AT THE AAGL GLOBAL CONGRESS
VANCOUVER (FRONTLINE MEDICAL NEWS) – Morcellation is an effective, lifesaving tool in gynecologic surgery when used appropriately and should not be abandoned despite recent concerns about the dissemination of occult cancers, according to an expert panel that weighed in on this issue at a meeting sponsored by AAGL.
Panelists presented new data to inform the intense debate over this procedure, which has culminated in the Food and Drug Administration (FDA) recommending against the use of power morcellators during fibroid removal by hysterectomy or myomectomy for most women.
Earlier this year, AAGL convened the Tissue Extraction Task Force to study this issue and respond to the controversy. The association presented a statement to the FDA on power morcellation and published the task force findings that morcellation can be done safely and effectively when performed by trained and experienced surgeons in informed, carefully screened premenopausal women ( J. Minim. Invasive Gynecol. 2014;21:517-30 ).
Abandoning it may raise mortality
“The priority of this entire discussion needs to focus on the patient’s welfare,” contended panelist Dr. Jubilee Brown, an associate professor in the department of gynecologic oncology and reproductive medicine, University of Texas M.D. Anderson Cancer Center, Houston. “For every piece of data that we look at, we need to keep that in the back of our minds as we analyze this.”
In a new study, she and her colleagues retrospectively studied outcomes in 808 consecutive patients with planned laparoscopic supracervical hysterectomy with morcellation who had at least 5 years of follow-up. The leading indications for surgery were menorrhagia and leiomyomata.
Only a single woman had a leiomyosarcoma; she was converted to an open procedure without morcellation but nonetheless died from the disease. “What hasn’t shown up in much of the literature is the wisdom of the operating surgeon, who identified that this uterus looked abnormal and called our group in,” commented Dr. Brown, who is also AAGL’s designated spokesperson on tissue extraction. “Unfortunately, what’s also missed in much of the literature is that leiomyosarcoma is an aggressive and often deadly disease. … In her case, as in so many cases, the problem was not the surgery, the problem was the cancer.”
Among the 778 women who underwent the planned laparoscopic hysterectomy with morcellation, 16 were found to have endometrial hyperplasia, two had adenocarcinoma, and one had an endometrial stromal sarcoma – but reassuringly, none had evidence of disease at follow-up.
“I think that what this tells us is that we need to be absolutely meticulous in our preoperative evaluation of patients in whom we are considering morcellation,” Dr. Brown said. The findings “speak to our obligation to educate our membership and everybody performing preoperative sampling on these patients.”
A decision analysis study also reported at the meeting by first author Dr. R. Wendel Naumann, Carolinas Medical Center in Charlotte, N.C., showed that mortality from laparoscopic hysterectomy with power morcellation – even accounting for possible dissemination of undiagnosed leiomyosarcomas – was 0.077%, still less than the 0.085% mortality from abdominal hysterectomy. “Though it is a small difference, it is an absolute difference in favor of laparoscopic hysterectomy with power morcellation. In fact, if all women were converted to an open hysterectomy, 17 more women each year would die of open hysterectomy than of power morcellation,” Dr. Brown commented.
“Power morcellation is an important tool,” she concluded, reiterating AAGL’s position that its use should be improved, not abandoned.
Low risk of leiomyosarcomas
Panelist Dr. Marit Lieng, an associate professor and consultant in the gynecology department of Oslo University Hospital, and her coinvestigators retrospectively studied 4,765 women who underwent surgery at the hospital for uterine fibroids between 2000 and 2013.
There were 26 cases of leiomyosarcoma (the majority in postmenopausal women), for an incidence of 0.54%, or 1 in 183 women.
However, only a single patient with leiomyosarcoma had laparoscopic supracervical hysterectomy with morcellation, because the tumor was identified or suspected preoperatively or intraoperatively in the rest, reported Dr. Lieng, who is also with the Institute of Clinical Medicine at the University of Oslo.
Therefore, the risk of unintended morcellation of an undiagnosed leiomyosarcoma was just 1 in 4,765 women, or 0.02%.
“I think the findings of our study support the conclusions of the AAGL expert group. … You can do power morcellation in selected patients,” Dr. Lieng commented. “Given a thorough preoperative evaluation, including a cervical cytology, endometrial biopsy, and evaluation of the myometrium by ultrasound or MRI, the risk of unintended morcellation of a uterine leiomyosarcoma in premenopausal women appears to be very low.”
Leiomyosarcomas best removed en bloc
“When you are creating public health care policy, decision analysis must begin with scientifically valid evidence,” asserted panelist Dr. Elizabeth Pritts, medical director of the Wisconsin Fertility Institute, Middleton.
She and her colleagues undertook a comprehensive new meta-analysis assessing the prevalence of occult leiomyosarcomas at hysterectomy or myomectomy for presumed uterine fibroids, including 133 original articles describing 30,193 women having explicit pathology.
Analysis of all prospective data showed that the predicted prevalence rate of occult leiomyosarcoma was 0.12 per 1,000 operations for presumed benign fibroids.
The corresponding 1 in 8,300 operations needed to find a leiomyosarcoma in this new meta-analysis differs greatly from the 1 in 498 found in an FDA meta-analysis , mainly because of the differing evidence base, Dr. Pritts maintained. “It really has to do with initial search criteria,” she said, noting, for example, that the FDA’s search strategy missed studies in which no cancer was found and studies in languages other than English.
Dr. Pritts and her colleagues also conducted a new systematic review looking at outcomes after morcellation of an unsuspected leiomyosarcoma, which was recently published ( J. Minim. Invasive Gynecol. 2014 Sept. 2 [doi: 10.1016/j.jmig.2014.08.781] ).
Main analyses here were based on six papers that compared morcellation with en bloc removal of leiomyosarcomas, most of which found worse survival for women whose tumors were morcellated.
“Now this is not great evidence, but remember, in evidence-based medicine, you’ve got to look at the very best available evidence. This is it,” Dr. Pritts maintained. “En bloc removal confers benefit—don’t cut into these.”
On closer inspection, only 3 of the 81 cases of morcellation reported were confirmed to be power morcellation. Comparisons of outcome with power versus hand morcellation, albeit limited by small numbers, suggested no difference in survival or upstaging.
“There are no data to suggest that any type of morcellation is better or worse than another type, even when including simple tumor biopsies,” Dr. Pritts concluded.
Dr. Brown, Dr. Lieng, and Dr. Pritts disclosed that they had no relevant conflicts of interest.