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Watch for abnormal movements in hospitalized COVID-19 patients
Myoclonus was diagnosed in about half of hospitalized COVID-19 patients who were evaluated for movement disorders, data from 50 cases show.
Abnormal movements often occur as complications from critical illness, and neurologic consultation can determine whether patients have experienced a seizure or stroke. However, restriction of bedside assessment in the wake of the COVID-19 pandemic increases the risk that abnormal movements will be missed, Jeffrey R. Clark and Eric M. Liotta, MD, of Northwestern University, Chicago, and colleagues wrote.
“Given the limited reports of abnormal movements in hospitalized COVID-19 patients and increased recognition of neurologic manifestations of COVID-19, we sought to examine the frequency and etiology of this finding as an indication of neurologic consultation,” they said.
In a study published in the Journal of the Neurological Sciences, the researchers reviewed data from the first 50 consecutive patients with COVID-19 symptoms who were hospitalized at a single center and underwent neurologic consultation between March 17, 2020, and May 18, 2020.
Overall, 11 patients (22.0%) of patients experienced abnormal movement, and all were admitted to the ICU within 7 days of meeting criteria for severe COVID-19. These patients included nine men and two women with an age range of 36-78 years. The most common comorbidities were obesity, hypertension, diabetes, chronic kidney disease, and coronary artery disease.
Myoclonus (generalized and focal) was the most common abnormal movement, and present in 6 of the 11 patients. Three cases were attributed to high-intensity sedation, and three to toxic-metabolic disturbances. In two patients, abnormal movements were attributed to focal seizures in the setting of encephalopathy, with focal facial twitching. An additional two patients experienced tremors; one showed an acute subdural hemorrhage on CT imaging. The second patient showed no sign of stroke or other abnormality on MRI and the tremor improved during the hospital stay. One patient who experienced abnormal high-amplitude nonrhythmic movements of the lower extremities was diagnosed with serotonin syndrome that resolved after discontinuing high-dose fentanyl.
The study findings were limited by several factors, including the small study population and limited availability of MRI, the researchers noted. Assessing severe COVID-19 cases in the ICU setting presents a challenge because of limited patient participation and the potentially confounding effects of sedation and mechanical ventilation.
However, the researchers said.
“A heightened awareness of abnormal eye movements, or subtle facial tremoring, may be the first steps in recognizing potentially dangerous neurologic manifestations,” and clinicians caring for patients with severe COVID-19 should be able to recognize abnormal movements and seek neurologic consultation when indicated, they emphasized.
The study was supported in part by grants to coauthors Nicholas J. Reish, MD, and Dr. Liotta from the National Institutes of Health. The researchers had no financial conflicts to disclose.
Myoclonus was diagnosed in about half of hospitalized COVID-19 patients who were evaluated for movement disorders, data from 50 cases show.
Abnormal movements often occur as complications from critical illness, and neurologic consultation can determine whether patients have experienced a seizure or stroke. However, restriction of bedside assessment in the wake of the COVID-19 pandemic increases the risk that abnormal movements will be missed, Jeffrey R. Clark and Eric M. Liotta, MD, of Northwestern University, Chicago, and colleagues wrote.
“Given the limited reports of abnormal movements in hospitalized COVID-19 patients and increased recognition of neurologic manifestations of COVID-19, we sought to examine the frequency and etiology of this finding as an indication of neurologic consultation,” they said.
In a study published in the Journal of the Neurological Sciences, the researchers reviewed data from the first 50 consecutive patients with COVID-19 symptoms who were hospitalized at a single center and underwent neurologic consultation between March 17, 2020, and May 18, 2020.
Overall, 11 patients (22.0%) of patients experienced abnormal movement, and all were admitted to the ICU within 7 days of meeting criteria for severe COVID-19. These patients included nine men and two women with an age range of 36-78 years. The most common comorbidities were obesity, hypertension, diabetes, chronic kidney disease, and coronary artery disease.
Myoclonus (generalized and focal) was the most common abnormal movement, and present in 6 of the 11 patients. Three cases were attributed to high-intensity sedation, and three to toxic-metabolic disturbances. In two patients, abnormal movements were attributed to focal seizures in the setting of encephalopathy, with focal facial twitching. An additional two patients experienced tremors; one showed an acute subdural hemorrhage on CT imaging. The second patient showed no sign of stroke or other abnormality on MRI and the tremor improved during the hospital stay. One patient who experienced abnormal high-amplitude nonrhythmic movements of the lower extremities was diagnosed with serotonin syndrome that resolved after discontinuing high-dose fentanyl.
The study findings were limited by several factors, including the small study population and limited availability of MRI, the researchers noted. Assessing severe COVID-19 cases in the ICU setting presents a challenge because of limited patient participation and the potentially confounding effects of sedation and mechanical ventilation.
However, the researchers said.
“A heightened awareness of abnormal eye movements, or subtle facial tremoring, may be the first steps in recognizing potentially dangerous neurologic manifestations,” and clinicians caring for patients with severe COVID-19 should be able to recognize abnormal movements and seek neurologic consultation when indicated, they emphasized.
The study was supported in part by grants to coauthors Nicholas J. Reish, MD, and Dr. Liotta from the National Institutes of Health. The researchers had no financial conflicts to disclose.
Myoclonus was diagnosed in about half of hospitalized COVID-19 patients who were evaluated for movement disorders, data from 50 cases show.
Abnormal movements often occur as complications from critical illness, and neurologic consultation can determine whether patients have experienced a seizure or stroke. However, restriction of bedside assessment in the wake of the COVID-19 pandemic increases the risk that abnormal movements will be missed, Jeffrey R. Clark and Eric M. Liotta, MD, of Northwestern University, Chicago, and colleagues wrote.
“Given the limited reports of abnormal movements in hospitalized COVID-19 patients and increased recognition of neurologic manifestations of COVID-19, we sought to examine the frequency and etiology of this finding as an indication of neurologic consultation,” they said.
In a study published in the Journal of the Neurological Sciences, the researchers reviewed data from the first 50 consecutive patients with COVID-19 symptoms who were hospitalized at a single center and underwent neurologic consultation between March 17, 2020, and May 18, 2020.
Overall, 11 patients (22.0%) of patients experienced abnormal movement, and all were admitted to the ICU within 7 days of meeting criteria for severe COVID-19. These patients included nine men and two women with an age range of 36-78 years. The most common comorbidities were obesity, hypertension, diabetes, chronic kidney disease, and coronary artery disease.
Myoclonus (generalized and focal) was the most common abnormal movement, and present in 6 of the 11 patients. Three cases were attributed to high-intensity sedation, and three to toxic-metabolic disturbances. In two patients, abnormal movements were attributed to focal seizures in the setting of encephalopathy, with focal facial twitching. An additional two patients experienced tremors; one showed an acute subdural hemorrhage on CT imaging. The second patient showed no sign of stroke or other abnormality on MRI and the tremor improved during the hospital stay. One patient who experienced abnormal high-amplitude nonrhythmic movements of the lower extremities was diagnosed with serotonin syndrome that resolved after discontinuing high-dose fentanyl.
The study findings were limited by several factors, including the small study population and limited availability of MRI, the researchers noted. Assessing severe COVID-19 cases in the ICU setting presents a challenge because of limited patient participation and the potentially confounding effects of sedation and mechanical ventilation.
However, the researchers said.
“A heightened awareness of abnormal eye movements, or subtle facial tremoring, may be the first steps in recognizing potentially dangerous neurologic manifestations,” and clinicians caring for patients with severe COVID-19 should be able to recognize abnormal movements and seek neurologic consultation when indicated, they emphasized.
The study was supported in part by grants to coauthors Nicholas J. Reish, MD, and Dr. Liotta from the National Institutes of Health. The researchers had no financial conflicts to disclose.
FROM THE JOURNAL OF THE NEUROLOGICAL SCIENCES
Twenty percent of dialysis patients are hesitant about COVID-19 vaccine
Among U.S. patients who regularly undergo hemodialysis, 20% had some degree of hesitancy about receiving a COVID-19 vaccine in a survey of 1,515 patients conducted during January and February 2021.
The most frequently cited concern associated with hesitancy over vaccination against the SARS-CoV-2 virus was with regard to possible adverse effects. This was cited by more than half of the patients who were concerned about being vaccinated.
Hesitancy rates were highest among people aged 44 years or younger, women, people who identified as non-Hispanic Black or non-Hispanic other (generally Native American or Pacific Islander), those with less than some college education, and those without a history of influenza vaccination, Pablo Garcia, MD, reported at the National Kidney Foundation (NKF) 2021 Spring Clinical Meetings.
Hesitancy or access?
Overall, however, the findings suggest that the main barrier to COVID-19 vaccine uptake is “access rather than hesitancy,” explained Dr. Garcia, a nephrologist at Stanford (Calif.) University. He predicts that this barrier will soon resolve, in part because of a Centers for Disease Control and Prevention program launched in March 2021 that is supplying COVID-19 vaccine to U.S. dialysis centers to administer to their patients.
“This will facilitate access to the vaccine” for patients who regularly receive hemodialysis, Dr. Garcia said during his presentation.
“Administering vaccines in dialysis clinics will help. Patients are already accustomed to receiving influenza vaccine in the clinic,” said Joseph A. Vassalotti, MD, a nephrologist at Mount Sinai Hospital, New York, and chief medical officer for the NKF.
Dr. Vassalotti cited the importance of protecting the vulnerable population of people who regularly receive hemodialysis. Among those patients, there was a 37% spike in all-cause mortality during peak weeks of the pandemic compared with similar periods during 2017-2019.
Any level of vaccine hesitancy is concerning
In an interview, he said, “Vaccination is the key to reducing this burden, so any level of vaccine hesitancy is concerning” with regard to patients who regularly undergo dialysis.
Hesitancy among patients who undergo dialysis appears to be less than in the general U.S. population, according to a series of surveys conducted from April through December 2020. In that series, hesitancy rates approached 50% in a sample of more than 8,000 people.
Hesitancy among people overall may have recently increased, at least for the short term, because of concerns over rare thrombotic events among people who receive certain types of COVID-19 vaccine, Dr. Vassalotti noted.
Dr. Garcia and associates conducted their survey from Jan. 8 to Feb. 11, 2021, among patients who regularly received hemodialysis at any of 150 randomly selected dialysis clinics that treat 30 or more patients and are managed by U.S. Renal Care. The study enrolled patients in 22 states. Most of the patients were aged 45-79 years; 30% were non-Hispanic White; 30% were Black, and 24% were Hispanic. The survey included 24 questions and took about 10 minutes to complete.
In reply to the statement, “If COVID-19 vaccine was proven safe and effective for the general population I would seek to get it,” 20% gave a reply of definitely not, probably not, or unsure; 79% answered either probably or definitely yes.
Another question asked about willingness to receive a vaccine if it was shown to be safe and effective for people receiving dialysis. In answer to that question, 19% said definitely not, probably not, or unsure.
Possible adverse effects an issue
Asked the reason why they were hesitant to receive the vaccine, 53% cited possible adverse effects; 19% cited general unease about vaccines; 19% said they did not think the COVID-19 vaccines would work; 17% said they did not think they needed a COVID-19 vaccine; and 15% said they had read or heard that COVID-19 vaccines were dangerous.
A set of questions asked survey respondents about their primary source of information about COVID-19 vaccines. About three-quarters cited television news; about 35% cited members of their dialysis clinic staff; about 30% cited friends and family; 20% cited social media; 20% cited their nephrologists; and roughly 15% cited newspapers.
The results suggest that potentially effective interventions to promote vaccine uptake include showing informational videos to patients during dialysis sessions and encouraging the staff at dialysis centers to proactively educate patients about COVID-19 vaccines and to promote uptake, suggest Dr. Garcia and Dr. Vassalotti.
Dr. Vassalotti noted that in a recent single-center survey of 90 U.S. patients undergoing hemodialysis that included 75 (85%) Black persons, the prevalence of hesitancy about COVID-19 vaccines was 50%. Hesitancy was often linked with gaps in patient education.
“We need broad educational measures, as well as targeting specific demographic groups” among whom the level of hesitancy is high, said Dr. Vassalotti.
He noted that patients who undergo dialysis are receptive to messages from dialysis clinic staff members and that this offers an “opportunity to understand misconceptions that underlie hesitancy and address them on an individual basis.”
The NKF has prepared a fact sheet for educating patients with kidney disease about the efficacy and safety of COVID-19 vaccines, Dr. Vassalotti noted.
Dr. Garcia has disclosed no relevant financial relationships. Dr. Vassalotti is an adviser and consultant to Renalytix AI and is a consultant to Janssen.
A version of this article first appeared on Medscape.com.
Among U.S. patients who regularly undergo hemodialysis, 20% had some degree of hesitancy about receiving a COVID-19 vaccine in a survey of 1,515 patients conducted during January and February 2021.
The most frequently cited concern associated with hesitancy over vaccination against the SARS-CoV-2 virus was with regard to possible adverse effects. This was cited by more than half of the patients who were concerned about being vaccinated.
Hesitancy rates were highest among people aged 44 years or younger, women, people who identified as non-Hispanic Black or non-Hispanic other (generally Native American or Pacific Islander), those with less than some college education, and those without a history of influenza vaccination, Pablo Garcia, MD, reported at the National Kidney Foundation (NKF) 2021 Spring Clinical Meetings.
Hesitancy or access?
Overall, however, the findings suggest that the main barrier to COVID-19 vaccine uptake is “access rather than hesitancy,” explained Dr. Garcia, a nephrologist at Stanford (Calif.) University. He predicts that this barrier will soon resolve, in part because of a Centers for Disease Control and Prevention program launched in March 2021 that is supplying COVID-19 vaccine to U.S. dialysis centers to administer to their patients.
“This will facilitate access to the vaccine” for patients who regularly receive hemodialysis, Dr. Garcia said during his presentation.
“Administering vaccines in dialysis clinics will help. Patients are already accustomed to receiving influenza vaccine in the clinic,” said Joseph A. Vassalotti, MD, a nephrologist at Mount Sinai Hospital, New York, and chief medical officer for the NKF.
Dr. Vassalotti cited the importance of protecting the vulnerable population of people who regularly receive hemodialysis. Among those patients, there was a 37% spike in all-cause mortality during peak weeks of the pandemic compared with similar periods during 2017-2019.
Any level of vaccine hesitancy is concerning
In an interview, he said, “Vaccination is the key to reducing this burden, so any level of vaccine hesitancy is concerning” with regard to patients who regularly undergo dialysis.
Hesitancy among patients who undergo dialysis appears to be less than in the general U.S. population, according to a series of surveys conducted from April through December 2020. In that series, hesitancy rates approached 50% in a sample of more than 8,000 people.
Hesitancy among people overall may have recently increased, at least for the short term, because of concerns over rare thrombotic events among people who receive certain types of COVID-19 vaccine, Dr. Vassalotti noted.
Dr. Garcia and associates conducted their survey from Jan. 8 to Feb. 11, 2021, among patients who regularly received hemodialysis at any of 150 randomly selected dialysis clinics that treat 30 or more patients and are managed by U.S. Renal Care. The study enrolled patients in 22 states. Most of the patients were aged 45-79 years; 30% were non-Hispanic White; 30% were Black, and 24% were Hispanic. The survey included 24 questions and took about 10 minutes to complete.
In reply to the statement, “If COVID-19 vaccine was proven safe and effective for the general population I would seek to get it,” 20% gave a reply of definitely not, probably not, or unsure; 79% answered either probably or definitely yes.
Another question asked about willingness to receive a vaccine if it was shown to be safe and effective for people receiving dialysis. In answer to that question, 19% said definitely not, probably not, or unsure.
Possible adverse effects an issue
Asked the reason why they were hesitant to receive the vaccine, 53% cited possible adverse effects; 19% cited general unease about vaccines; 19% said they did not think the COVID-19 vaccines would work; 17% said they did not think they needed a COVID-19 vaccine; and 15% said they had read or heard that COVID-19 vaccines were dangerous.
A set of questions asked survey respondents about their primary source of information about COVID-19 vaccines. About three-quarters cited television news; about 35% cited members of their dialysis clinic staff; about 30% cited friends and family; 20% cited social media; 20% cited their nephrologists; and roughly 15% cited newspapers.
The results suggest that potentially effective interventions to promote vaccine uptake include showing informational videos to patients during dialysis sessions and encouraging the staff at dialysis centers to proactively educate patients about COVID-19 vaccines and to promote uptake, suggest Dr. Garcia and Dr. Vassalotti.
Dr. Vassalotti noted that in a recent single-center survey of 90 U.S. patients undergoing hemodialysis that included 75 (85%) Black persons, the prevalence of hesitancy about COVID-19 vaccines was 50%. Hesitancy was often linked with gaps in patient education.
“We need broad educational measures, as well as targeting specific demographic groups” among whom the level of hesitancy is high, said Dr. Vassalotti.
He noted that patients who undergo dialysis are receptive to messages from dialysis clinic staff members and that this offers an “opportunity to understand misconceptions that underlie hesitancy and address them on an individual basis.”
The NKF has prepared a fact sheet for educating patients with kidney disease about the efficacy and safety of COVID-19 vaccines, Dr. Vassalotti noted.
Dr. Garcia has disclosed no relevant financial relationships. Dr. Vassalotti is an adviser and consultant to Renalytix AI and is a consultant to Janssen.
A version of this article first appeared on Medscape.com.
Among U.S. patients who regularly undergo hemodialysis, 20% had some degree of hesitancy about receiving a COVID-19 vaccine in a survey of 1,515 patients conducted during January and February 2021.
The most frequently cited concern associated with hesitancy over vaccination against the SARS-CoV-2 virus was with regard to possible adverse effects. This was cited by more than half of the patients who were concerned about being vaccinated.
Hesitancy rates were highest among people aged 44 years or younger, women, people who identified as non-Hispanic Black or non-Hispanic other (generally Native American or Pacific Islander), those with less than some college education, and those without a history of influenza vaccination, Pablo Garcia, MD, reported at the National Kidney Foundation (NKF) 2021 Spring Clinical Meetings.
Hesitancy or access?
Overall, however, the findings suggest that the main barrier to COVID-19 vaccine uptake is “access rather than hesitancy,” explained Dr. Garcia, a nephrologist at Stanford (Calif.) University. He predicts that this barrier will soon resolve, in part because of a Centers for Disease Control and Prevention program launched in March 2021 that is supplying COVID-19 vaccine to U.S. dialysis centers to administer to their patients.
“This will facilitate access to the vaccine” for patients who regularly receive hemodialysis, Dr. Garcia said during his presentation.
“Administering vaccines in dialysis clinics will help. Patients are already accustomed to receiving influenza vaccine in the clinic,” said Joseph A. Vassalotti, MD, a nephrologist at Mount Sinai Hospital, New York, and chief medical officer for the NKF.
Dr. Vassalotti cited the importance of protecting the vulnerable population of people who regularly receive hemodialysis. Among those patients, there was a 37% spike in all-cause mortality during peak weeks of the pandemic compared with similar periods during 2017-2019.
Any level of vaccine hesitancy is concerning
In an interview, he said, “Vaccination is the key to reducing this burden, so any level of vaccine hesitancy is concerning” with regard to patients who regularly undergo dialysis.
Hesitancy among patients who undergo dialysis appears to be less than in the general U.S. population, according to a series of surveys conducted from April through December 2020. In that series, hesitancy rates approached 50% in a sample of more than 8,000 people.
Hesitancy among people overall may have recently increased, at least for the short term, because of concerns over rare thrombotic events among people who receive certain types of COVID-19 vaccine, Dr. Vassalotti noted.
Dr. Garcia and associates conducted their survey from Jan. 8 to Feb. 11, 2021, among patients who regularly received hemodialysis at any of 150 randomly selected dialysis clinics that treat 30 or more patients and are managed by U.S. Renal Care. The study enrolled patients in 22 states. Most of the patients were aged 45-79 years; 30% were non-Hispanic White; 30% were Black, and 24% were Hispanic. The survey included 24 questions and took about 10 minutes to complete.
In reply to the statement, “If COVID-19 vaccine was proven safe and effective for the general population I would seek to get it,” 20% gave a reply of definitely not, probably not, or unsure; 79% answered either probably or definitely yes.
Another question asked about willingness to receive a vaccine if it was shown to be safe and effective for people receiving dialysis. In answer to that question, 19% said definitely not, probably not, or unsure.
Possible adverse effects an issue
Asked the reason why they were hesitant to receive the vaccine, 53% cited possible adverse effects; 19% cited general unease about vaccines; 19% said they did not think the COVID-19 vaccines would work; 17% said they did not think they needed a COVID-19 vaccine; and 15% said they had read or heard that COVID-19 vaccines were dangerous.
A set of questions asked survey respondents about their primary source of information about COVID-19 vaccines. About three-quarters cited television news; about 35% cited members of their dialysis clinic staff; about 30% cited friends and family; 20% cited social media; 20% cited their nephrologists; and roughly 15% cited newspapers.
The results suggest that potentially effective interventions to promote vaccine uptake include showing informational videos to patients during dialysis sessions and encouraging the staff at dialysis centers to proactively educate patients about COVID-19 vaccines and to promote uptake, suggest Dr. Garcia and Dr. Vassalotti.
Dr. Vassalotti noted that in a recent single-center survey of 90 U.S. patients undergoing hemodialysis that included 75 (85%) Black persons, the prevalence of hesitancy about COVID-19 vaccines was 50%. Hesitancy was often linked with gaps in patient education.
“We need broad educational measures, as well as targeting specific demographic groups” among whom the level of hesitancy is high, said Dr. Vassalotti.
He noted that patients who undergo dialysis are receptive to messages from dialysis clinic staff members and that this offers an “opportunity to understand misconceptions that underlie hesitancy and address them on an individual basis.”
The NKF has prepared a fact sheet for educating patients with kidney disease about the efficacy and safety of COVID-19 vaccines, Dr. Vassalotti noted.
Dr. Garcia has disclosed no relevant financial relationships. Dr. Vassalotti is an adviser and consultant to Renalytix AI and is a consultant to Janssen.
A version of this article first appeared on Medscape.com.
Addressing women’s concerns about the J&J vaccine
A rare form of venous thromboembolism (VTE) has developed in premenopausal women who have received the Johnson & Johnson (J&J) SARS-CoV-2 vaccine.
This week we learned that of the more than 6.8 million individuals in the United States who received the single-dose J&J vaccine, six women aged 18-48 years have been diagnosed with cerebral venous sinus thrombosis, and all had thrombocytopenia. In each case, symptoms were first noted 1-2 weeks after vaccination. The Food and Drug Administration and Centers for Disease Control and Prevention have recommended a pause in the administration of this vaccine.
Women’s health clinicians are already hearing from concerned patients, who understandably have questions about what this news means for them.
If they have already received the J&J vaccine within the past 3 weeks, I advise them that, although risks for any vaccine-related problems are extremely low, they should be mindful of new-onset leg or abdominal pain, or an unusual or severe headache. Such patients should contact their physician as soon as possible, and if they cannot be seen quickly, it would be appropriate to visit a hospital ED. When seeking medical care, patients should specify details of their vaccination history. Depending on the individual issues present, women with suggestive symptoms should receive blood work, Doppler venous studies (if there is a suspicion of lower-extremity deep vein thrombosis), and appropriate imaging (if there is concern for cerebral venous sinus thrombosis or pulmonary embolism).
As physicians and scientists at the CDC and FDA dig into this issue, I assume they are asking questions to determine whether the affected women have any factors that might increase their baseline risk for VTE, such as:
- A body mass index of at least 30 kg/m2
- Use of combination estrogen-progestin contraceptives (pill, ring, or patch)
- Known or suspected chronic inflammatory conditions such as rheumatoid arthritis, systemic lupus erythematosus, or
- Known familial or other thrombophilic conditions or chronic
- Recent prolonged immobility, such as a long airplane or automobile trip, which might increase risk for VTE
Experts say that the risk for a serious adverse event following receipt of the J&J vaccine is outweighed by the benefits of vaccination against COVID disease. However, that may not be enough to allay concerns among some premenopausal women.
Even if the “pause” in the administration of the vaccine is lifted, some women may be asking whether they should receive J&J’s viral vector vaccine or request one of the messenger RNA vaccines. I will be looking to the expert opinions of Anthony S. Fauci, MD, and advice from the CDC and FDA for guidance here. However, it may be reasonable to steer high-risk reproductive-age women away from the J&J vaccine in favor of the Moderna and Pfizer vaccines, if these options are available.
A version of this article first appeared on Medscape.com.
A rare form of venous thromboembolism (VTE) has developed in premenopausal women who have received the Johnson & Johnson (J&J) SARS-CoV-2 vaccine.
This week we learned that of the more than 6.8 million individuals in the United States who received the single-dose J&J vaccine, six women aged 18-48 years have been diagnosed with cerebral venous sinus thrombosis, and all had thrombocytopenia. In each case, symptoms were first noted 1-2 weeks after vaccination. The Food and Drug Administration and Centers for Disease Control and Prevention have recommended a pause in the administration of this vaccine.
Women’s health clinicians are already hearing from concerned patients, who understandably have questions about what this news means for them.
If they have already received the J&J vaccine within the past 3 weeks, I advise them that, although risks for any vaccine-related problems are extremely low, they should be mindful of new-onset leg or abdominal pain, or an unusual or severe headache. Such patients should contact their physician as soon as possible, and if they cannot be seen quickly, it would be appropriate to visit a hospital ED. When seeking medical care, patients should specify details of their vaccination history. Depending on the individual issues present, women with suggestive symptoms should receive blood work, Doppler venous studies (if there is a suspicion of lower-extremity deep vein thrombosis), and appropriate imaging (if there is concern for cerebral venous sinus thrombosis or pulmonary embolism).
As physicians and scientists at the CDC and FDA dig into this issue, I assume they are asking questions to determine whether the affected women have any factors that might increase their baseline risk for VTE, such as:
- A body mass index of at least 30 kg/m2
- Use of combination estrogen-progestin contraceptives (pill, ring, or patch)
- Known or suspected chronic inflammatory conditions such as rheumatoid arthritis, systemic lupus erythematosus, or
- Known familial or other thrombophilic conditions or chronic
- Recent prolonged immobility, such as a long airplane or automobile trip, which might increase risk for VTE
Experts say that the risk for a serious adverse event following receipt of the J&J vaccine is outweighed by the benefits of vaccination against COVID disease. However, that may not be enough to allay concerns among some premenopausal women.
Even if the “pause” in the administration of the vaccine is lifted, some women may be asking whether they should receive J&J’s viral vector vaccine or request one of the messenger RNA vaccines. I will be looking to the expert opinions of Anthony S. Fauci, MD, and advice from the CDC and FDA for guidance here. However, it may be reasonable to steer high-risk reproductive-age women away from the J&J vaccine in favor of the Moderna and Pfizer vaccines, if these options are available.
A version of this article first appeared on Medscape.com.
A rare form of venous thromboembolism (VTE) has developed in premenopausal women who have received the Johnson & Johnson (J&J) SARS-CoV-2 vaccine.
This week we learned that of the more than 6.8 million individuals in the United States who received the single-dose J&J vaccine, six women aged 18-48 years have been diagnosed with cerebral venous sinus thrombosis, and all had thrombocytopenia. In each case, symptoms were first noted 1-2 weeks after vaccination. The Food and Drug Administration and Centers for Disease Control and Prevention have recommended a pause in the administration of this vaccine.
Women’s health clinicians are already hearing from concerned patients, who understandably have questions about what this news means for them.
If they have already received the J&J vaccine within the past 3 weeks, I advise them that, although risks for any vaccine-related problems are extremely low, they should be mindful of new-onset leg or abdominal pain, or an unusual or severe headache. Such patients should contact their physician as soon as possible, and if they cannot be seen quickly, it would be appropriate to visit a hospital ED. When seeking medical care, patients should specify details of their vaccination history. Depending on the individual issues present, women with suggestive symptoms should receive blood work, Doppler venous studies (if there is a suspicion of lower-extremity deep vein thrombosis), and appropriate imaging (if there is concern for cerebral venous sinus thrombosis or pulmonary embolism).
As physicians and scientists at the CDC and FDA dig into this issue, I assume they are asking questions to determine whether the affected women have any factors that might increase their baseline risk for VTE, such as:
- A body mass index of at least 30 kg/m2
- Use of combination estrogen-progestin contraceptives (pill, ring, or patch)
- Known or suspected chronic inflammatory conditions such as rheumatoid arthritis, systemic lupus erythematosus, or
- Known familial or other thrombophilic conditions or chronic
- Recent prolonged immobility, such as a long airplane or automobile trip, which might increase risk for VTE
Experts say that the risk for a serious adverse event following receipt of the J&J vaccine is outweighed by the benefits of vaccination against COVID disease. However, that may not be enough to allay concerns among some premenopausal women.
Even if the “pause” in the administration of the vaccine is lifted, some women may be asking whether they should receive J&J’s viral vector vaccine or request one of the messenger RNA vaccines. I will be looking to the expert opinions of Anthony S. Fauci, MD, and advice from the CDC and FDA for guidance here. However, it may be reasonable to steer high-risk reproductive-age women away from the J&J vaccine in favor of the Moderna and Pfizer vaccines, if these options are available.
A version of this article first appeared on Medscape.com.
AGA News
AGAF applications now open
Applications are now open for the 2022 American Gastroenterological Association Fellowship cohort. AGA is proud to formally recognize its exemplary members whose accomplishments and contributions demonstrate a deep commitment to gastroenterology through the AGA Fellows Program. Those in clinical practice, education, or research (basic or clinical) are encouraged to apply today.
Longstanding members who apply and meet the program criteria are granted the distinguished honor of AGA Fellowship and receive the following:
- The privilege of using the designation “AGAF” in professional activities.
- An official certificate and pin denoting your status.
- International acknowledgment at Digestive Disease Week® (DDW).
- A listing on the AGA website alongside esteemed peers.
- A prewritten, fill-in press release and a digital badge to inform others of your accomplishment.
Apply for consideration and gain recognition worldwide for your commitment to the field. The deadline is Aug. 24.
Call for new AGA guideline topics
The AGA Institute Clinical Guidelines Committee wants your input on the next set of guidelines to be developed. By completing this online form, you can submit recommendations for guideline topics that will be developed within the next two years. The deadline to submit your ideas is Monday, May 3.
It’s easy – just take the following 3 steps to submit a guideline idea:
- Check out the guidelines that AGA has already developed or are in progress.
- Complete the survey. You can submit more than one guideline topic by filling out the form multiple times.
- Stay tuned for follow-up questions in case the committee needs more information on your recommendations.
The AGA Institute Clinical Guidelines Committee will review guideline topics in May, prioritizing and ranking topics based on the following criteria: prevalence of disease, resource utilization, variation in care, other existing guidelines, new data/changes in diagnosis or treatment, and potential for measure/quality development. Once vetted, four or more new guidelines will be recommended for development throughout the year. Complete the online survey at www.surveymonkey.com/r/AGAtopicsubmission
Get to know DDW® 2021 Virtual
The world’s premier meeting for gastroenterology, hepatology, endoscopy, and gastrointestinal surgery professionals will be a fully virtual event, May 21-23, 2021. We invite you to take advantage of this unique opportunity to exchange knowledge with colleagues from all over the world and explore the latest advances in the field – all from the convenience of your home. Plus, your registration grants you access to everything offered at Digestive Disease Week® (DDW) this year (no additional ticketed sessions). Learn more and register at ddw.org.
AGAF applications now open
Applications are now open for the 2022 American Gastroenterological Association Fellowship cohort. AGA is proud to formally recognize its exemplary members whose accomplishments and contributions demonstrate a deep commitment to gastroenterology through the AGA Fellows Program. Those in clinical practice, education, or research (basic or clinical) are encouraged to apply today.
Longstanding members who apply and meet the program criteria are granted the distinguished honor of AGA Fellowship and receive the following:
- The privilege of using the designation “AGAF” in professional activities.
- An official certificate and pin denoting your status.
- International acknowledgment at Digestive Disease Week® (DDW).
- A listing on the AGA website alongside esteemed peers.
- A prewritten, fill-in press release and a digital badge to inform others of your accomplishment.
Apply for consideration and gain recognition worldwide for your commitment to the field. The deadline is Aug. 24.
Call for new AGA guideline topics
The AGA Institute Clinical Guidelines Committee wants your input on the next set of guidelines to be developed. By completing this online form, you can submit recommendations for guideline topics that will be developed within the next two years. The deadline to submit your ideas is Monday, May 3.
It’s easy – just take the following 3 steps to submit a guideline idea:
- Check out the guidelines that AGA has already developed or are in progress.
- Complete the survey. You can submit more than one guideline topic by filling out the form multiple times.
- Stay tuned for follow-up questions in case the committee needs more information on your recommendations.
The AGA Institute Clinical Guidelines Committee will review guideline topics in May, prioritizing and ranking topics based on the following criteria: prevalence of disease, resource utilization, variation in care, other existing guidelines, new data/changes in diagnosis or treatment, and potential for measure/quality development. Once vetted, four or more new guidelines will be recommended for development throughout the year. Complete the online survey at www.surveymonkey.com/r/AGAtopicsubmission
Get to know DDW® 2021 Virtual
The world’s premier meeting for gastroenterology, hepatology, endoscopy, and gastrointestinal surgery professionals will be a fully virtual event, May 21-23, 2021. We invite you to take advantage of this unique opportunity to exchange knowledge with colleagues from all over the world and explore the latest advances in the field – all from the convenience of your home. Plus, your registration grants you access to everything offered at Digestive Disease Week® (DDW) this year (no additional ticketed sessions). Learn more and register at ddw.org.
AGAF applications now open
Applications are now open for the 2022 American Gastroenterological Association Fellowship cohort. AGA is proud to formally recognize its exemplary members whose accomplishments and contributions demonstrate a deep commitment to gastroenterology through the AGA Fellows Program. Those in clinical practice, education, or research (basic or clinical) are encouraged to apply today.
Longstanding members who apply and meet the program criteria are granted the distinguished honor of AGA Fellowship and receive the following:
- The privilege of using the designation “AGAF” in professional activities.
- An official certificate and pin denoting your status.
- International acknowledgment at Digestive Disease Week® (DDW).
- A listing on the AGA website alongside esteemed peers.
- A prewritten, fill-in press release and a digital badge to inform others of your accomplishment.
Apply for consideration and gain recognition worldwide for your commitment to the field. The deadline is Aug. 24.
Call for new AGA guideline topics
The AGA Institute Clinical Guidelines Committee wants your input on the next set of guidelines to be developed. By completing this online form, you can submit recommendations for guideline topics that will be developed within the next two years. The deadline to submit your ideas is Monday, May 3.
It’s easy – just take the following 3 steps to submit a guideline idea:
- Check out the guidelines that AGA has already developed or are in progress.
- Complete the survey. You can submit more than one guideline topic by filling out the form multiple times.
- Stay tuned for follow-up questions in case the committee needs more information on your recommendations.
The AGA Institute Clinical Guidelines Committee will review guideline topics in May, prioritizing and ranking topics based on the following criteria: prevalence of disease, resource utilization, variation in care, other existing guidelines, new data/changes in diagnosis or treatment, and potential for measure/quality development. Once vetted, four or more new guidelines will be recommended for development throughout the year. Complete the online survey at www.surveymonkey.com/r/AGAtopicsubmission
Get to know DDW® 2021 Virtual
The world’s premier meeting for gastroenterology, hepatology, endoscopy, and gastrointestinal surgery professionals will be a fully virtual event, May 21-23, 2021. We invite you to take advantage of this unique opportunity to exchange knowledge with colleagues from all over the world and explore the latest advances in the field – all from the convenience of your home. Plus, your registration grants you access to everything offered at Digestive Disease Week® (DDW) this year (no additional ticketed sessions). Learn more and register at ddw.org.
Cardiologists can perform stroke thrombectomy to fill ‘unmet need’
Cardiologists experienced in cardiac interventions can competently perform stroke thrombectomy after a short period of training, with outcomes comparable to those achieved by neuroradiology centers, a new study suggests.
“Using interventional cardiologists in this way will help address the huge unmet need for stroke thrombectomy that currently exists,” senior author Petr Widimsky, MD, said in an interview.
Although this may be a feasible way forward in Europe, there is strong opposition to such a proposal from U.S. neurointerventionalists.
The study, published in the April 12 issue of JACC: Cardiovascular Interventions, describes the establishment of a stroke thrombectomy program in University Hospital Kralovske Vinohrady, a large tertiary hospital in Prague, Czech Republic.
The hospital did not have a neurointerventional program until 2012 when a joint program was started involving an experienced team of cardiologists, angiologists, and one interventional radiologist who trained the cardiologists on the thrombectomy procedure.
The current paper reports on the outcomes of the 333 patients with large vessel occlusion stroke treated under this program between October 2012 and December 2019.
The decision to perform catheter-based thrombectomy was made by a neurologist and was based on acute stroke clinical symptoms and CT angiographic findings.
Results show that functional clinical outcomes, assessed via the Modified Rankin Scale (mRS) score at 3 months, did not vary significantly across years 2012 to 2019, with a favorable outcome (mRS 0 to 2) achieved in 47.9% of patients.
Symptomatic intracerebral hemorrhage occurred in 19 patients (5.7%) and embolization in a new vascular territory occurred in 6 patients (1.8%), outcomes similar to those of neuroradiology centers.
The desired clinical results were achieved from the onset of the program, without any signs of a learning curve effect, they reported.
“These findings support the potential role of interventional cardiac cath labs in the treatment of acute stroke in regions where this therapy is not readily available due to the lack of neurointerventionalists,” the authors concluded.
“Our main message is that our results were excellent from the beginning,” Dr. Widimsky said. “When centers prepare properly, they can achieve excellent results from the beginning with cardiologists who are experienced in interventional procedures and who have spent sufficient time learning about the brain.”
The authors noted that despite thrombectomy being an extremely beneficial treatment for severe stroke, many eligible patients remain untreated, largely because of a lack of neurointerventionalists in many regions worldwide. They estimate that about 15% of all stroke patients are eligible for thrombectomy but only around 2% of stroke patients in Europe actually receive such treatment.
Dr. Widimsky, an interventional cardiologist, first thought of the idea of using cardiologists to perform stroke thrombectomies after a good friend and colleague suffered a severe stroke in 2010.
“This made us realize that our hospital needed to be more active in the stroke field,” he said. “We decided that we needed to start doing stroke interventions.”
But the major problem was the lack of neurointerventionalists.
“There are not enough neurointerventionalists in Europe. Interventional cardiologists can perform thousands of procedures every year whereas a neurointerventionalist will at best perform hundreds a year. It is quicker and simpler to train the cardiologist to do it,” Dr. Widimsky said.
They hired one neurointerventionalist to lead the program. “He was our tutor, he taught us his skills,” Dr. Widimsky said. “The cath lab is open 24/7, but if we only have one neurointerventionalist we cannot offer a 24/7 service for stroke thrombectomy. But if we merge with cardiology then we can,” he added.
Their hospital is a very busy center for myocardial infarction, percutaneous coronary intervention, and carotid stenting, he noted. “It is not difficult to make the step from that to stroke thrombectomy. Interventional cardiologists are used to performing carotid and coronary artery stenting. Stroke thrombectomy is a similar technique. The thrombectomy procedure is different from coronary angioplasty but it is not more difficult. Actually, I think coronary angioplasty can be more difficult.”
Dr. Widimsky explained that cardiologists need to learn about the brain anatomy and physiology and learn the stroke imaging techniques. “I spent 1 month in the U.S. learning stroke interventions working with simulators,” he said. “I think interventional cardiologists can learn what they need to know in about 6 months. I would recommend they should watch about 50 procedures and perform at least 25 under supervision.”
He said this model is the way forward and hopes it will become routine. Thrombectomy is “tremendously effective” in improving outcomes in severe strokes, with a number needed to treat (NNT) of just 2.6 to prevent long-term disability in one patient, he said, while other procedures can have NNTs of 50 or more.
“But millions of patients with acute severe stroke are not getting this life-changing treatment,” he added. “We must do everything we can to make this service available to as many patients as possible.”
Dr. Widimsky acknowledges that there has been opposition to this idea from the neurointerventionalist professional bodies but this has lessened recently, at least in Europe. And a program that allows interventionalists with experience in extracranial carotid and vertebral endovascular procedures to “fast-track” technical training has now been proposed.
“There is an enormous unmet need for stroke thrombectomy in Europe, with some countries needing to increase the number of procedures done by 10 or 20 times. These include the U.K., Sweden, Italy, Spain, and Portugal. This cannot be done without cardiology,” Dr. Widimsky said.
Editorial strongly supportive
An accompanying editorial strongly endorses the idea of using interdisciplinary teams to deliver high standard stroke care.
Marius Hornung, MD, and Horst Sievert, MD, from CardioVascular Center Frankfurt (Germany), point out that many experienced cardiologists are trained in performing carotid artery interventions and are therefore experienced in accessing the supra-aortic arteries.
“To be able to guarantee optimized stroke therapy as soon as possible, disputes over competence among the individual medical societies involved must be ended,” they wrote.
They advocate for the creation of interdisciplinary teams, with diagnostics, patient selection, and follow-up care remaining the core competencies and tasks of neurology; in addition, they call for appropriately trained and experienced physicians – regardless of their specialties – performing acute stroke interventions and endovascular thrombectomy.
“Such a network must be installed as soon as possible to fulfill the mantra ‘time is brain’ ... and not losing unnecessary time to patient transfer, or continuing to offer only the second-best therapy,” they concluded.
Opposition in the United States
Dr. Widimsky explained that this proposal may not be so applicable to the United States, where the need for more clinicians capable of performing stroke thrombectomies does not appear to be as critical, possibly because vascular neurosurgeons as well as neuroradiologists are qualified to undertake these procedures.
In an interview, J. Mocco, MD, director of the cerebrovascular center, department of neurological surgery, at Mount Sinai Health System, New York, confirmed that this was the case.
“There is no legitimate data to support the claim that there is a lack of an adequate workforce to provide stroke thrombectomy, at least in the U.S.,” he said, adding that, rather, the primary limitation to patient access is a lack of adequate systems of care. “We should learn from the trauma model, which is strongly evidence based, and provide emergency stroke care in a similarly regionalized manner.”
Dr. Mocco, vice president of the Society of NeuroInterventional Surgery, was not impressed with the current study.
“This paper is a retrospective, single-center, unadjudicated, nonindependent assessor case series and therefore, as the authors acknowledge in the limitations section of their paper, it is invalid to compare these data to the results from high-quality, prospective, core-lab, and independent assessor adjudicated randomized trials,” he said. “The supposition that this trial provides evidence that the reported model should be widely considered lacks scientific rigor.”
Furthermore, “the interventional cardiology literature is replete with data regarding the importance of technical expertise and content knowledge,” he added. “Why would that community now propose that such expertise and knowledge is not necessary for the brain?”
Dr. Mocco argues that the concept that interventional cardiologists should be fast-tracked to perform stroke interventions because they use similar tools, navigate blood vessels, and are comfortable working in critical situations, does not hold up.
“Liver surgeons and brain surgeons are both familiar with tissue manipulation, are used to operating in critical situations, and use cautery, scissors, and scalpels; but no one would argue that a brain surgeon should be fast-tracked to perform liver surgery, or vice versa.”
He added: “Stroke patients do not have the luxury of choosing the physician who provides their thrombectomy. We should do everything reasonable to ensure that our systems of care are organized so that these vulnerable patients are treated by physicians who have appropriate knowledge and expertise.”
This study was supported by the Charles University Research program. The authors and editorialists have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Cardiologists experienced in cardiac interventions can competently perform stroke thrombectomy after a short period of training, with outcomes comparable to those achieved by neuroradiology centers, a new study suggests.
“Using interventional cardiologists in this way will help address the huge unmet need for stroke thrombectomy that currently exists,” senior author Petr Widimsky, MD, said in an interview.
Although this may be a feasible way forward in Europe, there is strong opposition to such a proposal from U.S. neurointerventionalists.
The study, published in the April 12 issue of JACC: Cardiovascular Interventions, describes the establishment of a stroke thrombectomy program in University Hospital Kralovske Vinohrady, a large tertiary hospital in Prague, Czech Republic.
The hospital did not have a neurointerventional program until 2012 when a joint program was started involving an experienced team of cardiologists, angiologists, and one interventional radiologist who trained the cardiologists on the thrombectomy procedure.
The current paper reports on the outcomes of the 333 patients with large vessel occlusion stroke treated under this program between October 2012 and December 2019.
The decision to perform catheter-based thrombectomy was made by a neurologist and was based on acute stroke clinical symptoms and CT angiographic findings.
Results show that functional clinical outcomes, assessed via the Modified Rankin Scale (mRS) score at 3 months, did not vary significantly across years 2012 to 2019, with a favorable outcome (mRS 0 to 2) achieved in 47.9% of patients.
Symptomatic intracerebral hemorrhage occurred in 19 patients (5.7%) and embolization in a new vascular territory occurred in 6 patients (1.8%), outcomes similar to those of neuroradiology centers.
The desired clinical results were achieved from the onset of the program, without any signs of a learning curve effect, they reported.
“These findings support the potential role of interventional cardiac cath labs in the treatment of acute stroke in regions where this therapy is not readily available due to the lack of neurointerventionalists,” the authors concluded.
“Our main message is that our results were excellent from the beginning,” Dr. Widimsky said. “When centers prepare properly, they can achieve excellent results from the beginning with cardiologists who are experienced in interventional procedures and who have spent sufficient time learning about the brain.”
The authors noted that despite thrombectomy being an extremely beneficial treatment for severe stroke, many eligible patients remain untreated, largely because of a lack of neurointerventionalists in many regions worldwide. They estimate that about 15% of all stroke patients are eligible for thrombectomy but only around 2% of stroke patients in Europe actually receive such treatment.
Dr. Widimsky, an interventional cardiologist, first thought of the idea of using cardiologists to perform stroke thrombectomies after a good friend and colleague suffered a severe stroke in 2010.
“This made us realize that our hospital needed to be more active in the stroke field,” he said. “We decided that we needed to start doing stroke interventions.”
But the major problem was the lack of neurointerventionalists.
“There are not enough neurointerventionalists in Europe. Interventional cardiologists can perform thousands of procedures every year whereas a neurointerventionalist will at best perform hundreds a year. It is quicker and simpler to train the cardiologist to do it,” Dr. Widimsky said.
They hired one neurointerventionalist to lead the program. “He was our tutor, he taught us his skills,” Dr. Widimsky said. “The cath lab is open 24/7, but if we only have one neurointerventionalist we cannot offer a 24/7 service for stroke thrombectomy. But if we merge with cardiology then we can,” he added.
Their hospital is a very busy center for myocardial infarction, percutaneous coronary intervention, and carotid stenting, he noted. “It is not difficult to make the step from that to stroke thrombectomy. Interventional cardiologists are used to performing carotid and coronary artery stenting. Stroke thrombectomy is a similar technique. The thrombectomy procedure is different from coronary angioplasty but it is not more difficult. Actually, I think coronary angioplasty can be more difficult.”
Dr. Widimsky explained that cardiologists need to learn about the brain anatomy and physiology and learn the stroke imaging techniques. “I spent 1 month in the U.S. learning stroke interventions working with simulators,” he said. “I think interventional cardiologists can learn what they need to know in about 6 months. I would recommend they should watch about 50 procedures and perform at least 25 under supervision.”
He said this model is the way forward and hopes it will become routine. Thrombectomy is “tremendously effective” in improving outcomes in severe strokes, with a number needed to treat (NNT) of just 2.6 to prevent long-term disability in one patient, he said, while other procedures can have NNTs of 50 or more.
“But millions of patients with acute severe stroke are not getting this life-changing treatment,” he added. “We must do everything we can to make this service available to as many patients as possible.”
Dr. Widimsky acknowledges that there has been opposition to this idea from the neurointerventionalist professional bodies but this has lessened recently, at least in Europe. And a program that allows interventionalists with experience in extracranial carotid and vertebral endovascular procedures to “fast-track” technical training has now been proposed.
“There is an enormous unmet need for stroke thrombectomy in Europe, with some countries needing to increase the number of procedures done by 10 or 20 times. These include the U.K., Sweden, Italy, Spain, and Portugal. This cannot be done without cardiology,” Dr. Widimsky said.
Editorial strongly supportive
An accompanying editorial strongly endorses the idea of using interdisciplinary teams to deliver high standard stroke care.
Marius Hornung, MD, and Horst Sievert, MD, from CardioVascular Center Frankfurt (Germany), point out that many experienced cardiologists are trained in performing carotid artery interventions and are therefore experienced in accessing the supra-aortic arteries.
“To be able to guarantee optimized stroke therapy as soon as possible, disputes over competence among the individual medical societies involved must be ended,” they wrote.
They advocate for the creation of interdisciplinary teams, with diagnostics, patient selection, and follow-up care remaining the core competencies and tasks of neurology; in addition, they call for appropriately trained and experienced physicians – regardless of their specialties – performing acute stroke interventions and endovascular thrombectomy.
“Such a network must be installed as soon as possible to fulfill the mantra ‘time is brain’ ... and not losing unnecessary time to patient transfer, or continuing to offer only the second-best therapy,” they concluded.
Opposition in the United States
Dr. Widimsky explained that this proposal may not be so applicable to the United States, where the need for more clinicians capable of performing stroke thrombectomies does not appear to be as critical, possibly because vascular neurosurgeons as well as neuroradiologists are qualified to undertake these procedures.
In an interview, J. Mocco, MD, director of the cerebrovascular center, department of neurological surgery, at Mount Sinai Health System, New York, confirmed that this was the case.
“There is no legitimate data to support the claim that there is a lack of an adequate workforce to provide stroke thrombectomy, at least in the U.S.,” he said, adding that, rather, the primary limitation to patient access is a lack of adequate systems of care. “We should learn from the trauma model, which is strongly evidence based, and provide emergency stroke care in a similarly regionalized manner.”
Dr. Mocco, vice president of the Society of NeuroInterventional Surgery, was not impressed with the current study.
“This paper is a retrospective, single-center, unadjudicated, nonindependent assessor case series and therefore, as the authors acknowledge in the limitations section of their paper, it is invalid to compare these data to the results from high-quality, prospective, core-lab, and independent assessor adjudicated randomized trials,” he said. “The supposition that this trial provides evidence that the reported model should be widely considered lacks scientific rigor.”
Furthermore, “the interventional cardiology literature is replete with data regarding the importance of technical expertise and content knowledge,” he added. “Why would that community now propose that such expertise and knowledge is not necessary for the brain?”
Dr. Mocco argues that the concept that interventional cardiologists should be fast-tracked to perform stroke interventions because they use similar tools, navigate blood vessels, and are comfortable working in critical situations, does not hold up.
“Liver surgeons and brain surgeons are both familiar with tissue manipulation, are used to operating in critical situations, and use cautery, scissors, and scalpels; but no one would argue that a brain surgeon should be fast-tracked to perform liver surgery, or vice versa.”
He added: “Stroke patients do not have the luxury of choosing the physician who provides their thrombectomy. We should do everything reasonable to ensure that our systems of care are organized so that these vulnerable patients are treated by physicians who have appropriate knowledge and expertise.”
This study was supported by the Charles University Research program. The authors and editorialists have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Cardiologists experienced in cardiac interventions can competently perform stroke thrombectomy after a short period of training, with outcomes comparable to those achieved by neuroradiology centers, a new study suggests.
“Using interventional cardiologists in this way will help address the huge unmet need for stroke thrombectomy that currently exists,” senior author Petr Widimsky, MD, said in an interview.
Although this may be a feasible way forward in Europe, there is strong opposition to such a proposal from U.S. neurointerventionalists.
The study, published in the April 12 issue of JACC: Cardiovascular Interventions, describes the establishment of a stroke thrombectomy program in University Hospital Kralovske Vinohrady, a large tertiary hospital in Prague, Czech Republic.
The hospital did not have a neurointerventional program until 2012 when a joint program was started involving an experienced team of cardiologists, angiologists, and one interventional radiologist who trained the cardiologists on the thrombectomy procedure.
The current paper reports on the outcomes of the 333 patients with large vessel occlusion stroke treated under this program between October 2012 and December 2019.
The decision to perform catheter-based thrombectomy was made by a neurologist and was based on acute stroke clinical symptoms and CT angiographic findings.
Results show that functional clinical outcomes, assessed via the Modified Rankin Scale (mRS) score at 3 months, did not vary significantly across years 2012 to 2019, with a favorable outcome (mRS 0 to 2) achieved in 47.9% of patients.
Symptomatic intracerebral hemorrhage occurred in 19 patients (5.7%) and embolization in a new vascular territory occurred in 6 patients (1.8%), outcomes similar to those of neuroradiology centers.
The desired clinical results were achieved from the onset of the program, without any signs of a learning curve effect, they reported.
“These findings support the potential role of interventional cardiac cath labs in the treatment of acute stroke in regions where this therapy is not readily available due to the lack of neurointerventionalists,” the authors concluded.
“Our main message is that our results were excellent from the beginning,” Dr. Widimsky said. “When centers prepare properly, they can achieve excellent results from the beginning with cardiologists who are experienced in interventional procedures and who have spent sufficient time learning about the brain.”
The authors noted that despite thrombectomy being an extremely beneficial treatment for severe stroke, many eligible patients remain untreated, largely because of a lack of neurointerventionalists in many regions worldwide. They estimate that about 15% of all stroke patients are eligible for thrombectomy but only around 2% of stroke patients in Europe actually receive such treatment.
Dr. Widimsky, an interventional cardiologist, first thought of the idea of using cardiologists to perform stroke thrombectomies after a good friend and colleague suffered a severe stroke in 2010.
“This made us realize that our hospital needed to be more active in the stroke field,” he said. “We decided that we needed to start doing stroke interventions.”
But the major problem was the lack of neurointerventionalists.
“There are not enough neurointerventionalists in Europe. Interventional cardiologists can perform thousands of procedures every year whereas a neurointerventionalist will at best perform hundreds a year. It is quicker and simpler to train the cardiologist to do it,” Dr. Widimsky said.
They hired one neurointerventionalist to lead the program. “He was our tutor, he taught us his skills,” Dr. Widimsky said. “The cath lab is open 24/7, but if we only have one neurointerventionalist we cannot offer a 24/7 service for stroke thrombectomy. But if we merge with cardiology then we can,” he added.
Their hospital is a very busy center for myocardial infarction, percutaneous coronary intervention, and carotid stenting, he noted. “It is not difficult to make the step from that to stroke thrombectomy. Interventional cardiologists are used to performing carotid and coronary artery stenting. Stroke thrombectomy is a similar technique. The thrombectomy procedure is different from coronary angioplasty but it is not more difficult. Actually, I think coronary angioplasty can be more difficult.”
Dr. Widimsky explained that cardiologists need to learn about the brain anatomy and physiology and learn the stroke imaging techniques. “I spent 1 month in the U.S. learning stroke interventions working with simulators,” he said. “I think interventional cardiologists can learn what they need to know in about 6 months. I would recommend they should watch about 50 procedures and perform at least 25 under supervision.”
He said this model is the way forward and hopes it will become routine. Thrombectomy is “tremendously effective” in improving outcomes in severe strokes, with a number needed to treat (NNT) of just 2.6 to prevent long-term disability in one patient, he said, while other procedures can have NNTs of 50 or more.
“But millions of patients with acute severe stroke are not getting this life-changing treatment,” he added. “We must do everything we can to make this service available to as many patients as possible.”
Dr. Widimsky acknowledges that there has been opposition to this idea from the neurointerventionalist professional bodies but this has lessened recently, at least in Europe. And a program that allows interventionalists with experience in extracranial carotid and vertebral endovascular procedures to “fast-track” technical training has now been proposed.
“There is an enormous unmet need for stroke thrombectomy in Europe, with some countries needing to increase the number of procedures done by 10 or 20 times. These include the U.K., Sweden, Italy, Spain, and Portugal. This cannot be done without cardiology,” Dr. Widimsky said.
Editorial strongly supportive
An accompanying editorial strongly endorses the idea of using interdisciplinary teams to deliver high standard stroke care.
Marius Hornung, MD, and Horst Sievert, MD, from CardioVascular Center Frankfurt (Germany), point out that many experienced cardiologists are trained in performing carotid artery interventions and are therefore experienced in accessing the supra-aortic arteries.
“To be able to guarantee optimized stroke therapy as soon as possible, disputes over competence among the individual medical societies involved must be ended,” they wrote.
They advocate for the creation of interdisciplinary teams, with diagnostics, patient selection, and follow-up care remaining the core competencies and tasks of neurology; in addition, they call for appropriately trained and experienced physicians – regardless of their specialties – performing acute stroke interventions and endovascular thrombectomy.
“Such a network must be installed as soon as possible to fulfill the mantra ‘time is brain’ ... and not losing unnecessary time to patient transfer, or continuing to offer only the second-best therapy,” they concluded.
Opposition in the United States
Dr. Widimsky explained that this proposal may not be so applicable to the United States, where the need for more clinicians capable of performing stroke thrombectomies does not appear to be as critical, possibly because vascular neurosurgeons as well as neuroradiologists are qualified to undertake these procedures.
In an interview, J. Mocco, MD, director of the cerebrovascular center, department of neurological surgery, at Mount Sinai Health System, New York, confirmed that this was the case.
“There is no legitimate data to support the claim that there is a lack of an adequate workforce to provide stroke thrombectomy, at least in the U.S.,” he said, adding that, rather, the primary limitation to patient access is a lack of adequate systems of care. “We should learn from the trauma model, which is strongly evidence based, and provide emergency stroke care in a similarly regionalized manner.”
Dr. Mocco, vice president of the Society of NeuroInterventional Surgery, was not impressed with the current study.
“This paper is a retrospective, single-center, unadjudicated, nonindependent assessor case series and therefore, as the authors acknowledge in the limitations section of their paper, it is invalid to compare these data to the results from high-quality, prospective, core-lab, and independent assessor adjudicated randomized trials,” he said. “The supposition that this trial provides evidence that the reported model should be widely considered lacks scientific rigor.”
Furthermore, “the interventional cardiology literature is replete with data regarding the importance of technical expertise and content knowledge,” he added. “Why would that community now propose that such expertise and knowledge is not necessary for the brain?”
Dr. Mocco argues that the concept that interventional cardiologists should be fast-tracked to perform stroke interventions because they use similar tools, navigate blood vessels, and are comfortable working in critical situations, does not hold up.
“Liver surgeons and brain surgeons are both familiar with tissue manipulation, are used to operating in critical situations, and use cautery, scissors, and scalpels; but no one would argue that a brain surgeon should be fast-tracked to perform liver surgery, or vice versa.”
He added: “Stroke patients do not have the luxury of choosing the physician who provides their thrombectomy. We should do everything reasonable to ensure that our systems of care are organized so that these vulnerable patients are treated by physicians who have appropriate knowledge and expertise.”
This study was supported by the Charles University Research program. The authors and editorialists have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
May 2021 – ICYMI
Gastroenterology
February 2021
Worldwide burden of, risk factors for, and trends in pancreatic cancer
Huang J et al. Gastroenterology. 2021 Mar 1;160(4):744-54. doi: 10.1053/j.gastro.2020.10.007.
Fibrates for Itch (FITCH) in fibrosing cholangiopathies: A double-blind, randomized, placebo-controlled trial
de Vries E et al. Gastroenterology. 2021 Mar 1;160(4):734-43.e6. doi: 10.1053/j.gastro.2020.10.001.
March 2021
How to integrate a medical ethics curriculum into gastroenterology fellowships
Rao VL et al. Gastroenterology. 2021 Mar 1;160(4):1003-6. https://doi.org/10.1053/j.gastro.2021.01.211.
Colonoscopist performance and colorectal cancer risk after adenoma removal to stratify surveillance: two nationwide observational studies
Wieszczy P et al. Gastroenterology. 2021 Mar 1;160(4):1067-74. doi: 10.1053/j.gastro.2020.10.009.
Pregnancy and neonatal outcomes after fetal exposure to biologics and thiopurines among women with inflammatory bowel disease
Mahadevan U et al. Gastroenterology. 2021 Mar 1;160(4):1131-9. doi: 10.1053/j.gastro.2020.11.038.
April 2021
AGA Clinical Practice Guidelines on intragastric balloons in the management of obesity
Muniraj T et al. Gastroenterology. 2021 Apr 1;160(5):1799-808. doi: 10.1053/j.gastro.2021.03.003.
How to strategically build your network for early career gastroenterologists
Gaidos JKJ et al. Gastroenterology. 2021 Apr 1;160(5):1461-6. doi: 10.1053/j.gastro.2021.01.025.
The microbiota-gut-brain axis: From motility to mood
Margolis KG et al. Gastroenterology. 2021 Apr 1;160(5):1486-501. doi: 10.1053/j.gastro.2020.10.066.
The association of histologic and noninvasive tests with adverse clinical and patient-reported outcomes in patients with advanced fibrosis due to nonalcoholic steatohepatitis
Younossi ZM et al. Gastroenterology. 2021 Apr 1;160(5):1608-19. doi: 10.1053/j.gastro.2020.12.003.
Clinical Gastroenterology and Hepatology
February 2021
Management of chronic abdominal distension and bloating
Lacy BE et al. Clin Gastroenterol Hepatol. 2021 Feb 1;19(2):219-31. doi: 10.1016/j.cgh.2020.03.056.
Prevalence of gastric intestinal metaplasia in a multiethnic US veterans population
Nguyen TH et al. Clin Gastroenterol Hepatol. 2021 Feb 1;19(2):269-76. doi: 10.1016/j.cgh.2020.03.015.
Rome IV functional gastrointestinal disorders and health impairment in subjects with hypermobility spectrum disorders or hypermobile Ehlers-Danlos syndrome
Lam CY et al. Clin Gastroenterol Hepatol. 2021 Feb 1;19(2):277-87. doi: 10.1016/j.cgh.2020.02.034.
Factors that affect adequacy of colon cleansing for colonoscopy in hospitalized patients
Fucci L et al. Clin Gastroenterol Hepatol. 2021 Feb 1;19(2):339-48. doi: org/10.1016/j.cgh.2020.02.055.
March 2021
Real-world gluten exposure in patients with celiac disease on gluten-free diets, determined from gliadin immunogenic peptides in urine and fecal samples
Stefanolo JP et al. Clin Gastroenterol Hepatol. 2021 Mar 1;19(3):484-91. doi: 10.1016/j.cgh.2020.03.038.
Factors associated with response to anorectal biofeedback therapy in patients with fecal incontinence
Mazor Y et al. Clin Gastroenterol Hepatol. 2021 Mar 1;19(3):492-502. doi: 10.1016/j.cgh.2020.03.050.
April 2021
Long-term outcome of gastric per-oral endoscopic pyloromyotomy in treatment of gastroparesis
Abdelfatah MM et al. Clin Gastroenterol Hepatol. 2021 Apr 1;19(4):816-24. doi: 10.1016/j.cgh.2020.05.039.
What gastroenterologists should know about COVID-19 vaccines
Rolak S et al. Clin Gastroenterol Hepatol. 2021 Apr 1;19(4):657-61. doi: 10.1016/j.cgh.2021.01.001.
No benefit of concomitant immunomodulator therapy on efficacy of biologics that are not tumor necrosis factor antagonists in patients with inflammatory bowel diseases: A meta-analysis
Yzet C et al. Clin Gastroenterol Hepatol. 2021 Apr 1;19(4):668-78. doi: 10.1016/j.cgh.2020.06.071.
Patient safety reporting in GI: All hands on deck
Wall A and Kothari D. Clin Gastroenterol Hepatol. 2021 Apr 1;19(4):626-32. doi: 10.1016/j.cgh.2020.11.007.
Techniques and Innovations in Gastrointestinal Endoscopy
Barriers and pitfalls for artificial intelligence in gastroenterology: Ethical and regulatory issues
Ahmad OF et al. Tech Innov Gastrointest Endosc. 2020 Apr 1;22(2):80-4. doi: 10.1016/j.tgie.2019.150636.
Development of a scoring system to predict a positive diagnosis on video capsule endoscopy for suspected small bowel bleeding
Marya NB et al. Tech Innov Gastrointest Endosc. 2020 Oct 1;22(4):178-84. doi: 10.1016/j.tige.2020.06.001.
Training for Advanced Endoscopic Imaging in Gastrointestinal Diseases
Hoogenboom SA et al. Tech Innov Gastrointest Endosc. 2021 Jan 1;23(1):99-106. doi: 10.1016/j.tige.2020.09.001.
Chromoendoscopy techniques in imaging of colorectal polyps and cancer: Overview and practical applications for detection and characterization.
Rivero-Sanchez L et al. Tech Innov Gastrointest Endosc. 2021 Jan 1;23(1):30-41. doi: 10.1016/j.tige.2020.10.006.
Gastroenterology
February 2021
Worldwide burden of, risk factors for, and trends in pancreatic cancer
Huang J et al. Gastroenterology. 2021 Mar 1;160(4):744-54. doi: 10.1053/j.gastro.2020.10.007.
Fibrates for Itch (FITCH) in fibrosing cholangiopathies: A double-blind, randomized, placebo-controlled trial
de Vries E et al. Gastroenterology. 2021 Mar 1;160(4):734-43.e6. doi: 10.1053/j.gastro.2020.10.001.
March 2021
How to integrate a medical ethics curriculum into gastroenterology fellowships
Rao VL et al. Gastroenterology. 2021 Mar 1;160(4):1003-6. https://doi.org/10.1053/j.gastro.2021.01.211.
Colonoscopist performance and colorectal cancer risk after adenoma removal to stratify surveillance: two nationwide observational studies
Wieszczy P et al. Gastroenterology. 2021 Mar 1;160(4):1067-74. doi: 10.1053/j.gastro.2020.10.009.
Pregnancy and neonatal outcomes after fetal exposure to biologics and thiopurines among women with inflammatory bowel disease
Mahadevan U et al. Gastroenterology. 2021 Mar 1;160(4):1131-9. doi: 10.1053/j.gastro.2020.11.038.
April 2021
AGA Clinical Practice Guidelines on intragastric balloons in the management of obesity
Muniraj T et al. Gastroenterology. 2021 Apr 1;160(5):1799-808. doi: 10.1053/j.gastro.2021.03.003.
How to strategically build your network for early career gastroenterologists
Gaidos JKJ et al. Gastroenterology. 2021 Apr 1;160(5):1461-6. doi: 10.1053/j.gastro.2021.01.025.
The microbiota-gut-brain axis: From motility to mood
Margolis KG et al. Gastroenterology. 2021 Apr 1;160(5):1486-501. doi: 10.1053/j.gastro.2020.10.066.
The association of histologic and noninvasive tests with adverse clinical and patient-reported outcomes in patients with advanced fibrosis due to nonalcoholic steatohepatitis
Younossi ZM et al. Gastroenterology. 2021 Apr 1;160(5):1608-19. doi: 10.1053/j.gastro.2020.12.003.
Clinical Gastroenterology and Hepatology
February 2021
Management of chronic abdominal distension and bloating
Lacy BE et al. Clin Gastroenterol Hepatol. 2021 Feb 1;19(2):219-31. doi: 10.1016/j.cgh.2020.03.056.
Prevalence of gastric intestinal metaplasia in a multiethnic US veterans population
Nguyen TH et al. Clin Gastroenterol Hepatol. 2021 Feb 1;19(2):269-76. doi: 10.1016/j.cgh.2020.03.015.
Rome IV functional gastrointestinal disorders and health impairment in subjects with hypermobility spectrum disorders or hypermobile Ehlers-Danlos syndrome
Lam CY et al. Clin Gastroenterol Hepatol. 2021 Feb 1;19(2):277-87. doi: 10.1016/j.cgh.2020.02.034.
Factors that affect adequacy of colon cleansing for colonoscopy in hospitalized patients
Fucci L et al. Clin Gastroenterol Hepatol. 2021 Feb 1;19(2):339-48. doi: org/10.1016/j.cgh.2020.02.055.
March 2021
Real-world gluten exposure in patients with celiac disease on gluten-free diets, determined from gliadin immunogenic peptides in urine and fecal samples
Stefanolo JP et al. Clin Gastroenterol Hepatol. 2021 Mar 1;19(3):484-91. doi: 10.1016/j.cgh.2020.03.038.
Factors associated with response to anorectal biofeedback therapy in patients with fecal incontinence
Mazor Y et al. Clin Gastroenterol Hepatol. 2021 Mar 1;19(3):492-502. doi: 10.1016/j.cgh.2020.03.050.
April 2021
Long-term outcome of gastric per-oral endoscopic pyloromyotomy in treatment of gastroparesis
Abdelfatah MM et al. Clin Gastroenterol Hepatol. 2021 Apr 1;19(4):816-24. doi: 10.1016/j.cgh.2020.05.039.
What gastroenterologists should know about COVID-19 vaccines
Rolak S et al. Clin Gastroenterol Hepatol. 2021 Apr 1;19(4):657-61. doi: 10.1016/j.cgh.2021.01.001.
No benefit of concomitant immunomodulator therapy on efficacy of biologics that are not tumor necrosis factor antagonists in patients with inflammatory bowel diseases: A meta-analysis
Yzet C et al. Clin Gastroenterol Hepatol. 2021 Apr 1;19(4):668-78. doi: 10.1016/j.cgh.2020.06.071.
Patient safety reporting in GI: All hands on deck
Wall A and Kothari D. Clin Gastroenterol Hepatol. 2021 Apr 1;19(4):626-32. doi: 10.1016/j.cgh.2020.11.007.
Techniques and Innovations in Gastrointestinal Endoscopy
Barriers and pitfalls for artificial intelligence in gastroenterology: Ethical and regulatory issues
Ahmad OF et al. Tech Innov Gastrointest Endosc. 2020 Apr 1;22(2):80-4. doi: 10.1016/j.tgie.2019.150636.
Development of a scoring system to predict a positive diagnosis on video capsule endoscopy for suspected small bowel bleeding
Marya NB et al. Tech Innov Gastrointest Endosc. 2020 Oct 1;22(4):178-84. doi: 10.1016/j.tige.2020.06.001.
Training for Advanced Endoscopic Imaging in Gastrointestinal Diseases
Hoogenboom SA et al. Tech Innov Gastrointest Endosc. 2021 Jan 1;23(1):99-106. doi: 10.1016/j.tige.2020.09.001.
Chromoendoscopy techniques in imaging of colorectal polyps and cancer: Overview and practical applications for detection and characterization.
Rivero-Sanchez L et al. Tech Innov Gastrointest Endosc. 2021 Jan 1;23(1):30-41. doi: 10.1016/j.tige.2020.10.006.
Gastroenterology
February 2021
Worldwide burden of, risk factors for, and trends in pancreatic cancer
Huang J et al. Gastroenterology. 2021 Mar 1;160(4):744-54. doi: 10.1053/j.gastro.2020.10.007.
Fibrates for Itch (FITCH) in fibrosing cholangiopathies: A double-blind, randomized, placebo-controlled trial
de Vries E et al. Gastroenterology. 2021 Mar 1;160(4):734-43.e6. doi: 10.1053/j.gastro.2020.10.001.
March 2021
How to integrate a medical ethics curriculum into gastroenterology fellowships
Rao VL et al. Gastroenterology. 2021 Mar 1;160(4):1003-6. https://doi.org/10.1053/j.gastro.2021.01.211.
Colonoscopist performance and colorectal cancer risk after adenoma removal to stratify surveillance: two nationwide observational studies
Wieszczy P et al. Gastroenterology. 2021 Mar 1;160(4):1067-74. doi: 10.1053/j.gastro.2020.10.009.
Pregnancy and neonatal outcomes after fetal exposure to biologics and thiopurines among women with inflammatory bowel disease
Mahadevan U et al. Gastroenterology. 2021 Mar 1;160(4):1131-9. doi: 10.1053/j.gastro.2020.11.038.
April 2021
AGA Clinical Practice Guidelines on intragastric balloons in the management of obesity
Muniraj T et al. Gastroenterology. 2021 Apr 1;160(5):1799-808. doi: 10.1053/j.gastro.2021.03.003.
How to strategically build your network for early career gastroenterologists
Gaidos JKJ et al. Gastroenterology. 2021 Apr 1;160(5):1461-6. doi: 10.1053/j.gastro.2021.01.025.
The microbiota-gut-brain axis: From motility to mood
Margolis KG et al. Gastroenterology. 2021 Apr 1;160(5):1486-501. doi: 10.1053/j.gastro.2020.10.066.
The association of histologic and noninvasive tests with adverse clinical and patient-reported outcomes in patients with advanced fibrosis due to nonalcoholic steatohepatitis
Younossi ZM et al. Gastroenterology. 2021 Apr 1;160(5):1608-19. doi: 10.1053/j.gastro.2020.12.003.
Clinical Gastroenterology and Hepatology
February 2021
Management of chronic abdominal distension and bloating
Lacy BE et al. Clin Gastroenterol Hepatol. 2021 Feb 1;19(2):219-31. doi: 10.1016/j.cgh.2020.03.056.
Prevalence of gastric intestinal metaplasia in a multiethnic US veterans population
Nguyen TH et al. Clin Gastroenterol Hepatol. 2021 Feb 1;19(2):269-76. doi: 10.1016/j.cgh.2020.03.015.
Rome IV functional gastrointestinal disorders and health impairment in subjects with hypermobility spectrum disorders or hypermobile Ehlers-Danlos syndrome
Lam CY et al. Clin Gastroenterol Hepatol. 2021 Feb 1;19(2):277-87. doi: 10.1016/j.cgh.2020.02.034.
Factors that affect adequacy of colon cleansing for colonoscopy in hospitalized patients
Fucci L et al. Clin Gastroenterol Hepatol. 2021 Feb 1;19(2):339-48. doi: org/10.1016/j.cgh.2020.02.055.
March 2021
Real-world gluten exposure in patients with celiac disease on gluten-free diets, determined from gliadin immunogenic peptides in urine and fecal samples
Stefanolo JP et al. Clin Gastroenterol Hepatol. 2021 Mar 1;19(3):484-91. doi: 10.1016/j.cgh.2020.03.038.
Factors associated with response to anorectal biofeedback therapy in patients with fecal incontinence
Mazor Y et al. Clin Gastroenterol Hepatol. 2021 Mar 1;19(3):492-502. doi: 10.1016/j.cgh.2020.03.050.
April 2021
Long-term outcome of gastric per-oral endoscopic pyloromyotomy in treatment of gastroparesis
Abdelfatah MM et al. Clin Gastroenterol Hepatol. 2021 Apr 1;19(4):816-24. doi: 10.1016/j.cgh.2020.05.039.
What gastroenterologists should know about COVID-19 vaccines
Rolak S et al. Clin Gastroenterol Hepatol. 2021 Apr 1;19(4):657-61. doi: 10.1016/j.cgh.2021.01.001.
No benefit of concomitant immunomodulator therapy on efficacy of biologics that are not tumor necrosis factor antagonists in patients with inflammatory bowel diseases: A meta-analysis
Yzet C et al. Clin Gastroenterol Hepatol. 2021 Apr 1;19(4):668-78. doi: 10.1016/j.cgh.2020.06.071.
Patient safety reporting in GI: All hands on deck
Wall A and Kothari D. Clin Gastroenterol Hepatol. 2021 Apr 1;19(4):626-32. doi: 10.1016/j.cgh.2020.11.007.
Techniques and Innovations in Gastrointestinal Endoscopy
Barriers and pitfalls for artificial intelligence in gastroenterology: Ethical and regulatory issues
Ahmad OF et al. Tech Innov Gastrointest Endosc. 2020 Apr 1;22(2):80-4. doi: 10.1016/j.tgie.2019.150636.
Development of a scoring system to predict a positive diagnosis on video capsule endoscopy for suspected small bowel bleeding
Marya NB et al. Tech Innov Gastrointest Endosc. 2020 Oct 1;22(4):178-84. doi: 10.1016/j.tige.2020.06.001.
Training for Advanced Endoscopic Imaging in Gastrointestinal Diseases
Hoogenboom SA et al. Tech Innov Gastrointest Endosc. 2021 Jan 1;23(1):99-106. doi: 10.1016/j.tige.2020.09.001.
Chromoendoscopy techniques in imaging of colorectal polyps and cancer: Overview and practical applications for detection and characterization.
Rivero-Sanchez L et al. Tech Innov Gastrointest Endosc. 2021 Jan 1;23(1):30-41. doi: 10.1016/j.tige.2020.10.006.
Pneumonia risk soars in heart failure patients, especially HFpEF
Patients with heart failure get pneumonia at a rate almost three times greater than expected and, once they do get pneumonia, have about a fourfold greater risk of death, investigators for a retrospective analysis of 13,000 patients from two landmark randomized HF trials have found.
The investigators also found that HF patients with preserved ejection fraction (HFpEF) are at the highest risk of developing pneumonia. The findings underscore the importance of patients with HF getting a pneumonia vaccination, they found.
The analysis showed that 6.3% of patients in the PARADIGM-HF trial and 10.6% of those in the PARAGON-HF trial developed pneumonia, reported the study authors, led by John J.V. McMurray, MD, of the British Heart Foundation Cardiovascular Research Center at the University of Glasgow in Scotland (J Am Coll Cardiol. 2021;77:1961-73).
“The main reason for doing this study was the fact that many heart failure patients are not vaccinated, as they should be, against pneumonia – both pneumococcus and influenza vaccination,” Dr. McMurray said in an interview. “We wanted to document the frequency and consequences of pneumonia in patients with heart failure to help highlight this deficiency in care.”
Dr. McMurray said he believes this is the first study to document the incidence of pneumonia and pneumonia-related outcomes according to the two major ejection fraction phenotypes.
PARADIGM-HF and PARAGON-HF
The post hoc analysis consisted of 8,399 patients with HF with reduced ejection fraction (HFrEF) in PARADIGM-HF (Eur J Heart Fail. 2013 Sep;15[9]:1062-73) and 4,796 patients with HFpEF in PARAGON-HF (N Engl J Med. 2014 Sep 11;371[11]:993-1004). The analysis focused on the 528 and 510 patients in each study, respectively, who developed pneumonia. Those rates translated to an incidence rate of 29 per 1,000 patient-years (95% confidence interval, 27-31) in PARADIGM-HF and 39 per 1,000 patient-years (95% CI, 36-42) in PARAGON-HF.
After pneumonia, the risk of death in patients increased substantially. In PARADIGM-HF, the adjusted hazard ratio for the risk of death from any cause after pneumonia was 4.34 (95% CI, 3.73-5.05). In PARAGON-HF, it was 3.76 (95% CI, 3.09-4.58). HF patients who contracted pneumonia also tended to have HF longer than their counterparts who didn’t develop pneumonia, but the frequency of previous hospitalization for HF didn’t vary between the pneumonia and no-pneumonia groups.
Patients who developed pneumonia tended to be older (average age of 66.9 years vs. 64.6 years, P < .001) and male (83.9% vs. 77.8%, P < .001). The mean age of patients in PARADIGM-HF was almost a decade younger than those in PARAGON-HF, 64 vs. 73 years.
Pneumonia patients also had worse Kansas City Cardiomyopathy Questionnaire scores (76 vs. 80 on average), but no difference in New York Heart Association functional class. “In general, patients who developed pneumonia had more symptoms and signs and HF than those who did not develop pneumonia,” Dr. McMurray and colleagues wrote.
Pneumonia patients also had higher rates of chronic obstructive pulmonary disease (26% vs. 12%), diabetes (43% vs. 34%), and atrial fibrillation (46% vs. 36%).
Another reason for conducting the study, Dr. McMurray said, “was the prior findings in patients with coronary disease and acute myocardial infarction that the risk associated with an episode of pneumonia [e.g., in subsequent vascular events and deaths] persisted long after the acute event. We wanted to see if this was also the case for heart failure, and indeed it was.”
For example, the adjusted HR for cardiovascular death or hospitalization in the first month following an episode of pneumonia was 9.48 (range of 6.85-13.12, P < .001), leveling off to 1.59 after 3 months or more.
Vaccination crucial in HF patients
Dr. McMurray noted that this study emphasizes the importance of pneumonia vaccination for patients with HF. “Given that we have so few treatments to offer patients with HFpEF, this makes the potential value of vaccination in these patients all the greater,” he said.
The COVID-19 pandemic, Dr. McMurray said, is a “good reminder of the dangers of a respiratory infection and the importance of vaccination in these patients. COVID-19 has interesting parallels in being a systemic disease and one with postacute, persisting effects.”
The persistent risk for adverse cardiovascular events 3 months and later after pneumonia is a novel finding of the study, wrote Donna Mancini, MD, and Gregory Gibson, MD, in an invited commentary (J Am Coll Cardiol. 2021;77:1974-6). Both are with the Icahn School of Medicine at Mt. Sinai in New York. The post hoc study also “serves as an important reminder” of pneumonia risk in patients with HF, especially during the pandemic, they wrote.
“Although vaccination alone appears unlikely to be a panacea, it is a readily accessible tool for mitigating disease severity and improving outcomes,” Dr. Mancini and Dr. Gibson wrote. “After all, an ounce of prevention is worth a pound of cure.”
Novartis provided funding for the PARADIGM-HF and PARAGON-HF trials, and Dr. McMurray and coauthors disclosed financial relationships with Novartis. Dr. Mancini and Dr. Gibson have no relevant financial relationships to disclose.
Patients with heart failure get pneumonia at a rate almost three times greater than expected and, once they do get pneumonia, have about a fourfold greater risk of death, investigators for a retrospective analysis of 13,000 patients from two landmark randomized HF trials have found.
The investigators also found that HF patients with preserved ejection fraction (HFpEF) are at the highest risk of developing pneumonia. The findings underscore the importance of patients with HF getting a pneumonia vaccination, they found.
The analysis showed that 6.3% of patients in the PARADIGM-HF trial and 10.6% of those in the PARAGON-HF trial developed pneumonia, reported the study authors, led by John J.V. McMurray, MD, of the British Heart Foundation Cardiovascular Research Center at the University of Glasgow in Scotland (J Am Coll Cardiol. 2021;77:1961-73).
“The main reason for doing this study was the fact that many heart failure patients are not vaccinated, as they should be, against pneumonia – both pneumococcus and influenza vaccination,” Dr. McMurray said in an interview. “We wanted to document the frequency and consequences of pneumonia in patients with heart failure to help highlight this deficiency in care.”
Dr. McMurray said he believes this is the first study to document the incidence of pneumonia and pneumonia-related outcomes according to the two major ejection fraction phenotypes.
PARADIGM-HF and PARAGON-HF
The post hoc analysis consisted of 8,399 patients with HF with reduced ejection fraction (HFrEF) in PARADIGM-HF (Eur J Heart Fail. 2013 Sep;15[9]:1062-73) and 4,796 patients with HFpEF in PARAGON-HF (N Engl J Med. 2014 Sep 11;371[11]:993-1004). The analysis focused on the 528 and 510 patients in each study, respectively, who developed pneumonia. Those rates translated to an incidence rate of 29 per 1,000 patient-years (95% confidence interval, 27-31) in PARADIGM-HF and 39 per 1,000 patient-years (95% CI, 36-42) in PARAGON-HF.
After pneumonia, the risk of death in patients increased substantially. In PARADIGM-HF, the adjusted hazard ratio for the risk of death from any cause after pneumonia was 4.34 (95% CI, 3.73-5.05). In PARAGON-HF, it was 3.76 (95% CI, 3.09-4.58). HF patients who contracted pneumonia also tended to have HF longer than their counterparts who didn’t develop pneumonia, but the frequency of previous hospitalization for HF didn’t vary between the pneumonia and no-pneumonia groups.
Patients who developed pneumonia tended to be older (average age of 66.9 years vs. 64.6 years, P < .001) and male (83.9% vs. 77.8%, P < .001). The mean age of patients in PARADIGM-HF was almost a decade younger than those in PARAGON-HF, 64 vs. 73 years.
Pneumonia patients also had worse Kansas City Cardiomyopathy Questionnaire scores (76 vs. 80 on average), but no difference in New York Heart Association functional class. “In general, patients who developed pneumonia had more symptoms and signs and HF than those who did not develop pneumonia,” Dr. McMurray and colleagues wrote.
Pneumonia patients also had higher rates of chronic obstructive pulmonary disease (26% vs. 12%), diabetes (43% vs. 34%), and atrial fibrillation (46% vs. 36%).
Another reason for conducting the study, Dr. McMurray said, “was the prior findings in patients with coronary disease and acute myocardial infarction that the risk associated with an episode of pneumonia [e.g., in subsequent vascular events and deaths] persisted long after the acute event. We wanted to see if this was also the case for heart failure, and indeed it was.”
For example, the adjusted HR for cardiovascular death or hospitalization in the first month following an episode of pneumonia was 9.48 (range of 6.85-13.12, P < .001), leveling off to 1.59 after 3 months or more.
Vaccination crucial in HF patients
Dr. McMurray noted that this study emphasizes the importance of pneumonia vaccination for patients with HF. “Given that we have so few treatments to offer patients with HFpEF, this makes the potential value of vaccination in these patients all the greater,” he said.
The COVID-19 pandemic, Dr. McMurray said, is a “good reminder of the dangers of a respiratory infection and the importance of vaccination in these patients. COVID-19 has interesting parallels in being a systemic disease and one with postacute, persisting effects.”
The persistent risk for adverse cardiovascular events 3 months and later after pneumonia is a novel finding of the study, wrote Donna Mancini, MD, and Gregory Gibson, MD, in an invited commentary (J Am Coll Cardiol. 2021;77:1974-6). Both are with the Icahn School of Medicine at Mt. Sinai in New York. The post hoc study also “serves as an important reminder” of pneumonia risk in patients with HF, especially during the pandemic, they wrote.
“Although vaccination alone appears unlikely to be a panacea, it is a readily accessible tool for mitigating disease severity and improving outcomes,” Dr. Mancini and Dr. Gibson wrote. “After all, an ounce of prevention is worth a pound of cure.”
Novartis provided funding for the PARADIGM-HF and PARAGON-HF trials, and Dr. McMurray and coauthors disclosed financial relationships with Novartis. Dr. Mancini and Dr. Gibson have no relevant financial relationships to disclose.
Patients with heart failure get pneumonia at a rate almost three times greater than expected and, once they do get pneumonia, have about a fourfold greater risk of death, investigators for a retrospective analysis of 13,000 patients from two landmark randomized HF trials have found.
The investigators also found that HF patients with preserved ejection fraction (HFpEF) are at the highest risk of developing pneumonia. The findings underscore the importance of patients with HF getting a pneumonia vaccination, they found.
The analysis showed that 6.3% of patients in the PARADIGM-HF trial and 10.6% of those in the PARAGON-HF trial developed pneumonia, reported the study authors, led by John J.V. McMurray, MD, of the British Heart Foundation Cardiovascular Research Center at the University of Glasgow in Scotland (J Am Coll Cardiol. 2021;77:1961-73).
“The main reason for doing this study was the fact that many heart failure patients are not vaccinated, as they should be, against pneumonia – both pneumococcus and influenza vaccination,” Dr. McMurray said in an interview. “We wanted to document the frequency and consequences of pneumonia in patients with heart failure to help highlight this deficiency in care.”
Dr. McMurray said he believes this is the first study to document the incidence of pneumonia and pneumonia-related outcomes according to the two major ejection fraction phenotypes.
PARADIGM-HF and PARAGON-HF
The post hoc analysis consisted of 8,399 patients with HF with reduced ejection fraction (HFrEF) in PARADIGM-HF (Eur J Heart Fail. 2013 Sep;15[9]:1062-73) and 4,796 patients with HFpEF in PARAGON-HF (N Engl J Med. 2014 Sep 11;371[11]:993-1004). The analysis focused on the 528 and 510 patients in each study, respectively, who developed pneumonia. Those rates translated to an incidence rate of 29 per 1,000 patient-years (95% confidence interval, 27-31) in PARADIGM-HF and 39 per 1,000 patient-years (95% CI, 36-42) in PARAGON-HF.
After pneumonia, the risk of death in patients increased substantially. In PARADIGM-HF, the adjusted hazard ratio for the risk of death from any cause after pneumonia was 4.34 (95% CI, 3.73-5.05). In PARAGON-HF, it was 3.76 (95% CI, 3.09-4.58). HF patients who contracted pneumonia also tended to have HF longer than their counterparts who didn’t develop pneumonia, but the frequency of previous hospitalization for HF didn’t vary between the pneumonia and no-pneumonia groups.
Patients who developed pneumonia tended to be older (average age of 66.9 years vs. 64.6 years, P < .001) and male (83.9% vs. 77.8%, P < .001). The mean age of patients in PARADIGM-HF was almost a decade younger than those in PARAGON-HF, 64 vs. 73 years.
Pneumonia patients also had worse Kansas City Cardiomyopathy Questionnaire scores (76 vs. 80 on average), but no difference in New York Heart Association functional class. “In general, patients who developed pneumonia had more symptoms and signs and HF than those who did not develop pneumonia,” Dr. McMurray and colleagues wrote.
Pneumonia patients also had higher rates of chronic obstructive pulmonary disease (26% vs. 12%), diabetes (43% vs. 34%), and atrial fibrillation (46% vs. 36%).
Another reason for conducting the study, Dr. McMurray said, “was the prior findings in patients with coronary disease and acute myocardial infarction that the risk associated with an episode of pneumonia [e.g., in subsequent vascular events and deaths] persisted long after the acute event. We wanted to see if this was also the case for heart failure, and indeed it was.”
For example, the adjusted HR for cardiovascular death or hospitalization in the first month following an episode of pneumonia was 9.48 (range of 6.85-13.12, P < .001), leveling off to 1.59 after 3 months or more.
Vaccination crucial in HF patients
Dr. McMurray noted that this study emphasizes the importance of pneumonia vaccination for patients with HF. “Given that we have so few treatments to offer patients with HFpEF, this makes the potential value of vaccination in these patients all the greater,” he said.
The COVID-19 pandemic, Dr. McMurray said, is a “good reminder of the dangers of a respiratory infection and the importance of vaccination in these patients. COVID-19 has interesting parallels in being a systemic disease and one with postacute, persisting effects.”
The persistent risk for adverse cardiovascular events 3 months and later after pneumonia is a novel finding of the study, wrote Donna Mancini, MD, and Gregory Gibson, MD, in an invited commentary (J Am Coll Cardiol. 2021;77:1974-6). Both are with the Icahn School of Medicine at Mt. Sinai in New York. The post hoc study also “serves as an important reminder” of pneumonia risk in patients with HF, especially during the pandemic, they wrote.
“Although vaccination alone appears unlikely to be a panacea, it is a readily accessible tool for mitigating disease severity and improving outcomes,” Dr. Mancini and Dr. Gibson wrote. “After all, an ounce of prevention is worth a pound of cure.”
Novartis provided funding for the PARADIGM-HF and PARAGON-HF trials, and Dr. McMurray and coauthors disclosed financial relationships with Novartis. Dr. Mancini and Dr. Gibson have no relevant financial relationships to disclose.
FROM JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
A Rash Against the Grain
ANSWER
The correct answer is dermatitis herpetiformis (DH; choice “b”).
DISCUSSION
DH is unusual, although not rare, and it is often overlooked in the investigation of itchy rashes—even by dermatologists. As is so often the case, the biopsy was the missing piece of the puzzle, since it clearly showed changes consistent with this condition.
The history of DH has some interesting overlap with that of biopsy. It was Rudolph Virchow, an 18th century Austrian pathologist, who first connected clinical disease to specific arrangements of disordered tissue seen microscopically—at that time, a giant leap for medicine. An American dermatologist, Louis Adolphus Duhring, had the good fortune to study under Virchow and his successors in Vienna and brought this cutting-edge knowledge back to this country, where he began the process of categorizing diseases by their histologic patterns as well as by their presentation and clinical course. This was when he discovered the basis for the condition that became known as Duhring disease, also known as dermatitis herpetiformis.
It was much later (1967) that a connection was made between DH and the ingestion of gluten. Our patient experienced a rapid decline in his itching and rash as soon as he started a gluten-free diet. However, since many patients find such a diet difficult to maintain, there are pharmacologic options as well: dapsone, colchicine, sulfa drugs, drugs from the tetracycline family, and nicotinamide. All have potential adverse effects with which the prescriber needs to become familiar.
With a combination of medication and reduced gluten intake, it’s entirely possible that the patient’s DH will permanently resolve, although he will remain at increased risk for other autoimmune conditions.
ANSWER
The correct answer is dermatitis herpetiformis (DH; choice “b”).
DISCUSSION
DH is unusual, although not rare, and it is often overlooked in the investigation of itchy rashes—even by dermatologists. As is so often the case, the biopsy was the missing piece of the puzzle, since it clearly showed changes consistent with this condition.
The history of DH has some interesting overlap with that of biopsy. It was Rudolph Virchow, an 18th century Austrian pathologist, who first connected clinical disease to specific arrangements of disordered tissue seen microscopically—at that time, a giant leap for medicine. An American dermatologist, Louis Adolphus Duhring, had the good fortune to study under Virchow and his successors in Vienna and brought this cutting-edge knowledge back to this country, where he began the process of categorizing diseases by their histologic patterns as well as by their presentation and clinical course. This was when he discovered the basis for the condition that became known as Duhring disease, also known as dermatitis herpetiformis.
It was much later (1967) that a connection was made between DH and the ingestion of gluten. Our patient experienced a rapid decline in his itching and rash as soon as he started a gluten-free diet. However, since many patients find such a diet difficult to maintain, there are pharmacologic options as well: dapsone, colchicine, sulfa drugs, drugs from the tetracycline family, and nicotinamide. All have potential adverse effects with which the prescriber needs to become familiar.
With a combination of medication and reduced gluten intake, it’s entirely possible that the patient’s DH will permanently resolve, although he will remain at increased risk for other autoimmune conditions.
ANSWER
The correct answer is dermatitis herpetiformis (DH; choice “b”).
DISCUSSION
DH is unusual, although not rare, and it is often overlooked in the investigation of itchy rashes—even by dermatologists. As is so often the case, the biopsy was the missing piece of the puzzle, since it clearly showed changes consistent with this condition.
The history of DH has some interesting overlap with that of biopsy. It was Rudolph Virchow, an 18th century Austrian pathologist, who first connected clinical disease to specific arrangements of disordered tissue seen microscopically—at that time, a giant leap for medicine. An American dermatologist, Louis Adolphus Duhring, had the good fortune to study under Virchow and his successors in Vienna and brought this cutting-edge knowledge back to this country, where he began the process of categorizing diseases by their histologic patterns as well as by their presentation and clinical course. This was when he discovered the basis for the condition that became known as Duhring disease, also known as dermatitis herpetiformis.
It was much later (1967) that a connection was made between DH and the ingestion of gluten. Our patient experienced a rapid decline in his itching and rash as soon as he started a gluten-free diet. However, since many patients find such a diet difficult to maintain, there are pharmacologic options as well: dapsone, colchicine, sulfa drugs, drugs from the tetracycline family, and nicotinamide. All have potential adverse effects with which the prescriber needs to become familiar.
With a combination of medication and reduced gluten intake, it’s entirely possible that the patient’s DH will permanently resolve, although he will remain at increased risk for other autoimmune conditions.
A 56-year-old man began to itch almost 10 years ago, when lesions appeared on his extensor forearms; they later branched out to his knees, scalp, and waistline. He has continued to suffer despite seeing numerous providers, including dermatologists.
An allergist pronounced him free of any significant allergies. Another provider was certain the patient had scabies, although his household was unaffected and the prescribed treatment—permethrin lotion and oral ivermectin—had no impact on the rash or the symptoms. Most of the other consulted providers diagnosed eczema, despite a complete lack of atopy in the patient or his family of origin. Furthermore, treatment with topical, oral, and intramuscular steroids had offered minimal and very short-lived relief. No one took a scraping or performed a biopsy of the rash.
The patient claims to be otherwise healthy, with no gastrointestinal symptoms and no new medications. Examination reveals a slightly overweight man in no distress.
The lesions in question are patches of excoriated papulovesicular lesions. Microscopic examination of a KOH prep shows no scabetic elements. His volar wrists, the sides of his fingers, and his genitals are free of lesions.
A shave biopsy is performed under local anesthetic. The pathology report indicates subepidermal collections of eosinophils.
Antibiotics may prolong PFS in HCC patients on immunotherapy
Response rates and overall survival (OS), on the other hand, did not seem to be affected by antibiotic administration, according to investigator Petros Fessas, MD, of Imperial College London.
Dr. Fessas and colleagues presented these findings in a poster at the American Association for Cancer Research Annual Meeting 2021: Week 1 (Abstract 485).
Dr. Fessas noted that, in other cancers, antibiotics have been shown to reduce both response and survival rates after ICI.
To assess the impact of early antibiotic exposure on ICI efficacy in HCC, Dr. Fessas and colleagues examined data from 449 patients treated at 12 centers in the United States, Europe, and Asia.
The patients’ median age was 65 years, and 79.1% were men. Nearly three-quarters (73.3%) were cirrhotic (60.4% because of viral hepatitis), 79.9% were Child-Pugh class A, 72.4% were Barcelona Clinic Liver Cancer stage C, and 79% had an Eastern Cooperative Oncology Group performance status of 0-1.
Response and survival results
The investigators compared outcomes between patients with and without antibiotic exposure in the early immunotherapy period (EIOP) 30 days before and after ICI initiation.
In all, 170 patients (37.9%) received antibiotics in the EIOP. There were no differences in response rates, disease control rates, or median OS between patients who received antibiotics and those who did not.
The objective response rate was 20.2% in patients who received antibiotics in the EIOP and 16.1% in patients who did not (P = .2808). Disease control rates were 63.1% and 55.4%, respectively (P = .1144). The median OS was 15.3 months and 15.4 months, respectively (hazard ratio, 0.93; 95% confidence interval, 0.72-1.21; P = .6275).
The median PFS, however, was significantly longer in patients who received antibiotics than in patients who did not – 6.1 months and 3.7 months, respectively (HR, 0.74; 95% CI, 0.60-0.93; P = .0135).
To overcome possible bias introduced by misclassification of patients who received antibiotics but discontinued immunotherapy within 30 days of initiation, the investigators conducted a landmark selection analysis among only those patients with a median follow-up for PFS of 30 days or longer (n = 402). This analysis confirmed the prior findings.
“Antibiotic exposure in the 30 days before or after immune checkpoint initiation in hepatocellular carcinoma is associated with prolonged progression-free survival,” Dr. Fessas concluded.
He added that a key question for future research is to discover the immune-microbiologic determinants of response to initiation of ICIs.
Positive effect surprising
“My group has shown that antibiotic therapy is normally detrimental in patients with cancer,” investigator David J. Pinato, MD, PhD, of Imperial College London, said in an interview. “So we were very surprised to see a positive effect on PFS.”
He added that the new findings should be interpreted with caution.
“My feeling is that, unlike with many other malignancies, the gut microbiome is heavily involved in the progression of the cirrhosis that pre-dates HCC onset,” he said.
That would suggest the relationship between antibiotics and perturbation of the gut microbiome is dictated by something more than changes in antitumor immune tolerance, he added.
“Overall, I think the interplay is more complex in HCC: cirrhosis/cancer/microbiome, not just microbiome/cancer as in many other tumors,” Dr. Pinato said. “So we are looking at microbial determinants of response in HCC patients undergoing ICI therapy, and we are hopeful to see some more mechanistic evidence behind this association.”
Dr. Pinato disclosed relationships with ViiV Healthcare, Bayer Healthcare, Bristol Myers Squibb, Mina Therapeutics, Eisai, Roche, and AstraZeneca. Dr. Fessas reported having no conflicts of interest. No funding source for the study was disclosed.
Response rates and overall survival (OS), on the other hand, did not seem to be affected by antibiotic administration, according to investigator Petros Fessas, MD, of Imperial College London.
Dr. Fessas and colleagues presented these findings in a poster at the American Association for Cancer Research Annual Meeting 2021: Week 1 (Abstract 485).
Dr. Fessas noted that, in other cancers, antibiotics have been shown to reduce both response and survival rates after ICI.
To assess the impact of early antibiotic exposure on ICI efficacy in HCC, Dr. Fessas and colleagues examined data from 449 patients treated at 12 centers in the United States, Europe, and Asia.
The patients’ median age was 65 years, and 79.1% were men. Nearly three-quarters (73.3%) were cirrhotic (60.4% because of viral hepatitis), 79.9% were Child-Pugh class A, 72.4% were Barcelona Clinic Liver Cancer stage C, and 79% had an Eastern Cooperative Oncology Group performance status of 0-1.
Response and survival results
The investigators compared outcomes between patients with and without antibiotic exposure in the early immunotherapy period (EIOP) 30 days before and after ICI initiation.
In all, 170 patients (37.9%) received antibiotics in the EIOP. There were no differences in response rates, disease control rates, or median OS between patients who received antibiotics and those who did not.
The objective response rate was 20.2% in patients who received antibiotics in the EIOP and 16.1% in patients who did not (P = .2808). Disease control rates were 63.1% and 55.4%, respectively (P = .1144). The median OS was 15.3 months and 15.4 months, respectively (hazard ratio, 0.93; 95% confidence interval, 0.72-1.21; P = .6275).
The median PFS, however, was significantly longer in patients who received antibiotics than in patients who did not – 6.1 months and 3.7 months, respectively (HR, 0.74; 95% CI, 0.60-0.93; P = .0135).
To overcome possible bias introduced by misclassification of patients who received antibiotics but discontinued immunotherapy within 30 days of initiation, the investigators conducted a landmark selection analysis among only those patients with a median follow-up for PFS of 30 days or longer (n = 402). This analysis confirmed the prior findings.
“Antibiotic exposure in the 30 days before or after immune checkpoint initiation in hepatocellular carcinoma is associated with prolonged progression-free survival,” Dr. Fessas concluded.
He added that a key question for future research is to discover the immune-microbiologic determinants of response to initiation of ICIs.
Positive effect surprising
“My group has shown that antibiotic therapy is normally detrimental in patients with cancer,” investigator David J. Pinato, MD, PhD, of Imperial College London, said in an interview. “So we were very surprised to see a positive effect on PFS.”
He added that the new findings should be interpreted with caution.
“My feeling is that, unlike with many other malignancies, the gut microbiome is heavily involved in the progression of the cirrhosis that pre-dates HCC onset,” he said.
That would suggest the relationship between antibiotics and perturbation of the gut microbiome is dictated by something more than changes in antitumor immune tolerance, he added.
“Overall, I think the interplay is more complex in HCC: cirrhosis/cancer/microbiome, not just microbiome/cancer as in many other tumors,” Dr. Pinato said. “So we are looking at microbial determinants of response in HCC patients undergoing ICI therapy, and we are hopeful to see some more mechanistic evidence behind this association.”
Dr. Pinato disclosed relationships with ViiV Healthcare, Bayer Healthcare, Bristol Myers Squibb, Mina Therapeutics, Eisai, Roche, and AstraZeneca. Dr. Fessas reported having no conflicts of interest. No funding source for the study was disclosed.
Response rates and overall survival (OS), on the other hand, did not seem to be affected by antibiotic administration, according to investigator Petros Fessas, MD, of Imperial College London.
Dr. Fessas and colleagues presented these findings in a poster at the American Association for Cancer Research Annual Meeting 2021: Week 1 (Abstract 485).
Dr. Fessas noted that, in other cancers, antibiotics have been shown to reduce both response and survival rates after ICI.
To assess the impact of early antibiotic exposure on ICI efficacy in HCC, Dr. Fessas and colleagues examined data from 449 patients treated at 12 centers in the United States, Europe, and Asia.
The patients’ median age was 65 years, and 79.1% were men. Nearly three-quarters (73.3%) were cirrhotic (60.4% because of viral hepatitis), 79.9% were Child-Pugh class A, 72.4% were Barcelona Clinic Liver Cancer stage C, and 79% had an Eastern Cooperative Oncology Group performance status of 0-1.
Response and survival results
The investigators compared outcomes between patients with and without antibiotic exposure in the early immunotherapy period (EIOP) 30 days before and after ICI initiation.
In all, 170 patients (37.9%) received antibiotics in the EIOP. There were no differences in response rates, disease control rates, or median OS between patients who received antibiotics and those who did not.
The objective response rate was 20.2% in patients who received antibiotics in the EIOP and 16.1% in patients who did not (P = .2808). Disease control rates were 63.1% and 55.4%, respectively (P = .1144). The median OS was 15.3 months and 15.4 months, respectively (hazard ratio, 0.93; 95% confidence interval, 0.72-1.21; P = .6275).
The median PFS, however, was significantly longer in patients who received antibiotics than in patients who did not – 6.1 months and 3.7 months, respectively (HR, 0.74; 95% CI, 0.60-0.93; P = .0135).
To overcome possible bias introduced by misclassification of patients who received antibiotics but discontinued immunotherapy within 30 days of initiation, the investigators conducted a landmark selection analysis among only those patients with a median follow-up for PFS of 30 days or longer (n = 402). This analysis confirmed the prior findings.
“Antibiotic exposure in the 30 days before or after immune checkpoint initiation in hepatocellular carcinoma is associated with prolonged progression-free survival,” Dr. Fessas concluded.
He added that a key question for future research is to discover the immune-microbiologic determinants of response to initiation of ICIs.
Positive effect surprising
“My group has shown that antibiotic therapy is normally detrimental in patients with cancer,” investigator David J. Pinato, MD, PhD, of Imperial College London, said in an interview. “So we were very surprised to see a positive effect on PFS.”
He added that the new findings should be interpreted with caution.
“My feeling is that, unlike with many other malignancies, the gut microbiome is heavily involved in the progression of the cirrhosis that pre-dates HCC onset,” he said.
That would suggest the relationship between antibiotics and perturbation of the gut microbiome is dictated by something more than changes in antitumor immune tolerance, he added.
“Overall, I think the interplay is more complex in HCC: cirrhosis/cancer/microbiome, not just microbiome/cancer as in many other tumors,” Dr. Pinato said. “So we are looking at microbial determinants of response in HCC patients undergoing ICI therapy, and we are hopeful to see some more mechanistic evidence behind this association.”
Dr. Pinato disclosed relationships with ViiV Healthcare, Bayer Healthcare, Bristol Myers Squibb, Mina Therapeutics, Eisai, Roche, and AstraZeneca. Dr. Fessas reported having no conflicts of interest. No funding source for the study was disclosed.
FROM AACR 2021
CLL patients: Diagnostic difficulties, treatment confusion with COVID-19
Chronic lymphocytic leukemia (CLL) patients present significant problems with regard to COVID-19 disease, according to a literature review by Yousef Roosta, MD, of Urmia (Iran) University of Medical Sciences, and colleagues.
Diagnostic interaction between CLL and COVID-19 provides a major challenge. CLL patients have a lower rate of anti–SARS-CoV-2 IgG development, and evidence shows worse therapeutic outcomes in these patients, according to study published in Leukemia Research Reports.
The researchers assessed 20 retrieved articles, 11 of which examined patients with CLL and with concomitant COVID-19; and 9 articles were designed as prospective or retrospective case series of such patients. The studies were assessed qualitatively by the QUADAS-2 tool.
Troubling results
Although the overall prevalence of CLL and COVID-19 concurrence was low, at 0.6% (95% confidence interval 0.5%-0.7%) according to the meta-analysis, the results showed some special challenges in the diagnosis and care of these patients.
Diagnostic difficulties are a unique problem. Lymphopenia is common in patients with COVID-19, while lymphocytosis may be considered a transient or even rare finding. The interplay between the two diseases is sometimes very misleading for specialists, and in patients with lymphocytosis, the diagnosis of CLL may be completely ignored, according to the researchers. They added that when performing a diagnostic approach for concurrent COVID-19 and CLL, due to differences in the amount and type of immune response, “relying on serological testing, and especially the evaluation of the anti–SARS-CoV-2 IgG levels may not be beneficial,” they indicated.
In addition, studies showed unacceptable therapeutic outcome in patients with concurrent CLL and COVID-19, with mortality ranging from 33% to 41.7%, showing a need to revise current treatment protocols, according to the authors. In one study, 85.7% of surviving patients showed a considerable decrease in functional class and significant fatigue, with such a poor prognosis occurring more commonly in the elderly.
With regard to treatment, “it is quite obvious that despite the use of current standard protocols, the prognosis of these patients will be much worse than the prognosis of CLL patients with no evidence of COVID-19. Even in the first-line treatment protocol for these patients, there is no agreement in combination therapy with selected CLL drugs along with management protocols of COVID-19 patients,” the researchers stated.
“[The] different hematological behaviors of two diseases might mimic the detection of COVID-19 in the CLL state and vise versa. Also, due to the low level of immune response against SARS-CoV-2 in CLL patients, both scheduled immunological-based diagnosis and treatment may fail,” the researchers added.
The authors reported that they had no disclosures.
Chronic lymphocytic leukemia (CLL) patients present significant problems with regard to COVID-19 disease, according to a literature review by Yousef Roosta, MD, of Urmia (Iran) University of Medical Sciences, and colleagues.
Diagnostic interaction between CLL and COVID-19 provides a major challenge. CLL patients have a lower rate of anti–SARS-CoV-2 IgG development, and evidence shows worse therapeutic outcomes in these patients, according to study published in Leukemia Research Reports.
The researchers assessed 20 retrieved articles, 11 of which examined patients with CLL and with concomitant COVID-19; and 9 articles were designed as prospective or retrospective case series of such patients. The studies were assessed qualitatively by the QUADAS-2 tool.
Troubling results
Although the overall prevalence of CLL and COVID-19 concurrence was low, at 0.6% (95% confidence interval 0.5%-0.7%) according to the meta-analysis, the results showed some special challenges in the diagnosis and care of these patients.
Diagnostic difficulties are a unique problem. Lymphopenia is common in patients with COVID-19, while lymphocytosis may be considered a transient or even rare finding. The interplay between the two diseases is sometimes very misleading for specialists, and in patients with lymphocytosis, the diagnosis of CLL may be completely ignored, according to the researchers. They added that when performing a diagnostic approach for concurrent COVID-19 and CLL, due to differences in the amount and type of immune response, “relying on serological testing, and especially the evaluation of the anti–SARS-CoV-2 IgG levels may not be beneficial,” they indicated.
In addition, studies showed unacceptable therapeutic outcome in patients with concurrent CLL and COVID-19, with mortality ranging from 33% to 41.7%, showing a need to revise current treatment protocols, according to the authors. In one study, 85.7% of surviving patients showed a considerable decrease in functional class and significant fatigue, with such a poor prognosis occurring more commonly in the elderly.
With regard to treatment, “it is quite obvious that despite the use of current standard protocols, the prognosis of these patients will be much worse than the prognosis of CLL patients with no evidence of COVID-19. Even in the first-line treatment protocol for these patients, there is no agreement in combination therapy with selected CLL drugs along with management protocols of COVID-19 patients,” the researchers stated.
“[The] different hematological behaviors of two diseases might mimic the detection of COVID-19 in the CLL state and vise versa. Also, due to the low level of immune response against SARS-CoV-2 in CLL patients, both scheduled immunological-based diagnosis and treatment may fail,” the researchers added.
The authors reported that they had no disclosures.
Chronic lymphocytic leukemia (CLL) patients present significant problems with regard to COVID-19 disease, according to a literature review by Yousef Roosta, MD, of Urmia (Iran) University of Medical Sciences, and colleagues.
Diagnostic interaction between CLL and COVID-19 provides a major challenge. CLL patients have a lower rate of anti–SARS-CoV-2 IgG development, and evidence shows worse therapeutic outcomes in these patients, according to study published in Leukemia Research Reports.
The researchers assessed 20 retrieved articles, 11 of which examined patients with CLL and with concomitant COVID-19; and 9 articles were designed as prospective or retrospective case series of such patients. The studies were assessed qualitatively by the QUADAS-2 tool.
Troubling results
Although the overall prevalence of CLL and COVID-19 concurrence was low, at 0.6% (95% confidence interval 0.5%-0.7%) according to the meta-analysis, the results showed some special challenges in the diagnosis and care of these patients.
Diagnostic difficulties are a unique problem. Lymphopenia is common in patients with COVID-19, while lymphocytosis may be considered a transient or even rare finding. The interplay between the two diseases is sometimes very misleading for specialists, and in patients with lymphocytosis, the diagnosis of CLL may be completely ignored, according to the researchers. They added that when performing a diagnostic approach for concurrent COVID-19 and CLL, due to differences in the amount and type of immune response, “relying on serological testing, and especially the evaluation of the anti–SARS-CoV-2 IgG levels may not be beneficial,” they indicated.
In addition, studies showed unacceptable therapeutic outcome in patients with concurrent CLL and COVID-19, with mortality ranging from 33% to 41.7%, showing a need to revise current treatment protocols, according to the authors. In one study, 85.7% of surviving patients showed a considerable decrease in functional class and significant fatigue, with such a poor prognosis occurring more commonly in the elderly.
With regard to treatment, “it is quite obvious that despite the use of current standard protocols, the prognosis of these patients will be much worse than the prognosis of CLL patients with no evidence of COVID-19. Even in the first-line treatment protocol for these patients, there is no agreement in combination therapy with selected CLL drugs along with management protocols of COVID-19 patients,” the researchers stated.
“[The] different hematological behaviors of two diseases might mimic the detection of COVID-19 in the CLL state and vise versa. Also, due to the low level of immune response against SARS-CoV-2 in CLL patients, both scheduled immunological-based diagnosis and treatment may fail,” the researchers added.
The authors reported that they had no disclosures.
FROM LEUKEMIA RESEARCH REPORTS