AAGL Global Congress of Minimally Invasive Gynecology 2014

VANCOUVER, B.C. – Trendelenburg position does not materially increase ventilator pressures during laparoscopic gynecologic surgery, according to investigators from McMaster University in Hamilton, Ont.

The use of the Trendelenburg position can sometimes cause tension in the operating room. Surgeons need to roll the small bowel out of the pelvis to get access to their gynecologic targets, but anesthesiologists worry that they’ll have to turn up ventilator pressures – and risk barotrauma – if women are placed in a head-down position. It’s unclear from previous studies if pressures really need to be increased when using a moderate Trendelenburg position, Dr. Stephen Bates, a professor of obstetrics and gynecology at McMaster University, said at a meeting sponsored by the AAGL.

To find out, Dr. Bates and his colleagues monitored peak inspiratory pressures (PIP), pneumoperitoneum pressures, degrees of Trendelenburg, and other factors as 100 women underwent laparoscopic hysterectomies performed by a total of seven surgeons. The women were aged 46 years, on average, and had a mean body mass index of 29 kg/m².

The surgeons opted for an average of 10 degrees Trendelenburg, which resulted in a 1.9 cm H₂0 (7%) increase in PIP from horizontal positioning, up from a mean of 26.7 to 28.6 cm H₂0.

“By all anesthesia standards, this is a trivial change and clinically insignificant,” Dr. Bates said in an interview. “The traditional dogma is that if you put patients in Trendelenburg, you’ll increase the difficulty of ventilating them. That was not the case.”

But body mass index, and to a greater degree pneumoperitoneum pressures, did predict increased ventilator pressures among the women.

“The higher pneumoperitoneum pressures are, the harder it is to ventilate,” Dr. Bates said. “There’s [almost] a linear relationship between PnP [pneumoperitoneum pressures] and ventilator pressures.”

When pneumoperitoneum pressures were reduced from 15 to 10 mm Hg, PIP fell by approximately 10%, but the surgeons – all blinded to the reduction in PnP – did not notice any deterioration in their surgical views, he said.

Taken together, the findings suggest a new way to negotiate Trendelenburg positioning in the operating room. “Anesthesiologists and gynecologic surgeons should consider minimizing the pneumoperitoneum pressure rather than reducing the degree of Trendelenburg,” Dr. Bates said.

The researchers also tested an inflatable pillow that lifted women’s buttocks a few inches above the table. The hope was that it would reduce the degree of Trendelenburg needed for their operations, and subsequently reduce PIP. Surgeons were able to decrease Trendelenburg by about 4 degrees with the pillow, but consistent with the study’s overall findings, it made no real difference in PIP. There was a clinically insignificant drop of 0.3 cm H₂0, from a mean of 28.6 to 28.3 cm H₂0, Dr. Bates said.

Dr. Bates reported having no financial disclosures.

aotto@frontlinemedcom.com

VANCOUVER, B.C. – Trendelenburg position does not materially increase ventilator pressures during laparoscopic gynecologic surgery, according to investigators from McMaster University in Hamilton, Ont.

The use of the Trendelenburg position can sometimes cause tension in the operating room. Surgeons need to roll the small bowel out of the pelvis to get access to their gynecologic targets, but anesthesiologists worry that they’ll have to turn up ventilator pressures – and risk barotrauma – if women are placed in a head-down position. It’s unclear from previous studies if pressures really need to be increased when using a moderate Trendelenburg position, Dr. Stephen Bates, a professor of obstetrics and gynecology at McMaster University, said at a meeting sponsored by the AAGL.

To find out, Dr. Bates and his colleagues monitored peak inspiratory pressures (PIP), pneumoperitoneum pressures, degrees of Trendelenburg, and other factors as 100 women underwent laparoscopic hysterectomies performed by a total of seven surgeons. The women were aged 46 years, on average, and had a mean body mass index of 29 kg/m².

The surgeons opted for an average of 10 degrees Trendelenburg, which resulted in a 1.9 cm H₂0 (7%) increase in PIP from horizontal positioning, up from a mean of 26.7 to 28.6 cm H₂0.

“By all anesthesia standards, this is a trivial change and clinically insignificant,” Dr. Bates said in an interview. “The traditional dogma is that if you put patients in Trendelenburg, you’ll increase the difficulty of ventilating them. That was not the case.”

But body mass index, and to a greater degree pneumoperitoneum pressures, did predict increased ventilator pressures among the women.

“The higher pneumoperitoneum pressures are, the harder it is to ventilate,” Dr. Bates said. “There’s [almost] a linear relationship between PnP [pneumoperitoneum pressures] and ventilator pressures.”

When pneumoperitoneum pressures were reduced from 15 to 10 mm Hg, PIP fell by approximately 10%, but the surgeons – all blinded to the reduction in PnP – did not notice any deterioration in their surgical views, he said.

Taken together, the findings suggest a new way to negotiate Trendelenburg positioning in the operating room. “Anesthesiologists and gynecologic surgeons should consider minimizing the pneumoperitoneum pressure rather than reducing the degree of Trendelenburg,” Dr. Bates said.

The researchers also tested an inflatable pillow that lifted women’s buttocks a few inches above the table. The hope was that it would reduce the degree of Trendelenburg needed for their operations, and subsequently reduce PIP. Surgeons were able to decrease Trendelenburg by about 4 degrees with the pillow, but consistent with the study’s overall findings, it made no real difference in PIP. There was a clinically insignificant drop of 0.3 cm H₂0, from a mean of 28.6 to 28.3 cm H₂0, Dr. Bates said.

Dr. Bates reported having no financial disclosures.

aotto@frontlinemedcom.com

VANCOUVER, B.C. – Trendelenburg position does not materially increase ventilator pressures during laparoscopic gynecologic surgery, according to investigators from McMaster University in Hamilton, Ont.

The use of the Trendelenburg position can sometimes cause tension in the operating room. Surgeons need to roll the small bowel out of the pelvis to get access to their gynecologic targets, but anesthesiologists worry that they’ll have to turn up ventilator pressures – and risk barotrauma – if women are placed in a head-down position. It’s unclear from previous studies if pressures really need to be increased when using a moderate Trendelenburg position, Dr. Stephen Bates, a professor of obstetrics and gynecology at McMaster University, said at a meeting sponsored by the AAGL.

To find out, Dr. Bates and his colleagues monitored peak inspiratory pressures (PIP), pneumoperitoneum pressures, degrees of Trendelenburg, and other factors as 100 women underwent laparoscopic hysterectomies performed by a total of seven surgeons. The women were aged 46 years, on average, and had a mean body mass index of 29 kg/m².

The surgeons opted for an average of 10 degrees Trendelenburg, which resulted in a 1.9 cm H₂0 (7%) increase in PIP from horizontal positioning, up from a mean of 26.7 to 28.6 cm H₂0.

“By all anesthesia standards, this is a trivial change and clinically insignificant,” Dr. Bates said in an interview. “The traditional dogma is that if you put patients in Trendelenburg, you’ll increase the difficulty of ventilating them. That was not the case.”

But body mass index, and to a greater degree pneumoperitoneum pressures, did predict increased ventilator pressures among the women.

“The higher pneumoperitoneum pressures are, the harder it is to ventilate,” Dr. Bates said. “There’s [almost] a linear relationship between PnP [pneumoperitoneum pressures] and ventilator pressures.”

When pneumoperitoneum pressures were reduced from 15 to 10 mm Hg, PIP fell by approximately 10%, but the surgeons – all blinded to the reduction in PnP – did not notice any deterioration in their surgical views, he said.

Taken together, the findings suggest a new way to negotiate Trendelenburg positioning in the operating room. “Anesthesiologists and gynecologic surgeons should consider minimizing the pneumoperitoneum pressure rather than reducing the degree of Trendelenburg,” Dr. Bates said.

The researchers also tested an inflatable pillow that lifted women’s buttocks a few inches above the table. The hope was that it would reduce the degree of Trendelenburg needed for their operations, and subsequently reduce PIP. Surgeons were able to decrease Trendelenburg by about 4 degrees with the pillow, but consistent with the study’s overall findings, it made no real difference in PIP. There was a clinically insignificant drop of 0.3 cm H₂0, from a mean of 28.6 to 28.3 cm H₂0, Dr. Bates said.

Dr. Bates reported having no financial disclosures.

aotto@frontlinemedcom.com

VANCOUVER, B.C. – A medical cocktail of tranexamic acid, gonadotropin-releasing hormone agonist, and an aromatase inhibitor stops bleeding from uterine arteriovenous malformations and eliminates the malformations on Doppler ultrasound within a few months, according to a small case series from Western University in London, Ont.

The finding could be a “game changer,” if it holds up under further testing, since it appears to resolve uterine arteriovenous malformations (AVMs) without compromising fertility, unlike uterine artery embolization or hysterectomy, said Dr. Angelos Vilos of Western University, the study’s lead investigator.

“We believe that we have come up with a novel and advantageous cocktail [that is] accessible to all physicians,” he said. “It eliminates uterine bleeding and AVMs. We know it’s safe, and all these medications are readily available.”

Dr. Vilos said he plans to use the drug cocktail as a first-line therapy in patients with uterine bleeding from AVMs.

The investigators used uterine tamponade, as needed, to control bleeding in nine women, then gave them oral tranexamic acid (Cyklokapron) 1 g three times daily for 5 days to clot AVM bleeders. The women also received gonadotropin-releasing hormone (GnRH) agonist injections to shrink the uterus and its vasculature – usually one shot of leuprolide, but goserelin was used for one woman – plus oral letrozole 2.5 mg/day for 5 days after the first injection to prevent GnRH flare.

The uterine AVMs “disappeared” on Doppler ultrasound within 3 months, Dr. Vilos said.

Four of the women went on to conceive spontaneously and have live births. Four others are on oral contraceptives. The ninth woman opted for a subsequent tubal ligation.

“We were able to preserve fertility and the uterus in all of these women,” he said.

The patients had been bleeding from uterine AVMs for up to 6 months, most following spontaneous or therapeutic abortions. They all had negative beta–human chorionic gonadotropin and Doppler-confirmed AVMs in the myometrium. Retained products were ruled out in all of the patients. Two women had failed embolization with coils and gel foam, and two women required transfusions before treatment. One woman required uterine tamponade before the protocol.

“These women weren’t resolving on their own,” Dr. Vilos said at the meeting sponsored by AAGL.

Based on previous work, Dr. Vilos said he and his team were comfortable using GnRH agonists and letrozole for endometriosis, and they frequently use tranexamic acid for acute bleeding. “So we kind of put these ideas together,” he said.

Several of the women were hemorrhaging in the middle of the night, and the community hospitals where they were being treated couldn’t do embolization. The hospitals called Western University, a tertiary care center, for assistance. “We initiated the protocol, and they resolved,” Dr. Vilos said. “[It’s] an effective management strategy.”

Dr. Vilos is an advisor for Bayer Healthcare and Actavis. The investigators did not receive outside funding for the work.

aotto@frontlinemedcom.com

VANCOUVER, B.C. – A medical cocktail of tranexamic acid, gonadotropin-releasing hormone agonist, and an aromatase inhibitor stops bleeding from uterine arteriovenous malformations and eliminates the malformations on Doppler ultrasound within a few months, according to a small case series from Western University in London, Ont.

The finding could be a “game changer,” if it holds up under further testing, since it appears to resolve uterine arteriovenous malformations (AVMs) without compromising fertility, unlike uterine artery embolization or hysterectomy, said Dr. Angelos Vilos of Western University, the study’s lead investigator.

“We believe that we have come up with a novel and advantageous cocktail [that is] accessible to all physicians,” he said. “It eliminates uterine bleeding and AVMs. We know it’s safe, and all these medications are readily available.”

Dr. Vilos said he plans to use the drug cocktail as a first-line therapy in patients with uterine bleeding from AVMs.

The investigators used uterine tamponade, as needed, to control bleeding in nine women, then gave them oral tranexamic acid (Cyklokapron) 1 g three times daily for 5 days to clot AVM bleeders. The women also received gonadotropin-releasing hormone (GnRH) agonist injections to shrink the uterus and its vasculature – usually one shot of leuprolide, but goserelin was used for one woman – plus oral letrozole 2.5 mg/day for 5 days after the first injection to prevent GnRH flare.

The uterine AVMs “disappeared” on Doppler ultrasound within 3 months, Dr. Vilos said.

Four of the women went on to conceive spontaneously and have live births. Four others are on oral contraceptives. The ninth woman opted for a subsequent tubal ligation.

“We were able to preserve fertility and the uterus in all of these women,” he said.

The patients had been bleeding from uterine AVMs for up to 6 months, most following spontaneous or therapeutic abortions. They all had negative beta–human chorionic gonadotropin and Doppler-confirmed AVMs in the myometrium. Retained products were ruled out in all of the patients. Two women had failed embolization with coils and gel foam, and two women required transfusions before treatment. One woman required uterine tamponade before the protocol.

“These women weren’t resolving on their own,” Dr. Vilos said at the meeting sponsored by AAGL.

Based on previous work, Dr. Vilos said he and his team were comfortable using GnRH agonists and letrozole for endometriosis, and they frequently use tranexamic acid for acute bleeding. “So we kind of put these ideas together,” he said.

Several of the women were hemorrhaging in the middle of the night, and the community hospitals where they were being treated couldn’t do embolization. The hospitals called Western University, a tertiary care center, for assistance. “We initiated the protocol, and they resolved,” Dr. Vilos said. “[It’s] an effective management strategy.”

Dr. Vilos is an advisor for Bayer Healthcare and Actavis. The investigators did not receive outside funding for the work.

aotto@frontlinemedcom.com

VANCOUVER, B.C. – A medical cocktail of tranexamic acid, gonadotropin-releasing hormone agonist, and an aromatase inhibitor stops bleeding from uterine arteriovenous malformations and eliminates the malformations on Doppler ultrasound within a few months, according to a small case series from Western University in London, Ont.

The finding could be a “game changer,” if it holds up under further testing, since it appears to resolve uterine arteriovenous malformations (AVMs) without compromising fertility, unlike uterine artery embolization or hysterectomy, said Dr. Angelos Vilos of Western University, the study’s lead investigator.

“We believe that we have come up with a novel and advantageous cocktail [that is] accessible to all physicians,” he said. “It eliminates uterine bleeding and AVMs. We know it’s safe, and all these medications are readily available.”

Dr. Vilos said he plans to use the drug cocktail as a first-line therapy in patients with uterine bleeding from AVMs.

The investigators used uterine tamponade, as needed, to control bleeding in nine women, then gave them oral tranexamic acid (Cyklokapron) 1 g three times daily for 5 days to clot AVM bleeders. The women also received gonadotropin-releasing hormone (GnRH) agonist injections to shrink the uterus and its vasculature – usually one shot of leuprolide, but goserelin was used for one woman – plus oral letrozole 2.5 mg/day for 5 days after the first injection to prevent GnRH flare.

The uterine AVMs “disappeared” on Doppler ultrasound within 3 months, Dr. Vilos said.

Four of the women went on to conceive spontaneously and have live births. Four others are on oral contraceptives. The ninth woman opted for a subsequent tubal ligation.

“We were able to preserve fertility and the uterus in all of these women,” he said.

The patients had been bleeding from uterine AVMs for up to 6 months, most following spontaneous or therapeutic abortions. They all had negative beta–human chorionic gonadotropin and Doppler-confirmed AVMs in the myometrium. Retained products were ruled out in all of the patients. Two women had failed embolization with coils and gel foam, and two women required transfusions before treatment. One woman required uterine tamponade before the protocol.

“These women weren’t resolving on their own,” Dr. Vilos said at the meeting sponsored by AAGL.

Based on previous work, Dr. Vilos said he and his team were comfortable using GnRH agonists and letrozole for endometriosis, and they frequently use tranexamic acid for acute bleeding. “So we kind of put these ideas together,” he said.

Several of the women were hemorrhaging in the middle of the night, and the community hospitals where they were being treated couldn’t do embolization. The hospitals called Western University, a tertiary care center, for assistance. “We initiated the protocol, and they resolved,” Dr. Vilos said. “[It’s] an effective management strategy.”

Dr. Vilos is an advisor for Bayer Healthcare and Actavis. The investigators did not receive outside funding for the work.

aotto@frontlinemedcom.com

VANCOUVER– To minimize the risk of spreading occult malignancy, Johns Hopkins University in Baltimore no longer uses uterine morcellation for fibroids or hysterectomies in women over age 50 years.

Morcellation is also contraindicated under the Hopkins protocol if women have other risk factors for gynecologic cancer, including tamoxifen use, pelvic radiation, hereditary cancer syndromes, and BRCA mutations.

For women who qualify, morcellation can be performed only by high-volume surgeons who isolate their targets within an endoscopy bag to catch spills. Case peer-review, endometrial sampling, and imaging – including an MRI for fibroids – are required beforehand to rule out occult malignancy, and women must be warned of the risk of occult malignancy before opting for morcellation.

“Given the review of our institutional data and recent national debate surrounding power morcellation, our institution developed the protocol to enhance safety for women [undergoing] minimally invasive surgery for benign indications,” said Dr. Stephanie Ricci, a gynecologic oncology fellow at Hopkins.

She explained the protocol just days before the Food and Drug Administration released similar guidance, contraindicating power morcellation in peri- or postmenopausal women, and when tissue can be removed en bloc either vaginally or by mini-laparotomy, which is the case in the majority of hysterectomies and myomectomies. Women must also be warned of the risk of occult malignancy before morcellation, the agency said Nov. 24.

Taken together, the Hopkins’ protocol and the FDA’s guidance could help define the narrow pool of women for whom morcellation might still be an option, be it to preserve fertility or for some other reason.

“It’s possible that a higher rate of peer-review and preop imaging and endometrial sampling counter the risk of occult malignancy,” Dr. Ricci said at a meeting sponsored by AAGL.

Hopkins developed its rules in part based on a review led by Dr. Ricci of 424 morcellation cases there from 2005 to 2014. Two occult cancers were identified in women who underwent power morcellation, giving an incidence of 0.47%.

One case was a 55-year-old woman who presented with pain and hematometra. Her preoperative endometrial biopsy was negative, and she had a preop CT. She was morcellized with endoscopy bag containment and found to have invasive cervical adenocarcinoma. The second case was a 56-year-old women morcellized in 2009 for fibroids with no preoperative imaging, biopsy, or containment bag. She was found to have a uterine sarcoma. Both patients underwent chemotherapy and are currently without evidence of disease.

Almost 90% of the morcellation cases in the series were under age 50 years, 93% had preop uterine imaging, and almost half had preoperative biopsy.

“The one thing our institution has always done, and it speaks to the low rate of sarcoma we found in our study, is that all patients are [reviewed] in a preop gynecological oncology conference, even if they are being taken to the OR for benign indications,” Dr. Ricci said.

Dr. Ricci reported having no financial disclosures.

aotto@frontlinemedcom.com

VANCOUVER– To minimize the risk of spreading occult malignancy, Johns Hopkins University in Baltimore no longer uses uterine morcellation for fibroids or hysterectomies in women over age 50 years.

Morcellation is also contraindicated under the Hopkins protocol if women have other risk factors for gynecologic cancer, including tamoxifen use, pelvic radiation, hereditary cancer syndromes, and BRCA mutations.

For women who qualify, morcellation can be performed only by high-volume surgeons who isolate their targets within an endoscopy bag to catch spills. Case peer-review, endometrial sampling, and imaging – including an MRI for fibroids – are required beforehand to rule out occult malignancy, and women must be warned of the risk of occult malignancy before opting for morcellation.

“Given the review of our institutional data and recent national debate surrounding power morcellation, our institution developed the protocol to enhance safety for women [undergoing] minimally invasive surgery for benign indications,” said Dr. Stephanie Ricci, a gynecologic oncology fellow at Hopkins.

She explained the protocol just days before the Food and Drug Administration released similar guidance, contraindicating power morcellation in peri- or postmenopausal women, and when tissue can be removed en bloc either vaginally or by mini-laparotomy, which is the case in the majority of hysterectomies and myomectomies. Women must also be warned of the risk of occult malignancy before morcellation, the agency said Nov. 24.

Taken together, the Hopkins’ protocol and the FDA’s guidance could help define the narrow pool of women for whom morcellation might still be an option, be it to preserve fertility or for some other reason.

“It’s possible that a higher rate of peer-review and preop imaging and endometrial sampling counter the risk of occult malignancy,” Dr. Ricci said at a meeting sponsored by AAGL.

Hopkins developed its rules in part based on a review led by Dr. Ricci of 424 morcellation cases there from 2005 to 2014. Two occult cancers were identified in women who underwent power morcellation, giving an incidence of 0.47%.

One case was a 55-year-old woman who presented with pain and hematometra. Her preoperative endometrial biopsy was negative, and she had a preop CT. She was morcellized with endoscopy bag containment and found to have invasive cervical adenocarcinoma. The second case was a 56-year-old women morcellized in 2009 for fibroids with no preoperative imaging, biopsy, or containment bag. She was found to have a uterine sarcoma. Both patients underwent chemotherapy and are currently without evidence of disease.

Almost 90% of the morcellation cases in the series were under age 50 years, 93% had preop uterine imaging, and almost half had preoperative biopsy.

“The one thing our institution has always done, and it speaks to the low rate of sarcoma we found in our study, is that all patients are [reviewed] in a preop gynecological oncology conference, even if they are being taken to the OR for benign indications,” Dr. Ricci said.

Dr. Ricci reported having no financial disclosures.

aotto@frontlinemedcom.com

VANCOUVER– To minimize the risk of spreading occult malignancy, Johns Hopkins University in Baltimore no longer uses uterine morcellation for fibroids or hysterectomies in women over age 50 years.

Morcellation is also contraindicated under the Hopkins protocol if women have other risk factors for gynecologic cancer, including tamoxifen use, pelvic radiation, hereditary cancer syndromes, and BRCA mutations.

For women who qualify, morcellation can be performed only by high-volume surgeons who isolate their targets within an endoscopy bag to catch spills. Case peer-review, endometrial sampling, and imaging – including an MRI for fibroids – are required beforehand to rule out occult malignancy, and women must be warned of the risk of occult malignancy before opting for morcellation.

“Given the review of our institutional data and recent national debate surrounding power morcellation, our institution developed the protocol to enhance safety for women [undergoing] minimally invasive surgery for benign indications,” said Dr. Stephanie Ricci, a gynecologic oncology fellow at Hopkins.

She explained the protocol just days before the Food and Drug Administration released similar guidance, contraindicating power morcellation in peri- or postmenopausal women, and when tissue can be removed en bloc either vaginally or by mini-laparotomy, which is the case in the majority of hysterectomies and myomectomies. Women must also be warned of the risk of occult malignancy before morcellation, the agency said Nov. 24.

Taken together, the Hopkins’ protocol and the FDA’s guidance could help define the narrow pool of women for whom morcellation might still be an option, be it to preserve fertility or for some other reason.

“It’s possible that a higher rate of peer-review and preop imaging and endometrial sampling counter the risk of occult malignancy,” Dr. Ricci said at a meeting sponsored by AAGL.

Hopkins developed its rules in part based on a review led by Dr. Ricci of 424 morcellation cases there from 2005 to 2014. Two occult cancers were identified in women who underwent power morcellation, giving an incidence of 0.47%.

One case was a 55-year-old woman who presented with pain and hematometra. Her preoperative endometrial biopsy was negative, and she had a preop CT. She was morcellized with endoscopy bag containment and found to have invasive cervical adenocarcinoma. The second case was a 56-year-old women morcellized in 2009 for fibroids with no preoperative imaging, biopsy, or containment bag. She was found to have a uterine sarcoma. Both patients underwent chemotherapy and are currently without evidence of disease.

Almost 90% of the morcellation cases in the series were under age 50 years, 93% had preop uterine imaging, and almost half had preoperative biopsy.

“The one thing our institution has always done, and it speaks to the low rate of sarcoma we found in our study, is that all patients are [reviewed] in a preop gynecological oncology conference, even if they are being taken to the OR for benign indications,” Dr. Ricci said.

Dr. Ricci reported having no financial disclosures.

aotto@frontlinemedcom.com

VANCOUVER, B.C. – The incidence of unsuspected uterine sarcoma found during surgery for other conditions is low, according to three cohort studies reported at the meeting, sponsored by AAGL.

In one study, researchers at Mount Sinai Hospital in New York City retrospectively studied 815 consecutive women who underwent laparoscopic supracervical hysterectomy or laparoscopic myomectomy with power morcellation at the hospital between 2006 and 2013.

Pathology of the morcellated uteri identified endometrial carcinoma in two patients (one with prolapse and one with a presumed prolapsing fibroid), for an incidence of 0.25%, according to Dr. Charles J. Ascher-Walsh, associate professor of obstetrics, gynecology, and reproductive science at Mount Sinai, and lead author of the study.

None of the patients were found to have a uterine sarcoma or any other cancer.

“There’s obviously very little data sort of looking forward on the risk of morcellating endometrial cancers. It doesn’t seem so far to significantly worsen the prognosis in these patients. There have been a few reviews looking at a cost-effectiveness analysis in biopsying postmenopausal asymptomatic patients who are having prolapse surgery, and so far the conclusions in both of those studies have shown that it’s not cost-effective to biopsy these patients,” Dr. Ascher-Walsh said. “Now I know there are institutions that are biopsying them anyway, and certainly as part of the revamp of people’s protocols with the morcellation debate, I think more institutions are starting to automatically biopsy every patient before morcellation.”

Total laparoscopic hysterectomies were not included in the study, because Dr. Ascher-Walsh usually performs that operation by vaginal approach, he said. “I wanted to focus just on the intra-abdominal morcellation technique. But obviously, in the debate, whether you cut into it vaginally or cut into it with an open myomectomy, you can potentially have the same concerns and risks.”

Mount Sinai has modified its policy on performing morcellation, somewhat, as a result of the ongoing debate, Dr. Ascher-Walsh said.

“We continue to do morcellation, but before doing morcellation, if we don’t have documentation of a typically growing fibroid, or if somebody presents with a large fibroid without any evidence of slow growth over time, we will get an MRI, although the evidence isn’t supportive of MRIs being diagnostic, other than the one study that combined it with [lactate dehydrogenase],” he said.

In the second study, a team led by Dr. Nichole Mahnert, a fellow in obstetrics and gynecology at the University of Michigan, Ann Arbor, used the Michigan Surgical Quality Collaborative database to prospectively study 6,360 women who underwent hysterectomy for a benign indication during 2013.

Pathology identified unexpected uterine sarcoma in 0.22% of patients (1 in 454) overall, and in 0.27% of patients (1 in 370) whose indication for surgery was specifically fibroids. These values are generally on par with the 0.28% of women operated on for fibroids (1 in 352) seen in the Food and Drug Administration assessment, she said.

In the cohort overall, prior venous thromboembolism and preoperative blood transfusion tended to be more common among patients later found to have uterine sarcoma.

Other cancers identified in the entire cohort included endometrial cancer (1.02%), ovarian cancer (1.06%), cervical cancer (0.17%), and metastatic cancer (0.20%).

“Comprehensive preoperative surgical counseling is paramount, and it should include not only the usual risks of surgery, but also the risk of unexpected malignancy and the risk of inadvertent morcellation of an unexpected malignancy. One should also consider the risks and benefits of a laparoscopic versus and open procedure,” Dr. Mahnert recommended. “And until we can more reliably risk-stratify patients to identify those with unexpected uterine sarcomas, we need to support technologies to limit the dissemination of specimens during minimally invasive procedures.”

In the third study, Dr. Katherine A. Hartzell, an ob.gyn. at Kaiser Permanente in San Diego, and her colleagues retrospectively reviewed the charts of all 3,523 women undergoing laparoscopic hysterectomy at the institution between 2001 and 2012.

Of the 941 cases in which power morcellation was used, uterine sarcoma was found in 6 cases or 0.6%; half were endometrial stromal sarcoma and half were leiomyosarcoma. Five of these patients had no evidence of disease after at least 31 months of follow-up. The sixth patient, who had high-grade leiomyosarcoma, died from her disease 3 years after diagnosis.

The uterine sarcoma rate of 0.6% was roughly double the 0.28% estimated by the FDA, Dr. Hartzell noted.

“This higher incidence was probably due to the inclusion of three patients with a delayed presentation of uterine sarcoma when initial pathology was benign,” she said. “These patients were likely discovered because of the captive nature of the Kaiser health care system.”

None of a wide variety of factors evaluated predicted the risk of uterine sarcoma in these patients undergoing morcellation, Dr. Hartzell said.

Among the 2,582 women who did not undergo power morcellation, uterine sarcoma was identified in 5 patients, or 0.2%. Four were alive without evidence of disease after at least 37 months of follow-up. The fifth patient, who had high-grade leiomyosarcoma, died from her disease 2 years after diagnosis.

“The patient about to undergo a minimally invasive procedure with possible power morcellation should be counseled about the possible consequences of morcellation of an undiagnosed malignancy. Alternatives such as mini-laparotomy or an open procedure should be offered. At our institution, we are also now performing morcellation within a tissue containment bag,” she said.

“Given the well-known advantages of laparoscopic surgery and the rarity of uterine sarcomas, it is our opinion that the risk of morcellation of occult malignancy is insufficient to abandon power morcellation,” Dr. Hartzell added.

The researchers reported that they had no relevant conflicts of interest.

VANCOUVER, B.C. – The incidence of unsuspected uterine sarcoma found during surgery for other conditions is low, according to three cohort studies reported at the meeting, sponsored by AAGL.

In one study, researchers at Mount Sinai Hospital in New York City retrospectively studied 815 consecutive women who underwent laparoscopic supracervical hysterectomy or laparoscopic myomectomy with power morcellation at the hospital between 2006 and 2013.

Pathology of the morcellated uteri identified endometrial carcinoma in two patients (one with prolapse and one with a presumed prolapsing fibroid), for an incidence of 0.25%, according to Dr. Charles J. Ascher-Walsh, associate professor of obstetrics, gynecology, and reproductive science at Mount Sinai, and lead author of the study.

None of the patients were found to have a uterine sarcoma or any other cancer.

“There’s obviously very little data sort of looking forward on the risk of morcellating endometrial cancers. It doesn’t seem so far to significantly worsen the prognosis in these patients. There have been a few reviews looking at a cost-effectiveness analysis in biopsying postmenopausal asymptomatic patients who are having prolapse surgery, and so far the conclusions in both of those studies have shown that it’s not cost-effective to biopsy these patients,” Dr. Ascher-Walsh said. “Now I know there are institutions that are biopsying them anyway, and certainly as part of the revamp of people’s protocols with the morcellation debate, I think more institutions are starting to automatically biopsy every patient before morcellation.”

Total laparoscopic hysterectomies were not included in the study, because Dr. Ascher-Walsh usually performs that operation by vaginal approach, he said. “I wanted to focus just on the intra-abdominal morcellation technique. But obviously, in the debate, whether you cut into it vaginally or cut into it with an open myomectomy, you can potentially have the same concerns and risks.”

Mount Sinai has modified its policy on performing morcellation, somewhat, as a result of the ongoing debate, Dr. Ascher-Walsh said.

“We continue to do morcellation, but before doing morcellation, if we don’t have documentation of a typically growing fibroid, or if somebody presents with a large fibroid without any evidence of slow growth over time, we will get an MRI, although the evidence isn’t supportive of MRIs being diagnostic, other than the one study that combined it with [lactate dehydrogenase],” he said.

In the second study, a team led by Dr. Nichole Mahnert, a fellow in obstetrics and gynecology at the University of Michigan, Ann Arbor, used the Michigan Surgical Quality Collaborative database to prospectively study 6,360 women who underwent hysterectomy for a benign indication during 2013.

Pathology identified unexpected uterine sarcoma in 0.22% of patients (1 in 454) overall, and in 0.27% of patients (1 in 370) whose indication for surgery was specifically fibroids. These values are generally on par with the 0.28% of women operated on for fibroids (1 in 352) seen in the Food and Drug Administration assessment, she said.

In the cohort overall, prior venous thromboembolism and preoperative blood transfusion tended to be more common among patients later found to have uterine sarcoma.

Other cancers identified in the entire cohort included endometrial cancer (1.02%), ovarian cancer (1.06%), cervical cancer (0.17%), and metastatic cancer (0.20%).

“Comprehensive preoperative surgical counseling is paramount, and it should include not only the usual risks of surgery, but also the risk of unexpected malignancy and the risk of inadvertent morcellation of an unexpected malignancy. One should also consider the risks and benefits of a laparoscopic versus and open procedure,” Dr. Mahnert recommended. “And until we can more reliably risk-stratify patients to identify those with unexpected uterine sarcomas, we need to support technologies to limit the dissemination of specimens during minimally invasive procedures.”

In the third study, Dr. Katherine A. Hartzell, an ob.gyn. at Kaiser Permanente in San Diego, and her colleagues retrospectively reviewed the charts of all 3,523 women undergoing laparoscopic hysterectomy at the institution between 2001 and 2012.

Of the 941 cases in which power morcellation was used, uterine sarcoma was found in 6 cases or 0.6%; half were endometrial stromal sarcoma and half were leiomyosarcoma. Five of these patients had no evidence of disease after at least 31 months of follow-up. The sixth patient, who had high-grade leiomyosarcoma, died from her disease 3 years after diagnosis.

The uterine sarcoma rate of 0.6% was roughly double the 0.28% estimated by the FDA, Dr. Hartzell noted.

“This higher incidence was probably due to the inclusion of three patients with a delayed presentation of uterine sarcoma when initial pathology was benign,” she said. “These patients were likely discovered because of the captive nature of the Kaiser health care system.”

None of a wide variety of factors evaluated predicted the risk of uterine sarcoma in these patients undergoing morcellation, Dr. Hartzell said.

Among the 2,582 women who did not undergo power morcellation, uterine sarcoma was identified in 5 patients, or 0.2%. Four were alive without evidence of disease after at least 37 months of follow-up. The fifth patient, who had high-grade leiomyosarcoma, died from her disease 2 years after diagnosis.

“The patient about to undergo a minimally invasive procedure with possible power morcellation should be counseled about the possible consequences of morcellation of an undiagnosed malignancy. Alternatives such as mini-laparotomy or an open procedure should be offered. At our institution, we are also now performing morcellation within a tissue containment bag,” she said.

“Given the well-known advantages of laparoscopic surgery and the rarity of uterine sarcomas, it is our opinion that the risk of morcellation of occult malignancy is insufficient to abandon power morcellation,” Dr. Hartzell added.

The researchers reported that they had no relevant conflicts of interest.

VANCOUVER, B.C. – The incidence of unsuspected uterine sarcoma found during surgery for other conditions is low, according to three cohort studies reported at the meeting, sponsored by AAGL.

In one study, researchers at Mount Sinai Hospital in New York City retrospectively studied 815 consecutive women who underwent laparoscopic supracervical hysterectomy or laparoscopic myomectomy with power morcellation at the hospital between 2006 and 2013.

Pathology of the morcellated uteri identified endometrial carcinoma in two patients (one with prolapse and one with a presumed prolapsing fibroid), for an incidence of 0.25%, according to Dr. Charles J. Ascher-Walsh, associate professor of obstetrics, gynecology, and reproductive science at Mount Sinai, and lead author of the study.

None of the patients were found to have a uterine sarcoma or any other cancer.

“There’s obviously very little data sort of looking forward on the risk of morcellating endometrial cancers. It doesn’t seem so far to significantly worsen the prognosis in these patients. There have been a few reviews looking at a cost-effectiveness analysis in biopsying postmenopausal asymptomatic patients who are having prolapse surgery, and so far the conclusions in both of those studies have shown that it’s not cost-effective to biopsy these patients,” Dr. Ascher-Walsh said. “Now I know there are institutions that are biopsying them anyway, and certainly as part of the revamp of people’s protocols with the morcellation debate, I think more institutions are starting to automatically biopsy every patient before morcellation.”

Total laparoscopic hysterectomies were not included in the study, because Dr. Ascher-Walsh usually performs that operation by vaginal approach, he said. “I wanted to focus just on the intra-abdominal morcellation technique. But obviously, in the debate, whether you cut into it vaginally or cut into it with an open myomectomy, you can potentially have the same concerns and risks.”

Mount Sinai has modified its policy on performing morcellation, somewhat, as a result of the ongoing debate, Dr. Ascher-Walsh said.

“We continue to do morcellation, but before doing morcellation, if we don’t have documentation of a typically growing fibroid, or if somebody presents with a large fibroid without any evidence of slow growth over time, we will get an MRI, although the evidence isn’t supportive of MRIs being diagnostic, other than the one study that combined it with [lactate dehydrogenase],” he said.

In the second study, a team led by Dr. Nichole Mahnert, a fellow in obstetrics and gynecology at the University of Michigan, Ann Arbor, used the Michigan Surgical Quality Collaborative database to prospectively study 6,360 women who underwent hysterectomy for a benign indication during 2013.

Pathology identified unexpected uterine sarcoma in 0.22% of patients (1 in 454) overall, and in 0.27% of patients (1 in 370) whose indication for surgery was specifically fibroids. These values are generally on par with the 0.28% of women operated on for fibroids (1 in 352) seen in the Food and Drug Administration assessment, she said.

In the cohort overall, prior venous thromboembolism and preoperative blood transfusion tended to be more common among patients later found to have uterine sarcoma.

Other cancers identified in the entire cohort included endometrial cancer (1.02%), ovarian cancer (1.06%), cervical cancer (0.17%), and metastatic cancer (0.20%).

“Comprehensive preoperative surgical counseling is paramount, and it should include not only the usual risks of surgery, but also the risk of unexpected malignancy and the risk of inadvertent morcellation of an unexpected malignancy. One should also consider the risks and benefits of a laparoscopic versus and open procedure,” Dr. Mahnert recommended. “And until we can more reliably risk-stratify patients to identify those with unexpected uterine sarcomas, we need to support technologies to limit the dissemination of specimens during minimally invasive procedures.”

In the third study, Dr. Katherine A. Hartzell, an ob.gyn. at Kaiser Permanente in San Diego, and her colleagues retrospectively reviewed the charts of all 3,523 women undergoing laparoscopic hysterectomy at the institution between 2001 and 2012.

Of the 941 cases in which power morcellation was used, uterine sarcoma was found in 6 cases or 0.6%; half were endometrial stromal sarcoma and half were leiomyosarcoma. Five of these patients had no evidence of disease after at least 31 months of follow-up. The sixth patient, who had high-grade leiomyosarcoma, died from her disease 3 years after diagnosis.

The uterine sarcoma rate of 0.6% was roughly double the 0.28% estimated by the FDA, Dr. Hartzell noted.

“This higher incidence was probably due to the inclusion of three patients with a delayed presentation of uterine sarcoma when initial pathology was benign,” she said. “These patients were likely discovered because of the captive nature of the Kaiser health care system.”

None of a wide variety of factors evaluated predicted the risk of uterine sarcoma in these patients undergoing morcellation, Dr. Hartzell said.

Among the 2,582 women who did not undergo power morcellation, uterine sarcoma was identified in 5 patients, or 0.2%. Four were alive without evidence of disease after at least 37 months of follow-up. The fifth patient, who had high-grade leiomyosarcoma, died from her disease 2 years after diagnosis.

“The patient about to undergo a minimally invasive procedure with possible power morcellation should be counseled about the possible consequences of morcellation of an undiagnosed malignancy. Alternatives such as mini-laparotomy or an open procedure should be offered. At our institution, we are also now performing morcellation within a tissue containment bag,” she said.

“Given the well-known advantages of laparoscopic surgery and the rarity of uterine sarcomas, it is our opinion that the risk of morcellation of occult malignancy is insufficient to abandon power morcellation,” Dr. Hartzell added.

The researchers reported that they had no relevant conflicts of interest.

VANCOUVER, B.C. – Waiting a few days to see which way beta–human chorionic gonadotropin levels are headed spares women with unruptured ectopic pregnancies from unnecessary methotrexate treatment, according to an Israeli review of 1,703 ectopic pregnancies over the course of more than 11 years.

Although prompt administration of the drug is standard practice, investigators from Tel Aviv Sourasky Medical Center found that about 40% of ectopic pregnancies resolved on their own without any treatment.

“Our clinical message is that methotrexate is overused. It’s considered a relatively safe drug, but it has its side effects,” said Dr. Yaron Gil, a gynecologist who led the study at Sourasky.

In addition to abdominal cramping and other well-known issues, methotrexate might cause damage to the surrounding fallopian tube and may cause ectopic pregnancies to enlarge, Dr. Gil said at the meeting sponsored by AAGL.

Methotrexate doesn’t resolve the risk of rupture –the main concern with watchful waiting – since ectopic pregnancies can rupture even as the beta-hCG levels decline. A day or two of watchful waiting “doesn’t change the risk of rupture,” Dr. Gil said.

All 1,703 women with ectopic pregnancy were admitted to the hospital between January 2001 and June 2013; 620 (36%) required immediate surgery. The remaining 1,083 women – all hemodynamically stable with beta-hCG levels below 10,000 mIU/mL, no fetal heart activity, and an intervention nearby – were assigned to the watchful waiting protocol.

The investigators measured beta-hCG on admission and followed it daily. Patients who had a daily decline of 15% were considered self-resolving and sent home. Women with a daily increase of 15% or more were treated with methotrexate. Those with daily increases below 15% were followed for a maximum of 5 days, and then given methotrexate.

Among the 1,083 women assigned to the watchful waiting protocol, 674 (62%) had spontaneous resolutions, while 409 (38%) had stable or increasing beta-hCG levels and received methotrexate, 50 mg/m² IM, usually once, but sometimes twice.

Methotrexate was effective in 356 (87%) of the women who received it. The remainder of the women underwent laparoscopic salpingectomies. Maternal age, parity, gestational age, endometrial thickness, and the size of the ectopic mass had no influence on whether the drug was effective.

In women with beta-hCG levels of 2,500-3,500 mIU/mL, methotrexate was effective 75% of the time. The drug was effective 65% of the time in women with beta-hCG levels greater than 4,500 mIU/mL (Am. J. Obstet. Gynecol. 2014;211:128.e1-5).

As expected, watchful waiting led to a lower rate of methotrexate success than in other reported series because the Israeli team limited use to women who truly needed it, according to Dr. Gil.

“Early administration gives higher success rates, but at the cost of giving methotrexate unnecessarily to some women,” he said. “Longer intervals should be considered before administering the drug.”

Dr. Gil said he has no financial disclosures and didn’t receive outside funding for the study.

aotto@frontlinemedcom.com

VANCOUVER, B.C. – Waiting a few days to see which way beta–human chorionic gonadotropin levels are headed spares women with unruptured ectopic pregnancies from unnecessary methotrexate treatment, according to an Israeli review of 1,703 ectopic pregnancies over the course of more than 11 years.

Although prompt administration of the drug is standard practice, investigators from Tel Aviv Sourasky Medical Center found that about 40% of ectopic pregnancies resolved on their own without any treatment.

“Our clinical message is that methotrexate is overused. It’s considered a relatively safe drug, but it has its side effects,” said Dr. Yaron Gil, a gynecologist who led the study at Sourasky.

In addition to abdominal cramping and other well-known issues, methotrexate might cause damage to the surrounding fallopian tube and may cause ectopic pregnancies to enlarge, Dr. Gil said at the meeting sponsored by AAGL.

Methotrexate doesn’t resolve the risk of rupture –the main concern with watchful waiting – since ectopic pregnancies can rupture even as the beta-hCG levels decline. A day or two of watchful waiting “doesn’t change the risk of rupture,” Dr. Gil said.

All 1,703 women with ectopic pregnancy were admitted to the hospital between January 2001 and June 2013; 620 (36%) required immediate surgery. The remaining 1,083 women – all hemodynamically stable with beta-hCG levels below 10,000 mIU/mL, no fetal heart activity, and an intervention nearby – were assigned to the watchful waiting protocol.

The investigators measured beta-hCG on admission and followed it daily. Patients who had a daily decline of 15% were considered self-resolving and sent home. Women with a daily increase of 15% or more were treated with methotrexate. Those with daily increases below 15% were followed for a maximum of 5 days, and then given methotrexate.

Among the 1,083 women assigned to the watchful waiting protocol, 674 (62%) had spontaneous resolutions, while 409 (38%) had stable or increasing beta-hCG levels and received methotrexate, 50 mg/m² IM, usually once, but sometimes twice.

Methotrexate was effective in 356 (87%) of the women who received it. The remainder of the women underwent laparoscopic salpingectomies. Maternal age, parity, gestational age, endometrial thickness, and the size of the ectopic mass had no influence on whether the drug was effective.

In women with beta-hCG levels of 2,500-3,500 mIU/mL, methotrexate was effective 75% of the time. The drug was effective 65% of the time in women with beta-hCG levels greater than 4,500 mIU/mL (Am. J. Obstet. Gynecol. 2014;211:128.e1-5).

As expected, watchful waiting led to a lower rate of methotrexate success than in other reported series because the Israeli team limited use to women who truly needed it, according to Dr. Gil.

“Early administration gives higher success rates, but at the cost of giving methotrexate unnecessarily to some women,” he said. “Longer intervals should be considered before administering the drug.”

Dr. Gil said he has no financial disclosures and didn’t receive outside funding for the study.

aotto@frontlinemedcom.com

VANCOUVER, B.C. – Waiting a few days to see which way beta–human chorionic gonadotropin levels are headed spares women with unruptured ectopic pregnancies from unnecessary methotrexate treatment, according to an Israeli review of 1,703 ectopic pregnancies over the course of more than 11 years.

Although prompt administration of the drug is standard practice, investigators from Tel Aviv Sourasky Medical Center found that about 40% of ectopic pregnancies resolved on their own without any treatment.

“Our clinical message is that methotrexate is overused. It’s considered a relatively safe drug, but it has its side effects,” said Dr. Yaron Gil, a gynecologist who led the study at Sourasky.

In addition to abdominal cramping and other well-known issues, methotrexate might cause damage to the surrounding fallopian tube and may cause ectopic pregnancies to enlarge, Dr. Gil said at the meeting sponsored by AAGL.

Methotrexate doesn’t resolve the risk of rupture –the main concern with watchful waiting – since ectopic pregnancies can rupture even as the beta-hCG levels decline. A day or two of watchful waiting “doesn’t change the risk of rupture,” Dr. Gil said.

All 1,703 women with ectopic pregnancy were admitted to the hospital between January 2001 and June 2013; 620 (36%) required immediate surgery. The remaining 1,083 women – all hemodynamically stable with beta-hCG levels below 10,000 mIU/mL, no fetal heart activity, and an intervention nearby – were assigned to the watchful waiting protocol.

The investigators measured beta-hCG on admission and followed it daily. Patients who had a daily decline of 15% were considered self-resolving and sent home. Women with a daily increase of 15% or more were treated with methotrexate. Those with daily increases below 15% were followed for a maximum of 5 days, and then given methotrexate.

Among the 1,083 women assigned to the watchful waiting protocol, 674 (62%) had spontaneous resolutions, while 409 (38%) had stable or increasing beta-hCG levels and received methotrexate, 50 mg/m² IM, usually once, but sometimes twice.

Methotrexate was effective in 356 (87%) of the women who received it. The remainder of the women underwent laparoscopic salpingectomies. Maternal age, parity, gestational age, endometrial thickness, and the size of the ectopic mass had no influence on whether the drug was effective.

In women with beta-hCG levels of 2,500-3,500 mIU/mL, methotrexate was effective 75% of the time. The drug was effective 65% of the time in women with beta-hCG levels greater than 4,500 mIU/mL (Am. J. Obstet. Gynecol. 2014;211:128.e1-5).

As expected, watchful waiting led to a lower rate of methotrexate success than in other reported series because the Israeli team limited use to women who truly needed it, according to Dr. Gil.

“Early administration gives higher success rates, but at the cost of giving methotrexate unnecessarily to some women,” he said. “Longer intervals should be considered before administering the drug.”

Dr. Gil said he has no financial disclosures and didn’t receive outside funding for the study.

aotto@frontlinemedcom.com

VANCOUVER, B.C. – Bleeding from uterine arteriovenous malformations was stopped with a combination of tranexamic acid, gonadotropin-releasing hormone agonist, and an aromatase inhibitor in a small case series in Canada.

The cocktail appears to be a safe alternative to uterine artery embolization and hysterectomy, which allows women to remain fertile, said Dr. Angelos Vilos, an ob.gyn. at Western University in London, Ontario, and the study’ lead investigator.

Dr. Vilos and his team used uterine tamponade to control bleeding, then gave the women oral tranexamic acid for 5 days. Patients also received a GnRH agonist – usually one injection of leuprolide – with oral letrozole for 5 days after the injection. In all cases, the arteriovenous malformations resolved within 3 months.

In a video interview at the AAGL meeting, Dr. Vilos said the approach could be a “game changer” if it holds up in future testing.

aotto@frontlinemedcom.com

VANCOUVER, B.C. – Bleeding from uterine arteriovenous malformations was stopped with a combination of tranexamic acid, gonadotropin-releasing hormone agonist, and an aromatase inhibitor in a small case series in Canada.

The cocktail appears to be a safe alternative to uterine artery embolization and hysterectomy, which allows women to remain fertile, said Dr. Angelos Vilos, an ob.gyn. at Western University in London, Ontario, and the study’ lead investigator.

Dr. Vilos and his team used uterine tamponade to control bleeding, then gave the women oral tranexamic acid for 5 days. Patients also received a GnRH agonist – usually one injection of leuprolide – with oral letrozole for 5 days after the injection. In all cases, the arteriovenous malformations resolved within 3 months.

In a video interview at the AAGL meeting, Dr. Vilos said the approach could be a “game changer” if it holds up in future testing.

aotto@frontlinemedcom.com

VANCOUVER, B.C. – Bleeding from uterine arteriovenous malformations was stopped with a combination of tranexamic acid, gonadotropin-releasing hormone agonist, and an aromatase inhibitor in a small case series in Canada.

The cocktail appears to be a safe alternative to uterine artery embolization and hysterectomy, which allows women to remain fertile, said Dr. Angelos Vilos, an ob.gyn. at Western University in London, Ontario, and the study’ lead investigator.

Dr. Vilos and his team used uterine tamponade to control bleeding, then gave the women oral tranexamic acid for 5 days. Patients also received a GnRH agonist – usually one injection of leuprolide – with oral letrozole for 5 days after the injection. In all cases, the arteriovenous malformations resolved within 3 months.

In a video interview at the AAGL meeting, Dr. Vilos said the approach could be a “game changer” if it holds up in future testing.

aotto@frontlinemedcom.com

VANCOUVER, B.C. – The media played a major role in determining the fate of uterine morcellation, suggested a study reported at a meeting sponsored by AAGL.

“How did we lose this battle of uterine morcellation? We lost it in the media,” asserted lead investigator Dr. Adrian C. Balica, director of the minimally invasive gynecologic surgery program at the Robert Wood Johnson Medical School in New Brunswick, N.J.

He and his colleagues used the Google Adwords Keyword Planner to collect Internet search data for a variety of relevant terms used in 2013 and in 2014 through August.

This interval spanned events that included the first report of the issue in the mainstream media (December 2013), the Food and Drug Administration’s initial statement discouraging use of power morcellation for uterine fibroids (April 2014), and the issuance of analyses and rebuttals by several medical professional associations (May 2104 and thereafter).

Subsequent to the AAGL meeting, the FDA issued a new warning on Nov. 24, 2014, not to use power morcellation in 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.

Results showed that the average monthly number of Google searches for the term “morcellation” held steady throughout most of 2013 at about 250 per month, reported Dr. Balica. There was, however, a sharp uptick in December 2013 to more than 2,000 per month, and the number continued to rise to a peak of about 18,000 per month in July 2014. A similar pattern was seen for the terms “morcellator,” “fibroids in uterus,” and “morcellation of uterine fibroid.”

Additionally, there were virtually no searches for “power morcellation” in 2013, but there were about 1,900 per month at the peak in April 2014. Much the same pattern was seen for “power morcellator,” he said.

Dr. Balica noted that the rapid cascade of events set into motion has had a profound impact for the field, including banning of morcellation at many hospitals and Johnson & Johnson withdrawing its power morcellator, which accounted for an estimated 72% of the devices used, from the market.

“Medical and surgical practice is going to be changed by the media,” he predicted. Thus, studying how the morcellator controversy unfolded in this venue can help inform strategies for addressing public perceptions.

His own hospital has stopped using power morcellation, according to Dr. Balica. “This is just the battle. Hopefully, we aren’t going to lose the war,” he concluded.

Dr. Balica disclosed that he had no relevant conflicts of interest.

VANCOUVER, B.C. – The media played a major role in determining the fate of uterine morcellation, suggested a study reported at a meeting sponsored by AAGL.

“How did we lose this battle of uterine morcellation? We lost it in the media,” asserted lead investigator Dr. Adrian C. Balica, director of the minimally invasive gynecologic surgery program at the Robert Wood Johnson Medical School in New Brunswick, N.J.

He and his colleagues used the Google Adwords Keyword Planner to collect Internet search data for a variety of relevant terms used in 2013 and in 2014 through August.

This interval spanned events that included the first report of the issue in the mainstream media (December 2013), the Food and Drug Administration’s initial statement discouraging use of power morcellation for uterine fibroids (April 2014), and the issuance of analyses and rebuttals by several medical professional associations (May 2104 and thereafter).

Subsequent to the AAGL meeting, the FDA issued a new warning on Nov. 24, 2014, not to use power morcellation in 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.

Results showed that the average monthly number of Google searches for the term “morcellation” held steady throughout most of 2013 at about 250 per month, reported Dr. Balica. There was, however, a sharp uptick in December 2013 to more than 2,000 per month, and the number continued to rise to a peak of about 18,000 per month in July 2014. A similar pattern was seen for the terms “morcellator,” “fibroids in uterus,” and “morcellation of uterine fibroid.”

Additionally, there were virtually no searches for “power morcellation” in 2013, but there were about 1,900 per month at the peak in April 2014. Much the same pattern was seen for “power morcellator,” he said.

Dr. Balica noted that the rapid cascade of events set into motion has had a profound impact for the field, including banning of morcellation at many hospitals and Johnson & Johnson withdrawing its power morcellator, which accounted for an estimated 72% of the devices used, from the market.

“Medical and surgical practice is going to be changed by the media,” he predicted. Thus, studying how the morcellator controversy unfolded in this venue can help inform strategies for addressing public perceptions.

His own hospital has stopped using power morcellation, according to Dr. Balica. “This is just the battle. Hopefully, we aren’t going to lose the war,” he concluded.

Dr. Balica disclosed that he had no relevant conflicts of interest.

VANCOUVER, B.C. – The media played a major role in determining the fate of uterine morcellation, suggested a study reported at a meeting sponsored by AAGL.

“How did we lose this battle of uterine morcellation? We lost it in the media,” asserted lead investigator Dr. Adrian C. Balica, director of the minimally invasive gynecologic surgery program at the Robert Wood Johnson Medical School in New Brunswick, N.J.

He and his colleagues used the Google Adwords Keyword Planner to collect Internet search data for a variety of relevant terms used in 2013 and in 2014 through August.

This interval spanned events that included the first report of the issue in the mainstream media (December 2013), the Food and Drug Administration’s initial statement discouraging use of power morcellation for uterine fibroids (April 2014), and the issuance of analyses and rebuttals by several medical professional associations (May 2104 and thereafter).

Subsequent to the AAGL meeting, the FDA issued a new warning on Nov. 24, 2014, not to use power morcellation in 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.

Results showed that the average monthly number of Google searches for the term “morcellation” held steady throughout most of 2013 at about 250 per month, reported Dr. Balica. There was, however, a sharp uptick in December 2013 to more than 2,000 per month, and the number continued to rise to a peak of about 18,000 per month in July 2014. A similar pattern was seen for the terms “morcellator,” “fibroids in uterus,” and “morcellation of uterine fibroid.”

Additionally, there were virtually no searches for “power morcellation” in 2013, but there were about 1,900 per month at the peak in April 2014. Much the same pattern was seen for “power morcellator,” he said.

Dr. Balica noted that the rapid cascade of events set into motion has had a profound impact for the field, including banning of morcellation at many hospitals and Johnson & Johnson withdrawing its power morcellator, which accounted for an estimated 72% of the devices used, from the market.

“Medical and surgical practice is going to be changed by the media,” he predicted. Thus, studying how the morcellator controversy unfolded in this venue can help inform strategies for addressing public perceptions.

His own hospital has stopped using power morcellation, according to Dr. Balica. “This is just the battle. Hopefully, we aren’t going to lose the war,” he concluded.

Dr. Balica disclosed that he had no relevant conflicts of interest.

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.

aotto@frontlinemedcom.com

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.

aotto@frontlinemedcom.com

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.

aotto@frontlinemedcom.com