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Coronary Artery Calcification Scores in Migraine Patients
No significant differences were demonstrated in the amount of coronary calcifications in patients with and without migraine, a new study found. Researchers evaluated if the increased cardiovascular (CV) risk in migraineurs is attributed to an increased coronary artery calcification (CAC). They found:
- The CAC score was assessed by computed tomography of the heart in 1,437 patients, of which 337 were migraineurs.
- All patients had a similar CV risk profile, so that the risk for CAC could be considered similar between migraineurs and non-migraineurs.
- There were no significant differences in the amount of CAC in patients with or without migraine.
Filippopulos FM, et al. Coronary artery calcification score in migraine patients. [Published online ahead of print October 1, 2019]. Sci Rep. doi: 10.1038/s41598-019-50660-9.
No significant differences were demonstrated in the amount of coronary calcifications in patients with and without migraine, a new study found. Researchers evaluated if the increased cardiovascular (CV) risk in migraineurs is attributed to an increased coronary artery calcification (CAC). They found:
- The CAC score was assessed by computed tomography of the heart in 1,437 patients, of which 337 were migraineurs.
- All patients had a similar CV risk profile, so that the risk for CAC could be considered similar between migraineurs and non-migraineurs.
- There were no significant differences in the amount of CAC in patients with or without migraine.
Filippopulos FM, et al. Coronary artery calcification score in migraine patients. [Published online ahead of print October 1, 2019]. Sci Rep. doi: 10.1038/s41598-019-50660-9.
No significant differences were demonstrated in the amount of coronary calcifications in patients with and without migraine, a new study found. Researchers evaluated if the increased cardiovascular (CV) risk in migraineurs is attributed to an increased coronary artery calcification (CAC). They found:
- The CAC score was assessed by computed tomography of the heart in 1,437 patients, of which 337 were migraineurs.
- All patients had a similar CV risk profile, so that the risk for CAC could be considered similar between migraineurs and non-migraineurs.
- There were no significant differences in the amount of CAC in patients with or without migraine.
Filippopulos FM, et al. Coronary artery calcification score in migraine patients. [Published online ahead of print October 1, 2019]. Sci Rep. doi: 10.1038/s41598-019-50660-9.
Abnormal CV Response to Nitroglycerin in Migraine
Patients with migraine who developed a migraine-like attack in response to nitroglycerin demonstrated stronger systemic cardiovascular (CV) responses compared to non-headache controls, a new study found. In 16 women with migraine without aura and 10 age- and gender-matched controls, intravenous nitroglycerin was administered. Researchers found:
- Nitroglycerin provoked a migraine-like attack in 81.2% of migraineurs but not in controls.
- Migraineurs who later developed a migraine-like attack showed different responses in all parameters vs controls.
- The decreases in cardiac output and stroke volume were more rapid and longer lasting, heart rate increased, mean arterial pressure and total peripheral resistance were higher and decreased after an initial increase.
van Oosterhout WPJ, et al. Abnormal cardiovascular response to nitroglycerin in migraine. [Published online ahead of print October 9, 2019]. Cephalalgia. doi: 10.1177/0333102419881657.
Patients with migraine who developed a migraine-like attack in response to nitroglycerin demonstrated stronger systemic cardiovascular (CV) responses compared to non-headache controls, a new study found. In 16 women with migraine without aura and 10 age- and gender-matched controls, intravenous nitroglycerin was administered. Researchers found:
- Nitroglycerin provoked a migraine-like attack in 81.2% of migraineurs but not in controls.
- Migraineurs who later developed a migraine-like attack showed different responses in all parameters vs controls.
- The decreases in cardiac output and stroke volume were more rapid and longer lasting, heart rate increased, mean arterial pressure and total peripheral resistance were higher and decreased after an initial increase.
van Oosterhout WPJ, et al. Abnormal cardiovascular response to nitroglycerin in migraine. [Published online ahead of print October 9, 2019]. Cephalalgia. doi: 10.1177/0333102419881657.
Patients with migraine who developed a migraine-like attack in response to nitroglycerin demonstrated stronger systemic cardiovascular (CV) responses compared to non-headache controls, a new study found. In 16 women with migraine without aura and 10 age- and gender-matched controls, intravenous nitroglycerin was administered. Researchers found:
- Nitroglycerin provoked a migraine-like attack in 81.2% of migraineurs but not in controls.
- Migraineurs who later developed a migraine-like attack showed different responses in all parameters vs controls.
- The decreases in cardiac output and stroke volume were more rapid and longer lasting, heart rate increased, mean arterial pressure and total peripheral resistance were higher and decreased after an initial increase.
van Oosterhout WPJ, et al. Abnormal cardiovascular response to nitroglycerin in migraine. [Published online ahead of print October 9, 2019]. Cephalalgia. doi: 10.1177/0333102419881657.
Three free apps for urogynecology providers
Thousands of medical apps are available for smart mobile devices; however, identifying accurate and high-quality apps poses a challenge to health care providers. In the field of urogynecology, also known as female pelvic medicine and reconstructive surgery (FPMRS), the authors of a recent study identified and rated a number of apps for use by urogynecologists.1
The 3 apps featured here are all free and are both informational and clinical decision-making apps.
Informational apps include one or more of the following datasets in a given condition: epidemiology, etiology/pathophysiology, histology/pathology, clinical presentation, treatment, follow-up care, prevention, and/or prognosis.
Clinical decision-making apps may have the following functionalities within the app: clinical decision support systems, clinical treatment guidelines, disease diagnosis aids, differential diagnosis aids, medical calculators, laboratory test ordering, laboratory test interpretation, and/or medical exams.
The TABLE details the features of these recommended apps based on a shortened version of the APPLICATIONS scoring system, APPLI (app comprehensiveness, price, platform, literature used, and important special features).2 I hope urogynecologists view these apps as innovative educational resources that provide quick medical knowledge and pelvic floor patient education.
1. Wallace SL, Mehta S, Farag S, et al. In search of mobile applications for urogynecology providers. Female Pelvic Med Reconstr Surg. 2018. doi:10.1097/SPV.0000000000000580.
2. Chyjek K, Farag S, Chen KT. Rating pregnancy wheel applications using the APPLICATIONS scoring system. Obstet Gynecol. 2015;125:1478-1483.
Thousands of medical apps are available for smart mobile devices; however, identifying accurate and high-quality apps poses a challenge to health care providers. In the field of urogynecology, also known as female pelvic medicine and reconstructive surgery (FPMRS), the authors of a recent study identified and rated a number of apps for use by urogynecologists.1
The 3 apps featured here are all free and are both informational and clinical decision-making apps.
Informational apps include one or more of the following datasets in a given condition: epidemiology, etiology/pathophysiology, histology/pathology, clinical presentation, treatment, follow-up care, prevention, and/or prognosis.
Clinical decision-making apps may have the following functionalities within the app: clinical decision support systems, clinical treatment guidelines, disease diagnosis aids, differential diagnosis aids, medical calculators, laboratory test ordering, laboratory test interpretation, and/or medical exams.
The TABLE details the features of these recommended apps based on a shortened version of the APPLICATIONS scoring system, APPLI (app comprehensiveness, price, platform, literature used, and important special features).2 I hope urogynecologists view these apps as innovative educational resources that provide quick medical knowledge and pelvic floor patient education.
Thousands of medical apps are available for smart mobile devices; however, identifying accurate and high-quality apps poses a challenge to health care providers. In the field of urogynecology, also known as female pelvic medicine and reconstructive surgery (FPMRS), the authors of a recent study identified and rated a number of apps for use by urogynecologists.1
The 3 apps featured here are all free and are both informational and clinical decision-making apps.
Informational apps include one or more of the following datasets in a given condition: epidemiology, etiology/pathophysiology, histology/pathology, clinical presentation, treatment, follow-up care, prevention, and/or prognosis.
Clinical decision-making apps may have the following functionalities within the app: clinical decision support systems, clinical treatment guidelines, disease diagnosis aids, differential diagnosis aids, medical calculators, laboratory test ordering, laboratory test interpretation, and/or medical exams.
The TABLE details the features of these recommended apps based on a shortened version of the APPLICATIONS scoring system, APPLI (app comprehensiveness, price, platform, literature used, and important special features).2 I hope urogynecologists view these apps as innovative educational resources that provide quick medical knowledge and pelvic floor patient education.
1. Wallace SL, Mehta S, Farag S, et al. In search of mobile applications for urogynecology providers. Female Pelvic Med Reconstr Surg. 2018. doi:10.1097/SPV.0000000000000580.
2. Chyjek K, Farag S, Chen KT. Rating pregnancy wheel applications using the APPLICATIONS scoring system. Obstet Gynecol. 2015;125:1478-1483.
1. Wallace SL, Mehta S, Farag S, et al. In search of mobile applications for urogynecology providers. Female Pelvic Med Reconstr Surg. 2018. doi:10.1097/SPV.0000000000000580.
2. Chyjek K, Farag S, Chen KT. Rating pregnancy wheel applications using the APPLICATIONS scoring system. Obstet Gynecol. 2015;125:1478-1483.
Poor Patient Awareness Common in Migraine
Poor awareness of migraine is common among patients in several countries, a new study found. The multicenter study was conducted in 12 headache centers in 7 countries with each center recruiting 100 or less patients referred for a first visit and diagnosed with migraine. Participants were given a structured clinical questionnaire-based interview about perceptions of the type of headache they suffer from, its cause, previous diagnoses, investigations, and treatments. Researchers found:
- Of the 1,161 patients who completed the study, 28% of participants were aware they suffer from migraine.
- 64% of participants called their migraine “headache,” less commonly used terms such as “cervical pain,” “tension headache,” and “sinusitis.”
- 8% of general practitioners and 35% of specialists consulted for migraine formulated the correct diagnosis.
Viana M, et al. Poor patient awareness and frequent misdiagnosis of migraine: findings from a large transcontinental cohort. [Published online ahead of print October 1, 2019]. Eur J Neurol. doi: 10.1111/ene.14098.
Poor awareness of migraine is common among patients in several countries, a new study found. The multicenter study was conducted in 12 headache centers in 7 countries with each center recruiting 100 or less patients referred for a first visit and diagnosed with migraine. Participants were given a structured clinical questionnaire-based interview about perceptions of the type of headache they suffer from, its cause, previous diagnoses, investigations, and treatments. Researchers found:
- Of the 1,161 patients who completed the study, 28% of participants were aware they suffer from migraine.
- 64% of participants called their migraine “headache,” less commonly used terms such as “cervical pain,” “tension headache,” and “sinusitis.”
- 8% of general practitioners and 35% of specialists consulted for migraine formulated the correct diagnosis.
Viana M, et al. Poor patient awareness and frequent misdiagnosis of migraine: findings from a large transcontinental cohort. [Published online ahead of print October 1, 2019]. Eur J Neurol. doi: 10.1111/ene.14098.
Poor awareness of migraine is common among patients in several countries, a new study found. The multicenter study was conducted in 12 headache centers in 7 countries with each center recruiting 100 or less patients referred for a first visit and diagnosed with migraine. Participants were given a structured clinical questionnaire-based interview about perceptions of the type of headache they suffer from, its cause, previous diagnoses, investigations, and treatments. Researchers found:
- Of the 1,161 patients who completed the study, 28% of participants were aware they suffer from migraine.
- 64% of participants called their migraine “headache,” less commonly used terms such as “cervical pain,” “tension headache,” and “sinusitis.”
- 8% of general practitioners and 35% of specialists consulted for migraine formulated the correct diagnosis.
Viana M, et al. Poor patient awareness and frequent misdiagnosis of migraine: findings from a large transcontinental cohort. [Published online ahead of print October 1, 2019]. Eur J Neurol. doi: 10.1111/ene.14098.
Minimize blood pressure peaks, variability after stroke reperfusion
ST. LOUIS – Albuquerque. Investigators found that every 10–mm Hg increase in peak systolic pressure boosted the risk of in-hospital death 24% (P = .01) and reduced the chance of being discharged home or to a inpatient rehabilitation facility 13% (P = .03). Results were even stronger for peak mean arterial pressure, at 76% (P = .01) and 29% (P = .04), respectively; trends in the same direction for peak diastolic pressure were not statistically significant.
Also, every 10–mm Hg increase in blood pressure variability again increased the risk of dying in the hospital, whether it was systolic (33%; P = .002), diastolic (33%; P = .03), or mean arterial pressure variability (58%; P = .02). Higher variability also reduced the chance of being discharged home or to a rehab 10%-20%, but the findings, although close, were not statistically significant.
Neurologists generally do what they can to control blood pressure after stroke, and the study confirms the need to do that. What’s new is that the work was limited to reperfusion patients – intravenous thrombolysis with alteplase in 83.5%, mechanical thrombectomy in 60%, with some having both – which has not been the specific focus of much research.
“Be much more aggressive in terms of making sure the variability is limited and limiting the peaks,” especially within 24 hours of reperfusion, said lead investigator and stroke neurologist Dinesh Jillella, MD, of Emory University, Atlanta, at the annual meeting of the American Neurological Association. “We want to be much more aggressive [with these patients]; it might limit our worse outcomes,” Dr. Jillella said. He conducted the review while in training at the University of New Mexico.
What led to the study is that Dr. Jillella and colleagues noticed that similar reperfusion patients can have very different outcomes, and he wanted to find modifiable risk factors that could account for the differences. The study did not address why high peaks and variability lead to worse outcomes, but he said hemorrhagic conversion might play a role.
It is also possible that higher pressures could be a marker of bad outcomes, as opposed to a direct cause, but the findings were adjusted for two significant confounders: age and the National Institutes of Health Stroke Scale score, which were both significantly higher in patients who did not do well. But after adjustment, “we [still] found an independent association with blood pressures and worse outcomes,” he said.
Higher peak systolic pressures and variability were also associated with about a 15% lower odds of leaving the hospital with a modified Rankin Scale score of 3 or less, which means the patient has some moderate disability but is still able to walk without assistance.
Patients were 69 years old on average, and about 60% were men. The majority were white. About a third had a modified Rankin Scale score at or below 3 at discharge, and about two-thirds were discharged home or to a rehabilitation facility; 17% of patients died in the hospital.
Differences in antihypertensive regimens were not associated with outcomes on univariate analysis. Dr. Jillella said that, ideally, he would like to run a multicenter, prospective trial of blood pressure reduction targets after reperfusion.
There was no external funding, and Dr. Jillella didn’t have any relevant disclosures.
ST. LOUIS – Albuquerque. Investigators found that every 10–mm Hg increase in peak systolic pressure boosted the risk of in-hospital death 24% (P = .01) and reduced the chance of being discharged home or to a inpatient rehabilitation facility 13% (P = .03). Results were even stronger for peak mean arterial pressure, at 76% (P = .01) and 29% (P = .04), respectively; trends in the same direction for peak diastolic pressure were not statistically significant.
Also, every 10–mm Hg increase in blood pressure variability again increased the risk of dying in the hospital, whether it was systolic (33%; P = .002), diastolic (33%; P = .03), or mean arterial pressure variability (58%; P = .02). Higher variability also reduced the chance of being discharged home or to a rehab 10%-20%, but the findings, although close, were not statistically significant.
Neurologists generally do what they can to control blood pressure after stroke, and the study confirms the need to do that. What’s new is that the work was limited to reperfusion patients – intravenous thrombolysis with alteplase in 83.5%, mechanical thrombectomy in 60%, with some having both – which has not been the specific focus of much research.
“Be much more aggressive in terms of making sure the variability is limited and limiting the peaks,” especially within 24 hours of reperfusion, said lead investigator and stroke neurologist Dinesh Jillella, MD, of Emory University, Atlanta, at the annual meeting of the American Neurological Association. “We want to be much more aggressive [with these patients]; it might limit our worse outcomes,” Dr. Jillella said. He conducted the review while in training at the University of New Mexico.
What led to the study is that Dr. Jillella and colleagues noticed that similar reperfusion patients can have very different outcomes, and he wanted to find modifiable risk factors that could account for the differences. The study did not address why high peaks and variability lead to worse outcomes, but he said hemorrhagic conversion might play a role.
It is also possible that higher pressures could be a marker of bad outcomes, as opposed to a direct cause, but the findings were adjusted for two significant confounders: age and the National Institutes of Health Stroke Scale score, which were both significantly higher in patients who did not do well. But after adjustment, “we [still] found an independent association with blood pressures and worse outcomes,” he said.
Higher peak systolic pressures and variability were also associated with about a 15% lower odds of leaving the hospital with a modified Rankin Scale score of 3 or less, which means the patient has some moderate disability but is still able to walk without assistance.
Patients were 69 years old on average, and about 60% were men. The majority were white. About a third had a modified Rankin Scale score at or below 3 at discharge, and about two-thirds were discharged home or to a rehabilitation facility; 17% of patients died in the hospital.
Differences in antihypertensive regimens were not associated with outcomes on univariate analysis. Dr. Jillella said that, ideally, he would like to run a multicenter, prospective trial of blood pressure reduction targets after reperfusion.
There was no external funding, and Dr. Jillella didn’t have any relevant disclosures.
ST. LOUIS – Albuquerque. Investigators found that every 10–mm Hg increase in peak systolic pressure boosted the risk of in-hospital death 24% (P = .01) and reduced the chance of being discharged home or to a inpatient rehabilitation facility 13% (P = .03). Results were even stronger for peak mean arterial pressure, at 76% (P = .01) and 29% (P = .04), respectively; trends in the same direction for peak diastolic pressure were not statistically significant.
Also, every 10–mm Hg increase in blood pressure variability again increased the risk of dying in the hospital, whether it was systolic (33%; P = .002), diastolic (33%; P = .03), or mean arterial pressure variability (58%; P = .02). Higher variability also reduced the chance of being discharged home or to a rehab 10%-20%, but the findings, although close, were not statistically significant.
Neurologists generally do what they can to control blood pressure after stroke, and the study confirms the need to do that. What’s new is that the work was limited to reperfusion patients – intravenous thrombolysis with alteplase in 83.5%, mechanical thrombectomy in 60%, with some having both – which has not been the specific focus of much research.
“Be much more aggressive in terms of making sure the variability is limited and limiting the peaks,” especially within 24 hours of reperfusion, said lead investigator and stroke neurologist Dinesh Jillella, MD, of Emory University, Atlanta, at the annual meeting of the American Neurological Association. “We want to be much more aggressive [with these patients]; it might limit our worse outcomes,” Dr. Jillella said. He conducted the review while in training at the University of New Mexico.
What led to the study is that Dr. Jillella and colleagues noticed that similar reperfusion patients can have very different outcomes, and he wanted to find modifiable risk factors that could account for the differences. The study did not address why high peaks and variability lead to worse outcomes, but he said hemorrhagic conversion might play a role.
It is also possible that higher pressures could be a marker of bad outcomes, as opposed to a direct cause, but the findings were adjusted for two significant confounders: age and the National Institutes of Health Stroke Scale score, which were both significantly higher in patients who did not do well. But after adjustment, “we [still] found an independent association with blood pressures and worse outcomes,” he said.
Higher peak systolic pressures and variability were also associated with about a 15% lower odds of leaving the hospital with a modified Rankin Scale score of 3 or less, which means the patient has some moderate disability but is still able to walk without assistance.
Patients were 69 years old on average, and about 60% were men. The majority were white. About a third had a modified Rankin Scale score at or below 3 at discharge, and about two-thirds were discharged home or to a rehabilitation facility; 17% of patients died in the hospital.
Differences in antihypertensive regimens were not associated with outcomes on univariate analysis. Dr. Jillella said that, ideally, he would like to run a multicenter, prospective trial of blood pressure reduction targets after reperfusion.
There was no external funding, and Dr. Jillella didn’t have any relevant disclosures.
REPORTING FROM ANA 2019
Uninsured population is big in Texas
There were just over 5 million uninsured people in the Lone Star State last year, representing an increase from 17.3% of the total population in 2017 to 17.7%, and that works out to an additional 186,000 residents with no health care coverage, the Census Bureau said in a recent report.
That 17.7% rate for 2018 gave Texas the highest proportion of uninsured population, putting it ahead of Oklahoma (14.2%), Georgia (13.7%), Florida (13.0%), Alaska (12.6%), and Mississippi (12.1%). Oklahoma had basically no change from 2017, while the other three each had a small but nonsignificant increase. Nationally, the rate of uninsured population went from 7.9% in 2017 to 8.5% in 2018, the Census Bureau investigators said.
On the other end of the coverage spectrum was Massachusetts, where only 2.8% of the population, or about 189,000 people, lacked health insurance in 2018. Washington, D.C., was next with an uninsured rate of 3.2%, followed by Vermont (4.0%), Hawaii (4.1%), Rhode Island (4.1%), and Minnesota (4.4%), they said, based on data from the American Community Survey.
A separate analysis of Census Bureau data by the personal finance website WalletHub showed that states that expanded Medicaid along with their Affordable Care Act implementation had an average uninsured rate of 7.0% in 2018, compared with 11.1% for states that did not expand eligibility.
All 50 states were in negative territory when changes in uninsured rates were calculated over a longer time period, 2010-2018, as the national rate fell by 6.6%. The largest drops among the states came in Nevada (–11.4%), California (–11.3%), Oregon (–10.1%), and New Mexico (–10.1%), while Massachusetts (–1.7%), Maine (–2.1%), and North Dakota (–2.5%) had the smallest declines, WalletHub reported.
There were just over 5 million uninsured people in the Lone Star State last year, representing an increase from 17.3% of the total population in 2017 to 17.7%, and that works out to an additional 186,000 residents with no health care coverage, the Census Bureau said in a recent report.
That 17.7% rate for 2018 gave Texas the highest proportion of uninsured population, putting it ahead of Oklahoma (14.2%), Georgia (13.7%), Florida (13.0%), Alaska (12.6%), and Mississippi (12.1%). Oklahoma had basically no change from 2017, while the other three each had a small but nonsignificant increase. Nationally, the rate of uninsured population went from 7.9% in 2017 to 8.5% in 2018, the Census Bureau investigators said.
On the other end of the coverage spectrum was Massachusetts, where only 2.8% of the population, or about 189,000 people, lacked health insurance in 2018. Washington, D.C., was next with an uninsured rate of 3.2%, followed by Vermont (4.0%), Hawaii (4.1%), Rhode Island (4.1%), and Minnesota (4.4%), they said, based on data from the American Community Survey.
A separate analysis of Census Bureau data by the personal finance website WalletHub showed that states that expanded Medicaid along with their Affordable Care Act implementation had an average uninsured rate of 7.0% in 2018, compared with 11.1% for states that did not expand eligibility.
All 50 states were in negative territory when changes in uninsured rates were calculated over a longer time period, 2010-2018, as the national rate fell by 6.6%. The largest drops among the states came in Nevada (–11.4%), California (–11.3%), Oregon (–10.1%), and New Mexico (–10.1%), while Massachusetts (–1.7%), Maine (–2.1%), and North Dakota (–2.5%) had the smallest declines, WalletHub reported.
There were just over 5 million uninsured people in the Lone Star State last year, representing an increase from 17.3% of the total population in 2017 to 17.7%, and that works out to an additional 186,000 residents with no health care coverage, the Census Bureau said in a recent report.
That 17.7% rate for 2018 gave Texas the highest proportion of uninsured population, putting it ahead of Oklahoma (14.2%), Georgia (13.7%), Florida (13.0%), Alaska (12.6%), and Mississippi (12.1%). Oklahoma had basically no change from 2017, while the other three each had a small but nonsignificant increase. Nationally, the rate of uninsured population went from 7.9% in 2017 to 8.5% in 2018, the Census Bureau investigators said.
On the other end of the coverage spectrum was Massachusetts, where only 2.8% of the population, or about 189,000 people, lacked health insurance in 2018. Washington, D.C., was next with an uninsured rate of 3.2%, followed by Vermont (4.0%), Hawaii (4.1%), Rhode Island (4.1%), and Minnesota (4.4%), they said, based on data from the American Community Survey.
A separate analysis of Census Bureau data by the personal finance website WalletHub showed that states that expanded Medicaid along with their Affordable Care Act implementation had an average uninsured rate of 7.0% in 2018, compared with 11.1% for states that did not expand eligibility.
All 50 states were in negative territory when changes in uninsured rates were calculated over a longer time period, 2010-2018, as the national rate fell by 6.6%. The largest drops among the states came in Nevada (–11.4%), California (–11.3%), Oregon (–10.1%), and New Mexico (–10.1%), while Massachusetts (–1.7%), Maine (–2.1%), and North Dakota (–2.5%) had the smallest declines, WalletHub reported.
What repair is best for juxtarenal aneurysm?
CHICAGO – Outcomes with fenestrated endografts and endograft anchors to repair abdominal aortic aneurysms (AAAs) in the region of the renal artery have improved as the techniques have gained popularity in recent years, but open repair may still achieve better overall results, vascular surgeons on opposite sides of the controversy contended during a debate at the annual meeting of the Midwestern Vascular Surgery Society.
Fenestrated endovascular aortic repair (FEVAR) “is as safe as open surgery to treat complex aneurysm,” said Carlos Bechara, MD, of Loyola University Medical Center in Chicago. “EndoAnchors [Medtronic] do provide an excellent off-the-shelf solution to treat short, hostile necks with promising short-term results.”
Arguing for open repair was Paul DiMusto, MD, of the University of Wisconsin–Madison. “Open repair has an equal perioperative mortality to FEVAR,” Dr. DiMusto said, adding that the open approach also has a higher long-term branch patency rate, lower secondary-intervention rate, a lower incidence of long-term renal failure, and higher long-term survival. “So putting that all together, open repair is best,” he said.
They staked out their positions by citing a host of published trials.
“The presence of a short neck can create a challenging clinical scenario for an endovascular repair of abdominal aortic aneurysm,” Dr. Bechara said. However, he noted he was discussing complex aneurysm in which the aortic clamp is placed above the renal arteries, differentiating it from infrarenal AAA in which the clamp is below the renal arteries with no renal ischemia time. He noted a 2011 study that determined a short neck was a predictor of Type 1A endoleak after AAA repair, but that compliance with best practices at the time was poor; more than 44% of EVARs did not follow the manufacturer’s instruction (Circulation. 2011;123:2848-55).
But FEVAR was approved by the Food and Drug Administration in 2012, with an indication for an infrarenal neck length of 4-14 mm, Dr. Bechara noted. Since then, several studies have reported excellent outcomes with the technique. An early small study of 67 patients reported a 100% technical success rate with one patient having a Type 1 endoleak at 3 years (J Vasc Surg. 2014;60:1420-8).
This year, a larger study evaluated 6,825 patients in the American College of Surgeons National Surgical Quality Improvement Program who had FEVAR, open AAA repair or standard infrarenal endovascular repair during 2012-2016. “Actually, the fenestrated approach had fewer complications than open repair and the outcomes were comparable to standard EVAR,” Dr. Bechara noted. The trial reported FEVAR had lower rates of perioperative mortality (1.8% vs. 8.8%; P = .001), postoperative renal dysfunction (1.4% vs. 7.7%; P = .002), and overall complications (11% vs. 33%; P less than.001) than did open repair (J Vasc Surg. 2019;69:1670-78).
In regard to the use of endograft anchors for treatment of endoleaks, migrating grafts, and high-risk seal zones, Dr. Bechara noted they are a good “off-the-shelf” choice for complex AAA repair. He cited current results of a cohort of 70 patients with short-neck AAA (J Vasc Surg. 2019;70:732-40). “This study showed a procedural success rate at 97% and a technical success rate at 88.6%,” he said. “They had no stent migration, no increase in sac size or AAA rupture or open conversion.”
He also pointed to just-published results from a randomized trial of 881 patients with up to 14 years of follow-up that found comparable rates of death/secondary procedures, as well as durability, between patients who had endovascular and open repairs (77.7% and 75.5%, respectively, N Engl J Med. 2019;380:2126-35). Also, he noted that hospital volume is an important predictor of success with open repair, with high-volume centers reporting lower mortality (3.9%) than low-volume centers (9%; Ann Surg. 2018 Nov 29. doi: 10.1097/SLA.0000000000002873). “So not many centers are doing high-volume open aortic surgery,” he said.
To make his case that open surgery for juxtarenal AAAs is superior, Dr. DiMusto cited a number of recent studies, including a three-center trial of 200 patients who had open and FEVAR procedures (J Endovasc Ther. 2019;26:105-12). “There was no difference in perioperative mortality [2.2% for FEVAR, 1.9% in open repair], ” Dr. DiMusto said “There was a higher freedom from reintervention in the open group [96% vs. 78%], and there was higher long-term vessel patency in the open group” (97.5% having target patency for open vs. 93.3% for FEVAR).
He also pointed to a meta-analysis of 2,326 patients that found similar outcomes for mortality and postoperative renal insufficiency between FEVAR and open repair, around 4.1%, but showed significantly higher rates of renal failure in FEVAR, at 19.7% versus 7.7% (J Vasc Surg. 2015;61:242-55). This study also reported significantly more secondary interventions with FEVAR, 12.7% vs. 4.9%, Dr. DiMusto said.
Another study of 3,253 complex AAA repairs, including 887 FEVAR and 2,125 open procedures, showed that FEVAR had a technical success rate of 97%, with no appreciable difference in perioperative mortality between the two procedures (Ann Surg. 2019 Feb 1. doi: 10.1097/SLA.0000000000003094).
However, Dr. DiMusto said, adjusted 3-year mortality in this study was higher with FEVAR, and further analysis yielded outcomes that favored open repair. “After excluding perioperative deaths, differences remained, with 9% mortality for FEVAR and 5% for open repair [P = .02],” he said. “This corresponded to a 66% higher risk for overall mortality following FEVAR.”
What’s more, Dr. DiMusto said, draft guidelines from the National Institute for Health and Care Excellence in the United Kingdom advise against offering complex EVAR to people with an unruptured AAA under two scenarios: if open surgery is an option; and even if they’re unable to have surgery because of anesthetic or medical issues. The final guidelines have yet to be released.
Dr. Bechara disclosed financial relationships with Gore Medical and Cook Medical and equity interest in MOKITA Medical. Dr. DiMusto has no relevant financial disclosures.
CHICAGO – Outcomes with fenestrated endografts and endograft anchors to repair abdominal aortic aneurysms (AAAs) in the region of the renal artery have improved as the techniques have gained popularity in recent years, but open repair may still achieve better overall results, vascular surgeons on opposite sides of the controversy contended during a debate at the annual meeting of the Midwestern Vascular Surgery Society.
Fenestrated endovascular aortic repair (FEVAR) “is as safe as open surgery to treat complex aneurysm,” said Carlos Bechara, MD, of Loyola University Medical Center in Chicago. “EndoAnchors [Medtronic] do provide an excellent off-the-shelf solution to treat short, hostile necks with promising short-term results.”
Arguing for open repair was Paul DiMusto, MD, of the University of Wisconsin–Madison. “Open repair has an equal perioperative mortality to FEVAR,” Dr. DiMusto said, adding that the open approach also has a higher long-term branch patency rate, lower secondary-intervention rate, a lower incidence of long-term renal failure, and higher long-term survival. “So putting that all together, open repair is best,” he said.
They staked out their positions by citing a host of published trials.
“The presence of a short neck can create a challenging clinical scenario for an endovascular repair of abdominal aortic aneurysm,” Dr. Bechara said. However, he noted he was discussing complex aneurysm in which the aortic clamp is placed above the renal arteries, differentiating it from infrarenal AAA in which the clamp is below the renal arteries with no renal ischemia time. He noted a 2011 study that determined a short neck was a predictor of Type 1A endoleak after AAA repair, but that compliance with best practices at the time was poor; more than 44% of EVARs did not follow the manufacturer’s instruction (Circulation. 2011;123:2848-55).
But FEVAR was approved by the Food and Drug Administration in 2012, with an indication for an infrarenal neck length of 4-14 mm, Dr. Bechara noted. Since then, several studies have reported excellent outcomes with the technique. An early small study of 67 patients reported a 100% technical success rate with one patient having a Type 1 endoleak at 3 years (J Vasc Surg. 2014;60:1420-8).
This year, a larger study evaluated 6,825 patients in the American College of Surgeons National Surgical Quality Improvement Program who had FEVAR, open AAA repair or standard infrarenal endovascular repair during 2012-2016. “Actually, the fenestrated approach had fewer complications than open repair and the outcomes were comparable to standard EVAR,” Dr. Bechara noted. The trial reported FEVAR had lower rates of perioperative mortality (1.8% vs. 8.8%; P = .001), postoperative renal dysfunction (1.4% vs. 7.7%; P = .002), and overall complications (11% vs. 33%; P less than.001) than did open repair (J Vasc Surg. 2019;69:1670-78).
In regard to the use of endograft anchors for treatment of endoleaks, migrating grafts, and high-risk seal zones, Dr. Bechara noted they are a good “off-the-shelf” choice for complex AAA repair. He cited current results of a cohort of 70 patients with short-neck AAA (J Vasc Surg. 2019;70:732-40). “This study showed a procedural success rate at 97% and a technical success rate at 88.6%,” he said. “They had no stent migration, no increase in sac size or AAA rupture or open conversion.”
He also pointed to just-published results from a randomized trial of 881 patients with up to 14 years of follow-up that found comparable rates of death/secondary procedures, as well as durability, between patients who had endovascular and open repairs (77.7% and 75.5%, respectively, N Engl J Med. 2019;380:2126-35). Also, he noted that hospital volume is an important predictor of success with open repair, with high-volume centers reporting lower mortality (3.9%) than low-volume centers (9%; Ann Surg. 2018 Nov 29. doi: 10.1097/SLA.0000000000002873). “So not many centers are doing high-volume open aortic surgery,” he said.
To make his case that open surgery for juxtarenal AAAs is superior, Dr. DiMusto cited a number of recent studies, including a three-center trial of 200 patients who had open and FEVAR procedures (J Endovasc Ther. 2019;26:105-12). “There was no difference in perioperative mortality [2.2% for FEVAR, 1.9% in open repair], ” Dr. DiMusto said “There was a higher freedom from reintervention in the open group [96% vs. 78%], and there was higher long-term vessel patency in the open group” (97.5% having target patency for open vs. 93.3% for FEVAR).
He also pointed to a meta-analysis of 2,326 patients that found similar outcomes for mortality and postoperative renal insufficiency between FEVAR and open repair, around 4.1%, but showed significantly higher rates of renal failure in FEVAR, at 19.7% versus 7.7% (J Vasc Surg. 2015;61:242-55). This study also reported significantly more secondary interventions with FEVAR, 12.7% vs. 4.9%, Dr. DiMusto said.
Another study of 3,253 complex AAA repairs, including 887 FEVAR and 2,125 open procedures, showed that FEVAR had a technical success rate of 97%, with no appreciable difference in perioperative mortality between the two procedures (Ann Surg. 2019 Feb 1. doi: 10.1097/SLA.0000000000003094).
However, Dr. DiMusto said, adjusted 3-year mortality in this study was higher with FEVAR, and further analysis yielded outcomes that favored open repair. “After excluding perioperative deaths, differences remained, with 9% mortality for FEVAR and 5% for open repair [P = .02],” he said. “This corresponded to a 66% higher risk for overall mortality following FEVAR.”
What’s more, Dr. DiMusto said, draft guidelines from the National Institute for Health and Care Excellence in the United Kingdom advise against offering complex EVAR to people with an unruptured AAA under two scenarios: if open surgery is an option; and even if they’re unable to have surgery because of anesthetic or medical issues. The final guidelines have yet to be released.
Dr. Bechara disclosed financial relationships with Gore Medical and Cook Medical and equity interest in MOKITA Medical. Dr. DiMusto has no relevant financial disclosures.
CHICAGO – Outcomes with fenestrated endografts and endograft anchors to repair abdominal aortic aneurysms (AAAs) in the region of the renal artery have improved as the techniques have gained popularity in recent years, but open repair may still achieve better overall results, vascular surgeons on opposite sides of the controversy contended during a debate at the annual meeting of the Midwestern Vascular Surgery Society.
Fenestrated endovascular aortic repair (FEVAR) “is as safe as open surgery to treat complex aneurysm,” said Carlos Bechara, MD, of Loyola University Medical Center in Chicago. “EndoAnchors [Medtronic] do provide an excellent off-the-shelf solution to treat short, hostile necks with promising short-term results.”
Arguing for open repair was Paul DiMusto, MD, of the University of Wisconsin–Madison. “Open repair has an equal perioperative mortality to FEVAR,” Dr. DiMusto said, adding that the open approach also has a higher long-term branch patency rate, lower secondary-intervention rate, a lower incidence of long-term renal failure, and higher long-term survival. “So putting that all together, open repair is best,” he said.
They staked out their positions by citing a host of published trials.
“The presence of a short neck can create a challenging clinical scenario for an endovascular repair of abdominal aortic aneurysm,” Dr. Bechara said. However, he noted he was discussing complex aneurysm in which the aortic clamp is placed above the renal arteries, differentiating it from infrarenal AAA in which the clamp is below the renal arteries with no renal ischemia time. He noted a 2011 study that determined a short neck was a predictor of Type 1A endoleak after AAA repair, but that compliance with best practices at the time was poor; more than 44% of EVARs did not follow the manufacturer’s instruction (Circulation. 2011;123:2848-55).
But FEVAR was approved by the Food and Drug Administration in 2012, with an indication for an infrarenal neck length of 4-14 mm, Dr. Bechara noted. Since then, several studies have reported excellent outcomes with the technique. An early small study of 67 patients reported a 100% technical success rate with one patient having a Type 1 endoleak at 3 years (J Vasc Surg. 2014;60:1420-8).
This year, a larger study evaluated 6,825 patients in the American College of Surgeons National Surgical Quality Improvement Program who had FEVAR, open AAA repair or standard infrarenal endovascular repair during 2012-2016. “Actually, the fenestrated approach had fewer complications than open repair and the outcomes were comparable to standard EVAR,” Dr. Bechara noted. The trial reported FEVAR had lower rates of perioperative mortality (1.8% vs. 8.8%; P = .001), postoperative renal dysfunction (1.4% vs. 7.7%; P = .002), and overall complications (11% vs. 33%; P less than.001) than did open repair (J Vasc Surg. 2019;69:1670-78).
In regard to the use of endograft anchors for treatment of endoleaks, migrating grafts, and high-risk seal zones, Dr. Bechara noted they are a good “off-the-shelf” choice for complex AAA repair. He cited current results of a cohort of 70 patients with short-neck AAA (J Vasc Surg. 2019;70:732-40). “This study showed a procedural success rate at 97% and a technical success rate at 88.6%,” he said. “They had no stent migration, no increase in sac size or AAA rupture or open conversion.”
He also pointed to just-published results from a randomized trial of 881 patients with up to 14 years of follow-up that found comparable rates of death/secondary procedures, as well as durability, between patients who had endovascular and open repairs (77.7% and 75.5%, respectively, N Engl J Med. 2019;380:2126-35). Also, he noted that hospital volume is an important predictor of success with open repair, with high-volume centers reporting lower mortality (3.9%) than low-volume centers (9%; Ann Surg. 2018 Nov 29. doi: 10.1097/SLA.0000000000002873). “So not many centers are doing high-volume open aortic surgery,” he said.
To make his case that open surgery for juxtarenal AAAs is superior, Dr. DiMusto cited a number of recent studies, including a three-center trial of 200 patients who had open and FEVAR procedures (J Endovasc Ther. 2019;26:105-12). “There was no difference in perioperative mortality [2.2% for FEVAR, 1.9% in open repair], ” Dr. DiMusto said “There was a higher freedom from reintervention in the open group [96% vs. 78%], and there was higher long-term vessel patency in the open group” (97.5% having target patency for open vs. 93.3% for FEVAR).
He also pointed to a meta-analysis of 2,326 patients that found similar outcomes for mortality and postoperative renal insufficiency between FEVAR and open repair, around 4.1%, but showed significantly higher rates of renal failure in FEVAR, at 19.7% versus 7.7% (J Vasc Surg. 2015;61:242-55). This study also reported significantly more secondary interventions with FEVAR, 12.7% vs. 4.9%, Dr. DiMusto said.
Another study of 3,253 complex AAA repairs, including 887 FEVAR and 2,125 open procedures, showed that FEVAR had a technical success rate of 97%, with no appreciable difference in perioperative mortality between the two procedures (Ann Surg. 2019 Feb 1. doi: 10.1097/SLA.0000000000003094).
However, Dr. DiMusto said, adjusted 3-year mortality in this study was higher with FEVAR, and further analysis yielded outcomes that favored open repair. “After excluding perioperative deaths, differences remained, with 9% mortality for FEVAR and 5% for open repair [P = .02],” he said. “This corresponded to a 66% higher risk for overall mortality following FEVAR.”
What’s more, Dr. DiMusto said, draft guidelines from the National Institute for Health and Care Excellence in the United Kingdom advise against offering complex EVAR to people with an unruptured AAA under two scenarios: if open surgery is an option; and even if they’re unable to have surgery because of anesthetic or medical issues. The final guidelines have yet to be released.
Dr. Bechara disclosed financial relationships with Gore Medical and Cook Medical and equity interest in MOKITA Medical. Dr. DiMusto has no relevant financial disclosures.
EXPERT ANALYSIS FROM MIDWESTERN VASCULAR 2019
SSRIs may reduce fecundability, live birth rate in reproductive-age women
PHILADELPHIA – Lindsey A. Sjaarda, PhD, reported at the annual meeting of the American Society for Reproductive Medicine.
In addition, women in a subgroup receiving fluoxetine experienced a lower live birth rate and greater incidence of pregnancy loss than women taking other SSRIs, but the results were not statistically significant, said Dr. Sjaarda of the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
“[It] is biologically plausible that fluoxetine might have some different effects,” she noted. “It does have some different interaction with [cytochrome] P-450 enzyme activity, and this translates to it having a much longer half-life as well. It’s different in terms of drug metabolism and in its interaction with the hormone biosynthesis pathway.”
Most of the research on antidepressants and SSRIs in pregnancy has focused on the safety of the agents, rather than the effect on pregnancy for women trying to conceive, explained Dr. Sjaarda. Previous research also has shown inconsistent findings for fecundability in women of reproductive age taking SSRIs, and the risk of specific SSRI compounds on pregnancy loss is unclear.
The researchers performed a longitudinal exposure assessment of the Effects of Aspirin in Gestation and Reproduction (EAGeR) trial, which consisted of 1,228 women aged between 18 and 40 years trying to conceive. Patients were included if they had one to two prior pregnancy losses, up to two live births, and had been trying to become pregnant for six menstrual cycles; they were excluded if they had a severe history of mental illness. There were 1,035 women who had no preconception antidepressant exposure and 183 who did have preconception antidepressant exposure.
Patients provided longitudinal urine samples at various time points, including while trying to conceive and in early pregnancy, during the menses phase of each menstrual cycle and at their last menstrual cycle, and at 4 and 8 weeks’ gestation if they become pregnant. The urine samples were collected at home or in clinic; human chorionic gonadotropin levels were measured on the stored samples. The researchers defined pregnancy loss as any kind of loss measured after detecting human chorionic gonadotropin, and they used the patient’s medical record to determine live birth. The fecundability odds ratio was used to estimate the odds of conception in menstrual cycles.
Aypical and tricyclic antidepressants and SSRIs such as sertraline, fluoxetine, and citalopram/escitalopram were analyzed, as well as use of opioids, cannabinoids, and benzodiazepines. In total, 172 women used SSRIs, which represented 94% of the patient group analyzed, said Dr. Sjaarda. “This cohort really represents women who are successfully controlled with first-line agents.”
Patients in both the SSRI and no-antidepressant groups had similar baseline characteristics, but there were differences with regard to body mass index (26 kg/m2 vs. 28 kg/m2), employment status (77% vs. 67%), perceived stress (1.0 vs. 0.9), and opioid exposure (16% vs. 23%).
The researchers found use of any SSRI was associated with a 23% reduction in fecundability, with patients using fluoxetine, sertraline, and citalopram/escitalopram having a similar reduction in fecundability, compared with patients not using SSRIs.
Patients who received SSRIs also had approximately a 53% live birth rate overall. When analyzed by individual SSRI, however, there was a statistically significant reduction in the live birth rate for patients who were using fluoxetine, compared with patients using sertraline and citalopram/escitalopram. “This suggests that there was something besides just reduced fecundability going on with the fluoxetine-exposed women,” said Dr. Sjaarda.
When SSRI use was analyzed with regard to pregnancy loss, there was a generally null effect between women exposed to SSRIs overall versus those not exposed at the time before conception, at last menstrual period, and at 4 or 8 weeks’ gestation. But when grouped by specific SSRI, patients receiving fluoxetine had increased risk of pregnancy loss prior to conception, compared with patients not taking fluoxetine (34% vs. 24%; adjusted risk ratio, 1.41; 95% confidence interval, 0.94-2.12) , as well as at their last menstrual period (34% vs. 24%; adjusted RR, 1.48; 95% CI, 0.98-2.24) and at 4 weeks of pregnancy (31% vs. 22%; adjusted RR, 1.61; 95% CI, 0.94-2.78). “This was about a 40%-60% increase in pregnancy loss, even though the sample size is generally small when you divide it into these groups,” said Dr. Sjaarda.
Mental health care is an important public health and maternal health issue, and SSRIs as a drug class are essential for helping to appropriately manage mental health, noted Dr. Sjaarda.
Because “patients’ disease severities all vary and the reactions to different drugs vary, no one-size-fits-all recommendation can be made for people planning a pregnancy while using SSRIs,” concluded Dr. Sjaarda. “However, we’re hoping that women and their physicians can now consider these new data, which are based on objective and longitudinally measured exposure, as well as prospectively-assessed outcomes for these most common antidepressants and develop to a more informed and individualized plan for women who are trying to conceive and use SSRIs.”
Dr. Sjaarda reported no relevant conflicts of interest.
SOURCE: Sjaarda L et al. ASRM 2019, Abstract O-1.
PHILADELPHIA – Lindsey A. Sjaarda, PhD, reported at the annual meeting of the American Society for Reproductive Medicine.
In addition, women in a subgroup receiving fluoxetine experienced a lower live birth rate and greater incidence of pregnancy loss than women taking other SSRIs, but the results were not statistically significant, said Dr. Sjaarda of the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
“[It] is biologically plausible that fluoxetine might have some different effects,” she noted. “It does have some different interaction with [cytochrome] P-450 enzyme activity, and this translates to it having a much longer half-life as well. It’s different in terms of drug metabolism and in its interaction with the hormone biosynthesis pathway.”
Most of the research on antidepressants and SSRIs in pregnancy has focused on the safety of the agents, rather than the effect on pregnancy for women trying to conceive, explained Dr. Sjaarda. Previous research also has shown inconsistent findings for fecundability in women of reproductive age taking SSRIs, and the risk of specific SSRI compounds on pregnancy loss is unclear.
The researchers performed a longitudinal exposure assessment of the Effects of Aspirin in Gestation and Reproduction (EAGeR) trial, which consisted of 1,228 women aged between 18 and 40 years trying to conceive. Patients were included if they had one to two prior pregnancy losses, up to two live births, and had been trying to become pregnant for six menstrual cycles; they were excluded if they had a severe history of mental illness. There were 1,035 women who had no preconception antidepressant exposure and 183 who did have preconception antidepressant exposure.
Patients provided longitudinal urine samples at various time points, including while trying to conceive and in early pregnancy, during the menses phase of each menstrual cycle and at their last menstrual cycle, and at 4 and 8 weeks’ gestation if they become pregnant. The urine samples were collected at home or in clinic; human chorionic gonadotropin levels were measured on the stored samples. The researchers defined pregnancy loss as any kind of loss measured after detecting human chorionic gonadotropin, and they used the patient’s medical record to determine live birth. The fecundability odds ratio was used to estimate the odds of conception in menstrual cycles.
Aypical and tricyclic antidepressants and SSRIs such as sertraline, fluoxetine, and citalopram/escitalopram were analyzed, as well as use of opioids, cannabinoids, and benzodiazepines. In total, 172 women used SSRIs, which represented 94% of the patient group analyzed, said Dr. Sjaarda. “This cohort really represents women who are successfully controlled with first-line agents.”
Patients in both the SSRI and no-antidepressant groups had similar baseline characteristics, but there were differences with regard to body mass index (26 kg/m2 vs. 28 kg/m2), employment status (77% vs. 67%), perceived stress (1.0 vs. 0.9), and opioid exposure (16% vs. 23%).
The researchers found use of any SSRI was associated with a 23% reduction in fecundability, with patients using fluoxetine, sertraline, and citalopram/escitalopram having a similar reduction in fecundability, compared with patients not using SSRIs.
Patients who received SSRIs also had approximately a 53% live birth rate overall. When analyzed by individual SSRI, however, there was a statistically significant reduction in the live birth rate for patients who were using fluoxetine, compared with patients using sertraline and citalopram/escitalopram. “This suggests that there was something besides just reduced fecundability going on with the fluoxetine-exposed women,” said Dr. Sjaarda.
When SSRI use was analyzed with regard to pregnancy loss, there was a generally null effect between women exposed to SSRIs overall versus those not exposed at the time before conception, at last menstrual period, and at 4 or 8 weeks’ gestation. But when grouped by specific SSRI, patients receiving fluoxetine had increased risk of pregnancy loss prior to conception, compared with patients not taking fluoxetine (34% vs. 24%; adjusted risk ratio, 1.41; 95% confidence interval, 0.94-2.12) , as well as at their last menstrual period (34% vs. 24%; adjusted RR, 1.48; 95% CI, 0.98-2.24) and at 4 weeks of pregnancy (31% vs. 22%; adjusted RR, 1.61; 95% CI, 0.94-2.78). “This was about a 40%-60% increase in pregnancy loss, even though the sample size is generally small when you divide it into these groups,” said Dr. Sjaarda.
Mental health care is an important public health and maternal health issue, and SSRIs as a drug class are essential for helping to appropriately manage mental health, noted Dr. Sjaarda.
Because “patients’ disease severities all vary and the reactions to different drugs vary, no one-size-fits-all recommendation can be made for people planning a pregnancy while using SSRIs,” concluded Dr. Sjaarda. “However, we’re hoping that women and their physicians can now consider these new data, which are based on objective and longitudinally measured exposure, as well as prospectively-assessed outcomes for these most common antidepressants and develop to a more informed and individualized plan for women who are trying to conceive and use SSRIs.”
Dr. Sjaarda reported no relevant conflicts of interest.
SOURCE: Sjaarda L et al. ASRM 2019, Abstract O-1.
PHILADELPHIA – Lindsey A. Sjaarda, PhD, reported at the annual meeting of the American Society for Reproductive Medicine.
In addition, women in a subgroup receiving fluoxetine experienced a lower live birth rate and greater incidence of pregnancy loss than women taking other SSRIs, but the results were not statistically significant, said Dr. Sjaarda of the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
“[It] is biologically plausible that fluoxetine might have some different effects,” she noted. “It does have some different interaction with [cytochrome] P-450 enzyme activity, and this translates to it having a much longer half-life as well. It’s different in terms of drug metabolism and in its interaction with the hormone biosynthesis pathway.”
Most of the research on antidepressants and SSRIs in pregnancy has focused on the safety of the agents, rather than the effect on pregnancy for women trying to conceive, explained Dr. Sjaarda. Previous research also has shown inconsistent findings for fecundability in women of reproductive age taking SSRIs, and the risk of specific SSRI compounds on pregnancy loss is unclear.
The researchers performed a longitudinal exposure assessment of the Effects of Aspirin in Gestation and Reproduction (EAGeR) trial, which consisted of 1,228 women aged between 18 and 40 years trying to conceive. Patients were included if they had one to two prior pregnancy losses, up to two live births, and had been trying to become pregnant for six menstrual cycles; they were excluded if they had a severe history of mental illness. There were 1,035 women who had no preconception antidepressant exposure and 183 who did have preconception antidepressant exposure.
Patients provided longitudinal urine samples at various time points, including while trying to conceive and in early pregnancy, during the menses phase of each menstrual cycle and at their last menstrual cycle, and at 4 and 8 weeks’ gestation if they become pregnant. The urine samples were collected at home or in clinic; human chorionic gonadotropin levels were measured on the stored samples. The researchers defined pregnancy loss as any kind of loss measured after detecting human chorionic gonadotropin, and they used the patient’s medical record to determine live birth. The fecundability odds ratio was used to estimate the odds of conception in menstrual cycles.
Aypical and tricyclic antidepressants and SSRIs such as sertraline, fluoxetine, and citalopram/escitalopram were analyzed, as well as use of opioids, cannabinoids, and benzodiazepines. In total, 172 women used SSRIs, which represented 94% of the patient group analyzed, said Dr. Sjaarda. “This cohort really represents women who are successfully controlled with first-line agents.”
Patients in both the SSRI and no-antidepressant groups had similar baseline characteristics, but there were differences with regard to body mass index (26 kg/m2 vs. 28 kg/m2), employment status (77% vs. 67%), perceived stress (1.0 vs. 0.9), and opioid exposure (16% vs. 23%).
The researchers found use of any SSRI was associated with a 23% reduction in fecundability, with patients using fluoxetine, sertraline, and citalopram/escitalopram having a similar reduction in fecundability, compared with patients not using SSRIs.
Patients who received SSRIs also had approximately a 53% live birth rate overall. When analyzed by individual SSRI, however, there was a statistically significant reduction in the live birth rate for patients who were using fluoxetine, compared with patients using sertraline and citalopram/escitalopram. “This suggests that there was something besides just reduced fecundability going on with the fluoxetine-exposed women,” said Dr. Sjaarda.
When SSRI use was analyzed with regard to pregnancy loss, there was a generally null effect between women exposed to SSRIs overall versus those not exposed at the time before conception, at last menstrual period, and at 4 or 8 weeks’ gestation. But when grouped by specific SSRI, patients receiving fluoxetine had increased risk of pregnancy loss prior to conception, compared with patients not taking fluoxetine (34% vs. 24%; adjusted risk ratio, 1.41; 95% confidence interval, 0.94-2.12) , as well as at their last menstrual period (34% vs. 24%; adjusted RR, 1.48; 95% CI, 0.98-2.24) and at 4 weeks of pregnancy (31% vs. 22%; adjusted RR, 1.61; 95% CI, 0.94-2.78). “This was about a 40%-60% increase in pregnancy loss, even though the sample size is generally small when you divide it into these groups,” said Dr. Sjaarda.
Mental health care is an important public health and maternal health issue, and SSRIs as a drug class are essential for helping to appropriately manage mental health, noted Dr. Sjaarda.
Because “patients’ disease severities all vary and the reactions to different drugs vary, no one-size-fits-all recommendation can be made for people planning a pregnancy while using SSRIs,” concluded Dr. Sjaarda. “However, we’re hoping that women and their physicians can now consider these new data, which are based on objective and longitudinally measured exposure, as well as prospectively-assessed outcomes for these most common antidepressants and develop to a more informed and individualized plan for women who are trying to conceive and use SSRIs.”
Dr. Sjaarda reported no relevant conflicts of interest.
SOURCE: Sjaarda L et al. ASRM 2019, Abstract O-1.
REPORTING FROM ASRM 2019
Bringing focus to the issue: Dr. Elizabeth Loder on gender in medicine
The recently published “Eleven Things Not to Say to Your Female Colleagues,” has sparked debate on medical Twitter. Senior author Elizabeth Loder, MD, developed the content collaboratively with members of the Migraine Mavens, a private Facebook group of North American headache practitioners and researchers.
In an interview, Dr. Loder, chief of the headache division in the neurology department at Brigham and Women’s Hospital, Boston, and professor of neurology at Harvard Medical School, Boston, shared the background and context for the article.
Q: Could you explain the impetus for putting this together? How did you arrive at the chart that is the center of the article?
A: In June, I gave the Seymour Solomon lecture at the American Headache Society annual scientific meeting. Because it was an award lecture, I was able to choose the topic. I decided to talk about gender-based problems faced by women in medicine, with a focus on the headache field.
These problems include sexual harassment, hurtful sex-based comments, gender-based barriers to career advancement, as well as the difficulties women face in getting institutions or professional societies to pay attention to these problems.
I wanted to provide real, recent examples of troubling behavior or comments, so I appealed to the Migraine Mavens group to describe their own experiences. I was not expecting the response I got. Not only did people post many examples of such behavior in the group, but I also received many private messages describing things that were so hurtful or private that the woman involved did not even feel comfortable posting them in our group.
I ended up with plenty of real-life vignettes. The title of my talk was “Time’s Up: Headache Medicine in the #MeToo Era.” Shortly after the talk, a member of the group posted this:
“Oh, Dr. Elizabeth Loder, how timely was your talk yesterday, and we have so much further to progress. ...
“Just now, I had this experience: I have been recently selected for a leadership position within AHS and I was talking to one of our male colleagues about it. ... He expressed his doubt in my ability to serve this role well.
“I thought it was because I am early in my career, and as I was reassuring him that I would reach out to him and others for mentorship, he then said ‘AND you have two small children. ... You don’t have time for this.’ ”
There was lively discussion in the group about how this poster could have responded and what bystanders could have said. One of the group members, Clarimar Borrero-Mejias, MD, a pediatric neurologist at Phoenix Children’s Hospital, pointed out that many men and women might benefit from knowing what kinds of things not to say to other colleagues. I suggested that we should take some of the problems we had discussed and write a paper, and that she should be the first author. We then crowdsourced the scenarios to be included.
The grid format came immediately to mind because I know that tables and charts and boxes are good ways to organize and present information. We also wanted to keep the article short and accessible, and thus the idea of “Ten Things” was born. At the end of our work, though, someone posted the vignette about the salary discussion. It was amazing to me how many women, even in this day and age, are still told that men deserve more money because of their family or other responsibilities. We thus decided that it had to be 11, not 10, things.
The article was possible only because of the supportive reaction of the editor of Headache, Thomas Ward, MD. He not only published the piece rapidly, but also agreed to make it free so that anyone who wanted to could access the entire article without hitting a paywall (Headache. 2019 Sep 26. doi: 10.1111/head.13647).
Q: Could you share some of the reactions you’ve gotten? I did see that Esther Choo, MD – an emergency medicine physician and prominent proponent for gender equity in medicine – highlighted the article on Twitter; are there other highlights, or surprising reactions, or pushback, that you’d like to share?
A: We were thrilled to be the subject of a “tweetorial” by Dr. Choo. It’s impossible to overestimate the boost this gave to the paper. She has over 75,000 Twitter followers, and it was quite impressive to watch the exponential increase in the article’s Altmetrics score after her tweetorial. This brought the article to the attention of people outside our own subspecialty. The experiences we described seem to be familiar to women doctors in every specialty and subspecialty, and also relevant outside medicine. I saw tweets from women lawyers, engineers, and others, many of whom said this sort of behavior is a problem in their own fields.
It’s probably not surprising that the vast majority of reactions came from women. A number of men tweeted the article, though, and recommended it to other men. This sort of #HeForShe support is gratifying. We did get some negative reactions, but there are Migraine Mavens on Twitter and we’ve taken them on.
Q: You offer suggestions for reframing many behaviors that reflect implicit bias. You also offer suggestions for bystanders to challenge these biases and support women who are on the receiving end of the behaviors you call out. Do you think exhibiting more of this kind of solidarity can help change the culture of medicine?
A: I believe many people who witness the behaviors are uncomfortable and would like to help but just don’t know what to say. Often, they are caught off guard. Some of our suggested responses are all-purpose lines that can be effective simply by calling attention to the behavior, for example, “What did you just say?” or “Why would you say something like that?” As Dr. Choo said, “Learn them, say them often.”
It’s critical to remember that problems like this are not in the past. This article gave real examples of things that have happened to real women recently. The sheer number of women who retweeted the article with statements such as, “How many of these have been said to you? Straw poll. I got 9,” demonstrates that behavior like this is common.
I recently received an email that forwarded a message written by a medical assistant. I’ve changed the names, but it otherwise read “Dr. Smith wants this patient to have a nerve block. ... You can schedule them with Abigail or Nancy.” Guess what? Abigail and Nancy are doctors. Not only that, they are Dr. Smith’s true peers in every way imaginable, having been hired at exactly the same time and having exactly the same titles and duties. There seems to be only one reason they are not addressed as doctor while their male colleague is, and that is their gender. So the struggle highlighted by #MyFirstNameIsDoctor is real. Women doctors live it every day.
The recently published “Eleven Things Not to Say to Your Female Colleagues,” has sparked debate on medical Twitter. Senior author Elizabeth Loder, MD, developed the content collaboratively with members of the Migraine Mavens, a private Facebook group of North American headache practitioners and researchers.
In an interview, Dr. Loder, chief of the headache division in the neurology department at Brigham and Women’s Hospital, Boston, and professor of neurology at Harvard Medical School, Boston, shared the background and context for the article.
Q: Could you explain the impetus for putting this together? How did you arrive at the chart that is the center of the article?
A: In June, I gave the Seymour Solomon lecture at the American Headache Society annual scientific meeting. Because it was an award lecture, I was able to choose the topic. I decided to talk about gender-based problems faced by women in medicine, with a focus on the headache field.
These problems include sexual harassment, hurtful sex-based comments, gender-based barriers to career advancement, as well as the difficulties women face in getting institutions or professional societies to pay attention to these problems.
I wanted to provide real, recent examples of troubling behavior or comments, so I appealed to the Migraine Mavens group to describe their own experiences. I was not expecting the response I got. Not only did people post many examples of such behavior in the group, but I also received many private messages describing things that were so hurtful or private that the woman involved did not even feel comfortable posting them in our group.
I ended up with plenty of real-life vignettes. The title of my talk was “Time’s Up: Headache Medicine in the #MeToo Era.” Shortly after the talk, a member of the group posted this:
“Oh, Dr. Elizabeth Loder, how timely was your talk yesterday, and we have so much further to progress. ...
“Just now, I had this experience: I have been recently selected for a leadership position within AHS and I was talking to one of our male colleagues about it. ... He expressed his doubt in my ability to serve this role well.
“I thought it was because I am early in my career, and as I was reassuring him that I would reach out to him and others for mentorship, he then said ‘AND you have two small children. ... You don’t have time for this.’ ”
There was lively discussion in the group about how this poster could have responded and what bystanders could have said. One of the group members, Clarimar Borrero-Mejias, MD, a pediatric neurologist at Phoenix Children’s Hospital, pointed out that many men and women might benefit from knowing what kinds of things not to say to other colleagues. I suggested that we should take some of the problems we had discussed and write a paper, and that she should be the first author. We then crowdsourced the scenarios to be included.
The grid format came immediately to mind because I know that tables and charts and boxes are good ways to organize and present information. We also wanted to keep the article short and accessible, and thus the idea of “Ten Things” was born. At the end of our work, though, someone posted the vignette about the salary discussion. It was amazing to me how many women, even in this day and age, are still told that men deserve more money because of their family or other responsibilities. We thus decided that it had to be 11, not 10, things.
The article was possible only because of the supportive reaction of the editor of Headache, Thomas Ward, MD. He not only published the piece rapidly, but also agreed to make it free so that anyone who wanted to could access the entire article without hitting a paywall (Headache. 2019 Sep 26. doi: 10.1111/head.13647).
Q: Could you share some of the reactions you’ve gotten? I did see that Esther Choo, MD – an emergency medicine physician and prominent proponent for gender equity in medicine – highlighted the article on Twitter; are there other highlights, or surprising reactions, or pushback, that you’d like to share?
A: We were thrilled to be the subject of a “tweetorial” by Dr. Choo. It’s impossible to overestimate the boost this gave to the paper. She has over 75,000 Twitter followers, and it was quite impressive to watch the exponential increase in the article’s Altmetrics score after her tweetorial. This brought the article to the attention of people outside our own subspecialty. The experiences we described seem to be familiar to women doctors in every specialty and subspecialty, and also relevant outside medicine. I saw tweets from women lawyers, engineers, and others, many of whom said this sort of behavior is a problem in their own fields.
It’s probably not surprising that the vast majority of reactions came from women. A number of men tweeted the article, though, and recommended it to other men. This sort of #HeForShe support is gratifying. We did get some negative reactions, but there are Migraine Mavens on Twitter and we’ve taken them on.
Q: You offer suggestions for reframing many behaviors that reflect implicit bias. You also offer suggestions for bystanders to challenge these biases and support women who are on the receiving end of the behaviors you call out. Do you think exhibiting more of this kind of solidarity can help change the culture of medicine?
A: I believe many people who witness the behaviors are uncomfortable and would like to help but just don’t know what to say. Often, they are caught off guard. Some of our suggested responses are all-purpose lines that can be effective simply by calling attention to the behavior, for example, “What did you just say?” or “Why would you say something like that?” As Dr. Choo said, “Learn them, say them often.”
It’s critical to remember that problems like this are not in the past. This article gave real examples of things that have happened to real women recently. The sheer number of women who retweeted the article with statements such as, “How many of these have been said to you? Straw poll. I got 9,” demonstrates that behavior like this is common.
I recently received an email that forwarded a message written by a medical assistant. I’ve changed the names, but it otherwise read “Dr. Smith wants this patient to have a nerve block. ... You can schedule them with Abigail or Nancy.” Guess what? Abigail and Nancy are doctors. Not only that, they are Dr. Smith’s true peers in every way imaginable, having been hired at exactly the same time and having exactly the same titles and duties. There seems to be only one reason they are not addressed as doctor while their male colleague is, and that is their gender. So the struggle highlighted by #MyFirstNameIsDoctor is real. Women doctors live it every day.
The recently published “Eleven Things Not to Say to Your Female Colleagues,” has sparked debate on medical Twitter. Senior author Elizabeth Loder, MD, developed the content collaboratively with members of the Migraine Mavens, a private Facebook group of North American headache practitioners and researchers.
In an interview, Dr. Loder, chief of the headache division in the neurology department at Brigham and Women’s Hospital, Boston, and professor of neurology at Harvard Medical School, Boston, shared the background and context for the article.
Q: Could you explain the impetus for putting this together? How did you arrive at the chart that is the center of the article?
A: In June, I gave the Seymour Solomon lecture at the American Headache Society annual scientific meeting. Because it was an award lecture, I was able to choose the topic. I decided to talk about gender-based problems faced by women in medicine, with a focus on the headache field.
These problems include sexual harassment, hurtful sex-based comments, gender-based barriers to career advancement, as well as the difficulties women face in getting institutions or professional societies to pay attention to these problems.
I wanted to provide real, recent examples of troubling behavior or comments, so I appealed to the Migraine Mavens group to describe their own experiences. I was not expecting the response I got. Not only did people post many examples of such behavior in the group, but I also received many private messages describing things that were so hurtful or private that the woman involved did not even feel comfortable posting them in our group.
I ended up with plenty of real-life vignettes. The title of my talk was “Time’s Up: Headache Medicine in the #MeToo Era.” Shortly after the talk, a member of the group posted this:
“Oh, Dr. Elizabeth Loder, how timely was your talk yesterday, and we have so much further to progress. ...
“Just now, I had this experience: I have been recently selected for a leadership position within AHS and I was talking to one of our male colleagues about it. ... He expressed his doubt in my ability to serve this role well.
“I thought it was because I am early in my career, and as I was reassuring him that I would reach out to him and others for mentorship, he then said ‘AND you have two small children. ... You don’t have time for this.’ ”
There was lively discussion in the group about how this poster could have responded and what bystanders could have said. One of the group members, Clarimar Borrero-Mejias, MD, a pediatric neurologist at Phoenix Children’s Hospital, pointed out that many men and women might benefit from knowing what kinds of things not to say to other colleagues. I suggested that we should take some of the problems we had discussed and write a paper, and that she should be the first author. We then crowdsourced the scenarios to be included.
The grid format came immediately to mind because I know that tables and charts and boxes are good ways to organize and present information. We also wanted to keep the article short and accessible, and thus the idea of “Ten Things” was born. At the end of our work, though, someone posted the vignette about the salary discussion. It was amazing to me how many women, even in this day and age, are still told that men deserve more money because of their family or other responsibilities. We thus decided that it had to be 11, not 10, things.
The article was possible only because of the supportive reaction of the editor of Headache, Thomas Ward, MD. He not only published the piece rapidly, but also agreed to make it free so that anyone who wanted to could access the entire article without hitting a paywall (Headache. 2019 Sep 26. doi: 10.1111/head.13647).
Q: Could you share some of the reactions you’ve gotten? I did see that Esther Choo, MD – an emergency medicine physician and prominent proponent for gender equity in medicine – highlighted the article on Twitter; are there other highlights, or surprising reactions, or pushback, that you’d like to share?
A: We were thrilled to be the subject of a “tweetorial” by Dr. Choo. It’s impossible to overestimate the boost this gave to the paper. She has over 75,000 Twitter followers, and it was quite impressive to watch the exponential increase in the article’s Altmetrics score after her tweetorial. This brought the article to the attention of people outside our own subspecialty. The experiences we described seem to be familiar to women doctors in every specialty and subspecialty, and also relevant outside medicine. I saw tweets from women lawyers, engineers, and others, many of whom said this sort of behavior is a problem in their own fields.
It’s probably not surprising that the vast majority of reactions came from women. A number of men tweeted the article, though, and recommended it to other men. This sort of #HeForShe support is gratifying. We did get some negative reactions, but there are Migraine Mavens on Twitter and we’ve taken them on.
Q: You offer suggestions for reframing many behaviors that reflect implicit bias. You also offer suggestions for bystanders to challenge these biases and support women who are on the receiving end of the behaviors you call out. Do you think exhibiting more of this kind of solidarity can help change the culture of medicine?
A: I believe many people who witness the behaviors are uncomfortable and would like to help but just don’t know what to say. Often, they are caught off guard. Some of our suggested responses are all-purpose lines that can be effective simply by calling attention to the behavior, for example, “What did you just say?” or “Why would you say something like that?” As Dr. Choo said, “Learn them, say them often.”
It’s critical to remember that problems like this are not in the past. This article gave real examples of things that have happened to real women recently. The sheer number of women who retweeted the article with statements such as, “How many of these have been said to you? Straw poll. I got 9,” demonstrates that behavior like this is common.
I recently received an email that forwarded a message written by a medical assistant. I’ve changed the names, but it otherwise read “Dr. Smith wants this patient to have a nerve block. ... You can schedule them with Abigail or Nancy.” Guess what? Abigail and Nancy are doctors. Not only that, they are Dr. Smith’s true peers in every way imaginable, having been hired at exactly the same time and having exactly the same titles and duties. There seems to be only one reason they are not addressed as doctor while their male colleague is, and that is their gender. So the struggle highlighted by #MyFirstNameIsDoctor is real. Women doctors live it every day.
Court of Appeals to decide fate of Medicaid work requirements
The debate over whether states can impose work requirements on Medicaid recipients is now in the hands of a federal appeals court.
The U.S. Court of Appeals for the District of Columbia heard oral arguments Oct. 11, 2019, in two cases that challenge state waivers that require work as part of Medicaid eligibility.
In Stewart v. Azar, 16 patients from Kentucky are suing the Department of Health & Human Services over its approval of changes to Kentucky’s Medicaid program that include work requirements, premiums, and lockouts. In Gresham v. Azar, several Arkansas residents are challenging HHS over the approval of modifications to Arkansas’ Medicaid program that require work requirements and eliminate retroactive coverage.
The restrictive conditions in the Medicaid waivers would cause thousands of Medicaid enrollees to lose coverage, according to Jane Perkins, legal director for the National Health Law Program, an advocacy firm representing the plaintiffs.
“Section 1115 of the Social Security Act only allows the [HHS] Secretary to approve experimental projects that further Medicaid’s purpose of furnishing medical assistance to low-income people,” Ms. Perkins said in a statement. “These waiver projects do not further this objective. By the government’s own framing, they are intended to transform Medicaid and explode Medicaid expansion. Only Congress can rewrite a statute – not this administration. We hope the appellate court will uphold the well-reasoned opinions of the district court.”
HHS argues that it has the authority to allow any experimental, pilot, or demonstration project likely to promote the objectives of Medicaid, which in addition to medical assistance include rehabilitation services that help patients attain or retain independence or self-care. The waivers from Kentucky and Arkansas are consistent with these objectives, attorneys for HHS argued in court documents.
Kentucky’s waiver project promotes beneficiary health and financial independence, while Arkansas’ demonstration is likely to assist in improving health outcomes through strategies that promote community engagement and address health determinants, according to letters from the Centers for Medicare & Medicaid Service approving the projects.
Arkansas’ demonstration project, approved in March 2018, includes a requirement that adults aged 19-49 years complete 80 hours per month of community engagement activities, such as employment, education, job-skills training, or community service, as a condition of continued Medicaid eligibility. Kentucky’s proposal, approved in November 2018, requires Medicaid patients to spend at least 80 hours per month on qualified activities, including employment, job skills training, education, community services and/or participation in substance use disorder treatment.
Medicaid patients in both states sued HHS shortly after the waivers were approved, arguing that the work requirements were arbitrary and capricious and that the agency exceeded its statutory authority in approving the projects. The U.S. District Court for the District of Columbia ruled in favor of the patients in March 2019, finding that HHS failed to fully consider the impact of the Kentucky and Arkansas changes on current and future Medicaid beneficiaries. In a decision for Kentucky and a separate ruling for Arkansas, the court vacated HHS’ approval of the projects and remanded both waivers back to HHS for reconsideration. In the interim, officials in both Kentucky and Arkansas halted implementation of the work requirements. The Department of Justice appealed in both cases.
According to court documents, 18,000 Arkansans lost coverage for failure to comply with the work requirements before the regulations were halted. In Kentucky, the state estimates that 95,000 Kentuckians could lose coverage if the project goes into effect.
A decision by the appeals court is expected by December 2019.
The debate over whether states can impose work requirements on Medicaid recipients is now in the hands of a federal appeals court.
The U.S. Court of Appeals for the District of Columbia heard oral arguments Oct. 11, 2019, in two cases that challenge state waivers that require work as part of Medicaid eligibility.
In Stewart v. Azar, 16 patients from Kentucky are suing the Department of Health & Human Services over its approval of changes to Kentucky’s Medicaid program that include work requirements, premiums, and lockouts. In Gresham v. Azar, several Arkansas residents are challenging HHS over the approval of modifications to Arkansas’ Medicaid program that require work requirements and eliminate retroactive coverage.
The restrictive conditions in the Medicaid waivers would cause thousands of Medicaid enrollees to lose coverage, according to Jane Perkins, legal director for the National Health Law Program, an advocacy firm representing the plaintiffs.
“Section 1115 of the Social Security Act only allows the [HHS] Secretary to approve experimental projects that further Medicaid’s purpose of furnishing medical assistance to low-income people,” Ms. Perkins said in a statement. “These waiver projects do not further this objective. By the government’s own framing, they are intended to transform Medicaid and explode Medicaid expansion. Only Congress can rewrite a statute – not this administration. We hope the appellate court will uphold the well-reasoned opinions of the district court.”
HHS argues that it has the authority to allow any experimental, pilot, or demonstration project likely to promote the objectives of Medicaid, which in addition to medical assistance include rehabilitation services that help patients attain or retain independence or self-care. The waivers from Kentucky and Arkansas are consistent with these objectives, attorneys for HHS argued in court documents.
Kentucky’s waiver project promotes beneficiary health and financial independence, while Arkansas’ demonstration is likely to assist in improving health outcomes through strategies that promote community engagement and address health determinants, according to letters from the Centers for Medicare & Medicaid Service approving the projects.
Arkansas’ demonstration project, approved in March 2018, includes a requirement that adults aged 19-49 years complete 80 hours per month of community engagement activities, such as employment, education, job-skills training, or community service, as a condition of continued Medicaid eligibility. Kentucky’s proposal, approved in November 2018, requires Medicaid patients to spend at least 80 hours per month on qualified activities, including employment, job skills training, education, community services and/or participation in substance use disorder treatment.
Medicaid patients in both states sued HHS shortly after the waivers were approved, arguing that the work requirements were arbitrary and capricious and that the agency exceeded its statutory authority in approving the projects. The U.S. District Court for the District of Columbia ruled in favor of the patients in March 2019, finding that HHS failed to fully consider the impact of the Kentucky and Arkansas changes on current and future Medicaid beneficiaries. In a decision for Kentucky and a separate ruling for Arkansas, the court vacated HHS’ approval of the projects and remanded both waivers back to HHS for reconsideration. In the interim, officials in both Kentucky and Arkansas halted implementation of the work requirements. The Department of Justice appealed in both cases.
According to court documents, 18,000 Arkansans lost coverage for failure to comply with the work requirements before the regulations were halted. In Kentucky, the state estimates that 95,000 Kentuckians could lose coverage if the project goes into effect.
A decision by the appeals court is expected by December 2019.
The debate over whether states can impose work requirements on Medicaid recipients is now in the hands of a federal appeals court.
The U.S. Court of Appeals for the District of Columbia heard oral arguments Oct. 11, 2019, in two cases that challenge state waivers that require work as part of Medicaid eligibility.
In Stewart v. Azar, 16 patients from Kentucky are suing the Department of Health & Human Services over its approval of changes to Kentucky’s Medicaid program that include work requirements, premiums, and lockouts. In Gresham v. Azar, several Arkansas residents are challenging HHS over the approval of modifications to Arkansas’ Medicaid program that require work requirements and eliminate retroactive coverage.
The restrictive conditions in the Medicaid waivers would cause thousands of Medicaid enrollees to lose coverage, according to Jane Perkins, legal director for the National Health Law Program, an advocacy firm representing the plaintiffs.
“Section 1115 of the Social Security Act only allows the [HHS] Secretary to approve experimental projects that further Medicaid’s purpose of furnishing medical assistance to low-income people,” Ms. Perkins said in a statement. “These waiver projects do not further this objective. By the government’s own framing, they are intended to transform Medicaid and explode Medicaid expansion. Only Congress can rewrite a statute – not this administration. We hope the appellate court will uphold the well-reasoned opinions of the district court.”
HHS argues that it has the authority to allow any experimental, pilot, or demonstration project likely to promote the objectives of Medicaid, which in addition to medical assistance include rehabilitation services that help patients attain or retain independence or self-care. The waivers from Kentucky and Arkansas are consistent with these objectives, attorneys for HHS argued in court documents.
Kentucky’s waiver project promotes beneficiary health and financial independence, while Arkansas’ demonstration is likely to assist in improving health outcomes through strategies that promote community engagement and address health determinants, according to letters from the Centers for Medicare & Medicaid Service approving the projects.
Arkansas’ demonstration project, approved in March 2018, includes a requirement that adults aged 19-49 years complete 80 hours per month of community engagement activities, such as employment, education, job-skills training, or community service, as a condition of continued Medicaid eligibility. Kentucky’s proposal, approved in November 2018, requires Medicaid patients to spend at least 80 hours per month on qualified activities, including employment, job skills training, education, community services and/or participation in substance use disorder treatment.
Medicaid patients in both states sued HHS shortly after the waivers were approved, arguing that the work requirements were arbitrary and capricious and that the agency exceeded its statutory authority in approving the projects. The U.S. District Court for the District of Columbia ruled in favor of the patients in March 2019, finding that HHS failed to fully consider the impact of the Kentucky and Arkansas changes on current and future Medicaid beneficiaries. In a decision for Kentucky and a separate ruling for Arkansas, the court vacated HHS’ approval of the projects and remanded both waivers back to HHS for reconsideration. In the interim, officials in both Kentucky and Arkansas halted implementation of the work requirements. The Department of Justice appealed in both cases.
According to court documents, 18,000 Arkansans lost coverage for failure to comply with the work requirements before the regulations were halted. In Kentucky, the state estimates that 95,000 Kentuckians could lose coverage if the project goes into effect.
A decision by the appeals court is expected by December 2019.