Another insurer has taken steps to restrict morcellator use. Two studies examine the effect of low molecular weight heparin and its effects on recurrent pregnancy loss.
Aetna has joined the ranks of insurers sharply restricting use of morcellators, a technology that has come under fire from the Food and Drug Administration (FDA) because of concern about the potential for seeding of uterine sarcomas undetected during laparoscopic hysterectomy.
In a policy statement issued on May 5, Aetna said that “myomectomy and hysterectomy procedures that use a power morcellator will not be covered in most circumstances because the safety and efficacy of this approach has not been demonstrated.” As of May 15, precertification will be required for any myomectomies or hysterectomies performed with the device.
A “clinical exception” to the new policy can be requested for premenopausal patients who want to maintain their fertility and for whom another surgical procedure would not be effective and/or women with severe comoribidities where risk of death or severe morbidity with another procedure outweighs the risk of an undiagnosed sarcoma.
The tightening of controls by Aetna-the country’s third largest health insurer-comes in the wake of a warning from the FDA in November 2014 about the use of morcellators during laparoscopic hysterectomies. The FDA estimates that approximately 1 in 350 women undergoing hysterectomy or myomectomy for treatment of fibroids has an unsuspected uterine sarcoma. In April, the country’s largest insurer, UnitedHealthCare, began requiring prior authorization for abdominal laparoscopic, vaginal, and laparoscopic-assisted vaginal hysterectomy. Morcellation is not performed during vaginal hysterectomy and the UnitedHealthCare restriction does not apply to outpatient vaginal surgeries.
According to a report in The Wall Street Journal, to date, “health plans covering 93 million Americans have either curtailed use of morcellators or are considering limits.” As noted in that report, the FDA has not banned morcellators but the largest manufacturer, J&J, is no longer selling the devices.
LMHW may not be answer for preventing pregnancy loss
Women with unexplained recurrent pregnancy loss (RPL) are often given daily injections of low-molecular weight heparin (LMWH) but results of a new randomized trial suggest that the practice may not help prevent miscarriage
In the study, performed at 14 university hospitals or perinatal care centers in Germany or Austria, researchers studied 449 women who had a history of at least 2 consecutive early miscarriages or 1 late miscarriage who were 5 to 8 weeks pregnant, confirmed by ultrasonography. The women in the control group received multivitamin pills while the intervention group received the vitamins and 5000 IU of dalteparin-sodium for up to 24 weeks’ gestation.
After 24 weeks’ gestation, pregnancies were intact in 191 of 220 (86.8%) of the women who received LMWH versus 188 of 214 (87.9%) of the women who received only vitamin pills (absolute difference, −1.1 percentage points [95% CI, −7.4 to 5.3 percentage points]). In the intervention group, the live birth rate was 86.0% (185 of 215 women) versus 86.7% (183 of 211 women) in the control group (absolute difference, −0.7 percentage point [CI, −7.3 to 5.9 percentage points]).
One of the 3 intrauterine fetal deaths occurred in a woman using LMWH. Of the 11 cases of intrauterine growth restriction or placental insufficiency, 5 occurred in women who used LMWH. In 9 women, of whom had received LMWH, preeclampsia or HELLP syndrome (hemolysis, elevated liver enzyme level, and low platelet count) was reported.
Daily injections of LMWH, the investigators concluded, did not appear to increase the ongoing pregnancy or live-birth rate in women with a history of RPL. Because the method can be burdensome, they do not recommend it for preventing miscarriage.
Enoxaparin’s effect on unexplained recurrent miscarriage
Results of a first-of-its kind study by French investigators cast doubt on use of enoxaparin to prevent unexplained recurrent miscarriage in women who are nonthrombophilic.
For the randomized, double-blind trial, researchers enrolled 258 pregnant women aged 18 to 45 at 13 hospitals between April 2007 and October 2012. All had a history of unexplained recurrent miscarriage, which was defined as ≥2 consecutive miscarriages before 15 weeks’ gestation, conception with the same partner, and no live births subsequent to the consecutive miscarriages.
The women were assigned to receive either 40 mg enoxaparin or a saline solution placebo, administered subcutaneously daily until 35 weeks’ gestation. Mean gestational age at time of randomization was 39 days. All the participants were followed with monthly prenatal clinic visits and one post-delivery visit at 2 months to ensure compliance with therapy and to observe for side effects.
Of the 258 women enrolled, 256 (mean age 32 years, ≥3 miscarriages: 72%; mean gestational age 39 days of amenorrhea) were studied. Of the 138 who received enoxaparin, 66.6% had a live births versus 72.9% of the 119 who had received placebo. Overall the absolute difference was - 6% (95% CI, −17.1 to 5.1), excluding a 10% increase in the live-birth rate on enoxaparin (P = .34).
The researchers concluded that enoxaparin did not improve the chances of a live birth in women who had a history of unexplained recurrent miscarriage.