PHOENIX, ARIZ. – Cardiovascular deaths and death rates related to atrial fibrillation have risen since 1999, with significant acceleration following 2009, results from a cross-sectional analysis of national data show.

Doug Brunk/MDedge News

“AFib is the most common arrhythmia disorder in the United States and it is estimated that it will effect more than 12 million Americans by 2030,” Yoshihiro Tanaka, MD, PhD, said at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting. “The predicted lifetime risk ranges from 25% to 35%, and AFib is associated with an increased risk for heart failure, stroke, and death.”

A recent review reported that declines in total heart disease mortality rates in the United States have plateaued since 2011 (JAMA 2019;322[8]:780-2). However, it is not well understood what factors such as AFib contribute to this rate of plateau. In an effort to quantify U.S. trends in AFib-related CVD death rates, Dr. Tanaka and colleagues conducted a serial cross-sectional analysis of death certificate data from the Centers for Disease Control and Prevention’s Wide-Ranging Online Data for Epidemiologic Research (WONDER) database during 1999-2017.

Outcomes included age-adjusted mortality per 100,000 based on the 2000 U.S. standard population. The researchers also used joinpoint regression to calculate the average annual percentage change over time and conducted subgroup analyses by race and sex and across two age groups: 35-64 years and 65-84 years.

In all, 522,104 AFib-related CVD deaths were identified during 1999-2017. Dr. Tanaka reported that age-adjusted mortality increased from 16.0 per 100,000 persons in 1999 to 22.2 per 100,000 person in 2017, with an acceleration following an inflection point in 2009. Specifically, the average annual percentage change in AFib-related CVD deaths rose from 0.4% in 2009 to 3.5% in 2017 (P < .001). “These increases were consistent across all race-sex subgroups,” said Dr. Tanaka, of the department of preventive medicine at Northwestern University, Chicago. “Relative increases were also greater in younger compared with older adults, although the absolute number of deaths in younger adults was less.”

The researchers observed that age-adjusted mortality increased across blacks and whites in both age groups, with a more pronounced increase among black and white men. Black men had the highest age-adjusted mortality among persons aged 35-64 (6.5 per 100,000 persons, compared with 4.2 among white men, 2.8 in black women, and 1.6 in white women 1.6 per 100,000). At the same time, white men had the highest age-adjusted mortality rate among those aged 65-84 years (112.5 per 100,000 persons, compared with 87.7 in black men, 77.4 in white women, and 61.3 in black women).

In an interview, one of the session’s moderators, Alvaro Alonso, MD, PhD, said that the study’s reliance on mortality data is a limitation. “You have to be careful with that, because it’s not the whole picture,” said Dr. Alonso, professor of epidemiology at the Rollins School of Public Health at Emory University, Atlanta. “It could be an underestimation of what is going on. The increase in recent years is probably due to a higher awareness of AFib as a risk factor for stroke; it’s more on the radar. Also, around 2009-2010, we started having new anticoagulants for AFib. It’s getting diagnosed more. When you look at coronary heart disease and stroke, there has been a decrease over time. In mortality and incidence of AFib, we don’t have that. That’s probably because we don’t know very much about what the risk factors for AFib are and how to prevent it.”

Dr. Tanaka said that the cause of increase in AFib-related CVD mortality can be classified into two major categories: a balance between case fatality of AFib and the prevalence of AFib. “The case fatality rate should have decreased over the last years,” he said at the meeting, which was sponsored by the American Heart Association. “In contrast, in the context of the aging of the population, the prevalence of AFib increased over the past years. Contributing factors include increasing awareness of AFib, a change in coding between ICD-9 and ICD-10, and a change in coding practices by physicians.”

Strengths of the study, he said, include its large sample size and the fact that the researchers were able to capture data from all death certificates filed in the United States. Limitations include the fact that the data “do not identify if changes in age-adjusted mortality rates are due to changing incidence or to case fatality rates,” he said. “CDC WONDER does not allow us to explore causes of these descriptive findings, but this would be an important next step.”

Dr. Tanaka reported having no financial disclosures.

dbrunk@mdedge.com

SOURCE: Tanaka Y. EPI/Lifestyle 2020, Session 5, Abstract 15.

PHOENIX, ARIZ. – Cardiovascular deaths and death rates related to atrial fibrillation have risen since 1999, with significant acceleration following 2009, results from a cross-sectional analysis of national data show.

Doug Brunk/MDedge News

“AFib is the most common arrhythmia disorder in the United States and it is estimated that it will effect more than 12 million Americans by 2030,” Yoshihiro Tanaka, MD, PhD, said at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting. “The predicted lifetime risk ranges from 25% to 35%, and AFib is associated with an increased risk for heart failure, stroke, and death.”

A recent review reported that declines in total heart disease mortality rates in the United States have plateaued since 2011 (JAMA 2019;322[8]:780-2). However, it is not well understood what factors such as AFib contribute to this rate of plateau. In an effort to quantify U.S. trends in AFib-related CVD death rates, Dr. Tanaka and colleagues conducted a serial cross-sectional analysis of death certificate data from the Centers for Disease Control and Prevention’s Wide-Ranging Online Data for Epidemiologic Research (WONDER) database during 1999-2017.

Outcomes included age-adjusted mortality per 100,000 based on the 2000 U.S. standard population. The researchers also used joinpoint regression to calculate the average annual percentage change over time and conducted subgroup analyses by race and sex and across two age groups: 35-64 years and 65-84 years.

In all, 522,104 AFib-related CVD deaths were identified during 1999-2017. Dr. Tanaka reported that age-adjusted mortality increased from 16.0 per 100,000 persons in 1999 to 22.2 per 100,000 person in 2017, with an acceleration following an inflection point in 2009. Specifically, the average annual percentage change in AFib-related CVD deaths rose from 0.4% in 2009 to 3.5% in 2017 (P < .001). “These increases were consistent across all race-sex subgroups,” said Dr. Tanaka, of the department of preventive medicine at Northwestern University, Chicago. “Relative increases were also greater in younger compared with older adults, although the absolute number of deaths in younger adults was less.”

The researchers observed that age-adjusted mortality increased across blacks and whites in both age groups, with a more pronounced increase among black and white men. Black men had the highest age-adjusted mortality among persons aged 35-64 (6.5 per 100,000 persons, compared with 4.2 among white men, 2.8 in black women, and 1.6 in white women 1.6 per 100,000). At the same time, white men had the highest age-adjusted mortality rate among those aged 65-84 years (112.5 per 100,000 persons, compared with 87.7 in black men, 77.4 in white women, and 61.3 in black women).

In an interview, one of the session’s moderators, Alvaro Alonso, MD, PhD, said that the study’s reliance on mortality data is a limitation. “You have to be careful with that, because it’s not the whole picture,” said Dr. Alonso, professor of epidemiology at the Rollins School of Public Health at Emory University, Atlanta. “It could be an underestimation of what is going on. The increase in recent years is probably due to a higher awareness of AFib as a risk factor for stroke; it’s more on the radar. Also, around 2009-2010, we started having new anticoagulants for AFib. It’s getting diagnosed more. When you look at coronary heart disease and stroke, there has been a decrease over time. In mortality and incidence of AFib, we don’t have that. That’s probably because we don’t know very much about what the risk factors for AFib are and how to prevent it.”

Dr. Tanaka said that the cause of increase in AFib-related CVD mortality can be classified into two major categories: a balance between case fatality of AFib and the prevalence of AFib. “The case fatality rate should have decreased over the last years,” he said at the meeting, which was sponsored by the American Heart Association. “In contrast, in the context of the aging of the population, the prevalence of AFib increased over the past years. Contributing factors include increasing awareness of AFib, a change in coding between ICD-9 and ICD-10, and a change in coding practices by physicians.”

Strengths of the study, he said, include its large sample size and the fact that the researchers were able to capture data from all death certificates filed in the United States. Limitations include the fact that the data “do not identify if changes in age-adjusted mortality rates are due to changing incidence or to case fatality rates,” he said. “CDC WONDER does not allow us to explore causes of these descriptive findings, but this would be an important next step.”

Dr. Tanaka reported having no financial disclosures.

dbrunk@mdedge.com

SOURCE: Tanaka Y. EPI/Lifestyle 2020, Session 5, Abstract 15.

PHOENIX, ARIZ. – Cardiovascular deaths and death rates related to atrial fibrillation have risen since 1999, with significant acceleration following 2009, results from a cross-sectional analysis of national data show.

Doug Brunk/MDedge News

“AFib is the most common arrhythmia disorder in the United States and it is estimated that it will effect more than 12 million Americans by 2030,” Yoshihiro Tanaka, MD, PhD, said at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting. “The predicted lifetime risk ranges from 25% to 35%, and AFib is associated with an increased risk for heart failure, stroke, and death.”

A recent review reported that declines in total heart disease mortality rates in the United States have plateaued since 2011 (JAMA 2019;322[8]:780-2). However, it is not well understood what factors such as AFib contribute to this rate of plateau. In an effort to quantify U.S. trends in AFib-related CVD death rates, Dr. Tanaka and colleagues conducted a serial cross-sectional analysis of death certificate data from the Centers for Disease Control and Prevention’s Wide-Ranging Online Data for Epidemiologic Research (WONDER) database during 1999-2017.

Outcomes included age-adjusted mortality per 100,000 based on the 2000 U.S. standard population. The researchers also used joinpoint regression to calculate the average annual percentage change over time and conducted subgroup analyses by race and sex and across two age groups: 35-64 years and 65-84 years.

In all, 522,104 AFib-related CVD deaths were identified during 1999-2017. Dr. Tanaka reported that age-adjusted mortality increased from 16.0 per 100,000 persons in 1999 to 22.2 per 100,000 person in 2017, with an acceleration following an inflection point in 2009. Specifically, the average annual percentage change in AFib-related CVD deaths rose from 0.4% in 2009 to 3.5% in 2017 (P < .001). “These increases were consistent across all race-sex subgroups,” said Dr. Tanaka, of the department of preventive medicine at Northwestern University, Chicago. “Relative increases were also greater in younger compared with older adults, although the absolute number of deaths in younger adults was less.”

The researchers observed that age-adjusted mortality increased across blacks and whites in both age groups, with a more pronounced increase among black and white men. Black men had the highest age-adjusted mortality among persons aged 35-64 (6.5 per 100,000 persons, compared with 4.2 among white men, 2.8 in black women, and 1.6 in white women 1.6 per 100,000). At the same time, white men had the highest age-adjusted mortality rate among those aged 65-84 years (112.5 per 100,000 persons, compared with 87.7 in black men, 77.4 in white women, and 61.3 in black women).

In an interview, one of the session’s moderators, Alvaro Alonso, MD, PhD, said that the study’s reliance on mortality data is a limitation. “You have to be careful with that, because it’s not the whole picture,” said Dr. Alonso, professor of epidemiology at the Rollins School of Public Health at Emory University, Atlanta. “It could be an underestimation of what is going on. The increase in recent years is probably due to a higher awareness of AFib as a risk factor for stroke; it’s more on the radar. Also, around 2009-2010, we started having new anticoagulants for AFib. It’s getting diagnosed more. When you look at coronary heart disease and stroke, there has been a decrease over time. In mortality and incidence of AFib, we don’t have that. That’s probably because we don’t know very much about what the risk factors for AFib are and how to prevent it.”

Dr. Tanaka said that the cause of increase in AFib-related CVD mortality can be classified into two major categories: a balance between case fatality of AFib and the prevalence of AFib. “The case fatality rate should have decreased over the last years,” he said at the meeting, which was sponsored by the American Heart Association. “In contrast, in the context of the aging of the population, the prevalence of AFib increased over the past years. Contributing factors include increasing awareness of AFib, a change in coding between ICD-9 and ICD-10, and a change in coding practices by physicians.”

Strengths of the study, he said, include its large sample size and the fact that the researchers were able to capture data from all death certificates filed in the United States. Limitations include the fact that the data “do not identify if changes in age-adjusted mortality rates are due to changing incidence or to case fatality rates,” he said. “CDC WONDER does not allow us to explore causes of these descriptive findings, but this would be an important next step.”

Dr. Tanaka reported having no financial disclosures.

dbrunk@mdedge.com

SOURCE: Tanaka Y. EPI/Lifestyle 2020, Session 5, Abstract 15.

Key clinical point: Galcanezumab is safe and effective in the prophylactic treatment of adult migraine.

Major finding: Compared with placebo, galcanezumab at doses of 120, 150, 240, and 300 mg significantly reduced monthly migraine days (mean difference [MD], −1.79, −1.20, −1.85, and –0.62, respectively). Reduction in migraine-specific medication days was statistically significant for galcanezumab doses of 120 and 240 mg vs. placebo. Total adverse events did not differ significantly between galcanezumab and placebo.

Study details: Meta-analysis of 5 studies evaluated the safety and efficacy of galcanezumab in the prophylactic treatment of adult migraine. 

Disclosures: No study sponsor was identified. The authors declared no conflicts of interest.

Citation: Zhao X et al. J Neurol. 2020 Jan 31. doi: 10.1007/s00415-020-09707-5. 

Key clinical point: Galcanezumab is safe and effective in the prophylactic treatment of adult migraine.

Major finding: Compared with placebo, galcanezumab at doses of 120, 150, 240, and 300 mg significantly reduced monthly migraine days (mean difference [MD], −1.79, −1.20, −1.85, and –0.62, respectively). Reduction in migraine-specific medication days was statistically significant for galcanezumab doses of 120 and 240 mg vs. placebo. Total adverse events did not differ significantly between galcanezumab and placebo.

Study details: Meta-analysis of 5 studies evaluated the safety and efficacy of galcanezumab in the prophylactic treatment of adult migraine. 

Disclosures: No study sponsor was identified. The authors declared no conflicts of interest.

Citation: Zhao X et al. J Neurol. 2020 Jan 31. doi: 10.1007/s00415-020-09707-5. 

Key clinical point: Galcanezumab is safe and effective in the prophylactic treatment of adult migraine.

Major finding: Compared with placebo, galcanezumab at doses of 120, 150, 240, and 300 mg significantly reduced monthly migraine days (mean difference [MD], −1.79, −1.20, −1.85, and –0.62, respectively). Reduction in migraine-specific medication days was statistically significant for galcanezumab doses of 120 and 240 mg vs. placebo. Total adverse events did not differ significantly between galcanezumab and placebo.

Study details: Meta-analysis of 5 studies evaluated the safety and efficacy of galcanezumab in the prophylactic treatment of adult migraine. 

Disclosures: No study sponsor was identified. The authors declared no conflicts of interest.

Citation: Zhao X et al. J Neurol. 2020 Jan 31. doi: 10.1007/s00415-020-09707-5. 

Amid the growing SARS-CoV-2 pandemic, currently in its expansive growth phase in the United States, the American Gastroenterological Association (AGA), the American Association for the Study of Liver Diseases (AASLD), the American College of Gastroenterology (ACG), and the American Society for Gastrointestinal Endoscopy (ASGE) have jointly released “COVID-19 Clinical Insights for Our Community of Gastroenterologists and Gastroenterology Care Providers,” which can be found on the websites of the various societies.

“The purpose of this communication is to jointly provide you with up to date COVID-19 information in order to maintain the highest level of health and safety for our patients, staff, community, and ourselves,” according to the AGA website announcement.

In particular, the societies point out that there is recent evidence suggesting the potential for coronavirus transmission through droplets and perhaps fecal shedding, which pose potential risks in particular during endoscopy and colonoscopy procedures to other patients, endoscopy personnel, and practitioners.

Relevant clinical factors related to COVID-19 are discussed, including the fact that asymptomatic spread can occur during the prodromal phase (the mean incubation period is approximately 5 days, with a range of 0-14 days), with viral shedding greatest when symptoms begin.

Between 20% and 30% of patients with COVID-19 infection show abnormal liver enzymes. In addition, COVID-19 patients show drops in their leukocyte counts, and elevated white blood cell counts is a poor prognostic sign, according to the release.

The Centers for Disease Control and Prevention lists vulnerable populations at the greatest risk for more serious outcomes; these include the elderly and those with severe chronic health conditions, such as heart disease, lung disease, diabetes, decompensated cirrhosis, HIV with low CD4 counts, and immunosuppression (including liver and other solid organ transplant recipients), are at higher risk of developing more serious illness. In addition pregnancy may provide added risk.
 

Specific advice for the gastroenterology profession

The joint statement urges that practitioners strongly consider rescheduling elective nonurgent endoscopic procedures, although some nonurgent procedures are higher priority and may need to be performed, including cancer evaluations, prosthetic removals, and evaluation of significant symptoms. “Of note, the Surgeon General on 3/14/20 advised hospitals to postpone all elective surgeries,” the document states.

Patient concerns

In all cases, patients should be prescreened for high-risk exposure or symptoms. This includes asking about history of fever or respiratory symptoms, family members or close contacts with similar symptoms, any contact with a confirmed case of COVID-19, and recent travel to a high-risk area. “Avoid bringing patients (or their escorts) into the medical facility who are over age 65 or have one of the CDC recognized risks listed above,” the societies advise.

Check body temperature of the patient upon arrival at endoscopy unit or clinic, and keep all patients at an appropriate distance from each other (6 feet is recommended) throughout the entire time in the endoscopy unit.

“For COVID-19 positive patients, or those awaiting test results, isolation precautions should be taken with procedures performed in negative pressure rooms,” according to the statement.

In addition, use telemedicine where possible in elective cases, and consider phone follow-up after any procedures at 7 and 14 days to ask about new diagnosis of COVID-19 or development of its symptoms, .

Those patients who are on immunosuppressive drugs for inflammatory bowel disease and autoimmune hepatitis should continue taking their medications because the risk of disease flare outweighs the chance of contracting coronavirus, according to the document. In addition, these patients should be advised to follow CDC guidelines for at-risk groups by avoiding crowds and limiting travel.
 

Protection of practitioners

Key factors in ensuring practitioner safety and maintaining practice functionality are discussed by the joint document. In particular, appropriate personal protective equipment (PPE) should be worn by all members of the endoscopy team: gloves, mask, eye shield/goggles, face shields, and gown, but practitioners should also be aware of how to put on and take off PPE appropriately.

“Conservation of PPE is critical. Only essential personnel should be present in cases. Consider extended use or reuse of surgical masks and eye protection in accordance with hospital policies,” the document recommends.

“It is important to address our collective staff needs and institute policies that protect our workforce.” To that end, the document recommends that centers should strategically assign available personnel in order to minimize concomitant exposure of those with similar or unique skill sets. This includes the use of nonphysician practitioners and fellows that cannot participate in cases for screening and triaging patients, or performing virtual visits.

Coming at a time of pandemic, when gastrointestinal symptoms have been recognized as a more common symptom of COVID-19 than previously expected and liver damage has been noted as a potential repercussion of SARS-CoV-2 infection, these clinical insights provide a template for gastroenterologists and related professionals for dealing with their patients and keeping themselves safe under dramatically changed circumstances.

The partnered organizations, AASLD, ACG, AGA, and ASGE, are committed to providing updated COVID-19 information as appropriate. However: “Given the evolving and fluid nature of the situation, institutions, hospitals and clinics have also been formulating their own local guidelines, so we urge you to follow the evolving CDC recommendations and your local requirements,” according to the AGA website announcement.

In addition to the joint communication, the society websites each offer additional COVID-19 information. The AGA practice updates on the COVID-19 webpage provides information about announcements, such as the cancellation of Digestive Disease Week^® in May, a location for AGA members to discuss their COVID-19 experiences and share advice, and links to the CDC COVID-19 updates.
 

mlesney@mdedge.com

SOURCE: American Gastroenterological Association et al. March 2020, COVID-19 Clinical Insights for Our Community of Gastroenterologists and Gastroenterology Care Providers.

Amid the growing SARS-CoV-2 pandemic, currently in its expansive growth phase in the United States, the American Gastroenterological Association (AGA), the American Association for the Study of Liver Diseases (AASLD), the American College of Gastroenterology (ACG), and the American Society for Gastrointestinal Endoscopy (ASGE) have jointly released “COVID-19 Clinical Insights for Our Community of Gastroenterologists and Gastroenterology Care Providers,” which can be found on the websites of the various societies.

“The purpose of this communication is to jointly provide you with up to date COVID-19 information in order to maintain the highest level of health and safety for our patients, staff, community, and ourselves,” according to the AGA website announcement.

In particular, the societies point out that there is recent evidence suggesting the potential for coronavirus transmission through droplets and perhaps fecal shedding, which pose potential risks in particular during endoscopy and colonoscopy procedures to other patients, endoscopy personnel, and practitioners.

Relevant clinical factors related to COVID-19 are discussed, including the fact that asymptomatic spread can occur during the prodromal phase (the mean incubation period is approximately 5 days, with a range of 0-14 days), with viral shedding greatest when symptoms begin.

Between 20% and 30% of patients with COVID-19 infection show abnormal liver enzymes. In addition, COVID-19 patients show drops in their leukocyte counts, and elevated white blood cell counts is a poor prognostic sign, according to the release.

The Centers for Disease Control and Prevention lists vulnerable populations at the greatest risk for more serious outcomes; these include the elderly and those with severe chronic health conditions, such as heart disease, lung disease, diabetes, decompensated cirrhosis, HIV with low CD4 counts, and immunosuppression (including liver and other solid organ transplant recipients), are at higher risk of developing more serious illness. In addition pregnancy may provide added risk.
 

Specific advice for the gastroenterology profession

The joint statement urges that practitioners strongly consider rescheduling elective nonurgent endoscopic procedures, although some nonurgent procedures are higher priority and may need to be performed, including cancer evaluations, prosthetic removals, and evaluation of significant symptoms. “Of note, the Surgeon General on 3/14/20 advised hospitals to postpone all elective surgeries,” the document states.

Patient concerns

In all cases, patients should be prescreened for high-risk exposure or symptoms. This includes asking about history of fever or respiratory symptoms, family members or close contacts with similar symptoms, any contact with a confirmed case of COVID-19, and recent travel to a high-risk area. “Avoid bringing patients (or their escorts) into the medical facility who are over age 65 or have one of the CDC recognized risks listed above,” the societies advise.

Check body temperature of the patient upon arrival at endoscopy unit or clinic, and keep all patients at an appropriate distance from each other (6 feet is recommended) throughout the entire time in the endoscopy unit.

“For COVID-19 positive patients, or those awaiting test results, isolation precautions should be taken with procedures performed in negative pressure rooms,” according to the statement.

In addition, use telemedicine where possible in elective cases, and consider phone follow-up after any procedures at 7 and 14 days to ask about new diagnosis of COVID-19 or development of its symptoms, .

Those patients who are on immunosuppressive drugs for inflammatory bowel disease and autoimmune hepatitis should continue taking their medications because the risk of disease flare outweighs the chance of contracting coronavirus, according to the document. In addition, these patients should be advised to follow CDC guidelines for at-risk groups by avoiding crowds and limiting travel.
 

Protection of practitioners

Key factors in ensuring practitioner safety and maintaining practice functionality are discussed by the joint document. In particular, appropriate personal protective equipment (PPE) should be worn by all members of the endoscopy team: gloves, mask, eye shield/goggles, face shields, and gown, but practitioners should also be aware of how to put on and take off PPE appropriately.

“Conservation of PPE is critical. Only essential personnel should be present in cases. Consider extended use or reuse of surgical masks and eye protection in accordance with hospital policies,” the document recommends.

“It is important to address our collective staff needs and institute policies that protect our workforce.” To that end, the document recommends that centers should strategically assign available personnel in order to minimize concomitant exposure of those with similar or unique skill sets. This includes the use of nonphysician practitioners and fellows that cannot participate in cases for screening and triaging patients, or performing virtual visits.

Coming at a time of pandemic, when gastrointestinal symptoms have been recognized as a more common symptom of COVID-19 than previously expected and liver damage has been noted as a potential repercussion of SARS-CoV-2 infection, these clinical insights provide a template for gastroenterologists and related professionals for dealing with their patients and keeping themselves safe under dramatically changed circumstances.

The partnered organizations, AASLD, ACG, AGA, and ASGE, are committed to providing updated COVID-19 information as appropriate. However: “Given the evolving and fluid nature of the situation, institutions, hospitals and clinics have also been formulating their own local guidelines, so we urge you to follow the evolving CDC recommendations and your local requirements,” according to the AGA website announcement.

In addition to the joint communication, the society websites each offer additional COVID-19 information. The AGA practice updates on the COVID-19 webpage provides information about announcements, such as the cancellation of Digestive Disease Week^® in May, a location for AGA members to discuss their COVID-19 experiences and share advice, and links to the CDC COVID-19 updates.
 

mlesney@mdedge.com

SOURCE: American Gastroenterological Association et al. March 2020, COVID-19 Clinical Insights for Our Community of Gastroenterologists and Gastroenterology Care Providers.

Amid the growing SARS-CoV-2 pandemic, currently in its expansive growth phase in the United States, the American Gastroenterological Association (AGA), the American Association for the Study of Liver Diseases (AASLD), the American College of Gastroenterology (ACG), and the American Society for Gastrointestinal Endoscopy (ASGE) have jointly released “COVID-19 Clinical Insights for Our Community of Gastroenterologists and Gastroenterology Care Providers,” which can be found on the websites of the various societies.

“The purpose of this communication is to jointly provide you with up to date COVID-19 information in order to maintain the highest level of health and safety for our patients, staff, community, and ourselves,” according to the AGA website announcement.

In particular, the societies point out that there is recent evidence suggesting the potential for coronavirus transmission through droplets and perhaps fecal shedding, which pose potential risks in particular during endoscopy and colonoscopy procedures to other patients, endoscopy personnel, and practitioners.

Relevant clinical factors related to COVID-19 are discussed, including the fact that asymptomatic spread can occur during the prodromal phase (the mean incubation period is approximately 5 days, with a range of 0-14 days), with viral shedding greatest when symptoms begin.

Between 20% and 30% of patients with COVID-19 infection show abnormal liver enzymes. In addition, COVID-19 patients show drops in their leukocyte counts, and elevated white blood cell counts is a poor prognostic sign, according to the release.

The Centers for Disease Control and Prevention lists vulnerable populations at the greatest risk for more serious outcomes; these include the elderly and those with severe chronic health conditions, such as heart disease, lung disease, diabetes, decompensated cirrhosis, HIV with low CD4 counts, and immunosuppression (including liver and other solid organ transplant recipients), are at higher risk of developing more serious illness. In addition pregnancy may provide added risk.
 

Specific advice for the gastroenterology profession

The joint statement urges that practitioners strongly consider rescheduling elective nonurgent endoscopic procedures, although some nonurgent procedures are higher priority and may need to be performed, including cancer evaluations, prosthetic removals, and evaluation of significant symptoms. “Of note, the Surgeon General on 3/14/20 advised hospitals to postpone all elective surgeries,” the document states.

Patient concerns

In all cases, patients should be prescreened for high-risk exposure or symptoms. This includes asking about history of fever or respiratory symptoms, family members or close contacts with similar symptoms, any contact with a confirmed case of COVID-19, and recent travel to a high-risk area. “Avoid bringing patients (or their escorts) into the medical facility who are over age 65 or have one of the CDC recognized risks listed above,” the societies advise.

Check body temperature of the patient upon arrival at endoscopy unit or clinic, and keep all patients at an appropriate distance from each other (6 feet is recommended) throughout the entire time in the endoscopy unit.

“For COVID-19 positive patients, or those awaiting test results, isolation precautions should be taken with procedures performed in negative pressure rooms,” according to the statement.

In addition, use telemedicine where possible in elective cases, and consider phone follow-up after any procedures at 7 and 14 days to ask about new diagnosis of COVID-19 or development of its symptoms, .

Those patients who are on immunosuppressive drugs for inflammatory bowel disease and autoimmune hepatitis should continue taking their medications because the risk of disease flare outweighs the chance of contracting coronavirus, according to the document. In addition, these patients should be advised to follow CDC guidelines for at-risk groups by avoiding crowds and limiting travel.
 

Protection of practitioners

Key factors in ensuring practitioner safety and maintaining practice functionality are discussed by the joint document. In particular, appropriate personal protective equipment (PPE) should be worn by all members of the endoscopy team: gloves, mask, eye shield/goggles, face shields, and gown, but practitioners should also be aware of how to put on and take off PPE appropriately.

“Conservation of PPE is critical. Only essential personnel should be present in cases. Consider extended use or reuse of surgical masks and eye protection in accordance with hospital policies,” the document recommends.

“It is important to address our collective staff needs and institute policies that protect our workforce.” To that end, the document recommends that centers should strategically assign available personnel in order to minimize concomitant exposure of those with similar or unique skill sets. This includes the use of nonphysician practitioners and fellows that cannot participate in cases for screening and triaging patients, or performing virtual visits.

Coming at a time of pandemic, when gastrointestinal symptoms have been recognized as a more common symptom of COVID-19 than previously expected and liver damage has been noted as a potential repercussion of SARS-CoV-2 infection, these clinical insights provide a template for gastroenterologists and related professionals for dealing with their patients and keeping themselves safe under dramatically changed circumstances.

The partnered organizations, AASLD, ACG, AGA, and ASGE, are committed to providing updated COVID-19 information as appropriate. However: “Given the evolving and fluid nature of the situation, institutions, hospitals and clinics have also been formulating their own local guidelines, so we urge you to follow the evolving CDC recommendations and your local requirements,” according to the AGA website announcement.

In addition to the joint communication, the society websites each offer additional COVID-19 information. The AGA practice updates on the COVID-19 webpage provides information about announcements, such as the cancellation of Digestive Disease Week^® in May, a location for AGA members to discuss their COVID-19 experiences and share advice, and links to the CDC COVID-19 updates.
 

mlesney@mdedge.com

SOURCE: American Gastroenterological Association et al. March 2020, COVID-19 Clinical Insights for Our Community of Gastroenterologists and Gastroenterology Care Providers.

Key clinical point: Intravenous (IV) eptinezumab could be a safe and effective preventive therapy for adult patients with episodic migraine.

Main finding: Eptinezumab 100 and 300 mg significantly reduced monthly migraine days across weeks 1-12 compared with the placebo (difference from placebo for 100 and 300 mg: –0.69; P = .0182 and –1.11; P = .0001, respectively). Safety and tolerability of eptinezumab across doses were acceptable compared with placebo, with no dose-related trend in the nature, frequency, or severity of treatment-related adverse events.

Study details: In phase 3, multicenter, double-blind, parallel-group study, 888 patients were randomly assigned to IV eptinezumab (30, 100, and 300 mg) or placebo administered every 12 weeks. 

Disclosures: The study was funded by H. Lundbeck A/S, Copenhagen, Denmark. Some of the authors were full-time employees of or contracted to Lundbeck Seattle BioPharmaceuticals, Inc. (previously known as Alder BioPharmaceuticals, Inc.), a subsidiary H. Lundbeck A/S. Some also were stockholders of Lundbeck Seattle BioPharmaceuticals, Inc.

Citation: Ashina M et al. Cephalalgia. 2020 Feb 19. doi: 10.1177/0333102420905132.

Key clinical point: Intravenous (IV) eptinezumab could be a safe and effective preventive therapy for adult patients with episodic migraine.

Main finding: Eptinezumab 100 and 300 mg significantly reduced monthly migraine days across weeks 1-12 compared with the placebo (difference from placebo for 100 and 300 mg: –0.69; P = .0182 and –1.11; P = .0001, respectively). Safety and tolerability of eptinezumab across doses were acceptable compared with placebo, with no dose-related trend in the nature, frequency, or severity of treatment-related adverse events.

Study details: In phase 3, multicenter, double-blind, parallel-group study, 888 patients were randomly assigned to IV eptinezumab (30, 100, and 300 mg) or placebo administered every 12 weeks. 

Disclosures: The study was funded by H. Lundbeck A/S, Copenhagen, Denmark. Some of the authors were full-time employees of or contracted to Lundbeck Seattle BioPharmaceuticals, Inc. (previously known as Alder BioPharmaceuticals, Inc.), a subsidiary H. Lundbeck A/S. Some also were stockholders of Lundbeck Seattle BioPharmaceuticals, Inc.

Citation: Ashina M et al. Cephalalgia. 2020 Feb 19. doi: 10.1177/0333102420905132.

Key clinical point: Intravenous (IV) eptinezumab could be a safe and effective preventive therapy for adult patients with episodic migraine.

Main finding: Eptinezumab 100 and 300 mg significantly reduced monthly migraine days across weeks 1-12 compared with the placebo (difference from placebo for 100 and 300 mg: –0.69; P = .0182 and –1.11; P = .0001, respectively). Safety and tolerability of eptinezumab across doses were acceptable compared with placebo, with no dose-related trend in the nature, frequency, or severity of treatment-related adverse events.

Study details: In phase 3, multicenter, double-blind, parallel-group study, 888 patients were randomly assigned to IV eptinezumab (30, 100, and 300 mg) or placebo administered every 12 weeks. 

Disclosures: The study was funded by H. Lundbeck A/S, Copenhagen, Denmark. Some of the authors were full-time employees of or contracted to Lundbeck Seattle BioPharmaceuticals, Inc. (previously known as Alder BioPharmaceuticals, Inc.), a subsidiary H. Lundbeck A/S. Some also were stockholders of Lundbeck Seattle BioPharmaceuticals, Inc.

Citation: Ashina M et al. Cephalalgia. 2020 Feb 19. doi: 10.1177/0333102420905132.

Key clinical point: Migraineurs with aura are more likely to show a higher anger response, but not impulsivity, compared with migraineurs without aura and healthy control individuals.

Main finding: Scores of anger symptoms were significantly higher migraineurs with aura than those without aura and control individuals (P less than .001); however, there was no significant difference in total Barratt impulsiveness scale-11 score, attentional impulsiveness, motor impulsiveness, and nonplanning impulsiveness between the 3 groups (P greater than .05).

Study details: The prospective cross-sectional study included 55 patients aged 18-55 years with episodic migraine (31 with aura and 24 without aura) and 40 healthy control individuals.

Disclosures: The authors declared no conflict of interest.

Citation: Tanik N et al. Neurol Res. 2020 Feb 5. doi: 10.1080/01616412.2020.1723974.

Key clinical point: Migraineurs with aura are more likely to show a higher anger response, but not impulsivity, compared with migraineurs without aura and healthy control individuals.

Main finding: Scores of anger symptoms were significantly higher migraineurs with aura than those without aura and control individuals (P less than .001); however, there was no significant difference in total Barratt impulsiveness scale-11 score, attentional impulsiveness, motor impulsiveness, and nonplanning impulsiveness between the 3 groups (P greater than .05).

Study details: The prospective cross-sectional study included 55 patients aged 18-55 years with episodic migraine (31 with aura and 24 without aura) and 40 healthy control individuals.

Disclosures: The authors declared no conflict of interest.

Citation: Tanik N et al. Neurol Res. 2020 Feb 5. doi: 10.1080/01616412.2020.1723974.

Key clinical point: Migraineurs with aura are more likely to show a higher anger response, but not impulsivity, compared with migraineurs without aura and healthy control individuals.

Main finding: Scores of anger symptoms were significantly higher migraineurs with aura than those without aura and control individuals (P less than .001); however, there was no significant difference in total Barratt impulsiveness scale-11 score, attentional impulsiveness, motor impulsiveness, and nonplanning impulsiveness between the 3 groups (P greater than .05).

Study details: The prospective cross-sectional study included 55 patients aged 18-55 years with episodic migraine (31 with aura and 24 without aura) and 40 healthy control individuals.

Disclosures: The authors declared no conflict of interest.

Citation: Tanik N et al. Neurol Res. 2020 Feb 5. doi: 10.1080/01616412.2020.1723974.

Key clinical point: Plasma glucose level increases during spontaneous migraine attacks, and the increase is independent of the presence of aura symptoms and pain intensity.

Main finding: Plasma glucose levels were higher in the ictal phase than in the interictal phase of migraine (mean, 98.83 vs. 88.63 mg/dL; P = .0014) after adjusting for diurnal variation. The attack-related elevation in plasma glucose level was not influenced by pain intensity or the presence of aura symptoms.

Study details: In this study, plasma glucose levels were measured during and outside of spontaneous attacks of migraine in 31 patients (13 with aura and 18 without aura).

Disclosures: The study was funded by the Lundbeck Foundation, the Novo Nordisk Foundation, the University of Copenhagen, the Research Foundation of the Capital Region of Denmark, and the Danish Council for Independent Research-Medical Sciences. Faisal Mohammad Amin and Anders Hougaard reported receiving personal fees and/or honoraria from multiple pharmaceutical companies. Messoud Ashina reported consultancy/advisory for multiple pharmaceutical companies. Other authors declared no disclosures. 

Citation: Zhang DG et al. Headache. 2020 Feb 7. doi: 10.1111/head.13760.

Key clinical point: Plasma glucose level increases during spontaneous migraine attacks, and the increase is independent of the presence of aura symptoms and pain intensity.

Main finding: Plasma glucose levels were higher in the ictal phase than in the interictal phase of migraine (mean, 98.83 vs. 88.63 mg/dL; P = .0014) after adjusting for diurnal variation. The attack-related elevation in plasma glucose level was not influenced by pain intensity or the presence of aura symptoms.

Study details: In this study, plasma glucose levels were measured during and outside of spontaneous attacks of migraine in 31 patients (13 with aura and 18 without aura).

Disclosures: The study was funded by the Lundbeck Foundation, the Novo Nordisk Foundation, the University of Copenhagen, the Research Foundation of the Capital Region of Denmark, and the Danish Council for Independent Research-Medical Sciences. Faisal Mohammad Amin and Anders Hougaard reported receiving personal fees and/or honoraria from multiple pharmaceutical companies. Messoud Ashina reported consultancy/advisory for multiple pharmaceutical companies. Other authors declared no disclosures. 

Citation: Zhang DG et al. Headache. 2020 Feb 7. doi: 10.1111/head.13760.

Key clinical point: Plasma glucose level increases during spontaneous migraine attacks, and the increase is independent of the presence of aura symptoms and pain intensity.

Main finding: Plasma glucose levels were higher in the ictal phase than in the interictal phase of migraine (mean, 98.83 vs. 88.63 mg/dL; P = .0014) after adjusting for diurnal variation. The attack-related elevation in plasma glucose level was not influenced by pain intensity or the presence of aura symptoms.

Study details: In this study, plasma glucose levels were measured during and outside of spontaneous attacks of migraine in 31 patients (13 with aura and 18 without aura).

Disclosures: The study was funded by the Lundbeck Foundation, the Novo Nordisk Foundation, the University of Copenhagen, the Research Foundation of the Capital Region of Denmark, and the Danish Council for Independent Research-Medical Sciences. Faisal Mohammad Amin and Anders Hougaard reported receiving personal fees and/or honoraria from multiple pharmaceutical companies. Messoud Ashina reported consultancy/advisory for multiple pharmaceutical companies. Other authors declared no disclosures. 

Citation: Zhang DG et al. Headache. 2020 Feb 7. doi: 10.1111/head.13760.

Key clinical point: Quarterly treatment with OnabotulinumtoxinA (BoNT-A) up to 4 years can provide long-lasting prevention of chronic migraine in real-life settings.

Main finding: From baseline to 48 months, there was a significant reduction in the mean number of monthly headache days and hours, consumption of analgesics, and latency time (P less than .001 for all). With repeated BoNT-A treatment, a progressive shift toward lower degrees of disability was seen at each subsequent timepoint (P less than .001 for trend). Six patients experienced transitory neck pain. 

Study details: The data come from a retrospective real-life study of patients with chronic migraine who received quarterly treatment with BoNT-A up to 16 cycles (n = 109).

Disclosures: The authors declared no conflict of interest.

Citation: Santoro A et al. Neurol Sci. 2020 Feb 12. doi: 10.1007/s10072-020-04283-y.

Key clinical point: Quarterly treatment with OnabotulinumtoxinA (BoNT-A) up to 4 years can provide long-lasting prevention of chronic migraine in real-life settings.

Main finding: From baseline to 48 months, there was a significant reduction in the mean number of monthly headache days and hours, consumption of analgesics, and latency time (P less than .001 for all). With repeated BoNT-A treatment, a progressive shift toward lower degrees of disability was seen at each subsequent timepoint (P less than .001 for trend). Six patients experienced transitory neck pain. 

Study details: The data come from a retrospective real-life study of patients with chronic migraine who received quarterly treatment with BoNT-A up to 16 cycles (n = 109).

Disclosures: The authors declared no conflict of interest.

Citation: Santoro A et al. Neurol Sci. 2020 Feb 12. doi: 10.1007/s10072-020-04283-y.

Key clinical point: Quarterly treatment with OnabotulinumtoxinA (BoNT-A) up to 4 years can provide long-lasting prevention of chronic migraine in real-life settings.

Main finding: From baseline to 48 months, there was a significant reduction in the mean number of monthly headache days and hours, consumption of analgesics, and latency time (P less than .001 for all). With repeated BoNT-A treatment, a progressive shift toward lower degrees of disability was seen at each subsequent timepoint (P less than .001 for trend). Six patients experienced transitory neck pain. 

Study details: The data come from a retrospective real-life study of patients with chronic migraine who received quarterly treatment with BoNT-A up to 16 cycles (n = 109).

Disclosures: The authors declared no conflict of interest.

Citation: Santoro A et al. Neurol Sci. 2020 Feb 12. doi: 10.1007/s10072-020-04283-y.

Key clinical point: Rimegepant 75 mg demonstrates favorable efficacy and safety for the treatment of acute migraine compared with the placebo.

Main finding: Rimegepant 75 mg resulted in a significant freedom from pain (20.6% vs. 12.5%; relative risk [RR], 1.70; P less than .001), pain relief (58.6% vs. 44.6%; RR, 1.34; P less than .001), and freedom from the most bothersome symptoms (36.0% vs. 25.1%; RR, 1.44; P less than .001) at 2 hours after dosing compared with the placebo. There was no significant increase in adverse events compared with the placebo.

Study details: A meta-analysis of 4 randomized controlled trials including 3,827 patients with acute migraine.

Disclosures: This study was supported by the Suzhou Health Talents Training Project. The authors declared no conflict of interest.

Citation: Gao B et al. Front Pharmacol. 2020 Jan 24. doi: 10.3389/fphar.2019.01577.

Key clinical point: Rimegepant 75 mg demonstrates favorable efficacy and safety for the treatment of acute migraine compared with the placebo.

Main finding: Rimegepant 75 mg resulted in a significant freedom from pain (20.6% vs. 12.5%; relative risk [RR], 1.70; P less than .001), pain relief (58.6% vs. 44.6%; RR, 1.34; P less than .001), and freedom from the most bothersome symptoms (36.0% vs. 25.1%; RR, 1.44; P less than .001) at 2 hours after dosing compared with the placebo. There was no significant increase in adverse events compared with the placebo.

Study details: A meta-analysis of 4 randomized controlled trials including 3,827 patients with acute migraine.

Disclosures: This study was supported by the Suzhou Health Talents Training Project. The authors declared no conflict of interest.

Citation: Gao B et al. Front Pharmacol. 2020 Jan 24. doi: 10.3389/fphar.2019.01577.

Key clinical point: Rimegepant 75 mg demonstrates favorable efficacy and safety for the treatment of acute migraine compared with the placebo.

Main finding: Rimegepant 75 mg resulted in a significant freedom from pain (20.6% vs. 12.5%; relative risk [RR], 1.70; P less than .001), pain relief (58.6% vs. 44.6%; RR, 1.34; P less than .001), and freedom from the most bothersome symptoms (36.0% vs. 25.1%; RR, 1.44; P less than .001) at 2 hours after dosing compared with the placebo. There was no significant increase in adverse events compared with the placebo.

Study details: A meta-analysis of 4 randomized controlled trials including 3,827 patients with acute migraine.

Disclosures: This study was supported by the Suzhou Health Talents Training Project. The authors declared no conflict of interest.

Citation: Gao B et al. Front Pharmacol. 2020 Jan 24. doi: 10.3389/fphar.2019.01577.

CASE Pregnant woman with symptoms of genital infection

A 23-year-old primigravid woman at 15 weeks and 2 days’ gestation reported having a 2-week history of increased urinary frequency and vaginal discharge. She said she experienced similar symptoms 6 weeks previously that resolved within a week. The patient has had 3 sexual partners in the past year. Her current partner was experiencing a yellow urethral discharge and dysuria. On the patient’s speculum examination, the clinician noted a yellow-green discharge emanating from the cervix as well as cervical motion tenderness.

What is the most likely diagnosis, and how would you treat this patient?
 

The culprit was chlamydia

Chlamydia trachomatis is an obligate intracellular bacterium that does not stain with Gram staining. A rigid cell wall encloses its intracellular component. C trachomatis infection begins when the chlamydial elementary body enters a susceptible host cell.

Once ingested, the organism’s surface antigens (major outer membrane protein and lipopolysaccharide antigens) provide intracellular sanctuary for the bacterium by inhibiting phagolysosomal fusion. Subsequently, the elementary body morphs into a reticular body, which replicates through adenosine triphosphate (ATP)–dependent binary fission. After approximately 48 hours of replication, the organism again morphs into an elementary body and is released to infect additional cells and acquire new ATP stores for further replication.

Chlamydia can be transmitted horizontally during oral, vaginal, or anal intercourse or vertically to the infant during vaginal delivery.

The US’s most common notifiable disease

According to the Centers for Disease Control and Prevention (CDC), the incidence of chlamydia infection in the United States increased considerably in recent years: from 976,455 cases in 2005 to 1,758,668 cases in 2018.¹ In 2018, rates of chlamydia infection in women were nearly double the rates in men, with an incidence of 688.2 versus 377.5 per 100,000 cases, and a prevalence of 1,150,672 versus 612,020.¹

Young adults have a higher frequency of chlamydia infection than any other age group. From 2017 to 2018, reported cases in women aged 15–19 years increased by 1.3%, to 3,306.8 per 100,000; in women aged 20–24 years, cases increased by 0.8%, to 4,064.6 per 100,000. In young men in the same age ranges, reported cases increased by 3.7%, to 959.0 cases per 100,000, and by 3.3%, to 1,784.5 per 100,000 cases, respectively.¹

Both the incidence and prevalence of chlamydia infection are higher in African Americans than in whites, while Asians have the lowest rates.¹ The prevalence of infection also is increased with incarceration, lower socioeconomic status, and residence in the southern United States.

The prevalence of chlamydia infection in pregnant women is approximately 2% to 3%, but it may be as high as 30% in high-risk populations, such as women who are unmarried, have multiple sex partners, are coinfected with another sexually transmitted disease (STD), have partners with nongonococcal urethritis, have mucopurulent discharge, have acute urethral syndrome, and have late or no prenatal care.² Since chlamydia infection often is asymptomatic and some infections resolve spontaneously, the true prevalence of infection probably is underreported.

Continue to: Chlamydia infection can cause serious clinical manifestations...

Chlamydia infection can cause serious clinical manifestations

The 15 serotypes of C trachomatis are grouped into 3 categories according to clinical manifestations:

• Serotypes A, B, Ba, and C cause endemic trachoma, characterized by bilateral irritation of the eyelids that progresses to eyelid thickening and scarring, eventually leading to corneal abrasion and blindness.
• Serotypes D–K manifest as conjunctivitis and pneumonia in newborns, proctitis in men (especially in men who have sex with men), and genitourinary infections in women. Reactive arthritis and inclusion conjunctivitis also can occur with D–K serotypes.
• Serotypes L1–L3 cause lymphogranuloma venereum.

About 70% of women with chlamydia infection are asymptomatic. Those who have symptoms often present with endocervicitis or acute urethral syndrome (acute urethritis). Manifestations of these 2 conditions include a frothy yellow-green vaginal and/or urethral discharge, dysuria, and frequency. Women who engage in rectal intercourse also may notice a purulent discharge from the anus. Untreated, C trachomatis organisms may ascend the reproductive tract, causing both endometritis and pelvic inflammatory disease (PID).

While a single episode of PID increases tubal infertility risk by 10%, a second episode increases the risk by 40%.³ Over time, recurrent and/or chronic PID causes scarring and adhesion formation, which may result in chronic pelvic pain. In addition, chronic infection is the single most important risk factor for ectopic pregnancy. Finally, chlamydia infection is a risk factor for Fitz-Hugh-Cutis syndrome (perihepatitis). In this condition, organisms ascend from the site of pelvic infection along the pericolic gutter to ultimately infect the liver capsule.

Specific complications in pregnancy

Chlamydia infection in pregnant women is associated with preterm delivery and preterm premature rupture of membranes. Infants born to mothers with untreated chlamydia infection are at risk for pneumonia, conjunctivitis, and even perinatal death.² Acquisition of infection occurs at the time of delivery rather than in the antepartum period.

The significant morbidity associated with chlamydia infection underscores the importance of regular screening, especially in pregnant women. The current United States Preventive Service Task Force guidelines recommend annual screening of all sexually active women who are 24 years of age or younger, as well as of older, high-risk women.

The CDC recommends routine screening of all pregnant women for chlamydia at the first prenatal visit. Repeat screening is recommended in the third trimester for all pregnant women younger than 25 years, those at increased risk, and those infected within the past 3 to 6 months or during the first trimester. Those who test positive should be retested 3 weeks after completion of treatment.¹

Chlamydia screening strategies

Historically, a chlamydia diagnosis was made by isolating the organisms in tissue culture. In the 1990s, however, that extremely time-consuming and resource-intensive procedure was replaced by nucleic acid amplification testing (NAAT).

NAAT methodology. NAAT is the gold standard for diagnosing C trachomatis infection; this methodology utilizes various assays, including polymerase chain reaction, ligase chain reaction, and transcription-mediated amplification.

Continue to: Compared with previous culture and antigen detection techniques...

Compared with previous culture and antigen detection techniques, NAAT’s advantages include excellent sensitivity and specificity (>90% and ≥99%, respectively), enabling detection of a low inoculum of organisms in a sample obtained by noninvasive methods, such as first-void urine collection or vaginal swab.^2,4,5 Furthermore, NAAT does not impose any specific storage regulations on collected specimens, is cost effective, and can jointly test for Neisseria gonorrhoeae, which commonly co-infects with C trachomatis.⁶

Screening in pregnancy. In 2012, Blatt and colleagues examined testing patterns in nearly 1.3 million obstetric patients and found that only 59% (761,315) of women were tested for chlamydia at least once in pregnancy.⁷ Only 1 in 3 women were tested during the first prenatal visit, as CDC guidelines recommend. Testing rates declined with increasing age. Of women screened, 3.5% tested positive for chlamydia.⁷ Of these, 3 of 4 were retested at least once, with almost 20% having at least 1 subsequent positive result.⁷

Of note, in a study of women who reported receptive anal intercourse (n = 2,818), 292 women tested positive for chlamydia; 10.4% tested positive in genital-only sites, 58.6% in genital and rectal sites, and 20.5% at the rectal site only.⁸

It is alarming that only 59% of pregnant women are screened for chlamydia given the significant perinatal complications associated with this infection. Barriers to screening pregnant women may include clinician discomfort in discussing STDs and patient refusal of screening. Furthermore, clinicians should routinely ask women about receptive anal sex. Women who report this risk factor should be tested for chlamydia in both the endocervix and rectum.

Retesting and follow-up. After the initial diagnosis of chlamydia, a test of cure 3 weeks after treatment is an important aspect of care. Thus, identifying and overcoming barriers to retesting is important. Clinicians should educate patients about the importance of follow-up. Also consider incorporating the use of home-based, self-obtained vaginal swabs for retesting. Results from 2 randomized trials showed that eliminating a patient’s transportation barriers and providing a home-based alternative to a follow-up visit significantly increased rescreening rates by 33% in STD clinic patients and by 59.2% in family planning clinic patients.⁹

Reinfection risk. The rate of venereal chlamydia transmission in heterosexual partners is 70%. Since sexually active chlamydia-positive patients are at risk for reinfection by their partner after treatment completion, clinicians should refer the sex partners for evaluation. If the sex partners are reluctant to have testing, it is reasonable to provide empiric antibiotic treatment to decrease the risk of re-infection in the patient.⁷ Before doing so, however, make certain that state law permits this practice, and be sure to document the prescribed treatment in the patient’s record.

Continue to: Treatment options...

Treatment options

Prompt treatment of C trachomatis infection is essential to decrease the risk of disease sequelae. Nonpregnant adults can be treated with oral doxycycline 100 mg twice daily for 7 days.

In a head-to-head study performed in a controlled environment that ensured treatment adherence, 97% efficacy was achieved with one oral dose of azithromycin (1 g) compared with 100% efficacy with doxycycline.¹⁰ However, in the real-world setting, imperfect adherence to the multi-day doxycycline regimen is associated with treatment failures. Thus, a single dose of azithromycin is preferable for patients with questionable compliance.¹¹

In obstetric patients, azithromycin and amoxicillin are preferred as first-line agents for treatment of C trachomatis due to their improved safety profile in this demographic. Amoxicillin 500 mg orally 3 times daily for 7 days has 95% efficacy.²

Women allergic to these agents may be treated with an alternative regimen of erythromycin base, 500 mg orally 4 times daily for 7 days, or erythromycin ethylsuccinate, 800 mg orally 4 times daily for 7 days. Erythromycin should be reserved for second-line therapy because of its lower efficacy (64%) and frequent gastrointestinal adverse effects.² Doxycycline is contraindicated in pregnancy because of possible teratogenic effects on the teeth and bone of the fetus.

CASE Pregnant woman with symptoms of genital infection

A 23-year-old primigravid woman at 15 weeks and 2 days’ gestation reported having a 2-week history of increased urinary frequency and vaginal discharge. She said she experienced similar symptoms 6 weeks previously that resolved within a week. The patient has had 3 sexual partners in the past year. Her current partner was experiencing a yellow urethral discharge and dysuria. On the patient’s speculum examination, the clinician noted a yellow-green discharge emanating from the cervix as well as cervical motion tenderness.

What is the most likely diagnosis, and how would you treat this patient?
 

The culprit was chlamydia

Chlamydia trachomatis is an obligate intracellular bacterium that does not stain with Gram staining. A rigid cell wall encloses its intracellular component. C trachomatis infection begins when the chlamydial elementary body enters a susceptible host cell.

Once ingested, the organism’s surface antigens (major outer membrane protein and lipopolysaccharide antigens) provide intracellular sanctuary for the bacterium by inhibiting phagolysosomal fusion. Subsequently, the elementary body morphs into a reticular body, which replicates through adenosine triphosphate (ATP)–dependent binary fission. After approximately 48 hours of replication, the organism again morphs into an elementary body and is released to infect additional cells and acquire new ATP stores for further replication.

Chlamydia can be transmitted horizontally during oral, vaginal, or anal intercourse or vertically to the infant during vaginal delivery.

The US’s most common notifiable disease

According to the Centers for Disease Control and Prevention (CDC), the incidence of chlamydia infection in the United States increased considerably in recent years: from 976,455 cases in 2005 to 1,758,668 cases in 2018.¹ In 2018, rates of chlamydia infection in women were nearly double the rates in men, with an incidence of 688.2 versus 377.5 per 100,000 cases, and a prevalence of 1,150,672 versus 612,020.¹

Young adults have a higher frequency of chlamydia infection than any other age group. From 2017 to 2018, reported cases in women aged 15–19 years increased by 1.3%, to 3,306.8 per 100,000; in women aged 20–24 years, cases increased by 0.8%, to 4,064.6 per 100,000. In young men in the same age ranges, reported cases increased by 3.7%, to 959.0 cases per 100,000, and by 3.3%, to 1,784.5 per 100,000 cases, respectively.¹

Both the incidence and prevalence of chlamydia infection are higher in African Americans than in whites, while Asians have the lowest rates.¹ The prevalence of infection also is increased with incarceration, lower socioeconomic status, and residence in the southern United States.

The prevalence of chlamydia infection in pregnant women is approximately 2% to 3%, but it may be as high as 30% in high-risk populations, such as women who are unmarried, have multiple sex partners, are coinfected with another sexually transmitted disease (STD), have partners with nongonococcal urethritis, have mucopurulent discharge, have acute urethral syndrome, and have late or no prenatal care.² Since chlamydia infection often is asymptomatic and some infections resolve spontaneously, the true prevalence of infection probably is underreported.

Continue to: Chlamydia infection can cause serious clinical manifestations...

Chlamydia infection can cause serious clinical manifestations

The 15 serotypes of C trachomatis are grouped into 3 categories according to clinical manifestations:

• Serotypes A, B, Ba, and C cause endemic trachoma, characterized by bilateral irritation of the eyelids that progresses to eyelid thickening and scarring, eventually leading to corneal abrasion and blindness.
• Serotypes D–K manifest as conjunctivitis and pneumonia in newborns, proctitis in men (especially in men who have sex with men), and genitourinary infections in women. Reactive arthritis and inclusion conjunctivitis also can occur with D–K serotypes.
• Serotypes L1–L3 cause lymphogranuloma venereum.

About 70% of women with chlamydia infection are asymptomatic. Those who have symptoms often present with endocervicitis or acute urethral syndrome (acute urethritis). Manifestations of these 2 conditions include a frothy yellow-green vaginal and/or urethral discharge, dysuria, and frequency. Women who engage in rectal intercourse also may notice a purulent discharge from the anus. Untreated, C trachomatis organisms may ascend the reproductive tract, causing both endometritis and pelvic inflammatory disease (PID).

While a single episode of PID increases tubal infertility risk by 10%, a second episode increases the risk by 40%.³ Over time, recurrent and/or chronic PID causes scarring and adhesion formation, which may result in chronic pelvic pain. In addition, chronic infection is the single most important risk factor for ectopic pregnancy. Finally, chlamydia infection is a risk factor for Fitz-Hugh-Cutis syndrome (perihepatitis). In this condition, organisms ascend from the site of pelvic infection along the pericolic gutter to ultimately infect the liver capsule.

Specific complications in pregnancy

Chlamydia infection in pregnant women is associated with preterm delivery and preterm premature rupture of membranes. Infants born to mothers with untreated chlamydia infection are at risk for pneumonia, conjunctivitis, and even perinatal death.² Acquisition of infection occurs at the time of delivery rather than in the antepartum period.

The significant morbidity associated with chlamydia infection underscores the importance of regular screening, especially in pregnant women. The current United States Preventive Service Task Force guidelines recommend annual screening of all sexually active women who are 24 years of age or younger, as well as of older, high-risk women.

The CDC recommends routine screening of all pregnant women for chlamydia at the first prenatal visit. Repeat screening is recommended in the third trimester for all pregnant women younger than 25 years, those at increased risk, and those infected within the past 3 to 6 months or during the first trimester. Those who test positive should be retested 3 weeks after completion of treatment.¹

Chlamydia screening strategies

Historically, a chlamydia diagnosis was made by isolating the organisms in tissue culture. In the 1990s, however, that extremely time-consuming and resource-intensive procedure was replaced by nucleic acid amplification testing (NAAT).

NAAT methodology. NAAT is the gold standard for diagnosing C trachomatis infection; this methodology utilizes various assays, including polymerase chain reaction, ligase chain reaction, and transcription-mediated amplification.

Continue to: Compared with previous culture and antigen detection techniques...

Compared with previous culture and antigen detection techniques, NAAT’s advantages include excellent sensitivity and specificity (>90% and ≥99%, respectively), enabling detection of a low inoculum of organisms in a sample obtained by noninvasive methods, such as first-void urine collection or vaginal swab.^2,4,5 Furthermore, NAAT does not impose any specific storage regulations on collected specimens, is cost effective, and can jointly test for Neisseria gonorrhoeae, which commonly co-infects with C trachomatis.⁶

Screening in pregnancy. In 2012, Blatt and colleagues examined testing patterns in nearly 1.3 million obstetric patients and found that only 59% (761,315) of women were tested for chlamydia at least once in pregnancy.⁷ Only 1 in 3 women were tested during the first prenatal visit, as CDC guidelines recommend. Testing rates declined with increasing age. Of women screened, 3.5% tested positive for chlamydia.⁷ Of these, 3 of 4 were retested at least once, with almost 20% having at least 1 subsequent positive result.⁷

Of note, in a study of women who reported receptive anal intercourse (n = 2,818), 292 women tested positive for chlamydia; 10.4% tested positive in genital-only sites, 58.6% in genital and rectal sites, and 20.5% at the rectal site only.⁸

It is alarming that only 59% of pregnant women are screened for chlamydia given the significant perinatal complications associated with this infection. Barriers to screening pregnant women may include clinician discomfort in discussing STDs and patient refusal of screening. Furthermore, clinicians should routinely ask women about receptive anal sex. Women who report this risk factor should be tested for chlamydia in both the endocervix and rectum.

Retesting and follow-up. After the initial diagnosis of chlamydia, a test of cure 3 weeks after treatment is an important aspect of care. Thus, identifying and overcoming barriers to retesting is important. Clinicians should educate patients about the importance of follow-up. Also consider incorporating the use of home-based, self-obtained vaginal swabs for retesting. Results from 2 randomized trials showed that eliminating a patient’s transportation barriers and providing a home-based alternative to a follow-up visit significantly increased rescreening rates by 33% in STD clinic patients and by 59.2% in family planning clinic patients.⁹

Reinfection risk. The rate of venereal chlamydia transmission in heterosexual partners is 70%. Since sexually active chlamydia-positive patients are at risk for reinfection by their partner after treatment completion, clinicians should refer the sex partners for evaluation. If the sex partners are reluctant to have testing, it is reasonable to provide empiric antibiotic treatment to decrease the risk of re-infection in the patient.⁷ Before doing so, however, make certain that state law permits this practice, and be sure to document the prescribed treatment in the patient’s record.

Continue to: Treatment options...

Treatment options

Prompt treatment of C trachomatis infection is essential to decrease the risk of disease sequelae. Nonpregnant adults can be treated with oral doxycycline 100 mg twice daily for 7 days.

In a head-to-head study performed in a controlled environment that ensured treatment adherence, 97% efficacy was achieved with one oral dose of azithromycin (1 g) compared with 100% efficacy with doxycycline.¹⁰ However, in the real-world setting, imperfect adherence to the multi-day doxycycline regimen is associated with treatment failures. Thus, a single dose of azithromycin is preferable for patients with questionable compliance.¹¹

In obstetric patients, azithromycin and amoxicillin are preferred as first-line agents for treatment of C trachomatis due to their improved safety profile in this demographic. Amoxicillin 500 mg orally 3 times daily for 7 days has 95% efficacy.²

Women allergic to these agents may be treated with an alternative regimen of erythromycin base, 500 mg orally 4 times daily for 7 days, or erythromycin ethylsuccinate, 800 mg orally 4 times daily for 7 days. Erythromycin should be reserved for second-line therapy because of its lower efficacy (64%) and frequent gastrointestinal adverse effects.² Doxycycline is contraindicated in pregnancy because of possible teratogenic effects on the teeth and bone of the fetus.

CASE Pregnant woman with symptoms of genital infection

A 23-year-old primigravid woman at 15 weeks and 2 days’ gestation reported having a 2-week history of increased urinary frequency and vaginal discharge. She said she experienced similar symptoms 6 weeks previously that resolved within a week. The patient has had 3 sexual partners in the past year. Her current partner was experiencing a yellow urethral discharge and dysuria. On the patient’s speculum examination, the clinician noted a yellow-green discharge emanating from the cervix as well as cervical motion tenderness.

What is the most likely diagnosis, and how would you treat this patient?
 

The culprit was chlamydia

Chlamydia trachomatis is an obligate intracellular bacterium that does not stain with Gram staining. A rigid cell wall encloses its intracellular component. C trachomatis infection begins when the chlamydial elementary body enters a susceptible host cell.

Once ingested, the organism’s surface antigens (major outer membrane protein and lipopolysaccharide antigens) provide intracellular sanctuary for the bacterium by inhibiting phagolysosomal fusion. Subsequently, the elementary body morphs into a reticular body, which replicates through adenosine triphosphate (ATP)–dependent binary fission. After approximately 48 hours of replication, the organism again morphs into an elementary body and is released to infect additional cells and acquire new ATP stores for further replication.

Chlamydia can be transmitted horizontally during oral, vaginal, or anal intercourse or vertically to the infant during vaginal delivery.

The US’s most common notifiable disease

According to the Centers for Disease Control and Prevention (CDC), the incidence of chlamydia infection in the United States increased considerably in recent years: from 976,455 cases in 2005 to 1,758,668 cases in 2018.¹ In 2018, rates of chlamydia infection in women were nearly double the rates in men, with an incidence of 688.2 versus 377.5 per 100,000 cases, and a prevalence of 1,150,672 versus 612,020.¹

Young adults have a higher frequency of chlamydia infection than any other age group. From 2017 to 2018, reported cases in women aged 15–19 years increased by 1.3%, to 3,306.8 per 100,000; in women aged 20–24 years, cases increased by 0.8%, to 4,064.6 per 100,000. In young men in the same age ranges, reported cases increased by 3.7%, to 959.0 cases per 100,000, and by 3.3%, to 1,784.5 per 100,000 cases, respectively.¹

Both the incidence and prevalence of chlamydia infection are higher in African Americans than in whites, while Asians have the lowest rates.¹ The prevalence of infection also is increased with incarceration, lower socioeconomic status, and residence in the southern United States.

The prevalence of chlamydia infection in pregnant women is approximately 2% to 3%, but it may be as high as 30% in high-risk populations, such as women who are unmarried, have multiple sex partners, are coinfected with another sexually transmitted disease (STD), have partners with nongonococcal urethritis, have mucopurulent discharge, have acute urethral syndrome, and have late or no prenatal care.² Since chlamydia infection often is asymptomatic and some infections resolve spontaneously, the true prevalence of infection probably is underreported.

Continue to: Chlamydia infection can cause serious clinical manifestations...

Chlamydia infection can cause serious clinical manifestations

The 15 serotypes of C trachomatis are grouped into 3 categories according to clinical manifestations:

• Serotypes A, B, Ba, and C cause endemic trachoma, characterized by bilateral irritation of the eyelids that progresses to eyelid thickening and scarring, eventually leading to corneal abrasion and blindness.
• Serotypes D–K manifest as conjunctivitis and pneumonia in newborns, proctitis in men (especially in men who have sex with men), and genitourinary infections in women. Reactive arthritis and inclusion conjunctivitis also can occur with D–K serotypes.
• Serotypes L1–L3 cause lymphogranuloma venereum.

About 70% of women with chlamydia infection are asymptomatic. Those who have symptoms often present with endocervicitis or acute urethral syndrome (acute urethritis). Manifestations of these 2 conditions include a frothy yellow-green vaginal and/or urethral discharge, dysuria, and frequency. Women who engage in rectal intercourse also may notice a purulent discharge from the anus. Untreated, C trachomatis organisms may ascend the reproductive tract, causing both endometritis and pelvic inflammatory disease (PID).

While a single episode of PID increases tubal infertility risk by 10%, a second episode increases the risk by 40%.³ Over time, recurrent and/or chronic PID causes scarring and adhesion formation, which may result in chronic pelvic pain. In addition, chronic infection is the single most important risk factor for ectopic pregnancy. Finally, chlamydia infection is a risk factor for Fitz-Hugh-Cutis syndrome (perihepatitis). In this condition, organisms ascend from the site of pelvic infection along the pericolic gutter to ultimately infect the liver capsule.

Specific complications in pregnancy

Chlamydia infection in pregnant women is associated with preterm delivery and preterm premature rupture of membranes. Infants born to mothers with untreated chlamydia infection are at risk for pneumonia, conjunctivitis, and even perinatal death.² Acquisition of infection occurs at the time of delivery rather than in the antepartum period.

The significant morbidity associated with chlamydia infection underscores the importance of regular screening, especially in pregnant women. The current United States Preventive Service Task Force guidelines recommend annual screening of all sexually active women who are 24 years of age or younger, as well as of older, high-risk women.

The CDC recommends routine screening of all pregnant women for chlamydia at the first prenatal visit. Repeat screening is recommended in the third trimester for all pregnant women younger than 25 years, those at increased risk, and those infected within the past 3 to 6 months or during the first trimester. Those who test positive should be retested 3 weeks after completion of treatment.¹

Chlamydia screening strategies

Historically, a chlamydia diagnosis was made by isolating the organisms in tissue culture. In the 1990s, however, that extremely time-consuming and resource-intensive procedure was replaced by nucleic acid amplification testing (NAAT).

NAAT methodology. NAAT is the gold standard for diagnosing C trachomatis infection; this methodology utilizes various assays, including polymerase chain reaction, ligase chain reaction, and transcription-mediated amplification.

Continue to: Compared with previous culture and antigen detection techniques...

Compared with previous culture and antigen detection techniques, NAAT’s advantages include excellent sensitivity and specificity (>90% and ≥99%, respectively), enabling detection of a low inoculum of organisms in a sample obtained by noninvasive methods, such as first-void urine collection or vaginal swab.^2,4,5 Furthermore, NAAT does not impose any specific storage regulations on collected specimens, is cost effective, and can jointly test for Neisseria gonorrhoeae, which commonly co-infects with C trachomatis.⁶

Screening in pregnancy. In 2012, Blatt and colleagues examined testing patterns in nearly 1.3 million obstetric patients and found that only 59% (761,315) of women were tested for chlamydia at least once in pregnancy.⁷ Only 1 in 3 women were tested during the first prenatal visit, as CDC guidelines recommend. Testing rates declined with increasing age. Of women screened, 3.5% tested positive for chlamydia.⁷ Of these, 3 of 4 were retested at least once, with almost 20% having at least 1 subsequent positive result.⁷

Of note, in a study of women who reported receptive anal intercourse (n = 2,818), 292 women tested positive for chlamydia; 10.4% tested positive in genital-only sites, 58.6% in genital and rectal sites, and 20.5% at the rectal site only.⁸

It is alarming that only 59% of pregnant women are screened for chlamydia given the significant perinatal complications associated with this infection. Barriers to screening pregnant women may include clinician discomfort in discussing STDs and patient refusal of screening. Furthermore, clinicians should routinely ask women about receptive anal sex. Women who report this risk factor should be tested for chlamydia in both the endocervix and rectum.

Retesting and follow-up. After the initial diagnosis of chlamydia, a test of cure 3 weeks after treatment is an important aspect of care. Thus, identifying and overcoming barriers to retesting is important. Clinicians should educate patients about the importance of follow-up. Also consider incorporating the use of home-based, self-obtained vaginal swabs for retesting. Results from 2 randomized trials showed that eliminating a patient’s transportation barriers and providing a home-based alternative to a follow-up visit significantly increased rescreening rates by 33% in STD clinic patients and by 59.2% in family planning clinic patients.⁹

Reinfection risk. The rate of venereal chlamydia transmission in heterosexual partners is 70%. Since sexually active chlamydia-positive patients are at risk for reinfection by their partner after treatment completion, clinicians should refer the sex partners for evaluation. If the sex partners are reluctant to have testing, it is reasonable to provide empiric antibiotic treatment to decrease the risk of re-infection in the patient.⁷ Before doing so, however, make certain that state law permits this practice, and be sure to document the prescribed treatment in the patient’s record.

Continue to: Treatment options...

Treatment options

Prompt treatment of C trachomatis infection is essential to decrease the risk of disease sequelae. Nonpregnant adults can be treated with oral doxycycline 100 mg twice daily for 7 days.

In a head-to-head study performed in a controlled environment that ensured treatment adherence, 97% efficacy was achieved with one oral dose of azithromycin (1 g) compared with 100% efficacy with doxycycline.¹⁰ However, in the real-world setting, imperfect adherence to the multi-day doxycycline regimen is associated with treatment failures. Thus, a single dose of azithromycin is preferable for patients with questionable compliance.¹¹

In obstetric patients, azithromycin and amoxicillin are preferred as first-line agents for treatment of C trachomatis due to their improved safety profile in this demographic. Amoxicillin 500 mg orally 3 times daily for 7 days has 95% efficacy.²

Women allergic to these agents may be treated with an alternative regimen of erythromycin base, 500 mg orally 4 times daily for 7 days, or erythromycin ethylsuccinate, 800 mg orally 4 times daily for 7 days. Erythromycin should be reserved for second-line therapy because of its lower efficacy (64%) and frequent gastrointestinal adverse effects.² Doxycycline is contraindicated in pregnancy because of possible teratogenic effects on the teeth and bone of the fetus.

Reference

1. US Preventive Services Task Force. Final recommendation statement: cognitive impairment in older adults: screening. www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/cognitive-impairment-in-older-adults-screening. Published February 2020. Accessed March 19, 2020.

Reference

1. US Preventive Services Task Force. Final recommendation statement: cognitive impairment in older adults: screening. www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/cognitive-impairment-in-older-adults-screening. Published February 2020. Accessed March 19, 2020.

Reference

1. US Preventive Services Task Force. Final recommendation statement: cognitive impairment in older adults: screening. www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/cognitive-impairment-in-older-adults-screening. Published February 2020. Accessed March 19, 2020.