Bruce Jancin

CHICAGO – Testosterone replacement therapy may provide a pharmacologic alternative to bariatric surgery in severely obese hypogonadal men.

Mean body mass index in 46 hypogonadal men with grade III obesity dropped from 41.9 to 33.6 kg/m2 while they were receiving testosterone undecanoate at 1,000 mg by intramuscular injection every 12 weeks for up to 6 years, Farid Saad, Ph.D., reported at the joint meeting of the International Congress of Endocrinology and the Endocrine Society.

The subjects, with a mean age was 60 years, were culled from two prospective registries totaling 561 men with a serum total testosterone of 12.1 nmol/L or less along with symptoms of testosterone deficiency. These 46 men were selected for the analysis because a BMI of 40 kg/m² or more is an indication for bariatric surgery, and the impact of testosterone replacement in hypogonadal men with grade III obesity has not previously been studied, explained Dr. Saad, director of scientific affairs at Bayer Pharma in Berlin.

Mean body weight in this group decreased from 129 to 103 kg. Weight loss grew over time: The men averaged a 2.7% reduction in body weight after 1 year of testosterone therapy, 7.3% after 2 years, 10.9% after 3 years, 14.1% after 4 years, 17.4% after 5 years, and a 20.8% decrease from baseline body weight after 6 years of therapy.

Mean waist circumference shrunk from 118.4 cm at baseline to 106.5 cm.

On the basis of these long-term results, testosterone replacement therapy appears to be an effective means of achieving sustained weight loss in severely obese hypogonadal men, he concluded.

The registry study was funded by Bayer Pharma, which markets testosterone undecanoate as Aveed.

CHICAGO – Testosterone replacement therapy may provide a pharmacologic alternative to bariatric surgery in severely obese hypogonadal men.

Mean body mass index in 46 hypogonadal men with grade III obesity dropped from 41.9 to 33.6 kg/m2 while they were receiving testosterone undecanoate at 1,000 mg by intramuscular injection every 12 weeks for up to 6 years, Farid Saad, Ph.D., reported at the joint meeting of the International Congress of Endocrinology and the Endocrine Society.

The subjects, with a mean age was 60 years, were culled from two prospective registries totaling 561 men with a serum total testosterone of 12.1 nmol/L or less along with symptoms of testosterone deficiency. These 46 men were selected for the analysis because a BMI of 40 kg/m² or more is an indication for bariatric surgery, and the impact of testosterone replacement in hypogonadal men with grade III obesity has not previously been studied, explained Dr. Saad, director of scientific affairs at Bayer Pharma in Berlin.

Mean body weight in this group decreased from 129 to 103 kg. Weight loss grew over time: The men averaged a 2.7% reduction in body weight after 1 year of testosterone therapy, 7.3% after 2 years, 10.9% after 3 years, 14.1% after 4 years, 17.4% after 5 years, and a 20.8% decrease from baseline body weight after 6 years of therapy.

Mean waist circumference shrunk from 118.4 cm at baseline to 106.5 cm.

On the basis of these long-term results, testosterone replacement therapy appears to be an effective means of achieving sustained weight loss in severely obese hypogonadal men, he concluded.

The registry study was funded by Bayer Pharma, which markets testosterone undecanoate as Aveed.

CHICAGO – Testosterone replacement therapy may provide a pharmacologic alternative to bariatric surgery in severely obese hypogonadal men.

Mean body mass index in 46 hypogonadal men with grade III obesity dropped from 41.9 to 33.6 kg/m2 while they were receiving testosterone undecanoate at 1,000 mg by intramuscular injection every 12 weeks for up to 6 years, Farid Saad, Ph.D., reported at the joint meeting of the International Congress of Endocrinology and the Endocrine Society.

The subjects, with a mean age was 60 years, were culled from two prospective registries totaling 561 men with a serum total testosterone of 12.1 nmol/L or less along with symptoms of testosterone deficiency. These 46 men were selected for the analysis because a BMI of 40 kg/m² or more is an indication for bariatric surgery, and the impact of testosterone replacement in hypogonadal men with grade III obesity has not previously been studied, explained Dr. Saad, director of scientific affairs at Bayer Pharma in Berlin.

Mean body weight in this group decreased from 129 to 103 kg. Weight loss grew over time: The men averaged a 2.7% reduction in body weight after 1 year of testosterone therapy, 7.3% after 2 years, 10.9% after 3 years, 14.1% after 4 years, 17.4% after 5 years, and a 20.8% decrease from baseline body weight after 6 years of therapy.

Mean waist circumference shrunk from 118.4 cm at baseline to 106.5 cm.

On the basis of these long-term results, testosterone replacement therapy appears to be an effective means of achieving sustained weight loss in severely obese hypogonadal men, he concluded.

The registry study was funded by Bayer Pharma, which markets testosterone undecanoate as Aveed.

CHICAGO – Testosterone replacement therapy may provide a pharmacologic alternative to bariatric surgery in severely obese hypogonadal men.

Mean body mass index in 46 hypogonadal men with grade III obesity dropped from 41.9 to 33.6 kg/m2 while they were receiving testosterone undecanoate at 1,000 mg by intramuscular injection every 12 weeks for up to 6 years, Farid Saad, Ph.D., reported at the joint meeting of the International Congress of Endocrinology and the Endocrine Society.

The subjects, with a mean age was 60 years, were culled from two prospective registries totaling 561 men with a serum total testosterone of 12.1 nmol/L or less along with symptoms of testosterone deficiency. These 46 men were selected for the analysis because a BMI of 40 kg/m² or more is an indication for bariatric surgery, and the impact of testosterone replacement in hypogonadal men with grade III obesity has not previously been studied, explained Dr. Saad, director of scientific affairs at Bayer Pharma in Berlin.

Mean body weight in this group decreased from 129 to 103 kg. Weight loss grew over time: The men averaged a 2.7% reduction in body weight after 1 year of testosterone therapy, 7.3% after 2 years, 10.9% after 3 years, 14.1% after 4 years, 17.4% after 5 years, and a 20.8% decrease from baseline body weight after 6 years of therapy.

Mean waist circumference shrunk from 118.4 cm at baseline to 106.5 cm.

On the basis of these long-term results, testosterone replacement therapy appears to be an effective means of achieving sustained weight loss in severely obese hypogonadal men, he concluded.

The registry study was funded by Bayer Pharma, which markets testosterone undecanoate as Aveed.

bjancin@frontlinemedcom.com

CHICAGO – Testosterone replacement therapy may provide a pharmacologic alternative to bariatric surgery in severely obese hypogonadal men.

Mean body mass index in 46 hypogonadal men with grade III obesity dropped from 41.9 to 33.6 kg/m2 while they were receiving testosterone undecanoate at 1,000 mg by intramuscular injection every 12 weeks for up to 6 years, Farid Saad, Ph.D., reported at the joint meeting of the International Congress of Endocrinology and the Endocrine Society.

The subjects, with a mean age was 60 years, were culled from two prospective registries totaling 561 men with a serum total testosterone of 12.1 nmol/L or less along with symptoms of testosterone deficiency. These 46 men were selected for the analysis because a BMI of 40 kg/m² or more is an indication for bariatric surgery, and the impact of testosterone replacement in hypogonadal men with grade III obesity has not previously been studied, explained Dr. Saad, director of scientific affairs at Bayer Pharma in Berlin.

Mean body weight in this group decreased from 129 to 103 kg. Weight loss grew over time: The men averaged a 2.7% reduction in body weight after 1 year of testosterone therapy, 7.3% after 2 years, 10.9% after 3 years, 14.1% after 4 years, 17.4% after 5 years, and a 20.8% decrease from baseline body weight after 6 years of therapy.

Mean waist circumference shrunk from 118.4 cm at baseline to 106.5 cm.

On the basis of these long-term results, testosterone replacement therapy appears to be an effective means of achieving sustained weight loss in severely obese hypogonadal men, he concluded.

The registry study was funded by Bayer Pharma, which markets testosterone undecanoate as Aveed.

bjancin@frontlinemedcom.com

CHICAGO – Testosterone replacement therapy may provide a pharmacologic alternative to bariatric surgery in severely obese hypogonadal men.

Mean body mass index in 46 hypogonadal men with grade III obesity dropped from 41.9 to 33.6 kg/m2 while they were receiving testosterone undecanoate at 1,000 mg by intramuscular injection every 12 weeks for up to 6 years, Farid Saad, Ph.D., reported at the joint meeting of the International Congress of Endocrinology and the Endocrine Society.

The subjects, with a mean age was 60 years, were culled from two prospective registries totaling 561 men with a serum total testosterone of 12.1 nmol/L or less along with symptoms of testosterone deficiency. These 46 men were selected for the analysis because a BMI of 40 kg/m² or more is an indication for bariatric surgery, and the impact of testosterone replacement in hypogonadal men with grade III obesity has not previously been studied, explained Dr. Saad, director of scientific affairs at Bayer Pharma in Berlin.

Mean body weight in this group decreased from 129 to 103 kg. Weight loss grew over time: The men averaged a 2.7% reduction in body weight after 1 year of testosterone therapy, 7.3% after 2 years, 10.9% after 3 years, 14.1% after 4 years, 17.4% after 5 years, and a 20.8% decrease from baseline body weight after 6 years of therapy.

Mean waist circumference shrunk from 118.4 cm at baseline to 106.5 cm.

On the basis of these long-term results, testosterone replacement therapy appears to be an effective means of achieving sustained weight loss in severely obese hypogonadal men, he concluded.

The registry study was funded by Bayer Pharma, which markets testosterone undecanoate as Aveed.

bjancin@frontlinemedcom.com

LAS VEGAS – Routine use of mesh reinforcement when performing laparoscopic repair of hiatal hernia defects 5 cm or larger in diameter is associated with a low recurrence rate, Dr. Chetan V. Aher reported at the annual Minimally Invasive Surgery Week.

His coinvestigators had shown in an earlier randomized controlled trial that mesh reinforcement of primary cruroplasty in patients with a hernia of 8 cm or greater was associated with no recurrences. Repair with simple cruroplasty was associated with a 22% recurrence rate (Arch. Surg. 2002;137:649-52).

However, Dr. Aher and his coinvestigators subsequently observed a high recurrence rate following mesh-free simple cruroplasty for defects in the 5- to 8-cm range. He presented a case series involving 1,094 laparoscopic hiatal hernia repairs performed since he and his colleagues changed their practice by lowering their threshold for polytetrafluoroethylene mesh reinforcement to defects of at least 5 cm from their prior standard of 8 cm or more.

Hernias were less than 5 cm in diameter in 84% of the patients, so mesh wasn’t used for those repairs. In the remaining 178 patients – those with hernias of at least 5 cm – PTFE mesh was utilized to circumferentially reinforce the cruroplasty.

During a mean follow-up of 3.1 years, the hernia recurrence rate was 1.7% in the group with hernia defects of less than 5 cm and similar at 1.1% in those who received mesh reinforcement because their hernias were larger, reported Dr. Aher of Rush University Medical Center in Chicago.

Operative time and length of stay were longer in the mesh reinforcement group (see chart).

“There’s more dissection when using mesh, and obviously the placement of the mesh takes a little longer,” he noted at the meeting presented by the Society of Laparoscopic Surgeons and affiliated societies.

All repairs were performed using cruroplasty with interrupted nonabsorbable sutures approximating the right and left bundles of the right crura.

Laparoscopic repair has become the standard approach in the primary repair of hiatal hernias. In a 2010 survey of members of the Society of Gastrointestinal and Endoscopic Surgeons conducted by Dr. Aher’s colleagues, respondents indicated they laparoscopically performed 77% of their mesh-reinforced repairs. However, the survey results underscored a lack of consensus within the surgical community regarding mesh usage. Biologic mesh was used by 28% of surgeons; 25% used PTFE (polytetrafluoroethylene), and 21% polypropylene. Mesh placement practices also varied widely: 14% of surgeons utilized anterior placement, 34% posterior, and only 10% circumferential (Surg. Endosc. 2010;24:1017-24).

Asked how he counsels patients about the competing risks of mesh erosion and hernia recurrence in the absence of mesh reinforcement, Dr. Aher pointed to the 22% recurrence risk with large hernias in the earlier randomized trial.

“I would counsel my own family that if you have a large hernia, the risk of mesh erosion is very low and the risk of undergoing a recurrent operation if there is no mesh reinforcement is, I think, overall higher. So I would say they should get the mesh reinforcement,” he concluded.

Dr. Aher reported having no financial conflicts regarding this study.

bjancin@frontlinemedcom.com

LAS VEGAS – Routine use of mesh reinforcement when performing laparoscopic repair of hiatal hernia defects 5 cm or larger in diameter is associated with a low recurrence rate, Dr. Chetan V. Aher reported at the annual Minimally Invasive Surgery Week.

His coinvestigators had shown in an earlier randomized controlled trial that mesh reinforcement of primary cruroplasty in patients with a hernia of 8 cm or greater was associated with no recurrences. Repair with simple cruroplasty was associated with a 22% recurrence rate (Arch. Surg. 2002;137:649-52).

However, Dr. Aher and his coinvestigators subsequently observed a high recurrence rate following mesh-free simple cruroplasty for defects in the 5- to 8-cm range. He presented a case series involving 1,094 laparoscopic hiatal hernia repairs performed since he and his colleagues changed their practice by lowering their threshold for polytetrafluoroethylene mesh reinforcement to defects of at least 5 cm from their prior standard of 8 cm or more.

Hernias were less than 5 cm in diameter in 84% of the patients, so mesh wasn’t used for those repairs. In the remaining 178 patients – those with hernias of at least 5 cm – PTFE mesh was utilized to circumferentially reinforce the cruroplasty.

During a mean follow-up of 3.1 years, the hernia recurrence rate was 1.7% in the group with hernia defects of less than 5 cm and similar at 1.1% in those who received mesh reinforcement because their hernias were larger, reported Dr. Aher of Rush University Medical Center in Chicago.

Operative time and length of stay were longer in the mesh reinforcement group (see chart).

“There’s more dissection when using mesh, and obviously the placement of the mesh takes a little longer,” he noted at the meeting presented by the Society of Laparoscopic Surgeons and affiliated societies.

All repairs were performed using cruroplasty with interrupted nonabsorbable sutures approximating the right and left bundles of the right crura.

Laparoscopic repair has become the standard approach in the primary repair of hiatal hernias. In a 2010 survey of members of the Society of Gastrointestinal and Endoscopic Surgeons conducted by Dr. Aher’s colleagues, respondents indicated they laparoscopically performed 77% of their mesh-reinforced repairs. However, the survey results underscored a lack of consensus within the surgical community regarding mesh usage. Biologic mesh was used by 28% of surgeons; 25% used PTFE (polytetrafluoroethylene), and 21% polypropylene. Mesh placement practices also varied widely: 14% of surgeons utilized anterior placement, 34% posterior, and only 10% circumferential (Surg. Endosc. 2010;24:1017-24).

Asked how he counsels patients about the competing risks of mesh erosion and hernia recurrence in the absence of mesh reinforcement, Dr. Aher pointed to the 22% recurrence risk with large hernias in the earlier randomized trial.

“I would counsel my own family that if you have a large hernia, the risk of mesh erosion is very low and the risk of undergoing a recurrent operation if there is no mesh reinforcement is, I think, overall higher. So I would say they should get the mesh reinforcement,” he concluded.

Dr. Aher reported having no financial conflicts regarding this study.

bjancin@frontlinemedcom.com

LAS VEGAS – Routine use of mesh reinforcement when performing laparoscopic repair of hiatal hernia defects 5 cm or larger in diameter is associated with a low recurrence rate, Dr. Chetan V. Aher reported at the annual Minimally Invasive Surgery Week.

His coinvestigators had shown in an earlier randomized controlled trial that mesh reinforcement of primary cruroplasty in patients with a hernia of 8 cm or greater was associated with no recurrences. Repair with simple cruroplasty was associated with a 22% recurrence rate (Arch. Surg. 2002;137:649-52).

However, Dr. Aher and his coinvestigators subsequently observed a high recurrence rate following mesh-free simple cruroplasty for defects in the 5- to 8-cm range. He presented a case series involving 1,094 laparoscopic hiatal hernia repairs performed since he and his colleagues changed their practice by lowering their threshold for polytetrafluoroethylene mesh reinforcement to defects of at least 5 cm from their prior standard of 8 cm or more.

Hernias were less than 5 cm in diameter in 84% of the patients, so mesh wasn’t used for those repairs. In the remaining 178 patients – those with hernias of at least 5 cm – PTFE mesh was utilized to circumferentially reinforce the cruroplasty.

During a mean follow-up of 3.1 years, the hernia recurrence rate was 1.7% in the group with hernia defects of less than 5 cm and similar at 1.1% in those who received mesh reinforcement because their hernias were larger, reported Dr. Aher of Rush University Medical Center in Chicago.

Operative time and length of stay were longer in the mesh reinforcement group (see chart).

“There’s more dissection when using mesh, and obviously the placement of the mesh takes a little longer,” he noted at the meeting presented by the Society of Laparoscopic Surgeons and affiliated societies.

All repairs were performed using cruroplasty with interrupted nonabsorbable sutures approximating the right and left bundles of the right crura.

Laparoscopic repair has become the standard approach in the primary repair of hiatal hernias. In a 2010 survey of members of the Society of Gastrointestinal and Endoscopic Surgeons conducted by Dr. Aher’s colleagues, respondents indicated they laparoscopically performed 77% of their mesh-reinforced repairs. However, the survey results underscored a lack of consensus within the surgical community regarding mesh usage. Biologic mesh was used by 28% of surgeons; 25% used PTFE (polytetrafluoroethylene), and 21% polypropylene. Mesh placement practices also varied widely: 14% of surgeons utilized anterior placement, 34% posterior, and only 10% circumferential (Surg. Endosc. 2010;24:1017-24).

Asked how he counsels patients about the competing risks of mesh erosion and hernia recurrence in the absence of mesh reinforcement, Dr. Aher pointed to the 22% recurrence risk with large hernias in the earlier randomized trial.

“I would counsel my own family that if you have a large hernia, the risk of mesh erosion is very low and the risk of undergoing a recurrent operation if there is no mesh reinforcement is, I think, overall higher. So I would say they should get the mesh reinforcement,” he concluded.

Dr. Aher reported having no financial conflicts regarding this study.

bjancin@frontlinemedcom.com

LAS VEGAS – Gynecologists, general surgeons, and primary care physicians now share an unprecedented opportunity to put a major dent in the incidence of ovarian cancer, according to Dr. Farr R. Nezhat.

Mounting evidence suggests that identification and complete surgical removal of endometriosis reduce the risk of several histologic types of ovarian cancer. So when a woman visits her primary care physician for pelvic pain or vaginal bleeding that might be due to endometrial pathology, or a general surgeon finds asymptomatic endometriosis during pelvic surgery, these encounters provide an opportunity for preventive intervention, explained Dr. Nezhat, professor of ob.gyn. and director of minimally invasive surgery and gynecologic robotics at Mount Sinai Medical Center, New York.

The latest thinking about the pathophysiology of ovarian cancer, he noted, is that there are two different types of the malignancy. One type, which likely arises from endometriosis as the precursor lesion, is characterized by low-grade serous, clear cell, and endometrioid carcinomas, which tend to present at an earlier stage and are more indolent. They are associated with mutations in the PTEN, BCL2, and ARID1A genes.

A pooled analysis of 13 ovarian cancer case-control studies conducted by investigators in the Ovarian Cancer Association Consortium made the point that women with endometriosis are at increased risk of specific subtypes of the malignancy. The analysis, which included 7,911 women with invasive ovarian cancer, 1,907 others with borderline ovarian cancer, and more than 13,000 controls, concluded that women with a self-reported history of endometriosis had a 3.05-fold increased risk of clear cell invasive ovarian cancer, compared with controls, a 2.04-fold increased risk of endometrioid ovarian cancer, and a 2.11-fold greater likelihood of low-grade serous ovarian cancer.

In contrast, no association was apparent between endometriosis and the risk of high-grade serous or mucinous invasive ovarian cancer or borderline tumors. Thus, the pathogenesis of low- and high-grade serous ovarian cancers may differ (Lancet Oncol. 2012;13:385-94).

Dr. Nezhat cited as another influential study a Swedish national registry case-control study involving all Swedes with a first-time hospital discharge diagnosis of endometriosis during 1969-2007. The cases in this study were all 220 Swedish women diagnosed with epithelial ovarian cancer at least 1 year after their endometriosis was diagnosed. Each was matched with two controls with no ovarian cancer diagnosis before the date of the case’s cancer diagnosis.

This was the first published study to demonstrate that treatment of endometriosis has a salutary impact on subsequent risk of ovarian cancer. Complete surgical removal of all visible endometriotic tissue was associated with a 63% reduction in the risk of ovarian cancer in a univariate analysis and a 70% relative risk reduction in a multivariate analysis. One-sided oophorectomy involving the endometriosis-involved ovary was similarly associated with a 58% risk reduction for ovarian cancer in a univariate analysis and an 81% reduction in risk in a multivariate analysis (Acta Obstet. Gynecol. Scand. 2013:92:546-54).

An earlier study in which Dr. Nezhat was senior author highlighted that different histologic types of early-stage ovarian carcinoma feature distinctive patterns of clinical symptoms. The study included 76 consecutive patients with FIGO stage I ovarian carcinoma, of which 54 – that is, more than two-thirds – were nonserous, which is a much higher proportion than is seen in women diagnosed with stage III and IV disease.

Most patients with serous papillary carcinoma in this series presented with an asymptomatic pelvic mass. In contrast, most of those with endometrioid or clear cell carcinoma presented with pelvic pain or abnormal vaginal bleeding with or without a pelvic mass (Fertil. Steril. 2007;88:906-10).

Endometrioisis is a pervasive condition. Dr. Nezhat said the endometriosis patients he considers to be at possible increased risk for ovarian cancer include those with longstanding endometriosis, a history of infertility, endometriosis diagnosed at an early age, as well as those with ovarian endometriomas. Eventually it will be possible to pin down more precisely the ovarian cancer risk of an individual with endometriosis through screening for genetic mutations, but the evidence base isn’t yet sufficient to introduce this into everyday practice, he said.

One audience member said it’s her practice and that of many of her gynecologic colleagues that when they incidentally find a patient has asymptomatic endometriosis, for example, during surgery for ectopic pregnancy, they will often leave it in place, even if it is quite severe. Is it time to rethink that practice and instead remove all visible endometriosis, even if the patient is asymptomatic? she asked.

“The short answer is, Yes,” Dr. Nezhat replied. “The most important thing is that when you do surgery, remove it all or else do biopsies to make sure you’re not leaving early ovarian cancer behind. Draining endometriomas is not adequate.”

He reported having no relevant financial conflicts.

bjancin@frontlinemedcom.com

LAS VEGAS – Gynecologists, general surgeons, and primary care physicians now share an unprecedented opportunity to put a major dent in the incidence of ovarian cancer, according to Dr. Farr R. Nezhat.

Mounting evidence suggests that identification and complete surgical removal of endometriosis reduce the risk of several histologic types of ovarian cancer. So when a woman visits her primary care physician for pelvic pain or vaginal bleeding that might be due to endometrial pathology, or a general surgeon finds asymptomatic endometriosis during pelvic surgery, these encounters provide an opportunity for preventive intervention, explained Dr. Nezhat, professor of ob.gyn. and director of minimally invasive surgery and gynecologic robotics at Mount Sinai Medical Center, New York.

The latest thinking about the pathophysiology of ovarian cancer, he noted, is that there are two different types of the malignancy. One type, which likely arises from endometriosis as the precursor lesion, is characterized by low-grade serous, clear cell, and endometrioid carcinomas, which tend to present at an earlier stage and are more indolent. They are associated with mutations in the PTEN, BCL2, and ARID1A genes.

A pooled analysis of 13 ovarian cancer case-control studies conducted by investigators in the Ovarian Cancer Association Consortium made the point that women with endometriosis are at increased risk of specific subtypes of the malignancy. The analysis, which included 7,911 women with invasive ovarian cancer, 1,907 others with borderline ovarian cancer, and more than 13,000 controls, concluded that women with a self-reported history of endometriosis had a 3.05-fold increased risk of clear cell invasive ovarian cancer, compared with controls, a 2.04-fold increased risk of endometrioid ovarian cancer, and a 2.11-fold greater likelihood of low-grade serous ovarian cancer.

In contrast, no association was apparent between endometriosis and the risk of high-grade serous or mucinous invasive ovarian cancer or borderline tumors. Thus, the pathogenesis of low- and high-grade serous ovarian cancers may differ (Lancet Oncol. 2012;13:385-94).

Dr. Nezhat cited as another influential study a Swedish national registry case-control study involving all Swedes with a first-time hospital discharge diagnosis of endometriosis during 1969-2007. The cases in this study were all 220 Swedish women diagnosed with epithelial ovarian cancer at least 1 year after their endometriosis was diagnosed. Each was matched with two controls with no ovarian cancer diagnosis before the date of the case’s cancer diagnosis.

This was the first published study to demonstrate that treatment of endometriosis has a salutary impact on subsequent risk of ovarian cancer. Complete surgical removal of all visible endometriotic tissue was associated with a 63% reduction in the risk of ovarian cancer in a univariate analysis and a 70% relative risk reduction in a multivariate analysis. One-sided oophorectomy involving the endometriosis-involved ovary was similarly associated with a 58% risk reduction for ovarian cancer in a univariate analysis and an 81% reduction in risk in a multivariate analysis (Acta Obstet. Gynecol. Scand. 2013:92:546-54).

An earlier study in which Dr. Nezhat was senior author highlighted that different histologic types of early-stage ovarian carcinoma feature distinctive patterns of clinical symptoms. The study included 76 consecutive patients with FIGO stage I ovarian carcinoma, of which 54 – that is, more than two-thirds – were nonserous, which is a much higher proportion than is seen in women diagnosed with stage III and IV disease.

Most patients with serous papillary carcinoma in this series presented with an asymptomatic pelvic mass. In contrast, most of those with endometrioid or clear cell carcinoma presented with pelvic pain or abnormal vaginal bleeding with or without a pelvic mass (Fertil. Steril. 2007;88:906-10).

Endometrioisis is a pervasive condition. Dr. Nezhat said the endometriosis patients he considers to be at possible increased risk for ovarian cancer include those with longstanding endometriosis, a history of infertility, endometriosis diagnosed at an early age, as well as those with ovarian endometriomas. Eventually it will be possible to pin down more precisely the ovarian cancer risk of an individual with endometriosis through screening for genetic mutations, but the evidence base isn’t yet sufficient to introduce this into everyday practice, he said.

One audience member said it’s her practice and that of many of her gynecologic colleagues that when they incidentally find a patient has asymptomatic endometriosis, for example, during surgery for ectopic pregnancy, they will often leave it in place, even if it is quite severe. Is it time to rethink that practice and instead remove all visible endometriosis, even if the patient is asymptomatic? she asked.

“The short answer is, Yes,” Dr. Nezhat replied. “The most important thing is that when you do surgery, remove it all or else do biopsies to make sure you’re not leaving early ovarian cancer behind. Draining endometriomas is not adequate.”

He reported having no relevant financial conflicts.

bjancin@frontlinemedcom.com

LAS VEGAS – Gynecologists, general surgeons, and primary care physicians now share an unprecedented opportunity to put a major dent in the incidence of ovarian cancer, according to Dr. Farr R. Nezhat.

Mounting evidence suggests that identification and complete surgical removal of endometriosis reduce the risk of several histologic types of ovarian cancer. So when a woman visits her primary care physician for pelvic pain or vaginal bleeding that might be due to endometrial pathology, or a general surgeon finds asymptomatic endometriosis during pelvic surgery, these encounters provide an opportunity for preventive intervention, explained Dr. Nezhat, professor of ob.gyn. and director of minimally invasive surgery and gynecologic robotics at Mount Sinai Medical Center, New York.

The latest thinking about the pathophysiology of ovarian cancer, he noted, is that there are two different types of the malignancy. One type, which likely arises from endometriosis as the precursor lesion, is characterized by low-grade serous, clear cell, and endometrioid carcinomas, which tend to present at an earlier stage and are more indolent. They are associated with mutations in the PTEN, BCL2, and ARID1A genes.

A pooled analysis of 13 ovarian cancer case-control studies conducted by investigators in the Ovarian Cancer Association Consortium made the point that women with endometriosis are at increased risk of specific subtypes of the malignancy. The analysis, which included 7,911 women with invasive ovarian cancer, 1,907 others with borderline ovarian cancer, and more than 13,000 controls, concluded that women with a self-reported history of endometriosis had a 3.05-fold increased risk of clear cell invasive ovarian cancer, compared with controls, a 2.04-fold increased risk of endometrioid ovarian cancer, and a 2.11-fold greater likelihood of low-grade serous ovarian cancer.

In contrast, no association was apparent between endometriosis and the risk of high-grade serous or mucinous invasive ovarian cancer or borderline tumors. Thus, the pathogenesis of low- and high-grade serous ovarian cancers may differ (Lancet Oncol. 2012;13:385-94).

Dr. Nezhat cited as another influential study a Swedish national registry case-control study involving all Swedes with a first-time hospital discharge diagnosis of endometriosis during 1969-2007. The cases in this study were all 220 Swedish women diagnosed with epithelial ovarian cancer at least 1 year after their endometriosis was diagnosed. Each was matched with two controls with no ovarian cancer diagnosis before the date of the case’s cancer diagnosis.

This was the first published study to demonstrate that treatment of endometriosis has a salutary impact on subsequent risk of ovarian cancer. Complete surgical removal of all visible endometriotic tissue was associated with a 63% reduction in the risk of ovarian cancer in a univariate analysis and a 70% relative risk reduction in a multivariate analysis. One-sided oophorectomy involving the endometriosis-involved ovary was similarly associated with a 58% risk reduction for ovarian cancer in a univariate analysis and an 81% reduction in risk in a multivariate analysis (Acta Obstet. Gynecol. Scand. 2013:92:546-54).

An earlier study in which Dr. Nezhat was senior author highlighted that different histologic types of early-stage ovarian carcinoma feature distinctive patterns of clinical symptoms. The study included 76 consecutive patients with FIGO stage I ovarian carcinoma, of which 54 – that is, more than two-thirds – were nonserous, which is a much higher proportion than is seen in women diagnosed with stage III and IV disease.

Most patients with serous papillary carcinoma in this series presented with an asymptomatic pelvic mass. In contrast, most of those with endometrioid or clear cell carcinoma presented with pelvic pain or abnormal vaginal bleeding with or without a pelvic mass (Fertil. Steril. 2007;88:906-10).

Endometrioisis is a pervasive condition. Dr. Nezhat said the endometriosis patients he considers to be at possible increased risk for ovarian cancer include those with longstanding endometriosis, a history of infertility, endometriosis diagnosed at an early age, as well as those with ovarian endometriomas. Eventually it will be possible to pin down more precisely the ovarian cancer risk of an individual with endometriosis through screening for genetic mutations, but the evidence base isn’t yet sufficient to introduce this into everyday practice, he said.

One audience member said it’s her practice and that of many of her gynecologic colleagues that when they incidentally find a patient has asymptomatic endometriosis, for example, during surgery for ectopic pregnancy, they will often leave it in place, even if it is quite severe. Is it time to rethink that practice and instead remove all visible endometriosis, even if the patient is asymptomatic? she asked.

“The short answer is, Yes,” Dr. Nezhat replied. “The most important thing is that when you do surgery, remove it all or else do biopsies to make sure you’re not leaving early ovarian cancer behind. Draining endometriomas is not adequate.”

He reported having no relevant financial conflicts.

bjancin@frontlinemedcom.com

BARCELONA – A low- and fixed-dose combination of perindopril 3.5 mg/amlodipine 2.5 mg once daily showed considerable promise as a potential first-step treatment in mild to moderate hypertension in a large, international, randomized trial.

The 8-week, double-blind, placebo- and active-controlled trial involved 1,297 patients, of whom 1,073 completed the study. The fixed-dose combo showed reductions in mean 24-hour blood pressure that were clinically meaningful and significantly greater than in patients randomized to perindopril monotherapy at 5 mg/day or placebo, Dr. Gianfranco Parati reported at the annual congress of the European Society of Cardiology.

Twenty-four–hour BP reductions in the lower-dose perindopril/amlodipine combination group were virtually identical to those seen in patients assigned to amlodipine monotherapy at 5 mg/day. However, the fixed-dose combo was better tolerated, with an incidence of peripheral edema of 1.6%, compared with 4.9% in patients on amlodipine at 5 mg/day.

Moreover, the rate of treatment withdrawal due to adverse effects was 1.2% with combination therapy compared to 2.6% with perindopril at 5 mg/day and 3.4% with amlodipine at 5 mg/day, added Dr. Parati of the University of Milan.

The decrease in mean 24-hour systolic BP in the lower-dose combo group was 3.8 mm Hg greater than with higher-dose perindopril monotherapy and 6.2 mm Hg greater than with placebo. The reduction in mean 24-hour diastolic BP with the fixed-dose combo was 2.4 mm Hg greater than with perindopril at 5 mg/day and 4.0 mm Hg more than with placebo.

The lower-dose combination also performed well in terms of the secondary endpoints of diurnal and nocturnal blood pressure lowering, as well as BP lowering during the previous 6 hours and in the morning.

Dr. Parati noted that current guidelines, as well as guidance from regulatory agencies, emphasize the high rate of uncontrolled hypertension and take a favorable view of the early use of fixed-dose combinations in patients with uncomplicated hypertension as a means of addressing the problem.

He received a research grant from Servier, which funded the multicenter study.

bjancin@frontlinemedcom.com

BARCELONA – A low- and fixed-dose combination of perindopril 3.5 mg/amlodipine 2.5 mg once daily showed considerable promise as a potential first-step treatment in mild to moderate hypertension in a large, international, randomized trial.

The 8-week, double-blind, placebo- and active-controlled trial involved 1,297 patients, of whom 1,073 completed the study. The fixed-dose combo showed reductions in mean 24-hour blood pressure that were clinically meaningful and significantly greater than in patients randomized to perindopril monotherapy at 5 mg/day or placebo, Dr. Gianfranco Parati reported at the annual congress of the European Society of Cardiology.

Twenty-four–hour BP reductions in the lower-dose perindopril/amlodipine combination group were virtually identical to those seen in patients assigned to amlodipine monotherapy at 5 mg/day. However, the fixed-dose combo was better tolerated, with an incidence of peripheral edema of 1.6%, compared with 4.9% in patients on amlodipine at 5 mg/day.

Moreover, the rate of treatment withdrawal due to adverse effects was 1.2% with combination therapy compared to 2.6% with perindopril at 5 mg/day and 3.4% with amlodipine at 5 mg/day, added Dr. Parati of the University of Milan.

The decrease in mean 24-hour systolic BP in the lower-dose combo group was 3.8 mm Hg greater than with higher-dose perindopril monotherapy and 6.2 mm Hg greater than with placebo. The reduction in mean 24-hour diastolic BP with the fixed-dose combo was 2.4 mm Hg greater than with perindopril at 5 mg/day and 4.0 mm Hg more than with placebo.

The lower-dose combination also performed well in terms of the secondary endpoints of diurnal and nocturnal blood pressure lowering, as well as BP lowering during the previous 6 hours and in the morning.

Dr. Parati noted that current guidelines, as well as guidance from regulatory agencies, emphasize the high rate of uncontrolled hypertension and take a favorable view of the early use of fixed-dose combinations in patients with uncomplicated hypertension as a means of addressing the problem.

He received a research grant from Servier, which funded the multicenter study.

bjancin@frontlinemedcom.com

BARCELONA – A low- and fixed-dose combination of perindopril 3.5 mg/amlodipine 2.5 mg once daily showed considerable promise as a potential first-step treatment in mild to moderate hypertension in a large, international, randomized trial.

The 8-week, double-blind, placebo- and active-controlled trial involved 1,297 patients, of whom 1,073 completed the study. The fixed-dose combo showed reductions in mean 24-hour blood pressure that were clinically meaningful and significantly greater than in patients randomized to perindopril monotherapy at 5 mg/day or placebo, Dr. Gianfranco Parati reported at the annual congress of the European Society of Cardiology.

Twenty-four–hour BP reductions in the lower-dose perindopril/amlodipine combination group were virtually identical to those seen in patients assigned to amlodipine monotherapy at 5 mg/day. However, the fixed-dose combo was better tolerated, with an incidence of peripheral edema of 1.6%, compared with 4.9% in patients on amlodipine at 5 mg/day.

Moreover, the rate of treatment withdrawal due to adverse effects was 1.2% with combination therapy compared to 2.6% with perindopril at 5 mg/day and 3.4% with amlodipine at 5 mg/day, added Dr. Parati of the University of Milan.

The decrease in mean 24-hour systolic BP in the lower-dose combo group was 3.8 mm Hg greater than with higher-dose perindopril monotherapy and 6.2 mm Hg greater than with placebo. The reduction in mean 24-hour diastolic BP with the fixed-dose combo was 2.4 mm Hg greater than with perindopril at 5 mg/day and 4.0 mm Hg more than with placebo.

The lower-dose combination also performed well in terms of the secondary endpoints of diurnal and nocturnal blood pressure lowering, as well as BP lowering during the previous 6 hours and in the morning.

Dr. Parati noted that current guidelines, as well as guidance from regulatory agencies, emphasize the high rate of uncontrolled hypertension and take a favorable view of the early use of fixed-dose combinations in patients with uncomplicated hypertension as a means of addressing the problem.

He received a research grant from Servier, which funded the multicenter study.

bjancin@frontlinemedcom.com

CHICAGO – Growth hormone therapy appears to protect against fractures in adults with growth hormone deficiency and no history of osteoporosis, according to an analysis from the HypoCCS study.

In contrast, growth hormone (GH)-deficient patients with preexisting osteoporosis are another story. GH replacement didn’t affect fracture risk in that subgroup of participants in HypoCCS (the Hypopituitary Control and Complications Study), Christopher J. Child, Ph.D., reported at the joint meeting of the International Congress of Endocrinology and the Endocrine Society. It’s well established that GH-deficient adults have lower bone mass and a two- to fivefold increased risk of fractures, compared with controls. Moreover, GH replacement therapy has been shown to increase bone-mineral density and bone-mass density and produce salutary effects on bone turnover markers.

Bruce Jancin/Frontline Medical News

But HypoCCS is the first prospective controlled study to suggest long-term GH therapy actually prevents fractures in adults with GH deficiency, noted Dr. Child of Lilly Research Laboratories in Windlesham, England.

He presented a retrospective analysis of prospectively collected data from the observational study, which included 8,374 GH-treated adults and 1,267 untreated controls, all with GH deficiency alone or in combination with other pituitary hormone deficiencies.

During a mean follow-up of 4.6 years in the GH-treated group, the combined incidence of vertebral and nonvertebral fractures was 11.9/1,000 person-years, compared with 19.1/1,000 person-years in controls, for a 37% relative risk reduction. The risk of vertebral fractures was 45% lower in the GH-treated patients; nonvertebral fractures were decreased by 32%.

In a multivariate Cox proportionate regression analysis, the protective effect of GH replacement therapy remained significant after adjustment for the common fracture risk factors, including age greater than 60 years, female gender, depression, the use of corticosteroids, and increased body weight. Dr. Child stressed in an interview that physicians shouldn’t take these HypoCCS findings as the final word on the issue of whether growth hormone replacement prevents fractures in GH-deficient adults. While this is the first-ever analysis of fracture risk from a long-term adult GH replacement study, as in any nonrandomized observational study selection bias is a possibility. And data were lacking on several potentially important confounding factors, including participants’ alcohol and calcium intake, as well as their level of physical activity.

Still, he said, the notion that GH replacement therapy may have a reduction in fracture risk as a side benefit is attractive.

He is an employee of Eli Lilly, which funds HypoCCS.

bjancin@frontlinemedcom.com

CHICAGO – Growth hormone therapy appears to protect against fractures in adults with growth hormone deficiency and no history of osteoporosis, according to an analysis from the HypoCCS study.

In contrast, growth hormone (GH)-deficient patients with preexisting osteoporosis are another story. GH replacement didn’t affect fracture risk in that subgroup of participants in HypoCCS (the Hypopituitary Control and Complications Study), Christopher J. Child, Ph.D., reported at the joint meeting of the International Congress of Endocrinology and the Endocrine Society. It’s well established that GH-deficient adults have lower bone mass and a two- to fivefold increased risk of fractures, compared with controls. Moreover, GH replacement therapy has been shown to increase bone-mineral density and bone-mass density and produce salutary effects on bone turnover markers.

Bruce Jancin/Frontline Medical News

But HypoCCS is the first prospective controlled study to suggest long-term GH therapy actually prevents fractures in adults with GH deficiency, noted Dr. Child of Lilly Research Laboratories in Windlesham, England.

He presented a retrospective analysis of prospectively collected data from the observational study, which included 8,374 GH-treated adults and 1,267 untreated controls, all with GH deficiency alone or in combination with other pituitary hormone deficiencies.

During a mean follow-up of 4.6 years in the GH-treated group, the combined incidence of vertebral and nonvertebral fractures was 11.9/1,000 person-years, compared with 19.1/1,000 person-years in controls, for a 37% relative risk reduction. The risk of vertebral fractures was 45% lower in the GH-treated patients; nonvertebral fractures were decreased by 32%.

In a multivariate Cox proportionate regression analysis, the protective effect of GH replacement therapy remained significant after adjustment for the common fracture risk factors, including age greater than 60 years, female gender, depression, the use of corticosteroids, and increased body weight. Dr. Child stressed in an interview that physicians shouldn’t take these HypoCCS findings as the final word on the issue of whether growth hormone replacement prevents fractures in GH-deficient adults. While this is the first-ever analysis of fracture risk from a long-term adult GH replacement study, as in any nonrandomized observational study selection bias is a possibility. And data were lacking on several potentially important confounding factors, including participants’ alcohol and calcium intake, as well as their level of physical activity.

Still, he said, the notion that GH replacement therapy may have a reduction in fracture risk as a side benefit is attractive.

He is an employee of Eli Lilly, which funds HypoCCS.

bjancin@frontlinemedcom.com

CHICAGO – Growth hormone therapy appears to protect against fractures in adults with growth hormone deficiency and no history of osteoporosis, according to an analysis from the HypoCCS study.

In contrast, growth hormone (GH)-deficient patients with preexisting osteoporosis are another story. GH replacement didn’t affect fracture risk in that subgroup of participants in HypoCCS (the Hypopituitary Control and Complications Study), Christopher J. Child, Ph.D., reported at the joint meeting of the International Congress of Endocrinology and the Endocrine Society. It’s well established that GH-deficient adults have lower bone mass and a two- to fivefold increased risk of fractures, compared with controls. Moreover, GH replacement therapy has been shown to increase bone-mineral density and bone-mass density and produce salutary effects on bone turnover markers.

Bruce Jancin/Frontline Medical News

But HypoCCS is the first prospective controlled study to suggest long-term GH therapy actually prevents fractures in adults with GH deficiency, noted Dr. Child of Lilly Research Laboratories in Windlesham, England.

He presented a retrospective analysis of prospectively collected data from the observational study, which included 8,374 GH-treated adults and 1,267 untreated controls, all with GH deficiency alone or in combination with other pituitary hormone deficiencies.

During a mean follow-up of 4.6 years in the GH-treated group, the combined incidence of vertebral and nonvertebral fractures was 11.9/1,000 person-years, compared with 19.1/1,000 person-years in controls, for a 37% relative risk reduction. The risk of vertebral fractures was 45% lower in the GH-treated patients; nonvertebral fractures were decreased by 32%.

In a multivariate Cox proportionate regression analysis, the protective effect of GH replacement therapy remained significant after adjustment for the common fracture risk factors, including age greater than 60 years, female gender, depression, the use of corticosteroids, and increased body weight. Dr. Child stressed in an interview that physicians shouldn’t take these HypoCCS findings as the final word on the issue of whether growth hormone replacement prevents fractures in GH-deficient adults. While this is the first-ever analysis of fracture risk from a long-term adult GH replacement study, as in any nonrandomized observational study selection bias is a possibility. And data were lacking on several potentially important confounding factors, including participants’ alcohol and calcium intake, as well as their level of physical activity.

Still, he said, the notion that GH replacement therapy may have a reduction in fracture risk as a side benefit is attractive.

He is an employee of Eli Lilly, which funds HypoCCS.

bjancin@frontlinemedcom.com

BARCELONA – In what is being called “the healthy immigrant effect,” Canadian investigators have found that adult diabetic immigrants from low-income countries with high cardiovascular mortality rates are relatively protected against cardiovascular events, compared with matched long-time or lifetime Canadian residents. This healthy immigrant effect appears to last for at least a decade following the immigrants’ arrival in their new land, and perhaps longer, Dr. Karen Okrainec reported at the annual congress of the European Society of Cardiology. Ontario is fertile territory in which to study the health of immigrants. Fully 43% of Ontario residents are foreign born, the highest proportion in all of Canada’s provinces, noted Dr. Okrainec of the University of Toronto.

She presented a population-based cohort study involving 87,707 adult diabetic subjects who immigrated to Ontario during 1965-2005 and an equal number of long-term or lifetime diabetic Ontario residents matched for age, sex, and neighborhood. Most of the immigrants came from South Asia and East Asia, although there were also significant numbers from the Caribbean, Sub-Saharan Africa, North Africa, and the Middle East, and Eastern and Western Europe. The immigrants had been in Canada for a mean of 11.6 years at the time of the analysis.

The primary outcome in the study was the composite endpoint of all-cause mortality or one or more hospitalizations or emergency department visits for acute MI, heart failure, unstable angina, stroke, or TIA between April 2005 and February 2012. There were 13,685 of these events among the immigrants, for an event rate of 2.4 cases/100 person-years.

This was fully 32% lower than the unadjusted event rate among the control group.

After researchers adjusted for years since diagnosis of diabetes, education level, income, the presence of hypertension, and other comorbid conditions, language barriers, marital status, and other potential confounders, they found that the risk of the composite endpoint remained 24% lower in immigrants than controls. Thus, it is clear there is not an accelerated risk of cardiovascular events among diabetic immigrants, despite their change in lifestyle in moving to a highly developed country where they may encounter cultural or language barriers to health care access, according to Dr. Okrainec.

Not all immigrants benefited from the healthy immigrant effect, however. Refugees did not. Neither did those who were single, nor did immigrants from Eastern and Central Europe or Latin America. Also, the healthy immigrant effect – the diabetic immigrants’ health advantage over longer-term Ontario residents – appeared to grow stronger with time; in other words, the healthy immigrant effect was weaker in those who arrived in Ontario less than 10 years earlier.

Dr. Okrainec’s study was funded by the Ontario Ministry of Health and Long-Term Care. She reported having no financial conflicts.

bjancin@frontlinemedcom.com

BARCELONA – In what is being called “the healthy immigrant effect,” Canadian investigators have found that adult diabetic immigrants from low-income countries with high cardiovascular mortality rates are relatively protected against cardiovascular events, compared with matched long-time or lifetime Canadian residents. This healthy immigrant effect appears to last for at least a decade following the immigrants’ arrival in their new land, and perhaps longer, Dr. Karen Okrainec reported at the annual congress of the European Society of Cardiology. Ontario is fertile territory in which to study the health of immigrants. Fully 43% of Ontario residents are foreign born, the highest proportion in all of Canada’s provinces, noted Dr. Okrainec of the University of Toronto.

She presented a population-based cohort study involving 87,707 adult diabetic subjects who immigrated to Ontario during 1965-2005 and an equal number of long-term or lifetime diabetic Ontario residents matched for age, sex, and neighborhood. Most of the immigrants came from South Asia and East Asia, although there were also significant numbers from the Caribbean, Sub-Saharan Africa, North Africa, and the Middle East, and Eastern and Western Europe. The immigrants had been in Canada for a mean of 11.6 years at the time of the analysis.

The primary outcome in the study was the composite endpoint of all-cause mortality or one or more hospitalizations or emergency department visits for acute MI, heart failure, unstable angina, stroke, or TIA between April 2005 and February 2012. There were 13,685 of these events among the immigrants, for an event rate of 2.4 cases/100 person-years.

This was fully 32% lower than the unadjusted event rate among the control group.

After researchers adjusted for years since diagnosis of diabetes, education level, income, the presence of hypertension, and other comorbid conditions, language barriers, marital status, and other potential confounders, they found that the risk of the composite endpoint remained 24% lower in immigrants than controls. Thus, it is clear there is not an accelerated risk of cardiovascular events among diabetic immigrants, despite their change in lifestyle in moving to a highly developed country where they may encounter cultural or language barriers to health care access, according to Dr. Okrainec.

Not all immigrants benefited from the healthy immigrant effect, however. Refugees did not. Neither did those who were single, nor did immigrants from Eastern and Central Europe or Latin America. Also, the healthy immigrant effect – the diabetic immigrants’ health advantage over longer-term Ontario residents – appeared to grow stronger with time; in other words, the healthy immigrant effect was weaker in those who arrived in Ontario less than 10 years earlier.

Dr. Okrainec’s study was funded by the Ontario Ministry of Health and Long-Term Care. She reported having no financial conflicts.

bjancin@frontlinemedcom.com

BARCELONA – In what is being called “the healthy immigrant effect,” Canadian investigators have found that adult diabetic immigrants from low-income countries with high cardiovascular mortality rates are relatively protected against cardiovascular events, compared with matched long-time or lifetime Canadian residents. This healthy immigrant effect appears to last for at least a decade following the immigrants’ arrival in their new land, and perhaps longer, Dr. Karen Okrainec reported at the annual congress of the European Society of Cardiology. Ontario is fertile territory in which to study the health of immigrants. Fully 43% of Ontario residents are foreign born, the highest proportion in all of Canada’s provinces, noted Dr. Okrainec of the University of Toronto.

She presented a population-based cohort study involving 87,707 adult diabetic subjects who immigrated to Ontario during 1965-2005 and an equal number of long-term or lifetime diabetic Ontario residents matched for age, sex, and neighborhood. Most of the immigrants came from South Asia and East Asia, although there were also significant numbers from the Caribbean, Sub-Saharan Africa, North Africa, and the Middle East, and Eastern and Western Europe. The immigrants had been in Canada for a mean of 11.6 years at the time of the analysis.

The primary outcome in the study was the composite endpoint of all-cause mortality or one or more hospitalizations or emergency department visits for acute MI, heart failure, unstable angina, stroke, or TIA between April 2005 and February 2012. There were 13,685 of these events among the immigrants, for an event rate of 2.4 cases/100 person-years.

This was fully 32% lower than the unadjusted event rate among the control group.

After researchers adjusted for years since diagnosis of diabetes, education level, income, the presence of hypertension, and other comorbid conditions, language barriers, marital status, and other potential confounders, they found that the risk of the composite endpoint remained 24% lower in immigrants than controls. Thus, it is clear there is not an accelerated risk of cardiovascular events among diabetic immigrants, despite their change in lifestyle in moving to a highly developed country where they may encounter cultural or language barriers to health care access, according to Dr. Okrainec.

Not all immigrants benefited from the healthy immigrant effect, however. Refugees did not. Neither did those who were single, nor did immigrants from Eastern and Central Europe or Latin America. Also, the healthy immigrant effect – the diabetic immigrants’ health advantage over longer-term Ontario residents – appeared to grow stronger with time; in other words, the healthy immigrant effect was weaker in those who arrived in Ontario less than 10 years earlier.

Dr. Okrainec’s study was funded by the Ontario Ministry of Health and Long-Term Care. She reported having no financial conflicts.

bjancin@frontlinemedcom.com

LAS VEGAS – Removing the fallopian tubes at the time of pelvic surgeries as a potential means of reducing ovarian cancer risk appears to be a movement that’s picking up steam in clinical practice.

A recent survey of 234 U.S. gynecologists showed prophylactic bilateral salpingectomy is catching on when performed in conjunction with hysterectomy, but far less so for tubal sterilization, Dr. Austin Findley observed at the annual Minimally Invasive Surgery Week.

A total of 54% of respondents indicated they routinely perform salpingectomy at the time of hysterectomy in an effort to reduce the risk of ovarian cancer as well as to avoid the need for reoperations. However, only 7% of the gynecologic surgeons said they perform salpingectomy for tubal sterilization, even though 58% of respondents stated they believe the procedure is the most effective form of tubal sterilization (J. Minim. Invasive Gynecol. 2013;20:517-21).

“In my experience at various hospitals, I think these numbers are a pretty accurate reflection of what folks are doing,” commented Dr. Findley of Wright State University in Dayton, Ohio.

The prophylactic salpingectomy movement is an outgrowth of the tubal hypothesis of ovarian cancer.

“There is now increasing and dramatic evidence to suggest that most ovarian cancers actually originate in the distal fallopian tubes. I think this is a concept most people are unaware of or are just becoming accustomed to. The tubal hypothesis represents a major paradigm shift in the way we think about ovarian cancers. The previous belief that excessive ovulation is a cause of ovarian cancer is no longer regarded as accurate,” he explained at the meeting presented by the Society of Laparoscopic Surgeons and affiliated societies.

Ovarian cancer is the No. 1 cause of mortality from gynecologic malignancy, accounting for more than 14,000 deaths per year, according to National Cancer Institute data. The lifetime risk of the malignancy is 1.3%, with the average age at diagnosis being 63 years.

Only 10%-15% of ovarian cancers occur in women at high risk for the malignancy because they carry a BRCA mutation or other predisposing gene. The vast majority of ovarian cancer deaths are caused by high-grade serous tumors that have been shown to be strongly associated with precursor lesions in the distal fallopian tubes of women at low risk for the malignancy.

There is no proven-effective screening program or risk-reduction method for these low-risk women. However, with 600,000 hysterectomies and 700,000 tubal sterilizations being performed annually in the United States, prophylactic salpingectomy has been advocated as an attractive opportunity to potentially reduce ovarian cancer risk. Other common pelvic surgeries in which it might be used for this purpose include excision of endometriosis and laparoscopy for pelvic pain. It also has recently been shown to be feasible and safe post partum at cesarean or vaginal delivery (Obstet. Gynecol. 2014 [doi: 10.1097/01.AOG.0000447427.80479.ae]).

But the key word here is “potentially.” It must be emphasized that at present the ovarian cancer prevention benefit of prophylactic salpingectomy remains hypothetical; in theory, the procedure should reduce ovarian cancer risk, but there is not yet persuasive evidence that it actually does, Dr. Findley emphasized at the meeting, presented by the Society of Laparoendoscopic Surgeons and affiliated societies.

In contrast, one well-established ancillary benefit of prophylactic salpingectomy is that it eliminates the need for future reoperation for salpingectomy. This was demonstrated in a large Danish cohort study including close to 10,000 women undergoing hysterectomy and a similar number undergoing sterilization procedures. Among the nearly two-thirds of hysterectomy patients who had both fallopian tubes retained, there was a 2.13-fold increased likelihood of subsequent salpingectomy, compared with nonhysterectomized women.

Similarly, Danish women who underwent a sterilization procedure with retention of the fallopian tubes – typically tubal ligation with clips – were 2.42 times more likely to undergo subsequent salpingectomy, most often because of the development of hydrosalpinx, infection, ectopic pregnancy, or other complications (BMJ Open 2013;3 [doi:10.1136/bmjopen-2013-002845]).

The most commonly cited potential risk of prophylactic salpingectomy – decreased ovarian function – now appears to be a nonissue. This was demonstrated in a recent retrospective Italian study (Gynecol. Oncol. 2013;129:448-51) as well as in a pilot randomized controlled trial conducted by Dr. Findley and his coworkers (Fertil. Steril. 2013;100:1704-8), which appears to have answered many skeptics’ concerns. Indeed, Dr. Findley’s coinvestigator Dr. Matthew Siedhoff said he has recently been approached by researchers interested in collaborating in a larger confirmatory randomized trial, but all parties eventually agreed it was a no-go.

“It’s a little hard to demonstrate equipoise for a larger randomized controlled trial. We’re beyond that now, given that prophylactic salpingectomy really doesn’t seem to make a difference as far as ovarian function,” according to Dr. Siedhoff, director of the division of advanced laparoscopy and pelvic pain at the University of North Carolina, Chapel Hill.

Another oft-expressed reservation about salpingectomy as a means of reducing ovarian cancer risk in women seeking sterilization is that salpingectomy’s irreversibility may lead to “tubal regret” on the part of patients who later change their mind about further pregnancies. However, Dr. Findley cited a recent editorial whose authors criticized colleagues who made that claim. The editorialists argued that the tubal regret concern indicates surgeons weren’t really listening to their patients’ true desires during the informed consent conversation.

“We should not have started thinking about salpingectomy for female sterilization only once a decrease in ovarian cancer risk became part of the equation,” they declared (Obstet. Gynecol. 2014;124:596-9).

Dr. Findley noted that Canadian gynecologists are leading the way forward regarding prophylactic salpingectomy as a potential method of ovarian cancer prevention. The Society of Gynecologic Oncology of Canada in a 2011 policy statement recommended patient/physician discussion of the risks and benefits of bilateral salpingectomy for patients undergoing hysterectomy or requesting permanent sterilization. The Society of Gynecologic Oncology followed suit with a similar clinical practice statement in late 2013.

Additionally, the Canadian group declared that a national ovarian cancer prevention study focused on fallopian tube removal should be a top priority.

Gynecologic oncologists in British Columbia recently reported the eye-catching results of a province-wide educational initiative targeting gynecologists and their patients. In 2010, all British Columbia gynecologists had to attend a course on the role of the fallopian tubes in the development of ovarian cancer, during which they were advised to consider performing bilateral salpingectomy for ovarian cancer risk reduction.

Surgical practice changed dramatically in British Columbia in response. In 2009 – the year prior to the physician education initiative – salpingectomy was utilized in just 0.3% of permanent sterilization procedures. In 2010, it was 11.4%. By 2011, it was 33.3%.

Similarly, only 7% of hysterectomies performed in British Columbia in 2009 were accompanied by bilateral salpingectomy. This figure climbed to 23% in 2010 and jumped further to 35% in 2011. Meanwhile the rate of hysterectomy with bilateral salpingo-oophorectomy remained steady over time at 44% (Am. J. Obstet. Gynecol. 2014;210:471.e1-11).

This project was conducted in collaboration with the B.C. Cancer Agency, which maintains comprehensive province-wide registries. Over time, it will be possible to demonstrate whether prophylactic salpingectomy is indeed associated with a reduction in the incidence of ovarian cancer. “I think this study demonstrated that there’s a lack of awareness on this issue, but also [that there’s] potential effectiveness of introducing an educational initiative like this in changing our practice patterns. As we start talking more about this issue amongst our colleagues and our patients, we’re more likely to see a practice pattern shift in the United States as well,” Dr. Findley commented.

He reported having no financial conflicts with regard to his presentation.

bjancin@frontlinemedcom.com

LAS VEGAS – Removing the fallopian tubes at the time of pelvic surgeries as a potential means of reducing ovarian cancer risk appears to be a movement that’s picking up steam in clinical practice.

A recent survey of 234 U.S. gynecologists showed prophylactic bilateral salpingectomy is catching on when performed in conjunction with hysterectomy, but far less so for tubal sterilization, Dr. Austin Findley observed at the annual Minimally Invasive Surgery Week.

A total of 54% of respondents indicated they routinely perform salpingectomy at the time of hysterectomy in an effort to reduce the risk of ovarian cancer as well as to avoid the need for reoperations. However, only 7% of the gynecologic surgeons said they perform salpingectomy for tubal sterilization, even though 58% of respondents stated they believe the procedure is the most effective form of tubal sterilization (J. Minim. Invasive Gynecol. 2013;20:517-21).

“In my experience at various hospitals, I think these numbers are a pretty accurate reflection of what folks are doing,” commented Dr. Findley of Wright State University in Dayton, Ohio.

The prophylactic salpingectomy movement is an outgrowth of the tubal hypothesis of ovarian cancer.

“There is now increasing and dramatic evidence to suggest that most ovarian cancers actually originate in the distal fallopian tubes. I think this is a concept most people are unaware of or are just becoming accustomed to. The tubal hypothesis represents a major paradigm shift in the way we think about ovarian cancers. The previous belief that excessive ovulation is a cause of ovarian cancer is no longer regarded as accurate,” he explained at the meeting presented by the Society of Laparoscopic Surgeons and affiliated societies.

Ovarian cancer is the No. 1 cause of mortality from gynecologic malignancy, accounting for more than 14,000 deaths per year, according to National Cancer Institute data. The lifetime risk of the malignancy is 1.3%, with the average age at diagnosis being 63 years.

Only 10%-15% of ovarian cancers occur in women at high risk for the malignancy because they carry a BRCA mutation or other predisposing gene. The vast majority of ovarian cancer deaths are caused by high-grade serous tumors that have been shown to be strongly associated with precursor lesions in the distal fallopian tubes of women at low risk for the malignancy.

There is no proven-effective screening program or risk-reduction method for these low-risk women. However, with 600,000 hysterectomies and 700,000 tubal sterilizations being performed annually in the United States, prophylactic salpingectomy has been advocated as an attractive opportunity to potentially reduce ovarian cancer risk. Other common pelvic surgeries in which it might be used for this purpose include excision of endometriosis and laparoscopy for pelvic pain. It also has recently been shown to be feasible and safe post partum at cesarean or vaginal delivery (Obstet. Gynecol. 2014 [doi: 10.1097/01.AOG.0000447427.80479.ae]).

But the key word here is “potentially.” It must be emphasized that at present the ovarian cancer prevention benefit of prophylactic salpingectomy remains hypothetical; in theory, the procedure should reduce ovarian cancer risk, but there is not yet persuasive evidence that it actually does, Dr. Findley emphasized at the meeting, presented by the Society of Laparoendoscopic Surgeons and affiliated societies.

In contrast, one well-established ancillary benefit of prophylactic salpingectomy is that it eliminates the need for future reoperation for salpingectomy. This was demonstrated in a large Danish cohort study including close to 10,000 women undergoing hysterectomy and a similar number undergoing sterilization procedures. Among the nearly two-thirds of hysterectomy patients who had both fallopian tubes retained, there was a 2.13-fold increased likelihood of subsequent salpingectomy, compared with nonhysterectomized women.

Similarly, Danish women who underwent a sterilization procedure with retention of the fallopian tubes – typically tubal ligation with clips – were 2.42 times more likely to undergo subsequent salpingectomy, most often because of the development of hydrosalpinx, infection, ectopic pregnancy, or other complications (BMJ Open 2013;3 [doi:10.1136/bmjopen-2013-002845]).

The most commonly cited potential risk of prophylactic salpingectomy – decreased ovarian function – now appears to be a nonissue. This was demonstrated in a recent retrospective Italian study (Gynecol. Oncol. 2013;129:448-51) as well as in a pilot randomized controlled trial conducted by Dr. Findley and his coworkers (Fertil. Steril. 2013;100:1704-8), which appears to have answered many skeptics’ concerns. Indeed, Dr. Findley’s coinvestigator Dr. Matthew Siedhoff said he has recently been approached by researchers interested in collaborating in a larger confirmatory randomized trial, but all parties eventually agreed it was a no-go.

“It’s a little hard to demonstrate equipoise for a larger randomized controlled trial. We’re beyond that now, given that prophylactic salpingectomy really doesn’t seem to make a difference as far as ovarian function,” according to Dr. Siedhoff, director of the division of advanced laparoscopy and pelvic pain at the University of North Carolina, Chapel Hill.

Another oft-expressed reservation about salpingectomy as a means of reducing ovarian cancer risk in women seeking sterilization is that salpingectomy’s irreversibility may lead to “tubal regret” on the part of patients who later change their mind about further pregnancies. However, Dr. Findley cited a recent editorial whose authors criticized colleagues who made that claim. The editorialists argued that the tubal regret concern indicates surgeons weren’t really listening to their patients’ true desires during the informed consent conversation.

“We should not have started thinking about salpingectomy for female sterilization only once a decrease in ovarian cancer risk became part of the equation,” they declared (Obstet. Gynecol. 2014;124:596-9).

Dr. Findley noted that Canadian gynecologists are leading the way forward regarding prophylactic salpingectomy as a potential method of ovarian cancer prevention. The Society of Gynecologic Oncology of Canada in a 2011 policy statement recommended patient/physician discussion of the risks and benefits of bilateral salpingectomy for patients undergoing hysterectomy or requesting permanent sterilization. The Society of Gynecologic Oncology followed suit with a similar clinical practice statement in late 2013.

Additionally, the Canadian group declared that a national ovarian cancer prevention study focused on fallopian tube removal should be a top priority.

Gynecologic oncologists in British Columbia recently reported the eye-catching results of a province-wide educational initiative targeting gynecologists and their patients. In 2010, all British Columbia gynecologists had to attend a course on the role of the fallopian tubes in the development of ovarian cancer, during which they were advised to consider performing bilateral salpingectomy for ovarian cancer risk reduction.

Surgical practice changed dramatically in British Columbia in response. In 2009 – the year prior to the physician education initiative – salpingectomy was utilized in just 0.3% of permanent sterilization procedures. In 2010, it was 11.4%. By 2011, it was 33.3%.

Similarly, only 7% of hysterectomies performed in British Columbia in 2009 were accompanied by bilateral salpingectomy. This figure climbed to 23% in 2010 and jumped further to 35% in 2011. Meanwhile the rate of hysterectomy with bilateral salpingo-oophorectomy remained steady over time at 44% (Am. J. Obstet. Gynecol. 2014;210:471.e1-11).

This project was conducted in collaboration with the B.C. Cancer Agency, which maintains comprehensive province-wide registries. Over time, it will be possible to demonstrate whether prophylactic salpingectomy is indeed associated with a reduction in the incidence of ovarian cancer. “I think this study demonstrated that there’s a lack of awareness on this issue, but also [that there’s] potential effectiveness of introducing an educational initiative like this in changing our practice patterns. As we start talking more about this issue amongst our colleagues and our patients, we’re more likely to see a practice pattern shift in the United States as well,” Dr. Findley commented.

He reported having no financial conflicts with regard to his presentation.

bjancin@frontlinemedcom.com

LAS VEGAS – Removing the fallopian tubes at the time of pelvic surgeries as a potential means of reducing ovarian cancer risk appears to be a movement that’s picking up steam in clinical practice.

A recent survey of 234 U.S. gynecologists showed prophylactic bilateral salpingectomy is catching on when performed in conjunction with hysterectomy, but far less so for tubal sterilization, Dr. Austin Findley observed at the annual Minimally Invasive Surgery Week.

A total of 54% of respondents indicated they routinely perform salpingectomy at the time of hysterectomy in an effort to reduce the risk of ovarian cancer as well as to avoid the need for reoperations. However, only 7% of the gynecologic surgeons said they perform salpingectomy for tubal sterilization, even though 58% of respondents stated they believe the procedure is the most effective form of tubal sterilization (J. Minim. Invasive Gynecol. 2013;20:517-21).

“In my experience at various hospitals, I think these numbers are a pretty accurate reflection of what folks are doing,” commented Dr. Findley of Wright State University in Dayton, Ohio.

The prophylactic salpingectomy movement is an outgrowth of the tubal hypothesis of ovarian cancer.

“There is now increasing and dramatic evidence to suggest that most ovarian cancers actually originate in the distal fallopian tubes. I think this is a concept most people are unaware of or are just becoming accustomed to. The tubal hypothesis represents a major paradigm shift in the way we think about ovarian cancers. The previous belief that excessive ovulation is a cause of ovarian cancer is no longer regarded as accurate,” he explained at the meeting presented by the Society of Laparoscopic Surgeons and affiliated societies.

Ovarian cancer is the No. 1 cause of mortality from gynecologic malignancy, accounting for more than 14,000 deaths per year, according to National Cancer Institute data. The lifetime risk of the malignancy is 1.3%, with the average age at diagnosis being 63 years.

Only 10%-15% of ovarian cancers occur in women at high risk for the malignancy because they carry a BRCA mutation or other predisposing gene. The vast majority of ovarian cancer deaths are caused by high-grade serous tumors that have been shown to be strongly associated with precursor lesions in the distal fallopian tubes of women at low risk for the malignancy.

There is no proven-effective screening program or risk-reduction method for these low-risk women. However, with 600,000 hysterectomies and 700,000 tubal sterilizations being performed annually in the United States, prophylactic salpingectomy has been advocated as an attractive opportunity to potentially reduce ovarian cancer risk. Other common pelvic surgeries in which it might be used for this purpose include excision of endometriosis and laparoscopy for pelvic pain. It also has recently been shown to be feasible and safe post partum at cesarean or vaginal delivery (Obstet. Gynecol. 2014 [doi: 10.1097/01.AOG.0000447427.80479.ae]).

But the key word here is “potentially.” It must be emphasized that at present the ovarian cancer prevention benefit of prophylactic salpingectomy remains hypothetical; in theory, the procedure should reduce ovarian cancer risk, but there is not yet persuasive evidence that it actually does, Dr. Findley emphasized at the meeting, presented by the Society of Laparoendoscopic Surgeons and affiliated societies.

In contrast, one well-established ancillary benefit of prophylactic salpingectomy is that it eliminates the need for future reoperation for salpingectomy. This was demonstrated in a large Danish cohort study including close to 10,000 women undergoing hysterectomy and a similar number undergoing sterilization procedures. Among the nearly two-thirds of hysterectomy patients who had both fallopian tubes retained, there was a 2.13-fold increased likelihood of subsequent salpingectomy, compared with nonhysterectomized women.

Similarly, Danish women who underwent a sterilization procedure with retention of the fallopian tubes – typically tubal ligation with clips – were 2.42 times more likely to undergo subsequent salpingectomy, most often because of the development of hydrosalpinx, infection, ectopic pregnancy, or other complications (BMJ Open 2013;3 [doi:10.1136/bmjopen-2013-002845]).

The most commonly cited potential risk of prophylactic salpingectomy – decreased ovarian function – now appears to be a nonissue. This was demonstrated in a recent retrospective Italian study (Gynecol. Oncol. 2013;129:448-51) as well as in a pilot randomized controlled trial conducted by Dr. Findley and his coworkers (Fertil. Steril. 2013;100:1704-8), which appears to have answered many skeptics’ concerns. Indeed, Dr. Findley’s coinvestigator Dr. Matthew Siedhoff said he has recently been approached by researchers interested in collaborating in a larger confirmatory randomized trial, but all parties eventually agreed it was a no-go.

“It’s a little hard to demonstrate equipoise for a larger randomized controlled trial. We’re beyond that now, given that prophylactic salpingectomy really doesn’t seem to make a difference as far as ovarian function,” according to Dr. Siedhoff, director of the division of advanced laparoscopy and pelvic pain at the University of North Carolina, Chapel Hill.

Another oft-expressed reservation about salpingectomy as a means of reducing ovarian cancer risk in women seeking sterilization is that salpingectomy’s irreversibility may lead to “tubal regret” on the part of patients who later change their mind about further pregnancies. However, Dr. Findley cited a recent editorial whose authors criticized colleagues who made that claim. The editorialists argued that the tubal regret concern indicates surgeons weren’t really listening to their patients’ true desires during the informed consent conversation.

“We should not have started thinking about salpingectomy for female sterilization only once a decrease in ovarian cancer risk became part of the equation,” they declared (Obstet. Gynecol. 2014;124:596-9).

Dr. Findley noted that Canadian gynecologists are leading the way forward regarding prophylactic salpingectomy as a potential method of ovarian cancer prevention. The Society of Gynecologic Oncology of Canada in a 2011 policy statement recommended patient/physician discussion of the risks and benefits of bilateral salpingectomy for patients undergoing hysterectomy or requesting permanent sterilization. The Society of Gynecologic Oncology followed suit with a similar clinical practice statement in late 2013.

Additionally, the Canadian group declared that a national ovarian cancer prevention study focused on fallopian tube removal should be a top priority.

Gynecologic oncologists in British Columbia recently reported the eye-catching results of a province-wide educational initiative targeting gynecologists and their patients. In 2010, all British Columbia gynecologists had to attend a course on the role of the fallopian tubes in the development of ovarian cancer, during which they were advised to consider performing bilateral salpingectomy for ovarian cancer risk reduction.

Surgical practice changed dramatically in British Columbia in response. In 2009 – the year prior to the physician education initiative – salpingectomy was utilized in just 0.3% of permanent sterilization procedures. In 2010, it was 11.4%. By 2011, it was 33.3%.

Similarly, only 7% of hysterectomies performed in British Columbia in 2009 were accompanied by bilateral salpingectomy. This figure climbed to 23% in 2010 and jumped further to 35% in 2011. Meanwhile the rate of hysterectomy with bilateral salpingo-oophorectomy remained steady over time at 44% (Am. J. Obstet. Gynecol. 2014;210:471.e1-11).

This project was conducted in collaboration with the B.C. Cancer Agency, which maintains comprehensive province-wide registries. Over time, it will be possible to demonstrate whether prophylactic salpingectomy is indeed associated with a reduction in the incidence of ovarian cancer. “I think this study demonstrated that there’s a lack of awareness on this issue, but also [that there’s] potential effectiveness of introducing an educational initiative like this in changing our practice patterns. As we start talking more about this issue amongst our colleagues and our patients, we’re more likely to see a practice pattern shift in the United States as well,” Dr. Findley commented.

He reported having no financial conflicts with regard to his presentation.

bjancin@frontlinemedcom.com

LAS VEGAS – Morcellation during laparoscopic hysterectomy or myomectomy for presumed large fibroids provides slightly better 5-year overall survival and higher quality of life scores than abdominal hysterectomy, according to a new study.

The strength of this soon-to-be-published decision analysis lies in its balance and comprehensive nature. It utilized the best-available published literature to estimate the mortality risk stemming from tissue dissemination of occult leiomyosarcoma through power morcellation – an issue of hot controversy – but it also incorporated the increased risks of procedure-related morbidity and mortality associated with the alternative to morcellation in patients with large fibroids: that is, abdominal hysterectomy, Dr. Matthew Siedhoff explained at the annual Minimally Invasive Surgery Week.

The decision analysis was undertaken in the wake of the Food and Drug Administration’s April 2014 safety warning citing a 1 in 350 risk of occult malignancy in women undergoing hysterectomies or myomectomies for removal of presumed fibroids and that laparoscopic surgeries involving power morcellation performed in women with unsuspected uterine sarcomas may spread cancerous tissue, potentially shortening survival. The attendant publicity has caused considerable alarm and confusion among patients and the general public. The FDA is currently deliberating possible actions ranging from a black box warning to outright banning of power morcellation.

Meanwhile, several prominent medical centers, including Brigham and Women’s Hospital, Massachusetts General Hospital, both in Boston, and the Cleveland Clinic, have banned the use of power morcellation – precipitously, in Dr. Siedhoff’s view.

Also since the FDA safety statement, Johnson & Johnson has taken its power morcellator off the market and several large insurance companies have announced plans to halt reimbursement when power morcellation is used in gynecologic surgery. However, exactly how that would happen is unclear because there is no billing code associated with power morcellation, and it would be arduous for insurers to actually read through all operative reports.

“This decision analysis is a tool for surgeons and patients to help make informed decisions. It balances the FDA analysis, which pretty much just emphasizes morcellation risk to the exclusion of all the known benefits of laparoscopy. The analysis argues that reducing the risk associated with morcellation – perhaps through the use of specimen containment or preoperative leiomyosarcoma diagnosis – is a better approach than abandoning minimally invasive gynecologic surgery for fibroids. That would be throwing the baby out with the bathwater,” declared Dr. Siedhoff, an ob.gyn. and director of the division of advanced laparoscopy and pelvic pain at the University of North Carolina, Chapel Hill.

A decision analysis entails probability modeling of outcomes based upon consensus event rates obtained from studies in the published literature.

“It’s helpful to do a decision analysis when you can’t do a randomized controlled trial, which you certainly can’t for this issue,” he observed at the meeting presented by the Society of Laparoscopic Surgeons and affiliated societies.

The decision analysis was carried out by Dr. Siedhoff and coinvestigators at the University of North Carolina at Chapel Hill, with department of obstetrics and gynecology chair Dr. Daniel Clarke-Peterson as senior author. The researchers assumed two hypothetical cohorts of 100,000 women undergoing hysterectomy for fibroids large enough that surgical options were limited to laparoscopic hysterectomy with morcellation or abdominal hysterectomy. The primary outcomes were 5-year overall mortality and quality of life as measured in quality-adjusted life-years (QALYs).

The analysis assumed that among the 100,000 women in each group there would be 120 FIGO Stage I or II occult leiomyosarcomas, with an associated 59% 5-year mortality from cancer. It was further assumed that intraperitoneal dissemination of tumor via morcellation would in effect boost those cancers to FIGO Stage III, with 72% mortality at 5 years. This would result in 86 deaths from leiomyosarcoma over 5 years in the morcellation group, compared with 71 in women who underwent abdominal hysterectomy. However, this was counterbalanced by more hysterectomy-related deaths in the abdominal hysterectomy group: 32, compared with 12 in women undergoing morcellation. The final 5-year tally: 98 deaths overall in the morcellation group and 103 in the abdominal hysterectomy group.

QALYs are calculated by estimating how much a given adverse event – for example, venous thromboembolism, along with its attendant treatment and potential further complications – would diminish a theoretical year of otherwise perfect health. The total QALYs in the group of 100,000 women undergoing morcellation was estimated at 499,171, compared with 490,711 over 5 years in the abdominal hysterectomy group. That’s because with the exception of vaginal cuff dehiscence, all of the other complications assessed in the decision analysis, including wound infections, transfusions, hernias, and venous thromboembolisms, were more frequent in the abdominal hysterectomy group. The forthcoming final publication will include the citations on which all of the event probabilities were based.

An alternative and perhaps more readily grasped way of expressing the QALY results is that patients undergoing laparoscopic hysterectomy enjoyed an additional 0.85 QALY, or roughly 1 extra month of life in perfect health over a 5-year time period, Dr. Siedhoff explained.

The decision analysis didn’t include the well-established facts that laparoscopic hysterectomy entails less postoperative pain, a shorter average hospital length of stay, and faster return to daily activities.

Dr. Siedhoff was quick to assert that the true incidence of occult leiomyosarcoma in women undergoing surgery for presumed fibroids is unknown. An American College of Obstetricians and Gynecologist’s position statement issued earlier this year quoted an estimate of 1 in 500. The FDA cited a figure of 1 in 350. But when the North Carolina researchers examined the 10 studies published during 1990-2013, upon which the FDA based its estimate, the investigators felt compelled to reject 6 of them because of poor quality. For example, several studies included morcellation in patients with preoperative known or suspected sarcoma, even though morcellation should absolutely never be done in that situation. Based upon a weighted analysis of the remaining four highest-quality studies, the investigators came up with an estimate of 12 cases/10,000 women.

Noting that the largest of the studies in the FDA analysis included just 1,584 women with 2 cases of leiomyosarcoma, Dr. Siedhoff said, “I think it’s important to point out that really important decisions are being made on awfully small numerators and denominators. The truth of the matter is we have no idea what the true number is. It could be twice as high as our estimate or half as low.”

He admitted that he has been personally affected by the rancorous tone of recent public debate regarding morcellation safety, in which the procedure’s defenders often are demonized.

“It’s been confusing to me why in the Wall Street Journal they talk about these evil doctors who want to use this technique, as if it somehow benefits us. It’s not easier to do laparoscopic surgery, and it’s certainly not easier to morcellate tissue. The only reason that we’re talking about this is because we care about the outcomes for our patients,” the gynecologic surgeon said at the meeting presented by the Society of Laparoendoscopic Surgeons and affiliated societies. “One of the things that has been most difficult about all this,” he continued, “is the way that the information has moved from some very vocal people who feel strongly about this issue to the level of the lay person that you see in the elevator, or worse yet, your own patient. I think it’s almost like a game of telephone, so that by the time it gets down to a person who’s not a surgeon, the message is ‘morcellation causes cancer.’”Not only is the true prevalence of occult malignancy in women undergoing laparoscopic surgery for removal of fibroids unclear, but the data on the adverse impact of morcellation in this situation is sketchy as well. To date, it consists of two single-center retrospective studies. The more recent report, from Brigham and Women’s Hospital, involved 19 patients who underwent morcellation and 39 who had a total abdominal hysterectomy, all found to have leiomyosarcoma. The cancer recurrence rate was significantly higher in women who had morcellation, by a margin of 74% to 51%. However, there was no significant difference in overall survival (Cancer 2014 [doi:10.1002/cncr.28844]).

In contrast, an earlier Korean study involving a consecutive series comprised of 25 patients with occult leiomyosarcoma who underwent morcellation and 31 with total abdominal hysterectomy found a significant difference in 5-year overall survival: 46% in the morcellation group, and what Dr. Siedhoff deemed an unusually favorable 73% in the total abdominal hysterectomy patients (Gynecol. Oncol. 2011;122:255-9).

There is a great unmet need for a reliable preoperative method to distinguish leiomyosarcomas from benign fibroids. Imaging is of limited value. Endometrial biopsy is rarely positive. No biomarkers have been identified. Clinical factors that increase the likelihood of leiomyosarcoma include rapid growth, African American ethnicity, older age, a history of pelvic radiation, and the presence of the retinoblastoma gene.

In his own practice, Dr. Siedhoff sometimes uses specimen retrieval bags when performing morcellation, but finds the currently available versions to be cumbersome and a challenge to work with. Besides, he noted, there is to date no evidence that they are actually effective in reducing leiomyosarcoma recurrence risk. He was a member of an AAGL task force which in May issued a position statement on morcellation, which noted, “Use of morcellation within specimen retrieval pouches for containment of benign or malignant uterine tissue requires significant skill and experience, and use of specimen retrieval pouches should be further investigated for safety and outcomes in a controlled setting.”

Dr. Siedhoff reported having no financial conflicts regarding the decision analysis, conducted with university funds.

bjancin@frontlinemedcom.com

LAS VEGAS – Morcellation during laparoscopic hysterectomy or myomectomy for presumed large fibroids provides slightly better 5-year overall survival and higher quality of life scores than abdominal hysterectomy, according to a new study.

The strength of this soon-to-be-published decision analysis lies in its balance and comprehensive nature. It utilized the best-available published literature to estimate the mortality risk stemming from tissue dissemination of occult leiomyosarcoma through power morcellation – an issue of hot controversy – but it also incorporated the increased risks of procedure-related morbidity and mortality associated with the alternative to morcellation in patients with large fibroids: that is, abdominal hysterectomy, Dr. Matthew Siedhoff explained at the annual Minimally Invasive Surgery Week.

The decision analysis was undertaken in the wake of the Food and Drug Administration’s April 2014 safety warning citing a 1 in 350 risk of occult malignancy in women undergoing hysterectomies or myomectomies for removal of presumed fibroids and that laparoscopic surgeries involving power morcellation performed in women with unsuspected uterine sarcomas may spread cancerous tissue, potentially shortening survival. The attendant publicity has caused considerable alarm and confusion among patients and the general public. The FDA is currently deliberating possible actions ranging from a black box warning to outright banning of power morcellation.

Meanwhile, several prominent medical centers, including Brigham and Women’s Hospital, Massachusetts General Hospital, both in Boston, and the Cleveland Clinic, have banned the use of power morcellation – precipitously, in Dr. Siedhoff’s view.

Also since the FDA safety statement, Johnson & Johnson has taken its power morcellator off the market and several large insurance companies have announced plans to halt reimbursement when power morcellation is used in gynecologic surgery. However, exactly how that would happen is unclear because there is no billing code associated with power morcellation, and it would be arduous for insurers to actually read through all operative reports.

“This decision analysis is a tool for surgeons and patients to help make informed decisions. It balances the FDA analysis, which pretty much just emphasizes morcellation risk to the exclusion of all the known benefits of laparoscopy. The analysis argues that reducing the risk associated with morcellation – perhaps through the use of specimen containment or preoperative leiomyosarcoma diagnosis – is a better approach than abandoning minimally invasive gynecologic surgery for fibroids. That would be throwing the baby out with the bathwater,” declared Dr. Siedhoff, an ob.gyn. and director of the division of advanced laparoscopy and pelvic pain at the University of North Carolina, Chapel Hill.

A decision analysis entails probability modeling of outcomes based upon consensus event rates obtained from studies in the published literature.

“It’s helpful to do a decision analysis when you can’t do a randomized controlled trial, which you certainly can’t for this issue,” he observed at the meeting presented by the Society of Laparoscopic Surgeons and affiliated societies.

The decision analysis was carried out by Dr. Siedhoff and coinvestigators at the University of North Carolina at Chapel Hill, with department of obstetrics and gynecology chair Dr. Daniel Clarke-Peterson as senior author. The researchers assumed two hypothetical cohorts of 100,000 women undergoing hysterectomy for fibroids large enough that surgical options were limited to laparoscopic hysterectomy with morcellation or abdominal hysterectomy. The primary outcomes were 5-year overall mortality and quality of life as measured in quality-adjusted life-years (QALYs).

The analysis assumed that among the 100,000 women in each group there would be 120 FIGO Stage I or II occult leiomyosarcomas, with an associated 59% 5-year mortality from cancer. It was further assumed that intraperitoneal dissemination of tumor via morcellation would in effect boost those cancers to FIGO Stage III, with 72% mortality at 5 years. This would result in 86 deaths from leiomyosarcoma over 5 years in the morcellation group, compared with 71 in women who underwent abdominal hysterectomy. However, this was counterbalanced by more hysterectomy-related deaths in the abdominal hysterectomy group: 32, compared with 12 in women undergoing morcellation. The final 5-year tally: 98 deaths overall in the morcellation group and 103 in the abdominal hysterectomy group.

QALYs are calculated by estimating how much a given adverse event – for example, venous thromboembolism, along with its attendant treatment and potential further complications – would diminish a theoretical year of otherwise perfect health. The total QALYs in the group of 100,000 women undergoing morcellation was estimated at 499,171, compared with 490,711 over 5 years in the abdominal hysterectomy group. That’s because with the exception of vaginal cuff dehiscence, all of the other complications assessed in the decision analysis, including wound infections, transfusions, hernias, and venous thromboembolisms, were more frequent in the abdominal hysterectomy group. The forthcoming final publication will include the citations on which all of the event probabilities were based.

An alternative and perhaps more readily grasped way of expressing the QALY results is that patients undergoing laparoscopic hysterectomy enjoyed an additional 0.85 QALY, or roughly 1 extra month of life in perfect health over a 5-year time period, Dr. Siedhoff explained.

The decision analysis didn’t include the well-established facts that laparoscopic hysterectomy entails less postoperative pain, a shorter average hospital length of stay, and faster return to daily activities.

Dr. Siedhoff was quick to assert that the true incidence of occult leiomyosarcoma in women undergoing surgery for presumed fibroids is unknown. An American College of Obstetricians and Gynecologist’s position statement issued earlier this year quoted an estimate of 1 in 500. The FDA cited a figure of 1 in 350. But when the North Carolina researchers examined the 10 studies published during 1990-2013, upon which the FDA based its estimate, the investigators felt compelled to reject 6 of them because of poor quality. For example, several studies included morcellation in patients with preoperative known or suspected sarcoma, even though morcellation should absolutely never be done in that situation. Based upon a weighted analysis of the remaining four highest-quality studies, the investigators came up with an estimate of 12 cases/10,000 women.

Noting that the largest of the studies in the FDA analysis included just 1,584 women with 2 cases of leiomyosarcoma, Dr. Siedhoff said, “I think it’s important to point out that really important decisions are being made on awfully small numerators and denominators. The truth of the matter is we have no idea what the true number is. It could be twice as high as our estimate or half as low.”

He admitted that he has been personally affected by the rancorous tone of recent public debate regarding morcellation safety, in which the procedure’s defenders often are demonized.

“It’s been confusing to me why in the Wall Street Journal they talk about these evil doctors who want to use this technique, as if it somehow benefits us. It’s not easier to do laparoscopic surgery, and it’s certainly not easier to morcellate tissue. The only reason that we’re talking about this is because we care about the outcomes for our patients,” the gynecologic surgeon said at the meeting presented by the Society of Laparoendoscopic Surgeons and affiliated societies. “One of the things that has been most difficult about all this,” he continued, “is the way that the information has moved from some very vocal people who feel strongly about this issue to the level of the lay person that you see in the elevator, or worse yet, your own patient. I think it’s almost like a game of telephone, so that by the time it gets down to a person who’s not a surgeon, the message is ‘morcellation causes cancer.’”Not only is the true prevalence of occult malignancy in women undergoing laparoscopic surgery for removal of fibroids unclear, but the data on the adverse impact of morcellation in this situation is sketchy as well. To date, it consists of two single-center retrospective studies. The more recent report, from Brigham and Women’s Hospital, involved 19 patients who underwent morcellation and 39 who had a total abdominal hysterectomy, all found to have leiomyosarcoma. The cancer recurrence rate was significantly higher in women who had morcellation, by a margin of 74% to 51%. However, there was no significant difference in overall survival (Cancer 2014 [doi:10.1002/cncr.28844]).

In contrast, an earlier Korean study involving a consecutive series comprised of 25 patients with occult leiomyosarcoma who underwent morcellation and 31 with total abdominal hysterectomy found a significant difference in 5-year overall survival: 46% in the morcellation group, and what Dr. Siedhoff deemed an unusually favorable 73% in the total abdominal hysterectomy patients (Gynecol. Oncol. 2011;122:255-9).

There is a great unmet need for a reliable preoperative method to distinguish leiomyosarcomas from benign fibroids. Imaging is of limited value. Endometrial biopsy is rarely positive. No biomarkers have been identified. Clinical factors that increase the likelihood of leiomyosarcoma include rapid growth, African American ethnicity, older age, a history of pelvic radiation, and the presence of the retinoblastoma gene.

In his own practice, Dr. Siedhoff sometimes uses specimen retrieval bags when performing morcellation, but finds the currently available versions to be cumbersome and a challenge to work with. Besides, he noted, there is to date no evidence that they are actually effective in reducing leiomyosarcoma recurrence risk. He was a member of an AAGL task force which in May issued a position statement on morcellation, which noted, “Use of morcellation within specimen retrieval pouches for containment of benign or malignant uterine tissue requires significant skill and experience, and use of specimen retrieval pouches should be further investigated for safety and outcomes in a controlled setting.”

Dr. Siedhoff reported having no financial conflicts regarding the decision analysis, conducted with university funds.

bjancin@frontlinemedcom.com

LAS VEGAS – Morcellation during laparoscopic hysterectomy or myomectomy for presumed large fibroids provides slightly better 5-year overall survival and higher quality of life scores than abdominal hysterectomy, according to a new study.

The strength of this soon-to-be-published decision analysis lies in its balance and comprehensive nature. It utilized the best-available published literature to estimate the mortality risk stemming from tissue dissemination of occult leiomyosarcoma through power morcellation – an issue of hot controversy – but it also incorporated the increased risks of procedure-related morbidity and mortality associated with the alternative to morcellation in patients with large fibroids: that is, abdominal hysterectomy, Dr. Matthew Siedhoff explained at the annual Minimally Invasive Surgery Week.

The decision analysis was undertaken in the wake of the Food and Drug Administration’s April 2014 safety warning citing a 1 in 350 risk of occult malignancy in women undergoing hysterectomies or myomectomies for removal of presumed fibroids and that laparoscopic surgeries involving power morcellation performed in women with unsuspected uterine sarcomas may spread cancerous tissue, potentially shortening survival. The attendant publicity has caused considerable alarm and confusion among patients and the general public. The FDA is currently deliberating possible actions ranging from a black box warning to outright banning of power morcellation.

Meanwhile, several prominent medical centers, including Brigham and Women’s Hospital, Massachusetts General Hospital, both in Boston, and the Cleveland Clinic, have banned the use of power morcellation – precipitously, in Dr. Siedhoff’s view.

Also since the FDA safety statement, Johnson & Johnson has taken its power morcellator off the market and several large insurance companies have announced plans to halt reimbursement when power morcellation is used in gynecologic surgery. However, exactly how that would happen is unclear because there is no billing code associated with power morcellation, and it would be arduous for insurers to actually read through all operative reports.

“This decision analysis is a tool for surgeons and patients to help make informed decisions. It balances the FDA analysis, which pretty much just emphasizes morcellation risk to the exclusion of all the known benefits of laparoscopy. The analysis argues that reducing the risk associated with morcellation – perhaps through the use of specimen containment or preoperative leiomyosarcoma diagnosis – is a better approach than abandoning minimally invasive gynecologic surgery for fibroids. That would be throwing the baby out with the bathwater,” declared Dr. Siedhoff, an ob.gyn. and director of the division of advanced laparoscopy and pelvic pain at the University of North Carolina, Chapel Hill.

A decision analysis entails probability modeling of outcomes based upon consensus event rates obtained from studies in the published literature.

“It’s helpful to do a decision analysis when you can’t do a randomized controlled trial, which you certainly can’t for this issue,” he observed at the meeting presented by the Society of Laparoscopic Surgeons and affiliated societies.

The decision analysis was carried out by Dr. Siedhoff and coinvestigators at the University of North Carolina at Chapel Hill, with department of obstetrics and gynecology chair Dr. Daniel Clarke-Peterson as senior author. The researchers assumed two hypothetical cohorts of 100,000 women undergoing hysterectomy for fibroids large enough that surgical options were limited to laparoscopic hysterectomy with morcellation or abdominal hysterectomy. The primary outcomes were 5-year overall mortality and quality of life as measured in quality-adjusted life-years (QALYs).

The analysis assumed that among the 100,000 women in each group there would be 120 FIGO Stage I or II occult leiomyosarcomas, with an associated 59% 5-year mortality from cancer. It was further assumed that intraperitoneal dissemination of tumor via morcellation would in effect boost those cancers to FIGO Stage III, with 72% mortality at 5 years. This would result in 86 deaths from leiomyosarcoma over 5 years in the morcellation group, compared with 71 in women who underwent abdominal hysterectomy. However, this was counterbalanced by more hysterectomy-related deaths in the abdominal hysterectomy group: 32, compared with 12 in women undergoing morcellation. The final 5-year tally: 98 deaths overall in the morcellation group and 103 in the abdominal hysterectomy group.

QALYs are calculated by estimating how much a given adverse event – for example, venous thromboembolism, along with its attendant treatment and potential further complications – would diminish a theoretical year of otherwise perfect health. The total QALYs in the group of 100,000 women undergoing morcellation was estimated at 499,171, compared with 490,711 over 5 years in the abdominal hysterectomy group. That’s because with the exception of vaginal cuff dehiscence, all of the other complications assessed in the decision analysis, including wound infections, transfusions, hernias, and venous thromboembolisms, were more frequent in the abdominal hysterectomy group. The forthcoming final publication will include the citations on which all of the event probabilities were based.

An alternative and perhaps more readily grasped way of expressing the QALY results is that patients undergoing laparoscopic hysterectomy enjoyed an additional 0.85 QALY, or roughly 1 extra month of life in perfect health over a 5-year time period, Dr. Siedhoff explained.

The decision analysis didn’t include the well-established facts that laparoscopic hysterectomy entails less postoperative pain, a shorter average hospital length of stay, and faster return to daily activities.

Dr. Siedhoff was quick to assert that the true incidence of occult leiomyosarcoma in women undergoing surgery for presumed fibroids is unknown. An American College of Obstetricians and Gynecologist’s position statement issued earlier this year quoted an estimate of 1 in 500. The FDA cited a figure of 1 in 350. But when the North Carolina researchers examined the 10 studies published during 1990-2013, upon which the FDA based its estimate, the investigators felt compelled to reject 6 of them because of poor quality. For example, several studies included morcellation in patients with preoperative known or suspected sarcoma, even though morcellation should absolutely never be done in that situation. Based upon a weighted analysis of the remaining four highest-quality studies, the investigators came up with an estimate of 12 cases/10,000 women.

Noting that the largest of the studies in the FDA analysis included just 1,584 women with 2 cases of leiomyosarcoma, Dr. Siedhoff said, “I think it’s important to point out that really important decisions are being made on awfully small numerators and denominators. The truth of the matter is we have no idea what the true number is. It could be twice as high as our estimate or half as low.”

He admitted that he has been personally affected by the rancorous tone of recent public debate regarding morcellation safety, in which the procedure’s defenders often are demonized.

“It’s been confusing to me why in the Wall Street Journal they talk about these evil doctors who want to use this technique, as if it somehow benefits us. It’s not easier to do laparoscopic surgery, and it’s certainly not easier to morcellate tissue. The only reason that we’re talking about this is because we care about the outcomes for our patients,” the gynecologic surgeon said at the meeting presented by the Society of Laparoendoscopic Surgeons and affiliated societies. “One of the things that has been most difficult about all this,” he continued, “is the way that the information has moved from some very vocal people who feel strongly about this issue to the level of the lay person that you see in the elevator, or worse yet, your own patient. I think it’s almost like a game of telephone, so that by the time it gets down to a person who’s not a surgeon, the message is ‘morcellation causes cancer.’”Not only is the true prevalence of occult malignancy in women undergoing laparoscopic surgery for removal of fibroids unclear, but the data on the adverse impact of morcellation in this situation is sketchy as well. To date, it consists of two single-center retrospective studies. The more recent report, from Brigham and Women’s Hospital, involved 19 patients who underwent morcellation and 39 who had a total abdominal hysterectomy, all found to have leiomyosarcoma. The cancer recurrence rate was significantly higher in women who had morcellation, by a margin of 74% to 51%. However, there was no significant difference in overall survival (Cancer 2014 [doi:10.1002/cncr.28844]).

In contrast, an earlier Korean study involving a consecutive series comprised of 25 patients with occult leiomyosarcoma who underwent morcellation and 31 with total abdominal hysterectomy found a significant difference in 5-year overall survival: 46% in the morcellation group, and what Dr. Siedhoff deemed an unusually favorable 73% in the total abdominal hysterectomy patients (Gynecol. Oncol. 2011;122:255-9).

There is a great unmet need for a reliable preoperative method to distinguish leiomyosarcomas from benign fibroids. Imaging is of limited value. Endometrial biopsy is rarely positive. No biomarkers have been identified. Clinical factors that increase the likelihood of leiomyosarcoma include rapid growth, African American ethnicity, older age, a history of pelvic radiation, and the presence of the retinoblastoma gene.

In his own practice, Dr. Siedhoff sometimes uses specimen retrieval bags when performing morcellation, but finds the currently available versions to be cumbersome and a challenge to work with. Besides, he noted, there is to date no evidence that they are actually effective in reducing leiomyosarcoma recurrence risk. He was a member of an AAGL task force which in May issued a position statement on morcellation, which noted, “Use of morcellation within specimen retrieval pouches for containment of benign or malignant uterine tissue requires significant skill and experience, and use of specimen retrieval pouches should be further investigated for safety and outcomes in a controlled setting.”

Dr. Siedhoff reported having no financial conflicts regarding the decision analysis, conducted with university funds.

bjancin@frontlinemedcom.com