FDA’s morcellation safety communication and hysterectomy trends

September 16, 2015

A look at the ramifications of the FDA safety communication on morcellation. Plus: Are the odds better for extremely preferm infants? And, how technology may improve LARC adherence.

In the 8 months immediately following the US Food and Drug Administration (FDA)’s statement discouraging use of power morcellation during hysterectomy, practice patterns changed, according to a new study by University of Michigan Researchers. The retrospective analysis showed that rates of laparoscopic and vaginal hysterectomy increased, as did non-transfusion complications and 30-day hospital admissions.

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The data are from a cohort of patients who underwent hysterectomy for benign indications in the Michigan Surgical Quality Collaborative from January 2013 to December 2014. Rates of hysterectomy (abdominal, laparoscopic, and vaginal), rates of major postoperative complications, and 30-day hospital readmissions and reoperations were compared before and after the FDA’s April 17, 2014 safety communication. Major complications included blood transfusions, vaginal cuff infection, deep and organ space surgical site infection (SSI), sepsis, pulmonary embolism, cardiac arrest, respiratory failure, and death. The median episode cost related to readmissions was calculated using Michigan Value Collaborative data.

During the reviewed period, 18,299 hysterectomies were performed. Of them, 2753 were excluded due to non-benign indications including cancer, cervical dysplasia, or endometrial hyperplasia and 174 due to missing covariate data. Compared to the 15 months before the safety communication, in the 8 months following the FDA statement, use of laparoscopic hysterectomies decreased by 4.1% (P=0.005), while abdominal and vaginal procedures increased by 1.7%  (P=0.112) and 2.4% (P=0.012), respectively.

Major surgical complications, excluding blood transfusions, significantly increased, from 2.2% to 2.8% (P=0.015). Rates of hospital readmission within 30 days also increased from 3.4% to 4.2% (P=0.025). No significant changes were seen in rates of reoperations or for all major surgical complications. The median risk-adjusted total episode cost for readmissions was $5847 (interquartile range $5478-$10,389).

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Two-decade trend shows more preemies surviving

A review of birth records over 2 decades by researchers from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) shows that more infants born extremely preterm (<28 weeks) are surviving, many of them without serious illness. Published in JAMA, the findings suggest that the simultaneous increase in cesarean delivery of these children may have played a role in their outcomes.

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Data from more than 34,000 births at 22 to 28 weeks’ gestation that occurred at 26 Neonatal Research Network centers between 1993 and 2012 were included. The objective of the analysis was assessment of 20-year trends in maternal/neonatal care, complications, and mortality among the infants. Regression models were used to assess annual changes, with adjustment for study center, race/ethnicity, gestational age, birth weight for gestational age, and sex.

The researchers found that significantly more infants born at 23 and 24 weeks survived in 2012 (65%) than in 1993 (52%). Between 2009 and 2012, survival increases from 27% to 33% (adjusted relative risk [RR] 1.09; 95% confidence interval [CI] 1.05-1.14) were seen in infants born at 23 weeks’ gestation and from 63% to 65% (adjusted RR 1.05 95% CI 1.03-1.07) in those born at 24 weeks. Smaller relative increases were seen in infants born at 25 and 27 weeks’ gestation and no change was seen for those born at 22, 26, and 28 weeks’ gestation.

Every year, the number of infants born at 25 to 28 weeks’ gestation who survived without major morbidity increased by 2% but it did not change in infants born at 22 to 24 weeks’ gestation. Over the 20-year period, use of antenatal corticosteroids significantly increased (from 24% to 87%; P<.001) as did rates of cesarean delivery (from 44% to 64%; P<.001).

Commenting on NICHD’s website, the physician who oversees the Neonatal Research Network theorized that cesarean section might be less traumatic to an extremely premature infant, thus potentially contributing to survival. The one notable complication that increased over the study period was bronchopulmonary dysplasia, which may be a consequence of the respiratory therapy used to support lung function in premature infants. (Continuous positive airway pressure without ventilation increased from 7% in 2002 to 11% in 2012 [P<.001]).   

NEXT: Technology and LARCs

 

Text message reminders boost Depo-Provera adherence

Using a text messaging system to remind adolescents of scheduled appointments for a contraception injection appears to improve clinic attendance. The 100 participants in a research study conducted in a Baltimore, Maryland clinic ranged in age from 13 to 21 years; were currently using Depo-Provera; and had a cell phone with text-messaging capability. The young women, who primarily were from low-income African American families living in a community with high rates of unplanned pregnancy, were followed for 3 Depo-Provera cycles.

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At every Depo-Provera visit, all participants received a nursing assessment, counseling, the contraceptive injection, and an appointment card with the date of the next injection. As part of this standard clinical protocol, they also received an automated reminder via their home phone before the next appointment and were called if they missed an appointment. Young women assigned to the intervention group also were sent a welcome text message at enrollment as well as daily texted appointment reminders beginning 72 hours before the scheduled visit. These text messages ceased when the respondent indicated “yes,” she planned to keep the appointment, whereas a “no” response triggered a call from the nurse case manager to reschedule the appointment.

Overall, on-time visit adherence declined over time: 51% of participants in both groups kept their first visit appointment; 47% kept the second appointment; and 43% the third. However, 68% of participants who received the text reminders kept their appointment for the first visit compared with 56% of their peers. For the second cycle, the comparable proportions were 68% versus 62%, and for the third, virtually no difference was seen between the 2 groups-73% versus 72% (Trent M, et al. J Adolesc Health. 2015;57[1]:100-106).