Surgery

Underlying cardiac disease, airway anomalies, and younger age each independently boosted the risk of severe perioperative respiratory adverse events (PRAE) in children undergoing adenotonsillectomy to treat obstructive sleep apnea, in a review of 374 patients treated at a single Canadian tertiary-referral center.

In contrast, the analysis failed to show independent, significant effects from any assessed polysomnography or oximetry parameters on the rate of postoperative respiratory complications. The utility of preoperative polysomnography or oximetry for risk stratification is questionable for pediatric patients scheduled to adenotonsillectomy to treat obstructive sleep apnea, wrote Sherri L. Katz, MD, of the University of Ottawa, and associates in a recent report published in the Journal of Clinical Sleep Medicine, although they also added that making these assessments may be “unavoidable” because of their need for diagnosing obstructive sleep apnea and determining the need for surgery.

Despite this caveat, “overall our study results highlight the need to better define the complex interaction between comorbidities, age, nocturnal respiratory events, and gas exchange abnormalities in predicting risk for PRAE” after adenotonsillectomy, the researchers wrote. These findings “are consistent with existing clinical care guidelines,” and “cardiac and craniofacial conditions have been associated with risk of postoperative complications in other studies.”

The analysis used data collected from all children aged 0-18 years who underwent polysomnography assessment followed by adenotonsillectomy at one Canadian tertiary-referral center, Children’s Hospital of Eastern Ontario in Ottawa, during 2010-2016. Their median age was just over 6 years, and 39 patients (10%) were younger than 3 years at the time of their surgery. More than three-quarters of the patients, 286, had at least one identified comorbidity, and nearly half had at least two comorbidities. Polysomnography identified sleep-disordered breathing in 344 of the children (92%), and diagnosed obstructive sleep apnea in 256 (68%), including 148 (43% of the full cohort) with a severe apnea-hypopnea index.

Sixty-six of the children (18%) had at least one severe PRAE that required intervention. Specifically these were either oxygen desaturations requiring intervention or need for airway or ventilatory support with interventions such as jaw thrust, oral or nasal airway placement, bag and mask ventilation, or endotracheal intubation.

A multivariate regression analysis of the measured comorbidity, polysomnography, and oximetry parameters, as well as age, identified three factors that independently linked with a statistically significant increase in the rate of severe PRAE: airway anomaly, underlying cardiac disease, and young age. Patients with an airway anomaly had a 219% increased rate of PRAE, compared with those with no anomaly; patients with underlying cardiac disease had a 109% increased rate, compared with those without cardiac disease; and patients aged younger than 3 years had a 310% higher rate of PRAE, compared with the children aged 6 years or older, while children aged 3-5 years had a 121% higher rate of PRAE, compared with older children.

The study received no commercial funding. Dr. Katz has received honoraria for speaking from Biogen that had no relevance to the study.

[email protected]

SOURCE: Katz SL et al. J Clin Sleep Med. 2020 Jan 15;16(1):41-8.

Underlying cardiac disease, airway anomalies, and younger age each independently boosted the risk of severe perioperative respiratory adverse events (PRAE) in children undergoing adenotonsillectomy to treat obstructive sleep apnea, in a review of 374 patients treated at a single Canadian tertiary-referral center.

In contrast, the analysis failed to show independent, significant effects from any assessed polysomnography or oximetry parameters on the rate of postoperative respiratory complications. The utility of preoperative polysomnography or oximetry for risk stratification is questionable for pediatric patients scheduled to adenotonsillectomy to treat obstructive sleep apnea, wrote Sherri L. Katz, MD, of the University of Ottawa, and associates in a recent report published in the Journal of Clinical Sleep Medicine, although they also added that making these assessments may be “unavoidable” because of their need for diagnosing obstructive sleep apnea and determining the need for surgery.

Despite this caveat, “overall our study results highlight the need to better define the complex interaction between comorbidities, age, nocturnal respiratory events, and gas exchange abnormalities in predicting risk for PRAE” after adenotonsillectomy, the researchers wrote. These findings “are consistent with existing clinical care guidelines,” and “cardiac and craniofacial conditions have been associated with risk of postoperative complications in other studies.”

The analysis used data collected from all children aged 0-18 years who underwent polysomnography assessment followed by adenotonsillectomy at one Canadian tertiary-referral center, Children’s Hospital of Eastern Ontario in Ottawa, during 2010-2016. Their median age was just over 6 years, and 39 patients (10%) were younger than 3 years at the time of their surgery. More than three-quarters of the patients, 286, had at least one identified comorbidity, and nearly half had at least two comorbidities. Polysomnography identified sleep-disordered breathing in 344 of the children (92%), and diagnosed obstructive sleep apnea in 256 (68%), including 148 (43% of the full cohort) with a severe apnea-hypopnea index.

Sixty-six of the children (18%) had at least one severe PRAE that required intervention. Specifically these were either oxygen desaturations requiring intervention or need for airway or ventilatory support with interventions such as jaw thrust, oral or nasal airway placement, bag and mask ventilation, or endotracheal intubation.

A multivariate regression analysis of the measured comorbidity, polysomnography, and oximetry parameters, as well as age, identified three factors that independently linked with a statistically significant increase in the rate of severe PRAE: airway anomaly, underlying cardiac disease, and young age. Patients with an airway anomaly had a 219% increased rate of PRAE, compared with those with no anomaly; patients with underlying cardiac disease had a 109% increased rate, compared with those without cardiac disease; and patients aged younger than 3 years had a 310% higher rate of PRAE, compared with the children aged 6 years or older, while children aged 3-5 years had a 121% higher rate of PRAE, compared with older children.

The study received no commercial funding. Dr. Katz has received honoraria for speaking from Biogen that had no relevance to the study.

[email protected]

SOURCE: Katz SL et al. J Clin Sleep Med. 2020 Jan 15;16(1):41-8.

Underlying cardiac disease, airway anomalies, and younger age each independently boosted the risk of severe perioperative respiratory adverse events (PRAE) in children undergoing adenotonsillectomy to treat obstructive sleep apnea, in a review of 374 patients treated at a single Canadian tertiary-referral center.

In contrast, the analysis failed to show independent, significant effects from any assessed polysomnography or oximetry parameters on the rate of postoperative respiratory complications. The utility of preoperative polysomnography or oximetry for risk stratification is questionable for pediatric patients scheduled to adenotonsillectomy to treat obstructive sleep apnea, wrote Sherri L. Katz, MD, of the University of Ottawa, and associates in a recent report published in the Journal of Clinical Sleep Medicine, although they also added that making these assessments may be “unavoidable” because of their need for diagnosing obstructive sleep apnea and determining the need for surgery.

Despite this caveat, “overall our study results highlight the need to better define the complex interaction between comorbidities, age, nocturnal respiratory events, and gas exchange abnormalities in predicting risk for PRAE” after adenotonsillectomy, the researchers wrote. These findings “are consistent with existing clinical care guidelines,” and “cardiac and craniofacial conditions have been associated with risk of postoperative complications in other studies.”

The analysis used data collected from all children aged 0-18 years who underwent polysomnography assessment followed by adenotonsillectomy at one Canadian tertiary-referral center, Children’s Hospital of Eastern Ontario in Ottawa, during 2010-2016. Their median age was just over 6 years, and 39 patients (10%) were younger than 3 years at the time of their surgery. More than three-quarters of the patients, 286, had at least one identified comorbidity, and nearly half had at least two comorbidities. Polysomnography identified sleep-disordered breathing in 344 of the children (92%), and diagnosed obstructive sleep apnea in 256 (68%), including 148 (43% of the full cohort) with a severe apnea-hypopnea index.

Sixty-six of the children (18%) had at least one severe PRAE that required intervention. Specifically these were either oxygen desaturations requiring intervention or need for airway or ventilatory support with interventions such as jaw thrust, oral or nasal airway placement, bag and mask ventilation, or endotracheal intubation.

A multivariate regression analysis of the measured comorbidity, polysomnography, and oximetry parameters, as well as age, identified three factors that independently linked with a statistically significant increase in the rate of severe PRAE: airway anomaly, underlying cardiac disease, and young age. Patients with an airway anomaly had a 219% increased rate of PRAE, compared with those with no anomaly; patients with underlying cardiac disease had a 109% increased rate, compared with those without cardiac disease; and patients aged younger than 3 years had a 310% higher rate of PRAE, compared with the children aged 6 years or older, while children aged 3-5 years had a 121% higher rate of PRAE, compared with older children.

The study received no commercial funding. Dr. Katz has received honoraria for speaking from Biogen that had no relevance to the study.

[email protected]

SOURCE: Katz SL et al. J Clin Sleep Med. 2020 Jan 15;16(1):41-8.

SNOWMASS, COLO. – Catheter ablation of atrial fibrillation was associated with a significant reduction in the composite endpoint of all-cause mortality, stroke, major bleeding, or cardiac arrest, compared with rhythm and/or rate control drugs in a propensity score–weighted, retrospective, observational study.

Bruce Jancin/MDedge News

Findings of the investigation, which included more than 183,000 real-world patients in routine clinical practice, were reported by Peter S. Noseworthy, MD, during the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

The results breathe new life into the controversy created by the previously reported CABANA trial (Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation), a 10-country study in which 2,204 patients with atrial fibrillation (AFib) were randomized to catheter ablation or antiarrhythmic and/or rhythm control medications and followed for a mean of about 4 years. CABANA yielded a negative result (JAMA. 2019 Apr 2;321[13]:1261-74), with the prespecified intent-to-treat analysis indicating no significant between-group difference in the primary composite endpoint – the very same one that was positive in the large observational study.

However, CABANA was marred by major problems arising from protocol deviations: Nearly 28% of patients assigned to medical therapy crossed over to catheter ablation, typically because their antiarrhythmic drugs failed, and 10% of patients randomized to catheter ablation never got it. This muddies the waters when trying to identify a true stroke/mortality benefit for catheter ablation, if indeed any such benefit was actually present.

Here’s where the controversy arose: While CABANA must be called a negative trial based upon the disappointing results of the intent-to-treat analysis, a prespecified post hoc analysis of patients as actually treated showed a statistically significant 27% relative risk reduction for the primary composite endpoint in the catheter ablation group. That’s strikingly similar to the 30% relative risk reduction for catheter ablation seen in the huge observational study, where the CABANA-type primary outcome occurred in 22.5% of the medically managed patients and 16.8% of those who underwent catheter ablation, noted Dr. Noseworthy, professor of medicine and director of heart rhythm and physiology at the Mayo Clinic in Rochester, Minn.

He ought to know: He was both an investigator in CABANA and first author of the published observational study (Eur Heart J. 2019 Apr 21;40[16]:1257-64).

In the observational study, Dr. Noseworthy and coinvestigators utilized a huge U.S. administrative health claims database in order to identify a nationally representative group of 183,760 AFib patients, 12,032 of whom were treated with catheter ablation and the rest with antiarrhythmic and/or rhythm control drugs during the same years the CABANA trial was enrolling patients. The two groups were balanced using propensity score weighting to adjust for baseline differences in 90 variables.

The investigators sought to learn if the CABANA study population was representative of real-world AFib patients, and whether the observational experience could help resolve the CABANA controversy. It turned out that most AFib patients seen in daily clinical practice were CABANA like; that is, 74% of them would have been eligible for the clinical trial because they were symptomatic, over age 65, or younger than 65 with at least one CHADS2 stroke risk factor. About 22% of the large real-world sample would have been excluded from CABANA because they’d failed on amiodarone and other antiarrhythmic agents or had previously undergone ablation. About 4% of patients failed to meet the CABANA inclusion criteria.

The risk reduction for the composite endpoint associated with catheter ablation in the large retrospective study was greatest in the CABANA-like patients, at 30%. It was less robust but still statistically significant at 15% in patients who met at least one of the exclusion criteria for the trial.

The sheer size of this study provides greater statistical power than in CABANA. Of course, a nonrandomized, propensity score–based comparison such as this is always susceptible to confounding, even after adjustment for 90 variables. But the observational study does offer “a glimmer of hope” that catheter ablation, done in the right patients, might confer a stroke risk reduction and mortality benefit, he said.

The 33% relative risk reduction in the small group of real-world patients who failed to meet the CABANA inclusion criteria, while numerically impressive, wasn’t close to statistical significance, probably because event rates in that population were so low.

“Even if you could reduce stroke risk with ablation in that low-risk group, it would be a very inefficient way to reduce the population burden of stroke,” Dr. Noseworthy observed.

Putting together the results of CABANA and the large observational study to sum up his view of where catheter ablation for AF[ib] stands today, Dr. Noseworthy commented, “Ablation is reasonable for symptom control in many patients, basically anyone who is either breaking through on drugs or doesn’t want to take the drugs and is highly symptomatic. And there may be a small stroke and/or mortality benefit for people who are in the sweet spot – and those are people who look a lot like the patients enrolled in CABANA.”

Patients who met the exclusion criteria for CABANA are too advanced in their AFib to be likely to derive a stroke or mortality benefit from catheter ablation. “It’s very hard to move the needle in these patients with either a drug or catheter ablation approach. I wouldn’t try to reduce the risk of stroke here with an expensive and invasive procedure,” the electrophysiologist concluded.

He reported having no financial conflicts regarding his presentation.

[email protected]

SNOWMASS, COLO. – Catheter ablation of atrial fibrillation was associated with a significant reduction in the composite endpoint of all-cause mortality, stroke, major bleeding, or cardiac arrest, compared with rhythm and/or rate control drugs in a propensity score–weighted, retrospective, observational study.

Bruce Jancin/MDedge News

Findings of the investigation, which included more than 183,000 real-world patients in routine clinical practice, were reported by Peter S. Noseworthy, MD, during the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

The results breathe new life into the controversy created by the previously reported CABANA trial (Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation), a 10-country study in which 2,204 patients with atrial fibrillation (AFib) were randomized to catheter ablation or antiarrhythmic and/or rhythm control medications and followed for a mean of about 4 years. CABANA yielded a negative result (JAMA. 2019 Apr 2;321[13]:1261-74), with the prespecified intent-to-treat analysis indicating no significant between-group difference in the primary composite endpoint – the very same one that was positive in the large observational study.

However, CABANA was marred by major problems arising from protocol deviations: Nearly 28% of patients assigned to medical therapy crossed over to catheter ablation, typically because their antiarrhythmic drugs failed, and 10% of patients randomized to catheter ablation never got it. This muddies the waters when trying to identify a true stroke/mortality benefit for catheter ablation, if indeed any such benefit was actually present.

Here’s where the controversy arose: While CABANA must be called a negative trial based upon the disappointing results of the intent-to-treat analysis, a prespecified post hoc analysis of patients as actually treated showed a statistically significant 27% relative risk reduction for the primary composite endpoint in the catheter ablation group. That’s strikingly similar to the 30% relative risk reduction for catheter ablation seen in the huge observational study, where the CABANA-type primary outcome occurred in 22.5% of the medically managed patients and 16.8% of those who underwent catheter ablation, noted Dr. Noseworthy, professor of medicine and director of heart rhythm and physiology at the Mayo Clinic in Rochester, Minn.

He ought to know: He was both an investigator in CABANA and first author of the published observational study (Eur Heart J. 2019 Apr 21;40[16]:1257-64).

In the observational study, Dr. Noseworthy and coinvestigators utilized a huge U.S. administrative health claims database in order to identify a nationally representative group of 183,760 AFib patients, 12,032 of whom were treated with catheter ablation and the rest with antiarrhythmic and/or rhythm control drugs during the same years the CABANA trial was enrolling patients. The two groups were balanced using propensity score weighting to adjust for baseline differences in 90 variables.

The investigators sought to learn if the CABANA study population was representative of real-world AFib patients, and whether the observational experience could help resolve the CABANA controversy. It turned out that most AFib patients seen in daily clinical practice were CABANA like; that is, 74% of them would have been eligible for the clinical trial because they were symptomatic, over age 65, or younger than 65 with at least one CHADS2 stroke risk factor. About 22% of the large real-world sample would have been excluded from CABANA because they’d failed on amiodarone and other antiarrhythmic agents or had previously undergone ablation. About 4% of patients failed to meet the CABANA inclusion criteria.

The risk reduction for the composite endpoint associated with catheter ablation in the large retrospective study was greatest in the CABANA-like patients, at 30%. It was less robust but still statistically significant at 15% in patients who met at least one of the exclusion criteria for the trial.

The sheer size of this study provides greater statistical power than in CABANA. Of course, a nonrandomized, propensity score–based comparison such as this is always susceptible to confounding, even after adjustment for 90 variables. But the observational study does offer “a glimmer of hope” that catheter ablation, done in the right patients, might confer a stroke risk reduction and mortality benefit, he said.

The 33% relative risk reduction in the small group of real-world patients who failed to meet the CABANA inclusion criteria, while numerically impressive, wasn’t close to statistical significance, probably because event rates in that population were so low.

“Even if you could reduce stroke risk with ablation in that low-risk group, it would be a very inefficient way to reduce the population burden of stroke,” Dr. Noseworthy observed.

Putting together the results of CABANA and the large observational study to sum up his view of where catheter ablation for AF[ib] stands today, Dr. Noseworthy commented, “Ablation is reasonable for symptom control in many patients, basically anyone who is either breaking through on drugs or doesn’t want to take the drugs and is highly symptomatic. And there may be a small stroke and/or mortality benefit for people who are in the sweet spot – and those are people who look a lot like the patients enrolled in CABANA.”

Patients who met the exclusion criteria for CABANA are too advanced in their AFib to be likely to derive a stroke or mortality benefit from catheter ablation. “It’s very hard to move the needle in these patients with either a drug or catheter ablation approach. I wouldn’t try to reduce the risk of stroke here with an expensive and invasive procedure,” the electrophysiologist concluded.

He reported having no financial conflicts regarding his presentation.

[email protected]

SNOWMASS, COLO. – Catheter ablation of atrial fibrillation was associated with a significant reduction in the composite endpoint of all-cause mortality, stroke, major bleeding, or cardiac arrest, compared with rhythm and/or rate control drugs in a propensity score–weighted, retrospective, observational study.

Bruce Jancin/MDedge News

Findings of the investigation, which included more than 183,000 real-world patients in routine clinical practice, were reported by Peter S. Noseworthy, MD, during the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

The results breathe new life into the controversy created by the previously reported CABANA trial (Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation), a 10-country study in which 2,204 patients with atrial fibrillation (AFib) were randomized to catheter ablation or antiarrhythmic and/or rhythm control medications and followed for a mean of about 4 years. CABANA yielded a negative result (JAMA. 2019 Apr 2;321[13]:1261-74), with the prespecified intent-to-treat analysis indicating no significant between-group difference in the primary composite endpoint – the very same one that was positive in the large observational study.

However, CABANA was marred by major problems arising from protocol deviations: Nearly 28% of patients assigned to medical therapy crossed over to catheter ablation, typically because their antiarrhythmic drugs failed, and 10% of patients randomized to catheter ablation never got it. This muddies the waters when trying to identify a true stroke/mortality benefit for catheter ablation, if indeed any such benefit was actually present.

Here’s where the controversy arose: While CABANA must be called a negative trial based upon the disappointing results of the intent-to-treat analysis, a prespecified post hoc analysis of patients as actually treated showed a statistically significant 27% relative risk reduction for the primary composite endpoint in the catheter ablation group. That’s strikingly similar to the 30% relative risk reduction for catheter ablation seen in the huge observational study, where the CABANA-type primary outcome occurred in 22.5% of the medically managed patients and 16.8% of those who underwent catheter ablation, noted Dr. Noseworthy, professor of medicine and director of heart rhythm and physiology at the Mayo Clinic in Rochester, Minn.

He ought to know: He was both an investigator in CABANA and first author of the published observational study (Eur Heart J. 2019 Apr 21;40[16]:1257-64).

In the observational study, Dr. Noseworthy and coinvestigators utilized a huge U.S. administrative health claims database in order to identify a nationally representative group of 183,760 AFib patients, 12,032 of whom were treated with catheter ablation and the rest with antiarrhythmic and/or rhythm control drugs during the same years the CABANA trial was enrolling patients. The two groups were balanced using propensity score weighting to adjust for baseline differences in 90 variables.

The investigators sought to learn if the CABANA study population was representative of real-world AFib patients, and whether the observational experience could help resolve the CABANA controversy. It turned out that most AFib patients seen in daily clinical practice were CABANA like; that is, 74% of them would have been eligible for the clinical trial because they were symptomatic, over age 65, or younger than 65 with at least one CHADS2 stroke risk factor. About 22% of the large real-world sample would have been excluded from CABANA because they’d failed on amiodarone and other antiarrhythmic agents or had previously undergone ablation. About 4% of patients failed to meet the CABANA inclusion criteria.

The risk reduction for the composite endpoint associated with catheter ablation in the large retrospective study was greatest in the CABANA-like patients, at 30%. It was less robust but still statistically significant at 15% in patients who met at least one of the exclusion criteria for the trial.

The sheer size of this study provides greater statistical power than in CABANA. Of course, a nonrandomized, propensity score–based comparison such as this is always susceptible to confounding, even after adjustment for 90 variables. But the observational study does offer “a glimmer of hope” that catheter ablation, done in the right patients, might confer a stroke risk reduction and mortality benefit, he said.

The 33% relative risk reduction in the small group of real-world patients who failed to meet the CABANA inclusion criteria, while numerically impressive, wasn’t close to statistical significance, probably because event rates in that population were so low.

“Even if you could reduce stroke risk with ablation in that low-risk group, it would be a very inefficient way to reduce the population burden of stroke,” Dr. Noseworthy observed.

Putting together the results of CABANA and the large observational study to sum up his view of where catheter ablation for AF[ib] stands today, Dr. Noseworthy commented, “Ablation is reasonable for symptom control in many patients, basically anyone who is either breaking through on drugs or doesn’t want to take the drugs and is highly symptomatic. And there may be a small stroke and/or mortality benefit for people who are in the sweet spot – and those are people who look a lot like the patients enrolled in CABANA.”

Patients who met the exclusion criteria for CABANA are too advanced in their AFib to be likely to derive a stroke or mortality benefit from catheter ablation. “It’s very hard to move the needle in these patients with either a drug or catheter ablation approach. I wouldn’t try to reduce the risk of stroke here with an expensive and invasive procedure,” the electrophysiologist concluded.

He reported having no financial conflicts regarding his presentation.

[email protected]

An analysis of four commonly performed surgical procedures for stress urinary incontinence found that they all improved sexual dysfunction to a similar degree over the course of 24 months.

Juanmonino/E+/Getty Images

“There is a growing body of literature concerning female sexual function after treatment for urinary incontinence,” Stephanie M. Glass Clark, MD, of the University of Pittsburgh, and colleagues wrote in a study published in Obstetrics & Gynecology. “Pelvic floor muscle therapy has been shown to improve sexual function as well as urinary incontinence symptoms. Surgical treatment, on the other hand, has had unclear effects on sexual function.”

Dr. Glass Clark and colleagues conducted a combined secondary analysis of the SISTEr (Stress Incontinence Surgical Treatment Efficacy Trial) and TOMUS (Trial of Mid-Urethral Slings) studies. Women in the original trials were randomized to receive surgical treatment for stress urinary incontinence with an autologous fascial sling or Burch colposuspension (SISTEr), or a retropubic or transobturator midurethral sling (TOMUS). Sexual function as assessed by the short version of the Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaire (PISQ-12) was compared between groups at baseline, 12 months, and 24 months.

Of the 924 women included, 249 (27%) had an autologous fascial sling, 239 (26%) underwent Burch colposuspension, 216 (23%) had a retropubic midurethral sling placed, and 220 (24%) had a transobturator midurethral sling placed. The researchers observed no significant differences in mean PISQ-12 scores between the four treatment groups at the time of baseline (P = .07) or at the 12- and 24-month visits (P = .42 and P = .50, respectively). Patients in the two studies showed an overall improvement in sexual function over the 24-month study period.

Specifically, PISQ-12 scores at baseline were 32.6 in the transobturator sling group, 33.1 in the retropubic sling group, 31.9 in the Burch procedure group, and 31.4 in the fascial sling group. At 12 months, the PISQ-12 scores rose to 37.7 in the transobturator sling group, 37.8 in the retropubic sling group, 36.9 in the Burch procedure group, and 37.1 in the fascial sling group. These scores were generally maintained at 24 months (37.7 in the transobturator sling group, 37.1 in the retropubic sling group, 36.7 in the Burch procedure group, and 37.4 in the fascial sling group), and were not statistically different than the scores tabulated at the 12-month follow-up visit (P = .97).

“This study and others demonstrate that sexual function improves with surgical improvement of stress incontinence which may suggest a possible association of urinary incontinence and sexual dysfunction,” Dr. Glass Clark and colleagues concluded. “As we continue to explore the complex and multifaceted problem of sexual dysfunction, further evaluation of the effect of pelvic floor disorders – and their treatments – will be important and necessary research.”

The researchers acknowledged certain limitations of the study, including the fact that there was a low degree of diversity among women in the studied trials, which limits the generalizability of the findings. They also pointed out that the PISQ-12 does not address sexual stimulation or nonpenetrative vaginal intercourse. “Additionally, it limits partner-related problems to erectile dysfunction and premature ejaculation; some eligible participants may be excluded secondary to sexual preferences given the assumptions inherent to the questionnaire that the partner is male,” they wrote.

This secondary analysis had no outside sources of funding. Dr. Glass Clark reported that she received a travel stipend from the Society of Gynecologic Surgeons, sponsored by OB-STATS. Her coauthors reported having no financial conflicts.

[email protected]

SOURCE: Glass Clark SM et al. Obstet Gynecol 2020;135(2):352-60.

An analysis of four commonly performed surgical procedures for stress urinary incontinence found that they all improved sexual dysfunction to a similar degree over the course of 24 months.

Juanmonino/E+/Getty Images

“There is a growing body of literature concerning female sexual function after treatment for urinary incontinence,” Stephanie M. Glass Clark, MD, of the University of Pittsburgh, and colleagues wrote in a study published in Obstetrics & Gynecology. “Pelvic floor muscle therapy has been shown to improve sexual function as well as urinary incontinence symptoms. Surgical treatment, on the other hand, has had unclear effects on sexual function.”

Dr. Glass Clark and colleagues conducted a combined secondary analysis of the SISTEr (Stress Incontinence Surgical Treatment Efficacy Trial) and TOMUS (Trial of Mid-Urethral Slings) studies. Women in the original trials were randomized to receive surgical treatment for stress urinary incontinence with an autologous fascial sling or Burch colposuspension (SISTEr), or a retropubic or transobturator midurethral sling (TOMUS). Sexual function as assessed by the short version of the Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaire (PISQ-12) was compared between groups at baseline, 12 months, and 24 months.

Of the 924 women included, 249 (27%) had an autologous fascial sling, 239 (26%) underwent Burch colposuspension, 216 (23%) had a retropubic midurethral sling placed, and 220 (24%) had a transobturator midurethral sling placed. The researchers observed no significant differences in mean PISQ-12 scores between the four treatment groups at the time of baseline (P = .07) or at the 12- and 24-month visits (P = .42 and P = .50, respectively). Patients in the two studies showed an overall improvement in sexual function over the 24-month study period.

Specifically, PISQ-12 scores at baseline were 32.6 in the transobturator sling group, 33.1 in the retropubic sling group, 31.9 in the Burch procedure group, and 31.4 in the fascial sling group. At 12 months, the PISQ-12 scores rose to 37.7 in the transobturator sling group, 37.8 in the retropubic sling group, 36.9 in the Burch procedure group, and 37.1 in the fascial sling group. These scores were generally maintained at 24 months (37.7 in the transobturator sling group, 37.1 in the retropubic sling group, 36.7 in the Burch procedure group, and 37.4 in the fascial sling group), and were not statistically different than the scores tabulated at the 12-month follow-up visit (P = .97).

“This study and others demonstrate that sexual function improves with surgical improvement of stress incontinence which may suggest a possible association of urinary incontinence and sexual dysfunction,” Dr. Glass Clark and colleagues concluded. “As we continue to explore the complex and multifaceted problem of sexual dysfunction, further evaluation of the effect of pelvic floor disorders – and their treatments – will be important and necessary research.”

The researchers acknowledged certain limitations of the study, including the fact that there was a low degree of diversity among women in the studied trials, which limits the generalizability of the findings. They also pointed out that the PISQ-12 does not address sexual stimulation or nonpenetrative vaginal intercourse. “Additionally, it limits partner-related problems to erectile dysfunction and premature ejaculation; some eligible participants may be excluded secondary to sexual preferences given the assumptions inherent to the questionnaire that the partner is male,” they wrote.

This secondary analysis had no outside sources of funding. Dr. Glass Clark reported that she received a travel stipend from the Society of Gynecologic Surgeons, sponsored by OB-STATS. Her coauthors reported having no financial conflicts.

[email protected]

SOURCE: Glass Clark SM et al. Obstet Gynecol 2020;135(2):352-60.

An analysis of four commonly performed surgical procedures for stress urinary incontinence found that they all improved sexual dysfunction to a similar degree over the course of 24 months.

Juanmonino/E+/Getty Images

“There is a growing body of literature concerning female sexual function after treatment for urinary incontinence,” Stephanie M. Glass Clark, MD, of the University of Pittsburgh, and colleagues wrote in a study published in Obstetrics & Gynecology. “Pelvic floor muscle therapy has been shown to improve sexual function as well as urinary incontinence symptoms. Surgical treatment, on the other hand, has had unclear effects on sexual function.”

Dr. Glass Clark and colleagues conducted a combined secondary analysis of the SISTEr (Stress Incontinence Surgical Treatment Efficacy Trial) and TOMUS (Trial of Mid-Urethral Slings) studies. Women in the original trials were randomized to receive surgical treatment for stress urinary incontinence with an autologous fascial sling or Burch colposuspension (SISTEr), or a retropubic or transobturator midurethral sling (TOMUS). Sexual function as assessed by the short version of the Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaire (PISQ-12) was compared between groups at baseline, 12 months, and 24 months.

Of the 924 women included, 249 (27%) had an autologous fascial sling, 239 (26%) underwent Burch colposuspension, 216 (23%) had a retropubic midurethral sling placed, and 220 (24%) had a transobturator midurethral sling placed. The researchers observed no significant differences in mean PISQ-12 scores between the four treatment groups at the time of baseline (P = .07) or at the 12- and 24-month visits (P = .42 and P = .50, respectively). Patients in the two studies showed an overall improvement in sexual function over the 24-month study period.

Specifically, PISQ-12 scores at baseline were 32.6 in the transobturator sling group, 33.1 in the retropubic sling group, 31.9 in the Burch procedure group, and 31.4 in the fascial sling group. At 12 months, the PISQ-12 scores rose to 37.7 in the transobturator sling group, 37.8 in the retropubic sling group, 36.9 in the Burch procedure group, and 37.1 in the fascial sling group. These scores were generally maintained at 24 months (37.7 in the transobturator sling group, 37.1 in the retropubic sling group, 36.7 in the Burch procedure group, and 37.4 in the fascial sling group), and were not statistically different than the scores tabulated at the 12-month follow-up visit (P = .97).

“This study and others demonstrate that sexual function improves with surgical improvement of stress incontinence which may suggest a possible association of urinary incontinence and sexual dysfunction,” Dr. Glass Clark and colleagues concluded. “As we continue to explore the complex and multifaceted problem of sexual dysfunction, further evaluation of the effect of pelvic floor disorders – and their treatments – will be important and necessary research.”

The researchers acknowledged certain limitations of the study, including the fact that there was a low degree of diversity among women in the studied trials, which limits the generalizability of the findings. They also pointed out that the PISQ-12 does not address sexual stimulation or nonpenetrative vaginal intercourse. “Additionally, it limits partner-related problems to erectile dysfunction and premature ejaculation; some eligible participants may be excluded secondary to sexual preferences given the assumptions inherent to the questionnaire that the partner is male,” they wrote.

This secondary analysis had no outside sources of funding. Dr. Glass Clark reported that she received a travel stipend from the Society of Gynecologic Surgeons, sponsored by OB-STATS. Her coauthors reported having no financial conflicts.

[email protected]

SOURCE: Glass Clark SM et al. Obstet Gynecol 2020;135(2):352-60.

An accelerated path to surgery after hip fracture did not improve mortality or major complications, according to a new international randomized trial. However, a fast track to surgery hastened mobilization, weight-bearing, and hospital discharge, and reduced the risk of urinary tract infection and delirium.

The HIP ATTACK (Hip Fracture Accelerated Surgical Treatment and Care Track) study enrolled 2,970 patients (median age, 79 years; 69% women) during March 2014-May 2019. The study excluded patients younger than 45 years, as well as those who were on nonreversible anticoagulation and who had high-energy or more complex hip fractures. In all, 1,487 patients were randomly assigned to the accelerated-surgery group, which received early medical evaluation with a goal of heading to surgery within 6 hours of a hip fracture diagnosis. The goal was achieved, with patients in the intervention arm receiving care at a median 6 hours after diagnosis. Patients in the 69 participating hospitals in 17 countries who were assigned to standard of care received surgery at a median 24 hours after diagnosis (P less than .001).

“Observational data, clinical experience, and biological rationale suggest that the longer a patient is immobile and lying in a bed, the higher the risk of poor outcomes,” wrote principal investigators Philip J. Devereaux, MD, PhD, and Mohit Bhandari, MD, PhD, of McMaster University, Hamilton, Ont., and their colleagues on the HIP ATTACK writing committee.

The study was the first large, randomized trial that directly compared accelerated surgery with standard of care, noted the authors. Previous observational studies had shown worse outcomes for those usual-care patients who waited longer for surgery.

In HIP ATTACK, there was no difference in the primary outcome measures of 90-day mortality and major complications for patients receiving surgery within 6 hours after hip fracture diagnosis, compared with those who received surgery within 24 hours. The coprimary outcome measures included serious complications, such as MI, stroke, venous thromboembolism, sepsis, pneumonia, and life-threatening or major bleeding.

In practice, the researchers found that patients in the accelerated-surgery group received medical clearance in a median time of 2 hours after a diagnosis of hip fracture, whereas the standard of care group was cleared in 4 hours.

At 90 days, 9% of patients in the accelerated-surgery group and 10% of those in the usual-care group had died, a nonsignificant difference between the two groups. In both groups, 22% of patients experienced a major complication. A post hoc analysis that looked for any site-clustering effects did not detect different outcomes, the investigators wrote.

Delirium occurred in 132 patients (9%) of the accelerated-surgery group and in 175 patients (12%) in the usual-care group (odds ratio, 0.72; 95% confidence interval, 0.58-0.92). Infection without sepsis and urinary tract infection were both less common in the accelerated-surgery group (hazard ratio, 0.80 and 0.78, respectively).

The authors noted that the potential benefits of a speedy course to surgery, including reduced immobility and less pain, could be negated if physicians had less time to optimize medical care for older patients with multiple comorbidities and who make up a significant proportion of those who sustain low-energy hip fractures. However, medical complications, such as MI and new-onset atrial fibrillation, were not seen more frequently in the accelerated-surgery group.

In an editorial accompanying the study, Alejandro Lizaur-Utrilla, MD, and Fernando Lopez-Prats, MD, of the Universidad Miguel Hernández, Alicante, Spain, observed that the 6-hour window for hip fracture surgery may be difficult to achieve given clinical practicalities and that, in some cases, the 6-hour window might be unavoidable if severe comorbidities and overall poor health make early surgery inadvisable.

They also expressed concern that, despite the lack of harm shown in the patients who underwent accelerated surgery, the surgery “might negatively affect patients’ outcomes by preventing or limiting the opportunity for optimization of patients’ medical conditions before surgery.” They called for further study to delineate how fitness for surgery affects outcomes in accelerated surgery and to further examine whether the better outcomes are associated with improved cost-effectiveness.

Multiple HIP ATTACK coinvestigators reported relationships with pharmaceutical and medical device companies, including companies that manufacture hip prosthesis and orthopedic surgical devices and implants. The study was sponsored by the Canadian Population Health Research Institute, the Ontario Strategy for Patient Oriented Research Support Unit, the Ontario Ministry of Health and Long-Term Care, the Hamilton Health Sciences Foundation, Physicians’ Services Incorporated Foundation, Michael G. DeGroote Institute for Pain Research and Care, Smith & Nephew (to recruit patients in Spain), and Indiegogo Crowdfunding.

SOURCE: Borges F et al. Lancet. 2020 Feb. 9. doi: 10.1016/S0140-6736(20)30058-1.


 

An accelerated path to surgery after hip fracture did not improve mortality or major complications, according to a new international randomized trial. However, a fast track to surgery hastened mobilization, weight-bearing, and hospital discharge, and reduced the risk of urinary tract infection and delirium.

The HIP ATTACK (Hip Fracture Accelerated Surgical Treatment and Care Track) study enrolled 2,970 patients (median age, 79 years; 69% women) during March 2014-May 2019. The study excluded patients younger than 45 years, as well as those who were on nonreversible anticoagulation and who had high-energy or more complex hip fractures. In all, 1,487 patients were randomly assigned to the accelerated-surgery group, which received early medical evaluation with a goal of heading to surgery within 6 hours of a hip fracture diagnosis. The goal was achieved, with patients in the intervention arm receiving care at a median 6 hours after diagnosis. Patients in the 69 participating hospitals in 17 countries who were assigned to standard of care received surgery at a median 24 hours after diagnosis (P less than .001).

“Observational data, clinical experience, and biological rationale suggest that the longer a patient is immobile and lying in a bed, the higher the risk of poor outcomes,” wrote principal investigators Philip J. Devereaux, MD, PhD, and Mohit Bhandari, MD, PhD, of McMaster University, Hamilton, Ont., and their colleagues on the HIP ATTACK writing committee.

The study was the first large, randomized trial that directly compared accelerated surgery with standard of care, noted the authors. Previous observational studies had shown worse outcomes for those usual-care patients who waited longer for surgery.

In HIP ATTACK, there was no difference in the primary outcome measures of 90-day mortality and major complications for patients receiving surgery within 6 hours after hip fracture diagnosis, compared with those who received surgery within 24 hours. The coprimary outcome measures included serious complications, such as MI, stroke, venous thromboembolism, sepsis, pneumonia, and life-threatening or major bleeding.

In practice, the researchers found that patients in the accelerated-surgery group received medical clearance in a median time of 2 hours after a diagnosis of hip fracture, whereas the standard of care group was cleared in 4 hours.

At 90 days, 9% of patients in the accelerated-surgery group and 10% of those in the usual-care group had died, a nonsignificant difference between the two groups. In both groups, 22% of patients experienced a major complication. A post hoc analysis that looked for any site-clustering effects did not detect different outcomes, the investigators wrote.

Delirium occurred in 132 patients (9%) of the accelerated-surgery group and in 175 patients (12%) in the usual-care group (odds ratio, 0.72; 95% confidence interval, 0.58-0.92). Infection without sepsis and urinary tract infection were both less common in the accelerated-surgery group (hazard ratio, 0.80 and 0.78, respectively).

The authors noted that the potential benefits of a speedy course to surgery, including reduced immobility and less pain, could be negated if physicians had less time to optimize medical care for older patients with multiple comorbidities and who make up a significant proportion of those who sustain low-energy hip fractures. However, medical complications, such as MI and new-onset atrial fibrillation, were not seen more frequently in the accelerated-surgery group.

In an editorial accompanying the study, Alejandro Lizaur-Utrilla, MD, and Fernando Lopez-Prats, MD, of the Universidad Miguel Hernández, Alicante, Spain, observed that the 6-hour window for hip fracture surgery may be difficult to achieve given clinical practicalities and that, in some cases, the 6-hour window might be unavoidable if severe comorbidities and overall poor health make early surgery inadvisable.

They also expressed concern that, despite the lack of harm shown in the patients who underwent accelerated surgery, the surgery “might negatively affect patients’ outcomes by preventing or limiting the opportunity for optimization of patients’ medical conditions before surgery.” They called for further study to delineate how fitness for surgery affects outcomes in accelerated surgery and to further examine whether the better outcomes are associated with improved cost-effectiveness.

Multiple HIP ATTACK coinvestigators reported relationships with pharmaceutical and medical device companies, including companies that manufacture hip prosthesis and orthopedic surgical devices and implants. The study was sponsored by the Canadian Population Health Research Institute, the Ontario Strategy for Patient Oriented Research Support Unit, the Ontario Ministry of Health and Long-Term Care, the Hamilton Health Sciences Foundation, Physicians’ Services Incorporated Foundation, Michael G. DeGroote Institute for Pain Research and Care, Smith & Nephew (to recruit patients in Spain), and Indiegogo Crowdfunding.

SOURCE: Borges F et al. Lancet. 2020 Feb. 9. doi: 10.1016/S0140-6736(20)30058-1.


 

An accelerated path to surgery after hip fracture did not improve mortality or major complications, according to a new international randomized trial. However, a fast track to surgery hastened mobilization, weight-bearing, and hospital discharge, and reduced the risk of urinary tract infection and delirium.

The HIP ATTACK (Hip Fracture Accelerated Surgical Treatment and Care Track) study enrolled 2,970 patients (median age, 79 years; 69% women) during March 2014-May 2019. The study excluded patients younger than 45 years, as well as those who were on nonreversible anticoagulation and who had high-energy or more complex hip fractures. In all, 1,487 patients were randomly assigned to the accelerated-surgery group, which received early medical evaluation with a goal of heading to surgery within 6 hours of a hip fracture diagnosis. The goal was achieved, with patients in the intervention arm receiving care at a median 6 hours after diagnosis. Patients in the 69 participating hospitals in 17 countries who were assigned to standard of care received surgery at a median 24 hours after diagnosis (P less than .001).

“Observational data, clinical experience, and biological rationale suggest that the longer a patient is immobile and lying in a bed, the higher the risk of poor outcomes,” wrote principal investigators Philip J. Devereaux, MD, PhD, and Mohit Bhandari, MD, PhD, of McMaster University, Hamilton, Ont., and their colleagues on the HIP ATTACK writing committee.

The study was the first large, randomized trial that directly compared accelerated surgery with standard of care, noted the authors. Previous observational studies had shown worse outcomes for those usual-care patients who waited longer for surgery.

In HIP ATTACK, there was no difference in the primary outcome measures of 90-day mortality and major complications for patients receiving surgery within 6 hours after hip fracture diagnosis, compared with those who received surgery within 24 hours. The coprimary outcome measures included serious complications, such as MI, stroke, venous thromboembolism, sepsis, pneumonia, and life-threatening or major bleeding.

In practice, the researchers found that patients in the accelerated-surgery group received medical clearance in a median time of 2 hours after a diagnosis of hip fracture, whereas the standard of care group was cleared in 4 hours.

At 90 days, 9% of patients in the accelerated-surgery group and 10% of those in the usual-care group had died, a nonsignificant difference between the two groups. In both groups, 22% of patients experienced a major complication. A post hoc analysis that looked for any site-clustering effects did not detect different outcomes, the investigators wrote.

Delirium occurred in 132 patients (9%) of the accelerated-surgery group and in 175 patients (12%) in the usual-care group (odds ratio, 0.72; 95% confidence interval, 0.58-0.92). Infection without sepsis and urinary tract infection were both less common in the accelerated-surgery group (hazard ratio, 0.80 and 0.78, respectively).

The authors noted that the potential benefits of a speedy course to surgery, including reduced immobility and less pain, could be negated if physicians had less time to optimize medical care for older patients with multiple comorbidities and who make up a significant proportion of those who sustain low-energy hip fractures. However, medical complications, such as MI and new-onset atrial fibrillation, were not seen more frequently in the accelerated-surgery group.

In an editorial accompanying the study, Alejandro Lizaur-Utrilla, MD, and Fernando Lopez-Prats, MD, of the Universidad Miguel Hernández, Alicante, Spain, observed that the 6-hour window for hip fracture surgery may be difficult to achieve given clinical practicalities and that, in some cases, the 6-hour window might be unavoidable if severe comorbidities and overall poor health make early surgery inadvisable.

They also expressed concern that, despite the lack of harm shown in the patients who underwent accelerated surgery, the surgery “might negatively affect patients’ outcomes by preventing or limiting the opportunity for optimization of patients’ medical conditions before surgery.” They called for further study to delineate how fitness for surgery affects outcomes in accelerated surgery and to further examine whether the better outcomes are associated with improved cost-effectiveness.

Multiple HIP ATTACK coinvestigators reported relationships with pharmaceutical and medical device companies, including companies that manufacture hip prosthesis and orthopedic surgical devices and implants. The study was sponsored by the Canadian Population Health Research Institute, the Ontario Strategy for Patient Oriented Research Support Unit, the Ontario Ministry of Health and Long-Term Care, the Hamilton Health Sciences Foundation, Physicians’ Services Incorporated Foundation, Michael G. DeGroote Institute for Pain Research and Care, Smith & Nephew (to recruit patients in Spain), and Indiegogo Crowdfunding.

SOURCE: Borges F et al. Lancet. 2020 Feb. 9. doi: 10.1016/S0140-6736(20)30058-1.


 

LAS VEGAS – While it’s fading in popularity, ovary removal in hysterectomy is still far from uncommon. A gynecologic surgeon urged colleagues to give deeper consideration to whether the ovaries can stay in place.

“Gynecologists should truly familiarize themselves with the data on cardiovascular, endocrine, bone, and sexual health implications of removing the ovaries when there isn’t a medical indication to do so,” Amanda Nickles Fader, MD, director of the Kelly gynecologic oncology service and the director of the center for rare gynecologic cancers at Johns Hopkins Hospital, Baltimore, said in an interview following her presentation at the Pelvic Anatomy and Gynecologic Surgery Symposium.

“Until I started giving this talk, I thought I knew this data. However, once I took a deeper dive into the studies of how hormonally active the postmenopausal ovaries are, as well as the population-based studies demonstrating worse all-cause mortality outcomes in low-risk women who have their ovaries surgically removed prior to their 60s, I was stunned at how compelling this data is,” she said.

The conventional wisdom about ovary removal in hysterectomy has changed dramatically over the decades. As Dr. Nickles Fader explained in the interview, “in the ’80s and early ’90s, the mantra was ‘just take everything out’ at hysterectomy surgery – tubes and ovaries should be removed – without understanding the implications. Then in the late ’90s and early 2000s, it was a more selective strategy of ‘wait until menopause to remove the ovaries.’ ”

Now, “more contemporary data suggests that the ovaries appear to be hormonally active to some degree well into the seventh decade of life, and even women in their early 60s who have their ovaries removed without a medical indication may be harmed.”

Still, ovary removal occurs in about 50%-60% of the 450,000-500,000 hysterectomies performed each year in the United States, Dr. Nickles Fader said at the meeting, which was jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company.

These findings seem to suggest that messages about the potential benefits of ovary preservation are not getting through to surgeons and patients.

Indeed, a 2017 study of 57,776 benign premenopausal hysterectomies with ovary removal in California from 2005 to 2011 found that 38% had no documented sign of an appropriate diagnosis signaling a need for oophorectomy. These included “ovarian cyst, breast cancer susceptibility gene carrier status, and other diagnoses,” the study authors wrote (Menopause. 2017 Aug;24[8]:947-53).

Dr. Nickles Fader emphasized that ovary removal is appropriate in cases of gynecologic malignancy, while patients at high genetic risk of ovarian cancer may consider salpingo-oophorectomy or salpingectomy.

What about other situations? She offered these pearls in the presentation:

• Don’t remove ovaries before age 60 “without a good reason” because the procedure may lower lifespan and increase cardiovascular risk.
• Ovary removal is linked to cognitive decline, Parkinson’s disease, depression and anxiety, glaucoma, sexual dysfunction, and bone fractures.
• Ovary preservation, in contrast, is linked to improvement of menopausal symptoms, sleep quality, urogenital atrophy, skin conditions, and metabolism.
• Fallopian tubes may be the true trouble area. “The prevailing theory amongst scientists and clinicians is that ‘ovarian cancer’ is in most cases a misnomer, and most of these malignancies start in the fallopian tube,” Dr. Nickles Fader said in the interview.

“It’s a better time than ever to be thoughtful about removing a woman’s ovaries in someone who is at low risk for ovarian cancer. The new, universal guideline is that instead of removing ovaries in most women undergoing hysterectomy, it’s quite important to consider removing just the fallopian tubes to best optimize cancer risk reduction and general health outcomes.”

Dr. Nickles Fader disclosed consulting work for Ethicon and Merck.

LAS VEGAS – While it’s fading in popularity, ovary removal in hysterectomy is still far from uncommon. A gynecologic surgeon urged colleagues to give deeper consideration to whether the ovaries can stay in place.

“Gynecologists should truly familiarize themselves with the data on cardiovascular, endocrine, bone, and sexual health implications of removing the ovaries when there isn’t a medical indication to do so,” Amanda Nickles Fader, MD, director of the Kelly gynecologic oncology service and the director of the center for rare gynecologic cancers at Johns Hopkins Hospital, Baltimore, said in an interview following her presentation at the Pelvic Anatomy and Gynecologic Surgery Symposium.

“Until I started giving this talk, I thought I knew this data. However, once I took a deeper dive into the studies of how hormonally active the postmenopausal ovaries are, as well as the population-based studies demonstrating worse all-cause mortality outcomes in low-risk women who have their ovaries surgically removed prior to their 60s, I was stunned at how compelling this data is,” she said.

The conventional wisdom about ovary removal in hysterectomy has changed dramatically over the decades. As Dr. Nickles Fader explained in the interview, “in the ’80s and early ’90s, the mantra was ‘just take everything out’ at hysterectomy surgery – tubes and ovaries should be removed – without understanding the implications. Then in the late ’90s and early 2000s, it was a more selective strategy of ‘wait until menopause to remove the ovaries.’ ”

Now, “more contemporary data suggests that the ovaries appear to be hormonally active to some degree well into the seventh decade of life, and even women in their early 60s who have their ovaries removed without a medical indication may be harmed.”

Still, ovary removal occurs in about 50%-60% of the 450,000-500,000 hysterectomies performed each year in the United States, Dr. Nickles Fader said at the meeting, which was jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company.

These findings seem to suggest that messages about the potential benefits of ovary preservation are not getting through to surgeons and patients.

Indeed, a 2017 study of 57,776 benign premenopausal hysterectomies with ovary removal in California from 2005 to 2011 found that 38% had no documented sign of an appropriate diagnosis signaling a need for oophorectomy. These included “ovarian cyst, breast cancer susceptibility gene carrier status, and other diagnoses,” the study authors wrote (Menopause. 2017 Aug;24[8]:947-53).

Dr. Nickles Fader emphasized that ovary removal is appropriate in cases of gynecologic malignancy, while patients at high genetic risk of ovarian cancer may consider salpingo-oophorectomy or salpingectomy.

What about other situations? She offered these pearls in the presentation:

• Don’t remove ovaries before age 60 “without a good reason” because the procedure may lower lifespan and increase cardiovascular risk.
• Ovary removal is linked to cognitive decline, Parkinson’s disease, depression and anxiety, glaucoma, sexual dysfunction, and bone fractures.
• Ovary preservation, in contrast, is linked to improvement of menopausal symptoms, sleep quality, urogenital atrophy, skin conditions, and metabolism.
• Fallopian tubes may be the true trouble area. “The prevailing theory amongst scientists and clinicians is that ‘ovarian cancer’ is in most cases a misnomer, and most of these malignancies start in the fallopian tube,” Dr. Nickles Fader said in the interview.

“It’s a better time than ever to be thoughtful about removing a woman’s ovaries in someone who is at low risk for ovarian cancer. The new, universal guideline is that instead of removing ovaries in most women undergoing hysterectomy, it’s quite important to consider removing just the fallopian tubes to best optimize cancer risk reduction and general health outcomes.”

Dr. Nickles Fader disclosed consulting work for Ethicon and Merck.

LAS VEGAS – While it’s fading in popularity, ovary removal in hysterectomy is still far from uncommon. A gynecologic surgeon urged colleagues to give deeper consideration to whether the ovaries can stay in place.

“Gynecologists should truly familiarize themselves with the data on cardiovascular, endocrine, bone, and sexual health implications of removing the ovaries when there isn’t a medical indication to do so,” Amanda Nickles Fader, MD, director of the Kelly gynecologic oncology service and the director of the center for rare gynecologic cancers at Johns Hopkins Hospital, Baltimore, said in an interview following her presentation at the Pelvic Anatomy and Gynecologic Surgery Symposium.

“Until I started giving this talk, I thought I knew this data. However, once I took a deeper dive into the studies of how hormonally active the postmenopausal ovaries are, as well as the population-based studies demonstrating worse all-cause mortality outcomes in low-risk women who have their ovaries surgically removed prior to their 60s, I was stunned at how compelling this data is,” she said.

The conventional wisdom about ovary removal in hysterectomy has changed dramatically over the decades. As Dr. Nickles Fader explained in the interview, “in the ’80s and early ’90s, the mantra was ‘just take everything out’ at hysterectomy surgery – tubes and ovaries should be removed – without understanding the implications. Then in the late ’90s and early 2000s, it was a more selective strategy of ‘wait until menopause to remove the ovaries.’ ”

Now, “more contemporary data suggests that the ovaries appear to be hormonally active to some degree well into the seventh decade of life, and even women in their early 60s who have their ovaries removed without a medical indication may be harmed.”

Still, ovary removal occurs in about 50%-60% of the 450,000-500,000 hysterectomies performed each year in the United States, Dr. Nickles Fader said at the meeting, which was jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company.

These findings seem to suggest that messages about the potential benefits of ovary preservation are not getting through to surgeons and patients.

Indeed, a 2017 study of 57,776 benign premenopausal hysterectomies with ovary removal in California from 2005 to 2011 found that 38% had no documented sign of an appropriate diagnosis signaling a need for oophorectomy. These included “ovarian cyst, breast cancer susceptibility gene carrier status, and other diagnoses,” the study authors wrote (Menopause. 2017 Aug;24[8]:947-53).

Dr. Nickles Fader emphasized that ovary removal is appropriate in cases of gynecologic malignancy, while patients at high genetic risk of ovarian cancer may consider salpingo-oophorectomy or salpingectomy.

What about other situations? She offered these pearls in the presentation:

• Don’t remove ovaries before age 60 “without a good reason” because the procedure may lower lifespan and increase cardiovascular risk.
• Ovary removal is linked to cognitive decline, Parkinson’s disease, depression and anxiety, glaucoma, sexual dysfunction, and bone fractures.
• Ovary preservation, in contrast, is linked to improvement of menopausal symptoms, sleep quality, urogenital atrophy, skin conditions, and metabolism.
• Fallopian tubes may be the true trouble area. “The prevailing theory amongst scientists and clinicians is that ‘ovarian cancer’ is in most cases a misnomer, and most of these malignancies start in the fallopian tube,” Dr. Nickles Fader said in the interview.

“It’s a better time than ever to be thoughtful about removing a woman’s ovaries in someone who is at low risk for ovarian cancer. The new, universal guideline is that instead of removing ovaries in most women undergoing hysterectomy, it’s quite important to consider removing just the fallopian tubes to best optimize cancer risk reduction and general health outcomes.”

Dr. Nickles Fader disclosed consulting work for Ethicon and Merck.

Cuzick J, Sestak I, Forbes JF, et al; IBIS-II Investigators. Use of anastrozole for breast cancer prevention (IBIS-II): long-term results of a randomised controlled trial. Lancet. 2020;395;117-122.

EXPERT COMMENTARY

A manufacturer-sponsored trial initiated in 2003, IBIS-II (International Breast Cancer Intervention Study II) included 3,864 menopausal women (mean age at baseline, 59.4 years) at elevated risk for breast cancer. The women were randomly assigned to 5-year treatment with either placebo (N = 1,944) or the aromatase inhibitor anastrozole 1 mg daily (N = 1,920).¹

Reporting on the long-term follow-up results of the trial, Cuzick and colleagues found that anastrozole use substantially reduced the incidence of all breast cancer, including invasive breast cancer and ductal carcinoma in situ. Key adverse events associated with anastrozole were fractures, arthralgias, and menopausal symptoms (vasomotor symptoms and vaginal dryness).

To determine whether anastrozole had any persistent impact, the investigators continued to follow participants for all breast cancers and other outcomes.²

Details of the study

This randomized controlled trial that included 3,864 postmenopausal women had a median overall follow-up of 131 months; the primary outcome was all breast cancer. Random assignment to anastrozole use (1,920 women) was associated with a 49% reduction in all breast cancer (85 cases vs 165 cases in the placebo group [N = 1,944]; HR, 0.51; 95% CI, 0.39–0.66; P<.0001).

In the first 5 years, risk reduction was 61% with anastrozole (P<.0001 for overall and the first 5 years of follow-up). Subsequently, the magnitude of the risk reduction attenuated to 37% (P = .014). With 12 years of follow-up, the estimated risk of being diagnosed with breast cancer was 8.8% and 5.3% in the placebo and anastrozole groups, respectively. The number needed to treat for 5 years to prevent 1 breast cancer was 29.

With anastrozole, prevention of estrogen–receptor positive tumors was substantially more robust at 54% (HR, 0.46; 95% CI, 0.33–0.65; P<.0001) than for estrogen–receptor negative tumors at 27% (HR, 0.77; 95% CI, 0.41–1.44; P = .41).

Over the course of the long-term study, the incidence of fractures and cardiovascular events was similar in the placebo and anastrozole groups. Arthralgias and menopausal symptoms were not assessed after the trial’s initial 5 years. Overall, the number of deaths (all cause as well as breast cancer related) were similar in the placebo and anastrozole groups.

Continue to: Study strengths and limitations...

Study strengths and limitations

The authors noted that this updated analysis of the IBIS-II trial data offers further support for the use of anastrozole in breast cancer prevention for high-risk postmenopausal women. The extended posttreatment follow-up showed a significant continuing reduction in breast cancer, and there was no evidence of new late adverse effects. A limitation of the analysis, however, is that very few deaths from breast cancer occurred during the study timeframe. Thus, additional follow-up would be needed to assess anastrozole’s effect on breast cancer mortality.

Cuzick J, Sestak I, Forbes JF, et al; IBIS-II Investigators. Use of anastrozole for breast cancer prevention (IBIS-II): long-term results of a randomised controlled trial. Lancet. 2020;395;117-122.

EXPERT COMMENTARY

A manufacturer-sponsored trial initiated in 2003, IBIS-II (International Breast Cancer Intervention Study II) included 3,864 menopausal women (mean age at baseline, 59.4 years) at elevated risk for breast cancer. The women were randomly assigned to 5-year treatment with either placebo (N = 1,944) or the aromatase inhibitor anastrozole 1 mg daily (N = 1,920).¹

Reporting on the long-term follow-up results of the trial, Cuzick and colleagues found that anastrozole use substantially reduced the incidence of all breast cancer, including invasive breast cancer and ductal carcinoma in situ. Key adverse events associated with anastrozole were fractures, arthralgias, and menopausal symptoms (vasomotor symptoms and vaginal dryness).

To determine whether anastrozole had any persistent impact, the investigators continued to follow participants for all breast cancers and other outcomes.²

Details of the study

This randomized controlled trial that included 3,864 postmenopausal women had a median overall follow-up of 131 months; the primary outcome was all breast cancer. Random assignment to anastrozole use (1,920 women) was associated with a 49% reduction in all breast cancer (85 cases vs 165 cases in the placebo group [N = 1,944]; HR, 0.51; 95% CI, 0.39–0.66; P<.0001).

In the first 5 years, risk reduction was 61% with anastrozole (P<.0001 for overall and the first 5 years of follow-up). Subsequently, the magnitude of the risk reduction attenuated to 37% (P = .014). With 12 years of follow-up, the estimated risk of being diagnosed with breast cancer was 8.8% and 5.3% in the placebo and anastrozole groups, respectively. The number needed to treat for 5 years to prevent 1 breast cancer was 29.

With anastrozole, prevention of estrogen–receptor positive tumors was substantially more robust at 54% (HR, 0.46; 95% CI, 0.33–0.65; P<.0001) than for estrogen–receptor negative tumors at 27% (HR, 0.77; 95% CI, 0.41–1.44; P = .41).

Over the course of the long-term study, the incidence of fractures and cardiovascular events was similar in the placebo and anastrozole groups. Arthralgias and menopausal symptoms were not assessed after the trial’s initial 5 years. Overall, the number of deaths (all cause as well as breast cancer related) were similar in the placebo and anastrozole groups.

Continue to: Study strengths and limitations...

Study strengths and limitations

The authors noted that this updated analysis of the IBIS-II trial data offers further support for the use of anastrozole in breast cancer prevention for high-risk postmenopausal women. The extended posttreatment follow-up showed a significant continuing reduction in breast cancer, and there was no evidence of new late adverse effects. A limitation of the analysis, however, is that very few deaths from breast cancer occurred during the study timeframe. Thus, additional follow-up would be needed to assess anastrozole’s effect on breast cancer mortality.

Cuzick J, Sestak I, Forbes JF, et al; IBIS-II Investigators. Use of anastrozole for breast cancer prevention (IBIS-II): long-term results of a randomised controlled trial. Lancet. 2020;395;117-122.

EXPERT COMMENTARY

A manufacturer-sponsored trial initiated in 2003, IBIS-II (International Breast Cancer Intervention Study II) included 3,864 menopausal women (mean age at baseline, 59.4 years) at elevated risk for breast cancer. The women were randomly assigned to 5-year treatment with either placebo (N = 1,944) or the aromatase inhibitor anastrozole 1 mg daily (N = 1,920).¹

Reporting on the long-term follow-up results of the trial, Cuzick and colleagues found that anastrozole use substantially reduced the incidence of all breast cancer, including invasive breast cancer and ductal carcinoma in situ. Key adverse events associated with anastrozole were fractures, arthralgias, and menopausal symptoms (vasomotor symptoms and vaginal dryness).

To determine whether anastrozole had any persistent impact, the investigators continued to follow participants for all breast cancers and other outcomes.²

Details of the study

This randomized controlled trial that included 3,864 postmenopausal women had a median overall follow-up of 131 months; the primary outcome was all breast cancer. Random assignment to anastrozole use (1,920 women) was associated with a 49% reduction in all breast cancer (85 cases vs 165 cases in the placebo group [N = 1,944]; HR, 0.51; 95% CI, 0.39–0.66; P<.0001).

In the first 5 years, risk reduction was 61% with anastrozole (P<.0001 for overall and the first 5 years of follow-up). Subsequently, the magnitude of the risk reduction attenuated to 37% (P = .014). With 12 years of follow-up, the estimated risk of being diagnosed with breast cancer was 8.8% and 5.3% in the placebo and anastrozole groups, respectively. The number needed to treat for 5 years to prevent 1 breast cancer was 29.

With anastrozole, prevention of estrogen–receptor positive tumors was substantially more robust at 54% (HR, 0.46; 95% CI, 0.33–0.65; P<.0001) than for estrogen–receptor negative tumors at 27% (HR, 0.77; 95% CI, 0.41–1.44; P = .41).

Over the course of the long-term study, the incidence of fractures and cardiovascular events was similar in the placebo and anastrozole groups. Arthralgias and menopausal symptoms were not assessed after the trial’s initial 5 years. Overall, the number of deaths (all cause as well as breast cancer related) were similar in the placebo and anastrozole groups.

Continue to: Study strengths and limitations...

Study strengths and limitations

The authors noted that this updated analysis of the IBIS-II trial data offers further support for the use of anastrozole in breast cancer prevention for high-risk postmenopausal women. The extended posttreatment follow-up showed a significant continuing reduction in breast cancer, and there was no evidence of new late adverse effects. A limitation of the analysis, however, is that very few deaths from breast cancer occurred during the study timeframe. Thus, additional follow-up would be needed to assess anastrozole’s effect on breast cancer mortality.

There were fewer complications with outpatient unicompartmental knee arthroplasty in a freestanding ambulatory surgery center than in the hospital, according to a review from the University of Tennessee Campbell Clinic, Memphis.

“In carefully selected patients, the ASC [ambulatory surgery center] seems to be a safe alternative to the inpatient hospital setting,” concluded investigators led by led by Marcus Ford, MD, a Campbell Clinic orthopedic surgeon.

He and his colleagues have been doing outpatient unicompartmental knee arthroplasty (UKA) since 2009, and “based on the subjective success,” recently increased the number of total knee, hip, and shoulder arthroplasties performed in their ASC.

They wanted to make sure, however, that their impression of good outpatient UKA results was supported by the data, so they compared outcomes in 48 UKA patients treated at their ASC with 48 treated in the hospital. The operations were done by two surgeons using the same technique and same medial UKA implant.

“Naturally, surgeons select those patients who are deemed physically and mentally capable of succeeding with an accelerated discharge plan” for outpatient service, the investigators wrote. To address that potential selection bias, the team matched their subjects by age and comorbidities.

There was only one minor complication in the outpatient group, a superficial stitch abscess. No patient needed a second operation, and all went home the same day.

It was different on the inpatient side. The average length of stay was 2.9 days, and there were four major complications: a deep venous thrombosis, a pulmonary embolus, an acute postoperative infection, and a periprosthetic fracture. All four required hospital readmission, and two patients needed a second operation.

The report didn’t directly address the reasons for the differences, but Dr. Ford and colleagues did note that they “believe that the ASC allows the surgeon greater direct control of perioperative variables that can impact patient outcome.”

Patients were in their late 50s, on average, and there were more women than men in both groups. The mean American Society of Anesthesiologists physical status classification score was 1.94 and mean body mass index was 34.3 kg/m² in the outpatient group, compared with a mean physical status classification score of 2.08 and mean body mass index of 32.9 kg/m² in the inpatient group. The differences were not statistically significant.

No funding source was reported. The investigators did not report any disclosures.

[email protected]

SOURCE: Ford M et al. Orthop Clin North Am. 2020 Jan;51[1]:1-5. doi: 10.1016/j.ocl.2019.08.001

There were fewer complications with outpatient unicompartmental knee arthroplasty in a freestanding ambulatory surgery center than in the hospital, according to a review from the University of Tennessee Campbell Clinic, Memphis.

“In carefully selected patients, the ASC [ambulatory surgery center] seems to be a safe alternative to the inpatient hospital setting,” concluded investigators led by led by Marcus Ford, MD, a Campbell Clinic orthopedic surgeon.

He and his colleagues have been doing outpatient unicompartmental knee arthroplasty (UKA) since 2009, and “based on the subjective success,” recently increased the number of total knee, hip, and shoulder arthroplasties performed in their ASC.

They wanted to make sure, however, that their impression of good outpatient UKA results was supported by the data, so they compared outcomes in 48 UKA patients treated at their ASC with 48 treated in the hospital. The operations were done by two surgeons using the same technique and same medial UKA implant.

“Naturally, surgeons select those patients who are deemed physically and mentally capable of succeeding with an accelerated discharge plan” for outpatient service, the investigators wrote. To address that potential selection bias, the team matched their subjects by age and comorbidities.

There was only one minor complication in the outpatient group, a superficial stitch abscess. No patient needed a second operation, and all went home the same day.

It was different on the inpatient side. The average length of stay was 2.9 days, and there were four major complications: a deep venous thrombosis, a pulmonary embolus, an acute postoperative infection, and a periprosthetic fracture. All four required hospital readmission, and two patients needed a second operation.

The report didn’t directly address the reasons for the differences, but Dr. Ford and colleagues did note that they “believe that the ASC allows the surgeon greater direct control of perioperative variables that can impact patient outcome.”

Patients were in their late 50s, on average, and there were more women than men in both groups. The mean American Society of Anesthesiologists physical status classification score was 1.94 and mean body mass index was 34.3 kg/m² in the outpatient group, compared with a mean physical status classification score of 2.08 and mean body mass index of 32.9 kg/m² in the inpatient group. The differences were not statistically significant.

No funding source was reported. The investigators did not report any disclosures.

[email protected]

SOURCE: Ford M et al. Orthop Clin North Am. 2020 Jan;51[1]:1-5. doi: 10.1016/j.ocl.2019.08.001

There were fewer complications with outpatient unicompartmental knee arthroplasty in a freestanding ambulatory surgery center than in the hospital, according to a review from the University of Tennessee Campbell Clinic, Memphis.

“In carefully selected patients, the ASC [ambulatory surgery center] seems to be a safe alternative to the inpatient hospital setting,” concluded investigators led by led by Marcus Ford, MD, a Campbell Clinic orthopedic surgeon.

He and his colleagues have been doing outpatient unicompartmental knee arthroplasty (UKA) since 2009, and “based on the subjective success,” recently increased the number of total knee, hip, and shoulder arthroplasties performed in their ASC.

They wanted to make sure, however, that their impression of good outpatient UKA results was supported by the data, so they compared outcomes in 48 UKA patients treated at their ASC with 48 treated in the hospital. The operations were done by two surgeons using the same technique and same medial UKA implant.

“Naturally, surgeons select those patients who are deemed physically and mentally capable of succeeding with an accelerated discharge plan” for outpatient service, the investigators wrote. To address that potential selection bias, the team matched their subjects by age and comorbidities.

There was only one minor complication in the outpatient group, a superficial stitch abscess. No patient needed a second operation, and all went home the same day.

It was different on the inpatient side. The average length of stay was 2.9 days, and there were four major complications: a deep venous thrombosis, a pulmonary embolus, an acute postoperative infection, and a periprosthetic fracture. All four required hospital readmission, and two patients needed a second operation.

The report didn’t directly address the reasons for the differences, but Dr. Ford and colleagues did note that they “believe that the ASC allows the surgeon greater direct control of perioperative variables that can impact patient outcome.”

Patients were in their late 50s, on average, and there were more women than men in both groups. The mean American Society of Anesthesiologists physical status classification score was 1.94 and mean body mass index was 34.3 kg/m² in the outpatient group, compared with a mean physical status classification score of 2.08 and mean body mass index of 32.9 kg/m² in the inpatient group. The differences were not statistically significant.

No funding source was reported. The investigators did not report any disclosures.

[email protected]

SOURCE: Ford M et al. Orthop Clin North Am. 2020 Jan;51[1]:1-5. doi: 10.1016/j.ocl.2019.08.001

It has now been 30 years since the first total laparoscopic hysterectomy was performed. The benefits of minimally invasive gynecologic surgery (MIGS) – and of minimally invasive hysterectomy specifically – are now well documented. Since this milestone procedure, both instrumentation and technique have improved significantly.

Physician experience is the most important determinant for which minimally invasive approach is used to perform hysterectomy. This includes traditional laparoscopy, as well as the robotically assisted laparoscopic approach. However, certain patient characteristics also may influence the choice. A uterus that is undescended, combined with a narrow introitus, for instance, can be a contributory factor in choosing to perform laparoscopic hysterectomy. Additionally, so can an extremely large uterus and an extremely high body mass index (BMI).

These latter two factors – a very large uterus (which we define as more than 15-16 weeks’ gestational size) and a BMI over 60 kg/m² – historically were considered to be contraindications to laparoscopic hysterectomy. But as the proficiency, comfort, and skill of a new generation of laparoscopic surgeons increases, the tide is shifting with respect to both morbid obesity and the very large uterus.

With growing experience and improved instrumentation, the majority of gynecologists who are fellowship-trained in MIGS are able to routinely and safely perform laparoscopic hysterectomy for uteri weighing 1-2 kg and in patients who have extreme morbid obesity. The literature, moreover, increasingly features case reports of laparoscopic removal of very large uteri and reviews/discussions of total laparoscopic hysterectomy being feasible.

In our own experience, total laparoscopic hysterectomy (TLH) of the very large uterus can be safely and advantageously performed using key instruments and refinements in technique, as well as thorough patient counseling regarding the risk of unexpected sarcomas. Recently, we safely performed total laparoscopic hysterectomy for a patient with a uterus that – somewhat unexpectedly – weighed 7.4 kg.
 

Surgical pearls

Performing safe and effective total laparoscopic hysterectomy for large uteri – and for morbidly obese patients – hinges largely on modifications in entry and port placement, patient positioning, and choice of instrumentation. With these modifications, we can achieve adequate visualization of critical anatomy and can minimize bleeding. Otherwise, the surgery itself is largely the same. Here are the principles we find most helpful.

Entry and port placement

Traditionally, for TLHs, a camera port is placed at the umbilicus to provide a full view of the pelvis. For the larger uterus – and in women who are extremely obese – we aim to introduce the laparoscope higher. A reliable landmark is the Palmer’s point in the left upper quadrant. From here, we can identify areas for the placement of additional trocars.

In general, we place ancillary 5-mm ports more cephalad and lateral to the uterus than we otherwise would. Such placement facilitates effective visualization while accommodating manipulation of the uterus and allows us to avoid bleeding around the vascular upper pedicles. Overall, we have much better control through all parts of the surgery when we operate lateral to the uterus.
 

Patient positioning

In addition to the Trendelenburg position, we have adopted an “airplaning” technique for patients with a very large uterus in which the bed is tilted from side to side so that the left and right sides of the body are rotated upward as needed. This allows for gravitational-assisted retraction when it otherwise is not possible.

Instrumentation

For morbidly obese patients, we use Kii Fios advanced fixation trocars. These come in 5- and 10-mm sizes and are equipped with an intraperitoneal balloon that can be inflated to prevent sliding of the trocar out of the abdominal wall.

By far the most valuable instrument for the morbidly obese and the very large uterus is a 30-degree laparoscope. With our higher port placement as described, the 30-degree scope provides visualization of critical structures that wouldn’t be possible with a 0-degree scope.

The Rumi uterine manipulator comes with cups that come in different sizes and can fit around the cervix and help delineate the cervicouterine junction. We use this manipulator for all laparoscopic hysterectomies, but it is a must for the very large uterus.

Extensive desiccation of the utero-ovarian pedicles and uterine arteries is critical, and for this we advise using the rotating bipolar RoBi instrument. Use of the conventional bipolar instrument allows us to use targeted and anatomically guided application of energy. This ensures certainty that vessels whose limits exceed the diameter for advanced bipolar devices (typically 7 mm) are completely sealed. In-depth knowledge of pelvic anatomy and advanced laparoscopic dissection is paramount during these steps to ensure that vital structures are not damaged by the wider thermal spread of the traditional bipolar device. For cutting, the use of ultrasonic energy is important to prevent energy from spreading laterally.

Lastly, we recommend a good suction irrigator because, if bleeding occurs, it tends to be heavy because of the enlarged nature of feeding vasculature. When placed through an umbilical or suprapubic port, the suction irrigator also may be used to help with the rotational vectors and traction for further uterine manipulation.
 

Technique

Courtesy Dr. Paya Pasic

We usually operate from top to bottom, transecting the upper pedicles such as the infundibulopelvic (IP) ligaments or utero-ovarian ligaments first, rather than the round ligaments. This helps us achieve additional mobility of the uterus. Some surgeons believe that retroperitoneal dissection and ligation of the uterine arteries at their origin is essential, but we find that, with good uterine manipulation and the use of a 30-degree scope, we achieve adequate visualization for identifying the ureter and uterine artery on the sidewall and consequently do not need to dissect retroperitoneally.

When using the uterine manipulator with the colpotomy cup, the uterus is pushed upward, increasing the distance between the vaginal fornix and the ureters. Uterine arteries can easily be identified and desiccated using conventional bipolar energy. When the colpotomy cup is pushed cephalad, the application of the bipolar energy within the limits of the cup is safe. The thermal spread does not pose a threat to the ureters, which are displaced 1.5-2 cm laterally. Large fibroids often contribute to distorted anatomical planes, and a colpotomy cup provides a firm palpable surface between the cervix and vagina during dissection.

When dealing with large uteri, one must sometimes think outside the box and deviate from standard technique. For instance, in patients with distorted anatomy because of large fibroids, it helps to first control the pedicles that are most easily accessible. Sometimes it is acceptable to perform oophorectomy if the IP ligament is more accessible and the utero-ovarian pedicle is distorted by dilated veins and adherent to the uterus. After transection of each pedicle, we gain more mobility of the uterus and better visualization for the next step.

Inserting the camera through ancillary ports – a technique known as “port hopping” – helps to visualize and take down adhesions much better and more safely than using the camera from the umbilical port only. Port hopping with a 30-degree laparoscope helps to obtain a 360-degree view of adhesions and anatomy, which is exceedingly helpful in cases in which crucial anatomical structures are within close proximity of one another.

In general it is more challenging to perform TLH on a patient with a broad uterus or a patient with low posterior fibroids that are occupying the pelvis than on a patient with fibroids in the upper abdomen. The main challenge for the surgeon is to safely secure the uterine arteries and control the blood supply to the uterus.

Access to the pelvic sidewall is obtained with the combination of 30-degree scope, uterine manipulator, and the suction irrigator introduced through the midline port; the cervix and uterus are deviated upward. Instead of the suction irrigator or blunt dissector used for internal uterine manipulation, some surgeons use myoma screws or a 5-mm single-tooth tenaculum to manipulate a large uterus. Both of those instruments are valuable and work well, but often a large uterus requires extensive manipulation. Repositioning of any sharp instruments that pierce the serosa can often lead to additional blood loss. It is preferable to avoid this blood loss on a large uterus at all costs because it can be brisk and stains the surgical pedicles, making the remainder of the procedure unnecessarily difficult.

Once the uterine arteries are desiccated, if fibroids are obscuring the view, the corpus of the uterus can be detached from the cervix as in supracervical hysterectomy fashion. From there, the uterus can be placed in the upper abdomen while colpotomy can be performed.

In patients with multiple fibroids, we do not recommend performing myomectomy first, unless the fibroid is pedunculated and on a very small stalk. Improved uterine manipulation and retroperitoneal dissection are preferred over myomectomy to safely complete hysterectomy for the broad uterus. In our opinion, any attempt at myomectomy would lead to unnecessary blood loss and additional operative time with minimal benefit.

In patients with fibroids that grow into the broad ligament and pelvic sidewall, the natural course of the ureter becomes displaced laterally. This is contrary to the popular misconception that the ureter is more medially located in the setting of broad-ligament fibroids. To ensure safe access to the uterine arteries, the vesicouterine peritoneum can be incised and extended cephalad along the broad ligament and, then, using the above-mentioned technique, by pushing the uterus and the fibroid to the contralateral side via the suction irrigator, the uterine arteries can be easily accessed.

Another useful technique is to use diluted vasopressin injected into the lower pole of the uterus to cause vasoconstriction and minimize the bleeding. The concentration is 1 cc of 20 units of vasopressin in 100-400 cc of saline. This technique is very useful for myomectomies, and some surgeons find it also helpful for hysterectomy. The plasma half-life of vasopressin is 10-20 minutes, and a large quantity is needed to help with vasoconstriction in a big uterus. The safe upper limits of vasopressin dosing are not firmly established. A fibroid uterus with aberrant vasculature may require a greater-than-acceptable dose to control bleeding.

It is important to ensure that patients have an optimized hemoglobin level preoperatively. We use a hemoglobin level of 8 g/dL as a lowest cutoff value for performing TLH without preoperative transfusion. Regarding bowel preparation, neither the literature nor our own experience support its value, so we typically do not use it.
 

Morcellation and patient counseling

Courtesy Dr. Paya Pasic

Uteri up to 12 weeks’ gestational size usually can be extracted transvaginally, and most uteri regardless of size can be morcellated and extracted through the vagina, providing that the vaginal fornix is accessible from below. In some cases, such as when the apex is too high, a minilaparotomic incision is needed to extract the uterus, or when available, power morcellation can be performed.

A major challenge, given our growing ability to laparoscopically remove very larger uteri, is that uteri heavier than about 2.5 kg in weight cannot be morcellated inside a morcellation bag. The risk of upstaging a known or suspected uterine malignancy, or of spreading an unknown malignant sarcoma (presumed benign myoma), should be incorporated in each patient’s decision making.

Thorough counseling about surgical options and on the risks of morcellating a very large uterus without containment in a bag is essential. Each patient must understand the risks and decide whether the benefits of minimally invasive surgery outweigh these risks. While MRI can sometimes provide increased suspicion of a leiomyosarcoma, malignancy can never be completed excluded preoperatively.
 

Removal of a 7.4-kg uterus

Our patient was a 44-year-old with a markedly enlarged fibroid uterus. Having been told by other providers that she was not a candidate for minimally invasive hysterectomy, she had delayed surgical management for a number of years, allowing for such a generous uterine size to develop.

The patient was knowledgeable about her condition and, given her comorbid obesity, she requested a minimally invasive approach. Preoperative imaging included an ultrasound, which had to be completed abdominally because of the size of her uterus, and an additional MRI was needed to further characterize the extent and nature of her uterus. A very detailed discussion regarding risk of leiomyosarcoma, operative complications, and conversion to laparotomy ensued.

Intraoperatively, we placed the first 5 mm port in the left upper quadrant initially to survey the anatomy for feasibility of laparoscopic hysterectomy. The left utero-ovarian pedicle was easily viewed by airplaning the bed alone. While the right utero-ovarian pedicle was much more skewed and enlarged, the right IP was easily accessible and the ureter well visualized.

The decision was made to place additional ports and proceed with laparoscopic hysterectomy. The 5-mm assistant ports were placed lateral and directly above the upper vascular pedicles. Operative time was 4 hours and 12 minutes, and blood loss was only 700 cc. Her preoperative hemoglobin was optimized at 13.3 g/dL and dropped to 11.3 g/dL postoperatively. The patient was discharged home the next morning and had a normal recovery with no complications.
 

Dr. Pasic is professor of obstetrics, gynecology & women’s health; director of the section of advanced gynecologic endoscopy; and codirector of the AAGL fellowship in minimally invasive gynecologic surgery at the University of Louisville (Ky.). Dr. Pasic is the current president of the International Society of Gynecologic Endoscopy. He is also a past president of the AAGL (2009). Dr. Cesta is Dr. Pasic’s current fellow in minimally invasive gynecologic surgery as well as an instructor in obstetrics and gynecology at the University of Louisville. Dr. Pasic disclosed he is a consultant for Ethicon Endo, Medtronic, and Olympus and is a speaker for Cooper Surgical, which manufactures some of the instruments mentioned in this article. Dr. Cesta had no relevant financial disclosures.

It has now been 30 years since the first total laparoscopic hysterectomy was performed. The benefits of minimally invasive gynecologic surgery (MIGS) – and of minimally invasive hysterectomy specifically – are now well documented. Since this milestone procedure, both instrumentation and technique have improved significantly.

Physician experience is the most important determinant for which minimally invasive approach is used to perform hysterectomy. This includes traditional laparoscopy, as well as the robotically assisted laparoscopic approach. However, certain patient characteristics also may influence the choice. A uterus that is undescended, combined with a narrow introitus, for instance, can be a contributory factor in choosing to perform laparoscopic hysterectomy. Additionally, so can an extremely large uterus and an extremely high body mass index (BMI).

These latter two factors – a very large uterus (which we define as more than 15-16 weeks’ gestational size) and a BMI over 60 kg/m² – historically were considered to be contraindications to laparoscopic hysterectomy. But as the proficiency, comfort, and skill of a new generation of laparoscopic surgeons increases, the tide is shifting with respect to both morbid obesity and the very large uterus.

With growing experience and improved instrumentation, the majority of gynecologists who are fellowship-trained in MIGS are able to routinely and safely perform laparoscopic hysterectomy for uteri weighing 1-2 kg and in patients who have extreme morbid obesity. The literature, moreover, increasingly features case reports of laparoscopic removal of very large uteri and reviews/discussions of total laparoscopic hysterectomy being feasible.

In our own experience, total laparoscopic hysterectomy (TLH) of the very large uterus can be safely and advantageously performed using key instruments and refinements in technique, as well as thorough patient counseling regarding the risk of unexpected sarcomas. Recently, we safely performed total laparoscopic hysterectomy for a patient with a uterus that – somewhat unexpectedly – weighed 7.4 kg.
 

Surgical pearls

Performing safe and effective total laparoscopic hysterectomy for large uteri – and for morbidly obese patients – hinges largely on modifications in entry and port placement, patient positioning, and choice of instrumentation. With these modifications, we can achieve adequate visualization of critical anatomy and can minimize bleeding. Otherwise, the surgery itself is largely the same. Here are the principles we find most helpful.

Entry and port placement

Traditionally, for TLHs, a camera port is placed at the umbilicus to provide a full view of the pelvis. For the larger uterus – and in women who are extremely obese – we aim to introduce the laparoscope higher. A reliable landmark is the Palmer’s point in the left upper quadrant. From here, we can identify areas for the placement of additional trocars.

In general, we place ancillary 5-mm ports more cephalad and lateral to the uterus than we otherwise would. Such placement facilitates effective visualization while accommodating manipulation of the uterus and allows us to avoid bleeding around the vascular upper pedicles. Overall, we have much better control through all parts of the surgery when we operate lateral to the uterus.
 

Patient positioning

In addition to the Trendelenburg position, we have adopted an “airplaning” technique for patients with a very large uterus in which the bed is tilted from side to side so that the left and right sides of the body are rotated upward as needed. This allows for gravitational-assisted retraction when it otherwise is not possible.

Instrumentation

For morbidly obese patients, we use Kii Fios advanced fixation trocars. These come in 5- and 10-mm sizes and are equipped with an intraperitoneal balloon that can be inflated to prevent sliding of the trocar out of the abdominal wall.

By far the most valuable instrument for the morbidly obese and the very large uterus is a 30-degree laparoscope. With our higher port placement as described, the 30-degree scope provides visualization of critical structures that wouldn’t be possible with a 0-degree scope.

The Rumi uterine manipulator comes with cups that come in different sizes and can fit around the cervix and help delineate the cervicouterine junction. We use this manipulator for all laparoscopic hysterectomies, but it is a must for the very large uterus.

Extensive desiccation of the utero-ovarian pedicles and uterine arteries is critical, and for this we advise using the rotating bipolar RoBi instrument. Use of the conventional bipolar instrument allows us to use targeted and anatomically guided application of energy. This ensures certainty that vessels whose limits exceed the diameter for advanced bipolar devices (typically 7 mm) are completely sealed. In-depth knowledge of pelvic anatomy and advanced laparoscopic dissection is paramount during these steps to ensure that vital structures are not damaged by the wider thermal spread of the traditional bipolar device. For cutting, the use of ultrasonic energy is important to prevent energy from spreading laterally.

Lastly, we recommend a good suction irrigator because, if bleeding occurs, it tends to be heavy because of the enlarged nature of feeding vasculature. When placed through an umbilical or suprapubic port, the suction irrigator also may be used to help with the rotational vectors and traction for further uterine manipulation.
 

Technique

Courtesy Dr. Paya Pasic

We usually operate from top to bottom, transecting the upper pedicles such as the infundibulopelvic (IP) ligaments or utero-ovarian ligaments first, rather than the round ligaments. This helps us achieve additional mobility of the uterus. Some surgeons believe that retroperitoneal dissection and ligation of the uterine arteries at their origin is essential, but we find that, with good uterine manipulation and the use of a 30-degree scope, we achieve adequate visualization for identifying the ureter and uterine artery on the sidewall and consequently do not need to dissect retroperitoneally.

When using the uterine manipulator with the colpotomy cup, the uterus is pushed upward, increasing the distance between the vaginal fornix and the ureters. Uterine arteries can easily be identified and desiccated using conventional bipolar energy. When the colpotomy cup is pushed cephalad, the application of the bipolar energy within the limits of the cup is safe. The thermal spread does not pose a threat to the ureters, which are displaced 1.5-2 cm laterally. Large fibroids often contribute to distorted anatomical planes, and a colpotomy cup provides a firm palpable surface between the cervix and vagina during dissection.

When dealing with large uteri, one must sometimes think outside the box and deviate from standard technique. For instance, in patients with distorted anatomy because of large fibroids, it helps to first control the pedicles that are most easily accessible. Sometimes it is acceptable to perform oophorectomy if the IP ligament is more accessible and the utero-ovarian pedicle is distorted by dilated veins and adherent to the uterus. After transection of each pedicle, we gain more mobility of the uterus and better visualization for the next step.

Inserting the camera through ancillary ports – a technique known as “port hopping” – helps to visualize and take down adhesions much better and more safely than using the camera from the umbilical port only. Port hopping with a 30-degree laparoscope helps to obtain a 360-degree view of adhesions and anatomy, which is exceedingly helpful in cases in which crucial anatomical structures are within close proximity of one another.

In general it is more challenging to perform TLH on a patient with a broad uterus or a patient with low posterior fibroids that are occupying the pelvis than on a patient with fibroids in the upper abdomen. The main challenge for the surgeon is to safely secure the uterine arteries and control the blood supply to the uterus.

Access to the pelvic sidewall is obtained with the combination of 30-degree scope, uterine manipulator, and the suction irrigator introduced through the midline port; the cervix and uterus are deviated upward. Instead of the suction irrigator or blunt dissector used for internal uterine manipulation, some surgeons use myoma screws or a 5-mm single-tooth tenaculum to manipulate a large uterus. Both of those instruments are valuable and work well, but often a large uterus requires extensive manipulation. Repositioning of any sharp instruments that pierce the serosa can often lead to additional blood loss. It is preferable to avoid this blood loss on a large uterus at all costs because it can be brisk and stains the surgical pedicles, making the remainder of the procedure unnecessarily difficult.

Once the uterine arteries are desiccated, if fibroids are obscuring the view, the corpus of the uterus can be detached from the cervix as in supracervical hysterectomy fashion. From there, the uterus can be placed in the upper abdomen while colpotomy can be performed.

In patients with multiple fibroids, we do not recommend performing myomectomy first, unless the fibroid is pedunculated and on a very small stalk. Improved uterine manipulation and retroperitoneal dissection are preferred over myomectomy to safely complete hysterectomy for the broad uterus. In our opinion, any attempt at myomectomy would lead to unnecessary blood loss and additional operative time with minimal benefit.

In patients with fibroids that grow into the broad ligament and pelvic sidewall, the natural course of the ureter becomes displaced laterally. This is contrary to the popular misconception that the ureter is more medially located in the setting of broad-ligament fibroids. To ensure safe access to the uterine arteries, the vesicouterine peritoneum can be incised and extended cephalad along the broad ligament and, then, using the above-mentioned technique, by pushing the uterus and the fibroid to the contralateral side via the suction irrigator, the uterine arteries can be easily accessed.

Another useful technique is to use diluted vasopressin injected into the lower pole of the uterus to cause vasoconstriction and minimize the bleeding. The concentration is 1 cc of 20 units of vasopressin in 100-400 cc of saline. This technique is very useful for myomectomies, and some surgeons find it also helpful for hysterectomy. The plasma half-life of vasopressin is 10-20 minutes, and a large quantity is needed to help with vasoconstriction in a big uterus. The safe upper limits of vasopressin dosing are not firmly established. A fibroid uterus with aberrant vasculature may require a greater-than-acceptable dose to control bleeding.

It is important to ensure that patients have an optimized hemoglobin level preoperatively. We use a hemoglobin level of 8 g/dL as a lowest cutoff value for performing TLH without preoperative transfusion. Regarding bowel preparation, neither the literature nor our own experience support its value, so we typically do not use it.
 

Morcellation and patient counseling

Courtesy Dr. Paya Pasic

Uteri up to 12 weeks’ gestational size usually can be extracted transvaginally, and most uteri regardless of size can be morcellated and extracted through the vagina, providing that the vaginal fornix is accessible from below. In some cases, such as when the apex is too high, a minilaparotomic incision is needed to extract the uterus, or when available, power morcellation can be performed.

A major challenge, given our growing ability to laparoscopically remove very larger uteri, is that uteri heavier than about 2.5 kg in weight cannot be morcellated inside a morcellation bag. The risk of upstaging a known or suspected uterine malignancy, or of spreading an unknown malignant sarcoma (presumed benign myoma), should be incorporated in each patient’s decision making.

Thorough counseling about surgical options and on the risks of morcellating a very large uterus without containment in a bag is essential. Each patient must understand the risks and decide whether the benefits of minimally invasive surgery outweigh these risks. While MRI can sometimes provide increased suspicion of a leiomyosarcoma, malignancy can never be completed excluded preoperatively.
 

Removal of a 7.4-kg uterus

Our patient was a 44-year-old with a markedly enlarged fibroid uterus. Having been told by other providers that she was not a candidate for minimally invasive hysterectomy, she had delayed surgical management for a number of years, allowing for such a generous uterine size to develop.

The patient was knowledgeable about her condition and, given her comorbid obesity, she requested a minimally invasive approach. Preoperative imaging included an ultrasound, which had to be completed abdominally because of the size of her uterus, and an additional MRI was needed to further characterize the extent and nature of her uterus. A very detailed discussion regarding risk of leiomyosarcoma, operative complications, and conversion to laparotomy ensued.

Intraoperatively, we placed the first 5 mm port in the left upper quadrant initially to survey the anatomy for feasibility of laparoscopic hysterectomy. The left utero-ovarian pedicle was easily viewed by airplaning the bed alone. While the right utero-ovarian pedicle was much more skewed and enlarged, the right IP was easily accessible and the ureter well visualized.

The decision was made to place additional ports and proceed with laparoscopic hysterectomy. The 5-mm assistant ports were placed lateral and directly above the upper vascular pedicles. Operative time was 4 hours and 12 minutes, and blood loss was only 700 cc. Her preoperative hemoglobin was optimized at 13.3 g/dL and dropped to 11.3 g/dL postoperatively. The patient was discharged home the next morning and had a normal recovery with no complications.
 

Dr. Pasic is professor of obstetrics, gynecology & women’s health; director of the section of advanced gynecologic endoscopy; and codirector of the AAGL fellowship in minimally invasive gynecologic surgery at the University of Louisville (Ky.). Dr. Pasic is the current president of the International Society of Gynecologic Endoscopy. He is also a past president of the AAGL (2009). Dr. Cesta is Dr. Pasic’s current fellow in minimally invasive gynecologic surgery as well as an instructor in obstetrics and gynecology at the University of Louisville. Dr. Pasic disclosed he is a consultant for Ethicon Endo, Medtronic, and Olympus and is a speaker for Cooper Surgical, which manufactures some of the instruments mentioned in this article. Dr. Cesta had no relevant financial disclosures.

It has now been 30 years since the first total laparoscopic hysterectomy was performed. The benefits of minimally invasive gynecologic surgery (MIGS) – and of minimally invasive hysterectomy specifically – are now well documented. Since this milestone procedure, both instrumentation and technique have improved significantly.

Physician experience is the most important determinant for which minimally invasive approach is used to perform hysterectomy. This includes traditional laparoscopy, as well as the robotically assisted laparoscopic approach. However, certain patient characteristics also may influence the choice. A uterus that is undescended, combined with a narrow introitus, for instance, can be a contributory factor in choosing to perform laparoscopic hysterectomy. Additionally, so can an extremely large uterus and an extremely high body mass index (BMI).

These latter two factors – a very large uterus (which we define as more than 15-16 weeks’ gestational size) and a BMI over 60 kg/m² – historically were considered to be contraindications to laparoscopic hysterectomy. But as the proficiency, comfort, and skill of a new generation of laparoscopic surgeons increases, the tide is shifting with respect to both morbid obesity and the very large uterus.

With growing experience and improved instrumentation, the majority of gynecologists who are fellowship-trained in MIGS are able to routinely and safely perform laparoscopic hysterectomy for uteri weighing 1-2 kg and in patients who have extreme morbid obesity. The literature, moreover, increasingly features case reports of laparoscopic removal of very large uteri and reviews/discussions of total laparoscopic hysterectomy being feasible.

In our own experience, total laparoscopic hysterectomy (TLH) of the very large uterus can be safely and advantageously performed using key instruments and refinements in technique, as well as thorough patient counseling regarding the risk of unexpected sarcomas. Recently, we safely performed total laparoscopic hysterectomy for a patient with a uterus that – somewhat unexpectedly – weighed 7.4 kg.
 

Surgical pearls

Performing safe and effective total laparoscopic hysterectomy for large uteri – and for morbidly obese patients – hinges largely on modifications in entry and port placement, patient positioning, and choice of instrumentation. With these modifications, we can achieve adequate visualization of critical anatomy and can minimize bleeding. Otherwise, the surgery itself is largely the same. Here are the principles we find most helpful.

Entry and port placement

Traditionally, for TLHs, a camera port is placed at the umbilicus to provide a full view of the pelvis. For the larger uterus – and in women who are extremely obese – we aim to introduce the laparoscope higher. A reliable landmark is the Palmer’s point in the left upper quadrant. From here, we can identify areas for the placement of additional trocars.

In general, we place ancillary 5-mm ports more cephalad and lateral to the uterus than we otherwise would. Such placement facilitates effective visualization while accommodating manipulation of the uterus and allows us to avoid bleeding around the vascular upper pedicles. Overall, we have much better control through all parts of the surgery when we operate lateral to the uterus.
 

Patient positioning

In addition to the Trendelenburg position, we have adopted an “airplaning” technique for patients with a very large uterus in which the bed is tilted from side to side so that the left and right sides of the body are rotated upward as needed. This allows for gravitational-assisted retraction when it otherwise is not possible.

Instrumentation

For morbidly obese patients, we use Kii Fios advanced fixation trocars. These come in 5- and 10-mm sizes and are equipped with an intraperitoneal balloon that can be inflated to prevent sliding of the trocar out of the abdominal wall.

By far the most valuable instrument for the morbidly obese and the very large uterus is a 30-degree laparoscope. With our higher port placement as described, the 30-degree scope provides visualization of critical structures that wouldn’t be possible with a 0-degree scope.

The Rumi uterine manipulator comes with cups that come in different sizes and can fit around the cervix and help delineate the cervicouterine junction. We use this manipulator for all laparoscopic hysterectomies, but it is a must for the very large uterus.

Extensive desiccation of the utero-ovarian pedicles and uterine arteries is critical, and for this we advise using the rotating bipolar RoBi instrument. Use of the conventional bipolar instrument allows us to use targeted and anatomically guided application of energy. This ensures certainty that vessels whose limits exceed the diameter for advanced bipolar devices (typically 7 mm) are completely sealed. In-depth knowledge of pelvic anatomy and advanced laparoscopic dissection is paramount during these steps to ensure that vital structures are not damaged by the wider thermal spread of the traditional bipolar device. For cutting, the use of ultrasonic energy is important to prevent energy from spreading laterally.

Lastly, we recommend a good suction irrigator because, if bleeding occurs, it tends to be heavy because of the enlarged nature of feeding vasculature. When placed through an umbilical or suprapubic port, the suction irrigator also may be used to help with the rotational vectors and traction for further uterine manipulation.
 

Technique

Courtesy Dr. Paya Pasic

We usually operate from top to bottom, transecting the upper pedicles such as the infundibulopelvic (IP) ligaments or utero-ovarian ligaments first, rather than the round ligaments. This helps us achieve additional mobility of the uterus. Some surgeons believe that retroperitoneal dissection and ligation of the uterine arteries at their origin is essential, but we find that, with good uterine manipulation and the use of a 30-degree scope, we achieve adequate visualization for identifying the ureter and uterine artery on the sidewall and consequently do not need to dissect retroperitoneally.

When using the uterine manipulator with the colpotomy cup, the uterus is pushed upward, increasing the distance between the vaginal fornix and the ureters. Uterine arteries can easily be identified and desiccated using conventional bipolar energy. When the colpotomy cup is pushed cephalad, the application of the bipolar energy within the limits of the cup is safe. The thermal spread does not pose a threat to the ureters, which are displaced 1.5-2 cm laterally. Large fibroids often contribute to distorted anatomical planes, and a colpotomy cup provides a firm palpable surface between the cervix and vagina during dissection.

When dealing with large uteri, one must sometimes think outside the box and deviate from standard technique. For instance, in patients with distorted anatomy because of large fibroids, it helps to first control the pedicles that are most easily accessible. Sometimes it is acceptable to perform oophorectomy if the IP ligament is more accessible and the utero-ovarian pedicle is distorted by dilated veins and adherent to the uterus. After transection of each pedicle, we gain more mobility of the uterus and better visualization for the next step.

Inserting the camera through ancillary ports – a technique known as “port hopping” – helps to visualize and take down adhesions much better and more safely than using the camera from the umbilical port only. Port hopping with a 30-degree laparoscope helps to obtain a 360-degree view of adhesions and anatomy, which is exceedingly helpful in cases in which crucial anatomical structures are within close proximity of one another.

In general it is more challenging to perform TLH on a patient with a broad uterus or a patient with low posterior fibroids that are occupying the pelvis than on a patient with fibroids in the upper abdomen. The main challenge for the surgeon is to safely secure the uterine arteries and control the blood supply to the uterus.

Access to the pelvic sidewall is obtained with the combination of 30-degree scope, uterine manipulator, and the suction irrigator introduced through the midline port; the cervix and uterus are deviated upward. Instead of the suction irrigator or blunt dissector used for internal uterine manipulation, some surgeons use myoma screws or a 5-mm single-tooth tenaculum to manipulate a large uterus. Both of those instruments are valuable and work well, but often a large uterus requires extensive manipulation. Repositioning of any sharp instruments that pierce the serosa can often lead to additional blood loss. It is preferable to avoid this blood loss on a large uterus at all costs because it can be brisk and stains the surgical pedicles, making the remainder of the procedure unnecessarily difficult.

Once the uterine arteries are desiccated, if fibroids are obscuring the view, the corpus of the uterus can be detached from the cervix as in supracervical hysterectomy fashion. From there, the uterus can be placed in the upper abdomen while colpotomy can be performed.

In patients with multiple fibroids, we do not recommend performing myomectomy first, unless the fibroid is pedunculated and on a very small stalk. Improved uterine manipulation and retroperitoneal dissection are preferred over myomectomy to safely complete hysterectomy for the broad uterus. In our opinion, any attempt at myomectomy would lead to unnecessary blood loss and additional operative time with minimal benefit.

In patients with fibroids that grow into the broad ligament and pelvic sidewall, the natural course of the ureter becomes displaced laterally. This is contrary to the popular misconception that the ureter is more medially located in the setting of broad-ligament fibroids. To ensure safe access to the uterine arteries, the vesicouterine peritoneum can be incised and extended cephalad along the broad ligament and, then, using the above-mentioned technique, by pushing the uterus and the fibroid to the contralateral side via the suction irrigator, the uterine arteries can be easily accessed.

Another useful technique is to use diluted vasopressin injected into the lower pole of the uterus to cause vasoconstriction and minimize the bleeding. The concentration is 1 cc of 20 units of vasopressin in 100-400 cc of saline. This technique is very useful for myomectomies, and some surgeons find it also helpful for hysterectomy. The plasma half-life of vasopressin is 10-20 minutes, and a large quantity is needed to help with vasoconstriction in a big uterus. The safe upper limits of vasopressin dosing are not firmly established. A fibroid uterus with aberrant vasculature may require a greater-than-acceptable dose to control bleeding.

It is important to ensure that patients have an optimized hemoglobin level preoperatively. We use a hemoglobin level of 8 g/dL as a lowest cutoff value for performing TLH without preoperative transfusion. Regarding bowel preparation, neither the literature nor our own experience support its value, so we typically do not use it.
 

Morcellation and patient counseling

Courtesy Dr. Paya Pasic

Uteri up to 12 weeks’ gestational size usually can be extracted transvaginally, and most uteri regardless of size can be morcellated and extracted through the vagina, providing that the vaginal fornix is accessible from below. In some cases, such as when the apex is too high, a minilaparotomic incision is needed to extract the uterus, or when available, power morcellation can be performed.

A major challenge, given our growing ability to laparoscopically remove very larger uteri, is that uteri heavier than about 2.5 kg in weight cannot be morcellated inside a morcellation bag. The risk of upstaging a known or suspected uterine malignancy, or of spreading an unknown malignant sarcoma (presumed benign myoma), should be incorporated in each patient’s decision making.

Thorough counseling about surgical options and on the risks of morcellating a very large uterus without containment in a bag is essential. Each patient must understand the risks and decide whether the benefits of minimally invasive surgery outweigh these risks. While MRI can sometimes provide increased suspicion of a leiomyosarcoma, malignancy can never be completed excluded preoperatively.
 

Removal of a 7.4-kg uterus

Our patient was a 44-year-old with a markedly enlarged fibroid uterus. Having been told by other providers that she was not a candidate for minimally invasive hysterectomy, she had delayed surgical management for a number of years, allowing for such a generous uterine size to develop.

The patient was knowledgeable about her condition and, given her comorbid obesity, she requested a minimally invasive approach. Preoperative imaging included an ultrasound, which had to be completed abdominally because of the size of her uterus, and an additional MRI was needed to further characterize the extent and nature of her uterus. A very detailed discussion regarding risk of leiomyosarcoma, operative complications, and conversion to laparotomy ensued.

Intraoperatively, we placed the first 5 mm port in the left upper quadrant initially to survey the anatomy for feasibility of laparoscopic hysterectomy. The left utero-ovarian pedicle was easily viewed by airplaning the bed alone. While the right utero-ovarian pedicle was much more skewed and enlarged, the right IP was easily accessible and the ureter well visualized.

The decision was made to place additional ports and proceed with laparoscopic hysterectomy. The 5-mm assistant ports were placed lateral and directly above the upper vascular pedicles. Operative time was 4 hours and 12 minutes, and blood loss was only 700 cc. Her preoperative hemoglobin was optimized at 13.3 g/dL and dropped to 11.3 g/dL postoperatively. The patient was discharged home the next morning and had a normal recovery with no complications.
 

Dr. Pasic is professor of obstetrics, gynecology & women’s health; director of the section of advanced gynecologic endoscopy; and codirector of the AAGL fellowship in minimally invasive gynecologic surgery at the University of Louisville (Ky.). Dr. Pasic is the current president of the International Society of Gynecologic Endoscopy. He is also a past president of the AAGL (2009). Dr. Cesta is Dr. Pasic’s current fellow in minimally invasive gynecologic surgery as well as an instructor in obstetrics and gynecology at the University of Louisville. Dr. Pasic disclosed he is a consultant for Ethicon Endo, Medtronic, and Olympus and is a speaker for Cooper Surgical, which manufactures some of the instruments mentioned in this article. Dr. Cesta had no relevant financial disclosures.

In his excellent treatise on the history of hysterectomy, Chris Sutton, MBBch, noted that, while Themison of Athens in 50 bc and Soranus of Ephesus in 120 ad were reported to have performed vaginal hysterectomy, these cases essentially were emergency amputation of severely prolapsed uteri, which usually involved cutting both ureters and the bladder (J Minim Invas Gynecol. 2010 Jul;17[4]:421–35). It was not until 1801 that the first planned elective vaginal hysterectomy was performed, and it was not until the mid 19th century, in 1853, that Walter Burnham, MD, in Lowell, Mass., performed the first abdominal hysterectomy resulting in patient survival.

Seemingly incredible, it was only 125 years later, in autumn of 1988 at William Nesbitt Memorial Hospital in Kingston, Pa., that Harry Reich, MD, performed the first total laparoscopically assisted hysterectomy.

Since Dr. Reich’s groundbreaking procedure, the performance of laparoscopic hysterectomy has advanced at a feverish pace. In my own practice, I have not performed an abdominal hysterectomy since 1998. My two partners, who are both fellowship-trained in minimally invasive gynecologic surgery (MIGS), Aarathi Cholkeri-Singh, MD, who joined my practice in 2007, and Kristen Sasaki, MD, who joined my practice in 2014, have never performed an open hysterectomy since starting practice. Despite these advances, a minimally invasive approach to hysterectomy is not without challenge. One of the most difficult situations is the truly large uterus – greater than 2,500 grams.

For this edition of the Master Class in Gynecologic Surgery, I have enlisted the assistance of Paya Pasic, MD, and Megan Cesta, MD, to discuss the next frontier: the removal of the multiple kilogram uterus.

Dr. Pasic is an internationally recognized leader in laparoscopic MIGS. He is professor of obstetrics, gynecology & women’s health; director, section of advanced gynecologic endoscopy, and codirector of the AAGL fellowship in MIGS at the University of Louisville (Ky.). Dr. Pasic is the current president of the International Society of Gynecologic Endoscopy. He is also a past president of the AAGL (2009). Dr. Pasic is published in the field of MIGS, having authored many publications, book chapters, monographs, and textbooks.

Dr. Cesta is Dr. Pasic’s current fellow in MIGS and an instructor in obstetrics and gynecology at the university.

It is truly a pleasure to welcome Dr. Pasic and Dr. Cesta to this edition of the Master Class in Gynecologic Surgery.

Dr. Miller is a clinical associate professor at the University of Illinois in Chicago and past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in metropolitan Chicago and the director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill. He has no disclosures relevant to this Master Class. Email him at [email protected].

In his excellent treatise on the history of hysterectomy, Chris Sutton, MBBch, noted that, while Themison of Athens in 50 bc and Soranus of Ephesus in 120 ad were reported to have performed vaginal hysterectomy, these cases essentially were emergency amputation of severely prolapsed uteri, which usually involved cutting both ureters and the bladder (J Minim Invas Gynecol. 2010 Jul;17[4]:421–35). It was not until 1801 that the first planned elective vaginal hysterectomy was performed, and it was not until the mid 19th century, in 1853, that Walter Burnham, MD, in Lowell, Mass., performed the first abdominal hysterectomy resulting in patient survival.

Seemingly incredible, it was only 125 years later, in autumn of 1988 at William Nesbitt Memorial Hospital in Kingston, Pa., that Harry Reich, MD, performed the first total laparoscopically assisted hysterectomy.

Since Dr. Reich’s groundbreaking procedure, the performance of laparoscopic hysterectomy has advanced at a feverish pace. In my own practice, I have not performed an abdominal hysterectomy since 1998. My two partners, who are both fellowship-trained in minimally invasive gynecologic surgery (MIGS), Aarathi Cholkeri-Singh, MD, who joined my practice in 2007, and Kristen Sasaki, MD, who joined my practice in 2014, have never performed an open hysterectomy since starting practice. Despite these advances, a minimally invasive approach to hysterectomy is not without challenge. One of the most difficult situations is the truly large uterus – greater than 2,500 grams.

For this edition of the Master Class in Gynecologic Surgery, I have enlisted the assistance of Paya Pasic, MD, and Megan Cesta, MD, to discuss the next frontier: the removal of the multiple kilogram uterus.

Dr. Pasic is an internationally recognized leader in laparoscopic MIGS. He is professor of obstetrics, gynecology & women’s health; director, section of advanced gynecologic endoscopy, and codirector of the AAGL fellowship in MIGS at the University of Louisville (Ky.). Dr. Pasic is the current president of the International Society of Gynecologic Endoscopy. He is also a past president of the AAGL (2009). Dr. Pasic is published in the field of MIGS, having authored many publications, book chapters, monographs, and textbooks.

Dr. Cesta is Dr. Pasic’s current fellow in MIGS and an instructor in obstetrics and gynecology at the university.

It is truly a pleasure to welcome Dr. Pasic and Dr. Cesta to this edition of the Master Class in Gynecologic Surgery.

Dr. Miller is a clinical associate professor at the University of Illinois in Chicago and past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in metropolitan Chicago and the director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill. He has no disclosures relevant to this Master Class. Email him at [email protected].

In his excellent treatise on the history of hysterectomy, Chris Sutton, MBBch, noted that, while Themison of Athens in 50 bc and Soranus of Ephesus in 120 ad were reported to have performed vaginal hysterectomy, these cases essentially were emergency amputation of severely prolapsed uteri, which usually involved cutting both ureters and the bladder (J Minim Invas Gynecol. 2010 Jul;17[4]:421–35). It was not until 1801 that the first planned elective vaginal hysterectomy was performed, and it was not until the mid 19th century, in 1853, that Walter Burnham, MD, in Lowell, Mass., performed the first abdominal hysterectomy resulting in patient survival.

Seemingly incredible, it was only 125 years later, in autumn of 1988 at William Nesbitt Memorial Hospital in Kingston, Pa., that Harry Reich, MD, performed the first total laparoscopically assisted hysterectomy.

Since Dr. Reich’s groundbreaking procedure, the performance of laparoscopic hysterectomy has advanced at a feverish pace. In my own practice, I have not performed an abdominal hysterectomy since 1998. My two partners, who are both fellowship-trained in minimally invasive gynecologic surgery (MIGS), Aarathi Cholkeri-Singh, MD, who joined my practice in 2007, and Kristen Sasaki, MD, who joined my practice in 2014, have never performed an open hysterectomy since starting practice. Despite these advances, a minimally invasive approach to hysterectomy is not without challenge. One of the most difficult situations is the truly large uterus – greater than 2,500 grams.

For this edition of the Master Class in Gynecologic Surgery, I have enlisted the assistance of Paya Pasic, MD, and Megan Cesta, MD, to discuss the next frontier: the removal of the multiple kilogram uterus.

Dr. Pasic is an internationally recognized leader in laparoscopic MIGS. He is professor of obstetrics, gynecology & women’s health; director, section of advanced gynecologic endoscopy, and codirector of the AAGL fellowship in MIGS at the University of Louisville (Ky.). Dr. Pasic is the current president of the International Society of Gynecologic Endoscopy. He is also a past president of the AAGL (2009). Dr. Pasic is published in the field of MIGS, having authored many publications, book chapters, monographs, and textbooks.

Dr. Cesta is Dr. Pasic’s current fellow in MIGS and an instructor in obstetrics and gynecology at the university.

It is truly a pleasure to welcome Dr. Pasic and Dr. Cesta to this edition of the Master Class in Gynecologic Surgery.

Dr. Miller is a clinical associate professor at the University of Illinois in Chicago and past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in metropolitan Chicago and the director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill. He has no disclosures relevant to this Master Class. Email him at [email protected].