Clinician Reviews

ANAHEIM – A wide range of factors can cause myocarditis; most often viral infections cause myocarditis in children and teens, according to Ryan Butts, MD, medical director of the pediatric advanced cardiac care program at the University of Texas Southwestern Medical Center and Children’s Health of Texas.

Dr. Butts provided an overview of what pediatricians and other clinicians caring for children and teens should know about myocarditis at the annual meeting of the American Academy of Pediatrics.

The important new things that attendees may want to take away from this for their practice are improved recognition and diagnostic workup for acute viral myocarditis, making sure cardiology follow-up occurs after an admission for the condition, enhanced evaluation of the child before they return to competitive sports, and the availability of written or verbal education for patients relating to COVID vaccine–associated myocarditis, Dr. Butts said.

He also provided a set of key takeaways:

• Myocarditis is rare.
• The most common viruses causing myocarditis are always changing.
• Myocarditis is most common in infants and teenagers but it has different clinical patterns in each population.
• MRI is becoming the diagnostic tool of choice.
• IVIG frequently is used but good evidence for the therapy is lacking.
• Patients may go home on cardiac medications but have good long-term outcomes.
• Patients must have a 6-month restriction on competitive sports after diagnosis.

Frank Han, MD, a pediatric cardiologist at OSF Medical Center and Children’s Hospital of Illinois in Peoria, said he found the most helpful parts of Dr. Butts’ presentation to be the diagnosis and triage of myocarditis in the major age groups.

“Myocarditis can have variable presentations, and its cause may influence how the myocarditis behaves,” Dr. Han said. Pediatric cardiologists, he said, are uniquely positioned to triage and diagnose myocarditis.
 

Epidemiology and presentation

Just 0.05% of admissions from 28.6 million U.S. pediatric ED visits every year are for myocarditis, Dr. Butts said. While viruses are the most common cause of myocarditis, bacterial infections and noninfectious causes, including hypersensitivity reactions, systemic disorders, and toxic substances, can also cause the condition. The dominant viruses causing myocarditis have shifted over the years as well. Coxsackie B was the most common cause in the 1980s, but adenovirus became more common in the 1990s and parvovirus B19 in the 2000s. Why some kids develop myocarditis while others don’t is unclear, but the host-immune response to the virus likely plays an important role.

Research has shown two substantial spikes in the incidence of myocarditis children: infants under 2 years old and teens aged 14-19. Although myocarditis refers to any inflammation of myocardium not caused by ischemia, the signs, symptoms, and lab results vary according to patient’s age group. The only constant is that diaphoresis is rare across all ages.

Infants are more likely to show respiratory distress (68%) and an enlarged liver (40%) but can also present with gastrointestinal symptoms (24%). Vomiting without fever or diarrhea should arouse clinical suspicion of myocarditis in infants, although fever and diarrhea can occur.

In young children, who have the lowest incidence, fatigue presents in about one-third, with 20% presenting with chest pain and 20% with hepatomegaly. The most common symptom in teens by far (80%) is chest pain. About one-third also have respiratory distress but gastrointestinal symptoms are less common (20%).

When should a clinician suspect myocarditis in a teen presenting with chest pain? “If the chest pain is reproducible and if you can localize it, they don’t need further evaluation,” Dr. Butts said. “After that, it’s a lot about the history.”

In terms of lab results, ventricular function measured by brain natriuretic peptide is significantly depressed in infants and young children but often near normal in teens. Inflammatory markers (C-reactive protein) tend to be low in infants but elevated in young children and teens. And troponin levels, denoting myocardial injury, are minimal in infants and young children but elevated in teens. Median ejection fraction on echocardiograms, about 55% in normal hearts, will often be low in infants and young children, around 30%-33%, but is near normal (54%) in teens.
 

Diagnosis and management

Cardiac MRI increasingly has been replacing endomyocardial biopsy for diagnosis, with MRI exceeding biopsy use between 2009 and 2010, Dr. Butts said. The advantage of endomyocardial biopsy is that it’s specific, if not very sensitive. The test is invasive, however, requiring sedation and carrying the risk of tricuspid injury. The most common finding on cardiac MRI is late gadolinium enhancement (80%) while early gadolinium enhancement is less common (55%).

Although Dr. Butts mentioned the Dallas diagnostic criteria from 1987, he advocated for the more recent Lake Louise Criteria, which require clinical suspicion of myocarditis and at least two of three findings on MRI: T2-weighted myocardial abnormalities, T1 early or late gadolinium enhancement, or regional wall motion abnormalities or evidence of pericarditis

Point-of-care ultrasound can be useful for detecting myocarditis, but its success depends on whether the user can pick up on the subtle changes in ventricular function. “Just because someone has a point-of-care ultrasound that’s normal or thought to be normal, it shouldn’t rule out the diagnosis,” he said.

Learning the etiology of viral myocarditis often is difficult, and etiology doesn’t affect management of the condition, Dr. Butts said. Even in cases of myocarditis confirmed by biopsy, the virus may be identified in only about 60%-70% of cases with myocardial polymerase chain reaction. In clinical cases, the virus can be determined only about 25%-30% of the time with serum PCR.

Prognosis is usually good, with 80%-90% of children and teens going home transplant free despite most arriving critically ill and 50%-80% initially being admitted to ICU. Two-thirds of those discharged go home with heart failure medications, but only one in six are readmitted within a year.

The strongest risk factors for poor prognosis are younger age and being critically ill at presentation but other risk factors include female sex, poor ventricular function, poor perfusion on exam, increased dilation on echocardiogram, and a need for ECMO or inotropes or mechanical ventilation.

That said, Dr. Butts cautioned attendees not to ignore normal function. In one study of 171 patients, among 75 who presented with normal function, 15% went home with inotropes, 12% required mechanical ventilation, 9% had arrhythmia, and 5% needed extracorporeal membrane oxygenation.

A big question in treatment is whether to give IVIG or not and the evidence is murky, Dr. Butts said. He reviewed a couple studies on IVIG, including one that suggested better ventricular functional recovery with the treatment but those who received IVIG were also more likely to be on an ACE inhibitor.

“Was it the ACE inhibitor or was it IVIG? We don’t know,” he said. Different cardiologists may give different opinions on IVIG. “It has nothing to do with the actual evidence behind it.”

IVIG has drawbacks: It’s very expensive and it involves risks that include serum sickness and interstitial nephritis.

“Pediatricians typically aren’t going to directly decide on giving or not giving IVIG,” Dr. Han said. “Typically, the ultimate choice comes from a group discussion between the hospital cardiologist – perhaps the hospitalist pediatrician if they are involved – and the family. We acknowledge the ambiguity of the evidence and decide based upon the severity of the initial disease process.”
 

Return to competitive sports; Follow-up critical

Experts are much more confident, however, about when teens admitted with viral myocarditis can return to competitive sports. But Dr. Butts said he suspects the guidelines for these children aren’t followed as closely as they should be. The American Heart Association recommends waiting 6 months after discharge and ensuring the athlete has a normal echocardiogram, Holter monitoring, and stress test.

“It’s incredibly important to have them come back and see the cardiologist 6 months after admission,” Dr. Butts said. “The only patient I’ve ever had who died 6-7 months post myocarditis is somebody who, during their stress test, had increasing ventricular ectopy. I told him not to do sports. He didn’t listen to me and unfortunately passed away – I’m assuming from arrhythmia.”
 

COVID and vaccine-associated myocarditis

Vaccine-associated myocarditis is substantially milder than viral myocarditis, Dr. Butts said. A small study from a single center in Atlanta found that ejection fraction at admission was normal, around 56%, in those with vaccine-associated myocarditis, compared with 45% with non-COVID viral myocarditis and 50% with multisystem inflammatory syndrome in children or myocarditis from COVID-19. All patients with vaccine-associated myocarditis had normal function at discharge, compared with 73% of those with viral myocarditis and 93% with COVID-associated myocarditis.

While 22% of those with vaccine-associated myocarditis were admitted to the ICU, twice as many (40%) with viral myocarditis were, and three times as many (68%) with COVID-associated myocarditis ended up in intensive care.

Dr. Butts also noted a Morbidity and Mortality Weekly Report from the Centers of Disease Control and Prevention that found teen boys had two to six times greater risk of heart complications after COVID-19 infection than after COVID vaccination.

In terms of direct comparisons, vaccine-related myocarditis occurred about 12-18 times per 100,000 doses for boys ages 5-11 years, compared with cardiac involvement in 93-133 cases out of 100,000 COVID-19 infections. Boys aged 12-17 years experienced 12-21 cases of myocarditis per 100,000 doses of the vaccine, compared with cardiac involvement in 50-64 out of 100,000 infections.

The bottom line, Dr. Butts said, is that cardiac involvement in MIS-C is common, but typically improves by discharge. “Vaccine-associated myocarditis is a mild clinical syndrome that has a very short duration, and, in my opinion, should never lead us to ever advise anybody not to get the vaccine. I’ve had many patients, even patients in their first year post transplant, who have gotten the COVID-19 vaccine and were just fine.”

Dr. Butts acknowledged that talking with families about the risk of myocarditis with the vaccine is challenging. He often starts these conversations by sharing the statistics, but he said relatable stories are the key. He will also relate the statistics to something the parents and teen will understand, whether it’s sports or another comparison. He does recommend that teens who develop vaccine-associated myocarditis complete the series and get the booster. Their chances of developing myocarditis again are extremely low, whereas “the likelihood of them being really ill from COVID-19 is much, much higher.”

Dr. Butts and Dr. Han had no disclosures. The presentation involved no external funding.

ANAHEIM – A wide range of factors can cause myocarditis; most often viral infections cause myocarditis in children and teens, according to Ryan Butts, MD, medical director of the pediatric advanced cardiac care program at the University of Texas Southwestern Medical Center and Children’s Health of Texas.

Dr. Butts provided an overview of what pediatricians and other clinicians caring for children and teens should know about myocarditis at the annual meeting of the American Academy of Pediatrics.

The important new things that attendees may want to take away from this for their practice are improved recognition and diagnostic workup for acute viral myocarditis, making sure cardiology follow-up occurs after an admission for the condition, enhanced evaluation of the child before they return to competitive sports, and the availability of written or verbal education for patients relating to COVID vaccine–associated myocarditis, Dr. Butts said.

He also provided a set of key takeaways:

• Myocarditis is rare.
• The most common viruses causing myocarditis are always changing.
• Myocarditis is most common in infants and teenagers but it has different clinical patterns in each population.
• MRI is becoming the diagnostic tool of choice.
• IVIG frequently is used but good evidence for the therapy is lacking.
• Patients may go home on cardiac medications but have good long-term outcomes.
• Patients must have a 6-month restriction on competitive sports after diagnosis.

Frank Han, MD, a pediatric cardiologist at OSF Medical Center and Children’s Hospital of Illinois in Peoria, said he found the most helpful parts of Dr. Butts’ presentation to be the diagnosis and triage of myocarditis in the major age groups.

“Myocarditis can have variable presentations, and its cause may influence how the myocarditis behaves,” Dr. Han said. Pediatric cardiologists, he said, are uniquely positioned to triage and diagnose myocarditis.
 

Epidemiology and presentation

Just 0.05% of admissions from 28.6 million U.S. pediatric ED visits every year are for myocarditis, Dr. Butts said. While viruses are the most common cause of myocarditis, bacterial infections and noninfectious causes, including hypersensitivity reactions, systemic disorders, and toxic substances, can also cause the condition. The dominant viruses causing myocarditis have shifted over the years as well. Coxsackie B was the most common cause in the 1980s, but adenovirus became more common in the 1990s and parvovirus B19 in the 2000s. Why some kids develop myocarditis while others don’t is unclear, but the host-immune response to the virus likely plays an important role.

Research has shown two substantial spikes in the incidence of myocarditis children: infants under 2 years old and teens aged 14-19. Although myocarditis refers to any inflammation of myocardium not caused by ischemia, the signs, symptoms, and lab results vary according to patient’s age group. The only constant is that diaphoresis is rare across all ages.

Infants are more likely to show respiratory distress (68%) and an enlarged liver (40%) but can also present with gastrointestinal symptoms (24%). Vomiting without fever or diarrhea should arouse clinical suspicion of myocarditis in infants, although fever and diarrhea can occur.

In young children, who have the lowest incidence, fatigue presents in about one-third, with 20% presenting with chest pain and 20% with hepatomegaly. The most common symptom in teens by far (80%) is chest pain. About one-third also have respiratory distress but gastrointestinal symptoms are less common (20%).

When should a clinician suspect myocarditis in a teen presenting with chest pain? “If the chest pain is reproducible and if you can localize it, they don’t need further evaluation,” Dr. Butts said. “After that, it’s a lot about the history.”

In terms of lab results, ventricular function measured by brain natriuretic peptide is significantly depressed in infants and young children but often near normal in teens. Inflammatory markers (C-reactive protein) tend to be low in infants but elevated in young children and teens. And troponin levels, denoting myocardial injury, are minimal in infants and young children but elevated in teens. Median ejection fraction on echocardiograms, about 55% in normal hearts, will often be low in infants and young children, around 30%-33%, but is near normal (54%) in teens.
 

Diagnosis and management

Cardiac MRI increasingly has been replacing endomyocardial biopsy for diagnosis, with MRI exceeding biopsy use between 2009 and 2010, Dr. Butts said. The advantage of endomyocardial biopsy is that it’s specific, if not very sensitive. The test is invasive, however, requiring sedation and carrying the risk of tricuspid injury. The most common finding on cardiac MRI is late gadolinium enhancement (80%) while early gadolinium enhancement is less common (55%).

Although Dr. Butts mentioned the Dallas diagnostic criteria from 1987, he advocated for the more recent Lake Louise Criteria, which require clinical suspicion of myocarditis and at least two of three findings on MRI: T2-weighted myocardial abnormalities, T1 early or late gadolinium enhancement, or regional wall motion abnormalities or evidence of pericarditis

Point-of-care ultrasound can be useful for detecting myocarditis, but its success depends on whether the user can pick up on the subtle changes in ventricular function. “Just because someone has a point-of-care ultrasound that’s normal or thought to be normal, it shouldn’t rule out the diagnosis,” he said.

Learning the etiology of viral myocarditis often is difficult, and etiology doesn’t affect management of the condition, Dr. Butts said. Even in cases of myocarditis confirmed by biopsy, the virus may be identified in only about 60%-70% of cases with myocardial polymerase chain reaction. In clinical cases, the virus can be determined only about 25%-30% of the time with serum PCR.

Prognosis is usually good, with 80%-90% of children and teens going home transplant free despite most arriving critically ill and 50%-80% initially being admitted to ICU. Two-thirds of those discharged go home with heart failure medications, but only one in six are readmitted within a year.

The strongest risk factors for poor prognosis are younger age and being critically ill at presentation but other risk factors include female sex, poor ventricular function, poor perfusion on exam, increased dilation on echocardiogram, and a need for ECMO or inotropes or mechanical ventilation.

That said, Dr. Butts cautioned attendees not to ignore normal function. In one study of 171 patients, among 75 who presented with normal function, 15% went home with inotropes, 12% required mechanical ventilation, 9% had arrhythmia, and 5% needed extracorporeal membrane oxygenation.

A big question in treatment is whether to give IVIG or not and the evidence is murky, Dr. Butts said. He reviewed a couple studies on IVIG, including one that suggested better ventricular functional recovery with the treatment but those who received IVIG were also more likely to be on an ACE inhibitor.

“Was it the ACE inhibitor or was it IVIG? We don’t know,” he said. Different cardiologists may give different opinions on IVIG. “It has nothing to do with the actual evidence behind it.”

IVIG has drawbacks: It’s very expensive and it involves risks that include serum sickness and interstitial nephritis.

“Pediatricians typically aren’t going to directly decide on giving or not giving IVIG,” Dr. Han said. “Typically, the ultimate choice comes from a group discussion between the hospital cardiologist – perhaps the hospitalist pediatrician if they are involved – and the family. We acknowledge the ambiguity of the evidence and decide based upon the severity of the initial disease process.”
 

Return to competitive sports; Follow-up critical

Experts are much more confident, however, about when teens admitted with viral myocarditis can return to competitive sports. But Dr. Butts said he suspects the guidelines for these children aren’t followed as closely as they should be. The American Heart Association recommends waiting 6 months after discharge and ensuring the athlete has a normal echocardiogram, Holter monitoring, and stress test.

“It’s incredibly important to have them come back and see the cardiologist 6 months after admission,” Dr. Butts said. “The only patient I’ve ever had who died 6-7 months post myocarditis is somebody who, during their stress test, had increasing ventricular ectopy. I told him not to do sports. He didn’t listen to me and unfortunately passed away – I’m assuming from arrhythmia.”
 

COVID and vaccine-associated myocarditis

Vaccine-associated myocarditis is substantially milder than viral myocarditis, Dr. Butts said. A small study from a single center in Atlanta found that ejection fraction at admission was normal, around 56%, in those with vaccine-associated myocarditis, compared with 45% with non-COVID viral myocarditis and 50% with multisystem inflammatory syndrome in children or myocarditis from COVID-19. All patients with vaccine-associated myocarditis had normal function at discharge, compared with 73% of those with viral myocarditis and 93% with COVID-associated myocarditis.

While 22% of those with vaccine-associated myocarditis were admitted to the ICU, twice as many (40%) with viral myocarditis were, and three times as many (68%) with COVID-associated myocarditis ended up in intensive care.

Dr. Butts also noted a Morbidity and Mortality Weekly Report from the Centers of Disease Control and Prevention that found teen boys had two to six times greater risk of heart complications after COVID-19 infection than after COVID vaccination.

In terms of direct comparisons, vaccine-related myocarditis occurred about 12-18 times per 100,000 doses for boys ages 5-11 years, compared with cardiac involvement in 93-133 cases out of 100,000 COVID-19 infections. Boys aged 12-17 years experienced 12-21 cases of myocarditis per 100,000 doses of the vaccine, compared with cardiac involvement in 50-64 out of 100,000 infections.

The bottom line, Dr. Butts said, is that cardiac involvement in MIS-C is common, but typically improves by discharge. “Vaccine-associated myocarditis is a mild clinical syndrome that has a very short duration, and, in my opinion, should never lead us to ever advise anybody not to get the vaccine. I’ve had many patients, even patients in their first year post transplant, who have gotten the COVID-19 vaccine and were just fine.”

Dr. Butts acknowledged that talking with families about the risk of myocarditis with the vaccine is challenging. He often starts these conversations by sharing the statistics, but he said relatable stories are the key. He will also relate the statistics to something the parents and teen will understand, whether it’s sports or another comparison. He does recommend that teens who develop vaccine-associated myocarditis complete the series and get the booster. Their chances of developing myocarditis again are extremely low, whereas “the likelihood of them being really ill from COVID-19 is much, much higher.”

Dr. Butts and Dr. Han had no disclosures. The presentation involved no external funding.

ANAHEIM – A wide range of factors can cause myocarditis; most often viral infections cause myocarditis in children and teens, according to Ryan Butts, MD, medical director of the pediatric advanced cardiac care program at the University of Texas Southwestern Medical Center and Children’s Health of Texas.

Dr. Butts provided an overview of what pediatricians and other clinicians caring for children and teens should know about myocarditis at the annual meeting of the American Academy of Pediatrics.

The important new things that attendees may want to take away from this for their practice are improved recognition and diagnostic workup for acute viral myocarditis, making sure cardiology follow-up occurs after an admission for the condition, enhanced evaluation of the child before they return to competitive sports, and the availability of written or verbal education for patients relating to COVID vaccine–associated myocarditis, Dr. Butts said.

He also provided a set of key takeaways:

• Myocarditis is rare.
• The most common viruses causing myocarditis are always changing.
• Myocarditis is most common in infants and teenagers but it has different clinical patterns in each population.
• MRI is becoming the diagnostic tool of choice.
• IVIG frequently is used but good evidence for the therapy is lacking.
• Patients may go home on cardiac medications but have good long-term outcomes.
• Patients must have a 6-month restriction on competitive sports after diagnosis.

Frank Han, MD, a pediatric cardiologist at OSF Medical Center and Children’s Hospital of Illinois in Peoria, said he found the most helpful parts of Dr. Butts’ presentation to be the diagnosis and triage of myocarditis in the major age groups.

“Myocarditis can have variable presentations, and its cause may influence how the myocarditis behaves,” Dr. Han said. Pediatric cardiologists, he said, are uniquely positioned to triage and diagnose myocarditis.
 

Epidemiology and presentation

Just 0.05% of admissions from 28.6 million U.S. pediatric ED visits every year are for myocarditis, Dr. Butts said. While viruses are the most common cause of myocarditis, bacterial infections and noninfectious causes, including hypersensitivity reactions, systemic disorders, and toxic substances, can also cause the condition. The dominant viruses causing myocarditis have shifted over the years as well. Coxsackie B was the most common cause in the 1980s, but adenovirus became more common in the 1990s and parvovirus B19 in the 2000s. Why some kids develop myocarditis while others don’t is unclear, but the host-immune response to the virus likely plays an important role.

Research has shown two substantial spikes in the incidence of myocarditis children: infants under 2 years old and teens aged 14-19. Although myocarditis refers to any inflammation of myocardium not caused by ischemia, the signs, symptoms, and lab results vary according to patient’s age group. The only constant is that diaphoresis is rare across all ages.

Infants are more likely to show respiratory distress (68%) and an enlarged liver (40%) but can also present with gastrointestinal symptoms (24%). Vomiting without fever or diarrhea should arouse clinical suspicion of myocarditis in infants, although fever and diarrhea can occur.

In young children, who have the lowest incidence, fatigue presents in about one-third, with 20% presenting with chest pain and 20% with hepatomegaly. The most common symptom in teens by far (80%) is chest pain. About one-third also have respiratory distress but gastrointestinal symptoms are less common (20%).

When should a clinician suspect myocarditis in a teen presenting with chest pain? “If the chest pain is reproducible and if you can localize it, they don’t need further evaluation,” Dr. Butts said. “After that, it’s a lot about the history.”

In terms of lab results, ventricular function measured by brain natriuretic peptide is significantly depressed in infants and young children but often near normal in teens. Inflammatory markers (C-reactive protein) tend to be low in infants but elevated in young children and teens. And troponin levels, denoting myocardial injury, are minimal in infants and young children but elevated in teens. Median ejection fraction on echocardiograms, about 55% in normal hearts, will often be low in infants and young children, around 30%-33%, but is near normal (54%) in teens.
 

Diagnosis and management

Cardiac MRI increasingly has been replacing endomyocardial biopsy for diagnosis, with MRI exceeding biopsy use between 2009 and 2010, Dr. Butts said. The advantage of endomyocardial biopsy is that it’s specific, if not very sensitive. The test is invasive, however, requiring sedation and carrying the risk of tricuspid injury. The most common finding on cardiac MRI is late gadolinium enhancement (80%) while early gadolinium enhancement is less common (55%).

Although Dr. Butts mentioned the Dallas diagnostic criteria from 1987, he advocated for the more recent Lake Louise Criteria, which require clinical suspicion of myocarditis and at least two of three findings on MRI: T2-weighted myocardial abnormalities, T1 early or late gadolinium enhancement, or regional wall motion abnormalities or evidence of pericarditis

Point-of-care ultrasound can be useful for detecting myocarditis, but its success depends on whether the user can pick up on the subtle changes in ventricular function. “Just because someone has a point-of-care ultrasound that’s normal or thought to be normal, it shouldn’t rule out the diagnosis,” he said.

Learning the etiology of viral myocarditis often is difficult, and etiology doesn’t affect management of the condition, Dr. Butts said. Even in cases of myocarditis confirmed by biopsy, the virus may be identified in only about 60%-70% of cases with myocardial polymerase chain reaction. In clinical cases, the virus can be determined only about 25%-30% of the time with serum PCR.

Prognosis is usually good, with 80%-90% of children and teens going home transplant free despite most arriving critically ill and 50%-80% initially being admitted to ICU. Two-thirds of those discharged go home with heart failure medications, but only one in six are readmitted within a year.

The strongest risk factors for poor prognosis are younger age and being critically ill at presentation but other risk factors include female sex, poor ventricular function, poor perfusion on exam, increased dilation on echocardiogram, and a need for ECMO or inotropes or mechanical ventilation.

That said, Dr. Butts cautioned attendees not to ignore normal function. In one study of 171 patients, among 75 who presented with normal function, 15% went home with inotropes, 12% required mechanical ventilation, 9% had arrhythmia, and 5% needed extracorporeal membrane oxygenation.

A big question in treatment is whether to give IVIG or not and the evidence is murky, Dr. Butts said. He reviewed a couple studies on IVIG, including one that suggested better ventricular functional recovery with the treatment but those who received IVIG were also more likely to be on an ACE inhibitor.

“Was it the ACE inhibitor or was it IVIG? We don’t know,” he said. Different cardiologists may give different opinions on IVIG. “It has nothing to do with the actual evidence behind it.”

IVIG has drawbacks: It’s very expensive and it involves risks that include serum sickness and interstitial nephritis.

“Pediatricians typically aren’t going to directly decide on giving or not giving IVIG,” Dr. Han said. “Typically, the ultimate choice comes from a group discussion between the hospital cardiologist – perhaps the hospitalist pediatrician if they are involved – and the family. We acknowledge the ambiguity of the evidence and decide based upon the severity of the initial disease process.”
 

Return to competitive sports; Follow-up critical

Experts are much more confident, however, about when teens admitted with viral myocarditis can return to competitive sports. But Dr. Butts said he suspects the guidelines for these children aren’t followed as closely as they should be. The American Heart Association recommends waiting 6 months after discharge and ensuring the athlete has a normal echocardiogram, Holter monitoring, and stress test.

“It’s incredibly important to have them come back and see the cardiologist 6 months after admission,” Dr. Butts said. “The only patient I’ve ever had who died 6-7 months post myocarditis is somebody who, during their stress test, had increasing ventricular ectopy. I told him not to do sports. He didn’t listen to me and unfortunately passed away – I’m assuming from arrhythmia.”
 

COVID and vaccine-associated myocarditis

Vaccine-associated myocarditis is substantially milder than viral myocarditis, Dr. Butts said. A small study from a single center in Atlanta found that ejection fraction at admission was normal, around 56%, in those with vaccine-associated myocarditis, compared with 45% with non-COVID viral myocarditis and 50% with multisystem inflammatory syndrome in children or myocarditis from COVID-19. All patients with vaccine-associated myocarditis had normal function at discharge, compared with 73% of those with viral myocarditis and 93% with COVID-associated myocarditis.

While 22% of those with vaccine-associated myocarditis were admitted to the ICU, twice as many (40%) with viral myocarditis were, and three times as many (68%) with COVID-associated myocarditis ended up in intensive care.

Dr. Butts also noted a Morbidity and Mortality Weekly Report from the Centers of Disease Control and Prevention that found teen boys had two to six times greater risk of heart complications after COVID-19 infection than after COVID vaccination.

In terms of direct comparisons, vaccine-related myocarditis occurred about 12-18 times per 100,000 doses for boys ages 5-11 years, compared with cardiac involvement in 93-133 cases out of 100,000 COVID-19 infections. Boys aged 12-17 years experienced 12-21 cases of myocarditis per 100,000 doses of the vaccine, compared with cardiac involvement in 50-64 out of 100,000 infections.

The bottom line, Dr. Butts said, is that cardiac involvement in MIS-C is common, but typically improves by discharge. “Vaccine-associated myocarditis is a mild clinical syndrome that has a very short duration, and, in my opinion, should never lead us to ever advise anybody not to get the vaccine. I’ve had many patients, even patients in their first year post transplant, who have gotten the COVID-19 vaccine and were just fine.”

Dr. Butts acknowledged that talking with families about the risk of myocarditis with the vaccine is challenging. He often starts these conversations by sharing the statistics, but he said relatable stories are the key. He will also relate the statistics to something the parents and teen will understand, whether it’s sports or another comparison. He does recommend that teens who develop vaccine-associated myocarditis complete the series and get the booster. Their chances of developing myocarditis again are extremely low, whereas “the likelihood of them being really ill from COVID-19 is much, much higher.”

Dr. Butts and Dr. Han had no disclosures. The presentation involved no external funding.

Geographic location within the United States appears to have an impact on the specific symptoms of polycystic ovary syndrome (PCOS) that any one particular woman will develop, according to a new prospective cohort study.

Women in California were more likely to exhibit high levels of testosterone (hyperandrogenism), while women in Alabama with PCOS had more metabolic dysfunction and hirsutism.

And although the women in Alabama were younger and had a higher body mass index (BMI), even after adjusting for these factors, the clinical differences were still present between the geographic locations, the authors said.

“This study suggests there are regional differences in hormonal and metabolic parameters in women with PCOS in California and Alabama, highlighting the impact of differing genetic and environmental modulators on PCOS development,” Katherine VanHise, MD, of Cedars-Sinai Medical Center, Los Angeles, and colleagues wrote in their article, published online in the Journal of Clinical Endocrinology and Metabolism.
 

Genetic and environmental factors play a role

Prior research has looked at variations in symptoms of PCOS across countries and identified differences in hirsutism and its prevalence, which is greater in Middle Eastern, Mediterranean, and Indian women, noted senior author Margareta D. Pisarska, MD.

And women of some other backgrounds “are at increased risk of developing metabolic syndrome and insulin resistance, including South Asian, African, and Hispanic women, so they are at a greater risk trajectory of developing manifestations later on in life that can ultimately lead to adverse outcomes in overall health,” Dr. Pisarska, director of the division of reproductive endocrinology and infertility in obstetrics and gynecology at Cedars-Sinai, told this news organization.

“We do see regional differences in the diagnosis of PCOS [in the United States] as well as the manifestations of PCOS including high andrenoemia, hirsutism, and metabolic parameters ... and we need to better understand it because, at least in the entire population, weight was not the entire factor contributing to these differences,” she explained.

“So there are definitely environmental factors and possibly genetic factors that we need to take into consideration as we try to study these women and try to help them decrease their risk of metabolic syndrome later in life,” she noted.
 

Differences not attributable to race either

PCOS is a common endocrine disorder affecting women and female adolescents worldwide. Diagnosis usually requires at least two of the following to be present: ovulatory dysfunction, hyperandrogenism, and/or polycystic ovarian morphology.

Because of the prior work that had identified differences in symptoms among women with PCOS in different countries, the investigators set out to determine if women of the same race would have distinct hormonal and metabolic traits of PCOS in two geographical locations in the United States, suggesting geo-epidemiologic contributors of the disease

They evaluated 889 women at the University of Alabama at Birmingham and 721 at Cedars-Sinai Medical Center. Participants in Birmingham were a mean age of 28 years, had a mean BMI of 33.1 kg/m2, a mean waist-to-hip ratio of 0.8, and a mean hirsute rate of 84.6%. Participants in California were a mean age of 29.5 years, had an average BMI of 30.1 kg/m2, a mean waist-to-hip ratio of 0.9, and a mean hirsute rate of 72.8%.

The study team gathered data on menstrual cycle history, metabolic and hormonal parameters, and demographic data for each participant. They assessed hirsutism based on modified Ferriman-Gallwey scores of four or more. Patients were classified as having hyperandrogenemia if they had elevated androgen values greater than the 95th percentile of all values or androgen values that exceeded laboratory reference ranges.

The findings showed that Alabama women with PCOS had elevated homeostatic model assessment for insulin resistance scores (adjusted beta coefficient, 3.6; P < .001) and were more likely to be hirsute (adjusted odds ratio, 1.8; P < .001) after adjustment for BMI and age than those in California.

In contrast, women with PCOS in California were more likely to have elevated free testosterone and total testosterone values than women in Alabama (both P < .001). These findings persisted after adjusting for age and BMI.

When stratified by White race, these findings were similar. Notably, BMI and waist-to-hip ratio did not vary between regions in Black women with PCOS, although variations in metabolic dysfunction and androgen profiles persisted.

“This study supports regional differences in hormonal and metabolic parameters in women with PCOS in the United States, highlighting the impact of the environment on PCOS phenotype. Individuals of the same race in different geographical locations of the United States may have differing genetic predispositions for developing diseases such as PCOS,” the researchers said.

“Ongoing research is needed to identify modifiable environmental risk factors for PCOS that may be race and ethnic specific to bring precision medicine to the management of PCOS,” they conclude.

This work was supported in part by grants from the National Institutes of Health and an endowment of the Helping Hand of Los Angeles. Dr. VanHise reported no relevant financial relationships.

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

Geographic location within the United States appears to have an impact on the specific symptoms of polycystic ovary syndrome (PCOS) that any one particular woman will develop, according to a new prospective cohort study.

Women in California were more likely to exhibit high levels of testosterone (hyperandrogenism), while women in Alabama with PCOS had more metabolic dysfunction and hirsutism.

And although the women in Alabama were younger and had a higher body mass index (BMI), even after adjusting for these factors, the clinical differences were still present between the geographic locations, the authors said.

“This study suggests there are regional differences in hormonal and metabolic parameters in women with PCOS in California and Alabama, highlighting the impact of differing genetic and environmental modulators on PCOS development,” Katherine VanHise, MD, of Cedars-Sinai Medical Center, Los Angeles, and colleagues wrote in their article, published online in the Journal of Clinical Endocrinology and Metabolism.
 

Genetic and environmental factors play a role

Prior research has looked at variations in symptoms of PCOS across countries and identified differences in hirsutism and its prevalence, which is greater in Middle Eastern, Mediterranean, and Indian women, noted senior author Margareta D. Pisarska, MD.

And women of some other backgrounds “are at increased risk of developing metabolic syndrome and insulin resistance, including South Asian, African, and Hispanic women, so they are at a greater risk trajectory of developing manifestations later on in life that can ultimately lead to adverse outcomes in overall health,” Dr. Pisarska, director of the division of reproductive endocrinology and infertility in obstetrics and gynecology at Cedars-Sinai, told this news organization.

“We do see regional differences in the diagnosis of PCOS [in the United States] as well as the manifestations of PCOS including high andrenoemia, hirsutism, and metabolic parameters ... and we need to better understand it because, at least in the entire population, weight was not the entire factor contributing to these differences,” she explained.

“So there are definitely environmental factors and possibly genetic factors that we need to take into consideration as we try to study these women and try to help them decrease their risk of metabolic syndrome later in life,” she noted.
 

Differences not attributable to race either

PCOS is a common endocrine disorder affecting women and female adolescents worldwide. Diagnosis usually requires at least two of the following to be present: ovulatory dysfunction, hyperandrogenism, and/or polycystic ovarian morphology.

Because of the prior work that had identified differences in symptoms among women with PCOS in different countries, the investigators set out to determine if women of the same race would have distinct hormonal and metabolic traits of PCOS in two geographical locations in the United States, suggesting geo-epidemiologic contributors of the disease

They evaluated 889 women at the University of Alabama at Birmingham and 721 at Cedars-Sinai Medical Center. Participants in Birmingham were a mean age of 28 years, had a mean BMI of 33.1 kg/m2, a mean waist-to-hip ratio of 0.8, and a mean hirsute rate of 84.6%. Participants in California were a mean age of 29.5 years, had an average BMI of 30.1 kg/m2, a mean waist-to-hip ratio of 0.9, and a mean hirsute rate of 72.8%.

The study team gathered data on menstrual cycle history, metabolic and hormonal parameters, and demographic data for each participant. They assessed hirsutism based on modified Ferriman-Gallwey scores of four or more. Patients were classified as having hyperandrogenemia if they had elevated androgen values greater than the 95th percentile of all values or androgen values that exceeded laboratory reference ranges.

The findings showed that Alabama women with PCOS had elevated homeostatic model assessment for insulin resistance scores (adjusted beta coefficient, 3.6; P < .001) and were more likely to be hirsute (adjusted odds ratio, 1.8; P < .001) after adjustment for BMI and age than those in California.

In contrast, women with PCOS in California were more likely to have elevated free testosterone and total testosterone values than women in Alabama (both P < .001). These findings persisted after adjusting for age and BMI.

When stratified by White race, these findings were similar. Notably, BMI and waist-to-hip ratio did not vary between regions in Black women with PCOS, although variations in metabolic dysfunction and androgen profiles persisted.

“This study supports regional differences in hormonal and metabolic parameters in women with PCOS in the United States, highlighting the impact of the environment on PCOS phenotype. Individuals of the same race in different geographical locations of the United States may have differing genetic predispositions for developing diseases such as PCOS,” the researchers said.

“Ongoing research is needed to identify modifiable environmental risk factors for PCOS that may be race and ethnic specific to bring precision medicine to the management of PCOS,” they conclude.

This work was supported in part by grants from the National Institutes of Health and an endowment of the Helping Hand of Los Angeles. Dr. VanHise reported no relevant financial relationships.

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

Geographic location within the United States appears to have an impact on the specific symptoms of polycystic ovary syndrome (PCOS) that any one particular woman will develop, according to a new prospective cohort study.

Women in California were more likely to exhibit high levels of testosterone (hyperandrogenism), while women in Alabama with PCOS had more metabolic dysfunction and hirsutism.

And although the women in Alabama were younger and had a higher body mass index (BMI), even after adjusting for these factors, the clinical differences were still present between the geographic locations, the authors said.

“This study suggests there are regional differences in hormonal and metabolic parameters in women with PCOS in California and Alabama, highlighting the impact of differing genetic and environmental modulators on PCOS development,” Katherine VanHise, MD, of Cedars-Sinai Medical Center, Los Angeles, and colleagues wrote in their article, published online in the Journal of Clinical Endocrinology and Metabolism.
 

Genetic and environmental factors play a role

Prior research has looked at variations in symptoms of PCOS across countries and identified differences in hirsutism and its prevalence, which is greater in Middle Eastern, Mediterranean, and Indian women, noted senior author Margareta D. Pisarska, MD.

And women of some other backgrounds “are at increased risk of developing metabolic syndrome and insulin resistance, including South Asian, African, and Hispanic women, so they are at a greater risk trajectory of developing manifestations later on in life that can ultimately lead to adverse outcomes in overall health,” Dr. Pisarska, director of the division of reproductive endocrinology and infertility in obstetrics and gynecology at Cedars-Sinai, told this news organization.

“We do see regional differences in the diagnosis of PCOS [in the United States] as well as the manifestations of PCOS including high andrenoemia, hirsutism, and metabolic parameters ... and we need to better understand it because, at least in the entire population, weight was not the entire factor contributing to these differences,” she explained.

“So there are definitely environmental factors and possibly genetic factors that we need to take into consideration as we try to study these women and try to help them decrease their risk of metabolic syndrome later in life,” she noted.
 

Differences not attributable to race either

PCOS is a common endocrine disorder affecting women and female adolescents worldwide. Diagnosis usually requires at least two of the following to be present: ovulatory dysfunction, hyperandrogenism, and/or polycystic ovarian morphology.

Because of the prior work that had identified differences in symptoms among women with PCOS in different countries, the investigators set out to determine if women of the same race would have distinct hormonal and metabolic traits of PCOS in two geographical locations in the United States, suggesting geo-epidemiologic contributors of the disease

They evaluated 889 women at the University of Alabama at Birmingham and 721 at Cedars-Sinai Medical Center. Participants in Birmingham were a mean age of 28 years, had a mean BMI of 33.1 kg/m2, a mean waist-to-hip ratio of 0.8, and a mean hirsute rate of 84.6%. Participants in California were a mean age of 29.5 years, had an average BMI of 30.1 kg/m2, a mean waist-to-hip ratio of 0.9, and a mean hirsute rate of 72.8%.

The study team gathered data on menstrual cycle history, metabolic and hormonal parameters, and demographic data for each participant. They assessed hirsutism based on modified Ferriman-Gallwey scores of four or more. Patients were classified as having hyperandrogenemia if they had elevated androgen values greater than the 95th percentile of all values or androgen values that exceeded laboratory reference ranges.

The findings showed that Alabama women with PCOS had elevated homeostatic model assessment for insulin resistance scores (adjusted beta coefficient, 3.6; P < .001) and were more likely to be hirsute (adjusted odds ratio, 1.8; P < .001) after adjustment for BMI and age than those in California.

In contrast, women with PCOS in California were more likely to have elevated free testosterone and total testosterone values than women in Alabama (both P < .001). These findings persisted after adjusting for age and BMI.

When stratified by White race, these findings were similar. Notably, BMI and waist-to-hip ratio did not vary between regions in Black women with PCOS, although variations in metabolic dysfunction and androgen profiles persisted.

“This study supports regional differences in hormonal and metabolic parameters in women with PCOS in the United States, highlighting the impact of the environment on PCOS phenotype. Individuals of the same race in different geographical locations of the United States may have differing genetic predispositions for developing diseases such as PCOS,” the researchers said.

“Ongoing research is needed to identify modifiable environmental risk factors for PCOS that may be race and ethnic specific to bring precision medicine to the management of PCOS,” they conclude.

This work was supported in part by grants from the National Institutes of Health and an endowment of the Helping Hand of Los Angeles. Dr. VanHise reported no relevant financial relationships.

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

The prosecution concluded its case on Oct. 13 against a nurse from Chester who is on trial for the murder of seven babies and the attempted murder of another 10 babies under her care. Lucy Letby, 32, who worked at the Countess of Chester Hospital, is accused of multiple baby murders in the hospital’s neonatal unit from June 2015 to June 2016. She denies all charges.

Manchester Crown Court heard how Ms. Letby allegedly attempted to kill the children by injecting them with air, milk, or insulin, including two brothers from a set of triplets and one premature baby girl, who was only 98 minutes old.

Prosecutor Nicholas Johnson KC said the circumstances of the girl’s death were “an extreme example even by the standards of this case.”

“There were four separate occasions on which we allege Lucy Letby tried to kill her,” he said. “But ultimately at the fourth attempt, Lucy Letby succeeded in killing her.”
 

Attempts to murder the child ‘cold-blooded’ and ‘calculated’, says prosecutor

In the first alleged attempt, Ms. Letby injected the girl, identified for legal reasons as Child I, with air, but she was “resilient,” said Mr. Johnson. After the second attempt, Ms. Letby had stood in the doorway of Child I’s darkened room and commented that she looked pale. The designated nurse then approached and turned on the light, noticing that the child wasn’t breathing. After a third attempt the child was found to have excess air in her stomach, which had affected her breathing. Child I was then transferred to Arrowe Park Hospital, where she was stabilized before she was returned to Chester.

After the fourth attempt, Child I’s medical alarm rang, leading a nurse to spot Ms. Letby by the child’s incubator. Child I died that morning, said Mr. Johnson, who described the nurse’s attacks as premeditated. “It was persistent, it was calculated, and it was cold-blooded.”

The judge, Mr. Justice Goss, and jury heard how shortly after the parents were told of their child’s death, Ms. Letby approached the mother, who testified that the nurse was “smiling and kept going on about how she was present at the baby’s first bath and how much the baby had loved it.” She also sent a sympathy card to the parents, and the prosecutor says she kept an image of the card on her phone.
 

Doctor interrupted another alleged attempt

Dr. Ravi Jayaram, a paediatric consultant, had become suspicious of Ms. Letby in a number of unexplained child deaths. He later interrupted her as she allegedly tried to kill another baby, identified as Child K. He noticed that the nurse was alone with the baby and walked into the room, seeing Ms. Letby standing over the child’s incubator. He was “uncomfortable” as he had “started to notice a coincidence between unexplained deaths, serious collapses, and the presence of Lucy Letby,” said the prosecutor.

“Dr. Jayaram could see from the monitor on the wall that Child K’s oxygen saturation level was falling dangerously low, to somewhere in the 80s,” said Mr. Johnson. “He said an alarm should have been sounding as Child K’s oxygen levels were falling.” Despite this, the nurse had not called for assistance.

“We allege she was trying to kill Child K when Dr. Jayaram walked in,” Mr. Johnson said, adding that the child’s breathing tube was found dislodged. The prosecutor said it was possible for this to happen in an active baby, but Child K was very premature and had been sedated.

Despite his concerns, Dr. Jayaram did not make a note of his suspicions. Later that morning, Ms. Letby was again at Child K’s incubator calling for help. The nurse was assisting the baby with her breathing and the breathing tube was found to have slipped too far into her throat. The child was transferred to another hospital but later died. Ms. Letby is not accused of Child K’s murder.

However, after the death of Child K, Ms. Letby was moved to day shifts “because the consultants were concerned about the correlation between her presence and unexpected deaths and life-threatening episodes on the night shifts,” said Mr. Johnson. She was removed from the neonatal ward in June 2016 and moved to clerical duties where she would not come into contact with children.
 

Post-it note: Admission or anguish?

At the end of the prosecution’s presentation, Mr. Johnson mentioned a Post-it on which Ms. Letby had written, “I AM EVIL I DID THIS.” In the defense’s opening statements, Ben Myers KC, said the note was an “anguished outpouring of a young woman in fear and despair when she realises the enormity of what’s being said about her, in a moment to herself.”

He added that the nurse was dealing with employment issues at the time it was written, including a grievance procedure with the NHS Trust where she worked. Another note was shown on screens to the jury, which read: “Not good enough. I’m an awful person. I will never have children or marry. Despair.” and “I haven’t done anything wrong.”

Mr. Myers said that Ms. Letby was the type of person who often scribbles things down and the note was “nothing more extraordinary than that.”

In presenting the defense case, Mr. Myers argued that there was no evidence of Letby hurting the children, and that the prosecution’s case was “driven by the assumption that someone was doing deliberate harm” and that this was combined with “coincidence on certain occasions of Miss Letby’s presence.”

“What it isn’t driven by is evidence of Miss Letby actually doing what is alleged against her,” he added.

“There is a real danger that people will simply accept the prosecution theory of guilt, and that’s all we have so far,” Mr. Myers said. “A theory of guilt based firmly on coincidence – if anything can be based firmly on coincidence.”

A version of this article first appeared on Medscape UK.

The prosecution concluded its case on Oct. 13 against a nurse from Chester who is on trial for the murder of seven babies and the attempted murder of another 10 babies under her care. Lucy Letby, 32, who worked at the Countess of Chester Hospital, is accused of multiple baby murders in the hospital’s neonatal unit from June 2015 to June 2016. She denies all charges.

Manchester Crown Court heard how Ms. Letby allegedly attempted to kill the children by injecting them with air, milk, or insulin, including two brothers from a set of triplets and one premature baby girl, who was only 98 minutes old.

Prosecutor Nicholas Johnson KC said the circumstances of the girl’s death were “an extreme example even by the standards of this case.”

“There were four separate occasions on which we allege Lucy Letby tried to kill her,” he said. “But ultimately at the fourth attempt, Lucy Letby succeeded in killing her.”
 

Attempts to murder the child ‘cold-blooded’ and ‘calculated’, says prosecutor

In the first alleged attempt, Ms. Letby injected the girl, identified for legal reasons as Child I, with air, but she was “resilient,” said Mr. Johnson. After the second attempt, Ms. Letby had stood in the doorway of Child I’s darkened room and commented that she looked pale. The designated nurse then approached and turned on the light, noticing that the child wasn’t breathing. After a third attempt the child was found to have excess air in her stomach, which had affected her breathing. Child I was then transferred to Arrowe Park Hospital, where she was stabilized before she was returned to Chester.

After the fourth attempt, Child I’s medical alarm rang, leading a nurse to spot Ms. Letby by the child’s incubator. Child I died that morning, said Mr. Johnson, who described the nurse’s attacks as premeditated. “It was persistent, it was calculated, and it was cold-blooded.”

The judge, Mr. Justice Goss, and jury heard how shortly after the parents were told of their child’s death, Ms. Letby approached the mother, who testified that the nurse was “smiling and kept going on about how she was present at the baby’s first bath and how much the baby had loved it.” She also sent a sympathy card to the parents, and the prosecutor says she kept an image of the card on her phone.
 

Doctor interrupted another alleged attempt

Dr. Ravi Jayaram, a paediatric consultant, had become suspicious of Ms. Letby in a number of unexplained child deaths. He later interrupted her as she allegedly tried to kill another baby, identified as Child K. He noticed that the nurse was alone with the baby and walked into the room, seeing Ms. Letby standing over the child’s incubator. He was “uncomfortable” as he had “started to notice a coincidence between unexplained deaths, serious collapses, and the presence of Lucy Letby,” said the prosecutor.

“Dr. Jayaram could see from the monitor on the wall that Child K’s oxygen saturation level was falling dangerously low, to somewhere in the 80s,” said Mr. Johnson. “He said an alarm should have been sounding as Child K’s oxygen levels were falling.” Despite this, the nurse had not called for assistance.

“We allege she was trying to kill Child K when Dr. Jayaram walked in,” Mr. Johnson said, adding that the child’s breathing tube was found dislodged. The prosecutor said it was possible for this to happen in an active baby, but Child K was very premature and had been sedated.

Despite his concerns, Dr. Jayaram did not make a note of his suspicions. Later that morning, Ms. Letby was again at Child K’s incubator calling for help. The nurse was assisting the baby with her breathing and the breathing tube was found to have slipped too far into her throat. The child was transferred to another hospital but later died. Ms. Letby is not accused of Child K’s murder.

However, after the death of Child K, Ms. Letby was moved to day shifts “because the consultants were concerned about the correlation between her presence and unexpected deaths and life-threatening episodes on the night shifts,” said Mr. Johnson. She was removed from the neonatal ward in June 2016 and moved to clerical duties where she would not come into contact with children.
 

Post-it note: Admission or anguish?

At the end of the prosecution’s presentation, Mr. Johnson mentioned a Post-it on which Ms. Letby had written, “I AM EVIL I DID THIS.” In the defense’s opening statements, Ben Myers KC, said the note was an “anguished outpouring of a young woman in fear and despair when she realises the enormity of what’s being said about her, in a moment to herself.”

He added that the nurse was dealing with employment issues at the time it was written, including a grievance procedure with the NHS Trust where she worked. Another note was shown on screens to the jury, which read: “Not good enough. I’m an awful person. I will never have children or marry. Despair.” and “I haven’t done anything wrong.”

Mr. Myers said that Ms. Letby was the type of person who often scribbles things down and the note was “nothing more extraordinary than that.”

In presenting the defense case, Mr. Myers argued that there was no evidence of Letby hurting the children, and that the prosecution’s case was “driven by the assumption that someone was doing deliberate harm” and that this was combined with “coincidence on certain occasions of Miss Letby’s presence.”

“What it isn’t driven by is evidence of Miss Letby actually doing what is alleged against her,” he added.

“There is a real danger that people will simply accept the prosecution theory of guilt, and that’s all we have so far,” Mr. Myers said. “A theory of guilt based firmly on coincidence – if anything can be based firmly on coincidence.”

A version of this article first appeared on Medscape UK.

The prosecution concluded its case on Oct. 13 against a nurse from Chester who is on trial for the murder of seven babies and the attempted murder of another 10 babies under her care. Lucy Letby, 32, who worked at the Countess of Chester Hospital, is accused of multiple baby murders in the hospital’s neonatal unit from June 2015 to June 2016. She denies all charges.

Manchester Crown Court heard how Ms. Letby allegedly attempted to kill the children by injecting them with air, milk, or insulin, including two brothers from a set of triplets and one premature baby girl, who was only 98 minutes old.

Prosecutor Nicholas Johnson KC said the circumstances of the girl’s death were “an extreme example even by the standards of this case.”

“There were four separate occasions on which we allege Lucy Letby tried to kill her,” he said. “But ultimately at the fourth attempt, Lucy Letby succeeded in killing her.”
 

Attempts to murder the child ‘cold-blooded’ and ‘calculated’, says prosecutor

In the first alleged attempt, Ms. Letby injected the girl, identified for legal reasons as Child I, with air, but she was “resilient,” said Mr. Johnson. After the second attempt, Ms. Letby had stood in the doorway of Child I’s darkened room and commented that she looked pale. The designated nurse then approached and turned on the light, noticing that the child wasn’t breathing. After a third attempt the child was found to have excess air in her stomach, which had affected her breathing. Child I was then transferred to Arrowe Park Hospital, where she was stabilized before she was returned to Chester.

After the fourth attempt, Child I’s medical alarm rang, leading a nurse to spot Ms. Letby by the child’s incubator. Child I died that morning, said Mr. Johnson, who described the nurse’s attacks as premeditated. “It was persistent, it was calculated, and it was cold-blooded.”

The judge, Mr. Justice Goss, and jury heard how shortly after the parents were told of their child’s death, Ms. Letby approached the mother, who testified that the nurse was “smiling and kept going on about how she was present at the baby’s first bath and how much the baby had loved it.” She also sent a sympathy card to the parents, and the prosecutor says she kept an image of the card on her phone.
 

Doctor interrupted another alleged attempt

Dr. Ravi Jayaram, a paediatric consultant, had become suspicious of Ms. Letby in a number of unexplained child deaths. He later interrupted her as she allegedly tried to kill another baby, identified as Child K. He noticed that the nurse was alone with the baby and walked into the room, seeing Ms. Letby standing over the child’s incubator. He was “uncomfortable” as he had “started to notice a coincidence between unexplained deaths, serious collapses, and the presence of Lucy Letby,” said the prosecutor.

“Dr. Jayaram could see from the monitor on the wall that Child K’s oxygen saturation level was falling dangerously low, to somewhere in the 80s,” said Mr. Johnson. “He said an alarm should have been sounding as Child K’s oxygen levels were falling.” Despite this, the nurse had not called for assistance.

“We allege she was trying to kill Child K when Dr. Jayaram walked in,” Mr. Johnson said, adding that the child’s breathing tube was found dislodged. The prosecutor said it was possible for this to happen in an active baby, but Child K was very premature and had been sedated.

Despite his concerns, Dr. Jayaram did not make a note of his suspicions. Later that morning, Ms. Letby was again at Child K’s incubator calling for help. The nurse was assisting the baby with her breathing and the breathing tube was found to have slipped too far into her throat. The child was transferred to another hospital but later died. Ms. Letby is not accused of Child K’s murder.

However, after the death of Child K, Ms. Letby was moved to day shifts “because the consultants were concerned about the correlation between her presence and unexpected deaths and life-threatening episodes on the night shifts,” said Mr. Johnson. She was removed from the neonatal ward in June 2016 and moved to clerical duties where she would not come into contact with children.
 

Post-it note: Admission or anguish?

At the end of the prosecution’s presentation, Mr. Johnson mentioned a Post-it on which Ms. Letby had written, “I AM EVIL I DID THIS.” In the defense’s opening statements, Ben Myers KC, said the note was an “anguished outpouring of a young woman in fear and despair when she realises the enormity of what’s being said about her, in a moment to herself.”

He added that the nurse was dealing with employment issues at the time it was written, including a grievance procedure with the NHS Trust where she worked. Another note was shown on screens to the jury, which read: “Not good enough. I’m an awful person. I will never have children or marry. Despair.” and “I haven’t done anything wrong.”

Mr. Myers said that Ms. Letby was the type of person who often scribbles things down and the note was “nothing more extraordinary than that.”

In presenting the defense case, Mr. Myers argued that there was no evidence of Letby hurting the children, and that the prosecution’s case was “driven by the assumption that someone was doing deliberate harm” and that this was combined with “coincidence on certain occasions of Miss Letby’s presence.”

“What it isn’t driven by is evidence of Miss Letby actually doing what is alleged against her,” he added.

“There is a real danger that people will simply accept the prosecution theory of guilt, and that’s all we have so far,” Mr. Myers said. “A theory of guilt based firmly on coincidence – if anything can be based firmly on coincidence.”

A version of this article first appeared on Medscape UK.

The ability of an Apple Watch to detect atrial fibrillation (AFib) is significantly affected by underlying ECG abnormalities such as sinus node dysfunction, atrioventricular (AV) block, or intraventricular conduction delay (IVCD), a single-center study suggests.

LDProd/Getty Images

“We were surprised to find that in one in every five patients, the smartwatch ECG failed to produce an automatic diagnosis,” study author Marc Strik, MD, PhD, a clinician at Bordeaux University Hospital in Pessac, France, told this news organization. “This [failure] was mostly due to insufficient quality of the tracing [60%], but in a third of cases, [34%], it was due to bradycardia, and in some cases, tachycardia [6%].

“We were also surprised to find that the existence of ventricular conduction disease was associated with a higher likelihood of missing AFib,” he said.

The study was published in the Canadian Journal of Cardiology.
 

Abnormalities affected detection

The investigators tested the accuracy of the Apple Watch (Apple, Cupertino, California) in detecting AFib in patients with various ECG anomalies. All participants underwent 12-lead ECG, followed by a 30-second ECG tracing with an Apple Watch Series 5. The smartwatch’s automated AFib detection algorithm gave a result of “no signs of AFib,” “AFib,” or “not checked for AFib (unclassified).”

Unclassified recordings resulted from “low heart rate” (below 50 beats/min), “high heart rate” (above 150 beats/min), “poor recording,” or “inconclusive recording.”

The smartwatch recordings were reviewed by a blinded electrophysiologist who interpreted each tracing and assigned a diagnosis of “AFib,” “absence of AFib,” or “diagnosis unclear.” To assess interobserver agreement, a second blinded electrophysiologist interpreted 100 randomly selected tracings.

Among the 734 patients (mean age, 66; 58% men) enrolled, 539 (73%) were in normal sinus rhythm (SR), 154 (21%) in AFib, 33 in atrial flutter or atrial tachycardia, 3 in ventricular tachycardia, and 5 in junctional tachycardia.

Furthermore, 65 (8.9%) had sinus node dysfunction, 21 (2.9%) had second- or third-degree AV block, 39 (5.3%) had a ventricular paced rhythm, 54 (7.4%) had premature ventricular contractions (PVCs), and 132 (18%) had IVCD (right or left bundle branch block or nonspecific IVCD).

Of the 539 patients in normal SR, 437 recordings were correctly diagnosed by the smartwatch, 7 were diagnosed incorrectly as AFib, and 95 were not classified.

Of the 187 patients in AFib, 129 were correctly diagnosed, 17 were incorrectly diagnosed as SR, and 41 were not classified.

When unclassified ECGs were considered false results, the smartwatch had a sensitivity of 69% and specificity of 81% for AFib detection. When unclassified ECGs were excluded from the analysis, sensitivity was 88%, and specificity was 98%.

Compared with patients without the abnormality, the relative risk of having false positive tracings was higher for patients with premature atrial contractions (PACs) or PVCs (risk ratio, 2.9), sinus node dysfunction (RR, 3.71), and AV block (RR, 7.8).

Fifty-eight patients with AFib were classified as SR or inconclusive by the smartwatch. Among them, 21 (36%) had an IVCD, 7 (12%) had a ventricular paced rhythm, and 5 (9%) had PACs or PVCs.

The risk of having false negative tracings (missed AF) was higher for patients with IVCD (RR, 2.6) and pacing (RR, 2.47), compared with those without the abnormality.
 

‘A powerful tool’

Overall, cardiac electrophysiologists showed high agreement in differentiating between AFib and non-AFib, with high interobserver reproducibility. A manual diagnosis was not possible for 10% of tracings because of either poor ECG quality (3%) or unclear P-waves (7%).

Fifty-nine of the 580 patients in SR were misclassified as AFib by the experts, and 5 of the 154 patients in AFib were misclassified as SR.

“Our results show that the presence of sinus node dysfunction, second- or third-degree AV block, ventricular paced rhythm, PVCs, and IVCD were more frequently represented in smartwatch misdiagnoses,” wrote the authors. “Patients with PVCs were three times as likely to have false positive AFib diagnoses.”

Study limitations included the single-center nature of the study and the fact that patients were recruited in a cardiology office. The latter factor may have influenced the incidence of ECG abnormalities, which was much higher than for the average smartwatch user.

“Even with its limitations, the smartwatch remains a powerful tool that is able to detect AFib and multiple other abnormalities,” said Dr. Strik. “Missed diagnosis of AFib may be less important in real life because of repeated measurements, and algorithms will continue to improve.”
 

Technology improving

Richard C. Becker, MD, director and physician in chief of the University of Cincinnati Heart, Lung, and Vascular Institute, said, “This is exactly the kind of investigation required to improve upon existing detection algorithms that will someday facilitate routine use in patient care. An ability to detect AFib in a large proportion of those with the heart rhythm abnormality is encouraging.”

The findings should not detract from well-conducted studies in otherwise healthy individuals of varied age in whom AFib was accurately detected, he added. “Similarly, an automatic diagnosis algorithm for AF, pending optimization and validation in a large and diverse cohort, should be viewed as a communication tool between patients and health care providers.”

Patients at risk for developing AFib could benefit from continuous monitoring using a smartwatch, said Dr. Becker. “Pre-existing heart rhythm abnormalities must be taken into consideration. Optimal utilization of emerging technology to include wearables requires an understanding of performance and limitations. It is best undertaken in coordination with a health care provider.”

Andrés F. Miranda-Arboleda, MD, and Adrian Baranchuk, MD, of Kingston Health Sciences Center, Canada, conclude in an accompanying editorial, “In a certain manner, the smartwatch algorithms for the detection of AFib in patients with cardiovascular conditions are not yet smart enough ... but they may soon be.”

The study was supported by the French government. Dr. Strik, Dr. Miranda-Arboleda, Dr. Baranchuk, and Dr. Becker reported no conflicts of interest.

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

The ability of an Apple Watch to detect atrial fibrillation (AFib) is significantly affected by underlying ECG abnormalities such as sinus node dysfunction, atrioventricular (AV) block, or intraventricular conduction delay (IVCD), a single-center study suggests.

LDProd/Getty Images

“We were surprised to find that in one in every five patients, the smartwatch ECG failed to produce an automatic diagnosis,” study author Marc Strik, MD, PhD, a clinician at Bordeaux University Hospital in Pessac, France, told this news organization. “This [failure] was mostly due to insufficient quality of the tracing [60%], but in a third of cases, [34%], it was due to bradycardia, and in some cases, tachycardia [6%].

“We were also surprised to find that the existence of ventricular conduction disease was associated with a higher likelihood of missing AFib,” he said.

The study was published in the Canadian Journal of Cardiology.
 

Abnormalities affected detection

The investigators tested the accuracy of the Apple Watch (Apple, Cupertino, California) in detecting AFib in patients with various ECG anomalies. All participants underwent 12-lead ECG, followed by a 30-second ECG tracing with an Apple Watch Series 5. The smartwatch’s automated AFib detection algorithm gave a result of “no signs of AFib,” “AFib,” or “not checked for AFib (unclassified).”

Unclassified recordings resulted from “low heart rate” (below 50 beats/min), “high heart rate” (above 150 beats/min), “poor recording,” or “inconclusive recording.”

The smartwatch recordings were reviewed by a blinded electrophysiologist who interpreted each tracing and assigned a diagnosis of “AFib,” “absence of AFib,” or “diagnosis unclear.” To assess interobserver agreement, a second blinded electrophysiologist interpreted 100 randomly selected tracings.

Among the 734 patients (mean age, 66; 58% men) enrolled, 539 (73%) were in normal sinus rhythm (SR), 154 (21%) in AFib, 33 in atrial flutter or atrial tachycardia, 3 in ventricular tachycardia, and 5 in junctional tachycardia.

Furthermore, 65 (8.9%) had sinus node dysfunction, 21 (2.9%) had second- or third-degree AV block, 39 (5.3%) had a ventricular paced rhythm, 54 (7.4%) had premature ventricular contractions (PVCs), and 132 (18%) had IVCD (right or left bundle branch block or nonspecific IVCD).

Of the 539 patients in normal SR, 437 recordings were correctly diagnosed by the smartwatch, 7 were diagnosed incorrectly as AFib, and 95 were not classified.

Of the 187 patients in AFib, 129 were correctly diagnosed, 17 were incorrectly diagnosed as SR, and 41 were not classified.

When unclassified ECGs were considered false results, the smartwatch had a sensitivity of 69% and specificity of 81% for AFib detection. When unclassified ECGs were excluded from the analysis, sensitivity was 88%, and specificity was 98%.

Compared with patients without the abnormality, the relative risk of having false positive tracings was higher for patients with premature atrial contractions (PACs) or PVCs (risk ratio, 2.9), sinus node dysfunction (RR, 3.71), and AV block (RR, 7.8).

Fifty-eight patients with AFib were classified as SR or inconclusive by the smartwatch. Among them, 21 (36%) had an IVCD, 7 (12%) had a ventricular paced rhythm, and 5 (9%) had PACs or PVCs.

The risk of having false negative tracings (missed AF) was higher for patients with IVCD (RR, 2.6) and pacing (RR, 2.47), compared with those without the abnormality.
 

‘A powerful tool’

Overall, cardiac electrophysiologists showed high agreement in differentiating between AFib and non-AFib, with high interobserver reproducibility. A manual diagnosis was not possible for 10% of tracings because of either poor ECG quality (3%) or unclear P-waves (7%).

Fifty-nine of the 580 patients in SR were misclassified as AFib by the experts, and 5 of the 154 patients in AFib were misclassified as SR.

“Our results show that the presence of sinus node dysfunction, second- or third-degree AV block, ventricular paced rhythm, PVCs, and IVCD were more frequently represented in smartwatch misdiagnoses,” wrote the authors. “Patients with PVCs were three times as likely to have false positive AFib diagnoses.”

Study limitations included the single-center nature of the study and the fact that patients were recruited in a cardiology office. The latter factor may have influenced the incidence of ECG abnormalities, which was much higher than for the average smartwatch user.

“Even with its limitations, the smartwatch remains a powerful tool that is able to detect AFib and multiple other abnormalities,” said Dr. Strik. “Missed diagnosis of AFib may be less important in real life because of repeated measurements, and algorithms will continue to improve.”
 

Technology improving

Richard C. Becker, MD, director and physician in chief of the University of Cincinnati Heart, Lung, and Vascular Institute, said, “This is exactly the kind of investigation required to improve upon existing detection algorithms that will someday facilitate routine use in patient care. An ability to detect AFib in a large proportion of those with the heart rhythm abnormality is encouraging.”

The findings should not detract from well-conducted studies in otherwise healthy individuals of varied age in whom AFib was accurately detected, he added. “Similarly, an automatic diagnosis algorithm for AF, pending optimization and validation in a large and diverse cohort, should be viewed as a communication tool between patients and health care providers.”

Patients at risk for developing AFib could benefit from continuous monitoring using a smartwatch, said Dr. Becker. “Pre-existing heart rhythm abnormalities must be taken into consideration. Optimal utilization of emerging technology to include wearables requires an understanding of performance and limitations. It is best undertaken in coordination with a health care provider.”

Andrés F. Miranda-Arboleda, MD, and Adrian Baranchuk, MD, of Kingston Health Sciences Center, Canada, conclude in an accompanying editorial, “In a certain manner, the smartwatch algorithms for the detection of AFib in patients with cardiovascular conditions are not yet smart enough ... but they may soon be.”

The study was supported by the French government. Dr. Strik, Dr. Miranda-Arboleda, Dr. Baranchuk, and Dr. Becker reported no conflicts of interest.

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

The ability of an Apple Watch to detect atrial fibrillation (AFib) is significantly affected by underlying ECG abnormalities such as sinus node dysfunction, atrioventricular (AV) block, or intraventricular conduction delay (IVCD), a single-center study suggests.

LDProd/Getty Images

“We were surprised to find that in one in every five patients, the smartwatch ECG failed to produce an automatic diagnosis,” study author Marc Strik, MD, PhD, a clinician at Bordeaux University Hospital in Pessac, France, told this news organization. “This [failure] was mostly due to insufficient quality of the tracing [60%], but in a third of cases, [34%], it was due to bradycardia, and in some cases, tachycardia [6%].

“We were also surprised to find that the existence of ventricular conduction disease was associated with a higher likelihood of missing AFib,” he said.

The study was published in the Canadian Journal of Cardiology.
 

Abnormalities affected detection

The investigators tested the accuracy of the Apple Watch (Apple, Cupertino, California) in detecting AFib in patients with various ECG anomalies. All participants underwent 12-lead ECG, followed by a 30-second ECG tracing with an Apple Watch Series 5. The smartwatch’s automated AFib detection algorithm gave a result of “no signs of AFib,” “AFib,” or “not checked for AFib (unclassified).”

Unclassified recordings resulted from “low heart rate” (below 50 beats/min), “high heart rate” (above 150 beats/min), “poor recording,” or “inconclusive recording.”

The smartwatch recordings were reviewed by a blinded electrophysiologist who interpreted each tracing and assigned a diagnosis of “AFib,” “absence of AFib,” or “diagnosis unclear.” To assess interobserver agreement, a second blinded electrophysiologist interpreted 100 randomly selected tracings.

Among the 734 patients (mean age, 66; 58% men) enrolled, 539 (73%) were in normal sinus rhythm (SR), 154 (21%) in AFib, 33 in atrial flutter or atrial tachycardia, 3 in ventricular tachycardia, and 5 in junctional tachycardia.

Furthermore, 65 (8.9%) had sinus node dysfunction, 21 (2.9%) had second- or third-degree AV block, 39 (5.3%) had a ventricular paced rhythm, 54 (7.4%) had premature ventricular contractions (PVCs), and 132 (18%) had IVCD (right or left bundle branch block or nonspecific IVCD).

Of the 539 patients in normal SR, 437 recordings were correctly diagnosed by the smartwatch, 7 were diagnosed incorrectly as AFib, and 95 were not classified.

Of the 187 patients in AFib, 129 were correctly diagnosed, 17 were incorrectly diagnosed as SR, and 41 were not classified.

When unclassified ECGs were considered false results, the smartwatch had a sensitivity of 69% and specificity of 81% for AFib detection. When unclassified ECGs were excluded from the analysis, sensitivity was 88%, and specificity was 98%.

Compared with patients without the abnormality, the relative risk of having false positive tracings was higher for patients with premature atrial contractions (PACs) or PVCs (risk ratio, 2.9), sinus node dysfunction (RR, 3.71), and AV block (RR, 7.8).

Fifty-eight patients with AFib were classified as SR or inconclusive by the smartwatch. Among them, 21 (36%) had an IVCD, 7 (12%) had a ventricular paced rhythm, and 5 (9%) had PACs or PVCs.

The risk of having false negative tracings (missed AF) was higher for patients with IVCD (RR, 2.6) and pacing (RR, 2.47), compared with those without the abnormality.
 

‘A powerful tool’

Overall, cardiac electrophysiologists showed high agreement in differentiating between AFib and non-AFib, with high interobserver reproducibility. A manual diagnosis was not possible for 10% of tracings because of either poor ECG quality (3%) or unclear P-waves (7%).

Fifty-nine of the 580 patients in SR were misclassified as AFib by the experts, and 5 of the 154 patients in AFib were misclassified as SR.

“Our results show that the presence of sinus node dysfunction, second- or third-degree AV block, ventricular paced rhythm, PVCs, and IVCD were more frequently represented in smartwatch misdiagnoses,” wrote the authors. “Patients with PVCs were three times as likely to have false positive AFib diagnoses.”

Study limitations included the single-center nature of the study and the fact that patients were recruited in a cardiology office. The latter factor may have influenced the incidence of ECG abnormalities, which was much higher than for the average smartwatch user.

“Even with its limitations, the smartwatch remains a powerful tool that is able to detect AFib and multiple other abnormalities,” said Dr. Strik. “Missed diagnosis of AFib may be less important in real life because of repeated measurements, and algorithms will continue to improve.”
 

Technology improving

Richard C. Becker, MD, director and physician in chief of the University of Cincinnati Heart, Lung, and Vascular Institute, said, “This is exactly the kind of investigation required to improve upon existing detection algorithms that will someday facilitate routine use in patient care. An ability to detect AFib in a large proportion of those with the heart rhythm abnormality is encouraging.”

The findings should not detract from well-conducted studies in otherwise healthy individuals of varied age in whom AFib was accurately detected, he added. “Similarly, an automatic diagnosis algorithm for AF, pending optimization and validation in a large and diverse cohort, should be viewed as a communication tool between patients and health care providers.”

Patients at risk for developing AFib could benefit from continuous monitoring using a smartwatch, said Dr. Becker. “Pre-existing heart rhythm abnormalities must be taken into consideration. Optimal utilization of emerging technology to include wearables requires an understanding of performance and limitations. It is best undertaken in coordination with a health care provider.”

Andrés F. Miranda-Arboleda, MD, and Adrian Baranchuk, MD, of Kingston Health Sciences Center, Canada, conclude in an accompanying editorial, “In a certain manner, the smartwatch algorithms for the detection of AFib in patients with cardiovascular conditions are not yet smart enough ... but they may soon be.”

The study was supported by the French government. Dr. Strik, Dr. Miranda-Arboleda, Dr. Baranchuk, and Dr. Becker reported no conflicts of interest.

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

Nirmatrelvir/ritonavir (Paxlovid) has been a game changer for high-risk patients with early COVID-19 symptoms but has significant interactions with commonly used cardiovascular medications, a new paper cautions.

COVID-19 patients with cardiovascular disease (CVD) or risk factors such as diabetes, hypertension, and chronic kidney disease are at high risk of severe disease and account for the lion’s share of those receiving Paxlovid. Data from the initial EPIC-HR trial and recent real-world data also suggest they’re among the most likely to benefit from the oral antiviral, regardless of their COVID-19 vaccination status.

ClaudioVentrella/Thinkstock

“But at the same time, it unfortunately interacts with many very commonly prescribed cardiovascular medications and with many of them in a very clinically meaningful way, which may lead to serious adverse consequences,” senior author Sarju Ganatra, MD, said in an interview. “So, while it’s being prescribed with a good intention to help these people, we may actually end up doing more harm than good.

“We don’t want to deter people from getting their necessary COVID-19 treatment, which is excellent for the most part these days as an outpatient,” he added. “So, we felt the need to make a comprehensive list of cardiac medications and level of interactions with Paxlovid and also to help the clinicians and prescribers at the point of care to make the clinical decision of what modifications they may need to do.”

The paper, published online in the Journal of the American College of Cardiology, details drug-drug interactions with some 80 CV medications including statins, antihypertensive agents, heart failure therapies, and antiplatelet/anticoagulants.

It also includes a color-coded figure denoting whether a drug is safe to coadminister with Paxlovid, may potentially interact and require a dose adjustment or temporary discontinuation, or is contraindicated.

Among the commonly used blood thinners, for example, the paper notes that Paxlovid significantly increases drug levels of the direct oral anticoagulants (DOACs) apixaban, rivaroxaban, edoxaban, and dabigatran and, thus, increases the risk of bleeding.

“It can still be administered, if it’s necessary, but the dose of the DOAC either needs to be reduced or held depending on what they are getting it for, whether they’re getting it for pulmonary embolism or atrial fibrillation, and we adjust for all those things in the table in the paper,” said Dr. Ganatra, from Lahey Hospital and Medical Center, Burlington, Mass.

When the DOAC can’t be interrupted or dose adjusted, however, Paxlovid should not be given, the experts said. The antiviral is safe to use with enoxaparin, a low-molecular-weight heparin, but can increase or decrease levels of warfarin and should be used with close international normalized ratio monitoring.

For patients on antiplatelet agents, clinicians are advised to avoid prescribing nirmatrelvir/ritonavir to those on ticagrelor or clopidogrel unless the agents can be replaced by prasugrel.

Ritonavir – an inhibitor of cytochrome P 450 enzymes, particularly CYP3A4 – poses an increased risk of bleeding when given with ticagrelor, a CYP3A4 substrate, and decreases the active metabolite of clopidogrel, cutting its platelet inhibition by 20%. Although there’s a twofold decrease in the maximum concentration of prasugrel in patients on ritonavir, this does not affect its antiplatelet activity, the paper explains.

Among the lipid-lowering agents, experts suggested temporarily withholding atorvastatin, rosuvastatin, simvastatin, and lovastatin because of an increased risk for myopathy and liver toxicity but say that other statins, fibrates, ezetimibe, and the proprotein convertase subtilisin/kexin type 9 inhibitors evolocumab and alirocumab are safe to coadminister with Paxlovid.

While statins typically leave the body within hours, most of the antiarrhythmic drugs, except for sotalol, are not safe to give with Paxlovid, Dr. Ganatra said. It’s technically not feasible to hold these drugs because most have long half-lives, reaching about 100 days, for example, for amiodarone.

“It’s going to hang around in your system for a long time, so you don’t want to be falsely reassured that you’re holding the drug and it’s going to be fine to go back slowly,” he said. “You need to look for alternative therapies in those scenarios for COVID-19 treatment, which could be other antivirals, or a monoclonal antibody individualized to the patient’s risk.”

Although there’s limited clinical information regarding interaction-related adverse events with Paxlovid, the team used pharmacokinetics and pharmacodynamics data to provide the guidance. Serious adverse events are also well documented for ritonavir, which has been prescribed for years to treat HIV, Dr. Ganatra noted.

The Infectious Disease Society of America also published guidance on the management of potential drug interactions with Paxlovid in May and, earlier in October, the Food and Drug Administration updated its Paxlovid patient eligibility screening checklist.

Still, most prescribers are actually primary care physicians and even pharmacists, who may not be completely attuned, said Dr. Ganatra, who noted that some centers have started programs to help connect primary care physicians with their cardiology colleagues to check on CV drugs in their COVID-19 patients.

“We need to be thinking more broadly and at a system level where the hospital or health care system leverages the electronic health record systems,” he said. “Most of them are sophisticated enough to incorporate simple drug-drug interaction information, so if you try to prescribe someone Paxlovid and it’s a heart transplant patient who is on immunosuppressive therapy or a patient on a blood thinner, then it should give you a warning ... or at least give them a link to our paper or other valuable resources.

“If someone is on a blood thinner and the blood thinner level goes up by ninefold, we can only imagine what we would be dealing with,” Dr. Ganatra said. “So, these interactions should be taken very seriously and I think it’s worth the time and investment.”

The authors reported no relevant financial relationships.

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

Nirmatrelvir/ritonavir (Paxlovid) has been a game changer for high-risk patients with early COVID-19 symptoms but has significant interactions with commonly used cardiovascular medications, a new paper cautions.

COVID-19 patients with cardiovascular disease (CVD) or risk factors such as diabetes, hypertension, and chronic kidney disease are at high risk of severe disease and account for the lion’s share of those receiving Paxlovid. Data from the initial EPIC-HR trial and recent real-world data also suggest they’re among the most likely to benefit from the oral antiviral, regardless of their COVID-19 vaccination status.

ClaudioVentrella/Thinkstock

“But at the same time, it unfortunately interacts with many very commonly prescribed cardiovascular medications and with many of them in a very clinically meaningful way, which may lead to serious adverse consequences,” senior author Sarju Ganatra, MD, said in an interview. “So, while it’s being prescribed with a good intention to help these people, we may actually end up doing more harm than good.

“We don’t want to deter people from getting their necessary COVID-19 treatment, which is excellent for the most part these days as an outpatient,” he added. “So, we felt the need to make a comprehensive list of cardiac medications and level of interactions with Paxlovid and also to help the clinicians and prescribers at the point of care to make the clinical decision of what modifications they may need to do.”

The paper, published online in the Journal of the American College of Cardiology, details drug-drug interactions with some 80 CV medications including statins, antihypertensive agents, heart failure therapies, and antiplatelet/anticoagulants.

It also includes a color-coded figure denoting whether a drug is safe to coadminister with Paxlovid, may potentially interact and require a dose adjustment or temporary discontinuation, or is contraindicated.

Among the commonly used blood thinners, for example, the paper notes that Paxlovid significantly increases drug levels of the direct oral anticoagulants (DOACs) apixaban, rivaroxaban, edoxaban, and dabigatran and, thus, increases the risk of bleeding.

“It can still be administered, if it’s necessary, but the dose of the DOAC either needs to be reduced or held depending on what they are getting it for, whether they’re getting it for pulmonary embolism or atrial fibrillation, and we adjust for all those things in the table in the paper,” said Dr. Ganatra, from Lahey Hospital and Medical Center, Burlington, Mass.

When the DOAC can’t be interrupted or dose adjusted, however, Paxlovid should not be given, the experts said. The antiviral is safe to use with enoxaparin, a low-molecular-weight heparin, but can increase or decrease levels of warfarin and should be used with close international normalized ratio monitoring.

For patients on antiplatelet agents, clinicians are advised to avoid prescribing nirmatrelvir/ritonavir to those on ticagrelor or clopidogrel unless the agents can be replaced by prasugrel.

Ritonavir – an inhibitor of cytochrome P 450 enzymes, particularly CYP3A4 – poses an increased risk of bleeding when given with ticagrelor, a CYP3A4 substrate, and decreases the active metabolite of clopidogrel, cutting its platelet inhibition by 20%. Although there’s a twofold decrease in the maximum concentration of prasugrel in patients on ritonavir, this does not affect its antiplatelet activity, the paper explains.

Among the lipid-lowering agents, experts suggested temporarily withholding atorvastatin, rosuvastatin, simvastatin, and lovastatin because of an increased risk for myopathy and liver toxicity but say that other statins, fibrates, ezetimibe, and the proprotein convertase subtilisin/kexin type 9 inhibitors evolocumab and alirocumab are safe to coadminister with Paxlovid.

While statins typically leave the body within hours, most of the antiarrhythmic drugs, except for sotalol, are not safe to give with Paxlovid, Dr. Ganatra said. It’s technically not feasible to hold these drugs because most have long half-lives, reaching about 100 days, for example, for amiodarone.

“It’s going to hang around in your system for a long time, so you don’t want to be falsely reassured that you’re holding the drug and it’s going to be fine to go back slowly,” he said. “You need to look for alternative therapies in those scenarios for COVID-19 treatment, which could be other antivirals, or a monoclonal antibody individualized to the patient’s risk.”

Although there’s limited clinical information regarding interaction-related adverse events with Paxlovid, the team used pharmacokinetics and pharmacodynamics data to provide the guidance. Serious adverse events are also well documented for ritonavir, which has been prescribed for years to treat HIV, Dr. Ganatra noted.

The Infectious Disease Society of America also published guidance on the management of potential drug interactions with Paxlovid in May and, earlier in October, the Food and Drug Administration updated its Paxlovid patient eligibility screening checklist.

Still, most prescribers are actually primary care physicians and even pharmacists, who may not be completely attuned, said Dr. Ganatra, who noted that some centers have started programs to help connect primary care physicians with their cardiology colleagues to check on CV drugs in their COVID-19 patients.

“We need to be thinking more broadly and at a system level where the hospital or health care system leverages the electronic health record systems,” he said. “Most of them are sophisticated enough to incorporate simple drug-drug interaction information, so if you try to prescribe someone Paxlovid and it’s a heart transplant patient who is on immunosuppressive therapy or a patient on a blood thinner, then it should give you a warning ... or at least give them a link to our paper or other valuable resources.

“If someone is on a blood thinner and the blood thinner level goes up by ninefold, we can only imagine what we would be dealing with,” Dr. Ganatra said. “So, these interactions should be taken very seriously and I think it’s worth the time and investment.”

The authors reported no relevant financial relationships.

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

Nirmatrelvir/ritonavir (Paxlovid) has been a game changer for high-risk patients with early COVID-19 symptoms but has significant interactions with commonly used cardiovascular medications, a new paper cautions.

COVID-19 patients with cardiovascular disease (CVD) or risk factors such as diabetes, hypertension, and chronic kidney disease are at high risk of severe disease and account for the lion’s share of those receiving Paxlovid. Data from the initial EPIC-HR trial and recent real-world data also suggest they’re among the most likely to benefit from the oral antiviral, regardless of their COVID-19 vaccination status.

ClaudioVentrella/Thinkstock

“But at the same time, it unfortunately interacts with many very commonly prescribed cardiovascular medications and with many of them in a very clinically meaningful way, which may lead to serious adverse consequences,” senior author Sarju Ganatra, MD, said in an interview. “So, while it’s being prescribed with a good intention to help these people, we may actually end up doing more harm than good.

“We don’t want to deter people from getting their necessary COVID-19 treatment, which is excellent for the most part these days as an outpatient,” he added. “So, we felt the need to make a comprehensive list of cardiac medications and level of interactions with Paxlovid and also to help the clinicians and prescribers at the point of care to make the clinical decision of what modifications they may need to do.”

The paper, published online in the Journal of the American College of Cardiology, details drug-drug interactions with some 80 CV medications including statins, antihypertensive agents, heart failure therapies, and antiplatelet/anticoagulants.

It also includes a color-coded figure denoting whether a drug is safe to coadminister with Paxlovid, may potentially interact and require a dose adjustment or temporary discontinuation, or is contraindicated.

Among the commonly used blood thinners, for example, the paper notes that Paxlovid significantly increases drug levels of the direct oral anticoagulants (DOACs) apixaban, rivaroxaban, edoxaban, and dabigatran and, thus, increases the risk of bleeding.

“It can still be administered, if it’s necessary, but the dose of the DOAC either needs to be reduced or held depending on what they are getting it for, whether they’re getting it for pulmonary embolism or atrial fibrillation, and we adjust for all those things in the table in the paper,” said Dr. Ganatra, from Lahey Hospital and Medical Center, Burlington, Mass.

When the DOAC can’t be interrupted or dose adjusted, however, Paxlovid should not be given, the experts said. The antiviral is safe to use with enoxaparin, a low-molecular-weight heparin, but can increase or decrease levels of warfarin and should be used with close international normalized ratio monitoring.

For patients on antiplatelet agents, clinicians are advised to avoid prescribing nirmatrelvir/ritonavir to those on ticagrelor or clopidogrel unless the agents can be replaced by prasugrel.

Ritonavir – an inhibitor of cytochrome P 450 enzymes, particularly CYP3A4 – poses an increased risk of bleeding when given with ticagrelor, a CYP3A4 substrate, and decreases the active metabolite of clopidogrel, cutting its platelet inhibition by 20%. Although there’s a twofold decrease in the maximum concentration of prasugrel in patients on ritonavir, this does not affect its antiplatelet activity, the paper explains.

Among the lipid-lowering agents, experts suggested temporarily withholding atorvastatin, rosuvastatin, simvastatin, and lovastatin because of an increased risk for myopathy and liver toxicity but say that other statins, fibrates, ezetimibe, and the proprotein convertase subtilisin/kexin type 9 inhibitors evolocumab and alirocumab are safe to coadminister with Paxlovid.

While statins typically leave the body within hours, most of the antiarrhythmic drugs, except for sotalol, are not safe to give with Paxlovid, Dr. Ganatra said. It’s technically not feasible to hold these drugs because most have long half-lives, reaching about 100 days, for example, for amiodarone.

“It’s going to hang around in your system for a long time, so you don’t want to be falsely reassured that you’re holding the drug and it’s going to be fine to go back slowly,” he said. “You need to look for alternative therapies in those scenarios for COVID-19 treatment, which could be other antivirals, or a monoclonal antibody individualized to the patient’s risk.”

Although there’s limited clinical information regarding interaction-related adverse events with Paxlovid, the team used pharmacokinetics and pharmacodynamics data to provide the guidance. Serious adverse events are also well documented for ritonavir, which has been prescribed for years to treat HIV, Dr. Ganatra noted.

The Infectious Disease Society of America also published guidance on the management of potential drug interactions with Paxlovid in May and, earlier in October, the Food and Drug Administration updated its Paxlovid patient eligibility screening checklist.

Still, most prescribers are actually primary care physicians and even pharmacists, who may not be completely attuned, said Dr. Ganatra, who noted that some centers have started programs to help connect primary care physicians with their cardiology colleagues to check on CV drugs in their COVID-19 patients.

“We need to be thinking more broadly and at a system level where the hospital or health care system leverages the electronic health record systems,” he said. “Most of them are sophisticated enough to incorporate simple drug-drug interaction information, so if you try to prescribe someone Paxlovid and it’s a heart transplant patient who is on immunosuppressive therapy or a patient on a blood thinner, then it should give you a warning ... or at least give them a link to our paper or other valuable resources.

“If someone is on a blood thinner and the blood thinner level goes up by ninefold, we can only imagine what we would be dealing with,” Dr. Ganatra said. “So, these interactions should be taken very seriously and I think it’s worth the time and investment.”

The authors reported no relevant financial relationships.

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

Patients’ reports of remission from inflammatory bowel disease (IBD) don’t always line up with remission as defined by patient-reported outcomes (PROs) or physician global assessment (PGA), according to a study published in Inflammatory Bowel Diseases.

javi_indy/ Thinkstock

Patients have various definitions of remission, which may focus on symptom improvement and the impact on daily activities, while physicians tend to focus on test results. “Examining patient-reported remission may be a valuable approach to better understand remission from the perspective of patients and can assist in aligning shared decision-making between patients and health care providers,” wrote Kendra Kamp, PhD, assistant professor of biobehavioral nursing and health informatics at the University of Washington, and colleagues, on behalf of the IBD Qorus.

In a retrospective study, Dr. Kamp and colleagues analyzed 3,257 deidentified surveys from 2,004 patients who participated in the Crohn’s and Colitis Foundation’s IBD Qorus Learning Health System between September 2019 and February 2021. Adults with IBD who participated in the IBD Qorus received an email before their gastroenterology clinical appointment with a link to a survey that asked questions about primary concerns or goals, symptoms, well-being, recent health care utilization, and medication use.

The researchers looked at the clinical and demographic factors associated with discordance among patient-defined remission, PROs, and PGAs. Patient-defined remission was captured as a yes/no response to the question: “Do you feel your disease is currently in remission (by remission we mean a complete absence of IBD-related symptoms)?”

PROs for ulcerative colitis were measured through stool frequency and rectal bleeding, with remission defined as no blood in the stool and a normal (or fewer than normal) number of stools. For Crohn’s disease, PROs were measured through the average number of liquid stools, abdominal pain, and general well-being, with remission defined as two or fewer loose stools, no or mild abdominal pain, and feeling generally well or slightly under par.

For PGAs, clinicians selected whether the patient had normal, mild, moderate, or severe disease activity. The values were included in the analysis if the clinicians completed the assessment within 14 days of the patient’s survey.

Among the 2,004 patients, 806 had ulcerative colitis and 1,198 had Crohn’s disease. Patients with ulcerative colitis as well as those with Crohn’s disease were aged 44 years on average. Most of the patients were women: 58% with ulcerative colitis and 56% with Crohn’s disease.

Among the 1,316 visits for ulcerative colitis, 668 patients (51%) self-reported to be in remission, compared with 55% in remission based on PROs. Of the people in PRO–defined remission, 77% reported being in remission, and 23% reported active disease. Of the people with PRO–defined active disease, 81% reported active disease and 19% reported remission. Overall concordance was 79% between patient self-reported and PRO–defined remission.

Discordance in patient-defined remission for ulcerative colitis was primarily influenced by tolerance of an increased stool frequency. About 25% of patients with one or two stools more than normal reported being in remission.

A subset of 397 ulcerative colitis visits had an associated PGA score. Among patients in PGA-defined remission, 53% reported being in remission. Of those with PGA-defined active disease, 60% reported active disease. Overall, concordance was 49% between patient self-reported and PGA-defined remission.

Among the 1,947 visits for Crohn’s disease, 929 patients (48%) self-reported to be in remission, compared with 63% in remission based on PRO. Of the people in PRO-defined remission, 63% reported being in remission, although 37% reported active disease. Of the people with PRO-defined active disease, 79% reported active disease and 21% reported remission. Overall concordance was 69% between patient self-reported and patient-reported outcomes–defined remission.

Discordance in patient-defined remission for Crohn’s disease was primarily influenced by patients with a tolerance of mild to moderate symptoms.

A subset of 575 Crohn’s disease visits had an associated PGA score. Among patients in PGA-defined remission, 52% reported being in remission. Of those with PGA-defined active disease, 57% reported active disease. Overall concordance was 54% between patient self-reported and PGA-defined remission.

Several factors were associated with discordance in remission definitions. Among patients in PRO-defined remission, those who had a diagnosis of IBD for fewer than 5 years were more likely to report having active disease compared with those who had received a diagnosis more than 15 years before.

Patients with high health confidence in managing their condition were less likely to report having active disease. In addition, patients with Crohn’s disease were more likely to report having active disease if they were using prednisone or opioids or if they had an IBD-related emergency department visit in the past 6 months.

Patients’ reports of remission from inflammatory bowel disease (IBD) don’t always line up with remission as defined by patient-reported outcomes (PROs) or physician global assessment (PGA), according to a study published in Inflammatory Bowel Diseases.

javi_indy/ Thinkstock

Patients have various definitions of remission, which may focus on symptom improvement and the impact on daily activities, while physicians tend to focus on test results. “Examining patient-reported remission may be a valuable approach to better understand remission from the perspective of patients and can assist in aligning shared decision-making between patients and health care providers,” wrote Kendra Kamp, PhD, assistant professor of biobehavioral nursing and health informatics at the University of Washington, and colleagues, on behalf of the IBD Qorus.

In a retrospective study, Dr. Kamp and colleagues analyzed 3,257 deidentified surveys from 2,004 patients who participated in the Crohn’s and Colitis Foundation’s IBD Qorus Learning Health System between September 2019 and February 2021. Adults with IBD who participated in the IBD Qorus received an email before their gastroenterology clinical appointment with a link to a survey that asked questions about primary concerns or goals, symptoms, well-being, recent health care utilization, and medication use.

The researchers looked at the clinical and demographic factors associated with discordance among patient-defined remission, PROs, and PGAs. Patient-defined remission was captured as a yes/no response to the question: “Do you feel your disease is currently in remission (by remission we mean a complete absence of IBD-related symptoms)?”

PROs for ulcerative colitis were measured through stool frequency and rectal bleeding, with remission defined as no blood in the stool and a normal (or fewer than normal) number of stools. For Crohn’s disease, PROs were measured through the average number of liquid stools, abdominal pain, and general well-being, with remission defined as two or fewer loose stools, no or mild abdominal pain, and feeling generally well or slightly under par.

For PGAs, clinicians selected whether the patient had normal, mild, moderate, or severe disease activity. The values were included in the analysis if the clinicians completed the assessment within 14 days of the patient’s survey.

Among the 2,004 patients, 806 had ulcerative colitis and 1,198 had Crohn’s disease. Patients with ulcerative colitis as well as those with Crohn’s disease were aged 44 years on average. Most of the patients were women: 58% with ulcerative colitis and 56% with Crohn’s disease.

Among the 1,316 visits for ulcerative colitis, 668 patients (51%) self-reported to be in remission, compared with 55% in remission based on PROs. Of the people in PRO–defined remission, 77% reported being in remission, and 23% reported active disease. Of the people with PRO–defined active disease, 81% reported active disease and 19% reported remission. Overall concordance was 79% between patient self-reported and PRO–defined remission.

Discordance in patient-defined remission for ulcerative colitis was primarily influenced by tolerance of an increased stool frequency. About 25% of patients with one or two stools more than normal reported being in remission.

A subset of 397 ulcerative colitis visits had an associated PGA score. Among patients in PGA-defined remission, 53% reported being in remission. Of those with PGA-defined active disease, 60% reported active disease. Overall, concordance was 49% between patient self-reported and PGA-defined remission.

Among the 1,947 visits for Crohn’s disease, 929 patients (48%) self-reported to be in remission, compared with 63% in remission based on PRO. Of the people in PRO-defined remission, 63% reported being in remission, although 37% reported active disease. Of the people with PRO-defined active disease, 79% reported active disease and 21% reported remission. Overall concordance was 69% between patient self-reported and patient-reported outcomes–defined remission.

Discordance in patient-defined remission for Crohn’s disease was primarily influenced by patients with a tolerance of mild to moderate symptoms.

A subset of 575 Crohn’s disease visits had an associated PGA score. Among patients in PGA-defined remission, 52% reported being in remission. Of those with PGA-defined active disease, 57% reported active disease. Overall concordance was 54% between patient self-reported and PGA-defined remission.

Several factors were associated with discordance in remission definitions. Among patients in PRO-defined remission, those who had a diagnosis of IBD for fewer than 5 years were more likely to report having active disease compared with those who had received a diagnosis more than 15 years before.

Patients with high health confidence in managing their condition were less likely to report having active disease. In addition, patients with Crohn’s disease were more likely to report having active disease if they were using prednisone or opioids or if they had an IBD-related emergency department visit in the past 6 months.

Patients’ reports of remission from inflammatory bowel disease (IBD) don’t always line up with remission as defined by patient-reported outcomes (PROs) or physician global assessment (PGA), according to a study published in Inflammatory Bowel Diseases.

javi_indy/ Thinkstock

Patients have various definitions of remission, which may focus on symptom improvement and the impact on daily activities, while physicians tend to focus on test results. “Examining patient-reported remission may be a valuable approach to better understand remission from the perspective of patients and can assist in aligning shared decision-making between patients and health care providers,” wrote Kendra Kamp, PhD, assistant professor of biobehavioral nursing and health informatics at the University of Washington, and colleagues, on behalf of the IBD Qorus.

In a retrospective study, Dr. Kamp and colleagues analyzed 3,257 deidentified surveys from 2,004 patients who participated in the Crohn’s and Colitis Foundation’s IBD Qorus Learning Health System between September 2019 and February 2021. Adults with IBD who participated in the IBD Qorus received an email before their gastroenterology clinical appointment with a link to a survey that asked questions about primary concerns or goals, symptoms, well-being, recent health care utilization, and medication use.

The researchers looked at the clinical and demographic factors associated with discordance among patient-defined remission, PROs, and PGAs. Patient-defined remission was captured as a yes/no response to the question: “Do you feel your disease is currently in remission (by remission we mean a complete absence of IBD-related symptoms)?”

PROs for ulcerative colitis were measured through stool frequency and rectal bleeding, with remission defined as no blood in the stool and a normal (or fewer than normal) number of stools. For Crohn’s disease, PROs were measured through the average number of liquid stools, abdominal pain, and general well-being, with remission defined as two or fewer loose stools, no or mild abdominal pain, and feeling generally well or slightly under par.

For PGAs, clinicians selected whether the patient had normal, mild, moderate, or severe disease activity. The values were included in the analysis if the clinicians completed the assessment within 14 days of the patient’s survey.

Among the 2,004 patients, 806 had ulcerative colitis and 1,198 had Crohn’s disease. Patients with ulcerative colitis as well as those with Crohn’s disease were aged 44 years on average. Most of the patients were women: 58% with ulcerative colitis and 56% with Crohn’s disease.

Among the 1,316 visits for ulcerative colitis, 668 patients (51%) self-reported to be in remission, compared with 55% in remission based on PROs. Of the people in PRO–defined remission, 77% reported being in remission, and 23% reported active disease. Of the people with PRO–defined active disease, 81% reported active disease and 19% reported remission. Overall concordance was 79% between patient self-reported and PRO–defined remission.

Discordance in patient-defined remission for ulcerative colitis was primarily influenced by tolerance of an increased stool frequency. About 25% of patients with one or two stools more than normal reported being in remission.

A subset of 397 ulcerative colitis visits had an associated PGA score. Among patients in PGA-defined remission, 53% reported being in remission. Of those with PGA-defined active disease, 60% reported active disease. Overall, concordance was 49% between patient self-reported and PGA-defined remission.

Among the 1,947 visits for Crohn’s disease, 929 patients (48%) self-reported to be in remission, compared with 63% in remission based on PRO. Of the people in PRO-defined remission, 63% reported being in remission, although 37% reported active disease. Of the people with PRO-defined active disease, 79% reported active disease and 21% reported remission. Overall concordance was 69% between patient self-reported and patient-reported outcomes–defined remission.

Discordance in patient-defined remission for Crohn’s disease was primarily influenced by patients with a tolerance of mild to moderate symptoms.

A subset of 575 Crohn’s disease visits had an associated PGA score. Among patients in PGA-defined remission, 52% reported being in remission. Of those with PGA-defined active disease, 57% reported active disease. Overall concordance was 54% between patient self-reported and PGA-defined remission.

Several factors were associated with discordance in remission definitions. Among patients in PRO-defined remission, those who had a diagnosis of IBD for fewer than 5 years were more likely to report having active disease compared with those who had received a diagnosis more than 15 years before.

Patients with high health confidence in managing their condition were less likely to report having active disease. In addition, patients with Crohn’s disease were more likely to report having active disease if they were using prednisone or opioids or if they had an IBD-related emergency department visit in the past 6 months.

Cardiac biomarkers vary according to sex hormones in healthy transgender adults, just as in cisgender individuals, a new cross-sectional study suggests.

Previous research in the general population has shown that females have a lower 99th percentile upper reference limit for high-sensitivity cardiac troponin (hs-cTn) than males, whereas N-terminal prohormone brain natriuretic peptide (NT-proBNP) concentrations are higher in females than males across all ages after puberty.

“That trend is similar for people that have been on gender-affirming hormones, saying that sex hormones are playing a role in how cardiac turnover happens in a healthy state,” study author Dina M. Greene, PhD, University of Washington, Seattle, said in an interview.

Although the number of transgender people seeking gender-affirming care is increasing, studies are limited and largely retrospective cohorts, she noted. The scientific literature evaluating and defining cardiac biomarker concentrations is “currently absent.”

The American Heart Association’s recent scientific statement on the cardiovascular health of transgender and gender diverse (TGD) people says mounting evidence points to worse CV health in TGD people and that part of this excess risk is driven by significant psychosocial stressors across the lifespan. “In addition, the use of gender-affirming hormone therapy may be associated with cardiometabolic changes, but health research in this area remains limited and, at times, contradictory.”

For the present study, Dr. Greene and colleagues reached out to LGBTQ-oriented primary care and internal medicine clinics in Seattle and Iowa City to recruit 79 transgender men prescribed testosterone (mean age, 28.8 years) and 93 transgender women (mean age, 35.1 years) prescribed estradiol for at least 12 months. The mean duration of hormone therapy was 4.8 and 3.5 years, respectively.

The median estradiol concentration was 51 pg/mL in transgender men and 207 pg/mL in transgender women. Median testosterone concentrations were 4.6 ng/mL and 0.4 ng/mL, respectively.

The cardiac biomarkers were measured with the ARCHITECT STAT (Abbott Diagnostics) and ACCESS (Beckman Coulter) high-sensitivity troponin I assays, the Elecsys Troponin T Gen 5 STAT assay (Roche Diagnostics), and the Elecsys ProBNP II immunoassay (Roche Diagnostics).

As reported in JAMA Cardiology, the median hs-cTnI level on the ARCHITECT STAT assay was 0.9 ng/L (range, 0.6-1.7) in transgender men and 0.6 ng/L (range, 0.3-1.0) in transgender women. The pattern was consistent across the two other assays.

In contrast, the median NT-proBNP level was 17 ng/L (range, 13-27) in transgender men and 49 ng/L (range, 32-86) in transgender women.

“It seems that sex hormone concentration is a stronger driver of baseline cardiac troponin and NT-proBNP concentrations relative to sex assigned at birth,” Dr. Greene said.

The observed differences in hs-cTn concentrations “are likely physiological and not pathological,” given that concentrations between healthy cisgender people are also apparent and not thought to portend adverse events, the authors noted.

Teasing out the clinical implications of sex-specific hs-cTn upper reference limits for ruling in acute myocardial infarction (MI), however, is complicated by biological and social factors that contribute to poorer outcomes in women, despite lower baseline levels, they added. “Ultimately, the psychosocial benefits of gender-affirming hormones are substantial, and informed consent is likely the ideal method to balance the undetermined risks.”

Dr. Greene pointed out that the study wasn’t powered to accurately calculate gender-specific hs-cTn 99th percentiles or reference intervals for NT-proBNP and assessed the biomarkers at a single time point.

For the transgender person presenting with chest pain, she said, the clinical implications are not yet known, but the data suggest that when sex-specific 99th percentiles for hs-cTn are used, the numeric value associated with the affirmed gender, rather than the sex assigned at birth, may be the appropriate URL.

“It really depends on what the triage pathway is and if that pathway has differences for people of different sexes and how often people get serial measurements,” Dr. Greene said. “Within this population, it’s very important to look at those serial measurements because for people that are not cismen, those 99th percentiles when they’re non–sex specific, are going to favor in detection of a heart attack. So, you need to look at the second value to make sure there hasn’t been a change over time.”

The observed differences in the distribution of NT-proBNP concentrations is similar to that in the cisgender population, Dr. Greene noted. But these differences do not lead to sex-specific diagnostic thresholds because of the significant elevations present in overt heart failure and cardiovascular disease. “For NT-proBNP, it’s not as important. People don’t usually have a little bit of heart failure, they have heart failure, where people have small MIs.”

Dr. Greene said she would like to see larger trials looking at biomarker measurements and cardiac imaging before hormone therapy but that the biggest issue is the need for inclusion of transgender people in all cardiovascular trials.

“The sample sizes are never going to be as big as we get for cisgender people for a number of reasons but ensuring that it’s something that’s being asked on intake and monitored over time so we can understand how transgender people fit into the general population for cardiac disease,” Dr. Greene said. “And so, we can normalize that they exist. I keep driving this point home, but this is the biggest thing right now when it’s such a political issue.”

The study was supported in part by the department of laboratory medicine at the University of Washington, the department of pathology at the University of Iowa, and a grant from Abbott Diagnostics for in-kind high-sensitivity cardiac troponin I reagent. One coauthor reported financial relationships with Siemens Healthineers, Roche Diagnostics, Beckman Coulter, Becton, Dickinson, Abbott Diagnostics, Quidel Diagnostics, Sphingotech, and PixCell Medical. No other disclosures were reported.

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

Cardiac biomarkers vary according to sex hormones in healthy transgender adults, just as in cisgender individuals, a new cross-sectional study suggests.

Previous research in the general population has shown that females have a lower 99th percentile upper reference limit for high-sensitivity cardiac troponin (hs-cTn) than males, whereas N-terminal prohormone brain natriuretic peptide (NT-proBNP) concentrations are higher in females than males across all ages after puberty.

“That trend is similar for people that have been on gender-affirming hormones, saying that sex hormones are playing a role in how cardiac turnover happens in a healthy state,” study author Dina M. Greene, PhD, University of Washington, Seattle, said in an interview.

Although the number of transgender people seeking gender-affirming care is increasing, studies are limited and largely retrospective cohorts, she noted. The scientific literature evaluating and defining cardiac biomarker concentrations is “currently absent.”

The American Heart Association’s recent scientific statement on the cardiovascular health of transgender and gender diverse (TGD) people says mounting evidence points to worse CV health in TGD people and that part of this excess risk is driven by significant psychosocial stressors across the lifespan. “In addition, the use of gender-affirming hormone therapy may be associated with cardiometabolic changes, but health research in this area remains limited and, at times, contradictory.”

For the present study, Dr. Greene and colleagues reached out to LGBTQ-oriented primary care and internal medicine clinics in Seattle and Iowa City to recruit 79 transgender men prescribed testosterone (mean age, 28.8 years) and 93 transgender women (mean age, 35.1 years) prescribed estradiol for at least 12 months. The mean duration of hormone therapy was 4.8 and 3.5 years, respectively.

The median estradiol concentration was 51 pg/mL in transgender men and 207 pg/mL in transgender women. Median testosterone concentrations were 4.6 ng/mL and 0.4 ng/mL, respectively.

The cardiac biomarkers were measured with the ARCHITECT STAT (Abbott Diagnostics) and ACCESS (Beckman Coulter) high-sensitivity troponin I assays, the Elecsys Troponin T Gen 5 STAT assay (Roche Diagnostics), and the Elecsys ProBNP II immunoassay (Roche Diagnostics).

As reported in JAMA Cardiology, the median hs-cTnI level on the ARCHITECT STAT assay was 0.9 ng/L (range, 0.6-1.7) in transgender men and 0.6 ng/L (range, 0.3-1.0) in transgender women. The pattern was consistent across the two other assays.

In contrast, the median NT-proBNP level was 17 ng/L (range, 13-27) in transgender men and 49 ng/L (range, 32-86) in transgender women.

“It seems that sex hormone concentration is a stronger driver of baseline cardiac troponin and NT-proBNP concentrations relative to sex assigned at birth,” Dr. Greene said.

The observed differences in hs-cTn concentrations “are likely physiological and not pathological,” given that concentrations between healthy cisgender people are also apparent and not thought to portend adverse events, the authors noted.

Teasing out the clinical implications of sex-specific hs-cTn upper reference limits for ruling in acute myocardial infarction (MI), however, is complicated by biological and social factors that contribute to poorer outcomes in women, despite lower baseline levels, they added. “Ultimately, the psychosocial benefits of gender-affirming hormones are substantial, and informed consent is likely the ideal method to balance the undetermined risks.”

Dr. Greene pointed out that the study wasn’t powered to accurately calculate gender-specific hs-cTn 99th percentiles or reference intervals for NT-proBNP and assessed the biomarkers at a single time point.

For the transgender person presenting with chest pain, she said, the clinical implications are not yet known, but the data suggest that when sex-specific 99th percentiles for hs-cTn are used, the numeric value associated with the affirmed gender, rather than the sex assigned at birth, may be the appropriate URL.

“It really depends on what the triage pathway is and if that pathway has differences for people of different sexes and how often people get serial measurements,” Dr. Greene said. “Within this population, it’s very important to look at those serial measurements because for people that are not cismen, those 99th percentiles when they’re non–sex specific, are going to favor in detection of a heart attack. So, you need to look at the second value to make sure there hasn’t been a change over time.”

The observed differences in the distribution of NT-proBNP concentrations is similar to that in the cisgender population, Dr. Greene noted. But these differences do not lead to sex-specific diagnostic thresholds because of the significant elevations present in overt heart failure and cardiovascular disease. “For NT-proBNP, it’s not as important. People don’t usually have a little bit of heart failure, they have heart failure, where people have small MIs.”

Dr. Greene said she would like to see larger trials looking at biomarker measurements and cardiac imaging before hormone therapy but that the biggest issue is the need for inclusion of transgender people in all cardiovascular trials.

“The sample sizes are never going to be as big as we get for cisgender people for a number of reasons but ensuring that it’s something that’s being asked on intake and monitored over time so we can understand how transgender people fit into the general population for cardiac disease,” Dr. Greene said. “And so, we can normalize that they exist. I keep driving this point home, but this is the biggest thing right now when it’s such a political issue.”

The study was supported in part by the department of laboratory medicine at the University of Washington, the department of pathology at the University of Iowa, and a grant from Abbott Diagnostics for in-kind high-sensitivity cardiac troponin I reagent. One coauthor reported financial relationships with Siemens Healthineers, Roche Diagnostics, Beckman Coulter, Becton, Dickinson, Abbott Diagnostics, Quidel Diagnostics, Sphingotech, and PixCell Medical. No other disclosures were reported.

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

Cardiac biomarkers vary according to sex hormones in healthy transgender adults, just as in cisgender individuals, a new cross-sectional study suggests.

Previous research in the general population has shown that females have a lower 99th percentile upper reference limit for high-sensitivity cardiac troponin (hs-cTn) than males, whereas N-terminal prohormone brain natriuretic peptide (NT-proBNP) concentrations are higher in females than males across all ages after puberty.

“That trend is similar for people that have been on gender-affirming hormones, saying that sex hormones are playing a role in how cardiac turnover happens in a healthy state,” study author Dina M. Greene, PhD, University of Washington, Seattle, said in an interview.

Although the number of transgender people seeking gender-affirming care is increasing, studies are limited and largely retrospective cohorts, she noted. The scientific literature evaluating and defining cardiac biomarker concentrations is “currently absent.”

The American Heart Association’s recent scientific statement on the cardiovascular health of transgender and gender diverse (TGD) people says mounting evidence points to worse CV health in TGD people and that part of this excess risk is driven by significant psychosocial stressors across the lifespan. “In addition, the use of gender-affirming hormone therapy may be associated with cardiometabolic changes, but health research in this area remains limited and, at times, contradictory.”

For the present study, Dr. Greene and colleagues reached out to LGBTQ-oriented primary care and internal medicine clinics in Seattle and Iowa City to recruit 79 transgender men prescribed testosterone (mean age, 28.8 years) and 93 transgender women (mean age, 35.1 years) prescribed estradiol for at least 12 months. The mean duration of hormone therapy was 4.8 and 3.5 years, respectively.

The median estradiol concentration was 51 pg/mL in transgender men and 207 pg/mL in transgender women. Median testosterone concentrations were 4.6 ng/mL and 0.4 ng/mL, respectively.

The cardiac biomarkers were measured with the ARCHITECT STAT (Abbott Diagnostics) and ACCESS (Beckman Coulter) high-sensitivity troponin I assays, the Elecsys Troponin T Gen 5 STAT assay (Roche Diagnostics), and the Elecsys ProBNP II immunoassay (Roche Diagnostics).

As reported in JAMA Cardiology, the median hs-cTnI level on the ARCHITECT STAT assay was 0.9 ng/L (range, 0.6-1.7) in transgender men and 0.6 ng/L (range, 0.3-1.0) in transgender women. The pattern was consistent across the two other assays.

In contrast, the median NT-proBNP level was 17 ng/L (range, 13-27) in transgender men and 49 ng/L (range, 32-86) in transgender women.

“It seems that sex hormone concentration is a stronger driver of baseline cardiac troponin and NT-proBNP concentrations relative to sex assigned at birth,” Dr. Greene said.

The observed differences in hs-cTn concentrations “are likely physiological and not pathological,” given that concentrations between healthy cisgender people are also apparent and not thought to portend adverse events, the authors noted.

Teasing out the clinical implications of sex-specific hs-cTn upper reference limits for ruling in acute myocardial infarction (MI), however, is complicated by biological and social factors that contribute to poorer outcomes in women, despite lower baseline levels, they added. “Ultimately, the psychosocial benefits of gender-affirming hormones are substantial, and informed consent is likely the ideal method to balance the undetermined risks.”

Dr. Greene pointed out that the study wasn’t powered to accurately calculate gender-specific hs-cTn 99th percentiles or reference intervals for NT-proBNP and assessed the biomarkers at a single time point.

For the transgender person presenting with chest pain, she said, the clinical implications are not yet known, but the data suggest that when sex-specific 99th percentiles for hs-cTn are used, the numeric value associated with the affirmed gender, rather than the sex assigned at birth, may be the appropriate URL.

“It really depends on what the triage pathway is and if that pathway has differences for people of different sexes and how often people get serial measurements,” Dr. Greene said. “Within this population, it’s very important to look at those serial measurements because for people that are not cismen, those 99th percentiles when they’re non–sex specific, are going to favor in detection of a heart attack. So, you need to look at the second value to make sure there hasn’t been a change over time.”

The observed differences in the distribution of NT-proBNP concentrations is similar to that in the cisgender population, Dr. Greene noted. But these differences do not lead to sex-specific diagnostic thresholds because of the significant elevations present in overt heart failure and cardiovascular disease. “For NT-proBNP, it’s not as important. People don’t usually have a little bit of heart failure, they have heart failure, where people have small MIs.”

Dr. Greene said she would like to see larger trials looking at biomarker measurements and cardiac imaging before hormone therapy but that the biggest issue is the need for inclusion of transgender people in all cardiovascular trials.

“The sample sizes are never going to be as big as we get for cisgender people for a number of reasons but ensuring that it’s something that’s being asked on intake and monitored over time so we can understand how transgender people fit into the general population for cardiac disease,” Dr. Greene said. “And so, we can normalize that they exist. I keep driving this point home, but this is the biggest thing right now when it’s such a political issue.”

The study was supported in part by the department of laboratory medicine at the University of Washington, the department of pathology at the University of Iowa, and a grant from Abbott Diagnostics for in-kind high-sensitivity cardiac troponin I reagent. One coauthor reported financial relationships with Siemens Healthineers, Roche Diagnostics, Beckman Coulter, Becton, Dickinson, Abbott Diagnostics, Quidel Diagnostics, Sphingotech, and PixCell Medical. No other disclosures were reported.

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

CVS is cutting the cost of its store-branded menstrual products and paying state sales taxes on them in a dozen states.

The drug store chain said that starting Thursday it was reducing prices on CVS Health and Live Better tampons, menstrual pads, liners, and cups by 25%.

“Women deserve quality when it comes to the products they may need each month,” CVS said in a statement. “We’re paying the tax on period products on behalf of our customers where and when possible, and are working to help eliminate the tax nationwide.”

The store is also trying to equalize costs between men’s and women’s hygiene products, like razors.

The chain is paying sales taxes on period products in these 12 states: Arkansas, Georgia, Hawaii, Louisiana, Missouri, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin, and West Virginia.

It can’t pay the taxes in other states that have them because of laws that prevent third parties from paying taxes for a customer.

“This move will highlight their commitment to addressing women’s health and pave the way for reducing menstrual inequity,” Padmini Murthy, MD, the global health lead for the American Medical Women’s Association, said in an email to CNN, “and not just to promote the use of CVS products.”

Twenty-three states don’t tax feminine hygiene products, says the Alliance for Period Supplies, an advocacy group seeking to expand access to menstrual supplies.

“Too often period products are taxed as luxury items and not recognized as basic necessities,” the organization said. “Period products are taxed at a similar rate to items like decor, electronics, makeup, and toys.” 

Tampon prices rose 12.2% for the year ending Oct. 2, according to market research firm IRI. 

And 25% of women struggle to buy the products because of the expense, says the group.

A version of this article first appeared on WebMD.com.

CVS is cutting the cost of its store-branded menstrual products and paying state sales taxes on them in a dozen states.

The drug store chain said that starting Thursday it was reducing prices on CVS Health and Live Better tampons, menstrual pads, liners, and cups by 25%.

“Women deserve quality when it comes to the products they may need each month,” CVS said in a statement. “We’re paying the tax on period products on behalf of our customers where and when possible, and are working to help eliminate the tax nationwide.”

The store is also trying to equalize costs between men’s and women’s hygiene products, like razors.

The chain is paying sales taxes on period products in these 12 states: Arkansas, Georgia, Hawaii, Louisiana, Missouri, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin, and West Virginia.

It can’t pay the taxes in other states that have them because of laws that prevent third parties from paying taxes for a customer.

“This move will highlight their commitment to addressing women’s health and pave the way for reducing menstrual inequity,” Padmini Murthy, MD, the global health lead for the American Medical Women’s Association, said in an email to CNN, “and not just to promote the use of CVS products.”

Twenty-three states don’t tax feminine hygiene products, says the Alliance for Period Supplies, an advocacy group seeking to expand access to menstrual supplies.

“Too often period products are taxed as luxury items and not recognized as basic necessities,” the organization said. “Period products are taxed at a similar rate to items like decor, electronics, makeup, and toys.” 

Tampon prices rose 12.2% for the year ending Oct. 2, according to market research firm IRI. 

And 25% of women struggle to buy the products because of the expense, says the group.

A version of this article first appeared on WebMD.com.

CVS is cutting the cost of its store-branded menstrual products and paying state sales taxes on them in a dozen states.

The drug store chain said that starting Thursday it was reducing prices on CVS Health and Live Better tampons, menstrual pads, liners, and cups by 25%.

“Women deserve quality when it comes to the products they may need each month,” CVS said in a statement. “We’re paying the tax on period products on behalf of our customers where and when possible, and are working to help eliminate the tax nationwide.”

The store is also trying to equalize costs between men’s and women’s hygiene products, like razors.

The chain is paying sales taxes on period products in these 12 states: Arkansas, Georgia, Hawaii, Louisiana, Missouri, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin, and West Virginia.

It can’t pay the taxes in other states that have them because of laws that prevent third parties from paying taxes for a customer.

“This move will highlight their commitment to addressing women’s health and pave the way for reducing menstrual inequity,” Padmini Murthy, MD, the global health lead for the American Medical Women’s Association, said in an email to CNN, “and not just to promote the use of CVS products.”

Twenty-three states don’t tax feminine hygiene products, says the Alliance for Period Supplies, an advocacy group seeking to expand access to menstrual supplies.

“Too often period products are taxed as luxury items and not recognized as basic necessities,” the organization said. “Period products are taxed at a similar rate to items like decor, electronics, makeup, and toys.” 

Tampon prices rose 12.2% for the year ending Oct. 2, according to market research firm IRI. 

And 25% of women struggle to buy the products because of the expense, says the group.

A version of this article first appeared on WebMD.com.

A “high-intensity-care” strategy based on early and rapid uptitration of guideline-directed meds improves postdischarge clinical outcomes for patients hospitalized with decompensated heart failure (HF), suggest topline results from a randomized trial.

The STRONG-HF study was halted early on recommendation from its data safety monitoring board after an interim analysis suggested the high-intensity-care strategy significantly cut risk of death or HF readmission, compared with a standard-of-care approach.

The trial termination was announced  in a press release from one of its sponsors, The Heart Initiative, a nonprofit organization. STRONG-HF was also supported by Roche Diagnostics.

The early termination was based on interim data from the approximately 1,000 patients, out of an estimated planned enrollment of 1,800, who had been followed for at least 90 days. The study’s actual primary endpoint had been defined by death or HF readmission at 6 months.

The announcement did not include outcomes data or P values, or any other indication of the magnitude of benefit from the high-intensity-care approach.

Patients in STRONG-HF who had been assigned to a high-intensity-care strategy had been started in-hospital on a beta blocker, a renin-angiotensin system inhibitor (RASi), and a mineralocorticoid receptor blocker (MRA) with dosages uptitrated at least halfway by the time of discharge.

The meds were uptitrated fully within 2 weeks of discharge guided by clinical and biomarker assessments, especially natriuretic peptides, at frequent postdischarge visits, the press release states.

Patients conducted “safety visits 1 week after any uptitration and follow-up visits at 6 weeks and 3 months,” the announcement notes. “At each visit, patients were assessed by physical examination for congestion and blood tests, including NT-proBNP measurements.”

The “full STRONG-HF trial results” are scheduled for presentation at the American Heart Association annual scientific sessions, the announcement states.

STRONG-HF is sponsored by The Heart Initiative and Roche Diagnostics.

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

A “high-intensity-care” strategy based on early and rapid uptitration of guideline-directed meds improves postdischarge clinical outcomes for patients hospitalized with decompensated heart failure (HF), suggest topline results from a randomized trial.

The STRONG-HF study was halted early on recommendation from its data safety monitoring board after an interim analysis suggested the high-intensity-care strategy significantly cut risk of death or HF readmission, compared with a standard-of-care approach.

The trial termination was announced  in a press release from one of its sponsors, The Heart Initiative, a nonprofit organization. STRONG-HF was also supported by Roche Diagnostics.

The early termination was based on interim data from the approximately 1,000 patients, out of an estimated planned enrollment of 1,800, who had been followed for at least 90 days. The study’s actual primary endpoint had been defined by death or HF readmission at 6 months.

The announcement did not include outcomes data or P values, or any other indication of the magnitude of benefit from the high-intensity-care approach.

Patients in STRONG-HF who had been assigned to a high-intensity-care strategy had been started in-hospital on a beta blocker, a renin-angiotensin system inhibitor (RASi), and a mineralocorticoid receptor blocker (MRA) with dosages uptitrated at least halfway by the time of discharge.

The meds were uptitrated fully within 2 weeks of discharge guided by clinical and biomarker assessments, especially natriuretic peptides, at frequent postdischarge visits, the press release states.

Patients conducted “safety visits 1 week after any uptitration and follow-up visits at 6 weeks and 3 months,” the announcement notes. “At each visit, patients were assessed by physical examination for congestion and blood tests, including NT-proBNP measurements.”

The “full STRONG-HF trial results” are scheduled for presentation at the American Heart Association annual scientific sessions, the announcement states.

STRONG-HF is sponsored by The Heart Initiative and Roche Diagnostics.

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

A “high-intensity-care” strategy based on early and rapid uptitration of guideline-directed meds improves postdischarge clinical outcomes for patients hospitalized with decompensated heart failure (HF), suggest topline results from a randomized trial.

The STRONG-HF study was halted early on recommendation from its data safety monitoring board after an interim analysis suggested the high-intensity-care strategy significantly cut risk of death or HF readmission, compared with a standard-of-care approach.

The trial termination was announced  in a press release from one of its sponsors, The Heart Initiative, a nonprofit organization. STRONG-HF was also supported by Roche Diagnostics.

The early termination was based on interim data from the approximately 1,000 patients, out of an estimated planned enrollment of 1,800, who had been followed for at least 90 days. The study’s actual primary endpoint had been defined by death or HF readmission at 6 months.

The announcement did not include outcomes data or P values, or any other indication of the magnitude of benefit from the high-intensity-care approach.

Patients in STRONG-HF who had been assigned to a high-intensity-care strategy had been started in-hospital on a beta blocker, a renin-angiotensin system inhibitor (RASi), and a mineralocorticoid receptor blocker (MRA) with dosages uptitrated at least halfway by the time of discharge.

The meds were uptitrated fully within 2 weeks of discharge guided by clinical and biomarker assessments, especially natriuretic peptides, at frequent postdischarge visits, the press release states.

Patients conducted “safety visits 1 week after any uptitration and follow-up visits at 6 weeks and 3 months,” the announcement notes. “At each visit, patients were assessed by physical examination for congestion and blood tests, including NT-proBNP measurements.”

The “full STRONG-HF trial results” are scheduled for presentation at the American Heart Association annual scientific sessions, the announcement states.

STRONG-HF is sponsored by The Heart Initiative and Roche Diagnostics.

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

Patient-reported symptoms and quality of life should guide treatment for the roughly 8.5 million people in the United States living with peripheral artery disease (PAD), the American Heart Association said in a new scientific statement released Oct. 13.

“The person living with PAD is the authority on the impact it has on their daily life. Our treatment must be grounded in their lived experiences and go beyond the clinical measures of how well blood flows through the arteries,” Kim G. Smolderen, PhD, lead author of the statement writing group, says in a release.

“We have spent years developing and validating standardized instruments to capture people’s experiences in a reliable and sensitive way. We are now at a point where we can start integrating this information into real-world care, through pilot programs that can develop quality benchmarks for different phenotypes of patients with PAD and the types of treatments they undergo, as seen from their perspective,” adds Dr. Smolderen, co-director of the Vascular Medicine Outcomes Research (VAMOS) lab at Yale University, New Haven, Conn.

The statement, “Advancing Peripheral Artery Disease Quality of Care and Outcomes Through Patient-Reported Health Status Assessment,” is published online in Circulation.

It comes on the heels of a 2021 AHA statement urging greater attention to PAD, which is underdiagnosed and undertreated in the United States despite its high prevalence.
 

Fragmented care

Dr. Smolderen said that the multidisciplinary writing group was united in one overarching goal: “How can we disrupt the fragmented care model for PAD and make PAD care more accountable, value-based, and patient-centered?”

“True disruption is needed in a clinical space where the treatment of lower-extremity disease lies in the hands of many different specialties and variability in care and outcomes is a major concern,” Dr. Smolderen said.

The statement calls for improving and individualizing PAD care by gathering feedback from their experience through treatment using systematic and validated patient-reported outcome measures (PROMs).

PROMs for PAD include the Walking Impairment Questionnaire (WIQ), the Vascular Quality of Life Questionnaire (VascuQoL), and Peripheral Artery Questionnaire (PAQ).
 

Accountability tied to reimbursement

Dr. Smolderen noted that PROMs are increasingly being integrated into definitions of what it means to deliver high-quality, patient-centered care, and PROMs scores may directly impact reimbursement.

“Using a template that has been implemented in other medical conditions, we propose a shift in metrics that will tell us whether high-quality PAD care has been delivered from a patients’ perspective,” Dr. Smolderen told this news organization.

That is, “have we been able to improve the health status of that person’s life? We may have removed the blockage in the arteries, but will the patient feel that this intervention has addressed their PAD-specific health status goals?”

To facilitate accountability in quality PAD care, the writing group calls for developing, testing, and implementing PAD-specific patient-reported outcomes performance measures – or PRO-PMs.

Pilot efforts demonstrating feasibility of PRO-PMs in various practice settings are needed, as is implementation research evaluating the integration of PRO-PMs and pragmatic clinical trial evidence to demonstrate efficacy of the use of PROs in real world care settings to improve overall PAD outcomes, the writing group says.

“Following that experience and data, we believe value-based models can be proposed integrating PRO information that will affect accountability in PAD care and may ultimately affect reimbursement,” Dr. Smolderen said.

“Adoption of this new paradigm will further improve the quality of care for PAD and will put the patient front and center, as an agent in their care,” she added.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Peripheral Vascular Disease and the Council on Lifestyle and Cardiometabolic Health. The writing group includes a patient advocate and experts in clinical psychology, outcomes research, nursing, cardiology, vascular surgery, and vascular medicine.

This research had no commercial funding. Dr. Smolderen has disclosed relationships with Optum, Abbott, Cook Medical, Happify, and Tegus.

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

Patient-reported symptoms and quality of life should guide treatment for the roughly 8.5 million people in the United States living with peripheral artery disease (PAD), the American Heart Association said in a new scientific statement released Oct. 13.

“The person living with PAD is the authority on the impact it has on their daily life. Our treatment must be grounded in their lived experiences and go beyond the clinical measures of how well blood flows through the arteries,” Kim G. Smolderen, PhD, lead author of the statement writing group, says in a release.

“We have spent years developing and validating standardized instruments to capture people’s experiences in a reliable and sensitive way. We are now at a point where we can start integrating this information into real-world care, through pilot programs that can develop quality benchmarks for different phenotypes of patients with PAD and the types of treatments they undergo, as seen from their perspective,” adds Dr. Smolderen, co-director of the Vascular Medicine Outcomes Research (VAMOS) lab at Yale University, New Haven, Conn.

The statement, “Advancing Peripheral Artery Disease Quality of Care and Outcomes Through Patient-Reported Health Status Assessment,” is published online in Circulation.

It comes on the heels of a 2021 AHA statement urging greater attention to PAD, which is underdiagnosed and undertreated in the United States despite its high prevalence.
 

Fragmented care

Dr. Smolderen said that the multidisciplinary writing group was united in one overarching goal: “How can we disrupt the fragmented care model for PAD and make PAD care more accountable, value-based, and patient-centered?”

“True disruption is needed in a clinical space where the treatment of lower-extremity disease lies in the hands of many different specialties and variability in care and outcomes is a major concern,” Dr. Smolderen said.

The statement calls for improving and individualizing PAD care by gathering feedback from their experience through treatment using systematic and validated patient-reported outcome measures (PROMs).

PROMs for PAD include the Walking Impairment Questionnaire (WIQ), the Vascular Quality of Life Questionnaire (VascuQoL), and Peripheral Artery Questionnaire (PAQ).
 

Accountability tied to reimbursement

Dr. Smolderen noted that PROMs are increasingly being integrated into definitions of what it means to deliver high-quality, patient-centered care, and PROMs scores may directly impact reimbursement.

“Using a template that has been implemented in other medical conditions, we propose a shift in metrics that will tell us whether high-quality PAD care has been delivered from a patients’ perspective,” Dr. Smolderen told this news organization.

That is, “have we been able to improve the health status of that person’s life? We may have removed the blockage in the arteries, but will the patient feel that this intervention has addressed their PAD-specific health status goals?”

To facilitate accountability in quality PAD care, the writing group calls for developing, testing, and implementing PAD-specific patient-reported outcomes performance measures – or PRO-PMs.

Pilot efforts demonstrating feasibility of PRO-PMs in various practice settings are needed, as is implementation research evaluating the integration of PRO-PMs and pragmatic clinical trial evidence to demonstrate efficacy of the use of PROs in real world care settings to improve overall PAD outcomes, the writing group says.

“Following that experience and data, we believe value-based models can be proposed integrating PRO information that will affect accountability in PAD care and may ultimately affect reimbursement,” Dr. Smolderen said.

“Adoption of this new paradigm will further improve the quality of care for PAD and will put the patient front and center, as an agent in their care,” she added.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Peripheral Vascular Disease and the Council on Lifestyle and Cardiometabolic Health. The writing group includes a patient advocate and experts in clinical psychology, outcomes research, nursing, cardiology, vascular surgery, and vascular medicine.

This research had no commercial funding. Dr. Smolderen has disclosed relationships with Optum, Abbott, Cook Medical, Happify, and Tegus.

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

Patient-reported symptoms and quality of life should guide treatment for the roughly 8.5 million people in the United States living with peripheral artery disease (PAD), the American Heart Association said in a new scientific statement released Oct. 13.

“The person living with PAD is the authority on the impact it has on their daily life. Our treatment must be grounded in their lived experiences and go beyond the clinical measures of how well blood flows through the arteries,” Kim G. Smolderen, PhD, lead author of the statement writing group, says in a release.

“We have spent years developing and validating standardized instruments to capture people’s experiences in a reliable and sensitive way. We are now at a point where we can start integrating this information into real-world care, through pilot programs that can develop quality benchmarks for different phenotypes of patients with PAD and the types of treatments they undergo, as seen from their perspective,” adds Dr. Smolderen, co-director of the Vascular Medicine Outcomes Research (VAMOS) lab at Yale University, New Haven, Conn.

The statement, “Advancing Peripheral Artery Disease Quality of Care and Outcomes Through Patient-Reported Health Status Assessment,” is published online in Circulation.

It comes on the heels of a 2021 AHA statement urging greater attention to PAD, which is underdiagnosed and undertreated in the United States despite its high prevalence.
 

Fragmented care

Dr. Smolderen said that the multidisciplinary writing group was united in one overarching goal: “How can we disrupt the fragmented care model for PAD and make PAD care more accountable, value-based, and patient-centered?”

“True disruption is needed in a clinical space where the treatment of lower-extremity disease lies in the hands of many different specialties and variability in care and outcomes is a major concern,” Dr. Smolderen said.

The statement calls for improving and individualizing PAD care by gathering feedback from their experience through treatment using systematic and validated patient-reported outcome measures (PROMs).

PROMs for PAD include the Walking Impairment Questionnaire (WIQ), the Vascular Quality of Life Questionnaire (VascuQoL), and Peripheral Artery Questionnaire (PAQ).
 

Accountability tied to reimbursement

Dr. Smolderen noted that PROMs are increasingly being integrated into definitions of what it means to deliver high-quality, patient-centered care, and PROMs scores may directly impact reimbursement.

“Using a template that has been implemented in other medical conditions, we propose a shift in metrics that will tell us whether high-quality PAD care has been delivered from a patients’ perspective,” Dr. Smolderen told this news organization.

That is, “have we been able to improve the health status of that person’s life? We may have removed the blockage in the arteries, but will the patient feel that this intervention has addressed their PAD-specific health status goals?”

To facilitate accountability in quality PAD care, the writing group calls for developing, testing, and implementing PAD-specific patient-reported outcomes performance measures – or PRO-PMs.

Pilot efforts demonstrating feasibility of PRO-PMs in various practice settings are needed, as is implementation research evaluating the integration of PRO-PMs and pragmatic clinical trial evidence to demonstrate efficacy of the use of PROs in real world care settings to improve overall PAD outcomes, the writing group says.

“Following that experience and data, we believe value-based models can be proposed integrating PRO information that will affect accountability in PAD care and may ultimately affect reimbursement,” Dr. Smolderen said.

“Adoption of this new paradigm will further improve the quality of care for PAD and will put the patient front and center, as an agent in their care,” she added.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Peripheral Vascular Disease and the Council on Lifestyle and Cardiometabolic Health. The writing group includes a patient advocate and experts in clinical psychology, outcomes research, nursing, cardiology, vascular surgery, and vascular medicine.

This research had no commercial funding. Dr. Smolderen has disclosed relationships with Optum, Abbott, Cook Medical, Happify, and Tegus.

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