User login
Broad application of JNC-8 would save lives, reduce costs
Antihypertensive therapy would prevent about 56,000 cardiovascular events annually and 13,000 deaths from strokes, myocardial infarctions, and other causes if it were used by all U.S. adults who qualify for treatment under 2014 Joint National Committee hypertension guidelines, according to computer modeling published online Jan. 28 in the New England Journal of Medicine.
Even though the new Joint Committee guidelines are a bit less stringent than the committee’s prior 2003 advice, blood pressure remains inadequately controlled in 44% of the 64 million U.S. adults with hypertension, according to the investigators, led by Dr. Andrew Moran of Columbia University Medical Center, New York (N. Engl. J. Med. 2015;372:447-55).
The team used data from the National Health and Nutrition Examination Survey, the Framingham Heart Study, and other sources to estimate costs and benefits of expanding treatment to all U.S. adults aged 35-74 years who meet the 2014 benchmarks. They then calculated cost-effectiveness of expanding use in various subpopulations, using $50,000/quality-adjusted life-year (QALY) gained, or less, as their cut-off.
Overall, the investigators found that fuller implementation of the Joint Committee goals would pay for itself in reduced cardiovascular morbidity and mortality. The results were driven primarily by secondary prevention in patients with cardiovascular disease and primary prevention in patients with stage 2 hypertension, meaning systolic BP of 160 mm Hg or higher or diastolic BP of 100 mm Hg or higher.
“There is an enormous potential for improving population health by expanding treatment and improving control. Our findings clearly show that it would be worthwhile to significantly increase spending on office visits, home blood pressure monitoring, and interventions to improve treatment adherence. In fact, we could double treatment and monitoring spending for some patients – namely those with severe hypertension – and still break even,” Dr. Moran said in a statement announcing the results.
Treatment of patients with existing cardiovascular disease or stage 2 hypertension would save lives and costs in all men 35-74 years old and in women aged 45-74 years. The treatment of more modest hypertension – systolic BP of 140-159 mm Hg or a diastolic BP of 90-99 mm Hg – was cost effective for all men and for women also between the ages of 45 and 74 years, but treating women 35-44 years old with moderate hypertension and diabetes or kidney disease had intermediate cost-effectiveness ($125,000 per QALY), and low cost-effectiveness ($181,000 per QALY) if those comorbidities were not present.
“Some people will be alarmed about our conclusion that it may not be cost effective to treat hypertension in young adults, especially young women. It’s worth noting that our analysis didn’t capture the cumulative, lifetime effects of hypertension. It may well turn out to be cost effective to treat this group if we look at data on costs and benefits over several decades,” Dr. Moran said.
The team assumed a medication adherence rate of 75%. The costs of treatment included medications, monitoring, and drug side effects.
They did not analyze the effect of diet and lifestyle interventions for lowering blood pressure, or compare the cost-effectiveness of specific antihypertensive medication classes or combinations.
The work was funded by the National Heart, Lung, and Blood Institute, among others. The authors reported no relevant financial disclosures.
Antihypertensive therapy would prevent about 56,000 cardiovascular events annually and 13,000 deaths from strokes, myocardial infarctions, and other causes if it were used by all U.S. adults who qualify for treatment under 2014 Joint National Committee hypertension guidelines, according to computer modeling published online Jan. 28 in the New England Journal of Medicine.
Even though the new Joint Committee guidelines are a bit less stringent than the committee’s prior 2003 advice, blood pressure remains inadequately controlled in 44% of the 64 million U.S. adults with hypertension, according to the investigators, led by Dr. Andrew Moran of Columbia University Medical Center, New York (N. Engl. J. Med. 2015;372:447-55).
The team used data from the National Health and Nutrition Examination Survey, the Framingham Heart Study, and other sources to estimate costs and benefits of expanding treatment to all U.S. adults aged 35-74 years who meet the 2014 benchmarks. They then calculated cost-effectiveness of expanding use in various subpopulations, using $50,000/quality-adjusted life-year (QALY) gained, or less, as their cut-off.
Overall, the investigators found that fuller implementation of the Joint Committee goals would pay for itself in reduced cardiovascular morbidity and mortality. The results were driven primarily by secondary prevention in patients with cardiovascular disease and primary prevention in patients with stage 2 hypertension, meaning systolic BP of 160 mm Hg or higher or diastolic BP of 100 mm Hg or higher.
“There is an enormous potential for improving population health by expanding treatment and improving control. Our findings clearly show that it would be worthwhile to significantly increase spending on office visits, home blood pressure monitoring, and interventions to improve treatment adherence. In fact, we could double treatment and monitoring spending for some patients – namely those with severe hypertension – and still break even,” Dr. Moran said in a statement announcing the results.
Treatment of patients with existing cardiovascular disease or stage 2 hypertension would save lives and costs in all men 35-74 years old and in women aged 45-74 years. The treatment of more modest hypertension – systolic BP of 140-159 mm Hg or a diastolic BP of 90-99 mm Hg – was cost effective for all men and for women also between the ages of 45 and 74 years, but treating women 35-44 years old with moderate hypertension and diabetes or kidney disease had intermediate cost-effectiveness ($125,000 per QALY), and low cost-effectiveness ($181,000 per QALY) if those comorbidities were not present.
“Some people will be alarmed about our conclusion that it may not be cost effective to treat hypertension in young adults, especially young women. It’s worth noting that our analysis didn’t capture the cumulative, lifetime effects of hypertension. It may well turn out to be cost effective to treat this group if we look at data on costs and benefits over several decades,” Dr. Moran said.
The team assumed a medication adherence rate of 75%. The costs of treatment included medications, monitoring, and drug side effects.
They did not analyze the effect of diet and lifestyle interventions for lowering blood pressure, or compare the cost-effectiveness of specific antihypertensive medication classes or combinations.
The work was funded by the National Heart, Lung, and Blood Institute, among others. The authors reported no relevant financial disclosures.
Antihypertensive therapy would prevent about 56,000 cardiovascular events annually and 13,000 deaths from strokes, myocardial infarctions, and other causes if it were used by all U.S. adults who qualify for treatment under 2014 Joint National Committee hypertension guidelines, according to computer modeling published online Jan. 28 in the New England Journal of Medicine.
Even though the new Joint Committee guidelines are a bit less stringent than the committee’s prior 2003 advice, blood pressure remains inadequately controlled in 44% of the 64 million U.S. adults with hypertension, according to the investigators, led by Dr. Andrew Moran of Columbia University Medical Center, New York (N. Engl. J. Med. 2015;372:447-55).
The team used data from the National Health and Nutrition Examination Survey, the Framingham Heart Study, and other sources to estimate costs and benefits of expanding treatment to all U.S. adults aged 35-74 years who meet the 2014 benchmarks. They then calculated cost-effectiveness of expanding use in various subpopulations, using $50,000/quality-adjusted life-year (QALY) gained, or less, as their cut-off.
Overall, the investigators found that fuller implementation of the Joint Committee goals would pay for itself in reduced cardiovascular morbidity and mortality. The results were driven primarily by secondary prevention in patients with cardiovascular disease and primary prevention in patients with stage 2 hypertension, meaning systolic BP of 160 mm Hg or higher or diastolic BP of 100 mm Hg or higher.
“There is an enormous potential for improving population health by expanding treatment and improving control. Our findings clearly show that it would be worthwhile to significantly increase spending on office visits, home blood pressure monitoring, and interventions to improve treatment adherence. In fact, we could double treatment and monitoring spending for some patients – namely those with severe hypertension – and still break even,” Dr. Moran said in a statement announcing the results.
Treatment of patients with existing cardiovascular disease or stage 2 hypertension would save lives and costs in all men 35-74 years old and in women aged 45-74 years. The treatment of more modest hypertension – systolic BP of 140-159 mm Hg or a diastolic BP of 90-99 mm Hg – was cost effective for all men and for women also between the ages of 45 and 74 years, but treating women 35-44 years old with moderate hypertension and diabetes or kidney disease had intermediate cost-effectiveness ($125,000 per QALY), and low cost-effectiveness ($181,000 per QALY) if those comorbidities were not present.
“Some people will be alarmed about our conclusion that it may not be cost effective to treat hypertension in young adults, especially young women. It’s worth noting that our analysis didn’t capture the cumulative, lifetime effects of hypertension. It may well turn out to be cost effective to treat this group if we look at data on costs and benefits over several decades,” Dr. Moran said.
The team assumed a medication adherence rate of 75%. The costs of treatment included medications, monitoring, and drug side effects.
They did not analyze the effect of diet and lifestyle interventions for lowering blood pressure, or compare the cost-effectiveness of specific antihypertensive medication classes or combinations.
The work was funded by the National Heart, Lung, and Blood Institute, among others. The authors reported no relevant financial disclosures.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Even young patients, in many cases, can benefit from adherence to theJoint National Committee 2014 hypertension guidelines.
Major finding: The treatment of modest hypertension is cost effective for men 35-74 years old, and women between the ages of 45 and 74 years, meaning that each quality-adjusted life-year gained would cost less than $50,000.
Data source: Computer estimates of the impact of applying JNC-8 to all hypertensive U.S. adults 35-74 years old.
Disclosures: The work was funded by the National Heart, Lung, and Blood Institute, among others. The authors reported no relevant financial disclosures.
Breaking down midurethral sling approaches
It has been nearly 20 years since the first minimally invasive midurethral sling was introduced. This development was followed 5 years later with the introduction of the transobturator midurethral sling. The advent of both ambulatory techniques has essentially changed the landscape in the surgical treatment of stress urinary incontinence; midurethral slings are certainly considered the procedure of choice for many women.
The midurethral sling has continued to evolve. Not only does the surgeon have the choice of placing a retropubic midurethral sling (bottom to top or top to bottom) and the transobturator midurethral sling (inside-out or outside-in), but, as of late, single incision midurethral slings (mini-slings or mini-tape) as well.
In the previous Master Class on urinary incontinence, Dr. Eric Sokol discussed issues of sling selection and the evidence in favor of various types of retropubic and transobturator slings. This month, we’ll discuss the technique behind these two approaches. I have elicited the assistance of Dr. Sokol, as well as Dr. Charles Rardin.
Dr. Sokol is an associate professor of obstetrics and gynecology, associate professor of urology (by courtesy), and cochief of the division of urogynecology and pelvic reconstructive surgery at Stanford (Calif.) University. He has published many articles regarding urogynecology and minimally invasive surgery. Dr. Sokol has been awarded numerous teaching awards, and he is a reviewer for multiple prestigious, peer-reviewed journals.
Dr. Rardin is the director of the robotic surgery program at Women & Infants Hospital of Rhode Island, Providence, a surgeon in the division of urogynecology and reconstructive pelvic surgery, and is the director of the hospital’s fellowship in urogynecology and reconstructive pelvic surgery. He is also an assistant professor at Brown University, also in Providence. He has published numerous articles in peer-reviewed journals.
Dr. Miller is clinical associate professor at the University of Illinois at Chicago, immediate past president of the International Society for Gynecologic Endoscopy (ISGE), and a past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in private practice in Naperville, Ill., and Schaumburg, Ill.; the director of minimally invasive gynecologic surgery and the director of the AAGL/SRS fellowship in minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill.; and the medical editor of this column, Master Class. Dr. Miller is a consultant and on the speaker’s bureau for Ethicon.
It has been nearly 20 years since the first minimally invasive midurethral sling was introduced. This development was followed 5 years later with the introduction of the transobturator midurethral sling. The advent of both ambulatory techniques has essentially changed the landscape in the surgical treatment of stress urinary incontinence; midurethral slings are certainly considered the procedure of choice for many women.
The midurethral sling has continued to evolve. Not only does the surgeon have the choice of placing a retropubic midurethral sling (bottom to top or top to bottom) and the transobturator midurethral sling (inside-out or outside-in), but, as of late, single incision midurethral slings (mini-slings or mini-tape) as well.
In the previous Master Class on urinary incontinence, Dr. Eric Sokol discussed issues of sling selection and the evidence in favor of various types of retropubic and transobturator slings. This month, we’ll discuss the technique behind these two approaches. I have elicited the assistance of Dr. Sokol, as well as Dr. Charles Rardin.
Dr. Sokol is an associate professor of obstetrics and gynecology, associate professor of urology (by courtesy), and cochief of the division of urogynecology and pelvic reconstructive surgery at Stanford (Calif.) University. He has published many articles regarding urogynecology and minimally invasive surgery. Dr. Sokol has been awarded numerous teaching awards, and he is a reviewer for multiple prestigious, peer-reviewed journals.
Dr. Rardin is the director of the robotic surgery program at Women & Infants Hospital of Rhode Island, Providence, a surgeon in the division of urogynecology and reconstructive pelvic surgery, and is the director of the hospital’s fellowship in urogynecology and reconstructive pelvic surgery. He is also an assistant professor at Brown University, also in Providence. He has published numerous articles in peer-reviewed journals.
Dr. Miller is clinical associate professor at the University of Illinois at Chicago, immediate past president of the International Society for Gynecologic Endoscopy (ISGE), and a past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in private practice in Naperville, Ill., and Schaumburg, Ill.; the director of minimally invasive gynecologic surgery and the director of the AAGL/SRS fellowship in minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill.; and the medical editor of this column, Master Class. Dr. Miller is a consultant and on the speaker’s bureau for Ethicon.
It has been nearly 20 years since the first minimally invasive midurethral sling was introduced. This development was followed 5 years later with the introduction of the transobturator midurethral sling. The advent of both ambulatory techniques has essentially changed the landscape in the surgical treatment of stress urinary incontinence; midurethral slings are certainly considered the procedure of choice for many women.
The midurethral sling has continued to evolve. Not only does the surgeon have the choice of placing a retropubic midurethral sling (bottom to top or top to bottom) and the transobturator midurethral sling (inside-out or outside-in), but, as of late, single incision midurethral slings (mini-slings or mini-tape) as well.
In the previous Master Class on urinary incontinence, Dr. Eric Sokol discussed issues of sling selection and the evidence in favor of various types of retropubic and transobturator slings. This month, we’ll discuss the technique behind these two approaches. I have elicited the assistance of Dr. Sokol, as well as Dr. Charles Rardin.
Dr. Sokol is an associate professor of obstetrics and gynecology, associate professor of urology (by courtesy), and cochief of the division of urogynecology and pelvic reconstructive surgery at Stanford (Calif.) University. He has published many articles regarding urogynecology and minimally invasive surgery. Dr. Sokol has been awarded numerous teaching awards, and he is a reviewer for multiple prestigious, peer-reviewed journals.
Dr. Rardin is the director of the robotic surgery program at Women & Infants Hospital of Rhode Island, Providence, a surgeon in the division of urogynecology and reconstructive pelvic surgery, and is the director of the hospital’s fellowship in urogynecology and reconstructive pelvic surgery. He is also an assistant professor at Brown University, also in Providence. He has published numerous articles in peer-reviewed journals.
Dr. Miller is clinical associate professor at the University of Illinois at Chicago, immediate past president of the International Society for Gynecologic Endoscopy (ISGE), and a past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in private practice in Naperville, Ill., and Schaumburg, Ill.; the director of minimally invasive gynecologic surgery and the director of the AAGL/SRS fellowship in minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill.; and the medical editor of this column, Master Class. Dr. Miller is a consultant and on the speaker’s bureau for Ethicon.
Few ACA marketplaces offer plans with abortion coverage
More than half of reproductive-age women who are eligible for tax credits through the Affordable Care Act marketplaces can’t buy a health plan that covers abortion, either because that coverage is banned in their state or it’s simply not offered.
In a new analysis of ACA health plans available in 2015, the Kaiser Family Foundation found that 1.76 million reproductive-age women live in states that have enacted laws banning abortion coverage through health plans sold on the marketplace. Another 123,000 women live in states where there is no ban, but no health plans offer the coverage. That leaves about 1.26 million reproductive-age women whose incomes are low enough to qualify for insurance subsidies with access to health plans that offer abortion.
Overall, 24 states have enacted bans or restrictions on abortion coverage within ACA marketplace plans, and 7 states have no restrictions but the coverage is still not available.
Researchers with the Kaiser Family Foundation said that it is unclear why some ACA health plans do not offer abortion coverage even in states where there are no restrictions. However, they speculated that the complexity of the ACA’s abortion rules could be a factor.
Under the 2010 health law, federal funds are not allowed to be used to pay for abortions, and states have the authority to enact additional bans and restrictions on whether plans can offer the coverage. For those states where bans are not in place, the health plans must collect an additional fee for abortion coverage and keep this funding separate from federal dollars. Aside from the extra administrative work, these plans must also meet additional reporting requirements and undergo audits.
More than half of reproductive-age women who are eligible for tax credits through the Affordable Care Act marketplaces can’t buy a health plan that covers abortion, either because that coverage is banned in their state or it’s simply not offered.
In a new analysis of ACA health plans available in 2015, the Kaiser Family Foundation found that 1.76 million reproductive-age women live in states that have enacted laws banning abortion coverage through health plans sold on the marketplace. Another 123,000 women live in states where there is no ban, but no health plans offer the coverage. That leaves about 1.26 million reproductive-age women whose incomes are low enough to qualify for insurance subsidies with access to health plans that offer abortion.
Overall, 24 states have enacted bans or restrictions on abortion coverage within ACA marketplace plans, and 7 states have no restrictions but the coverage is still not available.
Researchers with the Kaiser Family Foundation said that it is unclear why some ACA health plans do not offer abortion coverage even in states where there are no restrictions. However, they speculated that the complexity of the ACA’s abortion rules could be a factor.
Under the 2010 health law, federal funds are not allowed to be used to pay for abortions, and states have the authority to enact additional bans and restrictions on whether plans can offer the coverage. For those states where bans are not in place, the health plans must collect an additional fee for abortion coverage and keep this funding separate from federal dollars. Aside from the extra administrative work, these plans must also meet additional reporting requirements and undergo audits.
More than half of reproductive-age women who are eligible for tax credits through the Affordable Care Act marketplaces can’t buy a health plan that covers abortion, either because that coverage is banned in their state or it’s simply not offered.
In a new analysis of ACA health plans available in 2015, the Kaiser Family Foundation found that 1.76 million reproductive-age women live in states that have enacted laws banning abortion coverage through health plans sold on the marketplace. Another 123,000 women live in states where there is no ban, but no health plans offer the coverage. That leaves about 1.26 million reproductive-age women whose incomes are low enough to qualify for insurance subsidies with access to health plans that offer abortion.
Overall, 24 states have enacted bans or restrictions on abortion coverage within ACA marketplace plans, and 7 states have no restrictions but the coverage is still not available.
Researchers with the Kaiser Family Foundation said that it is unclear why some ACA health plans do not offer abortion coverage even in states where there are no restrictions. However, they speculated that the complexity of the ACA’s abortion rules could be a factor.
Under the 2010 health law, federal funds are not allowed to be used to pay for abortions, and states have the authority to enact additional bans and restrictions on whether plans can offer the coverage. For those states where bans are not in place, the health plans must collect an additional fee for abortion coverage and keep this funding separate from federal dollars. Aside from the extra administrative work, these plans must also meet additional reporting requirements and undergo audits.
ACOG outlines new treatment options for hypertensive emergencies in pregnancy
The American College of Obstetricians and Gynecologists has added nifedipine as a first-line treatment for acute-onset severe hypertension during pregnancy and the postpartum period in an updated opinion from its Committee on Obstetric Practice.
The update, released on Jan. 22, points to studies showing that women who received oral nifedipine had their blood pressure lowered more quickly than with either intravenous labetalol or hydralazine – the traditional first-line treatments – and had a significant increase in urine output. Concerns about neuromuscular blockade and severe hypotension with the use of nifedipine and magnesium sulphate were not borne out in a large review, the committee members wrote, but they advised careful monitoring since both drugs are calcium antagonists.
The committee opinion includes model order sets for the use of labetalol, hydralazine, and nifedipine for the initial management of acute onset severe hypertension in women who are pregnant or post partum with preeclampsia or eclampsia (Obstet. Gynecol. 2015;125:521-5).
While all three medications are appropriate in treating hypertensive emergencies during pregnancy, each drug has adverse effects.
For instance, parenteral hydralazine can increase the risk of maternal hypotension. Parenteral labetalol may cause neonatal bradycardia and should be avoided in women with asthma, heart disease, or heart failure. Nifedipine has been associated with increased maternal heart rate and overshoot hypotension.
“Patients may respond to one drug and not another,” the committee noted.
The ACOG committee also called for standardized clinical guidelines for the management of patients with preeclampsia and eclampsia.
“With the advent of pregnancy hypertension guidelines in the United Kingdom, care of maternity patients with preeclampsia or eclampsia improved significantly and maternal mortality rates decreased because of a reduction in cerebral and respiratory complications,” they wrote. “Individuals and institutions should have mechanisms in place to initiate the prompt administration of medication when a patient presents with a hypertensive emergency.”
The committee recommended checklists as one tool to help standardize the use of guidelines.
The American College of Obstetricians and Gynecologists has added nifedipine as a first-line treatment for acute-onset severe hypertension during pregnancy and the postpartum period in an updated opinion from its Committee on Obstetric Practice.
The update, released on Jan. 22, points to studies showing that women who received oral nifedipine had their blood pressure lowered more quickly than with either intravenous labetalol or hydralazine – the traditional first-line treatments – and had a significant increase in urine output. Concerns about neuromuscular blockade and severe hypotension with the use of nifedipine and magnesium sulphate were not borne out in a large review, the committee members wrote, but they advised careful monitoring since both drugs are calcium antagonists.
The committee opinion includes model order sets for the use of labetalol, hydralazine, and nifedipine for the initial management of acute onset severe hypertension in women who are pregnant or post partum with preeclampsia or eclampsia (Obstet. Gynecol. 2015;125:521-5).
While all three medications are appropriate in treating hypertensive emergencies during pregnancy, each drug has adverse effects.
For instance, parenteral hydralazine can increase the risk of maternal hypotension. Parenteral labetalol may cause neonatal bradycardia and should be avoided in women with asthma, heart disease, or heart failure. Nifedipine has been associated with increased maternal heart rate and overshoot hypotension.
“Patients may respond to one drug and not another,” the committee noted.
The ACOG committee also called for standardized clinical guidelines for the management of patients with preeclampsia and eclampsia.
“With the advent of pregnancy hypertension guidelines in the United Kingdom, care of maternity patients with preeclampsia or eclampsia improved significantly and maternal mortality rates decreased because of a reduction in cerebral and respiratory complications,” they wrote. “Individuals and institutions should have mechanisms in place to initiate the prompt administration of medication when a patient presents with a hypertensive emergency.”
The committee recommended checklists as one tool to help standardize the use of guidelines.
The American College of Obstetricians and Gynecologists has added nifedipine as a first-line treatment for acute-onset severe hypertension during pregnancy and the postpartum period in an updated opinion from its Committee on Obstetric Practice.
The update, released on Jan. 22, points to studies showing that women who received oral nifedipine had their blood pressure lowered more quickly than with either intravenous labetalol or hydralazine – the traditional first-line treatments – and had a significant increase in urine output. Concerns about neuromuscular blockade and severe hypotension with the use of nifedipine and magnesium sulphate were not borne out in a large review, the committee members wrote, but they advised careful monitoring since both drugs are calcium antagonists.
The committee opinion includes model order sets for the use of labetalol, hydralazine, and nifedipine for the initial management of acute onset severe hypertension in women who are pregnant or post partum with preeclampsia or eclampsia (Obstet. Gynecol. 2015;125:521-5).
While all three medications are appropriate in treating hypertensive emergencies during pregnancy, each drug has adverse effects.
For instance, parenteral hydralazine can increase the risk of maternal hypotension. Parenteral labetalol may cause neonatal bradycardia and should be avoided in women with asthma, heart disease, or heart failure. Nifedipine has been associated with increased maternal heart rate and overshoot hypotension.
“Patients may respond to one drug and not another,” the committee noted.
The ACOG committee also called for standardized clinical guidelines for the management of patients with preeclampsia and eclampsia.
“With the advent of pregnancy hypertension guidelines in the United Kingdom, care of maternity patients with preeclampsia or eclampsia improved significantly and maternal mortality rates decreased because of a reduction in cerebral and respiratory complications,” they wrote. “Individuals and institutions should have mechanisms in place to initiate the prompt administration of medication when a patient presents with a hypertensive emergency.”
The committee recommended checklists as one tool to help standardize the use of guidelines.
FROM OBSTETRICS AND GYNECOLOGY
Unnecessary hysterectomies still significant, Michigan data indicate
Almost one in five hysterectomies for benign indications were unnecessary, based on 2013 data from 52 Michigan hospitals.
Uterine pathology reports did not match or support the indication for surgery in 18% of the 3,397 hysterectomies reviewed from the Michigan Surgical Quality Collaborative, a state-wide program to improve surgical care. In women under 40 years old, pathology did not support surgery in 38% of hysterectomies for benign indications.
Endometriosis and chronic pain were the most common reasons for unnecessary uterus removal; pathology was unsupportive of surgery in about 40% of those cases. Pathology also was unsupportive in about 14% of women with fibroid or acute uterine bleeding (AUB) and in about 20% of the remaining cases, which were mostly indicated for a blend of bleeding, pain, and other problems (Am. J. Obstet. Gynecol. 2014 Dec 23 [doi:http://dx.doi.org/10.1016/j.ajog.2014.11.031]).
Almost half of the women had no documentation in their charts that alternatives to hysterectomy were tried or even considered. Hormonal management, operative hysteroscopy, endometrial ablation, levonorgestrel intrauterine devices (IUDs), and other approaches were documented in 68% of women under 40 years old, but documentation was less likely in women over 40 years old. Alternatives approaches were more likely in women with larger uteri and in women with endometriosis, but were, overall, “underutilized,” Dr. Daniel Morgan, an associate professor of obstetrics and gynecology at the University of Michigan in Ann Arbor, and his fellow researchers concluded.
Parity, body mass index, insurance, and common medical comorbidities did not seem to influence the use of alternatives in the study.
The researchers noted that checklists for preoperative appropriateness have been shown in previous studies to reduce the rate of benign hysterectomies, and increase the likelihood that pathology will support the reason for the operation.
The checklist approach “could help standardize treatment and ensure appropriate uterine-sparing management has been offered. The use of electronic medical records systems could potentially facilitate this type of standardization with relative ease,” the researchers wrote.
Also, the levonorgestrel IUD, “a highly effective, cost-saving intervention for women with acute uterine bleeding and pelvic pain, was considered [in] only 12%” of the Michigan cases. Increasing its use is another “important area for quality improvement and cost savings,” they added.
“We are now in the process of developing institution-specific reports ... on use of alternatives prior to hysterectomy and rates of negative pathology. It is our goal that each institution in the Collaborative will see their data and act on it accordingly. We hope that it will lead to more use (or at least consideration) of alternatives to hysterectomy and lower rates of negative pathology.”
The Michigan Surgical Quality Collaborative is funded by Blue Cross and Blue Shield of Michigan/Blue Care Network. Dr. Morgan reported no conflicts of interest.
Almost one in five hysterectomies for benign indications were unnecessary, based on 2013 data from 52 Michigan hospitals.
Uterine pathology reports did not match or support the indication for surgery in 18% of the 3,397 hysterectomies reviewed from the Michigan Surgical Quality Collaborative, a state-wide program to improve surgical care. In women under 40 years old, pathology did not support surgery in 38% of hysterectomies for benign indications.
Endometriosis and chronic pain were the most common reasons for unnecessary uterus removal; pathology was unsupportive of surgery in about 40% of those cases. Pathology also was unsupportive in about 14% of women with fibroid or acute uterine bleeding (AUB) and in about 20% of the remaining cases, which were mostly indicated for a blend of bleeding, pain, and other problems (Am. J. Obstet. Gynecol. 2014 Dec 23 [doi:http://dx.doi.org/10.1016/j.ajog.2014.11.031]).
Almost half of the women had no documentation in their charts that alternatives to hysterectomy were tried or even considered. Hormonal management, operative hysteroscopy, endometrial ablation, levonorgestrel intrauterine devices (IUDs), and other approaches were documented in 68% of women under 40 years old, but documentation was less likely in women over 40 years old. Alternatives approaches were more likely in women with larger uteri and in women with endometriosis, but were, overall, “underutilized,” Dr. Daniel Morgan, an associate professor of obstetrics and gynecology at the University of Michigan in Ann Arbor, and his fellow researchers concluded.
Parity, body mass index, insurance, and common medical comorbidities did not seem to influence the use of alternatives in the study.
The researchers noted that checklists for preoperative appropriateness have been shown in previous studies to reduce the rate of benign hysterectomies, and increase the likelihood that pathology will support the reason for the operation.
The checklist approach “could help standardize treatment and ensure appropriate uterine-sparing management has been offered. The use of electronic medical records systems could potentially facilitate this type of standardization with relative ease,” the researchers wrote.
Also, the levonorgestrel IUD, “a highly effective, cost-saving intervention for women with acute uterine bleeding and pelvic pain, was considered [in] only 12%” of the Michigan cases. Increasing its use is another “important area for quality improvement and cost savings,” they added.
“We are now in the process of developing institution-specific reports ... on use of alternatives prior to hysterectomy and rates of negative pathology. It is our goal that each institution in the Collaborative will see their data and act on it accordingly. We hope that it will lead to more use (or at least consideration) of alternatives to hysterectomy and lower rates of negative pathology.”
The Michigan Surgical Quality Collaborative is funded by Blue Cross and Blue Shield of Michigan/Blue Care Network. Dr. Morgan reported no conflicts of interest.
Almost one in five hysterectomies for benign indications were unnecessary, based on 2013 data from 52 Michigan hospitals.
Uterine pathology reports did not match or support the indication for surgery in 18% of the 3,397 hysterectomies reviewed from the Michigan Surgical Quality Collaborative, a state-wide program to improve surgical care. In women under 40 years old, pathology did not support surgery in 38% of hysterectomies for benign indications.
Endometriosis and chronic pain were the most common reasons for unnecessary uterus removal; pathology was unsupportive of surgery in about 40% of those cases. Pathology also was unsupportive in about 14% of women with fibroid or acute uterine bleeding (AUB) and in about 20% of the remaining cases, which were mostly indicated for a blend of bleeding, pain, and other problems (Am. J. Obstet. Gynecol. 2014 Dec 23 [doi:http://dx.doi.org/10.1016/j.ajog.2014.11.031]).
Almost half of the women had no documentation in their charts that alternatives to hysterectomy were tried or even considered. Hormonal management, operative hysteroscopy, endometrial ablation, levonorgestrel intrauterine devices (IUDs), and other approaches were documented in 68% of women under 40 years old, but documentation was less likely in women over 40 years old. Alternatives approaches were more likely in women with larger uteri and in women with endometriosis, but were, overall, “underutilized,” Dr. Daniel Morgan, an associate professor of obstetrics and gynecology at the University of Michigan in Ann Arbor, and his fellow researchers concluded.
Parity, body mass index, insurance, and common medical comorbidities did not seem to influence the use of alternatives in the study.
The researchers noted that checklists for preoperative appropriateness have been shown in previous studies to reduce the rate of benign hysterectomies, and increase the likelihood that pathology will support the reason for the operation.
The checklist approach “could help standardize treatment and ensure appropriate uterine-sparing management has been offered. The use of electronic medical records systems could potentially facilitate this type of standardization with relative ease,” the researchers wrote.
Also, the levonorgestrel IUD, “a highly effective, cost-saving intervention for women with acute uterine bleeding and pelvic pain, was considered [in] only 12%” of the Michigan cases. Increasing its use is another “important area for quality improvement and cost savings,” they added.
“We are now in the process of developing institution-specific reports ... on use of alternatives prior to hysterectomy and rates of negative pathology. It is our goal that each institution in the Collaborative will see their data and act on it accordingly. We hope that it will lead to more use (or at least consideration) of alternatives to hysterectomy and lower rates of negative pathology.”
The Michigan Surgical Quality Collaborative is funded by Blue Cross and Blue Shield of Michigan/Blue Care Network. Dr. Morgan reported no conflicts of interest.
FROM THE AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY
Key clinical point: Take the time to try levonorgestrel IUDs and other alternatives before removing a woman’s uterus.
Major finding: About 40% of hysterectomies for benign indications in women younger than 40 years old were not supported by post-surgical pathology.
Data source: Chart review of 3,397 hysterectomies at 52 Michigan hospitals
Disclosures:The Michigan Surgical Quality Collaborative is funded by Blue Cross and Blue Shield of Michigan/Blue Care Network. The lead investigator has no financial conflicts of interest.
Trendelenburg positioning does not increase ventilator injuries
VANCOUVER, B.C. – Trendelenburg position does not materially increase ventilator pressures during laparoscopic gynecologic surgery, according to investigators from McMaster University in Hamilton, Ont.
The use of the Trendelenburg position can sometimes cause tension in the operating room. Surgeons need to roll the small bowel out of the pelvis to get access to their gynecologic targets, but anesthesiologists worry that they’ll have to turn up ventilator pressures – and risk barotrauma – if women are placed in a head-down position. It’s unclear from previous studies if pressures really need to be increased when using a moderate Trendelenburg position, Dr. Stephen Bates, a professor of obstetrics and gynecology at McMaster University, said at a meeting sponsored by the AAGL.
To find out, Dr. Bates and his colleagues monitored peak inspiratory pressures (PIP), pneumoperitoneum pressures, degrees of Trendelenburg, and other factors as 100 women underwent laparoscopic hysterectomies performed by a total of seven surgeons. The women were aged 46 years, on average, and had a mean body mass index of 29 kg/m2.
The surgeons opted for an average of 10 degrees Trendelenburg, which resulted in a 1.9 cm H20 (7%) increase in PIP from horizontal positioning, up from a mean of 26.7 to 28.6 cm H20.
“By all anesthesia standards, this is a trivial change and clinically insignificant,” Dr. Bates said in an interview. “The traditional dogma is that if you put patients in Trendelenburg, you’ll increase the difficulty of ventilating them. That was not the case.”
But body mass index, and to a greater degree pneumoperitoneum pressures, did predict increased ventilator pressures among the women.
“The higher pneumoperitoneum pressures are, the harder it is to ventilate,” Dr. Bates said. “There’s [almost] a linear relationship between PnP [pneumoperitoneum pressures] and ventilator pressures.”
When pneumoperitoneum pressures were reduced from 15 to 10 mm Hg, PIP fell by approximately 10%, but the surgeons – all blinded to the reduction in PnP – did not notice any deterioration in their surgical views, he said.
Taken together, the findings suggest a new way to negotiate Trendelenburg positioning in the operating room. “Anesthesiologists and gynecologic surgeons should consider minimizing the pneumoperitoneum pressure rather than reducing the degree of Trendelenburg,” Dr. Bates said.
The researchers also tested an inflatable pillow that lifted women’s buttocks a few inches above the table. The hope was that it would reduce the degree of Trendelenburg needed for their operations, and subsequently reduce PIP. Surgeons were able to decrease Trendelenburg by about 4 degrees with the pillow, but consistent with the study’s overall findings, it made no real difference in PIP. There was a clinically insignificant drop of 0.3 cm H20, from a mean of 28.6 to 28.3 cm H20, Dr. Bates said.
Dr. Bates reported having no financial disclosures.
VANCOUVER, B.C. – Trendelenburg position does not materially increase ventilator pressures during laparoscopic gynecologic surgery, according to investigators from McMaster University in Hamilton, Ont.
The use of the Trendelenburg position can sometimes cause tension in the operating room. Surgeons need to roll the small bowel out of the pelvis to get access to their gynecologic targets, but anesthesiologists worry that they’ll have to turn up ventilator pressures – and risk barotrauma – if women are placed in a head-down position. It’s unclear from previous studies if pressures really need to be increased when using a moderate Trendelenburg position, Dr. Stephen Bates, a professor of obstetrics and gynecology at McMaster University, said at a meeting sponsored by the AAGL.
To find out, Dr. Bates and his colleagues monitored peak inspiratory pressures (PIP), pneumoperitoneum pressures, degrees of Trendelenburg, and other factors as 100 women underwent laparoscopic hysterectomies performed by a total of seven surgeons. The women were aged 46 years, on average, and had a mean body mass index of 29 kg/m2.
The surgeons opted for an average of 10 degrees Trendelenburg, which resulted in a 1.9 cm H20 (7%) increase in PIP from horizontal positioning, up from a mean of 26.7 to 28.6 cm H20.
“By all anesthesia standards, this is a trivial change and clinically insignificant,” Dr. Bates said in an interview. “The traditional dogma is that if you put patients in Trendelenburg, you’ll increase the difficulty of ventilating them. That was not the case.”
But body mass index, and to a greater degree pneumoperitoneum pressures, did predict increased ventilator pressures among the women.
“The higher pneumoperitoneum pressures are, the harder it is to ventilate,” Dr. Bates said. “There’s [almost] a linear relationship between PnP [pneumoperitoneum pressures] and ventilator pressures.”
When pneumoperitoneum pressures were reduced from 15 to 10 mm Hg, PIP fell by approximately 10%, but the surgeons – all blinded to the reduction in PnP – did not notice any deterioration in their surgical views, he said.
Taken together, the findings suggest a new way to negotiate Trendelenburg positioning in the operating room. “Anesthesiologists and gynecologic surgeons should consider minimizing the pneumoperitoneum pressure rather than reducing the degree of Trendelenburg,” Dr. Bates said.
The researchers also tested an inflatable pillow that lifted women’s buttocks a few inches above the table. The hope was that it would reduce the degree of Trendelenburg needed for their operations, and subsequently reduce PIP. Surgeons were able to decrease Trendelenburg by about 4 degrees with the pillow, but consistent with the study’s overall findings, it made no real difference in PIP. There was a clinically insignificant drop of 0.3 cm H20, from a mean of 28.6 to 28.3 cm H20, Dr. Bates said.
Dr. Bates reported having no financial disclosures.
VANCOUVER, B.C. – Trendelenburg position does not materially increase ventilator pressures during laparoscopic gynecologic surgery, according to investigators from McMaster University in Hamilton, Ont.
The use of the Trendelenburg position can sometimes cause tension in the operating room. Surgeons need to roll the small bowel out of the pelvis to get access to their gynecologic targets, but anesthesiologists worry that they’ll have to turn up ventilator pressures – and risk barotrauma – if women are placed in a head-down position. It’s unclear from previous studies if pressures really need to be increased when using a moderate Trendelenburg position, Dr. Stephen Bates, a professor of obstetrics and gynecology at McMaster University, said at a meeting sponsored by the AAGL.
To find out, Dr. Bates and his colleagues monitored peak inspiratory pressures (PIP), pneumoperitoneum pressures, degrees of Trendelenburg, and other factors as 100 women underwent laparoscopic hysterectomies performed by a total of seven surgeons. The women were aged 46 years, on average, and had a mean body mass index of 29 kg/m2.
The surgeons opted for an average of 10 degrees Trendelenburg, which resulted in a 1.9 cm H20 (7%) increase in PIP from horizontal positioning, up from a mean of 26.7 to 28.6 cm H20.
“By all anesthesia standards, this is a trivial change and clinically insignificant,” Dr. Bates said in an interview. “The traditional dogma is that if you put patients in Trendelenburg, you’ll increase the difficulty of ventilating them. That was not the case.”
But body mass index, and to a greater degree pneumoperitoneum pressures, did predict increased ventilator pressures among the women.
“The higher pneumoperitoneum pressures are, the harder it is to ventilate,” Dr. Bates said. “There’s [almost] a linear relationship between PnP [pneumoperitoneum pressures] and ventilator pressures.”
When pneumoperitoneum pressures were reduced from 15 to 10 mm Hg, PIP fell by approximately 10%, but the surgeons – all blinded to the reduction in PnP – did not notice any deterioration in their surgical views, he said.
Taken together, the findings suggest a new way to negotiate Trendelenburg positioning in the operating room. “Anesthesiologists and gynecologic surgeons should consider minimizing the pneumoperitoneum pressure rather than reducing the degree of Trendelenburg,” Dr. Bates said.
The researchers also tested an inflatable pillow that lifted women’s buttocks a few inches above the table. The hope was that it would reduce the degree of Trendelenburg needed for their operations, and subsequently reduce PIP. Surgeons were able to decrease Trendelenburg by about 4 degrees with the pillow, but consistent with the study’s overall findings, it made no real difference in PIP. There was a clinically insignificant drop of 0.3 cm H20, from a mean of 28.6 to 28.3 cm H20, Dr. Bates said.
Dr. Bates reported having no financial disclosures.
AT THE AAGL GLOBAL CONGRESS
Key clinical point: Gynecologic surgeons and anesthesiologists should negotiate to reduce pneumoperitoneum pressure instead of the degree of Trendelenburg.
Major finding: Use of a moderate Trendelenburg position increases peak inspiratory pressures (PIP) by 1.9 cm H20, but a 5 mm Hg drop in pneumoperitoneum pressures reduced PIP by about 10%.
Data source: Researchers monitored 100 women during laparoscopic hysterectomies.
Disclosures: There was no outside funding for the project, and the lead investigator reported having no financial disclosures.
States passed fewer abortion restrictions in 2014
State legislatures enacted fewer restrictions on abortion during 2014 than in the previous year, but that downward trend is unlikely to continue in the new year, according to an analysis from the Guttmacher Institute.
In 2014, state legislatures enacted only 26 of the 341 abortion restrictions introduced. And the total number of laws was down sharply from the 70 provisions enacted in 2013. The new laws included new counseling requirements before an abortion, longer waiting periods, second trimester abortion bans, and parental consent requirements.
But Elizabeth Nash, the senior state issues associate at the Guttmacher Institute, said the number of restrictive laws only looks small in comparision to the spike in legislative activity over the last 4 years, during which states enacted 231 laws limiting access to abortion.
“The scale has changed somewhat,” she said.
Some state legislatures that have been actively targeting abortion access, such as Texas, did not meet in 2014, and others had shortened sessions.
This year could bring more abortion restrictions, Ms. Nash said, as more Republican governors and state legislators take office. In 23 states, Republicans now control both legislative chambers and the governor’s office. An expected debate at the federal level on a 20-week abortion ban could also drive activity at the state level, she said.
For those states that do pursue abortion legislation in 2015, Ms. Nash said she expects them to build on existing restrictions, such as extending the waiting period between mandated counseling and an abortion.
“States will look at existing restrictions and try to make them more burdensome,” she said.
In 2014, Oklahoma enacted a requirement that abortion counseling include information on the availability perinatal hospice when a woman is seeking an abortion because of a fetal abnormality. In Alabama, lawmakers extended the waiting period between counseling and obtaining an abortion from 24 to 48 hours. Meanwhile, Mississippi lawmakers banned abortion at 18 weeks post-fertilization, citing fetal pain.
But other states took action to protect access to abortion in 2014. Following a U.S. Supreme Court ruling striking down a Massachusetts law providing a 35-foot buffer zone around abortion clinics, that state’s lawmakers enacted a new law establishing a 25-foot buffer zone for up to 8 hours after a police officer issues a dispersal order. Similarly, New Hampshire set a 25-foot buffer zone around abortion clinics. And in Utah, the legislature waived some counseling requirements in cases in which a woman is obtaining an abortion because of a diagnosed fetal impairment.
mschneider@frontlinemedcom.com
Twitter @maryellenny
State legislatures enacted fewer restrictions on abortion during 2014 than in the previous year, but that downward trend is unlikely to continue in the new year, according to an analysis from the Guttmacher Institute.
In 2014, state legislatures enacted only 26 of the 341 abortion restrictions introduced. And the total number of laws was down sharply from the 70 provisions enacted in 2013. The new laws included new counseling requirements before an abortion, longer waiting periods, second trimester abortion bans, and parental consent requirements.
But Elizabeth Nash, the senior state issues associate at the Guttmacher Institute, said the number of restrictive laws only looks small in comparision to the spike in legislative activity over the last 4 years, during which states enacted 231 laws limiting access to abortion.
“The scale has changed somewhat,” she said.
Some state legislatures that have been actively targeting abortion access, such as Texas, did not meet in 2014, and others had shortened sessions.
This year could bring more abortion restrictions, Ms. Nash said, as more Republican governors and state legislators take office. In 23 states, Republicans now control both legislative chambers and the governor’s office. An expected debate at the federal level on a 20-week abortion ban could also drive activity at the state level, she said.
For those states that do pursue abortion legislation in 2015, Ms. Nash said she expects them to build on existing restrictions, such as extending the waiting period between mandated counseling and an abortion.
“States will look at existing restrictions and try to make them more burdensome,” she said.
In 2014, Oklahoma enacted a requirement that abortion counseling include information on the availability perinatal hospice when a woman is seeking an abortion because of a fetal abnormality. In Alabama, lawmakers extended the waiting period between counseling and obtaining an abortion from 24 to 48 hours. Meanwhile, Mississippi lawmakers banned abortion at 18 weeks post-fertilization, citing fetal pain.
But other states took action to protect access to abortion in 2014. Following a U.S. Supreme Court ruling striking down a Massachusetts law providing a 35-foot buffer zone around abortion clinics, that state’s lawmakers enacted a new law establishing a 25-foot buffer zone for up to 8 hours after a police officer issues a dispersal order. Similarly, New Hampshire set a 25-foot buffer zone around abortion clinics. And in Utah, the legislature waived some counseling requirements in cases in which a woman is obtaining an abortion because of a diagnosed fetal impairment.
mschneider@frontlinemedcom.com
Twitter @maryellenny
State legislatures enacted fewer restrictions on abortion during 2014 than in the previous year, but that downward trend is unlikely to continue in the new year, according to an analysis from the Guttmacher Institute.
In 2014, state legislatures enacted only 26 of the 341 abortion restrictions introduced. And the total number of laws was down sharply from the 70 provisions enacted in 2013. The new laws included new counseling requirements before an abortion, longer waiting periods, second trimester abortion bans, and parental consent requirements.
But Elizabeth Nash, the senior state issues associate at the Guttmacher Institute, said the number of restrictive laws only looks small in comparision to the spike in legislative activity over the last 4 years, during which states enacted 231 laws limiting access to abortion.
“The scale has changed somewhat,” she said.
Some state legislatures that have been actively targeting abortion access, such as Texas, did not meet in 2014, and others had shortened sessions.
This year could bring more abortion restrictions, Ms. Nash said, as more Republican governors and state legislators take office. In 23 states, Republicans now control both legislative chambers and the governor’s office. An expected debate at the federal level on a 20-week abortion ban could also drive activity at the state level, she said.
For those states that do pursue abortion legislation in 2015, Ms. Nash said she expects them to build on existing restrictions, such as extending the waiting period between mandated counseling and an abortion.
“States will look at existing restrictions and try to make them more burdensome,” she said.
In 2014, Oklahoma enacted a requirement that abortion counseling include information on the availability perinatal hospice when a woman is seeking an abortion because of a fetal abnormality. In Alabama, lawmakers extended the waiting period between counseling and obtaining an abortion from 24 to 48 hours. Meanwhile, Mississippi lawmakers banned abortion at 18 weeks post-fertilization, citing fetal pain.
But other states took action to protect access to abortion in 2014. Following a U.S. Supreme Court ruling striking down a Massachusetts law providing a 35-foot buffer zone around abortion clinics, that state’s lawmakers enacted a new law establishing a 25-foot buffer zone for up to 8 hours after a police officer issues a dispersal order. Similarly, New Hampshire set a 25-foot buffer zone around abortion clinics. And in Utah, the legislature waived some counseling requirements in cases in which a woman is obtaining an abortion because of a diagnosed fetal impairment.
mschneider@frontlinemedcom.com
Twitter @maryellenny
Focus on cervical biopsy
Are multiple lesion-directed biopsies better than one at detecting cervical cancer precursors?
Yes. In this observational study of 690 women referred to colposcopy for abnormal cervical screening results, the sensitivity of biopsy in the detection of high-grade squamous intraepithelial lesions (HSIL) increased from 60.6% (95% confidence interval [CI], 54.8–66.6) for a single biopsy to 95.6% (95% CI, 91.3–99.2) for three biopsies.
Wentsensen N, Walker JL, Gold MA, et al. Multiple biopsies and detection of cervical cancer precursors at colposcopy [published online ahead of print November 24, 2014]. J Clin Oncol. pii:JCO.2014.55.9948.
Recent updates of cervical cancer screening protocols have altered the way we screen women but have not changed colposcopic practices, which vary widely in the United States. Investigators funded by the National Cancer Institute studied 690 women (median age, 26 years; range, 18–67 years) who underwent as many as four directed biopsies of distinct acetowhite lesions. HSIL (which included cervical intraepithelial neoplasia [CIN] 2 and 3 and invasive cancer) represented the gold standard for the sensitivity of the cervical biopsies.
Colposcopists performed a median of one, three, and four biopsies in women with no observed lesions, acetowhite lesions only, and low- or high-grade colposcopic impressions, respectively. More than 95% of HSIL was found in women noted to have a colposcopic impression of at least low-grade disease.
Although multiple biopsies increased the diagnostic yield in all groups, the greatest increase in yield was observed in women with HSIL cytology, positivity for HPV 16, and a colposcopic impression suggesting HSIL. Similar trends were observed for each of the six colposcopists (all well trained and highly experienced), each of whom performed at least 60 colposcopies in the study population.
What this evidence means for practice
When HSIL is missed at colposcopy, the patient is subjected to delayed treatment and repeat assessment. Although multiple biopsies can increase patient discomfort and costs, these findings add to other published data underscoring their value. Instead of biopsying only the worst-appearing lesion, obtain at least two or three biopsies when distinct lesions, including acetowhite areas, are noted.
—Andrew M. Kaunitz, MD
How useful is random biopsy when no lesions are seen?
Useful. It identifies approximately 20% of otherwise undetected cases of CIN 2, CIN 3, or worse. The absolute risks of disease associated with the random biopsy were higher for women positive for HPV 16 or 18, according to this large post hoc analysis.
Huh WK, Sideri M, Stoler M, Zhang G, Feldman R, Behrens CM. Relevance of random biopsy at the transformation zone when colposcopy is negative. Obstet Gynecol. 2014;124(4):670–678.
When performing colposcopy for abnormal cytology results or high-risk HPV, clinicians often are faced with an absence of visible lesions. This situation prompts the question: Is a random biopsy warranted?
Details of the study
In a multicenter US study of more than 47,000 women—conducted to assess HPV diagnostics between May 2008 and August 2009—nonpregnant women aged 25 or older with an intact uterus underwent colposcopy after a finding of atypical squamous cells of undetermined significance or higher-grade cytology results or high-risk HPV. Patients and colposcopists were blinded to the results. In women who had satisfactory colposcopy results but no visible lesions, one random biopsy of the squamocolumnar junction was obtained.
Among 2,796 women (mean age, 39.5 years) who underwent random biopsy, the findings were normal, CIN 1, CIN 2, and CIN 3 in 90.0%, 5.7%, 1.3%, and 1.4%, respectively. Among all participants aged 25 and older, random biopsies accounted for 20.9% and 18.9% of the CIN 2 or worse and CIN 3 or worse cases, respectively.
Among women positive for HPV 16 or 18, the likelihood of the random biopsy detecting CIN 2 or worse was 24.7% and 8.6% for those with abnormal cytology or normal cytology, respectively.
What this evidence means for practice
This post hoc analysis underscores the limitations of colposcopy, as have other reports. Just as the findings of Wentsensen and colleagues demonstrate that two or more lesion-directed biopsies increase the diagnostic yield over a single sample, this large study points out the substantial benefit of random biopsy of the squamocolumnar junction when no colposcopic lesions are identified.
—Andrew M. Kaunitz, MD
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
Are multiple lesion-directed biopsies better than one at detecting cervical cancer precursors?
Yes. In this observational study of 690 women referred to colposcopy for abnormal cervical screening results, the sensitivity of biopsy in the detection of high-grade squamous intraepithelial lesions (HSIL) increased from 60.6% (95% confidence interval [CI], 54.8–66.6) for a single biopsy to 95.6% (95% CI, 91.3–99.2) for three biopsies.
Wentsensen N, Walker JL, Gold MA, et al. Multiple biopsies and detection of cervical cancer precursors at colposcopy [published online ahead of print November 24, 2014]. J Clin Oncol. pii:JCO.2014.55.9948.
Recent updates of cervical cancer screening protocols have altered the way we screen women but have not changed colposcopic practices, which vary widely in the United States. Investigators funded by the National Cancer Institute studied 690 women (median age, 26 years; range, 18–67 years) who underwent as many as four directed biopsies of distinct acetowhite lesions. HSIL (which included cervical intraepithelial neoplasia [CIN] 2 and 3 and invasive cancer) represented the gold standard for the sensitivity of the cervical biopsies.
Colposcopists performed a median of one, three, and four biopsies in women with no observed lesions, acetowhite lesions only, and low- or high-grade colposcopic impressions, respectively. More than 95% of HSIL was found in women noted to have a colposcopic impression of at least low-grade disease.
Although multiple biopsies increased the diagnostic yield in all groups, the greatest increase in yield was observed in women with HSIL cytology, positivity for HPV 16, and a colposcopic impression suggesting HSIL. Similar trends were observed for each of the six colposcopists (all well trained and highly experienced), each of whom performed at least 60 colposcopies in the study population.
What this evidence means for practice
When HSIL is missed at colposcopy, the patient is subjected to delayed treatment and repeat assessment. Although multiple biopsies can increase patient discomfort and costs, these findings add to other published data underscoring their value. Instead of biopsying only the worst-appearing lesion, obtain at least two or three biopsies when distinct lesions, including acetowhite areas, are noted.
—Andrew M. Kaunitz, MD
How useful is random biopsy when no lesions are seen?
Useful. It identifies approximately 20% of otherwise undetected cases of CIN 2, CIN 3, or worse. The absolute risks of disease associated with the random biopsy were higher for women positive for HPV 16 or 18, according to this large post hoc analysis.
Huh WK, Sideri M, Stoler M, Zhang G, Feldman R, Behrens CM. Relevance of random biopsy at the transformation zone when colposcopy is negative. Obstet Gynecol. 2014;124(4):670–678.
When performing colposcopy for abnormal cytology results or high-risk HPV, clinicians often are faced with an absence of visible lesions. This situation prompts the question: Is a random biopsy warranted?
Details of the study
In a multicenter US study of more than 47,000 women—conducted to assess HPV diagnostics between May 2008 and August 2009—nonpregnant women aged 25 or older with an intact uterus underwent colposcopy after a finding of atypical squamous cells of undetermined significance or higher-grade cytology results or high-risk HPV. Patients and colposcopists were blinded to the results. In women who had satisfactory colposcopy results but no visible lesions, one random biopsy of the squamocolumnar junction was obtained.
Among 2,796 women (mean age, 39.5 years) who underwent random biopsy, the findings were normal, CIN 1, CIN 2, and CIN 3 in 90.0%, 5.7%, 1.3%, and 1.4%, respectively. Among all participants aged 25 and older, random biopsies accounted for 20.9% and 18.9% of the CIN 2 or worse and CIN 3 or worse cases, respectively.
Among women positive for HPV 16 or 18, the likelihood of the random biopsy detecting CIN 2 or worse was 24.7% and 8.6% for those with abnormal cytology or normal cytology, respectively.
What this evidence means for practice
This post hoc analysis underscores the limitations of colposcopy, as have other reports. Just as the findings of Wentsensen and colleagues demonstrate that two or more lesion-directed biopsies increase the diagnostic yield over a single sample, this large study points out the substantial benefit of random biopsy of the squamocolumnar junction when no colposcopic lesions are identified.
—Andrew M. Kaunitz, MD
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
Are multiple lesion-directed biopsies better than one at detecting cervical cancer precursors?
Yes. In this observational study of 690 women referred to colposcopy for abnormal cervical screening results, the sensitivity of biopsy in the detection of high-grade squamous intraepithelial lesions (HSIL) increased from 60.6% (95% confidence interval [CI], 54.8–66.6) for a single biopsy to 95.6% (95% CI, 91.3–99.2) for three biopsies.
Wentsensen N, Walker JL, Gold MA, et al. Multiple biopsies and detection of cervical cancer precursors at colposcopy [published online ahead of print November 24, 2014]. J Clin Oncol. pii:JCO.2014.55.9948.
Recent updates of cervical cancer screening protocols have altered the way we screen women but have not changed colposcopic practices, which vary widely in the United States. Investigators funded by the National Cancer Institute studied 690 women (median age, 26 years; range, 18–67 years) who underwent as many as four directed biopsies of distinct acetowhite lesions. HSIL (which included cervical intraepithelial neoplasia [CIN] 2 and 3 and invasive cancer) represented the gold standard for the sensitivity of the cervical biopsies.
Colposcopists performed a median of one, three, and four biopsies in women with no observed lesions, acetowhite lesions only, and low- or high-grade colposcopic impressions, respectively. More than 95% of HSIL was found in women noted to have a colposcopic impression of at least low-grade disease.
Although multiple biopsies increased the diagnostic yield in all groups, the greatest increase in yield was observed in women with HSIL cytology, positivity for HPV 16, and a colposcopic impression suggesting HSIL. Similar trends were observed for each of the six colposcopists (all well trained and highly experienced), each of whom performed at least 60 colposcopies in the study population.
What this evidence means for practice
When HSIL is missed at colposcopy, the patient is subjected to delayed treatment and repeat assessment. Although multiple biopsies can increase patient discomfort and costs, these findings add to other published data underscoring their value. Instead of biopsying only the worst-appearing lesion, obtain at least two or three biopsies when distinct lesions, including acetowhite areas, are noted.
—Andrew M. Kaunitz, MD
How useful is random biopsy when no lesions are seen?
Useful. It identifies approximately 20% of otherwise undetected cases of CIN 2, CIN 3, or worse. The absolute risks of disease associated with the random biopsy were higher for women positive for HPV 16 or 18, according to this large post hoc analysis.
Huh WK, Sideri M, Stoler M, Zhang G, Feldman R, Behrens CM. Relevance of random biopsy at the transformation zone when colposcopy is negative. Obstet Gynecol. 2014;124(4):670–678.
When performing colposcopy for abnormal cytology results or high-risk HPV, clinicians often are faced with an absence of visible lesions. This situation prompts the question: Is a random biopsy warranted?
Details of the study
In a multicenter US study of more than 47,000 women—conducted to assess HPV diagnostics between May 2008 and August 2009—nonpregnant women aged 25 or older with an intact uterus underwent colposcopy after a finding of atypical squamous cells of undetermined significance or higher-grade cytology results or high-risk HPV. Patients and colposcopists were blinded to the results. In women who had satisfactory colposcopy results but no visible lesions, one random biopsy of the squamocolumnar junction was obtained.
Among 2,796 women (mean age, 39.5 years) who underwent random biopsy, the findings were normal, CIN 1, CIN 2, and CIN 3 in 90.0%, 5.7%, 1.3%, and 1.4%, respectively. Among all participants aged 25 and older, random biopsies accounted for 20.9% and 18.9% of the CIN 2 or worse and CIN 3 or worse cases, respectively.
Among women positive for HPV 16 or 18, the likelihood of the random biopsy detecting CIN 2 or worse was 24.7% and 8.6% for those with abnormal cytology or normal cytology, respectively.
What this evidence means for practice
This post hoc analysis underscores the limitations of colposcopy, as have other reports. Just as the findings of Wentsensen and colleagues demonstrate that two or more lesion-directed biopsies increase the diagnostic yield over a single sample, this large study points out the substantial benefit of random biopsy of the squamocolumnar junction when no colposcopic lesions are identified.
—Andrew M. Kaunitz, MD
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
Drug cocktail offers alternative in treating uterine AVM bleeding
VANCOUVER, B.C. – A medical cocktail of tranexamic acid, gonadotropin-releasing hormone agonist, and an aromatase inhibitor stops bleeding from uterine arteriovenous malformations and eliminates the malformations on Doppler ultrasound within a few months, according to a small case series from Western University in London, Ont.
The finding could be a “game changer,” if it holds up under further testing, since it appears to resolve uterine arteriovenous malformations (AVMs) without compromising fertility, unlike uterine artery embolization or hysterectomy, said Dr. Angelos Vilos of Western University, the study’s lead investigator.
“We believe that we have come up with a novel and advantageous cocktail [that is] accessible to all physicians,” he said. “It eliminates uterine bleeding and AVMs. We know it’s safe, and all these medications are readily available.”
Dr. Vilos said he plans to use the drug cocktail as a first-line therapy in patients with uterine bleeding from AVMs.
The investigators used uterine tamponade, as needed, to control bleeding in nine women, then gave them oral tranexamic acid (Cyklokapron) 1 g three times daily for 5 days to clot AVM bleeders. The women also received gonadotropin-releasing hormone (GnRH) agonist injections to shrink the uterus and its vasculature – usually one shot of leuprolide, but goserelin was used for one woman – plus oral letrozole 2.5 mg/day for 5 days after the first injection to prevent GnRH flare.
The uterine AVMs “disappeared” on Doppler ultrasound within 3 months, Dr. Vilos said.
Four of the women went on to conceive spontaneously and have live births. Four others are on oral contraceptives. The ninth woman opted for a subsequent tubal ligation.
“We were able to preserve fertility and the uterus in all of these women,” he said.
The patients had been bleeding from uterine AVMs for up to 6 months, most following spontaneous or therapeutic abortions. They all had negative beta–human chorionic gonadotropin and Doppler-confirmed AVMs in the myometrium. Retained products were ruled out in all of the patients. Two women had failed embolization with coils and gel foam, and two women required transfusions before treatment. One woman required uterine tamponade before the protocol.
“These women weren’t resolving on their own,” Dr. Vilos said at the meeting sponsored by AAGL.
Based on previous work, Dr. Vilos said he and his team were comfortable using GnRH agonists and letrozole for endometriosis, and they frequently use tranexamic acid for acute bleeding. “So we kind of put these ideas together,” he said.
Several of the women were hemorrhaging in the middle of the night, and the community hospitals where they were being treated couldn’t do embolization. The hospitals called Western University, a tertiary care center, for assistance. “We initiated the protocol, and they resolved,” Dr. Vilos said. “[It’s] an effective management strategy.”
Dr. Vilos is an advisor for Bayer Healthcare and Actavis. The investigators did not receive outside funding for the work.
VANCOUVER, B.C. – A medical cocktail of tranexamic acid, gonadotropin-releasing hormone agonist, and an aromatase inhibitor stops bleeding from uterine arteriovenous malformations and eliminates the malformations on Doppler ultrasound within a few months, according to a small case series from Western University in London, Ont.
The finding could be a “game changer,” if it holds up under further testing, since it appears to resolve uterine arteriovenous malformations (AVMs) without compromising fertility, unlike uterine artery embolization or hysterectomy, said Dr. Angelos Vilos of Western University, the study’s lead investigator.
“We believe that we have come up with a novel and advantageous cocktail [that is] accessible to all physicians,” he said. “It eliminates uterine bleeding and AVMs. We know it’s safe, and all these medications are readily available.”
Dr. Vilos said he plans to use the drug cocktail as a first-line therapy in patients with uterine bleeding from AVMs.
The investigators used uterine tamponade, as needed, to control bleeding in nine women, then gave them oral tranexamic acid (Cyklokapron) 1 g three times daily for 5 days to clot AVM bleeders. The women also received gonadotropin-releasing hormone (GnRH) agonist injections to shrink the uterus and its vasculature – usually one shot of leuprolide, but goserelin was used for one woman – plus oral letrozole 2.5 mg/day for 5 days after the first injection to prevent GnRH flare.
The uterine AVMs “disappeared” on Doppler ultrasound within 3 months, Dr. Vilos said.
Four of the women went on to conceive spontaneously and have live births. Four others are on oral contraceptives. The ninth woman opted for a subsequent tubal ligation.
“We were able to preserve fertility and the uterus in all of these women,” he said.
The patients had been bleeding from uterine AVMs for up to 6 months, most following spontaneous or therapeutic abortions. They all had negative beta–human chorionic gonadotropin and Doppler-confirmed AVMs in the myometrium. Retained products were ruled out in all of the patients. Two women had failed embolization with coils and gel foam, and two women required transfusions before treatment. One woman required uterine tamponade before the protocol.
“These women weren’t resolving on their own,” Dr. Vilos said at the meeting sponsored by AAGL.
Based on previous work, Dr. Vilos said he and his team were comfortable using GnRH agonists and letrozole for endometriosis, and they frequently use tranexamic acid for acute bleeding. “So we kind of put these ideas together,” he said.
Several of the women were hemorrhaging in the middle of the night, and the community hospitals where they were being treated couldn’t do embolization. The hospitals called Western University, a tertiary care center, for assistance. “We initiated the protocol, and they resolved,” Dr. Vilos said. “[It’s] an effective management strategy.”
Dr. Vilos is an advisor for Bayer Healthcare and Actavis. The investigators did not receive outside funding for the work.
VANCOUVER, B.C. – A medical cocktail of tranexamic acid, gonadotropin-releasing hormone agonist, and an aromatase inhibitor stops bleeding from uterine arteriovenous malformations and eliminates the malformations on Doppler ultrasound within a few months, according to a small case series from Western University in London, Ont.
The finding could be a “game changer,” if it holds up under further testing, since it appears to resolve uterine arteriovenous malformations (AVMs) without compromising fertility, unlike uterine artery embolization or hysterectomy, said Dr. Angelos Vilos of Western University, the study’s lead investigator.
“We believe that we have come up with a novel and advantageous cocktail [that is] accessible to all physicians,” he said. “It eliminates uterine bleeding and AVMs. We know it’s safe, and all these medications are readily available.”
Dr. Vilos said he plans to use the drug cocktail as a first-line therapy in patients with uterine bleeding from AVMs.
The investigators used uterine tamponade, as needed, to control bleeding in nine women, then gave them oral tranexamic acid (Cyklokapron) 1 g three times daily for 5 days to clot AVM bleeders. The women also received gonadotropin-releasing hormone (GnRH) agonist injections to shrink the uterus and its vasculature – usually one shot of leuprolide, but goserelin was used for one woman – plus oral letrozole 2.5 mg/day for 5 days after the first injection to prevent GnRH flare.
The uterine AVMs “disappeared” on Doppler ultrasound within 3 months, Dr. Vilos said.
Four of the women went on to conceive spontaneously and have live births. Four others are on oral contraceptives. The ninth woman opted for a subsequent tubal ligation.
“We were able to preserve fertility and the uterus in all of these women,” he said.
The patients had been bleeding from uterine AVMs for up to 6 months, most following spontaneous or therapeutic abortions. They all had negative beta–human chorionic gonadotropin and Doppler-confirmed AVMs in the myometrium. Retained products were ruled out in all of the patients. Two women had failed embolization with coils and gel foam, and two women required transfusions before treatment. One woman required uterine tamponade before the protocol.
“These women weren’t resolving on their own,” Dr. Vilos said at the meeting sponsored by AAGL.
Based on previous work, Dr. Vilos said he and his team were comfortable using GnRH agonists and letrozole for endometriosis, and they frequently use tranexamic acid for acute bleeding. “So we kind of put these ideas together,” he said.
Several of the women were hemorrhaging in the middle of the night, and the community hospitals where they were being treated couldn’t do embolization. The hospitals called Western University, a tertiary care center, for assistance. “We initiated the protocol, and they resolved,” Dr. Vilos said. “[It’s] an effective management strategy.”
Dr. Vilos is an advisor for Bayer Healthcare and Actavis. The investigators did not receive outside funding for the work.
AT THE AAGL GLOBAL CONGRESS
Hot flashes linked to increased hip fracture risk
Hot flashes are associated with a significant increase in the risk of hip fracture, regardless of age, body mass index, and other confounders such as smoking, according to analysis of data from the Women’s Health Study.
The prospective, observational study among 4,867 women aged 50-79 years found a 78% increase in the risk of hip fracture among women with moderate to severe menopausal vasomotor symptoms at baseline, compared with women with no symptoms.
Vasomotor symptom severity was also inversely associated with bone mineral density (BMD) at both the femoral neck and the spine. Compared with women who had no vasomotor symptoms, those with moderate or severe symptoms had 0.015 g/cm2 lower femoral neck BMD and 0.016 g/cm2 lower lumbar spine BMD, according to an analysis published on Dec. 18 in the Journal of Clinical Endocrinology and Metabolism (2014 [doi:10.1210/jc.2014-3062]).
“Despite being younger and heavier than asymptomatic women, characteristics associated with higher BMD, women with moderate/severe [vasomotor symptoms] had a higher risk of hip fractures that was also independent of other established risk factors for fractures,” wrote Dr. Carolyn J. Crandall of the University of California, Los Angeles, and her colleagues.
The study was funded by the National Institutes of Health. Two of the study authors reported consulting and other financial relationships with drug and device companies.
Hot flashes are associated with a significant increase in the risk of hip fracture, regardless of age, body mass index, and other confounders such as smoking, according to analysis of data from the Women’s Health Study.
The prospective, observational study among 4,867 women aged 50-79 years found a 78% increase in the risk of hip fracture among women with moderate to severe menopausal vasomotor symptoms at baseline, compared with women with no symptoms.
Vasomotor symptom severity was also inversely associated with bone mineral density (BMD) at both the femoral neck and the spine. Compared with women who had no vasomotor symptoms, those with moderate or severe symptoms had 0.015 g/cm2 lower femoral neck BMD and 0.016 g/cm2 lower lumbar spine BMD, according to an analysis published on Dec. 18 in the Journal of Clinical Endocrinology and Metabolism (2014 [doi:10.1210/jc.2014-3062]).
“Despite being younger and heavier than asymptomatic women, characteristics associated with higher BMD, women with moderate/severe [vasomotor symptoms] had a higher risk of hip fractures that was also independent of other established risk factors for fractures,” wrote Dr. Carolyn J. Crandall of the University of California, Los Angeles, and her colleagues.
The study was funded by the National Institutes of Health. Two of the study authors reported consulting and other financial relationships with drug and device companies.
Hot flashes are associated with a significant increase in the risk of hip fracture, regardless of age, body mass index, and other confounders such as smoking, according to analysis of data from the Women’s Health Study.
The prospective, observational study among 4,867 women aged 50-79 years found a 78% increase in the risk of hip fracture among women with moderate to severe menopausal vasomotor symptoms at baseline, compared with women with no symptoms.
Vasomotor symptom severity was also inversely associated with bone mineral density (BMD) at both the femoral neck and the spine. Compared with women who had no vasomotor symptoms, those with moderate or severe symptoms had 0.015 g/cm2 lower femoral neck BMD and 0.016 g/cm2 lower lumbar spine BMD, according to an analysis published on Dec. 18 in the Journal of Clinical Endocrinology and Metabolism (2014 [doi:10.1210/jc.2014-3062]).
“Despite being younger and heavier than asymptomatic women, characteristics associated with higher BMD, women with moderate/severe [vasomotor symptoms] had a higher risk of hip fractures that was also independent of other established risk factors for fractures,” wrote Dr. Carolyn J. Crandall of the University of California, Los Angeles, and her colleagues.
The study was funded by the National Institutes of Health. Two of the study authors reported consulting and other financial relationships with drug and device companies.
FROM THE JOURNAL OF CLINICAL ENDOCRINOLOGY AND METABOLISM
Key clinical point: The severity of vasomotor menopause symptoms is associated with risk of hip fracture.
Major finding: Women with moderate to severe vasomotor symptoms have a 78% increase in their risk of hip fracture.
Data source: A prospective, observational study among 4,867 women aged 50-79 years.
Disclosures: The study was funded by the National Institutes of Health. Two of the study authors reported consulting and other financial relationships with drug and device companies.