VANCOUVER, B.C.– A thorough preop work-up can just about eliminate the risk of accidentally morcellating an occult uterine sarcoma, according to a prospective series of 2,824 women referred for minimally invasive myomectomy to a French university hospital from 2002 to 2013.
The message came just days before the Food and Drug Administration’s Nov. 24 advice not to use power morcellationin the majority of women undergoing hysterectomy or myomectomy for uterine fibroids because “there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma” that morcellation could spread. The agency estimated that about 1 in 350 fibroid patients actually have an occult sarcoma.
That’s close to the 1 in 400 incidence investigators at the Lariboisière Hospital in Paris found; the difference is that the French investigators detected all but one of the seven sarcomas in their series before entering the operating room, using a heightened screening protocol. “That’s the major difference between our series and the other series that the” FDA relied on for their advice, said lead investigator and gynecologic surgeon Dr. Afshin Fazel, an assistant professor of obstetrics and gynecology at Lariboisière Hospital.
Physicians at the hospital go further than some to rule out sarcomas prior to fibroid surgery. “Every single patient with a pelvic mass gets an MRI,” as well as a clinical exam and pelvic ultrasound. “If the endometrium is thicker than 4 mm, every patient older than 40 [years old] has endometrial sampling, and if there’s bleeding, every single patient has an office hysteroscopy.” A multidisciplinary team – oncologists, radiologists, gynecologists, and surgeons – review the results and select the appropriate surgical approach, Dr. Fazel said at a meeting sponsored by AAGL.
The screening protocol caught five of the seven sarcomas before surgery. A sixth case, a ruptured uterine sarcoma, presented emergently. All seven women had open surgeries, most had a hysterectomy as their initial operation, and none were morcellated. “The take-home message is that you need all the cards in your hand” to rule out sarcomas before myomectomy. No one screening test is sufficient. Some sarcomas, for instance, don’t have the usual MRI signs; of the three sarcomas the team had detected so far in 2014 – not included in the reported series – just one was found on MRI; the other two were found by endometrial sampling. “Preoperative diagnosis is the key to preventing [accidental] morcellation,” Dr. Fazel said.
The second message is that although “1 out of 400 fibroids in our series were actually sarcomas,” the extra screening meant that “the undiagnosed rate of sarcoma was” 0.035% (or 1 in 2,824), he said.
One of the sarcoma patients was from Taiwan, another was African, and the rest were French. Their age ranged from 38 to 78 years, with a mean age 50 years; two were postmenopausal. They had heavy bleeding and pain, and two had multiple masses. The average size of the uterus was 1,136 cc, and the average size of the mass 891 cc. Four of the seven patients died within 2 years of their surgery.
Among all 2,824 women, two-thirds had minimally invasive approaches, including 743 laparoscopic, 510 hysteroscopic, and 336 vaginal procedures; 262 had uterine artery embolization, which was pioneered by Lariboisière in the late 1980s.
Dr. Fazel said he has no disclosures.