Durable Improvement in Generic and Fibroid-Specific Quality of Life in Women Treated with Transcervical Fibroid Ablation with the Sonata System After Three Years.

Objective: To determine quality-adjusted life years (QALYs) over 3 years after transcervical fibroid ablation (TFA) with the Sonata System. Methods: The SONATA trial was a prospective multicenter interventional trial that assessed the safety and efficacy of TFA for treatment of women with symptomatic uterine fibroids. Change in generic health status was assessed with the EuroQol 5-Dimension questionnaire (0-1 scale). Fibroid-specific quality of life (QOL) was measured on a 0 to 100 scale with the health-related quality of life subscale of the Uterine Fibroid Symptom and Quality-of-Life (UFS-QOL). The number of QALYs gained relative to baseline and cumulative QALYs were calculated using the area under the curve at each follow-up visit over 3 years. Results: Among 147 women receiving TFA, fibroid-specific QOL increased from 40 ± 21 at baseline to 84 ± 19 at 1 year and 83 ± 23 at 3 years (p < 0.001). Generic QOL increased from 0.72 ± 0.21 at baseline to 0.89 ± 0.12 at 1 year and 0.88 ± 0.16 at 3 years (p < 0.001). Over 3 years, TFA resulted in 1.24 ± 0.64 QALYs gained when using fibroid-specific health utility scores and 0.49 ± 0.61 QALYs gained when using generic health utility scores. Cumulative QALYs experienced at 3 years as a percentage of perfect health were 82% with fibroid-specific scores and 88% with generic health scores. Conclusions: Women treated by TFA with the Sonata System for symptomatic uterine fibroids reported durable improvements in generic and fibroid-specific QOL, as well as clinically meaningful increases in QALYs over 3 years. Clinical Trials.gov ID: NCT02228174. (J GYNECOL SURG 38:143).

Surgical Equipment Price Awareness Amongst Obstetrician-Gynecologists.

BACKGROUND AND OBJECTIVES: Physicians typically have little information of surgical device pricing, although this trend has not been studied in the field of obstetrics and gynecology. We therefore aimed to determine how accurately obstetrician-gynecologists estimate surgical device prices, and to identify factors associated with accuracy. METHODS: An anonymous survey was emailed to all obstetrician-gynecologist attendings, fellows, and residents at 3 teaching hospitals in a single healthcare system in Arizona. We obtained demographic data, perceptions of price transparency and self-rated price knowledge, and price estimates for 31 surgical devices. RESULTS: After participants provided consent and demographics, they then estimated the purchasing price of 31 devices. We defined price accuracy as being within ±10% of the hospital's purchasing price. Fifty-six of the 170 (32.9%) invitees completed the survey and 48 (28.2%) provided price estimates. On average, participants identified 1.9 items correctly (6.1%; range, 0-7 items) out of 31 with no difference in accuracy based on seniority, surgical volume, physician reimbursement structure, nor subspecialty practice-focus. All (100%) respondents felt pricing should be transparent, and only 1.8% felt it is at least somewhat transparent. CONCLUSION: We found that price-estimate accuracy was very low and had no association with any of the demographics. Also notable was the perception that pricing is not transparent despite a unanimous desire for transparency. Although physicians reported a preference for using less-expensive surgical devices, we conclude that physicians are unequipped to make cost-conscious decisions highlighting a large potential for education.

Ultrasound-Guided Transcervical Ablation of Uterine Leiomyomas.

OBJECTIVE: To evaluate the 12-month safety and effectiveness of transcervical ablation for the treatment of symptomatic uterine leiomyomas. METHODS: In this prospective, multicenter, single-arm interventional trial, transcervical ablation was performed on 1-10 leiomyomas per patient with leiomyoma diameters ranging from 1 to 5 cm. Treated leiomyomas included all nonpedunculated types. Coprimary endpoints assessed at 12 months were reduction in menstrual blood loss and absence of surgical reintervention. Additional assessments included symptom severity, quality of life, patient satisfaction, reductions in uterine and leiomyoma volumes, and safety. RESULTS: One hundred forty-seven patients were enrolled and treated in the United States and Mexico. The study met its coprimary endpoints at 12 months (N=143; full analysis set), because 64.8% of patients (95% CI 56.3-72.6%) experienced 50% or greater reduction in menstrual bleeding and 99.3% of patients (95% CI 95.1-99.9%) were free from surgical reintervention. The mean pictorial blood loss assessment chart score decreased by 38.9%, 48.4%, and 51.1% at 3, 6, and 12 months, respectively (P<.001), and 95.1% of patients experienced a reduction in menstrual bleeding at 12 months. There were significant mean improvements in symptom severity and health-related quality of life of 32.1 points and 43.7 points, respectively, at 12 months (all P<.001). Mean maximal leiomyoma volume reduction per patient was 62.4% (P<.001). More than half of patients returned to normal activity within 1 day, 96.3% of patients reported symptom improvement at 12 months, and 97% expressed satisfaction with the treatment at 12 months. There were no device-related adverse events. CONCLUSION: Transcervical ablation was associated with a significant reduction in leiomyoma symptoms with no device-related adverse events and a low surgical reintervention rate through 12 months, demonstrating its potential to safely and effectively treat all nonpedunculated leiomyoma types through a uterus-conserving, incisionless approach. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02228174. FUNDING SOURCE: Supported by Gynesonics, Inc.

Abnormal Uterine Bleeding Control by Sequential Application of Hysteroscopic Lesion Morcellation and Endometrial Ablation.

Objective: To assess the efficacy and safety of combined hysteroscopic morcellation/endometrial ablation for treating abnormal uterine bleeding (AUB). Study Design: Prospective case series from 5 U.S. gynecology clinics. Women with intrauterine polyps and/or type-0 myomas and transformed Uterine Fibroid Symptom and Health-Related Quality-of-Life (UFS-HRQoL) symptom severity score ≥47 points (100 possible) underwent hysteroscopic morcellation (MyoSure) of intrauterine pathologies before endometrial radiofrequency ablation (NovaSure). Outcome measures were amenorrhea rate, UFS-HRQoL scoring, AUB retreatment/reintervention, bleeding days, and perioperative adverse events, through 12 months. Results: Of 26 enrolled women, 24 were available through study completion. Lesions were 27% myomas and 73% polyps. Procedure room time was 19±13 minutes. Complete lesion eradication occurred in 96% of women. At 12 months, amenorrhea prevalence was 46% (p<0.0001 vs. baseline), and 87% of women reported either no bleeding or normalized bleeding. Bleeding/spotting days decreased from 15.7±7.4 to 3.1±4.2 days/month (p<0.0001), symptom severity decreased from 75±13 to 12±18 points (p<0.0001), and QoL scores increased from 29±18 to 88±23 points (p<0.0001). Three women required additional AUB intervention. Perioperative adverse events were minor nausea (n=1) and abdominopelvic cramping (n=2) without sequelae. Conclusion: Sequential hysteroscopic morcellation and endometrial radiofrequency ablation of intrauterine lesions in women with AUB increases amenorrhea rate, alleviates bleeding symptoms, and improves quality of life, with an acceptable safety profile.

Randomized comparative trial of cervical block protocols for pain management during hysteroscopic removal of polyps and myomas.

PURPOSE: To evaluate the efficacy of two cervical block protocols for pain management during hysteroscopic removal of intrauterine polyps and myomas using the MyoSure(®) device. PATIENTS AND METHODS: This was a randomized, comparative treatment trial conducted by five private Obstetrics and Gynecology practices in the USA. Forty premenopausal women aged 18 years and older were randomized to receive either a combination para/intracervical block protocol of 37 cc local anesthetic administered at six injections sites in association with the application of topic 1% lidocaine gel, or an intracervical block protocol of 22 cc local anesthetic administered at three injections sites without topical anesthetic, for pain management during hysteroscopic removal of intrauterine polyps and/or a single type 0 or type 1 submucosal myoma ≤3 cm. The main outcomes were a composite measure of procedure-related pain and pain during the postoperative recovery period, assessed by the Wong-Baker Faces Rating Scale (0= no pain to 10= maximum pain). The lesion characteristics, procedure time, and adverse events were summarized. RESULTS: A total of 17 polyps and eight myomas were removed in the para/intracervical block group, with diameters of 1.3±0.5 cm and 1.8±0.8 cm, respectively. In the intracervical block group, 25 polyps with a mean diameter of 1.2±0.7 cm and 7 myomas with a mean diameter of 1.9±0.9 cm were removed. The mean tissue resection time was 1.2±2.0 minutes and 1.2±1.4 minutes for the para/intracervical and intracervical block groups, respectively. The mean composite procedure-related pain score was low for both cervical block protocols, 1.3±1.4 in the para/intracervical block group vs 2.1±1.5 in the intracervical block group. During the postoperative recovery period, the mean pain scores were 0.3±0.7 vs 1.2±1.7 for the para/intracervical and intracervical block groups, respectively. There were no serious adverse events. CONCLUSION: The MyoSure procedure for removal of polyps and myomas was well tolerated, with low pain scores reported for both the para/intracervical and intracervical block protocols.

The role of leadership in overcoming staff turnover in critical care.

This commentary discusses Laporta and coworkers analysis of a case study on the causes of and solutions for staff turnover in an intensive care setting. Staff turnover is a significant issue for health care leaders due to the shrinking workforce in Western countries and an increased demand for intensive care services as the population ages. The commentary considers reasons for turnover such as burnout and generational diversity, and highlights the importance of a team work approach to address the issue of turnover.

Airborne emissions of mercury from municipal solid waste. I: new measurements from six operating landfills in Florida.

Mercury-bearing material enters municipal landfills from a wide array of sources, including fluorescent lights, batteries, electrical switches, thermometers, and general waste; however, the fate of mercury (Hg) in landfills has not been widely studied. Using automated flux chambers and downwind atmospheric sampling, we quantified the primary pathways of Hg vapor releases to the atmosphere at six municipal landfill operations in Florida. These pathways included landfill gas (LFG) releases from active vent systems, passive emissions from landfill surface covers, and emissions from daily activities at each working face (WF). We spiked the WF at two sites with known Hg sources; these were readily detected downwind, and were used to test our emission modeling approaches. Gaseous elemental mercury (Hg(O)) was released to the atmosphere at readily detectable rates from all sources measured; rates ranged from approximately 1-10 ng m(-2) hr(-1) over aged landfill cover, from approximately 8-20 mg/hr from LFG flares (LFG included Hg(O) at microg/m3 concentrations), and from approximately 200-400 mg/hr at the WF. These fluxes exceed our earlier published estimates. Attempts to identify specific Hg sources in excavated and sorted waste indicated few readily identifiable sources; because of effective mixing and diffusion of Hg(O), the entire waste mass acts as a source. We estimate that atmospheric Hg releases from municipal landfill operations in the state of Florida are on the order of 10-50 kg/yr, substantially larger than our original estimates, but still a small fraction of current overall anthropogenic losses.

Tubal sterilization with a waterborne polyethylene glycol in situ cross-linking material: a minimally invasive approach.

OBJECTIVE: To assess the effectiveness and compatibility of an in situ-gelling polymeric device when implanted in the fallopian tube to prevent pregnancy. DESIGN: Controlled laboratory study. SETTING: Animals in a controlled laboratory environment. ANIMAL(S): Ten white New Zealand rabbits (nine female and one male). INTERVENTION(S): The material was implanted through a small incision into one of each rabbit's twin fallopian tubes. The rabbits then were allowed to heal. After a healing period of 6 to 10 weeks, the rabbits were bred. After breeding, the animals were killed, and samples were collected from their fallopian tubes for histology. MAIN OUTCOME MEASURE(S): Pregnancy of the specimens. RESULT(S): Four specimens showed unilateral pregnancy (pregnancy in only one uterus). Because rabbits have the capacity to be pregnant in both uteri simultaneously, this suggests strong potential of the material for use as a contraceptive. CONCLUSION(S): Although concerns remain concerning distension and potential injury resulting from use of the system, enough data have been gathered to warrant further study of this material for use in humans.

Partition-controlled progesterone release from waterborne, in situ-gelling materials.

The primary goal of this work was to evaluate the long-term constant zero-order release of progesterone from a waterborne, in situ-gelling, injectable material. The motivation for this is to develop an intrafallopian tube embolization system for contraception. Poly(ethylene glycol) diacrylate (PEGDA, 575 g/mol) or poly(propylene glycol) diacrylate (PPODA, 540 g/mol) as a Michael-type addition acceptor was combined with pentaerythritol-tetrakis (3-mercaptopropionate; a Michael-type addition donor) to create a 75 wt.% emulsion solution in 0.1M PBS (pH 7.4 for PEGDA and pH 12 for PPODA) that gels in minutes by the Michael-type reaction to form a hydrophobic solid. Samples, with approximately 5.5 or 25 wt.% progesterone, were formed in Tygon tubing. Samples (1.6 mm x 1.0 cm cylinders) showed constant, partition-controlled release of progesterone for a prolonged period (time dependent on the mass of progesterone). Cylinders with approximately 25 wt.% load of progesterone exhibited constant release (approximately 40 microg per day) for more than 50 days in both the PEGDA and PPODA systems. This type of release is normally associated with preformed hydrophobic matrix systems. In contrast, these in situ-gelling materials reported here can be used to provide zero-order, partition-controlled release of progesterone and enhance the efficiency of an intrafallopian tube embolization system through progesterone release in an injectable, in situ-forming system.

Advances in endometrial ablation.

UNLABELLED: The evolution of the surgical treatment of dysfunctional uterine bleeding has resulted in the design and manufacture of instrumentation that is minimally invasive, has a low risk profile, and is technically simple to operate. Whereas hysterectomy was the only definitive surgical option before 1981, operative hysteroscopy with transcervical resection of the endometrium and rollerball ablation of the endometrium gained favor in the mid-1980s and 1990s. During the past 10 years, devices dedicated entirely to the ablation (or destruction) of the endometrium have been designed, modeled, tested, and approved for clinical use in the United States. This review describes the methods by which the technologies are evaluated and approved for clinical use by the Food and Drug Administration. In addition, the reported efficacy of each approved device is reviewed. The complications associated with the devices, as well as the potential long-term risks of endometrial ablation, also are reported. Finally, the cost for device disposables and nondisposables is presented. TARGET AUDIENCE: Obstetricians & Gynecologists, Family Physicians LEARNING OBJECTIVES: After completion of this article, the reader will be able to list the various FDA-approved uterine ablation devices, compare the effectiveness of the various uterine ablation devices, and summarize the various adverse events associated with the use of the uterine ablation devices.