.5 ± 4.9 years. The mean operating time was 153 ± 51 minutes, and mean estimated blood loss was 24 ± 40 cc. There were no intraoperative complications and no major adverse events. Menstrual bleeding, sexual function, and quality of life symptoms improved significantly from baseline to 12 weeks, with a 25 ± 18-point, or 47%, decrease in the Leiomyoma Symptom Severity Score. After the first procedure, the mean difficulty score was 6 (95% confidence interval [CI], 4-7.5) on a 10-point scale, and 89% of surgeons felt "very or somewhat" confident in performing laparoscopic RFA. The difficulty score decreased to 4.25 (95% CI, 1.2-6) after the fourth procedure, with all gynecologists reporting surgical confidence. CONCLUSION: Laparoscopic RFA of leiomyomas can be introduced into surgical practice with good clinical outcomes for patients. Gynecologists with no previous experience are able to gain confidence and skill with the procedure in fewer than 5 cases.

Misdiagnosis of Leiomyosarcoma after Radiofrequency Ablation of Uterine Myomas.

Minimally invasive therapies to treat symptoms of uterine myomas can be effective alternatives to major surgery. Such modalities include pharmacologic agents, uterine artery embolization, magnetic resonance-guided focused ultrasound, and laparoscopic radiofrequency ablation, known as the Acessa procedure. Acessa is used to treat women with symptomatic myomas and was approved by the US Food and Drug Administration in 2012. This case describes a patient who underwent Acessa and subsequently required hysterectomy for refractory symptoms. Pathology of her tumor was initially classified as epithelioid leiomyosarcoma but on subsequent review was classified as benign. This report highlights the challenges of accurate histologic diagnosis in the setting of using new therapeutic modalities. Clinicians should report such interventions to pathologists at the time of surgery to allow for accurate diagnosis.

Myoma Imaging by Gynecologic Surgeons Training in Intraoperative Ultrasound Technique.

STUDY OBJECTIVE: To compare preoperative transvaginal ultrasound (TVUS) and magnetic resonance imaging (MRI) with intraoperative ultrasound (IOUS) in surgeons first learning to use this technique. DESIGN: A prospective study of IOUS accuracy for mapping the size and location of myomas compared with TVUS or MRI (Canadian Task Force classification II-2). SETTING: Five University of California academic centers (Davis, Irvine, Los Angeles, San Diego, and San Francisco). PATIENTS: Twenty-six premenopausal women seeking uterine-sparing surgical treatment of myomas. Eligible participants could have no more than 6 myomas ≥2 cm and <10 cm and a uterine size no larger than 16 weeks by pelvic examination. INTERVENTIONS: Measurement of myomas by IOUS followed by radiofrequency ablation (RFA) of fibroids. MEASUREMENTS AND MAIN RESULTS: Eligible participants had to have imaging with TVUS or MRI within the last year to assess myoma characteristics. During the RFA operation, surgeons who had undergone a 1-day training on RFA and IOUS measured all myomas visualized with IOUS. Surgeons measured more myomas than were reported on MRI (12 on MRI and 16 on IOUS) or TVUS (41 on TVUS and 62 on IOUS) in all positions (anterior, posterior, lateral, and fundal). In particular, they identified more myomas <2 cm (4 on MRI, 9 on IOUS, 1 on TVUS, and 19 on IOUS). They located 2.3 times as many myomas in the anterior position as TVUS. For the myomas ≥2 cm identified by IOUS and MRI or IOUS and TVUS, there was no statistically significant difference in the mean myoma number or the mean myoma diameter measurements. CONCLUSION: Surgeons first learning to use IOUS detect the same number of myomas ≥2 cm as identified by TVUS and MRI and find a greater number of myomas <2 cm on IOUS compared with radiologist-reported TVUS.

Cost-Benefit Analysis of Hysteroscopic Polypectomy Before Controlled Ovarian Hyperstimulation and Intrauterine Insemination in Infertile Women.

Objective: To examine the cost benefit of performing hysteroscopic polypectomy (HP) in infertile women with endometrial polyp(s) before controlled ovarian hyperstimulation with intrauterine insemination (COH/IUI). Study Design: Decision analytic model comparing costs and clinical outcomes. Results: HP and COH/IUI costs ranged from $537­$12,530 and $800­$7,600, respectively. Performing an HP before COH/IUI lowered fertility cost by $7,652 per clinical pregnancy. When COH/IUI costs remained constant, HP was most cost beneficial when the cost of HP was below a threshold value of $9,452. When HP costs remained constant, the threshold value at which HP was no longer cost beneficial was at COH/IUI costs below $704. The cost benefit was greatest when an office-based HP is performed. Conclusion: HP before COH/IUI is more cost beneficial than fertility treatment alone, particularly when office-based hysteroscopy is performed.

Obstacles to Studying Emerging Technologies.

Laparoscopic radiofrequency ablation of uterine leiomyomas with a new Federal Drug Administration (FDA)-approved device, a device that delivers radiofrequency energy, is a novel procedure that aims to meet patient and physician demand for effective, minimally invasive leiomyoma treatment. However, as a new procedure, the durability of symptom relief, the safety in widespread use, and ultimately the comparative effectiveness of radiofrequency ablation of leiomyomas need further study. In June 2013, the University of California Fibroid Network, a collaboration of the five University of California Departments of Obstetrics and Gynecology, launched the Uterine Leiomyoma Treatment with Radiofrequency Ablation Study, an investigator-initiated early postmarket approval clinical trial of radiofrequency ablation of leiomyomas. In this commentary, we provide a review of the FDA approval process for medical devices using the device that delivers radiofrequency energy as a case study and describe significant limitations of this process that may adversely affect clinical care. We show how the deficiencies in the FDA process have challenged our ability to conduct independent early postmarket research evaluating the safety and long-term effectiveness of this novel technology. Our experience validates the Institute of Medicine's recommendation that advancements in surgical technology introducing new treatments without long-term effectiveness data, comparative study, or both should emerge onto the market under research conditions. Until the FDA requires more rigorous study of novel devices, we suggest ways of working together as a community of gynecologic surgeons to evaluate promising new technologies in early postmarket studies, putting research before widespread adoption of surgical innovation.

Solid pseudopapillary neoplasm, pancreas type, presenting as a primary ovarian neoplasm.

Solid pseudopapillary neoplasm has historically been associated with the pancreas, categorized as a tumor of low malignancy. Recently, solid pseudopapillary neoplasm was reported to arise as a primary ovarian tumor in 3 women. We report a fourth case identified in a 48 year-old woman with an 8-cm left ovarian mass. A left salpingo-oophorectomy was performed. Microscopic examination demonstrated a predominately cystic neoplasm comprised of solid nests of cells with an epithelioid to plasmacytoid appearance, associated with blood vessels, hemorrhage, and degenerative changes, that is, pseudopapillary structures. The tumor cells stained focally for pancytokeratin, progesterone receptor, and CD57 with diffuse nuclear expression of ß-catenin. Ki-67 was 5% to 10%. Synaptophysin, inhibin, and E-cadherin stains were negative. Clinical and radiologic follow-up of our patient demonstrated no pancreatic lesions. This is a rare report of a primary ovarian solid pseudopapillary neoplasm. Prolonged follow-up is needed to determine how this case will fare clinically.

Number of oral contraceptive pill packages dispensed, method continuation, and costs.

OBJECTIVE: To estimate the effect of the number of cycles of oral contraceptive pills (OCPs) dispensed per visit on method continuation, pill wastage, use of services, and health care costs. METHODS: We used paid claims data for 82,319 women dispensed OCPs through the California Family PACT (Planning, Access, Care, and Treatment) Program in January 2003 to examine contraceptive continuation and service use. RESULTS: Women who received 13 cycles at their first visit in January 2003 received 14.5 cycles over the course of 2003 compared with 9.0 cycles among women receiving three cycles at first visit. When client characteristics are controlled, women who received 13 cycles were 28% more likely to have OCPs on hand and twice as likely to have sufficient OCP cycles for 15 months of continuous use compared with women who received three cycles. Oral contraceptive pill wastage was higher among women initially dispensed 13 cycles (6.5% of the cycles dispensed) than among women who received three cycles (2% of cycles). Despite having one fewer clinician visit, women dispensed 13 cycles were more likely to receive Pap and Chlamydia tests and less likely to have a pregnancy test than women initially dispensed fewer cycles. Over the course of the year, Family PACT paid 99 US dollars more for women who received three cycles and 44 US dollars more for women who received only one cycle than it did for women who received 13 cycles at their first visits of 2003. CONCLUSION: Dispensing a year's supply of OCP cycles to women is associated with higher method continuation and lower costs than dispensing fewer cycles per visit. LEVEL OF EVIDENCE: II-2.

Abortion training in Canadian obstetrics and gynecology residency programs.

OBJECTIVE: To study abortion training in Canadian obstetrics and gynecology (ob-gyn) residency programs. METHODS: An anonymous questionnaire was sent to all postgraduate year (PGY)-4 and PGY-5 ob-gyn residents (n=130) and residency program directors (n=16) in Canada. The questionnaires inquired about demographic information, details of abortion training, resident participation in training, and intention to provide abortions after residency. RESULTS: Ninety-two of 130 residents (71%) and 15 of 16 program directors (94%) responded. Abortion training is considered routine in approximately half of programs and elective in half. The majority of residents (71%) participated in abortion training, and half plan to do elective abortions after residency. More than half of residents felt competent after training to perform first-trimester aspiration and second-trimester inductions but did not feel competent in first-trimester medical abortions or dilation and evacuation (D&E). Residents were more likely to participate in training if the program arranged the training for residents (P=.04) and were more likely to intend to provide abortions if the training was considered routine (P=.02), while controlling for all significant demographic and training variables. CONCLUSION: Most Canadian ob-gyn programs offer some training in elective abortion, but only half include it routinely in training, and the minority of residents feels competent in D&E and medical abortion. Integrated abortion training was associated with greater resident participation in training and increased likelihood of intention to provide abortions after residency.