Can adopting quality measures decrease the cesarean rate? Plus: The Government Accountability Office issues a report on power morcellators and the FDA's system of evaluation. Also, does the volume of one type of heart fat indicate the risk of heart disease?
A new study in The Joint Commission Journal of Quality and Safety led by researchers at Beth Israel Deaconess Medical Center (BIDMC) indicates that hospital-led interventions over the course of 7 years led to significant reductions in the center’s cesarean delivery rate.
From 2008 to 2015, BIDMC adopted a multi-strategy approach which included provider feedback, provider education, and new policies that targeted evidence-based and inferred factors such as the nulliparous term singleton vertex (NTSV) cesarean delivery rates. Administrative claims data and birth certificates supplied data on maternal outcomes, mode of delivery, and neonatal outcomes. The p-trend for categorical and continuous variables were calculated with the help of liner regression and the Cochran-Armitage test.
During the course of the study period there were 51,973 deliveries, of which 15,144 were NTSV. The rate of NTSV cesarean delivery decreased from 34.8% before the study period to 21.2% in 2015 and the overall cesarean delivery rate declined as well from 40.0% to 29.1%. No change in the operative vaginal delivery was seen among NTSV deliveries. Mean gestational age at time of delivery went from 39.3 to 39.6 weeks and average neonatal birth weight declined by roughly 54 g. No change in the incidence of shoulder dystocia was seen and meconium aspiration syndrome saw an increase over the course of the study with an incidence of 0.9% in 2015.
The researchers concluded that instituting quality improvement initiatives can reduce the NTSV cesarean delivery rate. They also urge that any increased incidence of fetal or maternal complications tied to decreased NTSV cesarean delivery must be considered in context with risks and benefits of vaginal delivery.
GAO issues report on power morcellators
A new review of power morcellators by the US Government Accountability Office (GAO) has found that the US Food and Drug Administration’s (FDA) system for evaluating the devices is reliant on adverse events reporting. The assessment, prepared for Congress, looked at 501(k) submissions for power morcellators, FDA’s understanding of concerns about the devices and the agency’s responses, and professional standards and guidance for physicians about power morcellators and information that manufacturers provided.
For the analysis, published in GAO Highlights, GAO also conducted a search for articles published between January 1980 and March 2016 on prevalence of uterine cancer and risks of spreading cancer when power morcellation is used to treat uterine fibroids. In addition, 10 professional societies were contacted as were other stakeholder organizations. Organizations whose representatives were interviewed or that provided information were AAGL, the American Board of Obstetrics and Gynecology, the American College of Obstetricians and Gynecologists, America’s Health Insurance Plans, The Joint Commission, and the Society of Gynecologic Oncology.
Between 1991 and 2014, the report says, FDA cleared 25 submissions for laparoscopic power morcellators for marketing in the United States and with the first approval, the agency was aware of the potential for the devices to spread tissue. Before any adverse event reports about them were received, “FDA understood the risk of having unsuspected cancer that could be spread using a power morcellator was low.” Since the emergence of reports of spread of unsuspected cancer following use of power morcellators to treat fibroids in 2013, FDA has issued a safety communication and guidance to manufacturers and conducted inspections to ensure hospital compliance with medical device reporting requirements.
Discussions by GAO with the professional societies found a lack of professional standards specific to use of power morcellators but availability of some guidance and educational resources on surgical procedures to treat fibroids that involve power morcellation. Some of the professional societies had concerns about FDA’s estimate of cancer risk in women undergoing surgical treatment for uterine fibroids. Of 12 manufacturers contacted, three provided information about the instructions for use for their devices. GAO said that its interviews with stakeholders underscore the ongoing questions about the long-term impact on patients of FDA’s guidance about power morcellators.
How body fat may signal risk of heart disease in menopausal women
The volume of paracardial adipose tissue (PAT) in women who have gone through menopause may be an indicator of increased risk of coronary artery disease, according to a new study published in the Journal of the American Heart Association.
Researchers looked at women in the Study of Women’s Health Across the Nation from the Cardiovascular Fat Ancillary Study, which included 608 women. Of those 608 participants, 564 underwent electron beam computed tomography scan to measure their heart fat depot. Forty-two women were excluded due to being surgically menopausal, having undetermined menopausal status due to hormone therapy use, or were missing information on their menopausal status. An additional 44 women were excluded for missing coronary artery calcification (CAC) data or there was an inability to quantify heart fat depots as a result of technical problems.
The 478 women who met all criteria for the analysis were aged 50.9 years (58% preâ or early perimenopausal, 10% late perimenopausal, and 32% postmenopausal). Researchers found that epicardial adipose tissue was linked with CAC measured, which was not modified by menopausal status or estradiol. However, menopausal status did modify the link between PAT and CAC measures (interactionâP ≤ 0.01).Each 1-standard deviation unit increase in log PAT was tied with 102% higher risk of CAC presence (P = 0.04) and an 80% increase in CAC extent (P = 0.008) in postmenopausal women when compared to women who were premenopausal or in early perimenopause, independent of any study covariate. Adjustment for estradiol and hormone therapy weakened the differences. The link between PAT and CAC extent was stronger in women who had lower estradiol levels (interaction P = 0.004).
Researchers concluded that PAT could serve as a potential menopause-specific coronary artery disease risk marker.