OK to treat many cancer patients despite pandemic, says ESMO

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Not all are highly vulnerable to COVID-19

In the era of COVID-19, cancer treatment should not be discontinued or delayed if it can affect overall survival, according to new recommendations from an international team of experts.

Another important recommendation is to stop labeling all patients with cancer as being vulnerable to infection with the virus as it can lead to inappropriate care with potential negative outcomes.

“Although it was reasonable to adopt over-protective measures for our patients at the outbreak of a novel infective disease which was not previously observed in humans, we now need to step away from the assumption that all cancer patients are vulnerable to COVID-19,” said first author of the consensus article Giuseppe Curigliano, MD, PhD, of the European Institute of Oncology, Milan, Italy, in a statement. “The implications have been important because for some patients treatment was delayed or interrupted over the last few months, and I believe that we will see the impact of this over-precautionary approach in the...future.”

The recommendations were issued by the European Society of Medical Oncology (ESMO) to help guide physicians in “optimizing the pathway to cancer care” as well as to improve outcomes during the pandemic. The recommendations were published online July 31 in Annals of Oncology.

Studies have found that patients with cancer face a higher risk of serious complications and death if they develop COVID-19. Data from the COVID-19 and Cancer Consortium registry, for example, showed that patients with progressing cancer and COVID-19 infection had a fivefold increase in the risk of 30-day mortality compared with COVID-19–positive cancer patients who were in remission or had no evidence of cancer.

But while this may be true for some patients, Curigliano and colleagues emphasize that individuals with cancer are not a heterogeneous group and that the term “cancer” itself represents myriad different diseases. The European experts note that current evidence suggests many patients with solid tumors are not more vulnerable to serious complications than the general population.

Thus, cancer prognoses vary considerably, and addressing all patients with cancer as being “COVID-19-vulnerable is probably neither reasonable nor informative,” say the authors.

Dramatic changes were initiated in cancer management for all cancer types, nevertheless, and although these changes seemed reasonable in an acute pandemic situation, note the authors, they were made in the absence of strong supportive evidence. Attempts to define the individualized risk for a given patient, taking into account their primary tumor subtype, stage, age, and gender, have been limited.

“Based on current evidence, only patients who are elderly, with multiple comorbidities, and receiving chemotherapy are vulnerable to the infection,” explained Curigliano.

However, on a positive note, a recently published prospective cohort study looked at approximately 800 patients with cancer – who had symptomatic COVID-19 – in the United Kingdom. The analysis showed no association at all between the risk for death and receiving chemotherapy or immunotherapy, points out Medscape commentator David Kerr, MD, of the University of Oxford, UK, in a recent commentary.

Key recommendations

An international consortium was established by ESMO, and the interdisciplinary expert panel consisted of 64 experts and one voting patient advocate. They agreed on 28 statements that can be used to help with many of the current clinical and technical areas of uncertainty that range from diagnosis to treatment decisions.

The following are several of the key recommendations:

  • Patients with cancer who face the highest risk of severe COVID-19 are characterized by active and progressive cancer, advanced age, poor performance status, smoking status, comorbidities, and possibly type of cancer.
  • Telehealth and digital health can be excellent tools for some types of care such as primary care triage and counseling, but meeting in person may be more effective for situations that include delivery of key cancer-related information and for patients with complex cancer needs.
  • Prior to hospital admission, patients with cancer should be tested for COVID-19, if feasible, and if they are considered at high risk, regardless of symptoms or chest radiological findings.
  • Patients with cancer and COVID-19 have a higher risk of thromboembolic events, and prophylaxis using low molecular weight  or novel oral anticoagulants is recommended.
  • Immune checkpoint inhibitors should not be withheld or delayed when there is a significant survival benefit, but use should be postponed in patients who test positive for COVID-19 until they recover.
  • Use of high-dose steroids in patients with cancer infected with COVID-19 could potentially increase the risk of mortality, and a switch should be made to another immunosuppressant, if possible.
  • The decision to use tyrosine kinase inhibitors (TKIs) of the PI3K/AKT/mTOR or RAS/RAF/MEK axis is complex, as they interfere with critical pathways involved in innate or adaptive immune responses. Stopping or withholding therapy depends on the risk-benefit balance, and the magnitude of benefit from the TKI needs to be considered.

The authors conclude that “ultimately, this set of statements will serve as a dynamic knowledge repository that will be better informed by accumulating data on SARS-CoV-2 biology, COVID-19 pandemic characteristics, on the risk of cancer patients for COVID-19 and its modulating factors, and finally, on optimal cancer care in the presence of the virus.”

No funding was reported for the current study. Several authors have disclosed relationships with industry, which are listed in the article.
 

This article first appeared on Medscape.com.

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Not all are highly vulnerable to COVID-19

Not all are highly vulnerable to COVID-19

In the era of COVID-19, cancer treatment should not be discontinued or delayed if it can affect overall survival, according to new recommendations from an international team of experts.

Another important recommendation is to stop labeling all patients with cancer as being vulnerable to infection with the virus as it can lead to inappropriate care with potential negative outcomes.

“Although it was reasonable to adopt over-protective measures for our patients at the outbreak of a novel infective disease which was not previously observed in humans, we now need to step away from the assumption that all cancer patients are vulnerable to COVID-19,” said first author of the consensus article Giuseppe Curigliano, MD, PhD, of the European Institute of Oncology, Milan, Italy, in a statement. “The implications have been important because for some patients treatment was delayed or interrupted over the last few months, and I believe that we will see the impact of this over-precautionary approach in the...future.”

The recommendations were issued by the European Society of Medical Oncology (ESMO) to help guide physicians in “optimizing the pathway to cancer care” as well as to improve outcomes during the pandemic. The recommendations were published online July 31 in Annals of Oncology.

Studies have found that patients with cancer face a higher risk of serious complications and death if they develop COVID-19. Data from the COVID-19 and Cancer Consortium registry, for example, showed that patients with progressing cancer and COVID-19 infection had a fivefold increase in the risk of 30-day mortality compared with COVID-19–positive cancer patients who were in remission or had no evidence of cancer.

But while this may be true for some patients, Curigliano and colleagues emphasize that individuals with cancer are not a heterogeneous group and that the term “cancer” itself represents myriad different diseases. The European experts note that current evidence suggests many patients with solid tumors are not more vulnerable to serious complications than the general population.

Thus, cancer prognoses vary considerably, and addressing all patients with cancer as being “COVID-19-vulnerable is probably neither reasonable nor informative,” say the authors.

Dramatic changes were initiated in cancer management for all cancer types, nevertheless, and although these changes seemed reasonable in an acute pandemic situation, note the authors, they were made in the absence of strong supportive evidence. Attempts to define the individualized risk for a given patient, taking into account their primary tumor subtype, stage, age, and gender, have been limited.

“Based on current evidence, only patients who are elderly, with multiple comorbidities, and receiving chemotherapy are vulnerable to the infection,” explained Curigliano.

However, on a positive note, a recently published prospective cohort study looked at approximately 800 patients with cancer – who had symptomatic COVID-19 – in the United Kingdom. The analysis showed no association at all between the risk for death and receiving chemotherapy or immunotherapy, points out Medscape commentator David Kerr, MD, of the University of Oxford, UK, in a recent commentary.

Key recommendations

An international consortium was established by ESMO, and the interdisciplinary expert panel consisted of 64 experts and one voting patient advocate. They agreed on 28 statements that can be used to help with many of the current clinical and technical areas of uncertainty that range from diagnosis to treatment decisions.

The following are several of the key recommendations:

  • Patients with cancer who face the highest risk of severe COVID-19 are characterized by active and progressive cancer, advanced age, poor performance status, smoking status, comorbidities, and possibly type of cancer.
  • Telehealth and digital health can be excellent tools for some types of care such as primary care triage and counseling, but meeting in person may be more effective for situations that include delivery of key cancer-related information and for patients with complex cancer needs.
  • Prior to hospital admission, patients with cancer should be tested for COVID-19, if feasible, and if they are considered at high risk, regardless of symptoms or chest radiological findings.
  • Patients with cancer and COVID-19 have a higher risk of thromboembolic events, and prophylaxis using low molecular weight  or novel oral anticoagulants is recommended.
  • Immune checkpoint inhibitors should not be withheld or delayed when there is a significant survival benefit, but use should be postponed in patients who test positive for COVID-19 until they recover.
  • Use of high-dose steroids in patients with cancer infected with COVID-19 could potentially increase the risk of mortality, and a switch should be made to another immunosuppressant, if possible.
  • The decision to use tyrosine kinase inhibitors (TKIs) of the PI3K/AKT/mTOR or RAS/RAF/MEK axis is complex, as they interfere with critical pathways involved in innate or adaptive immune responses. Stopping or withholding therapy depends on the risk-benefit balance, and the magnitude of benefit from the TKI needs to be considered.

The authors conclude that “ultimately, this set of statements will serve as a dynamic knowledge repository that will be better informed by accumulating data on SARS-CoV-2 biology, COVID-19 pandemic characteristics, on the risk of cancer patients for COVID-19 and its modulating factors, and finally, on optimal cancer care in the presence of the virus.”

No funding was reported for the current study. Several authors have disclosed relationships with industry, which are listed in the article.
 

This article first appeared on Medscape.com.

In the era of COVID-19, cancer treatment should not be discontinued or delayed if it can affect overall survival, according to new recommendations from an international team of experts.

Another important recommendation is to stop labeling all patients with cancer as being vulnerable to infection with the virus as it can lead to inappropriate care with potential negative outcomes.

“Although it was reasonable to adopt over-protective measures for our patients at the outbreak of a novel infective disease which was not previously observed in humans, we now need to step away from the assumption that all cancer patients are vulnerable to COVID-19,” said first author of the consensus article Giuseppe Curigliano, MD, PhD, of the European Institute of Oncology, Milan, Italy, in a statement. “The implications have been important because for some patients treatment was delayed or interrupted over the last few months, and I believe that we will see the impact of this over-precautionary approach in the...future.”

The recommendations were issued by the European Society of Medical Oncology (ESMO) to help guide physicians in “optimizing the pathway to cancer care” as well as to improve outcomes during the pandemic. The recommendations were published online July 31 in Annals of Oncology.

Studies have found that patients with cancer face a higher risk of serious complications and death if they develop COVID-19. Data from the COVID-19 and Cancer Consortium registry, for example, showed that patients with progressing cancer and COVID-19 infection had a fivefold increase in the risk of 30-day mortality compared with COVID-19–positive cancer patients who were in remission or had no evidence of cancer.

But while this may be true for some patients, Curigliano and colleagues emphasize that individuals with cancer are not a heterogeneous group and that the term “cancer” itself represents myriad different diseases. The European experts note that current evidence suggests many patients with solid tumors are not more vulnerable to serious complications than the general population.

Thus, cancer prognoses vary considerably, and addressing all patients with cancer as being “COVID-19-vulnerable is probably neither reasonable nor informative,” say the authors.

Dramatic changes were initiated in cancer management for all cancer types, nevertheless, and although these changes seemed reasonable in an acute pandemic situation, note the authors, they were made in the absence of strong supportive evidence. Attempts to define the individualized risk for a given patient, taking into account their primary tumor subtype, stage, age, and gender, have been limited.

“Based on current evidence, only patients who are elderly, with multiple comorbidities, and receiving chemotherapy are vulnerable to the infection,” explained Curigliano.

However, on a positive note, a recently published prospective cohort study looked at approximately 800 patients with cancer – who had symptomatic COVID-19 – in the United Kingdom. The analysis showed no association at all between the risk for death and receiving chemotherapy or immunotherapy, points out Medscape commentator David Kerr, MD, of the University of Oxford, UK, in a recent commentary.

Key recommendations

An international consortium was established by ESMO, and the interdisciplinary expert panel consisted of 64 experts and one voting patient advocate. They agreed on 28 statements that can be used to help with many of the current clinical and technical areas of uncertainty that range from diagnosis to treatment decisions.

The following are several of the key recommendations:

  • Patients with cancer who face the highest risk of severe COVID-19 are characterized by active and progressive cancer, advanced age, poor performance status, smoking status, comorbidities, and possibly type of cancer.
  • Telehealth and digital health can be excellent tools for some types of care such as primary care triage and counseling, but meeting in person may be more effective for situations that include delivery of key cancer-related information and for patients with complex cancer needs.
  • Prior to hospital admission, patients with cancer should be tested for COVID-19, if feasible, and if they are considered at high risk, regardless of symptoms or chest radiological findings.
  • Patients with cancer and COVID-19 have a higher risk of thromboembolic events, and prophylaxis using low molecular weight  or novel oral anticoagulants is recommended.
  • Immune checkpoint inhibitors should not be withheld or delayed when there is a significant survival benefit, but use should be postponed in patients who test positive for COVID-19 until they recover.
  • Use of high-dose steroids in patients with cancer infected with COVID-19 could potentially increase the risk of mortality, and a switch should be made to another immunosuppressant, if possible.
  • The decision to use tyrosine kinase inhibitors (TKIs) of the PI3K/AKT/mTOR or RAS/RAF/MEK axis is complex, as they interfere with critical pathways involved in innate or adaptive immune responses. Stopping or withholding therapy depends on the risk-benefit balance, and the magnitude of benefit from the TKI needs to be considered.

The authors conclude that “ultimately, this set of statements will serve as a dynamic knowledge repository that will be better informed by accumulating data on SARS-CoV-2 biology, COVID-19 pandemic characteristics, on the risk of cancer patients for COVID-19 and its modulating factors, and finally, on optimal cancer care in the presence of the virus.”

No funding was reported for the current study. Several authors have disclosed relationships with industry, which are listed in the article.
 

This article first appeared on Medscape.com.

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Psychiatrists report rare case of woman who thinks she’s a chicken 

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LEUVEN, Belgium — A 54-year-old woman has suffered the delusion of thinking she is a chicken for 24 hours. This very rare condition, known as zoanthropy, in which people think they are an animal is often not recognised, say researchers from the University of Leuven.

Zoanthropy can include people believing they are, or behaving like, any kind of animal: from a dog, to a lion or tiger, crocodile, snake, or bee.

It’s important to recognise this as a potential symptom of something serious, say the researchers in the July issue of the Belgian Journal of Psychiatry, Tijdschrift voor Psychiatrie.

The delusion can be a sign of an underlying psychiatric disorder, or it can be secondary to structural or functional abnormalities in the brain.

“Additional investigations with brain imaging and electroencephalogram are therefore advised,” say the authors. 
 

Psychiatrists Need to Be Aware That Clinical Zoanthropy Exists

In their paper, they describe the case of the woman who briefly thought she was a chicken, which was followed by her having a generalized epileptic seizure.

“Clinically, we saw a lady who perspired profusely, trembled, blew up her cheeks, and ... seemed to imitate a chicken, [making noises] like clucking, cackling, and crowing like a rooster,” they say.

“After about 10 minutes she seemed to tighten her muscles for a few seconds, her face turned red and for a short time she didn’t react. These symptoms repeated themselves at intervals of a few minutes [and her] consciousness was fluctuating,” with the patient “disoriented in time and space.”

Lead author Dr Athena Beckers of University Psychiatric Centre, KU Leuven, Belgium, said in an interview with MediQuality: “With only 56 case descriptions in the medical literature from 1850 to the present day, the condition is rare. It amounts to about one description every 3 years.

“We suspect, however, that the delusion is not always noticed: the patient shows bizarre behaviour or makes animal sounds, it is probably often catalogued under the general term ‘psychosis’.”

Dr Beckers adds that it is important that the symptoms are recognised, because of the possible underlying causes which can include epilepsy. So this might require a different or complementary treatment “with, for example, antiepileptic drugs”.

“I myself have only seen this type of delusion once, but I ... heard anecdotal stories from other patients whose family member, for example with schizophrenia, sometimes thought he was a cow [during] ... a psychosis.

“After the publication of my article I was also contacted by someone who told me they had experienced the same thing 30 years ago – he thought he was a chicken.

“I think it’s a good thing that we psychiatrists are aware of the fact that clinical zoanthropy exists and may require additional research,” she observed.

Fortunately, this woman’s experience ended well. After about one year of disability, the patient was able to return to work progressively. Her mood remained stable and there were no more psychotic symptoms or any indication of epileptic episodes.
 

Such Delusions Are Rare 

Dr Georges Otte, a recently retired neuropsychiatrist who formerly worked at Ghent University, Belgium, gave his thoughts to Mediquality: “The interface between neurology and psychiatry ... is a fertile meadow on which many crops thrive. But it is in the darkest corners of psychosis that one finds the most bizarre and also rarest excesses.”

There are a number of delusions of identity, said Dr Otte.

These include Cotard’s syndrome, a rare condition marked by the false belief that the person or their body parts are dead, dying, or don’t exist, or Capgras delusion, where the affected person believes that a spouse or close family member has been replaced with an imposter. Delusions can also occur as a result of substance abuse, for example after using psilocybin (magic mushrooms), he added.

“Delusions in which patients are convinced of ‘shape shifting’ (man to animal) are quite rare,” Dr Otte observed.

“In the literature we know that lycanthropy [a person thinks he or she is turning into a werewolf],” has been reported, and has “apparently inspired many authors of horror stories,” he added.

“But it’s not every day that as a psychiatrist, you will encounter such an extreme psychotic depersonalization as someone turning into a chicken.”
 

This article first appeared on Medscape.com.

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LEUVEN, Belgium — A 54-year-old woman has suffered the delusion of thinking she is a chicken for 24 hours. This very rare condition, known as zoanthropy, in which people think they are an animal is often not recognised, say researchers from the University of Leuven.

Zoanthropy can include people believing they are, or behaving like, any kind of animal: from a dog, to a lion or tiger, crocodile, snake, or bee.

It’s important to recognise this as a potential symptom of something serious, say the researchers in the July issue of the Belgian Journal of Psychiatry, Tijdschrift voor Psychiatrie.

The delusion can be a sign of an underlying psychiatric disorder, or it can be secondary to structural or functional abnormalities in the brain.

“Additional investigations with brain imaging and electroencephalogram are therefore advised,” say the authors. 
 

Psychiatrists Need to Be Aware That Clinical Zoanthropy Exists

In their paper, they describe the case of the woman who briefly thought she was a chicken, which was followed by her having a generalized epileptic seizure.

“Clinically, we saw a lady who perspired profusely, trembled, blew up her cheeks, and ... seemed to imitate a chicken, [making noises] like clucking, cackling, and crowing like a rooster,” they say.

“After about 10 minutes she seemed to tighten her muscles for a few seconds, her face turned red and for a short time she didn’t react. These symptoms repeated themselves at intervals of a few minutes [and her] consciousness was fluctuating,” with the patient “disoriented in time and space.”

Lead author Dr Athena Beckers of University Psychiatric Centre, KU Leuven, Belgium, said in an interview with MediQuality: “With only 56 case descriptions in the medical literature from 1850 to the present day, the condition is rare. It amounts to about one description every 3 years.

“We suspect, however, that the delusion is not always noticed: the patient shows bizarre behaviour or makes animal sounds, it is probably often catalogued under the general term ‘psychosis’.”

Dr Beckers adds that it is important that the symptoms are recognised, because of the possible underlying causes which can include epilepsy. So this might require a different or complementary treatment “with, for example, antiepileptic drugs”.

“I myself have only seen this type of delusion once, but I ... heard anecdotal stories from other patients whose family member, for example with schizophrenia, sometimes thought he was a cow [during] ... a psychosis.

“After the publication of my article I was also contacted by someone who told me they had experienced the same thing 30 years ago – he thought he was a chicken.

“I think it’s a good thing that we psychiatrists are aware of the fact that clinical zoanthropy exists and may require additional research,” she observed.

Fortunately, this woman’s experience ended well. After about one year of disability, the patient was able to return to work progressively. Her mood remained stable and there were no more psychotic symptoms or any indication of epileptic episodes.
 

Such Delusions Are Rare 

Dr Georges Otte, a recently retired neuropsychiatrist who formerly worked at Ghent University, Belgium, gave his thoughts to Mediquality: “The interface between neurology and psychiatry ... is a fertile meadow on which many crops thrive. But it is in the darkest corners of psychosis that one finds the most bizarre and also rarest excesses.”

There are a number of delusions of identity, said Dr Otte.

These include Cotard’s syndrome, a rare condition marked by the false belief that the person or their body parts are dead, dying, or don’t exist, or Capgras delusion, where the affected person believes that a spouse or close family member has been replaced with an imposter. Delusions can also occur as a result of substance abuse, for example after using psilocybin (magic mushrooms), he added.

“Delusions in which patients are convinced of ‘shape shifting’ (man to animal) are quite rare,” Dr Otte observed.

“In the literature we know that lycanthropy [a person thinks he or she is turning into a werewolf],” has been reported, and has “apparently inspired many authors of horror stories,” he added.

“But it’s not every day that as a psychiatrist, you will encounter such an extreme psychotic depersonalization as someone turning into a chicken.”
 

This article first appeared on Medscape.com.

LEUVEN, Belgium — A 54-year-old woman has suffered the delusion of thinking she is a chicken for 24 hours. This very rare condition, known as zoanthropy, in which people think they are an animal is often not recognised, say researchers from the University of Leuven.

Zoanthropy can include people believing they are, or behaving like, any kind of animal: from a dog, to a lion or tiger, crocodile, snake, or bee.

It’s important to recognise this as a potential symptom of something serious, say the researchers in the July issue of the Belgian Journal of Psychiatry, Tijdschrift voor Psychiatrie.

The delusion can be a sign of an underlying psychiatric disorder, or it can be secondary to structural or functional abnormalities in the brain.

“Additional investigations with brain imaging and electroencephalogram are therefore advised,” say the authors. 
 

Psychiatrists Need to Be Aware That Clinical Zoanthropy Exists

In their paper, they describe the case of the woman who briefly thought she was a chicken, which was followed by her having a generalized epileptic seizure.

“Clinically, we saw a lady who perspired profusely, trembled, blew up her cheeks, and ... seemed to imitate a chicken, [making noises] like clucking, cackling, and crowing like a rooster,” they say.

“After about 10 minutes she seemed to tighten her muscles for a few seconds, her face turned red and for a short time she didn’t react. These symptoms repeated themselves at intervals of a few minutes [and her] consciousness was fluctuating,” with the patient “disoriented in time and space.”

Lead author Dr Athena Beckers of University Psychiatric Centre, KU Leuven, Belgium, said in an interview with MediQuality: “With only 56 case descriptions in the medical literature from 1850 to the present day, the condition is rare. It amounts to about one description every 3 years.

“We suspect, however, that the delusion is not always noticed: the patient shows bizarre behaviour or makes animal sounds, it is probably often catalogued under the general term ‘psychosis’.”

Dr Beckers adds that it is important that the symptoms are recognised, because of the possible underlying causes which can include epilepsy. So this might require a different or complementary treatment “with, for example, antiepileptic drugs”.

“I myself have only seen this type of delusion once, but I ... heard anecdotal stories from other patients whose family member, for example with schizophrenia, sometimes thought he was a cow [during] ... a psychosis.

“After the publication of my article I was also contacted by someone who told me they had experienced the same thing 30 years ago – he thought he was a chicken.

“I think it’s a good thing that we psychiatrists are aware of the fact that clinical zoanthropy exists and may require additional research,” she observed.

Fortunately, this woman’s experience ended well. After about one year of disability, the patient was able to return to work progressively. Her mood remained stable and there were no more psychotic symptoms or any indication of epileptic episodes.
 

Such Delusions Are Rare 

Dr Georges Otte, a recently retired neuropsychiatrist who formerly worked at Ghent University, Belgium, gave his thoughts to Mediquality: “The interface between neurology and psychiatry ... is a fertile meadow on which many crops thrive. But it is in the darkest corners of psychosis that one finds the most bizarre and also rarest excesses.”

There are a number of delusions of identity, said Dr Otte.

These include Cotard’s syndrome, a rare condition marked by the false belief that the person or their body parts are dead, dying, or don’t exist, or Capgras delusion, where the affected person believes that a spouse or close family member has been replaced with an imposter. Delusions can also occur as a result of substance abuse, for example after using psilocybin (magic mushrooms), he added.

“Delusions in which patients are convinced of ‘shape shifting’ (man to animal) are quite rare,” Dr Otte observed.

“In the literature we know that lycanthropy [a person thinks he or she is turning into a werewolf],” has been reported, and has “apparently inspired many authors of horror stories,” he added.

“But it’s not every day that as a psychiatrist, you will encounter such an extreme psychotic depersonalization as someone turning into a chicken.”
 

This article first appeared on Medscape.com.

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Q2. Correct answer: D  
 
Rationale  
Episodic hepatic encephalopathy is usually precipitant-induced in over 80% of cases and includes dehydration, infections, over diuresis, gastrointestinal bleeding, constipation, and the use of narcotics and sedatives. Key is to identify and treat the precipitant. A diagnostic workup to rule out other disorders that can alter brain function and mimic hepatic encephalopathy should also be performed.  
 
Reference  
1. Viltstrup H et al. Hepatic encephalopathy in chronic liver disease: 2014 Practice Guideline by the American Association for the Study of Liver Diseases and the European Association for the Study of the Liver. Hepatology. 2014;60(2):715-35. 
 
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Q2. Correct answer: D  
 
Rationale  
Episodic hepatic encephalopathy is usually precipitant-induced in over 80% of cases and includes dehydration, infections, over diuresis, gastrointestinal bleeding, constipation, and the use of narcotics and sedatives. Key is to identify and treat the precipitant. A diagnostic workup to rule out other disorders that can alter brain function and mimic hepatic encephalopathy should also be performed.  
 
Reference  
1. Viltstrup H et al. Hepatic encephalopathy in chronic liver disease: 2014 Practice Guideline by the American Association for the Study of Liver Diseases and the European Association for the Study of the Liver. Hepatology. 2014;60(2):715-35. 
 
[email protected]

Q2. Correct answer: D  
 
Rationale  
Episodic hepatic encephalopathy is usually precipitant-induced in over 80% of cases and includes dehydration, infections, over diuresis, gastrointestinal bleeding, constipation, and the use of narcotics and sedatives. Key is to identify and treat the precipitant. A diagnostic workup to rule out other disorders that can alter brain function and mimic hepatic encephalopathy should also be performed.  
 
Reference  
1. Viltstrup H et al. Hepatic encephalopathy in chronic liver disease: 2014 Practice Guideline by the American Association for the Study of Liver Diseases and the European Association for the Study of the Liver. Hepatology. 2014;60(2):715-35. 
 
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A 62-year-old man with hepatitis C cirrhosis is admitted with altered mental status. He had a recent dental procedure and was given pain medication and a short course of antibiotics. He is only taking spironolactone 50 mg for small ascites. Patient is alert but not oriented to place and time. He has evidence of asterixis. His mucous membranes are dry and he has no evidence of ascites on exam. His labs include WBC, 4.7 × 103 mm3; AST, 45 U/L; ALT, 40 U/L; total bilirubin of 2.5 mg/dL; albumin of 3.7 g/dL; sodium 142 mEq/L; and a creatinine of 0.5 mg/dL.

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In the United States, pigmented stones (black and brown) are less common than cholesterol gallstones. Both types of pigmented stones contain an excess of unconjugated bilirubin and are composed of calcium hydrogen bilirubinate, which is oxidized and polymerized in the hard black stones but unpolymerized in softer brown stones. Black pigmented gallstones are frequently radiopaque and form in sterile bile. Risk factors for black pigmented stones include hemolysis (example, sickle cell disease), cirrhosis, cystic fibrosis, and diseases affecting the ileum (example, Crohn's disease). In contrast, brown stones are more likely to occur in the bile ducts, are radiolucent, and form secondary to biliary stasis (example, biliary stricture) and infection (example, Clonorchis sinensis).  
Obesity, female sex, and hyperlipidemia are risk factors for cholesterol gallstone formation. Octreotide decreases gallbladder motility and long-term use can increase the risk of cholelithiasis.  
 
References  
1. Stinton LM, Myers RP, Shaffer EA. Epidemiology of gallstones. Gastroenterol Clin N Am. 2010;39:157-69.  
2. Vitek L, Carey MC. New pathophysiological concepts underlying pathogenesis of pigment gallstones. Clin Res Hepatol Gastroenterol. 2012;36:122-9.

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Q1. Correct answer: A  
 
Rationale  
In the United States, pigmented stones (black and brown) are less common than cholesterol gallstones. Both types of pigmented stones contain an excess of unconjugated bilirubin and are composed of calcium hydrogen bilirubinate, which is oxidized and polymerized in the hard black stones but unpolymerized in softer brown stones. Black pigmented gallstones are frequently radiopaque and form in sterile bile. Risk factors for black pigmented stones include hemolysis (example, sickle cell disease), cirrhosis, cystic fibrosis, and diseases affecting the ileum (example, Crohn's disease). In contrast, brown stones are more likely to occur in the bile ducts, are radiolucent, and form secondary to biliary stasis (example, biliary stricture) and infection (example, Clonorchis sinensis).  
Obesity, female sex, and hyperlipidemia are risk factors for cholesterol gallstone formation. Octreotide decreases gallbladder motility and long-term use can increase the risk of cholelithiasis.  
 
References  
1. Stinton LM, Myers RP, Shaffer EA. Epidemiology of gallstones. Gastroenterol Clin N Am. 2010;39:157-69.  
2. Vitek L, Carey MC. New pathophysiological concepts underlying pathogenesis of pigment gallstones. Clin Res Hepatol Gastroenterol. 2012;36:122-9.

[email protected]

Q1. Correct answer: A  
 
Rationale  
In the United States, pigmented stones (black and brown) are less common than cholesterol gallstones. Both types of pigmented stones contain an excess of unconjugated bilirubin and are composed of calcium hydrogen bilirubinate, which is oxidized and polymerized in the hard black stones but unpolymerized in softer brown stones. Black pigmented gallstones are frequently radiopaque and form in sterile bile. Risk factors for black pigmented stones include hemolysis (example, sickle cell disease), cirrhosis, cystic fibrosis, and diseases affecting the ileum (example, Crohn's disease). In contrast, brown stones are more likely to occur in the bile ducts, are radiolucent, and form secondary to biliary stasis (example, biliary stricture) and infection (example, Clonorchis sinensis).  
Obesity, female sex, and hyperlipidemia are risk factors for cholesterol gallstone formation. Octreotide decreases gallbladder motility and long-term use can increase the risk of cholelithiasis.  
 
References  
1. Stinton LM, Myers RP, Shaffer EA. Epidemiology of gallstones. Gastroenterol Clin N Am. 2010;39:157-69.  
2. Vitek L, Carey MC. New pathophysiological concepts underlying pathogenesis of pigment gallstones. Clin Res Hepatol Gastroenterol. 2012;36:122-9.

[email protected]

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A 56-year-old woman presents for evaluation of right upper-quadrant pain. Her medical history is remarkable for obesity with a BMI of 31 kg/m2, hyperlipidemia, diabetes mellitus, NASH cirrhosis, and a recent admission for melena. During her prior admission, she was treated with a proton pump inhibitor and octreotide. Esophagogastroduodenoscopy revealed a gastric ulcer with signs of recent bleeding and small esophageal varices without red wale signs.  
Her lab evaluation is as follows: AST, 69 U/L; ALT, 35 U/L; total bilirubin, 1.6 mg/dL; alkaline phosphatase, 121 U/L, leukocytes 7,500/microL. An abdominal ultrasound is notable for a positive sonographic Murphy's sign, cholelithiasis, an 8-mm gallbladder wall, normal appearing bile ducts, and a cirrhotic appearing liver with splenomegaly. She undergoes cholecystectomy. Examination of the gallbladder reveals numerous hard gallstones, which are predominately composed of calcium bilirubinate.

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How often does risk-reducing salpingo-oophorectomy identify cancer?

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Among women with BRCA mutations who underwent risk-reducing bilateral salpingo-oophorectomy, the procedure led to a cancer diagnosis in 3%, according to research presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.

HRAUN/Getty Images

Of 269 patients, 8 (3%) received a cancer diagnosis. In five cases, the cancer was diagnosed on final pathology, and three had immediate conversion to staging.

The data suggest that gynecologists as well as gynecologic oncologists may perform the procedure, but gynecologists may be less likely to obtain pelvic washings in accordance with guidelines for this indication.

“It may not be necessary for oncologists alone to be performing risk-reducing salpingo-oophorectomies given that the overall incidence of cancer is low,” said study author Coralee Toal, MD, of UPMC Magee-Womans Hospital in Pittsburgh. “It is often a diagnosis that is found at the time of pathology, so the initial procedure would not have been changed either way.”

Still, doctors who perform the procedure should follow recommended practices such as obtaining pelvic washings and identifying patients for the procedure within target age ranges, Dr. Toal said.

BRCA1 and BRCA2 mutations confer an increased risk of ovarian and breast cancer, but there is no effective form of ovarian cancer screening. Women with a known mutation may have a bilateral salpingo-oophorectomy to reduce the risk of cancer. The recommended age range for the procedure is 35-40 years for women with BRCA1 mutations and 40-45 years for women with BRCA2 mutations.

When the procedure is performed for this indication, various recommendations apply that may differ from those when the procedure is performed under different circumstances.

During risk-reducing bilateral salpingo-oophorectomy, the surgeon should thoroughly evaluate the abdominal cavity, obtain pelvic washings for cytology, remove at least 2 cm of the infundibulopelvic ligament, and divide the fallopian tube at the uterine cornua.

To assess the incidence of occult ovarian cancer at the time of risk-reducing bilateral salpingo-oophorectomy and surgeon adherence to recommended practices, Dr. Toal and colleagues performed a retrospective chart review.

They included patients who had a known BRCA mutation and underwent a risk-reducing bilateral salpingo-oophorectomy between July 2007 and September 2018. They excluded patients who had a suspicious adnexal mass before the procedure but not a known diagnosis, as well as patients with another malignancy or genetic syndrome.

The researchers evaluated adherence to recommendations by reviewing operative reports.

In all, they reviewed data from 269 patients. In 220 cases, a gynecologic oncologist performed the procedure, and in 49 cases a gynecologist performed the procedure.

Patients tended to be older than would be expected, said Dr. Toal. Patients with BRCA1 mutations had an average age of 46 years, and patients with BRCA2 mutations had an average age of 49 years.

Patients who received a cancer diagnosis were significantly older on average, compared with the other patients: 58 years versus 48 years.

Pelvic washings were performed during 95% of the procedures performed by a gynecologic oncologist, compared with 63% of the procedures performed by a gynecologist. In addition, patients who had the procedure performed by a gynecologist were significantly older than those who had the procedure performed by a gynecologic oncologist (49 vs. 47 years).

Miles Murphy, MD, president of the Society of Gynecologic Surgeons, asked how doctors should weigh the possibility of risk-reducing oophorectomy at the time of benign hysterectomy in patients without a family history of female cancer.

It could be that genetic testing would be appropriate for some of those patients, Dr. Toal said. It is “important to take a thorough family history to make sure that you are identifying anybody who may benefit from genetic counseling and genetic testing, where you might identify an otherwise not known mutation prior to an otherwise benign or routine surgery,” Dr. Toal said. “Then you would have the opportunity to perform this.”

For patients without known mutations, however, “we do know the benefit of ovaries remaining in situ ... including cardiac health,” she said. “You have to remember that people can die of a broken hip as well. The risk of osteoporosis and those things is not zero and in fact may be much higher than their ovarian cancer risk.”

One of the study authors is a surgeon educator for Covidien and Medtronic.

SOURCE: Newcomb LK et al. SGS 2020, Abstract 18.

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Among women with BRCA mutations who underwent risk-reducing bilateral salpingo-oophorectomy, the procedure led to a cancer diagnosis in 3%, according to research presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.

HRAUN/Getty Images

Of 269 patients, 8 (3%) received a cancer diagnosis. In five cases, the cancer was diagnosed on final pathology, and three had immediate conversion to staging.

The data suggest that gynecologists as well as gynecologic oncologists may perform the procedure, but gynecologists may be less likely to obtain pelvic washings in accordance with guidelines for this indication.

“It may not be necessary for oncologists alone to be performing risk-reducing salpingo-oophorectomies given that the overall incidence of cancer is low,” said study author Coralee Toal, MD, of UPMC Magee-Womans Hospital in Pittsburgh. “It is often a diagnosis that is found at the time of pathology, so the initial procedure would not have been changed either way.”

Still, doctors who perform the procedure should follow recommended practices such as obtaining pelvic washings and identifying patients for the procedure within target age ranges, Dr. Toal said.

BRCA1 and BRCA2 mutations confer an increased risk of ovarian and breast cancer, but there is no effective form of ovarian cancer screening. Women with a known mutation may have a bilateral salpingo-oophorectomy to reduce the risk of cancer. The recommended age range for the procedure is 35-40 years for women with BRCA1 mutations and 40-45 years for women with BRCA2 mutations.

When the procedure is performed for this indication, various recommendations apply that may differ from those when the procedure is performed under different circumstances.

During risk-reducing bilateral salpingo-oophorectomy, the surgeon should thoroughly evaluate the abdominal cavity, obtain pelvic washings for cytology, remove at least 2 cm of the infundibulopelvic ligament, and divide the fallopian tube at the uterine cornua.

To assess the incidence of occult ovarian cancer at the time of risk-reducing bilateral salpingo-oophorectomy and surgeon adherence to recommended practices, Dr. Toal and colleagues performed a retrospective chart review.

They included patients who had a known BRCA mutation and underwent a risk-reducing bilateral salpingo-oophorectomy between July 2007 and September 2018. They excluded patients who had a suspicious adnexal mass before the procedure but not a known diagnosis, as well as patients with another malignancy or genetic syndrome.

The researchers evaluated adherence to recommendations by reviewing operative reports.

In all, they reviewed data from 269 patients. In 220 cases, a gynecologic oncologist performed the procedure, and in 49 cases a gynecologist performed the procedure.

Patients tended to be older than would be expected, said Dr. Toal. Patients with BRCA1 mutations had an average age of 46 years, and patients with BRCA2 mutations had an average age of 49 years.

Patients who received a cancer diagnosis were significantly older on average, compared with the other patients: 58 years versus 48 years.

Pelvic washings were performed during 95% of the procedures performed by a gynecologic oncologist, compared with 63% of the procedures performed by a gynecologist. In addition, patients who had the procedure performed by a gynecologist were significantly older than those who had the procedure performed by a gynecologic oncologist (49 vs. 47 years).

Miles Murphy, MD, president of the Society of Gynecologic Surgeons, asked how doctors should weigh the possibility of risk-reducing oophorectomy at the time of benign hysterectomy in patients without a family history of female cancer.

It could be that genetic testing would be appropriate for some of those patients, Dr. Toal said. It is “important to take a thorough family history to make sure that you are identifying anybody who may benefit from genetic counseling and genetic testing, where you might identify an otherwise not known mutation prior to an otherwise benign or routine surgery,” Dr. Toal said. “Then you would have the opportunity to perform this.”

For patients without known mutations, however, “we do know the benefit of ovaries remaining in situ ... including cardiac health,” she said. “You have to remember that people can die of a broken hip as well. The risk of osteoporosis and those things is not zero and in fact may be much higher than their ovarian cancer risk.”

One of the study authors is a surgeon educator for Covidien and Medtronic.

SOURCE: Newcomb LK et al. SGS 2020, Abstract 18.

Among women with BRCA mutations who underwent risk-reducing bilateral salpingo-oophorectomy, the procedure led to a cancer diagnosis in 3%, according to research presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.

HRAUN/Getty Images

Of 269 patients, 8 (3%) received a cancer diagnosis. In five cases, the cancer was diagnosed on final pathology, and three had immediate conversion to staging.

The data suggest that gynecologists as well as gynecologic oncologists may perform the procedure, but gynecologists may be less likely to obtain pelvic washings in accordance with guidelines for this indication.

“It may not be necessary for oncologists alone to be performing risk-reducing salpingo-oophorectomies given that the overall incidence of cancer is low,” said study author Coralee Toal, MD, of UPMC Magee-Womans Hospital in Pittsburgh. “It is often a diagnosis that is found at the time of pathology, so the initial procedure would not have been changed either way.”

Still, doctors who perform the procedure should follow recommended practices such as obtaining pelvic washings and identifying patients for the procedure within target age ranges, Dr. Toal said.

BRCA1 and BRCA2 mutations confer an increased risk of ovarian and breast cancer, but there is no effective form of ovarian cancer screening. Women with a known mutation may have a bilateral salpingo-oophorectomy to reduce the risk of cancer. The recommended age range for the procedure is 35-40 years for women with BRCA1 mutations and 40-45 years for women with BRCA2 mutations.

When the procedure is performed for this indication, various recommendations apply that may differ from those when the procedure is performed under different circumstances.

During risk-reducing bilateral salpingo-oophorectomy, the surgeon should thoroughly evaluate the abdominal cavity, obtain pelvic washings for cytology, remove at least 2 cm of the infundibulopelvic ligament, and divide the fallopian tube at the uterine cornua.

To assess the incidence of occult ovarian cancer at the time of risk-reducing bilateral salpingo-oophorectomy and surgeon adherence to recommended practices, Dr. Toal and colleagues performed a retrospective chart review.

They included patients who had a known BRCA mutation and underwent a risk-reducing bilateral salpingo-oophorectomy between July 2007 and September 2018. They excluded patients who had a suspicious adnexal mass before the procedure but not a known diagnosis, as well as patients with another malignancy or genetic syndrome.

The researchers evaluated adherence to recommendations by reviewing operative reports.

In all, they reviewed data from 269 patients. In 220 cases, a gynecologic oncologist performed the procedure, and in 49 cases a gynecologist performed the procedure.

Patients tended to be older than would be expected, said Dr. Toal. Patients with BRCA1 mutations had an average age of 46 years, and patients with BRCA2 mutations had an average age of 49 years.

Patients who received a cancer diagnosis were significantly older on average, compared with the other patients: 58 years versus 48 years.

Pelvic washings were performed during 95% of the procedures performed by a gynecologic oncologist, compared with 63% of the procedures performed by a gynecologist. In addition, patients who had the procedure performed by a gynecologist were significantly older than those who had the procedure performed by a gynecologic oncologist (49 vs. 47 years).

Miles Murphy, MD, president of the Society of Gynecologic Surgeons, asked how doctors should weigh the possibility of risk-reducing oophorectomy at the time of benign hysterectomy in patients without a family history of female cancer.

It could be that genetic testing would be appropriate for some of those patients, Dr. Toal said. It is “important to take a thorough family history to make sure that you are identifying anybody who may benefit from genetic counseling and genetic testing, where you might identify an otherwise not known mutation prior to an otherwise benign or routine surgery,” Dr. Toal said. “Then you would have the opportunity to perform this.”

For patients without known mutations, however, “we do know the benefit of ovaries remaining in situ ... including cardiac health,” she said. “You have to remember that people can die of a broken hip as well. The risk of osteoporosis and those things is not zero and in fact may be much higher than their ovarian cancer risk.”

One of the study authors is a surgeon educator for Covidien and Medtronic.

SOURCE: Newcomb LK et al. SGS 2020, Abstract 18.

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Better continence rate gives robotic prostatectomy the edge

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Higher continence rates were seen after robot-assisted radical prostatectomy (RARP) than after laparoscopic radical prostatectomy (LRP) in the first large-scale, prospective, multicenter, randomized trial to compare the two surgical approaches.

At 3 months, 54.3% of prostate cancer patients who underwent RARP and 45.6% of those who had LRP were continent after catheter removal (P = .027).

“We did use a very strong definition for continence, meaning no pad or safety pad; patients wearing one pad per day we’re not classified as continent,” said study investigator Jens-Uwe Stolzenburg, MD, PhD, professor and head of urology at the University of Leipzig Hospital in Germany.

Dr. Stolzenburg presented these findings at the European Association of Urology virtual annual congress.

The findings fit with previous research showing higher continence rates with RARP (69%-80%) than with LRP (62%-63%), although those studies did not always find the difference to be statistically significant, and higher quality evidence was needed (J Sex Med. 2011 May;8[5]:1503-12; Eur Urol. 2013 Apr;63[4]:606-14). “Up to now, there are only two randomized studies published in the literature comparing robotic and classical laparoscopic prostatectomy, and my point of view is that there are strong limitations of both studies,” Dr. Stolzenburg said.

“First of all, both studies are based on the single experience of surgeons, so only one surgeon has performed surgery. The second limitation is the limited numbers of patients included,” he observed. One study had 64 patients in each arm, and the other had 60 patients in each arm.
 

Providing higher quality evidence

Dr. Stolzenburg presented results of the LAP-01 study, which was designed to close the knowledge gap and determine if there really was an advantage for RARP over LRP for preserving continence.

The trial was conducted at three academic centers and one public hospital in Germany. The final analysis included 718 patients with prostate cancer referred for prostate surgery. They were randomized, in a ratio of three to one, to undergo RARP (n = 530) or LRP (n = 188), being unaware themselves of which surgery they would be having until the 3-month primary endpoint.

In addition to improved continence over LRP, RARP was associated with significantly better erectile function at 3 months (P = .016), as measured by the International Index of Erectile Function (IIEF).

That said, erectile function was still severely affected by both surgical procedures. Total IIEF scores were 6.0 with RARP and 4.7 with LRP, compared with 15.9 and 16.2, respectively, at baseline.

A higher percentage of men who had nerve-sparing procedures reported having an erection suitable for sexual intercourse at 2 months in the RARP group than in the LRP group (17.7% vs. 6.7%, P = .007).

The complication rate was “a little bit higher” in the LRP group than in the RARP group, “but the difference was not statistically significant,” Dr. Stolzenburg said. He added that “the most frequent complication was anastomotic leakage, and most complications overall were low-grade complications in both groups.”
 

Multicenter experience

The potential for prostatectomy to have effects on urinary continence and sexual function are important issues that need to be discussed upfront with patients, observed Alexandre de la Taille, MD, PhD, who was invited to discuss the study.

Current European guidance says “there is no surgical approach – open, laparoscopic, or robotic radical prostatectomy – that has proven superiority in terms of functional or oncological results,” he said. However, the LAP-01 study “found that the continence rate was better when we use a robotic approach compared to a laparoscopic approach.”

Dr. de la Taille, who is professor and chair of the urology service at CHU Mondor in Cretéil, France, also highlighted that this result was achieved with no increase in the morbidity profile or compromise of cancer control.

“My very first impression is that we are missing a little bit, some granularity of the data in terms of one key question, which is volume of surgery,” said the chair of the session Alberto Briganti, MD, PhD, associate professor of urology at Università Vita-Salute San Raffaele, and deputy director of the Urological Research Institute of IRCCS Ospedale San Raffaele, both in Milan.

“We know that recovery of outcomes is volume-dependent, both in the laparoscopic and robotic setting,” Dr. Briganti added.

“This is really a multicenter study including a lot of surgeons,” Dr. de la Taille countered, agreeing that the volume of surgeries might be something the LAP-01 study investigators could look at in a sub-analysis.

“Of course, some of them have a huge experience in the robotic approach and some of them a lower experience of the robotic approach, but when you put all together, there is a better continence recovery at 3 months when compared to the laparoscopic approach,” Dr. de la Taille said.

Calling the study a “real-life practice study,” he noted that urinary continence at 12 months might be a stronger endpoint, and the difference between the two surgical approaches may become less with time.

“But for the patient, again, daily practice, it’s better to have early urinary continence recovery compared to a late recovery,” Dr. de la Taille said.

This study was funded by the University of Leipzig via a German Cancer Aid grant. All speakers declared no conflicts of interest.

SOURCE: Stolzenburg J-E. EAU20, Abstract.

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Higher continence rates were seen after robot-assisted radical prostatectomy (RARP) than after laparoscopic radical prostatectomy (LRP) in the first large-scale, prospective, multicenter, randomized trial to compare the two surgical approaches.

At 3 months, 54.3% of prostate cancer patients who underwent RARP and 45.6% of those who had LRP were continent after catheter removal (P = .027).

“We did use a very strong definition for continence, meaning no pad or safety pad; patients wearing one pad per day we’re not classified as continent,” said study investigator Jens-Uwe Stolzenburg, MD, PhD, professor and head of urology at the University of Leipzig Hospital in Germany.

Dr. Stolzenburg presented these findings at the European Association of Urology virtual annual congress.

The findings fit with previous research showing higher continence rates with RARP (69%-80%) than with LRP (62%-63%), although those studies did not always find the difference to be statistically significant, and higher quality evidence was needed (J Sex Med. 2011 May;8[5]:1503-12; Eur Urol. 2013 Apr;63[4]:606-14). “Up to now, there are only two randomized studies published in the literature comparing robotic and classical laparoscopic prostatectomy, and my point of view is that there are strong limitations of both studies,” Dr. Stolzenburg said.

“First of all, both studies are based on the single experience of surgeons, so only one surgeon has performed surgery. The second limitation is the limited numbers of patients included,” he observed. One study had 64 patients in each arm, and the other had 60 patients in each arm.
 

Providing higher quality evidence

Dr. Stolzenburg presented results of the LAP-01 study, which was designed to close the knowledge gap and determine if there really was an advantage for RARP over LRP for preserving continence.

The trial was conducted at three academic centers and one public hospital in Germany. The final analysis included 718 patients with prostate cancer referred for prostate surgery. They were randomized, in a ratio of three to one, to undergo RARP (n = 530) or LRP (n = 188), being unaware themselves of which surgery they would be having until the 3-month primary endpoint.

In addition to improved continence over LRP, RARP was associated with significantly better erectile function at 3 months (P = .016), as measured by the International Index of Erectile Function (IIEF).

That said, erectile function was still severely affected by both surgical procedures. Total IIEF scores were 6.0 with RARP and 4.7 with LRP, compared with 15.9 and 16.2, respectively, at baseline.

A higher percentage of men who had nerve-sparing procedures reported having an erection suitable for sexual intercourse at 2 months in the RARP group than in the LRP group (17.7% vs. 6.7%, P = .007).

The complication rate was “a little bit higher” in the LRP group than in the RARP group, “but the difference was not statistically significant,” Dr. Stolzenburg said. He added that “the most frequent complication was anastomotic leakage, and most complications overall were low-grade complications in both groups.”
 

Multicenter experience

The potential for prostatectomy to have effects on urinary continence and sexual function are important issues that need to be discussed upfront with patients, observed Alexandre de la Taille, MD, PhD, who was invited to discuss the study.

Current European guidance says “there is no surgical approach – open, laparoscopic, or robotic radical prostatectomy – that has proven superiority in terms of functional or oncological results,” he said. However, the LAP-01 study “found that the continence rate was better when we use a robotic approach compared to a laparoscopic approach.”

Dr. de la Taille, who is professor and chair of the urology service at CHU Mondor in Cretéil, France, also highlighted that this result was achieved with no increase in the morbidity profile or compromise of cancer control.

“My very first impression is that we are missing a little bit, some granularity of the data in terms of one key question, which is volume of surgery,” said the chair of the session Alberto Briganti, MD, PhD, associate professor of urology at Università Vita-Salute San Raffaele, and deputy director of the Urological Research Institute of IRCCS Ospedale San Raffaele, both in Milan.

“We know that recovery of outcomes is volume-dependent, both in the laparoscopic and robotic setting,” Dr. Briganti added.

“This is really a multicenter study including a lot of surgeons,” Dr. de la Taille countered, agreeing that the volume of surgeries might be something the LAP-01 study investigators could look at in a sub-analysis.

“Of course, some of them have a huge experience in the robotic approach and some of them a lower experience of the robotic approach, but when you put all together, there is a better continence recovery at 3 months when compared to the laparoscopic approach,” Dr. de la Taille said.

Calling the study a “real-life practice study,” he noted that urinary continence at 12 months might be a stronger endpoint, and the difference between the two surgical approaches may become less with time.

“But for the patient, again, daily practice, it’s better to have early urinary continence recovery compared to a late recovery,” Dr. de la Taille said.

This study was funded by the University of Leipzig via a German Cancer Aid grant. All speakers declared no conflicts of interest.

SOURCE: Stolzenburg J-E. EAU20, Abstract.

Higher continence rates were seen after robot-assisted radical prostatectomy (RARP) than after laparoscopic radical prostatectomy (LRP) in the first large-scale, prospective, multicenter, randomized trial to compare the two surgical approaches.

At 3 months, 54.3% of prostate cancer patients who underwent RARP and 45.6% of those who had LRP were continent after catheter removal (P = .027).

“We did use a very strong definition for continence, meaning no pad or safety pad; patients wearing one pad per day we’re not classified as continent,” said study investigator Jens-Uwe Stolzenburg, MD, PhD, professor and head of urology at the University of Leipzig Hospital in Germany.

Dr. Stolzenburg presented these findings at the European Association of Urology virtual annual congress.

The findings fit with previous research showing higher continence rates with RARP (69%-80%) than with LRP (62%-63%), although those studies did not always find the difference to be statistically significant, and higher quality evidence was needed (J Sex Med. 2011 May;8[5]:1503-12; Eur Urol. 2013 Apr;63[4]:606-14). “Up to now, there are only two randomized studies published in the literature comparing robotic and classical laparoscopic prostatectomy, and my point of view is that there are strong limitations of both studies,” Dr. Stolzenburg said.

“First of all, both studies are based on the single experience of surgeons, so only one surgeon has performed surgery. The second limitation is the limited numbers of patients included,” he observed. One study had 64 patients in each arm, and the other had 60 patients in each arm.
 

Providing higher quality evidence

Dr. Stolzenburg presented results of the LAP-01 study, which was designed to close the knowledge gap and determine if there really was an advantage for RARP over LRP for preserving continence.

The trial was conducted at three academic centers and one public hospital in Germany. The final analysis included 718 patients with prostate cancer referred for prostate surgery. They were randomized, in a ratio of three to one, to undergo RARP (n = 530) or LRP (n = 188), being unaware themselves of which surgery they would be having until the 3-month primary endpoint.

In addition to improved continence over LRP, RARP was associated with significantly better erectile function at 3 months (P = .016), as measured by the International Index of Erectile Function (IIEF).

That said, erectile function was still severely affected by both surgical procedures. Total IIEF scores were 6.0 with RARP and 4.7 with LRP, compared with 15.9 and 16.2, respectively, at baseline.

A higher percentage of men who had nerve-sparing procedures reported having an erection suitable for sexual intercourse at 2 months in the RARP group than in the LRP group (17.7% vs. 6.7%, P = .007).

The complication rate was “a little bit higher” in the LRP group than in the RARP group, “but the difference was not statistically significant,” Dr. Stolzenburg said. He added that “the most frequent complication was anastomotic leakage, and most complications overall were low-grade complications in both groups.”
 

Multicenter experience

The potential for prostatectomy to have effects on urinary continence and sexual function are important issues that need to be discussed upfront with patients, observed Alexandre de la Taille, MD, PhD, who was invited to discuss the study.

Current European guidance says “there is no surgical approach – open, laparoscopic, or robotic radical prostatectomy – that has proven superiority in terms of functional or oncological results,” he said. However, the LAP-01 study “found that the continence rate was better when we use a robotic approach compared to a laparoscopic approach.”

Dr. de la Taille, who is professor and chair of the urology service at CHU Mondor in Cretéil, France, also highlighted that this result was achieved with no increase in the morbidity profile or compromise of cancer control.

“My very first impression is that we are missing a little bit, some granularity of the data in terms of one key question, which is volume of surgery,” said the chair of the session Alberto Briganti, MD, PhD, associate professor of urology at Università Vita-Salute San Raffaele, and deputy director of the Urological Research Institute of IRCCS Ospedale San Raffaele, both in Milan.

“We know that recovery of outcomes is volume-dependent, both in the laparoscopic and robotic setting,” Dr. Briganti added.

“This is really a multicenter study including a lot of surgeons,” Dr. de la Taille countered, agreeing that the volume of surgeries might be something the LAP-01 study investigators could look at in a sub-analysis.

“Of course, some of them have a huge experience in the robotic approach and some of them a lower experience of the robotic approach, but when you put all together, there is a better continence recovery at 3 months when compared to the laparoscopic approach,” Dr. de la Taille said.

Calling the study a “real-life practice study,” he noted that urinary continence at 12 months might be a stronger endpoint, and the difference between the two surgical approaches may become less with time.

“But for the patient, again, daily practice, it’s better to have early urinary continence recovery compared to a late recovery,” Dr. de la Taille said.

This study was funded by the University of Leipzig via a German Cancer Aid grant. All speakers declared no conflicts of interest.

SOURCE: Stolzenburg J-E. EAU20, Abstract.

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Heart damage even after COVID-19 ‘recovery’ evokes specter of later heart failure

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Evidence that the heart can take a major hit in patients hospitalized with COVID-19, especially those already with cardiovascular disease (CV) or its risk factors, has been sadly apparent from the pandemic’s earliest days.

Less clear from case studies and small series to date has been whether SARS-CoV-2 directly attacks the heart and whether acute cardiac effects of the illness may lead to some kind of lingering cardiomyopathy.

The field’s grasp of those issues advanced a bit in two new reports published July 27 in JAMA Cardiology that seem to validate concerns the virus can infect the myocardium, without necessarily causing myocarditis and the possibility that some “recovered” patients may be left with persisting myocardial injury and inflammation that potentially could later manifest as heart failure.

Persisting inflammation by cardiac magnetic resonance

A prospective cohort study with 100 patients recovered from a recent bout of the disease showed evidence of ventricular dysfunction, greater ventricular mass, and in 78% of the cohort, signs of myocardial inflammation by cardiac magnetic resonance (CMR) imaging. The CMR findings correlated with elevations in troponin T by high-sensitivity assay (hs-TnT).

Two-thirds of the cohort, whose acute COVID-19 severity had “ranged from asymptomatic to minor-to-moderate symptoms,” had recovered at home, whereas the remaining “severely unwell patients” had been hospitalized, wrote the authors, led by Valentina O. Püntmann, MD, PhD, University Hospital Frankfurt (Germany).

None of the patients had a history of heart failure or cardiomyopathy, although some had hypertension, diabetes, or evidence of coronary disease.

“Our findings demonstrate that participants with a relative paucity of preexisting cardiovascular condition and with mostly home-based recovery had frequent cardiac inflammatory involvement, which was similar to the hospitalized subgroup with regards to severity and extent,” the group noted.

“There is a considerable ongoing myocardial inflammation in the heart muscle weeks after recovery from COVID-19 illness. This finding is important because it may herald a considerable burden of heart failure in a few years down the line,” Dr. Püntmann said in an interview.

Early diagnosis would offer “a good chance that early treatment could reduce the relentless course of inflammatory damage or even halt it,” she said.

“The relatively clear onset of COVID-19 illness provides an opportunity, which we often do not have with other conditions, to take a proactive action and to look for heart involvement early, within a few weeks of recovery.”

Dr. Biykem Bozkurt

The study’s CMR evidence of inflammation edema, scarring, and pericardial effusion are among “the major diagnostic criteria for inflammatory and viral myocarditis,” observed Biykem Bozkurt, MD, PhD, from Baylor College of Medicine, Houston, who wasn’t part of either new study.

The findings suggest – consistent with previous evidence – that some patients with recent COVID-19 may be left with ongoing myocardial inflammation, and this study further adds that it could potentially become subacute or even chronic and in some may not be totally reversible, she said in an interview. How long the effects are likely to persist “remains to be determined. We need longer-term outcomes data.”

 

 

Viral presence without myocarditis

The accompanying report featured a postmortem analysis of hearts from 39 patients with mostly severe COVID-19 that pointed to a significant SARS-CoV-2 presence and signs that the virus vigorously replicated in the myocardium.

But there was no evidence that the infection led to fulminant myocarditis. Rather, the virus had apparently infiltrated the heart by localizing in interstitial cells or in macrophages that took up in the myocardium without actually entering myocytes, concluded the report’s authors, led by Diana Lindner, PhD, from the University Heart and Vascular Centre, Hamburg (Germany).

The findings suggest “that the presence of SARS-CoV-2 in cardiac tissue does not necessarily cause an inflammatory reaction consistent with clinical myocarditis,” the group wrote.

Previously in the literature, in “cases in which myocardial inflammation was present, there was also evidence of clinical myocarditis, and therefore the current cases underlie a different pathophysiology,” they concluded.

No evidence of the virus was seen in 15 cases, about 61% of the group. In 16 of the remaining 24 hearts, the viral load exceeded 1,000 copies per mcg of RNA, a substantial presence. Those 16 showed increased expression of inflammatory cytokines but no inflammatory cell infiltrates or changes in leukocyte counts, the researchers noted.

“Findings of suggested viral replication in the cases with a very high viral load are showing that we need to do more studies to find out long-term consequences, which we do not know right now,” senior author Dirk Westermann, MD, also from the University Heart and Vascular Centre, Hamburg, said.

Implications for heart failure

Dr. Clyde W. Yancy

The postmortem findings from Dr. Lindner and associates “provide intriguing evidence that COVID-19 is associated with at least some component of myocardial injury, perhaps as the result of direct viral infection of the heart,” wrote Clyde W. Yancy, MD, MSc, from Northwestern University, Chicago, and Gregg C. Fonarow, MD, from the University of California, Los Angeles, in an editorial accompanying both reports.

The CMR study from Dr. Püntmann and colleagues – on the backdrop of earlier COVID-19 observations – suggests the potential for “residual left ventricular dysfunction and ongoing inflammation” in the months following a COVID-19 diagnosis. Both developments may be “of sufficient concern to represent a nidus for new-onset heart failure and other cardiovascular complications,” contend Dr. Yancy and Dr. Fonarow.

“When added to the postmortem pathological findings from Lindner et al, we see the plot thickening and we are inclined to raise a new and very evident concern that cardiomyopathy and heart failure related to COVID-19 may potentially evolve as the natural history of this infection becomes clearer,” they wrote.

Some patients, having recovered from the acute illness, may be left with a chronic inflammatory state that probably puts them at increased risk for future heart failure, agreed Dr. Bozkurt when interviewed. “They could show further decline in cardiac function, and their recovery might take longer than with the usual viral illnesses that we see,” she said.

“There could also be a risk of sudden death. Inflammation sometimes gives rise to sudden death and ventricular arrhythmia, which I would be very worried about, especially if the myocardium is stressed,” Dr. Bozkurt said. “So competitive sports in those patients potentially could be risky.”

 

 

COVID-19 cohort vs. matched control subjects

The CMR study from Dr. Püntmann and colleagues prospectively entered 100 patients recently recovered from an acute bout of COVID-19, either at home or at a hospital, who were followed in a registry based at University Hospital Frankfurt. Their median age was 49 years; 47% were female. They were compared with 50 age- and sex-matched control patients and 50 apparently healthy volunteers matched for risk factors, the group noted.

On the same day as the CMR assessment, the recently recovered patients, compared with the healthy control subjects and risk-factor matched control subjects, respectively, showed (P ≤ .001 in each case):

  • A reduced left ventricular (LV) ejection fraction: 56% vs. 60% and 61%.
  • A higher LV end-diastolic volume index: 86 mL/m2 vs. 80 mL/m2 and 75 mL/m2.
  • A greater LV mass index: 51 g/m2 vs. 47 g/m2 and 53 g/m2.
  • A higher hs-TnT level: 5.6 pg/mL vs. 3.2 pg/mL and 3.9 pg/mL.
  • A greater prevalence of hs-TnT levels 3 pg/mL or more: 71% vs. 11% and 31%.

At CMR, 78% of the recovered COVID-19 patients showed abnormalities that included raised myocardial native T1 and T2 mapping, which is suggestive of fibrosis and edema from inflammation, compared with the two control groups (P < .001 for all differences), “independent of preexisting conditions, severity and overall course of the acute illness, and the time from the original diagnosis,” the group wrote. Native T1 and T2 mapping correlated significantly with hs-TnT.



“We now have the diagnostic means to detect cardiac inflammation early, and we need make every effort to apply them in every day practice,”Dr. Püntmann said in the interview.

“Using cardiac MRI will allow us to raise our game against COVID-19 and proactively develop efficient cardioprotective treatments,” she said. “Until we have effective means of protecting from the infection, that is vaccination, we must act swiftly and within the means at hand.”

The analysis evokes several other ways patients with COVID-19 might be screened for significant myocardial involvement.

“Strategies could include checking troponins, not only at admission but maybe at discharge and perhaps even those individuals who are at home and are not necessarily requiring care,” Dr. Bozkurt said.

“Biomarker profiling and screening for ongoing inflammation probably are going to be important components of COVID-19, especially for those with subclinical risk and disease.”

Dr. Westermann proposed that troponin elevations at discharge “might be a good starting point” for selecting COVID-19 patients for functional testing or imaging to screen for cardiac sequelae. Performing such tests routinely now “would be overwhelming given the massive increase in patients we still see today.”

Dr. Püntmann had no disclosures; statements of potential conflict for the other authors are in the report. Dr. Bozkurt has previously disclosed receiving consultant fees or honoraria from Bayer Healthcare, Bristol-Myers Squibb, Lantheus Medical Imaging, and Respicardia; serving on a data safety monitoring board for LivaNova USA ; and having unspecified relationships with Abbott Laboratories. Dr. Lindner had no disclosures; Dr. Westermann reported receiving personal fees from AstraZeneca, Bayer, Novartis, and Medtronic. Dr. Yancy is a deputy editor and Dr. Fonarow a section editor for JAMA Cardiology. Dr. Yancy had no other disclosures. Dr. Fonarow reported receiving personal fees from Abbott Laboratories, Amgen, AstraZeneca, Bayer, CHF Solutions, Edwards Lifesciences, Janssen, Medtronic, Merck, and Novartis.

A version of this article originally appeared on Medscape.com.

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Evidence that the heart can take a major hit in patients hospitalized with COVID-19, especially those already with cardiovascular disease (CV) or its risk factors, has been sadly apparent from the pandemic’s earliest days.

Less clear from case studies and small series to date has been whether SARS-CoV-2 directly attacks the heart and whether acute cardiac effects of the illness may lead to some kind of lingering cardiomyopathy.

The field’s grasp of those issues advanced a bit in two new reports published July 27 in JAMA Cardiology that seem to validate concerns the virus can infect the myocardium, without necessarily causing myocarditis and the possibility that some “recovered” patients may be left with persisting myocardial injury and inflammation that potentially could later manifest as heart failure.

Persisting inflammation by cardiac magnetic resonance

A prospective cohort study with 100 patients recovered from a recent bout of the disease showed evidence of ventricular dysfunction, greater ventricular mass, and in 78% of the cohort, signs of myocardial inflammation by cardiac magnetic resonance (CMR) imaging. The CMR findings correlated with elevations in troponin T by high-sensitivity assay (hs-TnT).

Two-thirds of the cohort, whose acute COVID-19 severity had “ranged from asymptomatic to minor-to-moderate symptoms,” had recovered at home, whereas the remaining “severely unwell patients” had been hospitalized, wrote the authors, led by Valentina O. Püntmann, MD, PhD, University Hospital Frankfurt (Germany).

None of the patients had a history of heart failure or cardiomyopathy, although some had hypertension, diabetes, or evidence of coronary disease.

“Our findings demonstrate that participants with a relative paucity of preexisting cardiovascular condition and with mostly home-based recovery had frequent cardiac inflammatory involvement, which was similar to the hospitalized subgroup with regards to severity and extent,” the group noted.

“There is a considerable ongoing myocardial inflammation in the heart muscle weeks after recovery from COVID-19 illness. This finding is important because it may herald a considerable burden of heart failure in a few years down the line,” Dr. Püntmann said in an interview.

Early diagnosis would offer “a good chance that early treatment could reduce the relentless course of inflammatory damage or even halt it,” she said.

“The relatively clear onset of COVID-19 illness provides an opportunity, which we often do not have with other conditions, to take a proactive action and to look for heart involvement early, within a few weeks of recovery.”

Dr. Biykem Bozkurt

The study’s CMR evidence of inflammation edema, scarring, and pericardial effusion are among “the major diagnostic criteria for inflammatory and viral myocarditis,” observed Biykem Bozkurt, MD, PhD, from Baylor College of Medicine, Houston, who wasn’t part of either new study.

The findings suggest – consistent with previous evidence – that some patients with recent COVID-19 may be left with ongoing myocardial inflammation, and this study further adds that it could potentially become subacute or even chronic and in some may not be totally reversible, she said in an interview. How long the effects are likely to persist “remains to be determined. We need longer-term outcomes data.”

 

 

Viral presence without myocarditis

The accompanying report featured a postmortem analysis of hearts from 39 patients with mostly severe COVID-19 that pointed to a significant SARS-CoV-2 presence and signs that the virus vigorously replicated in the myocardium.

But there was no evidence that the infection led to fulminant myocarditis. Rather, the virus had apparently infiltrated the heart by localizing in interstitial cells or in macrophages that took up in the myocardium without actually entering myocytes, concluded the report’s authors, led by Diana Lindner, PhD, from the University Heart and Vascular Centre, Hamburg (Germany).

The findings suggest “that the presence of SARS-CoV-2 in cardiac tissue does not necessarily cause an inflammatory reaction consistent with clinical myocarditis,” the group wrote.

Previously in the literature, in “cases in which myocardial inflammation was present, there was also evidence of clinical myocarditis, and therefore the current cases underlie a different pathophysiology,” they concluded.

No evidence of the virus was seen in 15 cases, about 61% of the group. In 16 of the remaining 24 hearts, the viral load exceeded 1,000 copies per mcg of RNA, a substantial presence. Those 16 showed increased expression of inflammatory cytokines but no inflammatory cell infiltrates or changes in leukocyte counts, the researchers noted.

“Findings of suggested viral replication in the cases with a very high viral load are showing that we need to do more studies to find out long-term consequences, which we do not know right now,” senior author Dirk Westermann, MD, also from the University Heart and Vascular Centre, Hamburg, said.

Implications for heart failure

Dr. Clyde W. Yancy

The postmortem findings from Dr. Lindner and associates “provide intriguing evidence that COVID-19 is associated with at least some component of myocardial injury, perhaps as the result of direct viral infection of the heart,” wrote Clyde W. Yancy, MD, MSc, from Northwestern University, Chicago, and Gregg C. Fonarow, MD, from the University of California, Los Angeles, in an editorial accompanying both reports.

The CMR study from Dr. Püntmann and colleagues – on the backdrop of earlier COVID-19 observations – suggests the potential for “residual left ventricular dysfunction and ongoing inflammation” in the months following a COVID-19 diagnosis. Both developments may be “of sufficient concern to represent a nidus for new-onset heart failure and other cardiovascular complications,” contend Dr. Yancy and Dr. Fonarow.

“When added to the postmortem pathological findings from Lindner et al, we see the plot thickening and we are inclined to raise a new and very evident concern that cardiomyopathy and heart failure related to COVID-19 may potentially evolve as the natural history of this infection becomes clearer,” they wrote.

Some patients, having recovered from the acute illness, may be left with a chronic inflammatory state that probably puts them at increased risk for future heart failure, agreed Dr. Bozkurt when interviewed. “They could show further decline in cardiac function, and their recovery might take longer than with the usual viral illnesses that we see,” she said.

“There could also be a risk of sudden death. Inflammation sometimes gives rise to sudden death and ventricular arrhythmia, which I would be very worried about, especially if the myocardium is stressed,” Dr. Bozkurt said. “So competitive sports in those patients potentially could be risky.”

 

 

COVID-19 cohort vs. matched control subjects

The CMR study from Dr. Püntmann and colleagues prospectively entered 100 patients recently recovered from an acute bout of COVID-19, either at home or at a hospital, who were followed in a registry based at University Hospital Frankfurt. Their median age was 49 years; 47% were female. They were compared with 50 age- and sex-matched control patients and 50 apparently healthy volunteers matched for risk factors, the group noted.

On the same day as the CMR assessment, the recently recovered patients, compared with the healthy control subjects and risk-factor matched control subjects, respectively, showed (P ≤ .001 in each case):

  • A reduced left ventricular (LV) ejection fraction: 56% vs. 60% and 61%.
  • A higher LV end-diastolic volume index: 86 mL/m2 vs. 80 mL/m2 and 75 mL/m2.
  • A greater LV mass index: 51 g/m2 vs. 47 g/m2 and 53 g/m2.
  • A higher hs-TnT level: 5.6 pg/mL vs. 3.2 pg/mL and 3.9 pg/mL.
  • A greater prevalence of hs-TnT levels 3 pg/mL or more: 71% vs. 11% and 31%.

At CMR, 78% of the recovered COVID-19 patients showed abnormalities that included raised myocardial native T1 and T2 mapping, which is suggestive of fibrosis and edema from inflammation, compared with the two control groups (P < .001 for all differences), “independent of preexisting conditions, severity and overall course of the acute illness, and the time from the original diagnosis,” the group wrote. Native T1 and T2 mapping correlated significantly with hs-TnT.



“We now have the diagnostic means to detect cardiac inflammation early, and we need make every effort to apply them in every day practice,”Dr. Püntmann said in the interview.

“Using cardiac MRI will allow us to raise our game against COVID-19 and proactively develop efficient cardioprotective treatments,” she said. “Until we have effective means of protecting from the infection, that is vaccination, we must act swiftly and within the means at hand.”

The analysis evokes several other ways patients with COVID-19 might be screened for significant myocardial involvement.

“Strategies could include checking troponins, not only at admission but maybe at discharge and perhaps even those individuals who are at home and are not necessarily requiring care,” Dr. Bozkurt said.

“Biomarker profiling and screening for ongoing inflammation probably are going to be important components of COVID-19, especially for those with subclinical risk and disease.”

Dr. Westermann proposed that troponin elevations at discharge “might be a good starting point” for selecting COVID-19 patients for functional testing or imaging to screen for cardiac sequelae. Performing such tests routinely now “would be overwhelming given the massive increase in patients we still see today.”

Dr. Püntmann had no disclosures; statements of potential conflict for the other authors are in the report. Dr. Bozkurt has previously disclosed receiving consultant fees or honoraria from Bayer Healthcare, Bristol-Myers Squibb, Lantheus Medical Imaging, and Respicardia; serving on a data safety monitoring board for LivaNova USA ; and having unspecified relationships with Abbott Laboratories. Dr. Lindner had no disclosures; Dr. Westermann reported receiving personal fees from AstraZeneca, Bayer, Novartis, and Medtronic. Dr. Yancy is a deputy editor and Dr. Fonarow a section editor for JAMA Cardiology. Dr. Yancy had no other disclosures. Dr. Fonarow reported receiving personal fees from Abbott Laboratories, Amgen, AstraZeneca, Bayer, CHF Solutions, Edwards Lifesciences, Janssen, Medtronic, Merck, and Novartis.

A version of this article originally appeared on Medscape.com.

Evidence that the heart can take a major hit in patients hospitalized with COVID-19, especially those already with cardiovascular disease (CV) or its risk factors, has been sadly apparent from the pandemic’s earliest days.

Less clear from case studies and small series to date has been whether SARS-CoV-2 directly attacks the heart and whether acute cardiac effects of the illness may lead to some kind of lingering cardiomyopathy.

The field’s grasp of those issues advanced a bit in two new reports published July 27 in JAMA Cardiology that seem to validate concerns the virus can infect the myocardium, without necessarily causing myocarditis and the possibility that some “recovered” patients may be left with persisting myocardial injury and inflammation that potentially could later manifest as heart failure.

Persisting inflammation by cardiac magnetic resonance

A prospective cohort study with 100 patients recovered from a recent bout of the disease showed evidence of ventricular dysfunction, greater ventricular mass, and in 78% of the cohort, signs of myocardial inflammation by cardiac magnetic resonance (CMR) imaging. The CMR findings correlated with elevations in troponin T by high-sensitivity assay (hs-TnT).

Two-thirds of the cohort, whose acute COVID-19 severity had “ranged from asymptomatic to minor-to-moderate symptoms,” had recovered at home, whereas the remaining “severely unwell patients” had been hospitalized, wrote the authors, led by Valentina O. Püntmann, MD, PhD, University Hospital Frankfurt (Germany).

None of the patients had a history of heart failure or cardiomyopathy, although some had hypertension, diabetes, or evidence of coronary disease.

“Our findings demonstrate that participants with a relative paucity of preexisting cardiovascular condition and with mostly home-based recovery had frequent cardiac inflammatory involvement, which was similar to the hospitalized subgroup with regards to severity and extent,” the group noted.

“There is a considerable ongoing myocardial inflammation in the heart muscle weeks after recovery from COVID-19 illness. This finding is important because it may herald a considerable burden of heart failure in a few years down the line,” Dr. Püntmann said in an interview.

Early diagnosis would offer “a good chance that early treatment could reduce the relentless course of inflammatory damage or even halt it,” she said.

“The relatively clear onset of COVID-19 illness provides an opportunity, which we often do not have with other conditions, to take a proactive action and to look for heart involvement early, within a few weeks of recovery.”

Dr. Biykem Bozkurt

The study’s CMR evidence of inflammation edema, scarring, and pericardial effusion are among “the major diagnostic criteria for inflammatory and viral myocarditis,” observed Biykem Bozkurt, MD, PhD, from Baylor College of Medicine, Houston, who wasn’t part of either new study.

The findings suggest – consistent with previous evidence – that some patients with recent COVID-19 may be left with ongoing myocardial inflammation, and this study further adds that it could potentially become subacute or even chronic and in some may not be totally reversible, she said in an interview. How long the effects are likely to persist “remains to be determined. We need longer-term outcomes data.”

 

 

Viral presence without myocarditis

The accompanying report featured a postmortem analysis of hearts from 39 patients with mostly severe COVID-19 that pointed to a significant SARS-CoV-2 presence and signs that the virus vigorously replicated in the myocardium.

But there was no evidence that the infection led to fulminant myocarditis. Rather, the virus had apparently infiltrated the heart by localizing in interstitial cells or in macrophages that took up in the myocardium without actually entering myocytes, concluded the report’s authors, led by Diana Lindner, PhD, from the University Heart and Vascular Centre, Hamburg (Germany).

The findings suggest “that the presence of SARS-CoV-2 in cardiac tissue does not necessarily cause an inflammatory reaction consistent with clinical myocarditis,” the group wrote.

Previously in the literature, in “cases in which myocardial inflammation was present, there was also evidence of clinical myocarditis, and therefore the current cases underlie a different pathophysiology,” they concluded.

No evidence of the virus was seen in 15 cases, about 61% of the group. In 16 of the remaining 24 hearts, the viral load exceeded 1,000 copies per mcg of RNA, a substantial presence. Those 16 showed increased expression of inflammatory cytokines but no inflammatory cell infiltrates or changes in leukocyte counts, the researchers noted.

“Findings of suggested viral replication in the cases with a very high viral load are showing that we need to do more studies to find out long-term consequences, which we do not know right now,” senior author Dirk Westermann, MD, also from the University Heart and Vascular Centre, Hamburg, said.

Implications for heart failure

Dr. Clyde W. Yancy

The postmortem findings from Dr. Lindner and associates “provide intriguing evidence that COVID-19 is associated with at least some component of myocardial injury, perhaps as the result of direct viral infection of the heart,” wrote Clyde W. Yancy, MD, MSc, from Northwestern University, Chicago, and Gregg C. Fonarow, MD, from the University of California, Los Angeles, in an editorial accompanying both reports.

The CMR study from Dr. Püntmann and colleagues – on the backdrop of earlier COVID-19 observations – suggests the potential for “residual left ventricular dysfunction and ongoing inflammation” in the months following a COVID-19 diagnosis. Both developments may be “of sufficient concern to represent a nidus for new-onset heart failure and other cardiovascular complications,” contend Dr. Yancy and Dr. Fonarow.

“When added to the postmortem pathological findings from Lindner et al, we see the plot thickening and we are inclined to raise a new and very evident concern that cardiomyopathy and heart failure related to COVID-19 may potentially evolve as the natural history of this infection becomes clearer,” they wrote.

Some patients, having recovered from the acute illness, may be left with a chronic inflammatory state that probably puts them at increased risk for future heart failure, agreed Dr. Bozkurt when interviewed. “They could show further decline in cardiac function, and their recovery might take longer than with the usual viral illnesses that we see,” she said.

“There could also be a risk of sudden death. Inflammation sometimes gives rise to sudden death and ventricular arrhythmia, which I would be very worried about, especially if the myocardium is stressed,” Dr. Bozkurt said. “So competitive sports in those patients potentially could be risky.”

 

 

COVID-19 cohort vs. matched control subjects

The CMR study from Dr. Püntmann and colleagues prospectively entered 100 patients recently recovered from an acute bout of COVID-19, either at home or at a hospital, who were followed in a registry based at University Hospital Frankfurt. Their median age was 49 years; 47% were female. They were compared with 50 age- and sex-matched control patients and 50 apparently healthy volunteers matched for risk factors, the group noted.

On the same day as the CMR assessment, the recently recovered patients, compared with the healthy control subjects and risk-factor matched control subjects, respectively, showed (P ≤ .001 in each case):

  • A reduced left ventricular (LV) ejection fraction: 56% vs. 60% and 61%.
  • A higher LV end-diastolic volume index: 86 mL/m2 vs. 80 mL/m2 and 75 mL/m2.
  • A greater LV mass index: 51 g/m2 vs. 47 g/m2 and 53 g/m2.
  • A higher hs-TnT level: 5.6 pg/mL vs. 3.2 pg/mL and 3.9 pg/mL.
  • A greater prevalence of hs-TnT levels 3 pg/mL or more: 71% vs. 11% and 31%.

At CMR, 78% of the recovered COVID-19 patients showed abnormalities that included raised myocardial native T1 and T2 mapping, which is suggestive of fibrosis and edema from inflammation, compared with the two control groups (P < .001 for all differences), “independent of preexisting conditions, severity and overall course of the acute illness, and the time from the original diagnosis,” the group wrote. Native T1 and T2 mapping correlated significantly with hs-TnT.



“We now have the diagnostic means to detect cardiac inflammation early, and we need make every effort to apply them in every day practice,”Dr. Püntmann said in the interview.

“Using cardiac MRI will allow us to raise our game against COVID-19 and proactively develop efficient cardioprotective treatments,” she said. “Until we have effective means of protecting from the infection, that is vaccination, we must act swiftly and within the means at hand.”

The analysis evokes several other ways patients with COVID-19 might be screened for significant myocardial involvement.

“Strategies could include checking troponins, not only at admission but maybe at discharge and perhaps even those individuals who are at home and are not necessarily requiring care,” Dr. Bozkurt said.

“Biomarker profiling and screening for ongoing inflammation probably are going to be important components of COVID-19, especially for those with subclinical risk and disease.”

Dr. Westermann proposed that troponin elevations at discharge “might be a good starting point” for selecting COVID-19 patients for functional testing or imaging to screen for cardiac sequelae. Performing such tests routinely now “would be overwhelming given the massive increase in patients we still see today.”

Dr. Püntmann had no disclosures; statements of potential conflict for the other authors are in the report. Dr. Bozkurt has previously disclosed receiving consultant fees or honoraria from Bayer Healthcare, Bristol-Myers Squibb, Lantheus Medical Imaging, and Respicardia; serving on a data safety monitoring board for LivaNova USA ; and having unspecified relationships with Abbott Laboratories. Dr. Lindner had no disclosures; Dr. Westermann reported receiving personal fees from AstraZeneca, Bayer, Novartis, and Medtronic. Dr. Yancy is a deputy editor and Dr. Fonarow a section editor for JAMA Cardiology. Dr. Yancy had no other disclosures. Dr. Fonarow reported receiving personal fees from Abbott Laboratories, Amgen, AstraZeneca, Bayer, CHF Solutions, Edwards Lifesciences, Janssen, Medtronic, Merck, and Novartis.

A version of this article originally appeared on Medscape.com.

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AAP report aims to educate providers on female genital mutilation/cutting

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Although female genital mutilation or cutting (FGM/C) is outlawed in much of the world, it still occurs for cultural reasons despite having no medical benefit, according to a clinical report from the American Academy of Pediatrics.

FGM/C is mainly performed on children and adolescents, but most of the research and teaching to date has addressed the impact of FGM/C on women of childbearing age and management during pregnancy and post partum, wrote Janine Young, MD, of the University of Colorado Denver in Aurora and colleagues. They are members of the AAP section on global health, committee on medical liability and risk management, or the committee on bioethics.

Dr. Janine Young


Published in Pediatrics, the report provides “the first comprehensive summary of FGM/C in children and includes education regarding a standard-of-care approach for examination of external female genitalia at all health supervision examinations, diagnosis, complications, management, treatment, culturally sensitive discussion and counseling approaches, and legal and ethical considerations,” they wrote.

The World Health Organization categorizes FGM/C into four subtypes. “Type I includes cutting of the glans or part of the body of the clitoris and/or prepuce; type II includes excision of the clitoris and labia minora, with or without excision of the labia majora; type III, infibulation, includes cutting and apposing the labia minora and/or majora over the urethral meatus and vaginal opening to significantly narrow it and may include clitoral excision; and type IV includes piercing, scraping, nicking, stretching, or otherwise injuring the external female genitalia without removing any genital tissue and includes practices that do not fall into the other three categories,” the authors wrote. Of these, type III is associated with the greatest long-term morbidity.

Data suggest that the prevalence and type of FGM/C varies by region, with the highest prevalence of type III in East Africa, where 82%-99% of girls reported FGM/C and 34%-79% of these cases involved type III, the authors reported.

Generally, pediatric health care providers in the United States have limited knowledge of FGM/C in the absence of any required courses on diagnosis or treatment for most primary care specialties. However, clinicians should be aware of possible risk factors, including a mother or sibling with a history of FGM/C, or patients with a country of origin, birth country, or travel history to a country where FGM/C is practiced, Dr. Young and associates noted.

They recommend that an assessment of FGM/C status should be part of routine pediatric care for children with possible risk factors, but acknowledged the challenges in raising the topic and addressing it in a culturally sensitive way. “Experts suggest that health care providers ask the patient or parent the term they use to name female genital cutting” and avoid the term mutilation, which may be offensive or misunderstood.

Many girls who have undergone FGM/C were too young to remember, the authors note. “Instead, it is advisable that the FGM/C clinical history taking include both the girl and parent or guardian once rapport has been established.”

Review potential medical complications if FGM/C is identified, and plans should be made for follow-up visits to monitor development of complications, the authors said. In addition, engage in a culturally sensitive discussion with teenagers, who may or may not have known about their FGM/C. In some cases, parents and caregivers may not have known about the FGM/C, which may be a community practice in some cultures with decisions made by other family members or authority figures.

“It is important for health care providers to assess each patient individually and make no assumptions about her and her parents’ beliefs regarding FGM/C,” Dr. Young and associates emphasized. “Mothers and fathers may or may not hold discordant views about FGM/C, and some clinical experts suggest that mothers who have themselves undergone FGM/C may nonetheless oppose subjecting their daughters to this practice. Instead, treating patients and caregivers with respect, sensitivity, and professionalism will encourage them to return and supports health-seeking behavior.”

The report presents 11 specific recommendations, including that health care providers should not perform any type of FGM/C and actively counsel families against such practices. In addition, children should have external genitalia checked at all health supervision examinations (with the consent of the guardian and/or child), and an assessment for FGM/C should be documented in the health records of patients with risk factors.

Notably, “[i]f genital examination findings are equivocal for the presence of FGM/C and risk factors for FGM/ C are present, a specialist trained in identification of FGM/C should be consulted,” Dr. Young and associates recommended. They also recommended defibulation for all girls and teenagers with type III FGM/C, especially for those with complications, and the procedure should be performed by an experienced pediatric gynecologist, gynecologist, urologist, or urogynecologist.

Finally, “[i]f FGM/C is suspected to have occurred in the United States, or as vacation cutting after immigration to the United States, the child should be evaluated for potential abuse. ... Expressed intention to engage in FGM/C, either in the United States or abroad, should also prompt a report to CPS [child protective services] if the child’s parent or caregiver cannot be dissuaded,” the authors wrote.

The report also includes case examples and expert analyses from legal and medical ethics experts to provide additional guidance for clinicians.

Dr. M. Susan Jay

“This work seeks to educate pediatric health care providers on the occurrence of FGM/C, and the broader applications to the patients/population it impacts as well as the intersecting issues of diagnosis, complications, treatment, counseling needs, and the ethical and legal implications,” M. Susan Jay, MD, of the Medical College of Wisconsin, Milwaukee, said in an interview.

However, challenges in implementing the recommendations “relate to the complexity of the issue and also the need for greater education of primary providers,” Dr. Jay said. “The overall message for providers, I believe, is a greater understanding of the practice [of FGM/C] as most providers have limited knowledge of this practice in the United States.”

“I believe the case-based presentations allow for a better understanding of how best to approach patients and families,” she added.

Dr. Kelly Curran

Kelly Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, said, “I think one of largest barriers to implementing the strategies [from] this report is the limited knowledge of FGM/C by most clinicians.”

“In general, many pediatricians are uncomfortable with genital examinations,” she said in an interview. “I suspect most feel uncomfortable with identifying FGM/C versus other genital pathology and may not have ready access to FGM/C experts. Additionally, having these difficult conversations with families about this sensitive topic may be challenging,” said Dr. Curran. “Fortunately, this report is incredibly comprehensive, providing extensive background into FGM/C, effectively using diagrams and pictures, and explaining the legal and ethical issues that arise in the care of these patients.”

“Ultimately, I think there will need to be more education within medical training and further research into FGM/C,” Dr. Curran added. “Clinicians should be knowledgeable about FGM/C, including prevalence, identification, health complications, and treatment, as well as legal and ethical implications.” However, “in addition to knowledge, clinicians must be able to navigate counseling patients and their families around this culturally sensitive topic.”

The report is thorough and well written, yet “there still remains significant gaps in knowledge about FGM/C in children and adolescents,” she said. “I think future research into prevalence, along with the health effects of FGM/C, including its impact on mental and sexual health, in the pediatric population will be essential.”

The study received no outside funding. Coauthor Christa Johnson-Agbakwu, MD, disclosed a grant relationship with Arizona State University from the 2018 copyright of “Female Genital Mutilation/Cutting (FGM/C): A Visual Reference and Learning Tool for Health Care Professionals.” The other researchers had no financial conflicts to disclose. Dr. Jay and Dr. Curran had no relevant financial conflicts to disclose. They are members of the Pediatric News editorial advisory board.

SOURCE: Young J et al. Pediatrics. 2020 Jul 27. doi: 10.1542/peds.2020-1012.

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Although female genital mutilation or cutting (FGM/C) is outlawed in much of the world, it still occurs for cultural reasons despite having no medical benefit, according to a clinical report from the American Academy of Pediatrics.

FGM/C is mainly performed on children and adolescents, but most of the research and teaching to date has addressed the impact of FGM/C on women of childbearing age and management during pregnancy and post partum, wrote Janine Young, MD, of the University of Colorado Denver in Aurora and colleagues. They are members of the AAP section on global health, committee on medical liability and risk management, or the committee on bioethics.

Dr. Janine Young


Published in Pediatrics, the report provides “the first comprehensive summary of FGM/C in children and includes education regarding a standard-of-care approach for examination of external female genitalia at all health supervision examinations, diagnosis, complications, management, treatment, culturally sensitive discussion and counseling approaches, and legal and ethical considerations,” they wrote.

The World Health Organization categorizes FGM/C into four subtypes. “Type I includes cutting of the glans or part of the body of the clitoris and/or prepuce; type II includes excision of the clitoris and labia minora, with or without excision of the labia majora; type III, infibulation, includes cutting and apposing the labia minora and/or majora over the urethral meatus and vaginal opening to significantly narrow it and may include clitoral excision; and type IV includes piercing, scraping, nicking, stretching, or otherwise injuring the external female genitalia without removing any genital tissue and includes practices that do not fall into the other three categories,” the authors wrote. Of these, type III is associated with the greatest long-term morbidity.

Data suggest that the prevalence and type of FGM/C varies by region, with the highest prevalence of type III in East Africa, where 82%-99% of girls reported FGM/C and 34%-79% of these cases involved type III, the authors reported.

Generally, pediatric health care providers in the United States have limited knowledge of FGM/C in the absence of any required courses on diagnosis or treatment for most primary care specialties. However, clinicians should be aware of possible risk factors, including a mother or sibling with a history of FGM/C, or patients with a country of origin, birth country, or travel history to a country where FGM/C is practiced, Dr. Young and associates noted.

They recommend that an assessment of FGM/C status should be part of routine pediatric care for children with possible risk factors, but acknowledged the challenges in raising the topic and addressing it in a culturally sensitive way. “Experts suggest that health care providers ask the patient or parent the term they use to name female genital cutting” and avoid the term mutilation, which may be offensive or misunderstood.

Many girls who have undergone FGM/C were too young to remember, the authors note. “Instead, it is advisable that the FGM/C clinical history taking include both the girl and parent or guardian once rapport has been established.”

Review potential medical complications if FGM/C is identified, and plans should be made for follow-up visits to monitor development of complications, the authors said. In addition, engage in a culturally sensitive discussion with teenagers, who may or may not have known about their FGM/C. In some cases, parents and caregivers may not have known about the FGM/C, which may be a community practice in some cultures with decisions made by other family members or authority figures.

“It is important for health care providers to assess each patient individually and make no assumptions about her and her parents’ beliefs regarding FGM/C,” Dr. Young and associates emphasized. “Mothers and fathers may or may not hold discordant views about FGM/C, and some clinical experts suggest that mothers who have themselves undergone FGM/C may nonetheless oppose subjecting their daughters to this practice. Instead, treating patients and caregivers with respect, sensitivity, and professionalism will encourage them to return and supports health-seeking behavior.”

The report presents 11 specific recommendations, including that health care providers should not perform any type of FGM/C and actively counsel families against such practices. In addition, children should have external genitalia checked at all health supervision examinations (with the consent of the guardian and/or child), and an assessment for FGM/C should be documented in the health records of patients with risk factors.

Notably, “[i]f genital examination findings are equivocal for the presence of FGM/C and risk factors for FGM/ C are present, a specialist trained in identification of FGM/C should be consulted,” Dr. Young and associates recommended. They also recommended defibulation for all girls and teenagers with type III FGM/C, especially for those with complications, and the procedure should be performed by an experienced pediatric gynecologist, gynecologist, urologist, or urogynecologist.

Finally, “[i]f FGM/C is suspected to have occurred in the United States, or as vacation cutting after immigration to the United States, the child should be evaluated for potential abuse. ... Expressed intention to engage in FGM/C, either in the United States or abroad, should also prompt a report to CPS [child protective services] if the child’s parent or caregiver cannot be dissuaded,” the authors wrote.

The report also includes case examples and expert analyses from legal and medical ethics experts to provide additional guidance for clinicians.

Dr. M. Susan Jay

“This work seeks to educate pediatric health care providers on the occurrence of FGM/C, and the broader applications to the patients/population it impacts as well as the intersecting issues of diagnosis, complications, treatment, counseling needs, and the ethical and legal implications,” M. Susan Jay, MD, of the Medical College of Wisconsin, Milwaukee, said in an interview.

However, challenges in implementing the recommendations “relate to the complexity of the issue and also the need for greater education of primary providers,” Dr. Jay said. “The overall message for providers, I believe, is a greater understanding of the practice [of FGM/C] as most providers have limited knowledge of this practice in the United States.”

“I believe the case-based presentations allow for a better understanding of how best to approach patients and families,” she added.

Dr. Kelly Curran

Kelly Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, said, “I think one of largest barriers to implementing the strategies [from] this report is the limited knowledge of FGM/C by most clinicians.”

“In general, many pediatricians are uncomfortable with genital examinations,” she said in an interview. “I suspect most feel uncomfortable with identifying FGM/C versus other genital pathology and may not have ready access to FGM/C experts. Additionally, having these difficult conversations with families about this sensitive topic may be challenging,” said Dr. Curran. “Fortunately, this report is incredibly comprehensive, providing extensive background into FGM/C, effectively using diagrams and pictures, and explaining the legal and ethical issues that arise in the care of these patients.”

“Ultimately, I think there will need to be more education within medical training and further research into FGM/C,” Dr. Curran added. “Clinicians should be knowledgeable about FGM/C, including prevalence, identification, health complications, and treatment, as well as legal and ethical implications.” However, “in addition to knowledge, clinicians must be able to navigate counseling patients and their families around this culturally sensitive topic.”

The report is thorough and well written, yet “there still remains significant gaps in knowledge about FGM/C in children and adolescents,” she said. “I think future research into prevalence, along with the health effects of FGM/C, including its impact on mental and sexual health, in the pediatric population will be essential.”

The study received no outside funding. Coauthor Christa Johnson-Agbakwu, MD, disclosed a grant relationship with Arizona State University from the 2018 copyright of “Female Genital Mutilation/Cutting (FGM/C): A Visual Reference and Learning Tool for Health Care Professionals.” The other researchers had no financial conflicts to disclose. Dr. Jay and Dr. Curran had no relevant financial conflicts to disclose. They are members of the Pediatric News editorial advisory board.

SOURCE: Young J et al. Pediatrics. 2020 Jul 27. doi: 10.1542/peds.2020-1012.

Although female genital mutilation or cutting (FGM/C) is outlawed in much of the world, it still occurs for cultural reasons despite having no medical benefit, according to a clinical report from the American Academy of Pediatrics.

FGM/C is mainly performed on children and adolescents, but most of the research and teaching to date has addressed the impact of FGM/C on women of childbearing age and management during pregnancy and post partum, wrote Janine Young, MD, of the University of Colorado Denver in Aurora and colleagues. They are members of the AAP section on global health, committee on medical liability and risk management, or the committee on bioethics.

Dr. Janine Young


Published in Pediatrics, the report provides “the first comprehensive summary of FGM/C in children and includes education regarding a standard-of-care approach for examination of external female genitalia at all health supervision examinations, diagnosis, complications, management, treatment, culturally sensitive discussion and counseling approaches, and legal and ethical considerations,” they wrote.

The World Health Organization categorizes FGM/C into four subtypes. “Type I includes cutting of the glans or part of the body of the clitoris and/or prepuce; type II includes excision of the clitoris and labia minora, with or without excision of the labia majora; type III, infibulation, includes cutting and apposing the labia minora and/or majora over the urethral meatus and vaginal opening to significantly narrow it and may include clitoral excision; and type IV includes piercing, scraping, nicking, stretching, or otherwise injuring the external female genitalia without removing any genital tissue and includes practices that do not fall into the other three categories,” the authors wrote. Of these, type III is associated with the greatest long-term morbidity.

Data suggest that the prevalence and type of FGM/C varies by region, with the highest prevalence of type III in East Africa, where 82%-99% of girls reported FGM/C and 34%-79% of these cases involved type III, the authors reported.

Generally, pediatric health care providers in the United States have limited knowledge of FGM/C in the absence of any required courses on diagnosis or treatment for most primary care specialties. However, clinicians should be aware of possible risk factors, including a mother or sibling with a history of FGM/C, or patients with a country of origin, birth country, or travel history to a country where FGM/C is practiced, Dr. Young and associates noted.

They recommend that an assessment of FGM/C status should be part of routine pediatric care for children with possible risk factors, but acknowledged the challenges in raising the topic and addressing it in a culturally sensitive way. “Experts suggest that health care providers ask the patient or parent the term they use to name female genital cutting” and avoid the term mutilation, which may be offensive or misunderstood.

Many girls who have undergone FGM/C were too young to remember, the authors note. “Instead, it is advisable that the FGM/C clinical history taking include both the girl and parent or guardian once rapport has been established.”

Review potential medical complications if FGM/C is identified, and plans should be made for follow-up visits to monitor development of complications, the authors said. In addition, engage in a culturally sensitive discussion with teenagers, who may or may not have known about their FGM/C. In some cases, parents and caregivers may not have known about the FGM/C, which may be a community practice in some cultures with decisions made by other family members or authority figures.

“It is important for health care providers to assess each patient individually and make no assumptions about her and her parents’ beliefs regarding FGM/C,” Dr. Young and associates emphasized. “Mothers and fathers may or may not hold discordant views about FGM/C, and some clinical experts suggest that mothers who have themselves undergone FGM/C may nonetheless oppose subjecting their daughters to this practice. Instead, treating patients and caregivers with respect, sensitivity, and professionalism will encourage them to return and supports health-seeking behavior.”

The report presents 11 specific recommendations, including that health care providers should not perform any type of FGM/C and actively counsel families against such practices. In addition, children should have external genitalia checked at all health supervision examinations (with the consent of the guardian and/or child), and an assessment for FGM/C should be documented in the health records of patients with risk factors.

Notably, “[i]f genital examination findings are equivocal for the presence of FGM/C and risk factors for FGM/ C are present, a specialist trained in identification of FGM/C should be consulted,” Dr. Young and associates recommended. They also recommended defibulation for all girls and teenagers with type III FGM/C, especially for those with complications, and the procedure should be performed by an experienced pediatric gynecologist, gynecologist, urologist, or urogynecologist.

Finally, “[i]f FGM/C is suspected to have occurred in the United States, or as vacation cutting after immigration to the United States, the child should be evaluated for potential abuse. ... Expressed intention to engage in FGM/C, either in the United States or abroad, should also prompt a report to CPS [child protective services] if the child’s parent or caregiver cannot be dissuaded,” the authors wrote.

The report also includes case examples and expert analyses from legal and medical ethics experts to provide additional guidance for clinicians.

Dr. M. Susan Jay

“This work seeks to educate pediatric health care providers on the occurrence of FGM/C, and the broader applications to the patients/population it impacts as well as the intersecting issues of diagnosis, complications, treatment, counseling needs, and the ethical and legal implications,” M. Susan Jay, MD, of the Medical College of Wisconsin, Milwaukee, said in an interview.

However, challenges in implementing the recommendations “relate to the complexity of the issue and also the need for greater education of primary providers,” Dr. Jay said. “The overall message for providers, I believe, is a greater understanding of the practice [of FGM/C] as most providers have limited knowledge of this practice in the United States.”

“I believe the case-based presentations allow for a better understanding of how best to approach patients and families,” she added.

Dr. Kelly Curran

Kelly Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, said, “I think one of largest barriers to implementing the strategies [from] this report is the limited knowledge of FGM/C by most clinicians.”

“In general, many pediatricians are uncomfortable with genital examinations,” she said in an interview. “I suspect most feel uncomfortable with identifying FGM/C versus other genital pathology and may not have ready access to FGM/C experts. Additionally, having these difficult conversations with families about this sensitive topic may be challenging,” said Dr. Curran. “Fortunately, this report is incredibly comprehensive, providing extensive background into FGM/C, effectively using diagrams and pictures, and explaining the legal and ethical issues that arise in the care of these patients.”

“Ultimately, I think there will need to be more education within medical training and further research into FGM/C,” Dr. Curran added. “Clinicians should be knowledgeable about FGM/C, including prevalence, identification, health complications, and treatment, as well as legal and ethical implications.” However, “in addition to knowledge, clinicians must be able to navigate counseling patients and their families around this culturally sensitive topic.”

The report is thorough and well written, yet “there still remains significant gaps in knowledge about FGM/C in children and adolescents,” she said. “I think future research into prevalence, along with the health effects of FGM/C, including its impact on mental and sexual health, in the pediatric population will be essential.”

The study received no outside funding. Coauthor Christa Johnson-Agbakwu, MD, disclosed a grant relationship with Arizona State University from the 2018 copyright of “Female Genital Mutilation/Cutting (FGM/C): A Visual Reference and Learning Tool for Health Care Professionals.” The other researchers had no financial conflicts to disclose. Dr. Jay and Dr. Curran had no relevant financial conflicts to disclose. They are members of the Pediatric News editorial advisory board.

SOURCE: Young J et al. Pediatrics. 2020 Jul 27. doi: 10.1542/peds.2020-1012.

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Patients with COPD plus sleep problems should be screened for mood disorders

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A study has shown a strong link between sleeping disturbances and depression in patients with chronic obstructive pulmonary disease.

magicmine/Getty Images

Adults with clinically stable COPD who reported sleep problems were significantly more likely to report depression or anxiety, poor self-efficacy, and poor health-related quality of life, compared with those not reporting sleep problems, according to the findings from a study of 245 patients.

Sleep problems are common in patients with COPD and have been associated with poor COPD-related outcomes, wrote Sang Hee Lee, MD, of Wonkwang University Sanbon Hospital, Gunpo-si, South Korea, and colleagues.

“However, there is a lack of research on factors associated with sleep disturbance in patients with COPD,” they wrote.

In a prospective, multicenter, cross-sectional study published in the Clinical Respiratory Journal, the researchers enrolled 245 adults with COPD who completed the COPD and Asthma Impact Scale (CASIS) to determine sleep impairment. The CASIS was developed to measure sleep-related problems associated with respiratory disease, and scored on a scale of 1-100, with higher scores indicating greater sleep impairment. The average CASIS score was 40.9. The average age of the patients was 67 years, and 92% were men.

Patients’ health-related quality of life, anxiety/depression, and self-efficacy were assessed using the St. George’s Respiratory Questionnaire (SGRQ), the 36-item Short-Form Health Survey (SF-36), Hospital Anxiety and Depression Scale (HADS), and the COPD Self-Efficacy Scale (CSES). The average scores on these measures were 36.0 for the SGRQ; 48.1 and 50.6, respectively, for the physical and mental components of the SF-36; 3.8 and 6.4, respectively, for the HADS-A and HADS-D measures of anxiety and depression; and 3.3 on the CSES.

Worse sleep in these patients was associated with worse scores on measures of mood. In a multivariate analysis, higher scores on all four measures of health-related quality of life were significantly associated with higher CASIS scores (P = .006 for SGRQ; P = .037 for SF-36, P < .001 for HADS, and P = .010 for CSES).

Although the CASIS did not allow for measurement of symptom severity and did not include many items related to breathing problems, the test “shows good internal consistency, test-retest reproducibility, and construct validity according to previous studies,” the researchers wrote. “The CASIS may be a good tool for evaluating sleep disturbances in COPD patients, and further study is needed,” they added.

The study findings were limited by several factors including the cross-sectional study design, lack of data on obstructive sleep apnea, and lack of information on specific treatments such as at-home oxygen use or high-dose steroid use, the researchers noted. However, the results were strengthened by the use of a disease-specific sleep measure, and the study is the first known to include self-efficacy in relation to sleep quality in COPD patients, they reported.

The results highlight the association between depression, poor quality of life, and self-efficacy in relation to poor sleep, and suggest that “Sleep quality could be improved by enhancing HRQL and self-efficacy,” the researchers said. “Screening for mood disorder in patients with COPD is also needed,” they concluded.

The study was supported by the Basic Science Research Program of the National Research Foundation of Korea (NRF) funded by the Ministry of Education, Science and Technology. The researchers had no financial conflicts to disclose.

SOURCE: Lee SH et al. Clin Respir J. 2020 Jul 24. doi: 10.1111/crj.13235.

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A study has shown a strong link between sleeping disturbances and depression in patients with chronic obstructive pulmonary disease.

magicmine/Getty Images

Adults with clinically stable COPD who reported sleep problems were significantly more likely to report depression or anxiety, poor self-efficacy, and poor health-related quality of life, compared with those not reporting sleep problems, according to the findings from a study of 245 patients.

Sleep problems are common in patients with COPD and have been associated with poor COPD-related outcomes, wrote Sang Hee Lee, MD, of Wonkwang University Sanbon Hospital, Gunpo-si, South Korea, and colleagues.

“However, there is a lack of research on factors associated with sleep disturbance in patients with COPD,” they wrote.

In a prospective, multicenter, cross-sectional study published in the Clinical Respiratory Journal, the researchers enrolled 245 adults with COPD who completed the COPD and Asthma Impact Scale (CASIS) to determine sleep impairment. The CASIS was developed to measure sleep-related problems associated with respiratory disease, and scored on a scale of 1-100, with higher scores indicating greater sleep impairment. The average CASIS score was 40.9. The average age of the patients was 67 years, and 92% were men.

Patients’ health-related quality of life, anxiety/depression, and self-efficacy were assessed using the St. George’s Respiratory Questionnaire (SGRQ), the 36-item Short-Form Health Survey (SF-36), Hospital Anxiety and Depression Scale (HADS), and the COPD Self-Efficacy Scale (CSES). The average scores on these measures were 36.0 for the SGRQ; 48.1 and 50.6, respectively, for the physical and mental components of the SF-36; 3.8 and 6.4, respectively, for the HADS-A and HADS-D measures of anxiety and depression; and 3.3 on the CSES.

Worse sleep in these patients was associated with worse scores on measures of mood. In a multivariate analysis, higher scores on all four measures of health-related quality of life were significantly associated with higher CASIS scores (P = .006 for SGRQ; P = .037 for SF-36, P < .001 for HADS, and P = .010 for CSES).

Although the CASIS did not allow for measurement of symptom severity and did not include many items related to breathing problems, the test “shows good internal consistency, test-retest reproducibility, and construct validity according to previous studies,” the researchers wrote. “The CASIS may be a good tool for evaluating sleep disturbances in COPD patients, and further study is needed,” they added.

The study findings were limited by several factors including the cross-sectional study design, lack of data on obstructive sleep apnea, and lack of information on specific treatments such as at-home oxygen use or high-dose steroid use, the researchers noted. However, the results were strengthened by the use of a disease-specific sleep measure, and the study is the first known to include self-efficacy in relation to sleep quality in COPD patients, they reported.

The results highlight the association between depression, poor quality of life, and self-efficacy in relation to poor sleep, and suggest that “Sleep quality could be improved by enhancing HRQL and self-efficacy,” the researchers said. “Screening for mood disorder in patients with COPD is also needed,” they concluded.

The study was supported by the Basic Science Research Program of the National Research Foundation of Korea (NRF) funded by the Ministry of Education, Science and Technology. The researchers had no financial conflicts to disclose.

SOURCE: Lee SH et al. Clin Respir J. 2020 Jul 24. doi: 10.1111/crj.13235.

A study has shown a strong link between sleeping disturbances and depression in patients with chronic obstructive pulmonary disease.

magicmine/Getty Images

Adults with clinically stable COPD who reported sleep problems were significantly more likely to report depression or anxiety, poor self-efficacy, and poor health-related quality of life, compared with those not reporting sleep problems, according to the findings from a study of 245 patients.

Sleep problems are common in patients with COPD and have been associated with poor COPD-related outcomes, wrote Sang Hee Lee, MD, of Wonkwang University Sanbon Hospital, Gunpo-si, South Korea, and colleagues.

“However, there is a lack of research on factors associated with sleep disturbance in patients with COPD,” they wrote.

In a prospective, multicenter, cross-sectional study published in the Clinical Respiratory Journal, the researchers enrolled 245 adults with COPD who completed the COPD and Asthma Impact Scale (CASIS) to determine sleep impairment. The CASIS was developed to measure sleep-related problems associated with respiratory disease, and scored on a scale of 1-100, with higher scores indicating greater sleep impairment. The average CASIS score was 40.9. The average age of the patients was 67 years, and 92% were men.

Patients’ health-related quality of life, anxiety/depression, and self-efficacy were assessed using the St. George’s Respiratory Questionnaire (SGRQ), the 36-item Short-Form Health Survey (SF-36), Hospital Anxiety and Depression Scale (HADS), and the COPD Self-Efficacy Scale (CSES). The average scores on these measures were 36.0 for the SGRQ; 48.1 and 50.6, respectively, for the physical and mental components of the SF-36; 3.8 and 6.4, respectively, for the HADS-A and HADS-D measures of anxiety and depression; and 3.3 on the CSES.

Worse sleep in these patients was associated with worse scores on measures of mood. In a multivariate analysis, higher scores on all four measures of health-related quality of life were significantly associated with higher CASIS scores (P = .006 for SGRQ; P = .037 for SF-36, P < .001 for HADS, and P = .010 for CSES).

Although the CASIS did not allow for measurement of symptom severity and did not include many items related to breathing problems, the test “shows good internal consistency, test-retest reproducibility, and construct validity according to previous studies,” the researchers wrote. “The CASIS may be a good tool for evaluating sleep disturbances in COPD patients, and further study is needed,” they added.

The study findings were limited by several factors including the cross-sectional study design, lack of data on obstructive sleep apnea, and lack of information on specific treatments such as at-home oxygen use or high-dose steroid use, the researchers noted. However, the results were strengthened by the use of a disease-specific sleep measure, and the study is the first known to include self-efficacy in relation to sleep quality in COPD patients, they reported.

The results highlight the association between depression, poor quality of life, and self-efficacy in relation to poor sleep, and suggest that “Sleep quality could be improved by enhancing HRQL and self-efficacy,” the researchers said. “Screening for mood disorder in patients with COPD is also needed,” they concluded.

The study was supported by the Basic Science Research Program of the National Research Foundation of Korea (NRF) funded by the Ministry of Education, Science and Technology. The researchers had no financial conflicts to disclose.

SOURCE: Lee SH et al. Clin Respir J. 2020 Jul 24. doi: 10.1111/crj.13235.

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So, you’ve been sued. What now?

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By the time physicians turn 65 years old, more than 75% of those in low-risk specialties such as pediatric dermatology have been named in a lawsuit, compared with 99% of those in high-risk specialties such as obstetrics and gynecology, according to Ilona J. Frieden, MD.

Dr. Ilona J. Frieden

“We all know there’s a possibility that we could get named in a lawsuit,” she said during the virtual annual meeting of the Society for Pediatric Dermatology. “It could happen to any of us. Lawsuits are not uncommon, but few of us have received any kind of training for how to handle them.”

Based on her experience being named in a malpractice/wrongful death lawsuit, Dr. Frieden, who has had a nearly 4-decade career as a pediatric dermatologist at the University of California, San Francisco, offered the following tips for clinicians facing practice-related litigation:

First, immediately inform the risk management representatives at your institution or your malpractice insurance carrier. “Tell them about the situation and arrange to talk to a lawyer,” she advised.

Second, prepare to confront a range of emotions. “Depending on the circumstances, [that could be] fear, anger, dread, and defensiveness,” said Dr. Frieden, professor of dermatology and pediatrics, at UCSF. “What surprised me was this sort of physical sensation. I felt like I had been kicked in the stomach. In retrospect, this is not such a surprising finding. It really is an assault on your professional identity, so it made sense to me as I thought about this.”



Third, slow yourself down. The litigation process typically takes 2-5 years, “so this is a marathon; this is not a sprint,” she said. “While you are waiting you will be told, ‘Don’t discuss this case with anyone.’ While this may be true for the specific details of the case, it isn’t true about what you are feeling and how this affects you. You can and you should talk to a trusted friend, to a spouse, or even to a therapist so that you can process what you’re going through and not feel alone.”

Fourth, try to focus on the patients that you help. Having a patient in your pediatric dermatology practice die “is a rare event,” she said. “Try to not let such an event define you in terms of your professional identity. Meanwhile [remember that] you’re helping lots and lots of people.”

Fifth, be humble, both for yourself and the experts you might turn to for advice when you’re facing a complex case. “Though I have decades of experience, I find myself feeling more willing rather than less willing to ask for help,” Dr. Frieden said. “Also, the culture has changed. We email colleagues all the time to say, ‘This doesn’t make sense. Can you please tell me what your thoughts are?’ ”

She closed her remarks by noting that physicians “put ourselves in harm’s way in the process of trying to do the best we can for patients. That is something we have to accept.” She reported having no financial disclosures.

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By the time physicians turn 65 years old, more than 75% of those in low-risk specialties such as pediatric dermatology have been named in a lawsuit, compared with 99% of those in high-risk specialties such as obstetrics and gynecology, according to Ilona J. Frieden, MD.

Dr. Ilona J. Frieden

“We all know there’s a possibility that we could get named in a lawsuit,” she said during the virtual annual meeting of the Society for Pediatric Dermatology. “It could happen to any of us. Lawsuits are not uncommon, but few of us have received any kind of training for how to handle them.”

Based on her experience being named in a malpractice/wrongful death lawsuit, Dr. Frieden, who has had a nearly 4-decade career as a pediatric dermatologist at the University of California, San Francisco, offered the following tips for clinicians facing practice-related litigation:

First, immediately inform the risk management representatives at your institution or your malpractice insurance carrier. “Tell them about the situation and arrange to talk to a lawyer,” she advised.

Second, prepare to confront a range of emotions. “Depending on the circumstances, [that could be] fear, anger, dread, and defensiveness,” said Dr. Frieden, professor of dermatology and pediatrics, at UCSF. “What surprised me was this sort of physical sensation. I felt like I had been kicked in the stomach. In retrospect, this is not such a surprising finding. It really is an assault on your professional identity, so it made sense to me as I thought about this.”



Third, slow yourself down. The litigation process typically takes 2-5 years, “so this is a marathon; this is not a sprint,” she said. “While you are waiting you will be told, ‘Don’t discuss this case with anyone.’ While this may be true for the specific details of the case, it isn’t true about what you are feeling and how this affects you. You can and you should talk to a trusted friend, to a spouse, or even to a therapist so that you can process what you’re going through and not feel alone.”

Fourth, try to focus on the patients that you help. Having a patient in your pediatric dermatology practice die “is a rare event,” she said. “Try to not let such an event define you in terms of your professional identity. Meanwhile [remember that] you’re helping lots and lots of people.”

Fifth, be humble, both for yourself and the experts you might turn to for advice when you’re facing a complex case. “Though I have decades of experience, I find myself feeling more willing rather than less willing to ask for help,” Dr. Frieden said. “Also, the culture has changed. We email colleagues all the time to say, ‘This doesn’t make sense. Can you please tell me what your thoughts are?’ ”

She closed her remarks by noting that physicians “put ourselves in harm’s way in the process of trying to do the best we can for patients. That is something we have to accept.” She reported having no financial disclosures.

By the time physicians turn 65 years old, more than 75% of those in low-risk specialties such as pediatric dermatology have been named in a lawsuit, compared with 99% of those in high-risk specialties such as obstetrics and gynecology, according to Ilona J. Frieden, MD.

Dr. Ilona J. Frieden

“We all know there’s a possibility that we could get named in a lawsuit,” she said during the virtual annual meeting of the Society for Pediatric Dermatology. “It could happen to any of us. Lawsuits are not uncommon, but few of us have received any kind of training for how to handle them.”

Based on her experience being named in a malpractice/wrongful death lawsuit, Dr. Frieden, who has had a nearly 4-decade career as a pediatric dermatologist at the University of California, San Francisco, offered the following tips for clinicians facing practice-related litigation:

First, immediately inform the risk management representatives at your institution or your malpractice insurance carrier. “Tell them about the situation and arrange to talk to a lawyer,” she advised.

Second, prepare to confront a range of emotions. “Depending on the circumstances, [that could be] fear, anger, dread, and defensiveness,” said Dr. Frieden, professor of dermatology and pediatrics, at UCSF. “What surprised me was this sort of physical sensation. I felt like I had been kicked in the stomach. In retrospect, this is not such a surprising finding. It really is an assault on your professional identity, so it made sense to me as I thought about this.”



Third, slow yourself down. The litigation process typically takes 2-5 years, “so this is a marathon; this is not a sprint,” she said. “While you are waiting you will be told, ‘Don’t discuss this case with anyone.’ While this may be true for the specific details of the case, it isn’t true about what you are feeling and how this affects you. You can and you should talk to a trusted friend, to a spouse, or even to a therapist so that you can process what you’re going through and not feel alone.”

Fourth, try to focus on the patients that you help. Having a patient in your pediatric dermatology practice die “is a rare event,” she said. “Try to not let such an event define you in terms of your professional identity. Meanwhile [remember that] you’re helping lots and lots of people.”

Fifth, be humble, both for yourself and the experts you might turn to for advice when you’re facing a complex case. “Though I have decades of experience, I find myself feeling more willing rather than less willing to ask for help,” Dr. Frieden said. “Also, the culture has changed. We email colleagues all the time to say, ‘This doesn’t make sense. Can you please tell me what your thoughts are?’ ”

She closed her remarks by noting that physicians “put ourselves in harm’s way in the process of trying to do the best we can for patients. That is something we have to accept.” She reported having no financial disclosures.

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