Cardiology News

Patients on oral anticoagulants who experience a bleeding event may be able to discontinue therapy if certain circumstances apply, according to updated guidance from the American College of Cardiology.

The emergence of direct-acting oral anticoagulants (DOACs) to prevent venous thromboembolism and the introduction of new reversal strategies for factor Xa inhibitors prompted the creation of an Expert Consensus Decision Pathway to update the version from 2017, according to the ACC. Expert consensus decision pathways (ECDPs) are a component of the solution sets issued by the ACC to “address key questions facing care teams and attempt to provide practical guidance to be applied at the point of care.”

In an ECDP published in the Journal of the American College of Cardiology, the writing committee members developed treatment algorithms for managing bleeding in patients on DOACs and vitamin K antagonists (VKAs).

Bleeding was classified as major or nonmajor, with major defined as “bleeding that is associated with hemodynamic compromise, occurs in an anatomically critical site, requires transfusion of at least 2 units of packed red blood cells [RBCs]), or results in a hemoglobin drop greater than 2 g/dL. All other types of bleeding were classified as nonmajor.

The document includes a graphic algorithm for assessing bleed severity and managing major versus nonmajor bleeding, and a separate graphic describes considerations for reversal and use of hemostatic agents according to whether the patient is taking a VKA (warfarin and other coumarins), a direct thrombin inhibitor (dabigatran), the factor Xa inhibitors apixaban and rivaroxaban, or the factor Xa inhibitors betrixaban and edoxaban.

Another algorithm outlines whether to discontinue, delay, or restart anticoagulation. Considerations for restarting anticoagulation include whether the patient is pregnant, awaiting an invasive procedure, not able to receive medication by mouth, has a high risk of rebleeding, or is being bridged back to a vitamin K antagonist with high thrombotic risk.

In most cases of GI bleeding, for example, current data support restarting oral anticoagulants once hemostasis is achieved, but patients who experience intracranial hemorrhage should delay restarting any anticoagulation for at least 4 weeks if they are without high thrombotic risk, according to the document.

The report also recommends clinician-patient discussion before resuming anticoagulation, ideally with time allowed for patients to develop questions. Discussions should include the signs of bleeding, assessment of risk for a thromboembolic event, and the benefits of anticoagulation.

“The proliferation of oral anticoagulants (warfarin and DOACs) and growing indications for their use prompted the need for guidance on the management of these drugs,” said Gordon F. Tomaselli, MD, chair of the writing committee, in an interview. “This document provides guidance on management at the time of a bleeding complication. This includes acute management, starting and stopping drugs, and use of reversal agents,” he said. “This of course will be a dynamic document as the list of these drugs and their antidotes expand,” he noted.  

“The biggest change from the previous guidelines are twofold: an update on laboratory assessment to monitor drug levels and use of reversal agents,” while the acute management strategies have otherwise remained similar to previous documents, said Dr. Tomaselli.

Dr. Tomaselli said that he was not surprised by the biological aspects of recent research while developing the statement. However, “the extent of the use of multiple anticoagulants and antiplatelet agents was a bit surprising and complicates therapy with each of the agents,” he noted.

The way the pathways are presented may make them challenging to follow in clinical practice, said Dr. Tomaselli. “The pathways are described linearly and in practice often many things have to happen at once,” he said. “The other main issue may be limitations in the availability of some of the newer reversal agents,” he added.

“The complication of bleeding is difficult to avoid,” said Dr. Tomaselli, and for future research, “the focus needs to continue to refine the indications for anticoagulation and appropriate use with other drugs that predispose to bleeding. We also need better methods and testing to monitor drugs levels and the effect on coagulation,” he said.

In accordance with the ACC Solution Set Oversight Committee, the writing committee members, including Dr. Tomaselli, had no relevant relationships with industry to disclose.

SOURCE: Tomaselli GF et al. J Am Coll Cardiol. 2020. doi: 10.1016/j.jacc.2020.04.053.

Patients on oral anticoagulants who experience a bleeding event may be able to discontinue therapy if certain circumstances apply, according to updated guidance from the American College of Cardiology.

The emergence of direct-acting oral anticoagulants (DOACs) to prevent venous thromboembolism and the introduction of new reversal strategies for factor Xa inhibitors prompted the creation of an Expert Consensus Decision Pathway to update the version from 2017, according to the ACC. Expert consensus decision pathways (ECDPs) are a component of the solution sets issued by the ACC to “address key questions facing care teams and attempt to provide practical guidance to be applied at the point of care.”

In an ECDP published in the Journal of the American College of Cardiology, the writing committee members developed treatment algorithms for managing bleeding in patients on DOACs and vitamin K antagonists (VKAs).

Bleeding was classified as major or nonmajor, with major defined as “bleeding that is associated with hemodynamic compromise, occurs in an anatomically critical site, requires transfusion of at least 2 units of packed red blood cells [RBCs]), or results in a hemoglobin drop greater than 2 g/dL. All other types of bleeding were classified as nonmajor.

The document includes a graphic algorithm for assessing bleed severity and managing major versus nonmajor bleeding, and a separate graphic describes considerations for reversal and use of hemostatic agents according to whether the patient is taking a VKA (warfarin and other coumarins), a direct thrombin inhibitor (dabigatran), the factor Xa inhibitors apixaban and rivaroxaban, or the factor Xa inhibitors betrixaban and edoxaban.

Another algorithm outlines whether to discontinue, delay, or restart anticoagulation. Considerations for restarting anticoagulation include whether the patient is pregnant, awaiting an invasive procedure, not able to receive medication by mouth, has a high risk of rebleeding, or is being bridged back to a vitamin K antagonist with high thrombotic risk.

In most cases of GI bleeding, for example, current data support restarting oral anticoagulants once hemostasis is achieved, but patients who experience intracranial hemorrhage should delay restarting any anticoagulation for at least 4 weeks if they are without high thrombotic risk, according to the document.

The report also recommends clinician-patient discussion before resuming anticoagulation, ideally with time allowed for patients to develop questions. Discussions should include the signs of bleeding, assessment of risk for a thromboembolic event, and the benefits of anticoagulation.

“The proliferation of oral anticoagulants (warfarin and DOACs) and growing indications for their use prompted the need for guidance on the management of these drugs,” said Gordon F. Tomaselli, MD, chair of the writing committee, in an interview. “This document provides guidance on management at the time of a bleeding complication. This includes acute management, starting and stopping drugs, and use of reversal agents,” he said. “This of course will be a dynamic document as the list of these drugs and their antidotes expand,” he noted.  

“The biggest change from the previous guidelines are twofold: an update on laboratory assessment to monitor drug levels and use of reversal agents,” while the acute management strategies have otherwise remained similar to previous documents, said Dr. Tomaselli.

Dr. Tomaselli said that he was not surprised by the biological aspects of recent research while developing the statement. However, “the extent of the use of multiple anticoagulants and antiplatelet agents was a bit surprising and complicates therapy with each of the agents,” he noted.

The way the pathways are presented may make them challenging to follow in clinical practice, said Dr. Tomaselli. “The pathways are described linearly and in practice often many things have to happen at once,” he said. “The other main issue may be limitations in the availability of some of the newer reversal agents,” he added.

“The complication of bleeding is difficult to avoid,” said Dr. Tomaselli, and for future research, “the focus needs to continue to refine the indications for anticoagulation and appropriate use with other drugs that predispose to bleeding. We also need better methods and testing to monitor drugs levels and the effect on coagulation,” he said.

In accordance with the ACC Solution Set Oversight Committee, the writing committee members, including Dr. Tomaselli, had no relevant relationships with industry to disclose.

SOURCE: Tomaselli GF et al. J Am Coll Cardiol. 2020. doi: 10.1016/j.jacc.2020.04.053.

Patients on oral anticoagulants who experience a bleeding event may be able to discontinue therapy if certain circumstances apply, according to updated guidance from the American College of Cardiology.

The emergence of direct-acting oral anticoagulants (DOACs) to prevent venous thromboembolism and the introduction of new reversal strategies for factor Xa inhibitors prompted the creation of an Expert Consensus Decision Pathway to update the version from 2017, according to the ACC. Expert consensus decision pathways (ECDPs) are a component of the solution sets issued by the ACC to “address key questions facing care teams and attempt to provide practical guidance to be applied at the point of care.”

In an ECDP published in the Journal of the American College of Cardiology, the writing committee members developed treatment algorithms for managing bleeding in patients on DOACs and vitamin K antagonists (VKAs).

Bleeding was classified as major or nonmajor, with major defined as “bleeding that is associated with hemodynamic compromise, occurs in an anatomically critical site, requires transfusion of at least 2 units of packed red blood cells [RBCs]), or results in a hemoglobin drop greater than 2 g/dL. All other types of bleeding were classified as nonmajor.

The document includes a graphic algorithm for assessing bleed severity and managing major versus nonmajor bleeding, and a separate graphic describes considerations for reversal and use of hemostatic agents according to whether the patient is taking a VKA (warfarin and other coumarins), a direct thrombin inhibitor (dabigatran), the factor Xa inhibitors apixaban and rivaroxaban, or the factor Xa inhibitors betrixaban and edoxaban.

Another algorithm outlines whether to discontinue, delay, or restart anticoagulation. Considerations for restarting anticoagulation include whether the patient is pregnant, awaiting an invasive procedure, not able to receive medication by mouth, has a high risk of rebleeding, or is being bridged back to a vitamin K antagonist with high thrombotic risk.

In most cases of GI bleeding, for example, current data support restarting oral anticoagulants once hemostasis is achieved, but patients who experience intracranial hemorrhage should delay restarting any anticoagulation for at least 4 weeks if they are without high thrombotic risk, according to the document.

The report also recommends clinician-patient discussion before resuming anticoagulation, ideally with time allowed for patients to develop questions. Discussions should include the signs of bleeding, assessment of risk for a thromboembolic event, and the benefits of anticoagulation.

“The proliferation of oral anticoagulants (warfarin and DOACs) and growing indications for their use prompted the need for guidance on the management of these drugs,” said Gordon F. Tomaselli, MD, chair of the writing committee, in an interview. “This document provides guidance on management at the time of a bleeding complication. This includes acute management, starting and stopping drugs, and use of reversal agents,” he said. “This of course will be a dynamic document as the list of these drugs and their antidotes expand,” he noted.  

“The biggest change from the previous guidelines are twofold: an update on laboratory assessment to monitor drug levels and use of reversal agents,” while the acute management strategies have otherwise remained similar to previous documents, said Dr. Tomaselli.

Dr. Tomaselli said that he was not surprised by the biological aspects of recent research while developing the statement. However, “the extent of the use of multiple anticoagulants and antiplatelet agents was a bit surprising and complicates therapy with each of the agents,” he noted.

The way the pathways are presented may make them challenging to follow in clinical practice, said Dr. Tomaselli. “The pathways are described linearly and in practice often many things have to happen at once,” he said. “The other main issue may be limitations in the availability of some of the newer reversal agents,” he added.

“The complication of bleeding is difficult to avoid,” said Dr. Tomaselli, and for future research, “the focus needs to continue to refine the indications for anticoagulation and appropriate use with other drugs that predispose to bleeding. We also need better methods and testing to monitor drugs levels and the effect on coagulation,” he said.

In accordance with the ACC Solution Set Oversight Committee, the writing committee members, including Dr. Tomaselli, had no relevant relationships with industry to disclose.

SOURCE: Tomaselli GF et al. J Am Coll Cardiol. 2020. doi: 10.1016/j.jacc.2020.04.053.

Thousands of coronavirus patients risk going without treatment and support for debilitating symptoms lasting months because of a lack of awareness of ‘long COVID’, according to a group formed by clinicians with extended serious after-effects of the virus.

Many members of the 100-strong Facebook group UK doctors: COVID “Long tail” have been unable to work for weeks after failing to recover from an episode of COVID-19. They warn of the need for clinical recognition of “long COVID,” along with systems to log symptoms and manage patients in the community. Without this, there could be major consequences for return to work across all professions, as well as implications for disease prevention.
 

‘Weird symptoms’

Three of the group: Dr Amali Lokugamage, consultant obstetrician at the Whittington Hospital; Dr Sharon Taylor, child psychiatrist at St Mary’s Hospital London, and Dr Clare Rayner, a retired occupational health physician and lecturer at the University of Manchester, have highlighted their concerns in The BMJ and on social media groups. They say colleagues are observing a range of symptoms of long COVID in their practices.

These include cardiac, gut and respiratory symptoms, skin manifestations, neurological and psychiatric symptoms, severe fatigue, and relapsing fevers, sometimes continuing for more than 16 weeks, and which they say go well beyond definitions of chronic fatigue. The authors are also aware of a pattern of symptom clusters recurring every third or fourth day, which in some cases are so severe that people are having to take extended periods of sick leave.

Writing in The BMJ the authors say: “Concerns have been raised about the lack of awareness among NHS doctors, nurses, paramedics, and other healthcare professionals with regard to the prolonged, varied, and weird symptoms [of COVID-19].”

Speaking to Medscape News UK, Dr. Clare Rayner said: “We see a huge need that is not being met, because these cases are just not being seen in hospital. All the attention has been on the acute illness.”

She pointed to the urgent need for government planning for a surge in people requiring support to return to work following long-term COVID-19 symptoms. According to occupational health research, only 10-40% of people who take 6 weeks off work return to work, dropping to 5%-10% after an absence of 6 months.

In her own case, she is recovering after 4 months of illness, including a hospital admission with gut symptoms and dehydration, and 2 weeks of social service home support. She has experienced a range of relapsing and remitting symptoms, which she describes as ‘bizarre and coming in phases’.
 

Stimulating recovery

The recently-announced NHS portal for COVID-19 patients has been welcomed by the authors as an opportunity for long-standing symptoms to reach the medical and Government radar. But Dr Taylor believes it should have been set up from the start with input from patients with symptoms, to make sure that any support provided reflects the nature of the problems experienced.

In her case, as a previously regular gym attender with a resting heart rate in the 50s, she has now been diagnosed as having multi-organ disease affecting her heart, spleen, lung, and autonomic system. She has fluid on the lungs and heart, and suffers from continuous chest pain and oxygen desaturation when lying down. She has not been able to work since she contracted COVID-19 in March.

“COVID patients with the chronic form of the disease need to be involved in research right from the start to ensure the right questions are asked - not just those who have had acute disease,” she insists to Medscape News UK. “We need to gather evidence, to inform the development of a multi-disciplinary approach and a range of rehabilitation options depending on the organs involved.

“The focus needs to be on stimulating recovery and preventing development of chronic problems. We still don’t know if those with chronic COVID disease are infectious, how long their prolonged cardio-respiratory and neurological complications will last, and crucially whether treatment will reduce the duration of their problems. The worry is that left unattended, these patients may develop irreversible damage leading to chronic illness.”
 

General practice

GPs have been at the forefront of management of the long-standing consequences of COVID-19. In its recent report General practice in the post-COVID world, the Royal College of General Practitioners highlights the need for urgent government planning and funding to prepare general practice services for facilitating the recovery of local communities.

The report calls on the four governments of the UK each to produce a comprehensive plan to support GPs in managing the longer-term effects of COVID-19 in the community, including costed proposals for additional funding for general practice; workforce solutions; reductions in regulatory burdens and ‘red tape’; a systematic approach for identifying patients most likely to need primary care support, and proposals for how health inequalities will be minimized to ensure all patients have access to the necessary post-COVID-19 care.

RCGP Chair Professor Martin Marshall said: “COVID-19 will leave a lingering and difficult legacy and it is GPs working with patients in their communities who will be picking up the pieces.”

One issue is the lack of a reliable estimate of the prevalence of post viral symptoms for other viruses, let alone for COVID-19. Even a 1% chance of long-term problems amongst survivors would suggest 2500 with a need for extra support, but experience with post-viral syndrome generally suggests the prevalence may be more like 3%.

The BMA has been carrying out tracker surveys of its own members at 2-week intervals since March. The most recent, involving more than 5000 doctors, indicated that around 30% of doctors who believed they’d had COVID-19 were still experiencing physical symptoms they thought were caused by the virus, 21% had taken sick leave, and a further 9% had taken annual leave to deal with ongoing symptoms.

Dr David Strain, chair of the BMA medical academic staff committee and clinical senior lecturer at the University of Exeter Medical School, has a particular interest in the after-effects of COVID-19. He said it was becoming evident that the virus was leaving a lasting legacy with a significant number of people, even younger ones.

He told Medscape News UK: “Once COVID-19 enters the nervous system, the lasting symptoms on people can range from a mild loss of sense of smell or taste, to more severe symptoms such as difficulties in concentration. A small number have also been left with chronic fatigue syndrome, which is poorly understood, and can be difficult to treat. This does not appear to be dependent on the initial severity of COVID-19 symptoms.

“Currently, it is impossible to predict the prevalence of longer-lasting effects. A full assessment of COVID-19’s impact will only be possible once people return to work on a regular basis and the effect on their physical health becomes evident. Of the doctors in the BMA survey who had experienced COVID-19, 15% took sick leave beyond their acute illness, and another 6% used annual leave allowance to extend their recovery time.

“Clearly, more research will be needed into the long-term consequences of COVID-19 and the future treatments needed to deal with them.”
 

Further research

The National Institute for Health Research (NIHR) has called for applications for research to enhance understanding and management of the health and social care consequences of the global COVID-19 pandemic beyond the acute phase, with a particular focus on ‘health outcomes, public health, social care and health service delivery and to mitigate the impact of subsequent phases and aftermath’.

The authors of The BMJ article stress the wide-ranging nature of  ‘long COVID’ symptoms and warn of the dangers of treating them for research purposes under the banner of chronic fatigue. They say: “These wide-ranging, unusual, and potentially very serious symptoms can be anxiety-provoking, particularly secondary to a virus that has only been known to the world for 8 months and which we have barely begun to understand. However, it is dismissive solely to attribute such symptoms to anxiety in the thousands of patients like ourselves who have attended hospital or general practice with chronic COVID-19.”

This article first appeared on Medscape.com.

Thousands of coronavirus patients risk going without treatment and support for debilitating symptoms lasting months because of a lack of awareness of ‘long COVID’, according to a group formed by clinicians with extended serious after-effects of the virus.

Many members of the 100-strong Facebook group UK doctors: COVID “Long tail” have been unable to work for weeks after failing to recover from an episode of COVID-19. They warn of the need for clinical recognition of “long COVID,” along with systems to log symptoms and manage patients in the community. Without this, there could be major consequences for return to work across all professions, as well as implications for disease prevention.
 

‘Weird symptoms’

Three of the group: Dr Amali Lokugamage, consultant obstetrician at the Whittington Hospital; Dr Sharon Taylor, child psychiatrist at St Mary’s Hospital London, and Dr Clare Rayner, a retired occupational health physician and lecturer at the University of Manchester, have highlighted their concerns in The BMJ and on social media groups. They say colleagues are observing a range of symptoms of long COVID in their practices.

These include cardiac, gut and respiratory symptoms, skin manifestations, neurological and psychiatric symptoms, severe fatigue, and relapsing fevers, sometimes continuing for more than 16 weeks, and which they say go well beyond definitions of chronic fatigue. The authors are also aware of a pattern of symptom clusters recurring every third or fourth day, which in some cases are so severe that people are having to take extended periods of sick leave.

Writing in The BMJ the authors say: “Concerns have been raised about the lack of awareness among NHS doctors, nurses, paramedics, and other healthcare professionals with regard to the prolonged, varied, and weird symptoms [of COVID-19].”

Speaking to Medscape News UK, Dr. Clare Rayner said: “We see a huge need that is not being met, because these cases are just not being seen in hospital. All the attention has been on the acute illness.”

She pointed to the urgent need for government planning for a surge in people requiring support to return to work following long-term COVID-19 symptoms. According to occupational health research, only 10-40% of people who take 6 weeks off work return to work, dropping to 5%-10% after an absence of 6 months.

In her own case, she is recovering after 4 months of illness, including a hospital admission with gut symptoms and dehydration, and 2 weeks of social service home support. She has experienced a range of relapsing and remitting symptoms, which she describes as ‘bizarre and coming in phases’.
 

Stimulating recovery

The recently-announced NHS portal for COVID-19 patients has been welcomed by the authors as an opportunity for long-standing symptoms to reach the medical and Government radar. But Dr Taylor believes it should have been set up from the start with input from patients with symptoms, to make sure that any support provided reflects the nature of the problems experienced.

In her case, as a previously regular gym attender with a resting heart rate in the 50s, she has now been diagnosed as having multi-organ disease affecting her heart, spleen, lung, and autonomic system. She has fluid on the lungs and heart, and suffers from continuous chest pain and oxygen desaturation when lying down. She has not been able to work since she contracted COVID-19 in March.

“COVID patients with the chronic form of the disease need to be involved in research right from the start to ensure the right questions are asked - not just those who have had acute disease,” she insists to Medscape News UK. “We need to gather evidence, to inform the development of a multi-disciplinary approach and a range of rehabilitation options depending on the organs involved.

“The focus needs to be on stimulating recovery and preventing development of chronic problems. We still don’t know if those with chronic COVID disease are infectious, how long their prolonged cardio-respiratory and neurological complications will last, and crucially whether treatment will reduce the duration of their problems. The worry is that left unattended, these patients may develop irreversible damage leading to chronic illness.”
 

General practice

GPs have been at the forefront of management of the long-standing consequences of COVID-19. In its recent report General practice in the post-COVID world, the Royal College of General Practitioners highlights the need for urgent government planning and funding to prepare general practice services for facilitating the recovery of local communities.

The report calls on the four governments of the UK each to produce a comprehensive plan to support GPs in managing the longer-term effects of COVID-19 in the community, including costed proposals for additional funding for general practice; workforce solutions; reductions in regulatory burdens and ‘red tape’; a systematic approach for identifying patients most likely to need primary care support, and proposals for how health inequalities will be minimized to ensure all patients have access to the necessary post-COVID-19 care.

RCGP Chair Professor Martin Marshall said: “COVID-19 will leave a lingering and difficult legacy and it is GPs working with patients in their communities who will be picking up the pieces.”

One issue is the lack of a reliable estimate of the prevalence of post viral symptoms for other viruses, let alone for COVID-19. Even a 1% chance of long-term problems amongst survivors would suggest 2500 with a need for extra support, but experience with post-viral syndrome generally suggests the prevalence may be more like 3%.

The BMA has been carrying out tracker surveys of its own members at 2-week intervals since March. The most recent, involving more than 5000 doctors, indicated that around 30% of doctors who believed they’d had COVID-19 were still experiencing physical symptoms they thought were caused by the virus, 21% had taken sick leave, and a further 9% had taken annual leave to deal with ongoing symptoms.

Dr David Strain, chair of the BMA medical academic staff committee and clinical senior lecturer at the University of Exeter Medical School, has a particular interest in the after-effects of COVID-19. He said it was becoming evident that the virus was leaving a lasting legacy with a significant number of people, even younger ones.

He told Medscape News UK: “Once COVID-19 enters the nervous system, the lasting symptoms on people can range from a mild loss of sense of smell or taste, to more severe symptoms such as difficulties in concentration. A small number have also been left with chronic fatigue syndrome, which is poorly understood, and can be difficult to treat. This does not appear to be dependent on the initial severity of COVID-19 symptoms.

“Currently, it is impossible to predict the prevalence of longer-lasting effects. A full assessment of COVID-19’s impact will only be possible once people return to work on a regular basis and the effect on their physical health becomes evident. Of the doctors in the BMA survey who had experienced COVID-19, 15% took sick leave beyond their acute illness, and another 6% used annual leave allowance to extend their recovery time.

“Clearly, more research will be needed into the long-term consequences of COVID-19 and the future treatments needed to deal with them.”
 

Further research

The National Institute for Health Research (NIHR) has called for applications for research to enhance understanding and management of the health and social care consequences of the global COVID-19 pandemic beyond the acute phase, with a particular focus on ‘health outcomes, public health, social care and health service delivery and to mitigate the impact of subsequent phases and aftermath’.

The authors of The BMJ article stress the wide-ranging nature of  ‘long COVID’ symptoms and warn of the dangers of treating them for research purposes under the banner of chronic fatigue. They say: “These wide-ranging, unusual, and potentially very serious symptoms can be anxiety-provoking, particularly secondary to a virus that has only been known to the world for 8 months and which we have barely begun to understand. However, it is dismissive solely to attribute such symptoms to anxiety in the thousands of patients like ourselves who have attended hospital or general practice with chronic COVID-19.”

This article first appeared on Medscape.com.

Thousands of coronavirus patients risk going without treatment and support for debilitating symptoms lasting months because of a lack of awareness of ‘long COVID’, according to a group formed by clinicians with extended serious after-effects of the virus.

Many members of the 100-strong Facebook group UK doctors: COVID “Long tail” have been unable to work for weeks after failing to recover from an episode of COVID-19. They warn of the need for clinical recognition of “long COVID,” along with systems to log symptoms and manage patients in the community. Without this, there could be major consequences for return to work across all professions, as well as implications for disease prevention.
 

‘Weird symptoms’

Three of the group: Dr Amali Lokugamage, consultant obstetrician at the Whittington Hospital; Dr Sharon Taylor, child psychiatrist at St Mary’s Hospital London, and Dr Clare Rayner, a retired occupational health physician and lecturer at the University of Manchester, have highlighted their concerns in The BMJ and on social media groups. They say colleagues are observing a range of symptoms of long COVID in their practices.

These include cardiac, gut and respiratory symptoms, skin manifestations, neurological and psychiatric symptoms, severe fatigue, and relapsing fevers, sometimes continuing for more than 16 weeks, and which they say go well beyond definitions of chronic fatigue. The authors are also aware of a pattern of symptom clusters recurring every third or fourth day, which in some cases are so severe that people are having to take extended periods of sick leave.

Writing in The BMJ the authors say: “Concerns have been raised about the lack of awareness among NHS doctors, nurses, paramedics, and other healthcare professionals with regard to the prolonged, varied, and weird symptoms [of COVID-19].”

Speaking to Medscape News UK, Dr. Clare Rayner said: “We see a huge need that is not being met, because these cases are just not being seen in hospital. All the attention has been on the acute illness.”

She pointed to the urgent need for government planning for a surge in people requiring support to return to work following long-term COVID-19 symptoms. According to occupational health research, only 10-40% of people who take 6 weeks off work return to work, dropping to 5%-10% after an absence of 6 months.

In her own case, she is recovering after 4 months of illness, including a hospital admission with gut symptoms and dehydration, and 2 weeks of social service home support. She has experienced a range of relapsing and remitting symptoms, which she describes as ‘bizarre and coming in phases’.
 

Stimulating recovery

The recently-announced NHS portal for COVID-19 patients has been welcomed by the authors as an opportunity for long-standing symptoms to reach the medical and Government radar. But Dr Taylor believes it should have been set up from the start with input from patients with symptoms, to make sure that any support provided reflects the nature of the problems experienced.

In her case, as a previously regular gym attender with a resting heart rate in the 50s, she has now been diagnosed as having multi-organ disease affecting her heart, spleen, lung, and autonomic system. She has fluid on the lungs and heart, and suffers from continuous chest pain and oxygen desaturation when lying down. She has not been able to work since she contracted COVID-19 in March.

“COVID patients with the chronic form of the disease need to be involved in research right from the start to ensure the right questions are asked - not just those who have had acute disease,” she insists to Medscape News UK. “We need to gather evidence, to inform the development of a multi-disciplinary approach and a range of rehabilitation options depending on the organs involved.

“The focus needs to be on stimulating recovery and preventing development of chronic problems. We still don’t know if those with chronic COVID disease are infectious, how long their prolonged cardio-respiratory and neurological complications will last, and crucially whether treatment will reduce the duration of their problems. The worry is that left unattended, these patients may develop irreversible damage leading to chronic illness.”
 

General practice

GPs have been at the forefront of management of the long-standing consequences of COVID-19. In its recent report General practice in the post-COVID world, the Royal College of General Practitioners highlights the need for urgent government planning and funding to prepare general practice services for facilitating the recovery of local communities.

The report calls on the four governments of the UK each to produce a comprehensive plan to support GPs in managing the longer-term effects of COVID-19 in the community, including costed proposals for additional funding for general practice; workforce solutions; reductions in regulatory burdens and ‘red tape’; a systematic approach for identifying patients most likely to need primary care support, and proposals for how health inequalities will be minimized to ensure all patients have access to the necessary post-COVID-19 care.

RCGP Chair Professor Martin Marshall said: “COVID-19 will leave a lingering and difficult legacy and it is GPs working with patients in their communities who will be picking up the pieces.”

One issue is the lack of a reliable estimate of the prevalence of post viral symptoms for other viruses, let alone for COVID-19. Even a 1% chance of long-term problems amongst survivors would suggest 2500 with a need for extra support, but experience with post-viral syndrome generally suggests the prevalence may be more like 3%.

The BMA has been carrying out tracker surveys of its own members at 2-week intervals since March. The most recent, involving more than 5000 doctors, indicated that around 30% of doctors who believed they’d had COVID-19 were still experiencing physical symptoms they thought were caused by the virus, 21% had taken sick leave, and a further 9% had taken annual leave to deal with ongoing symptoms.

Dr David Strain, chair of the BMA medical academic staff committee and clinical senior lecturer at the University of Exeter Medical School, has a particular interest in the after-effects of COVID-19. He said it was becoming evident that the virus was leaving a lasting legacy with a significant number of people, even younger ones.

He told Medscape News UK: “Once COVID-19 enters the nervous system, the lasting symptoms on people can range from a mild loss of sense of smell or taste, to more severe symptoms such as difficulties in concentration. A small number have also been left with chronic fatigue syndrome, which is poorly understood, and can be difficult to treat. This does not appear to be dependent on the initial severity of COVID-19 symptoms.

“Currently, it is impossible to predict the prevalence of longer-lasting effects. A full assessment of COVID-19’s impact will only be possible once people return to work on a regular basis and the effect on their physical health becomes evident. Of the doctors in the BMA survey who had experienced COVID-19, 15% took sick leave beyond their acute illness, and another 6% used annual leave allowance to extend their recovery time.

“Clearly, more research will be needed into the long-term consequences of COVID-19 and the future treatments needed to deal with them.”
 

Further research

The National Institute for Health Research (NIHR) has called for applications for research to enhance understanding and management of the health and social care consequences of the global COVID-19 pandemic beyond the acute phase, with a particular focus on ‘health outcomes, public health, social care and health service delivery and to mitigate the impact of subsequent phases and aftermath’.

The authors of The BMJ article stress the wide-ranging nature of  ‘long COVID’ symptoms and warn of the dangers of treating them for research purposes under the banner of chronic fatigue. They say: “These wide-ranging, unusual, and potentially very serious symptoms can be anxiety-provoking, particularly secondary to a virus that has only been known to the world for 8 months and which we have barely begun to understand. However, it is dismissive solely to attribute such symptoms to anxiety in the thousands of patients like ourselves who have attended hospital or general practice with chronic COVID-19.”

This article first appeared on Medscape.com.

The combination of ticagrelor and aspirin is superior to aspirin alone in reducing the risk for secondary stroke, transient ischemic attack (TIA), and death, new data show. However, severe bleeding was more common in the ticagrelor/aspirin group than in the aspirin-only group.

“We found that ticagrelor plus aspirin reduced the risk of stroke or death, compared to aspirin alone in patients presenting acutely with stroke or TIA,” reported lead author S. Claiborne Johnston, MD, PhD, dean and vice president for medical affairs, Dell Medical School, the University of Texas, Austin.

Although the combination also increased the risk for major hemorrhage, that increase was small and would not overwhelm the benefit, he said.

The study was published online July 16 in The New England Journal of Medicine.
 

Attractive properties

“Lots of patients have stroke in the days to weeks after first presenting with a stroke or TIA,” said Dr. Johnston, who is also the Frank and Charmaine Denius Distinguished Dean’s Chair at Dell Medical School. “Aspirin has been the standard of care but is only partially effective. Clopidogrel plus aspirin is another option that has recently been proven, [but] ticagrelor has attractive properties as an antiplatelet agent and works synergistically with aspirin,” he added.

Ticagrelor is a direct-acting antiplatelet agent that does not depend on metabolic activation and that “reversibly binds” and inhibits the P2Y12 receptor on platelets. Previous research has evaluated clopidogrel and aspirin for the secondary prevention of ischemic stroke or TIA. In an earlier trial, ticagrelor was no better than aspirin in preventing these subsequent events. However, the investigators noted that the combination of the two drugs has not been well studied.

The randomized, placebo-controlled, double-blind trial involved 11,016 patients at 414 sites in 28 countries. Patients who had experienced mild to moderate acute noncardioembolic ischemic stroke (mean age, 65 years; 39% women; roughly 54% White) were randomly assigned to receive either ticagrelor plus aspirin (n = 5,523) or aspirin alone (n = 5,493) for 30 days. Of these patients, 91% had sustained a stroke, and 9% had sustained a TIA.

Thirty days was chosen as the treatment period because the risk for subsequent stroke tends to occur mainly in the first month after an acute ischemic stroke or TIA. The primary outcome was “a composite of stroke or death in a time-to-first-event analysis from randomization to 30 days of follow-up.” For the study, “stroke” encompassed ischemic, hemorrhagic, or stroke of undetermined type, and “death” included deaths of all causes. Secondary outcomes included first subsequent ischemic stroke and disability (defined as a score of >1 on the Rankin Scale).

Almost all patients (99.5%) were taking aspirin during the treatment period, and most were also taking an antihypertensive and a statin (74% and 83%, respectively).

Patients in the ticagrelor/aspirin group had fewer primary-outcome events in comparison with those in the aspirin-only group (303 patients [5.5%] vs. 362 patients [6.6%]; hazard ratio, 0.83; 95% confidence interval, 0.71-0.96; P = 0.02). Incidence of subsequent ischemic stroke were similarly lower in the ticagrelor/aspirin group in comparison with the aspirin-only group (276 patients [5.0%] vs. 345 patients [6.3%]; HR, 0.79; 95% CI, 0.68-0.93; P = .004).

On the other hand, there was no significant difference between the groups in the incidence of overall disability (23.8% of the patients in the ticagrelor/aspirin group and in 24.1% of the patients in the aspirin group; odds ratio, 0.98; 95% CI, 0.89-1.07; P = .61).

There were differences between the groups in severe bleeding, which occurred in 28 patients (0.5%) in the ticagrelor/aspirin group and in seven patients (0.15) in the ticagrelor group (HR, 3.99; 95% CI, 1.74-9.14; P = .001). Moreover, more patients in the ticagrelor/aspirin group experienced a composite of intracranial hemorrhage or fatal bleeding compared with the aspirin-only group (0.4% vs 0.1%). Fatal bleeding occurred in 0.2% of patients in the ticagrelor/aspirin group versus 0.1% of patients in the aspirin group. More patients in the ticagrelor-aspirin group permanently discontinued the treatment because of bleeding than in the aspirin-only group (2.8% vs. 0.6%).

“The benefit from treatment with ticagrelor/aspirin, as compared with aspirin alone, would be expected to result in a number needed to treat of 92 to prevent one primary outcome event, and a number needed to harm of 263 for severe bleeding,” the authors noted.
 

Risks versus benefits

Commenting on the study, Konark Malhotra, MD, a vascular neurologist at Allegheny Health Network, Pittsburgh, noted that ticagrelor is an antiplatelet medication “that adds to the armamentarium of stroke neurologists for the treatment of mild acute ischemic or high-risk TIA patients.” Dr. Malhotra, who was not involved with the study, added that the “combined use of ticagrelor and aspirin is effective in the reduction of ischemic events, however, at the expense of increased risk of bleeding events.”

In an accompanying editorial, Peter Rothwell, MD, PhD, of the Wolfson Center for Prevention of Stroke and Dementia, Nuffield Department of Clinical Neurosciences at the University of Oxford (England) who was not involved with the study, suggested that the “bleeding risk associated with ticagrelor and aspirin might exceed the benefit among lower-risk patients who make up the majority in practice, and so the results should not be overgeneralized.” Moreover, “regardless of which combination of antiplatelet therapy is favored for the high-risk minority, all patients should receive aspirin immediately after TIA, unless aspirin is contraindicated.”

He noted that “too many patients are sent home from emergency departments without this simple treatment that substantially reduces the risk and severity of early recurrent stroke.”

The study was supported by AstraZeneca. Dr. Johnston has received a grant from AstraZeneca and nonfinancial support from SANOFI. Dr. Rothwell has received personal fees from Bayer and BMS. Dr. Malhotra has disclosed no relevant financial relationships.

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

The combination of ticagrelor and aspirin is superior to aspirin alone in reducing the risk for secondary stroke, transient ischemic attack (TIA), and death, new data show. However, severe bleeding was more common in the ticagrelor/aspirin group than in the aspirin-only group.

“We found that ticagrelor plus aspirin reduced the risk of stroke or death, compared to aspirin alone in patients presenting acutely with stroke or TIA,” reported lead author S. Claiborne Johnston, MD, PhD, dean and vice president for medical affairs, Dell Medical School, the University of Texas, Austin.

Although the combination also increased the risk for major hemorrhage, that increase was small and would not overwhelm the benefit, he said.

The study was published online July 16 in The New England Journal of Medicine.
 

Attractive properties

“Lots of patients have stroke in the days to weeks after first presenting with a stroke or TIA,” said Dr. Johnston, who is also the Frank and Charmaine Denius Distinguished Dean’s Chair at Dell Medical School. “Aspirin has been the standard of care but is only partially effective. Clopidogrel plus aspirin is another option that has recently been proven, [but] ticagrelor has attractive properties as an antiplatelet agent and works synergistically with aspirin,” he added.

Ticagrelor is a direct-acting antiplatelet agent that does not depend on metabolic activation and that “reversibly binds” and inhibits the P2Y12 receptor on platelets. Previous research has evaluated clopidogrel and aspirin for the secondary prevention of ischemic stroke or TIA. In an earlier trial, ticagrelor was no better than aspirin in preventing these subsequent events. However, the investigators noted that the combination of the two drugs has not been well studied.

The randomized, placebo-controlled, double-blind trial involved 11,016 patients at 414 sites in 28 countries. Patients who had experienced mild to moderate acute noncardioembolic ischemic stroke (mean age, 65 years; 39% women; roughly 54% White) were randomly assigned to receive either ticagrelor plus aspirin (n = 5,523) or aspirin alone (n = 5,493) for 30 days. Of these patients, 91% had sustained a stroke, and 9% had sustained a TIA.

Thirty days was chosen as the treatment period because the risk for subsequent stroke tends to occur mainly in the first month after an acute ischemic stroke or TIA. The primary outcome was “a composite of stroke or death in a time-to-first-event analysis from randomization to 30 days of follow-up.” For the study, “stroke” encompassed ischemic, hemorrhagic, or stroke of undetermined type, and “death” included deaths of all causes. Secondary outcomes included first subsequent ischemic stroke and disability (defined as a score of >1 on the Rankin Scale).

Almost all patients (99.5%) were taking aspirin during the treatment period, and most were also taking an antihypertensive and a statin (74% and 83%, respectively).

Patients in the ticagrelor/aspirin group had fewer primary-outcome events in comparison with those in the aspirin-only group (303 patients [5.5%] vs. 362 patients [6.6%]; hazard ratio, 0.83; 95% confidence interval, 0.71-0.96; P = 0.02). Incidence of subsequent ischemic stroke were similarly lower in the ticagrelor/aspirin group in comparison with the aspirin-only group (276 patients [5.0%] vs. 345 patients [6.3%]; HR, 0.79; 95% CI, 0.68-0.93; P = .004).

On the other hand, there was no significant difference between the groups in the incidence of overall disability (23.8% of the patients in the ticagrelor/aspirin group and in 24.1% of the patients in the aspirin group; odds ratio, 0.98; 95% CI, 0.89-1.07; P = .61).

There were differences between the groups in severe bleeding, which occurred in 28 patients (0.5%) in the ticagrelor/aspirin group and in seven patients (0.15) in the ticagrelor group (HR, 3.99; 95% CI, 1.74-9.14; P = .001). Moreover, more patients in the ticagrelor/aspirin group experienced a composite of intracranial hemorrhage or fatal bleeding compared with the aspirin-only group (0.4% vs 0.1%). Fatal bleeding occurred in 0.2% of patients in the ticagrelor/aspirin group versus 0.1% of patients in the aspirin group. More patients in the ticagrelor-aspirin group permanently discontinued the treatment because of bleeding than in the aspirin-only group (2.8% vs. 0.6%).

“The benefit from treatment with ticagrelor/aspirin, as compared with aspirin alone, would be expected to result in a number needed to treat of 92 to prevent one primary outcome event, and a number needed to harm of 263 for severe bleeding,” the authors noted.
 

Risks versus benefits

Commenting on the study, Konark Malhotra, MD, a vascular neurologist at Allegheny Health Network, Pittsburgh, noted that ticagrelor is an antiplatelet medication “that adds to the armamentarium of stroke neurologists for the treatment of mild acute ischemic or high-risk TIA patients.” Dr. Malhotra, who was not involved with the study, added that the “combined use of ticagrelor and aspirin is effective in the reduction of ischemic events, however, at the expense of increased risk of bleeding events.”

In an accompanying editorial, Peter Rothwell, MD, PhD, of the Wolfson Center for Prevention of Stroke and Dementia, Nuffield Department of Clinical Neurosciences at the University of Oxford (England) who was not involved with the study, suggested that the “bleeding risk associated with ticagrelor and aspirin might exceed the benefit among lower-risk patients who make up the majority in practice, and so the results should not be overgeneralized.” Moreover, “regardless of which combination of antiplatelet therapy is favored for the high-risk minority, all patients should receive aspirin immediately after TIA, unless aspirin is contraindicated.”

He noted that “too many patients are sent home from emergency departments without this simple treatment that substantially reduces the risk and severity of early recurrent stroke.”

The study was supported by AstraZeneca. Dr. Johnston has received a grant from AstraZeneca and nonfinancial support from SANOFI. Dr. Rothwell has received personal fees from Bayer and BMS. Dr. Malhotra has disclosed no relevant financial relationships.

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

The combination of ticagrelor and aspirin is superior to aspirin alone in reducing the risk for secondary stroke, transient ischemic attack (TIA), and death, new data show. However, severe bleeding was more common in the ticagrelor/aspirin group than in the aspirin-only group.

“We found that ticagrelor plus aspirin reduced the risk of stroke or death, compared to aspirin alone in patients presenting acutely with stroke or TIA,” reported lead author S. Claiborne Johnston, MD, PhD, dean and vice president for medical affairs, Dell Medical School, the University of Texas, Austin.

Although the combination also increased the risk for major hemorrhage, that increase was small and would not overwhelm the benefit, he said.

The study was published online July 16 in The New England Journal of Medicine.
 

Attractive properties

“Lots of patients have stroke in the days to weeks after first presenting with a stroke or TIA,” said Dr. Johnston, who is also the Frank and Charmaine Denius Distinguished Dean’s Chair at Dell Medical School. “Aspirin has been the standard of care but is only partially effective. Clopidogrel plus aspirin is another option that has recently been proven, [but] ticagrelor has attractive properties as an antiplatelet agent and works synergistically with aspirin,” he added.

Ticagrelor is a direct-acting antiplatelet agent that does not depend on metabolic activation and that “reversibly binds” and inhibits the P2Y12 receptor on platelets. Previous research has evaluated clopidogrel and aspirin for the secondary prevention of ischemic stroke or TIA. In an earlier trial, ticagrelor was no better than aspirin in preventing these subsequent events. However, the investigators noted that the combination of the two drugs has not been well studied.

The randomized, placebo-controlled, double-blind trial involved 11,016 patients at 414 sites in 28 countries. Patients who had experienced mild to moderate acute noncardioembolic ischemic stroke (mean age, 65 years; 39% women; roughly 54% White) were randomly assigned to receive either ticagrelor plus aspirin (n = 5,523) or aspirin alone (n = 5,493) for 30 days. Of these patients, 91% had sustained a stroke, and 9% had sustained a TIA.

Thirty days was chosen as the treatment period because the risk for subsequent stroke tends to occur mainly in the first month after an acute ischemic stroke or TIA. The primary outcome was “a composite of stroke or death in a time-to-first-event analysis from randomization to 30 days of follow-up.” For the study, “stroke” encompassed ischemic, hemorrhagic, or stroke of undetermined type, and “death” included deaths of all causes. Secondary outcomes included first subsequent ischemic stroke and disability (defined as a score of >1 on the Rankin Scale).

Almost all patients (99.5%) were taking aspirin during the treatment period, and most were also taking an antihypertensive and a statin (74% and 83%, respectively).

Patients in the ticagrelor/aspirin group had fewer primary-outcome events in comparison with those in the aspirin-only group (303 patients [5.5%] vs. 362 patients [6.6%]; hazard ratio, 0.83; 95% confidence interval, 0.71-0.96; P = 0.02). Incidence of subsequent ischemic stroke were similarly lower in the ticagrelor/aspirin group in comparison with the aspirin-only group (276 patients [5.0%] vs. 345 patients [6.3%]; HR, 0.79; 95% CI, 0.68-0.93; P = .004).

On the other hand, there was no significant difference between the groups in the incidence of overall disability (23.8% of the patients in the ticagrelor/aspirin group and in 24.1% of the patients in the aspirin group; odds ratio, 0.98; 95% CI, 0.89-1.07; P = .61).

There were differences between the groups in severe bleeding, which occurred in 28 patients (0.5%) in the ticagrelor/aspirin group and in seven patients (0.15) in the ticagrelor group (HR, 3.99; 95% CI, 1.74-9.14; P = .001). Moreover, more patients in the ticagrelor/aspirin group experienced a composite of intracranial hemorrhage or fatal bleeding compared with the aspirin-only group (0.4% vs 0.1%). Fatal bleeding occurred in 0.2% of patients in the ticagrelor/aspirin group versus 0.1% of patients in the aspirin group. More patients in the ticagrelor-aspirin group permanently discontinued the treatment because of bleeding than in the aspirin-only group (2.8% vs. 0.6%).

“The benefit from treatment with ticagrelor/aspirin, as compared with aspirin alone, would be expected to result in a number needed to treat of 92 to prevent one primary outcome event, and a number needed to harm of 263 for severe bleeding,” the authors noted.
 

Risks versus benefits

Commenting on the study, Konark Malhotra, MD, a vascular neurologist at Allegheny Health Network, Pittsburgh, noted that ticagrelor is an antiplatelet medication “that adds to the armamentarium of stroke neurologists for the treatment of mild acute ischemic or high-risk TIA patients.” Dr. Malhotra, who was not involved with the study, added that the “combined use of ticagrelor and aspirin is effective in the reduction of ischemic events, however, at the expense of increased risk of bleeding events.”

In an accompanying editorial, Peter Rothwell, MD, PhD, of the Wolfson Center for Prevention of Stroke and Dementia, Nuffield Department of Clinical Neurosciences at the University of Oxford (England) who was not involved with the study, suggested that the “bleeding risk associated with ticagrelor and aspirin might exceed the benefit among lower-risk patients who make up the majority in practice, and so the results should not be overgeneralized.” Moreover, “regardless of which combination of antiplatelet therapy is favored for the high-risk minority, all patients should receive aspirin immediately after TIA, unless aspirin is contraindicated.”

He noted that “too many patients are sent home from emergency departments without this simple treatment that substantially reduces the risk and severity of early recurrent stroke.”

The study was supported by AstraZeneca. Dr. Johnston has received a grant from AstraZeneca and nonfinancial support from SANOFI. Dr. Rothwell has received personal fees from Bayer and BMS. Dr. Malhotra has disclosed no relevant financial relationships.

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

Work-life balance was the top concern for female physicians who responded to a new Medscape survey, far outpacing concerns about pay.

A psychiatrist who responded to the survey commented, “I’ve been trying to use all my vacation to spend time with my spouse. I’m always apologizing for being late, not being able to go to an event due to my work schedule, and missing out on life with my husband.”

Nearly two thirds (64%) said the balance was their top concern whereas 43% put pay at the top.

Medscape surveyed more than 3,000 women physicians about how they deal with parenthood, work pressures, and relationships in Women Physicians 2020: The Issues They Care About.
 

Almost all are making personal trade-offs

An overwhelming percentage (94%) said they have had to make personal trade-offs for work obligations.

“Women are more likely to make work compromises to benefit their families,” a cardiologist responded. “I won’t/can’t take a position that would disrupt my husband’s community ties, my children’s schooling, and relationships with family.”

More than one-third of women (36%) said that being a woman had a negative or very negative impact on their compensation. Only 4% said their gender had a positive or very positive impact on pay and 59% said gender had no effect.

The Medscape Physician Compensation Report 2020 showed male specialists made 31% more than their female counterparts and male primary care physicians earned 25% more.

Some factors may help explain some of the difference, but others remain unclear.

Poor negotiating skills have long been cited as a reason women get paid less; in this survey 39% said they were unskilled or very unskilled in salary negotiations, compared with 28% who said they were skilled or very skilled in those talks.

Katie Donovan, founder of Equal Pay Negotiations, reports that only 30% of women negotiate pay at all, compared with 46% of men.

Additionally, women tend to gravitate in specialties that don’t pay as well.

They are poorly represented in some of the highest-paying specialties: orthopedics (9%), urology (12%), and cardiology (14%).

“Society’s view of women as caretaker is powerful,” a radiologist commented. “Women feel like they need to choose specialties where they can work part-time or flexible time in order to be the primary caretaker at home.”
 

Confidence high in leadership abilities

The survey asked women about their confidence in taking a leadership role, and 90% answered that they were confident about taking such a role. However, only half said they had a leadership or supervisory role.

According to the American Medical Association, women make up 3% of healthcare chief medical officers, 6% of department chairs, and 9% of division leaders.

Asked whether women have experienced gender inequity in the workplace, respondents were almost evenly split, but hospital-based physicians at 61% were more likely to report inequity than were 42% of office-based physicians.

A family physician responded, “I have experienced gender inequality more from administrators than from my male colleagues. I think it’s coming from corporate more than from medical professionals.”

In this survey, 3% said their male colleagues were unsupportive of gender equality in the workplace.

The survey responses indicate most women physicians who have children are also conflicted as parents regarding their careers. Almost two-thirds (64%) said they were always or often conflicted with these dueling priorities; only 8% said they sometimes or rarely are.

Those conflicts start even before having children. More than half in this survey (52%) said their career influenced the number of children they have.

A family physician said, “I delayed starting a family because of my career. That affected my fertility and made it hard to complete [in-vitro fertilization].”
 

Family responsibilities meet stigma

Half of the respondents said women physicians are stigmatized for taking a full maternity leave (6 weeks or longer). An even higher percentage (65%) said women are stigmatized for taking more flexible or fewer hours to accommodate family responsibilities.

A 2019 survey of 844 physician mothers found that physicians who took maternity leave received lower peer evaluation scores, lost potential income, and reported experiencing discrimination. One-quarter of the participants (25.8%) reported experiencing discrimination related to breastfeeding or breast milk pumping upon their return to work.

Burnout at work puts stress on primary relationships, 63% of respondents said, although 24% said it did not strain those relationships. Thirteen percent of women gave the response “not applicable.”

“I try to be present when I’m home, but to be honest, I don’t deal with it very well,” a family physician commented.

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

Work-life balance was the top concern for female physicians who responded to a new Medscape survey, far outpacing concerns about pay.

A psychiatrist who responded to the survey commented, “I’ve been trying to use all my vacation to spend time with my spouse. I’m always apologizing for being late, not being able to go to an event due to my work schedule, and missing out on life with my husband.”

Nearly two thirds (64%) said the balance was their top concern whereas 43% put pay at the top.

Medscape surveyed more than 3,000 women physicians about how they deal with parenthood, work pressures, and relationships in Women Physicians 2020: The Issues They Care About.
 

Almost all are making personal trade-offs

An overwhelming percentage (94%) said they have had to make personal trade-offs for work obligations.

“Women are more likely to make work compromises to benefit their families,” a cardiologist responded. “I won’t/can’t take a position that would disrupt my husband’s community ties, my children’s schooling, and relationships with family.”

More than one-third of women (36%) said that being a woman had a negative or very negative impact on their compensation. Only 4% said their gender had a positive or very positive impact on pay and 59% said gender had no effect.

The Medscape Physician Compensation Report 2020 showed male specialists made 31% more than their female counterparts and male primary care physicians earned 25% more.

Some factors may help explain some of the difference, but others remain unclear.

Poor negotiating skills have long been cited as a reason women get paid less; in this survey 39% said they were unskilled or very unskilled in salary negotiations, compared with 28% who said they were skilled or very skilled in those talks.

Katie Donovan, founder of Equal Pay Negotiations, reports that only 30% of women negotiate pay at all, compared with 46% of men.

Additionally, women tend to gravitate in specialties that don’t pay as well.

They are poorly represented in some of the highest-paying specialties: orthopedics (9%), urology (12%), and cardiology (14%).

“Society’s view of women as caretaker is powerful,” a radiologist commented. “Women feel like they need to choose specialties where they can work part-time or flexible time in order to be the primary caretaker at home.”
 

Confidence high in leadership abilities

The survey asked women about their confidence in taking a leadership role, and 90% answered that they were confident about taking such a role. However, only half said they had a leadership or supervisory role.

According to the American Medical Association, women make up 3% of healthcare chief medical officers, 6% of department chairs, and 9% of division leaders.

Asked whether women have experienced gender inequity in the workplace, respondents were almost evenly split, but hospital-based physicians at 61% were more likely to report inequity than were 42% of office-based physicians.

A family physician responded, “I have experienced gender inequality more from administrators than from my male colleagues. I think it’s coming from corporate more than from medical professionals.”

In this survey, 3% said their male colleagues were unsupportive of gender equality in the workplace.

The survey responses indicate most women physicians who have children are also conflicted as parents regarding their careers. Almost two-thirds (64%) said they were always or often conflicted with these dueling priorities; only 8% said they sometimes or rarely are.

Those conflicts start even before having children. More than half in this survey (52%) said their career influenced the number of children they have.

A family physician said, “I delayed starting a family because of my career. That affected my fertility and made it hard to complete [in-vitro fertilization].”
 

Family responsibilities meet stigma

Half of the respondents said women physicians are stigmatized for taking a full maternity leave (6 weeks or longer). An even higher percentage (65%) said women are stigmatized for taking more flexible or fewer hours to accommodate family responsibilities.

A 2019 survey of 844 physician mothers found that physicians who took maternity leave received lower peer evaluation scores, lost potential income, and reported experiencing discrimination. One-quarter of the participants (25.8%) reported experiencing discrimination related to breastfeeding or breast milk pumping upon their return to work.

Burnout at work puts stress on primary relationships, 63% of respondents said, although 24% said it did not strain those relationships. Thirteen percent of women gave the response “not applicable.”

“I try to be present when I’m home, but to be honest, I don’t deal with it very well,” a family physician commented.

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

Work-life balance was the top concern for female physicians who responded to a new Medscape survey, far outpacing concerns about pay.

A psychiatrist who responded to the survey commented, “I’ve been trying to use all my vacation to spend time with my spouse. I’m always apologizing for being late, not being able to go to an event due to my work schedule, and missing out on life with my husband.”

Nearly two thirds (64%) said the balance was their top concern whereas 43% put pay at the top.

Medscape surveyed more than 3,000 women physicians about how they deal with parenthood, work pressures, and relationships in Women Physicians 2020: The Issues They Care About.
 

Almost all are making personal trade-offs

An overwhelming percentage (94%) said they have had to make personal trade-offs for work obligations.

“Women are more likely to make work compromises to benefit their families,” a cardiologist responded. “I won’t/can’t take a position that would disrupt my husband’s community ties, my children’s schooling, and relationships with family.”

More than one-third of women (36%) said that being a woman had a negative or very negative impact on their compensation. Only 4% said their gender had a positive or very positive impact on pay and 59% said gender had no effect.

The Medscape Physician Compensation Report 2020 showed male specialists made 31% more than their female counterparts and male primary care physicians earned 25% more.

Some factors may help explain some of the difference, but others remain unclear.

Poor negotiating skills have long been cited as a reason women get paid less; in this survey 39% said they were unskilled or very unskilled in salary negotiations, compared with 28% who said they were skilled or very skilled in those talks.

Katie Donovan, founder of Equal Pay Negotiations, reports that only 30% of women negotiate pay at all, compared with 46% of men.

Additionally, women tend to gravitate in specialties that don’t pay as well.

They are poorly represented in some of the highest-paying specialties: orthopedics (9%), urology (12%), and cardiology (14%).

“Society’s view of women as caretaker is powerful,” a radiologist commented. “Women feel like they need to choose specialties where they can work part-time or flexible time in order to be the primary caretaker at home.”
 

Confidence high in leadership abilities

The survey asked women about their confidence in taking a leadership role, and 90% answered that they were confident about taking such a role. However, only half said they had a leadership or supervisory role.

According to the American Medical Association, women make up 3% of healthcare chief medical officers, 6% of department chairs, and 9% of division leaders.

Asked whether women have experienced gender inequity in the workplace, respondents were almost evenly split, but hospital-based physicians at 61% were more likely to report inequity than were 42% of office-based physicians.

A family physician responded, “I have experienced gender inequality more from administrators than from my male colleagues. I think it’s coming from corporate more than from medical professionals.”

In this survey, 3% said their male colleagues were unsupportive of gender equality in the workplace.

The survey responses indicate most women physicians who have children are also conflicted as parents regarding their careers. Almost two-thirds (64%) said they were always or often conflicted with these dueling priorities; only 8% said they sometimes or rarely are.

Those conflicts start even before having children. More than half in this survey (52%) said their career influenced the number of children they have.

A family physician said, “I delayed starting a family because of my career. That affected my fertility and made it hard to complete [in-vitro fertilization].”
 

Family responsibilities meet stigma

Half of the respondents said women physicians are stigmatized for taking a full maternity leave (6 weeks or longer). An even higher percentage (65%) said women are stigmatized for taking more flexible or fewer hours to accommodate family responsibilities.

A 2019 survey of 844 physician mothers found that physicians who took maternity leave received lower peer evaluation scores, lost potential income, and reported experiencing discrimination. One-quarter of the participants (25.8%) reported experiencing discrimination related to breastfeeding or breast milk pumping upon their return to work.

Burnout at work puts stress on primary relationships, 63% of respondents said, although 24% said it did not strain those relationships. Thirteen percent of women gave the response “not applicable.”

“I try to be present when I’m home, but to be honest, I don’t deal with it very well,” a family physician commented.

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

“The sewer is the conscience of the city. Everything there converges and confronts everything else. In that livid spot there are shades, but there are no longer any secrets.” Victor Hugo – “Les Miserables”

To get a sense of the prevalence of COVID-19 in a community you need to test hundreds to thousands of people. This is difficult, resource intensive, and requires cooperation for testing among people both with and without symptoms. It turns out that Sewage Chemical Information Mining (SCIM), a technology that has been in development for over a decade, is now being developed to track COVID-19.

In various locations from China to medieval London, there have been attempts to utilize human excrement for the betterment of mankind, from employing it as fertilizer to processing it to make gunpowder. Such attempts did not always work as planned. The use of sewage for fertilizer in Europe and the United States in the 1840s and 1850s led to the spread of waterborne diseases, including cholera and typhoid. As the importance of sanitary elimination of human waste became ever clearer, ideas and technology for our modern system of sewage management evolved. We have since advanced a great deal, so that all industrialized nations now have a well-developed system for clean water entry, as well as sewage treatment and disposal. Nonetheless, there remains a nagging question of whether human waste could be used for something productive.¹

In the early 2000s, SCIM was developed as a technique to assess population-level human health and disease. In SCIM, untreated sewage is tested for a chemical of interest which reflects a health parameter for a community. Chemicals of interest and usage rates can be calculated for substances as varied as opioids, tobacco, pesticides, and even nonnutritive sweeteners. For instance, relative opioid use can be calculated over time for a given “sewershed” or sewage catchment area. The calculation of community-wide exposure to substances as a means of getting real-time data on shifts of usage without having to collect and collate data from thousands of individuals has been termed wastewater-based epidemiology.

We use urine and stool testing in so many other areas, such as urinalysis, urine drug testing, urine Legionella antigen testing, and stool testing for common pathogens. What a rich source of information is present in the combination of urine and stool that collectively make up sewage! With the average volume of urine per adult being approximately 1 liter daily (and with urine calculated to be approximately 1% of wastewater), accurate analytic techniques can estimate per capita exposure to different substances. Applications of wastewater-based epidemiology have included tracking community prevalence of enteric viral infections, opioid and tobacco use, and many other indicators of health and disease.²

Given the enormous work in the field over the last 2 decades and that SARS-CoV-2 RNA has been detected in feces of both symptomatic and asymptomatic patients, it was only a short conceptual step for those familiar with sewage epidemiology to consider adapting it to assess the prevalence of COVID-19 in a community.

An elegant study collected untreated sewage from southeast Queensland, Australia. The sewage was processed, concentrated, and then tested with reverse transcriptase polymerase chain reaction analysis for SARS-CoV-2 RNA. The number of RNA copies was then entered into an equation that included the population served by the sewage encatchment area, as well as the measured liters of wastewater and grams of feces per day. This provided an estimate of the number of persons infected in the community, and the researchers were able to show reasonable agreement between the numbers estimated by sewage analysis and that found in traditional clinical testing.^3,4

The promise of wastewater-based epidemiology is large. Early research indicates that quantification of viral particles in sewage can be accurately assessed and correlated with the prevalence of the infection in the community. Such levels can then be used to track infection rates of COVID-19 over time, as well as to compare the relative rates in different communities.

Our sewage may hold the answer to accurately and easily tracking COVID-19, and ultimately help us gain a better hold on this disease.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. History of water supply and sanitation. Wikipedia, https://en.wikipedia.org/wiki/History_of_water_supply_and_sanitation.

2. Daughton C. Monitoring wastewater for assessing community health: Sewage Chemical-Information Mining (SCIM). Sci Total Environ. 2017 Nov 29. doi: 10.1016/j.scitotenv.2017.11.102.

3. Ahmed W et al. First confirmed detection of SARS-CoV-2 in untreated wastewater in Australia: A proof of concept for the wastewater surveillance of COVID-19 in the community. Sci Total Environ. 2020 Apr 18. doi: doi.org/10.1016/j.scitotenv.2020.138764.

4. Daughton C. The international imperative to rapidly and inexpensively monitor community-wide COVID-19 infection status and trends. Sci Total Environ. 2020 Mar 23. doi: 10.1016/j.scitotenv.2020.138149.

“The sewer is the conscience of the city. Everything there converges and confronts everything else. In that livid spot there are shades, but there are no longer any secrets.” Victor Hugo – “Les Miserables”

To get a sense of the prevalence of COVID-19 in a community you need to test hundreds to thousands of people. This is difficult, resource intensive, and requires cooperation for testing among people both with and without symptoms. It turns out that Sewage Chemical Information Mining (SCIM), a technology that has been in development for over a decade, is now being developed to track COVID-19.

In various locations from China to medieval London, there have been attempts to utilize human excrement for the betterment of mankind, from employing it as fertilizer to processing it to make gunpowder. Such attempts did not always work as planned. The use of sewage for fertilizer in Europe and the United States in the 1840s and 1850s led to the spread of waterborne diseases, including cholera and typhoid. As the importance of sanitary elimination of human waste became ever clearer, ideas and technology for our modern system of sewage management evolved. We have since advanced a great deal, so that all industrialized nations now have a well-developed system for clean water entry, as well as sewage treatment and disposal. Nonetheless, there remains a nagging question of whether human waste could be used for something productive.¹

In the early 2000s, SCIM was developed as a technique to assess population-level human health and disease. In SCIM, untreated sewage is tested for a chemical of interest which reflects a health parameter for a community. Chemicals of interest and usage rates can be calculated for substances as varied as opioids, tobacco, pesticides, and even nonnutritive sweeteners. For instance, relative opioid use can be calculated over time for a given “sewershed” or sewage catchment area. The calculation of community-wide exposure to substances as a means of getting real-time data on shifts of usage without having to collect and collate data from thousands of individuals has been termed wastewater-based epidemiology.

We use urine and stool testing in so many other areas, such as urinalysis, urine drug testing, urine Legionella antigen testing, and stool testing for common pathogens. What a rich source of information is present in the combination of urine and stool that collectively make up sewage! With the average volume of urine per adult being approximately 1 liter daily (and with urine calculated to be approximately 1% of wastewater), accurate analytic techniques can estimate per capita exposure to different substances. Applications of wastewater-based epidemiology have included tracking community prevalence of enteric viral infections, opioid and tobacco use, and many other indicators of health and disease.²

Given the enormous work in the field over the last 2 decades and that SARS-CoV-2 RNA has been detected in feces of both symptomatic and asymptomatic patients, it was only a short conceptual step for those familiar with sewage epidemiology to consider adapting it to assess the prevalence of COVID-19 in a community.

An elegant study collected untreated sewage from southeast Queensland, Australia. The sewage was processed, concentrated, and then tested with reverse transcriptase polymerase chain reaction analysis for SARS-CoV-2 RNA. The number of RNA copies was then entered into an equation that included the population served by the sewage encatchment area, as well as the measured liters of wastewater and grams of feces per day. This provided an estimate of the number of persons infected in the community, and the researchers were able to show reasonable agreement between the numbers estimated by sewage analysis and that found in traditional clinical testing.^3,4

The promise of wastewater-based epidemiology is large. Early research indicates that quantification of viral particles in sewage can be accurately assessed and correlated with the prevalence of the infection in the community. Such levels can then be used to track infection rates of COVID-19 over time, as well as to compare the relative rates in different communities.

Our sewage may hold the answer to accurately and easily tracking COVID-19, and ultimately help us gain a better hold on this disease.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. History of water supply and sanitation. Wikipedia, https://en.wikipedia.org/wiki/History_of_water_supply_and_sanitation.

2. Daughton C. Monitoring wastewater for assessing community health: Sewage Chemical-Information Mining (SCIM). Sci Total Environ. 2017 Nov 29. doi: 10.1016/j.scitotenv.2017.11.102.

3. Ahmed W et al. First confirmed detection of SARS-CoV-2 in untreated wastewater in Australia: A proof of concept for the wastewater surveillance of COVID-19 in the community. Sci Total Environ. 2020 Apr 18. doi: doi.org/10.1016/j.scitotenv.2020.138764.

4. Daughton C. The international imperative to rapidly and inexpensively monitor community-wide COVID-19 infection status and trends. Sci Total Environ. 2020 Mar 23. doi: 10.1016/j.scitotenv.2020.138149.

“The sewer is the conscience of the city. Everything there converges and confronts everything else. In that livid spot there are shades, but there are no longer any secrets.” Victor Hugo – “Les Miserables”

To get a sense of the prevalence of COVID-19 in a community you need to test hundreds to thousands of people. This is difficult, resource intensive, and requires cooperation for testing among people both with and without symptoms. It turns out that Sewage Chemical Information Mining (SCIM), a technology that has been in development for over a decade, is now being developed to track COVID-19.

In various locations from China to medieval London, there have been attempts to utilize human excrement for the betterment of mankind, from employing it as fertilizer to processing it to make gunpowder. Such attempts did not always work as planned. The use of sewage for fertilizer in Europe and the United States in the 1840s and 1850s led to the spread of waterborne diseases, including cholera and typhoid. As the importance of sanitary elimination of human waste became ever clearer, ideas and technology for our modern system of sewage management evolved. We have since advanced a great deal, so that all industrialized nations now have a well-developed system for clean water entry, as well as sewage treatment and disposal. Nonetheless, there remains a nagging question of whether human waste could be used for something productive.¹

In the early 2000s, SCIM was developed as a technique to assess population-level human health and disease. In SCIM, untreated sewage is tested for a chemical of interest which reflects a health parameter for a community. Chemicals of interest and usage rates can be calculated for substances as varied as opioids, tobacco, pesticides, and even nonnutritive sweeteners. For instance, relative opioid use can be calculated over time for a given “sewershed” or sewage catchment area. The calculation of community-wide exposure to substances as a means of getting real-time data on shifts of usage without having to collect and collate data from thousands of individuals has been termed wastewater-based epidemiology.

We use urine and stool testing in so many other areas, such as urinalysis, urine drug testing, urine Legionella antigen testing, and stool testing for common pathogens. What a rich source of information is present in the combination of urine and stool that collectively make up sewage! With the average volume of urine per adult being approximately 1 liter daily (and with urine calculated to be approximately 1% of wastewater), accurate analytic techniques can estimate per capita exposure to different substances. Applications of wastewater-based epidemiology have included tracking community prevalence of enteric viral infections, opioid and tobacco use, and many other indicators of health and disease.²

Given the enormous work in the field over the last 2 decades and that SARS-CoV-2 RNA has been detected in feces of both symptomatic and asymptomatic patients, it was only a short conceptual step for those familiar with sewage epidemiology to consider adapting it to assess the prevalence of COVID-19 in a community.

An elegant study collected untreated sewage from southeast Queensland, Australia. The sewage was processed, concentrated, and then tested with reverse transcriptase polymerase chain reaction analysis for SARS-CoV-2 RNA. The number of RNA copies was then entered into an equation that included the population served by the sewage encatchment area, as well as the measured liters of wastewater and grams of feces per day. This provided an estimate of the number of persons infected in the community, and the researchers were able to show reasonable agreement between the numbers estimated by sewage analysis and that found in traditional clinical testing.^3,4

The promise of wastewater-based epidemiology is large. Early research indicates that quantification of viral particles in sewage can be accurately assessed and correlated with the prevalence of the infection in the community. Such levels can then be used to track infection rates of COVID-19 over time, as well as to compare the relative rates in different communities.

Our sewage may hold the answer to accurately and easily tracking COVID-19, and ultimately help us gain a better hold on this disease.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. History of water supply and sanitation. Wikipedia, https://en.wikipedia.org/wiki/History_of_water_supply_and_sanitation.

2. Daughton C. Monitoring wastewater for assessing community health: Sewage Chemical-Information Mining (SCIM). Sci Total Environ. 2017 Nov 29. doi: 10.1016/j.scitotenv.2017.11.102.

3. Ahmed W et al. First confirmed detection of SARS-CoV-2 in untreated wastewater in Australia: A proof of concept for the wastewater surveillance of COVID-19 in the community. Sci Total Environ. 2020 Apr 18. doi: doi.org/10.1016/j.scitotenv.2020.138764.

4. Daughton C. The international imperative to rapidly and inexpensively monitor community-wide COVID-19 infection status and trends. Sci Total Environ. 2020 Mar 23. doi: 10.1016/j.scitotenv.2020.138149.

Bicycling has always been part of who I am because it offered me the freedom to explore as a preteen. As an adult I have always been a bicycle commuter and a very visible part of the community as I pedal around town to do my errands. But, I didn’t always wear a helmet ... because well, I just didn’t. I saw the helmet as a nuisance with very little benefit to myself. Eventually, when bike races required helmets I bought one just for the competitions. Until one day about 30 years ago when the mother of a child I was seeing in the office said, “Dr. Wilkoff, you know as an influential member of this community, particularly its children, you should be wearing a helmet.” My wife had been badgering me for years but this woman’s courage to speak up embarrassed me into changing my ways.

For some, maybe many, people, wearing a mask during the COVID-19 pandemic is a nuisance and an assault on their independence just as I viewed a bicycle helmet. Initially there was some information being circulated that any mask less robust than a N-95 had very little if any effect, either as protection or as way to decrease spread. I certainly had my doubts about the value of mask other than as a statement of solidarity. However, we are now learning that masks can serve an important role along with social distancing in a comprehensive community effort to minimize contagion.

In light of this new information, why are there are still people who won’t wear a mask? It may be that they are receiving their news filtered through a lens that discredits science. But, it is more likely the result of the same mindset that permeates the anti-vaccine faction that the common good is less important than personal freedom to follow their beliefs.

Do we have any tools at our disposal to increase the number of folks wearing masks? Based on our experience with attempts to convince those who are anti-vaccine, education will be ineffective in shifting the focus from personal freedom to a commitment to the welfare of the community at large. Shaming might be effective, but it runs the risk of igniting conflicts and further widening the gaps in our society. Some establishments have been effective in simply saying “no mask, no entry,” but this runs the same risk of creating friction depending on the community and the situation.

The ship may have already sailed on our best opportunity to achieve community compliance when the leaders of our national government have chosen to ignore their obligation to set an example by refusing to wear masks. I fear that the wedge has already been set and the widening of the gap between those who see their responsibility to the community at large and those who do not will continue to grow.

I am fortunate to live in a town whose residents look out for each other and have relied on local leaders to set an example in the absence of leadership on a national level.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

Bicycling has always been part of who I am because it offered me the freedom to explore as a preteen. As an adult I have always been a bicycle commuter and a very visible part of the community as I pedal around town to do my errands. But, I didn’t always wear a helmet ... because well, I just didn’t. I saw the helmet as a nuisance with very little benefit to myself. Eventually, when bike races required helmets I bought one just for the competitions. Until one day about 30 years ago when the mother of a child I was seeing in the office said, “Dr. Wilkoff, you know as an influential member of this community, particularly its children, you should be wearing a helmet.” My wife had been badgering me for years but this woman’s courage to speak up embarrassed me into changing my ways.

For some, maybe many, people, wearing a mask during the COVID-19 pandemic is a nuisance and an assault on their independence just as I viewed a bicycle helmet. Initially there was some information being circulated that any mask less robust than a N-95 had very little if any effect, either as protection or as way to decrease spread. I certainly had my doubts about the value of mask other than as a statement of solidarity. However, we are now learning that masks can serve an important role along with social distancing in a comprehensive community effort to minimize contagion.

In light of this new information, why are there are still people who won’t wear a mask? It may be that they are receiving their news filtered through a lens that discredits science. But, it is more likely the result of the same mindset that permeates the anti-vaccine faction that the common good is less important than personal freedom to follow their beliefs.

Do we have any tools at our disposal to increase the number of folks wearing masks? Based on our experience with attempts to convince those who are anti-vaccine, education will be ineffective in shifting the focus from personal freedom to a commitment to the welfare of the community at large. Shaming might be effective, but it runs the risk of igniting conflicts and further widening the gaps in our society. Some establishments have been effective in simply saying “no mask, no entry,” but this runs the same risk of creating friction depending on the community and the situation.

The ship may have already sailed on our best opportunity to achieve community compliance when the leaders of our national government have chosen to ignore their obligation to set an example by refusing to wear masks. I fear that the wedge has already been set and the widening of the gap between those who see their responsibility to the community at large and those who do not will continue to grow.

I am fortunate to live in a town whose residents look out for each other and have relied on local leaders to set an example in the absence of leadership on a national level.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

Bicycling has always been part of who I am because it offered me the freedom to explore as a preteen. As an adult I have always been a bicycle commuter and a very visible part of the community as I pedal around town to do my errands. But, I didn’t always wear a helmet ... because well, I just didn’t. I saw the helmet as a nuisance with very little benefit to myself. Eventually, when bike races required helmets I bought one just for the competitions. Until one day about 30 years ago when the mother of a child I was seeing in the office said, “Dr. Wilkoff, you know as an influential member of this community, particularly its children, you should be wearing a helmet.” My wife had been badgering me for years but this woman’s courage to speak up embarrassed me into changing my ways.

For some, maybe many, people, wearing a mask during the COVID-19 pandemic is a nuisance and an assault on their independence just as I viewed a bicycle helmet. Initially there was some information being circulated that any mask less robust than a N-95 had very little if any effect, either as protection or as way to decrease spread. I certainly had my doubts about the value of mask other than as a statement of solidarity. However, we are now learning that masks can serve an important role along with social distancing in a comprehensive community effort to minimize contagion.

In light of this new information, why are there are still people who won’t wear a mask? It may be that they are receiving their news filtered through a lens that discredits science. But, it is more likely the result of the same mindset that permeates the anti-vaccine faction that the common good is less important than personal freedom to follow their beliefs.

Do we have any tools at our disposal to increase the number of folks wearing masks? Based on our experience with attempts to convince those who are anti-vaccine, education will be ineffective in shifting the focus from personal freedom to a commitment to the welfare of the community at large. Shaming might be effective, but it runs the risk of igniting conflicts and further widening the gaps in our society. Some establishments have been effective in simply saying “no mask, no entry,” but this runs the same risk of creating friction depending on the community and the situation.

The ship may have already sailed on our best opportunity to achieve community compliance when the leaders of our national government have chosen to ignore their obligation to set an example by refusing to wear masks. I fear that the wedge has already been set and the widening of the gap between those who see their responsibility to the community at large and those who do not will continue to grow.

I am fortunate to live in a town whose residents look out for each other and have relied on local leaders to set an example in the absence of leadership on a national level.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

Young adult smokers who stop smoking in the first year after an initial myocardial infarction are far less likely to die over the next 10 years than their peers who continue to smoke. Yet nearly two-thirds keep smoking after the event, according to new data from the Partners YOUNG-MI Registry.

“Smoking is one of the most common risk factors for developing an MI at a young age. ... This reinforces the need to have more young individuals avoid, or quit, the use of tobacco,” Ron Blankstein, MD, Brigham and Women’s Hospital and Harvard Medical School, Boston, said in an interview.

Yet, the finding that 62% of young adults continue to smoke 1 year after MI points to an “enormous need for better smoking cessation efforts following a heart attack,” he said.
 

“Powerful” message for clinicians

“This study joins an incredibly powerful body of evidence that says if you quit smoking, you’re going to live longer,” said Michael Fiore, MD, MPH, MBA, director of the University of Wisconsin Center for Tobacco Research and Intervention, Madison, who wasn’t involved in the study.

“As physicians, there is nothing we can do that will have a greater impact for our patients than quitting smoking. The study is a powerful call for clinicians to intervene with their patients that smoke – both if you have an MI or if you don’t,” Dr. Fiore told this news organization.

The study involved 2,072 individuals 50 years or younger (median age, 45 years; 81% male) who were hospitalized for an initial MI at two large academic medical centers in Boston. Of these, 33.9% were never-smokers, 13.6% were former smokers, and 52.5% were smokers at the time of their MI.

During a median follow-up of 10.2 years, those who quit smoking had a significantly lower rate of death from any cause (unadjusted hazard ratio, 0.35; 95% confidence interval, 0.19-0.63; P < .001) and a cardiovascular cause (HR, 0.29; 95% CI, 0.11-0.79; P = .02), relative to those who continued to smoke.

The results remained statistically significant in a propensity-matched analysis for both all-cause (HR, 0.30; 95% CI, 0.16-0.56; P < .001) and CV mortality (HR, 0.19; 95% CI, 0.06-0.56; P = .003).

“Although patients who quit smoking were similar to those who continued to smoke with respect to their baseline characteristics, smoking cessation was associated with an approximate 70%-80% reduction in all-cause and CV mortality,” the authors note in their article, published online July 8 in JAMA Network Open.

They say it’s also noteworthy that long-term death rates of never-smokers and former smokers who quit before the MI were nearly identical.

‘A failure of our health care system’

The bottom line, said Dr. Blankstein, is that it is “never too late to quit, and those who experience an MI should do so right away. Our health care system must help promote such efforts, as there is immense room for improvement.”

Dr. Fiore said: “When I see an article like this, it just reminds me that, if you’re really thinking about staying healthy, there is nothing better you can do to improve the quality and longevity of your life than quitting smoking.”

The observation that many patients continue to smoke after MI is a “failure of our health care system, and it’s an individual failure in that these individuals are not able to overcome their powerful nicotine dependence. It’s an unfortunate occurrence that’s resulting in unnecessary deaths,” said Dr. Fiore.

There is no “magic bullet” to overcome nicotine addiction, but there are approved treatments that can “substantially boost quit rates,” he noted.

The two most effective smoking-cessation treatments are varenicline (Chantix) and combination nicotine replacement therapy, a patch combined ideally with nicotine mini lozenges, particularly when combined with some brief counseling, said Fiore.

He encourages cardiologists to get their patients to commit to quitting and then link them to resources such as 1-800-QUIT-NOW or SmokeFree.gov.

Funding for the study was provided by grants from the National Heart, Lung, and Blood Institute. Dr. Blankstein reported receiving research support from Amgen and Astellas. Dr. Fiore had no relevant disclosures.

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

Young adult smokers who stop smoking in the first year after an initial myocardial infarction are far less likely to die over the next 10 years than their peers who continue to smoke. Yet nearly two-thirds keep smoking after the event, according to new data from the Partners YOUNG-MI Registry.

“Smoking is one of the most common risk factors for developing an MI at a young age. ... This reinforces the need to have more young individuals avoid, or quit, the use of tobacco,” Ron Blankstein, MD, Brigham and Women’s Hospital and Harvard Medical School, Boston, said in an interview.

Yet, the finding that 62% of young adults continue to smoke 1 year after MI points to an “enormous need for better smoking cessation efforts following a heart attack,” he said.
 

“Powerful” message for clinicians

“This study joins an incredibly powerful body of evidence that says if you quit smoking, you’re going to live longer,” said Michael Fiore, MD, MPH, MBA, director of the University of Wisconsin Center for Tobacco Research and Intervention, Madison, who wasn’t involved in the study.

“As physicians, there is nothing we can do that will have a greater impact for our patients than quitting smoking. The study is a powerful call for clinicians to intervene with their patients that smoke – both if you have an MI or if you don’t,” Dr. Fiore told this news organization.

The study involved 2,072 individuals 50 years or younger (median age, 45 years; 81% male) who were hospitalized for an initial MI at two large academic medical centers in Boston. Of these, 33.9% were never-smokers, 13.6% were former smokers, and 52.5% were smokers at the time of their MI.

During a median follow-up of 10.2 years, those who quit smoking had a significantly lower rate of death from any cause (unadjusted hazard ratio, 0.35; 95% confidence interval, 0.19-0.63; P < .001) and a cardiovascular cause (HR, 0.29; 95% CI, 0.11-0.79; P = .02), relative to those who continued to smoke.

The results remained statistically significant in a propensity-matched analysis for both all-cause (HR, 0.30; 95% CI, 0.16-0.56; P < .001) and CV mortality (HR, 0.19; 95% CI, 0.06-0.56; P = .003).

“Although patients who quit smoking were similar to those who continued to smoke with respect to their baseline characteristics, smoking cessation was associated with an approximate 70%-80% reduction in all-cause and CV mortality,” the authors note in their article, published online July 8 in JAMA Network Open.

They say it’s also noteworthy that long-term death rates of never-smokers and former smokers who quit before the MI were nearly identical.

‘A failure of our health care system’

The bottom line, said Dr. Blankstein, is that it is “never too late to quit, and those who experience an MI should do so right away. Our health care system must help promote such efforts, as there is immense room for improvement.”

Dr. Fiore said: “When I see an article like this, it just reminds me that, if you’re really thinking about staying healthy, there is nothing better you can do to improve the quality and longevity of your life than quitting smoking.”

The observation that many patients continue to smoke after MI is a “failure of our health care system, and it’s an individual failure in that these individuals are not able to overcome their powerful nicotine dependence. It’s an unfortunate occurrence that’s resulting in unnecessary deaths,” said Dr. Fiore.

There is no “magic bullet” to overcome nicotine addiction, but there are approved treatments that can “substantially boost quit rates,” he noted.

The two most effective smoking-cessation treatments are varenicline (Chantix) and combination nicotine replacement therapy, a patch combined ideally with nicotine mini lozenges, particularly when combined with some brief counseling, said Fiore.

He encourages cardiologists to get their patients to commit to quitting and then link them to resources such as 1-800-QUIT-NOW or SmokeFree.gov.

Funding for the study was provided by grants from the National Heart, Lung, and Blood Institute. Dr. Blankstein reported receiving research support from Amgen and Astellas. Dr. Fiore had no relevant disclosures.

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

Young adult smokers who stop smoking in the first year after an initial myocardial infarction are far less likely to die over the next 10 years than their peers who continue to smoke. Yet nearly two-thirds keep smoking after the event, according to new data from the Partners YOUNG-MI Registry.

“Smoking is one of the most common risk factors for developing an MI at a young age. ... This reinforces the need to have more young individuals avoid, or quit, the use of tobacco,” Ron Blankstein, MD, Brigham and Women’s Hospital and Harvard Medical School, Boston, said in an interview.

Yet, the finding that 62% of young adults continue to smoke 1 year after MI points to an “enormous need for better smoking cessation efforts following a heart attack,” he said.
 

“Powerful” message for clinicians

“This study joins an incredibly powerful body of evidence that says if you quit smoking, you’re going to live longer,” said Michael Fiore, MD, MPH, MBA, director of the University of Wisconsin Center for Tobacco Research and Intervention, Madison, who wasn’t involved in the study.

“As physicians, there is nothing we can do that will have a greater impact for our patients than quitting smoking. The study is a powerful call for clinicians to intervene with their patients that smoke – both if you have an MI or if you don’t,” Dr. Fiore told this news organization.

The study involved 2,072 individuals 50 years or younger (median age, 45 years; 81% male) who were hospitalized for an initial MI at two large academic medical centers in Boston. Of these, 33.9% were never-smokers, 13.6% were former smokers, and 52.5% were smokers at the time of their MI.

During a median follow-up of 10.2 years, those who quit smoking had a significantly lower rate of death from any cause (unadjusted hazard ratio, 0.35; 95% confidence interval, 0.19-0.63; P < .001) and a cardiovascular cause (HR, 0.29; 95% CI, 0.11-0.79; P = .02), relative to those who continued to smoke.

The results remained statistically significant in a propensity-matched analysis for both all-cause (HR, 0.30; 95% CI, 0.16-0.56; P < .001) and CV mortality (HR, 0.19; 95% CI, 0.06-0.56; P = .003).

“Although patients who quit smoking were similar to those who continued to smoke with respect to their baseline characteristics, smoking cessation was associated with an approximate 70%-80% reduction in all-cause and CV mortality,” the authors note in their article, published online July 8 in JAMA Network Open.

They say it’s also noteworthy that long-term death rates of never-smokers and former smokers who quit before the MI were nearly identical.

‘A failure of our health care system’

The bottom line, said Dr. Blankstein, is that it is “never too late to quit, and those who experience an MI should do so right away. Our health care system must help promote such efforts, as there is immense room for improvement.”

Dr. Fiore said: “When I see an article like this, it just reminds me that, if you’re really thinking about staying healthy, there is nothing better you can do to improve the quality and longevity of your life than quitting smoking.”

The observation that many patients continue to smoke after MI is a “failure of our health care system, and it’s an individual failure in that these individuals are not able to overcome their powerful nicotine dependence. It’s an unfortunate occurrence that’s resulting in unnecessary deaths,” said Dr. Fiore.

There is no “magic bullet” to overcome nicotine addiction, but there are approved treatments that can “substantially boost quit rates,” he noted.

The two most effective smoking-cessation treatments are varenicline (Chantix) and combination nicotine replacement therapy, a patch combined ideally with nicotine mini lozenges, particularly when combined with some brief counseling, said Fiore.

He encourages cardiologists to get their patients to commit to quitting and then link them to resources such as 1-800-QUIT-NOW or SmokeFree.gov.

Funding for the study was provided by grants from the National Heart, Lung, and Blood Institute. Dr. Blankstein reported receiving research support from Amgen and Astellas. Dr. Fiore had no relevant disclosures.

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

The first order of business in the long-awaited, recently released Centers for Medicare & Medicaid Services (CMS) proposed national coverage decision (NCD) for transcatheter mitral valve repair (TMVR) was to get rid of its familiar moniker.

The document tosses the term TMVR in favor of transcatheter edge-to-edge repair (TEER) “to more precisely define the treatment addressed in this NCD” and differentiate it from other therapies that repair or replace the mitral valve.

(In an off-the-cuff Twitter poll launched right after the CMS document’s release, 80.3% of respondents answered that they “hate” the new acronym and the remainder said they “love” it; those two were the poll’s only choices.)

The NCD proposal goes on to say that CMS coverage of TEER would expand to include treatment of symptomatic moderate-to-severe or severe functional mitral regurgitation (MR) when used with maximally tolerated guideline-directed medical therapy.

The proposed NCD has been expected since March 2019 when the US Food and Drug Administration (FDA) approved the MitraClip (Abbott Vascular) for secondary functional MR. Medicare has covered MitraClip for primary degenerative MR since 2014.

Abbott announced in October 2019 that it would ramp up production of the MitraClip, which is currently the only FDA-approved TEER device.

Further specifications

Even as the new proposed NCD would add CMS coverage for functional MR, it would also decline a coverage statement for degenerative MR. Instead, it proposes to leave such coverage decisions to local Medical Administrative Contractors (MACs), given a relatively low incidence of clip intervention for degenerative MR. Less than 1% of the Medicare population undergo TEER of the mitral valve for that indication, the document says.

“The MACs are structured to be able to take into account local patient, physician, and institutional factors, which are especially important when overall prevalence is very low.”

The proposal also emphasizes that patients undergoing such covered TEER procedures be “under the care of a heart failure physician specialist experienced in the care and treatment of mitral valve disease,» with additional care provided by a heart team that includes a cardiac surgeon, interventional cardiologist, interventional echocardiographer.

The new document is generally consistent with a Consensus Statement from the American Association for Thoracic Surgery, the American College of Cardiology (ACC), the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons published in December 2019 and covered then by theheart.org / Medscape Cardiology.

In anticipation the CMS coverage proposal, the ACC earlier this year published a Focused Update of the 2017 Expert Consensus Decision Pathway on the Management of Mitral Regurgitation to reflect new evidence in the field, mainly the recent clinical trial data on functional MR from the MITRA-FR and COAPT trials.

“The proposed criteria are nicely guided by the multisociety consensus document, which sought to foster optimal patient outcomes while also maintaining access to TEER,” Sammy Elmariah, MD, MPH, from Massachusetts General Hospital in Boston, commented by email.

“These criteria, in conjunction with results of the COAPT trial, establish TEER as the standard of care for patients with symptomatic functional MR despite guideline-directed medical therapy who do not possess an alternative indication for cardiac surgery,” said Elmariah, a coauthor on both the Consensus Statement and the Focused Update.

The proposed NCD seems “reasonable,” cardiothoracic surgeon Michael J. Reardon, MD, Houston Methodist Hospital, said by email. But he thought there might be some objections to the requirement for TEER centers to have a surgery program with a minimum annual volume for mitral-valve surgeries.

The proposed NCD says a hospital must have “a surgical program that performs ≥25 total mitral valve surgical procedures for severe MR per year, of which at least 10 must be mitral valve repairs.”

“There is a very definite relationship between mitral valve surgery volume and surgical outcomes and between TEER volume and TEER outcomes, but no real relationship between mitral valve surgery volumes and TEER outcomes,” Reardon said. “A mitral valve surgery program is important, but how many cases do you need to be able to start and run a TEER program?”

Edwards Lifesciences is currently testing its own device for TEER: the PASCAL transcatheter mitral valve repair system. Early findings from the company’s ongoing CLASP IID trial, a head-to-head comparison of Pascal and MitraClip, are expected in December 2023.

CMS is seeking comments on the proposed national coverage determination, and will render a final decision within 60 days of the end of the 30-day public comment period.

Elmariah discloses receiving research grants from the American Heart Association, the National Institutes of Health, Edwards Lifesciences, Svelte Medical, and Medtronic, and consulting fees from AstraZeneca. Reardon recently reported no relevant conflicts of interest.

This article first appeared on Medscape.com.

The first order of business in the long-awaited, recently released Centers for Medicare & Medicaid Services (CMS) proposed national coverage decision (NCD) for transcatheter mitral valve repair (TMVR) was to get rid of its familiar moniker.

The document tosses the term TMVR in favor of transcatheter edge-to-edge repair (TEER) “to more precisely define the treatment addressed in this NCD” and differentiate it from other therapies that repair or replace the mitral valve.

(In an off-the-cuff Twitter poll launched right after the CMS document’s release, 80.3% of respondents answered that they “hate” the new acronym and the remainder said they “love” it; those two were the poll’s only choices.)

The NCD proposal goes on to say that CMS coverage of TEER would expand to include treatment of symptomatic moderate-to-severe or severe functional mitral regurgitation (MR) when used with maximally tolerated guideline-directed medical therapy.

The proposed NCD has been expected since March 2019 when the US Food and Drug Administration (FDA) approved the MitraClip (Abbott Vascular) for secondary functional MR. Medicare has covered MitraClip for primary degenerative MR since 2014.

Abbott announced in October 2019 that it would ramp up production of the MitraClip, which is currently the only FDA-approved TEER device.

Further specifications

Even as the new proposed NCD would add CMS coverage for functional MR, it would also decline a coverage statement for degenerative MR. Instead, it proposes to leave such coverage decisions to local Medical Administrative Contractors (MACs), given a relatively low incidence of clip intervention for degenerative MR. Less than 1% of the Medicare population undergo TEER of the mitral valve for that indication, the document says.

“The MACs are structured to be able to take into account local patient, physician, and institutional factors, which are especially important when overall prevalence is very low.”

The proposal also emphasizes that patients undergoing such covered TEER procedures be “under the care of a heart failure physician specialist experienced in the care and treatment of mitral valve disease,» with additional care provided by a heart team that includes a cardiac surgeon, interventional cardiologist, interventional echocardiographer.

The new document is generally consistent with a Consensus Statement from the American Association for Thoracic Surgery, the American College of Cardiology (ACC), the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons published in December 2019 and covered then by theheart.org / Medscape Cardiology.

In anticipation the CMS coverage proposal, the ACC earlier this year published a Focused Update of the 2017 Expert Consensus Decision Pathway on the Management of Mitral Regurgitation to reflect new evidence in the field, mainly the recent clinical trial data on functional MR from the MITRA-FR and COAPT trials.

“The proposed criteria are nicely guided by the multisociety consensus document, which sought to foster optimal patient outcomes while also maintaining access to TEER,” Sammy Elmariah, MD, MPH, from Massachusetts General Hospital in Boston, commented by email.

“These criteria, in conjunction with results of the COAPT trial, establish TEER as the standard of care for patients with symptomatic functional MR despite guideline-directed medical therapy who do not possess an alternative indication for cardiac surgery,” said Elmariah, a coauthor on both the Consensus Statement and the Focused Update.

The proposed NCD seems “reasonable,” cardiothoracic surgeon Michael J. Reardon, MD, Houston Methodist Hospital, said by email. But he thought there might be some objections to the requirement for TEER centers to have a surgery program with a minimum annual volume for mitral-valve surgeries.

The proposed NCD says a hospital must have “a surgical program that performs ≥25 total mitral valve surgical procedures for severe MR per year, of which at least 10 must be mitral valve repairs.”

“There is a very definite relationship between mitral valve surgery volume and surgical outcomes and between TEER volume and TEER outcomes, but no real relationship between mitral valve surgery volumes and TEER outcomes,” Reardon said. “A mitral valve surgery program is important, but how many cases do you need to be able to start and run a TEER program?”

Edwards Lifesciences is currently testing its own device for TEER: the PASCAL transcatheter mitral valve repair system. Early findings from the company’s ongoing CLASP IID trial, a head-to-head comparison of Pascal and MitraClip, are expected in December 2023.

CMS is seeking comments on the proposed national coverage determination, and will render a final decision within 60 days of the end of the 30-day public comment period.

Elmariah discloses receiving research grants from the American Heart Association, the National Institutes of Health, Edwards Lifesciences, Svelte Medical, and Medtronic, and consulting fees from AstraZeneca. Reardon recently reported no relevant conflicts of interest.

This article first appeared on Medscape.com.

The first order of business in the long-awaited, recently released Centers for Medicare & Medicaid Services (CMS) proposed national coverage decision (NCD) for transcatheter mitral valve repair (TMVR) was to get rid of its familiar moniker.

The document tosses the term TMVR in favor of transcatheter edge-to-edge repair (TEER) “to more precisely define the treatment addressed in this NCD” and differentiate it from other therapies that repair or replace the mitral valve.

(In an off-the-cuff Twitter poll launched right after the CMS document’s release, 80.3% of respondents answered that they “hate” the new acronym and the remainder said they “love” it; those two were the poll’s only choices.)

The NCD proposal goes on to say that CMS coverage of TEER would expand to include treatment of symptomatic moderate-to-severe or severe functional mitral regurgitation (MR) when used with maximally tolerated guideline-directed medical therapy.

The proposed NCD has been expected since March 2019 when the US Food and Drug Administration (FDA) approved the MitraClip (Abbott Vascular) for secondary functional MR. Medicare has covered MitraClip for primary degenerative MR since 2014.

Abbott announced in October 2019 that it would ramp up production of the MitraClip, which is currently the only FDA-approved TEER device.

Further specifications

Even as the new proposed NCD would add CMS coverage for functional MR, it would also decline a coverage statement for degenerative MR. Instead, it proposes to leave such coverage decisions to local Medical Administrative Contractors (MACs), given a relatively low incidence of clip intervention for degenerative MR. Less than 1% of the Medicare population undergo TEER of the mitral valve for that indication, the document says.

“The MACs are structured to be able to take into account local patient, physician, and institutional factors, which are especially important when overall prevalence is very low.”

The proposal also emphasizes that patients undergoing such covered TEER procedures be “under the care of a heart failure physician specialist experienced in the care and treatment of mitral valve disease,» with additional care provided by a heart team that includes a cardiac surgeon, interventional cardiologist, interventional echocardiographer.

The new document is generally consistent with a Consensus Statement from the American Association for Thoracic Surgery, the American College of Cardiology (ACC), the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons published in December 2019 and covered then by theheart.org / Medscape Cardiology.

In anticipation the CMS coverage proposal, the ACC earlier this year published a Focused Update of the 2017 Expert Consensus Decision Pathway on the Management of Mitral Regurgitation to reflect new evidence in the field, mainly the recent clinical trial data on functional MR from the MITRA-FR and COAPT trials.

“The proposed criteria are nicely guided by the multisociety consensus document, which sought to foster optimal patient outcomes while also maintaining access to TEER,” Sammy Elmariah, MD, MPH, from Massachusetts General Hospital in Boston, commented by email.

“These criteria, in conjunction with results of the COAPT trial, establish TEER as the standard of care for patients with symptomatic functional MR despite guideline-directed medical therapy who do not possess an alternative indication for cardiac surgery,” said Elmariah, a coauthor on both the Consensus Statement and the Focused Update.

The proposed NCD seems “reasonable,” cardiothoracic surgeon Michael J. Reardon, MD, Houston Methodist Hospital, said by email. But he thought there might be some objections to the requirement for TEER centers to have a surgery program with a minimum annual volume for mitral-valve surgeries.

The proposed NCD says a hospital must have “a surgical program that performs ≥25 total mitral valve surgical procedures for severe MR per year, of which at least 10 must be mitral valve repairs.”

“There is a very definite relationship between mitral valve surgery volume and surgical outcomes and between TEER volume and TEER outcomes, but no real relationship between mitral valve surgery volumes and TEER outcomes,” Reardon said. “A mitral valve surgery program is important, but how many cases do you need to be able to start and run a TEER program?”

Edwards Lifesciences is currently testing its own device for TEER: the PASCAL transcatheter mitral valve repair system. Early findings from the company’s ongoing CLASP IID trial, a head-to-head comparison of Pascal and MitraClip, are expected in December 2023.

CMS is seeking comments on the proposed national coverage determination, and will render a final decision within 60 days of the end of the 30-day public comment period.

Elmariah discloses receiving research grants from the American Heart Association, the National Institutes of Health, Edwards Lifesciences, Svelte Medical, and Medtronic, and consulting fees from AstraZeneca. Reardon recently reported no relevant conflicts of interest.

This article first appeared on Medscape.com.

A phase 1/2 trial of a vaccine against SARS-CoV-2 being developed by the University of Oxford has found that the vaccine is safe, causes few side effects, and induces strong immune responses.

The early stage results, published in The Lancet, found that the candidate vaccine, known as ChAdOx1 nCoV-19, provoked a T-cell response peaking 14 days after vaccination, and an antibody response within 28 days.

Andrew Pollard, chief investigator on the study, and professor of pediatric infection and immunity at Oxford University, described the results as “encouraging”. He told a briefing convened by the Science Media Centre on Monday that it was “a really important milestone on the path to the development of the vaccine”.

In the Commons, the Health Secretary, Matt Hancock, hailed the results for taking us “one step closer to finding a vaccine that can potentially save lives, all around the world”.

The trial, which has so far involved 1,077 healthy adults, caused minor side effects when compared with a control group given a meningitis vaccine. Fatigue and headache were the most commonly reported reactions.

However, there were no serious adverse events from the vaccine, the researchers said.
 

‘Still a long way to go’

Sarah Gilbert, lead researcher of the vaccine development program, and professor of vaccinology at Oxford, cautioned that there was still a long way to go before the team could confirm that the vaccine could protect against developing COVID-19.

“The difficulty that we have, and that all vaccine developers have in trying to make a vaccine against this particular virus, is that we don’t know how strong that immune response needs to be,” she said.

“So, we can’t say just by looking at immune responses whether this is going to protect people or not. And the only way we’re going to find out is by doing the large phase 3 trials and wait for people to be infected as part of that trial before we know if the vaccine can work.”

The authors noted some limitations to their findings. They said more research was needed to confirm their results in different groups of people – including older age groups, those with other health conditions, and in ethnically and geographically diverse populations.

A notable result of the trial was that participants given a second dose of the vaccine appeared to display a stronger immune response, a finding that had influenced plans to “look at two dose regimes as well as one dose regimes in the phase 3 trial”, Prof Adrian Hill, director of Oxford’s Jenner Institute, confirmed.

ChAdOx1 nCoV-19 is made from a weakened version of an adenovirus that causes infections in chimpanzees. The virus has been genetically modified so that it cannot grow in humans.

On Monday, the government announced that it had struck a deal with AstraZeneca for access to 100 million doses of the Oxford vaccine, in addition to millions of doses of other promising candidate vaccines.
 

Expert reaction to the findings

The Medical Research Council helped to fund the trial. Executive Chair Professor Fiona Watt commented: “It is truly remarkable how fast this vaccine has progressed, with our support, through early clinical trials, and it is very encouraging that it shows no safety concerns and evokes strong immune responses.

“There is a lot that we don’t yet know about immunity to the virus that causes COVID-19. However, it seems that both antibody and T cell immunity are important, and this vaccine triggers both responses. The much anticipated next milestone will be the results of the larger trials that are happening now to find out if the vaccine will protect people from the virus.”

Jonathan Ball, professor of molecular virology at the University of Nottingham, told the SMC: “The results of the Oxford chimp adenovirus vaccine candidate show that the vaccine is able to generate antibodies and T cells in humans and these persisted for several weeks. Whilst encouraging there is still a long way to go before we can herald the arrival of a successful coronavirus vaccine.

“It is unclear whether the levels of immunity can protect against infection – that’s what the larger ongoing phase III trials are designed to test. Nor do we know if this vaccine can protect those most vulnerable to severe COVID-19 disease.”

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, commented: “For the vaccine to be really useful, we not only need the larger studies conducted where COVID-19 is still occurring at a high rate, but we need to be reasonably sure that the protection lasts for a considerable time.”

He said it was also vital that people older than 55 were included in later trials.

Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, said: “Developing a vaccine is an incredibly difficult challenge; the fact that there are multiple candidates in development is hopefully a sign that the hard work will ultimately pay off.

“But we must be patient. Proving that a vaccine is safe and effective is a long process and we could still be many months away.”

This article first appeared on Medscape.com.

A phase 1/2 trial of a vaccine against SARS-CoV-2 being developed by the University of Oxford has found that the vaccine is safe, causes few side effects, and induces strong immune responses.

The early stage results, published in The Lancet, found that the candidate vaccine, known as ChAdOx1 nCoV-19, provoked a T-cell response peaking 14 days after vaccination, and an antibody response within 28 days.

Andrew Pollard, chief investigator on the study, and professor of pediatric infection and immunity at Oxford University, described the results as “encouraging”. He told a briefing convened by the Science Media Centre on Monday that it was “a really important milestone on the path to the development of the vaccine”.

In the Commons, the Health Secretary, Matt Hancock, hailed the results for taking us “one step closer to finding a vaccine that can potentially save lives, all around the world”.

The trial, which has so far involved 1,077 healthy adults, caused minor side effects when compared with a control group given a meningitis vaccine. Fatigue and headache were the most commonly reported reactions.

However, there were no serious adverse events from the vaccine, the researchers said.
 

‘Still a long way to go’

Sarah Gilbert, lead researcher of the vaccine development program, and professor of vaccinology at Oxford, cautioned that there was still a long way to go before the team could confirm that the vaccine could protect against developing COVID-19.

“The difficulty that we have, and that all vaccine developers have in trying to make a vaccine against this particular virus, is that we don’t know how strong that immune response needs to be,” she said.

“So, we can’t say just by looking at immune responses whether this is going to protect people or not. And the only way we’re going to find out is by doing the large phase 3 trials and wait for people to be infected as part of that trial before we know if the vaccine can work.”

The authors noted some limitations to their findings. They said more research was needed to confirm their results in different groups of people – including older age groups, those with other health conditions, and in ethnically and geographically diverse populations.

A notable result of the trial was that participants given a second dose of the vaccine appeared to display a stronger immune response, a finding that had influenced plans to “look at two dose regimes as well as one dose regimes in the phase 3 trial”, Prof Adrian Hill, director of Oxford’s Jenner Institute, confirmed.

ChAdOx1 nCoV-19 is made from a weakened version of an adenovirus that causes infections in chimpanzees. The virus has been genetically modified so that it cannot grow in humans.

On Monday, the government announced that it had struck a deal with AstraZeneca for access to 100 million doses of the Oxford vaccine, in addition to millions of doses of other promising candidate vaccines.
 

Expert reaction to the findings

The Medical Research Council helped to fund the trial. Executive Chair Professor Fiona Watt commented: “It is truly remarkable how fast this vaccine has progressed, with our support, through early clinical trials, and it is very encouraging that it shows no safety concerns and evokes strong immune responses.

“There is a lot that we don’t yet know about immunity to the virus that causes COVID-19. However, it seems that both antibody and T cell immunity are important, and this vaccine triggers both responses. The much anticipated next milestone will be the results of the larger trials that are happening now to find out if the vaccine will protect people from the virus.”

Jonathan Ball, professor of molecular virology at the University of Nottingham, told the SMC: “The results of the Oxford chimp adenovirus vaccine candidate show that the vaccine is able to generate antibodies and T cells in humans and these persisted for several weeks. Whilst encouraging there is still a long way to go before we can herald the arrival of a successful coronavirus vaccine.

“It is unclear whether the levels of immunity can protect against infection – that’s what the larger ongoing phase III trials are designed to test. Nor do we know if this vaccine can protect those most vulnerable to severe COVID-19 disease.”

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, commented: “For the vaccine to be really useful, we not only need the larger studies conducted where COVID-19 is still occurring at a high rate, but we need to be reasonably sure that the protection lasts for a considerable time.”

He said it was also vital that people older than 55 were included in later trials.

Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, said: “Developing a vaccine is an incredibly difficult challenge; the fact that there are multiple candidates in development is hopefully a sign that the hard work will ultimately pay off.

“But we must be patient. Proving that a vaccine is safe and effective is a long process and we could still be many months away.”

This article first appeared on Medscape.com.

A phase 1/2 trial of a vaccine against SARS-CoV-2 being developed by the University of Oxford has found that the vaccine is safe, causes few side effects, and induces strong immune responses.

The early stage results, published in The Lancet, found that the candidate vaccine, known as ChAdOx1 nCoV-19, provoked a T-cell response peaking 14 days after vaccination, and an antibody response within 28 days.

Andrew Pollard, chief investigator on the study, and professor of pediatric infection and immunity at Oxford University, described the results as “encouraging”. He told a briefing convened by the Science Media Centre on Monday that it was “a really important milestone on the path to the development of the vaccine”.

In the Commons, the Health Secretary, Matt Hancock, hailed the results for taking us “one step closer to finding a vaccine that can potentially save lives, all around the world”.

The trial, which has so far involved 1,077 healthy adults, caused minor side effects when compared with a control group given a meningitis vaccine. Fatigue and headache were the most commonly reported reactions.

However, there were no serious adverse events from the vaccine, the researchers said.
 

‘Still a long way to go’

Sarah Gilbert, lead researcher of the vaccine development program, and professor of vaccinology at Oxford, cautioned that there was still a long way to go before the team could confirm that the vaccine could protect against developing COVID-19.

“The difficulty that we have, and that all vaccine developers have in trying to make a vaccine against this particular virus, is that we don’t know how strong that immune response needs to be,” she said.

“So, we can’t say just by looking at immune responses whether this is going to protect people or not. And the only way we’re going to find out is by doing the large phase 3 trials and wait for people to be infected as part of that trial before we know if the vaccine can work.”

The authors noted some limitations to their findings. They said more research was needed to confirm their results in different groups of people – including older age groups, those with other health conditions, and in ethnically and geographically diverse populations.

A notable result of the trial was that participants given a second dose of the vaccine appeared to display a stronger immune response, a finding that had influenced plans to “look at two dose regimes as well as one dose regimes in the phase 3 trial”, Prof Adrian Hill, director of Oxford’s Jenner Institute, confirmed.

ChAdOx1 nCoV-19 is made from a weakened version of an adenovirus that causes infections in chimpanzees. The virus has been genetically modified so that it cannot grow in humans.

On Monday, the government announced that it had struck a deal with AstraZeneca for access to 100 million doses of the Oxford vaccine, in addition to millions of doses of other promising candidate vaccines.
 

Expert reaction to the findings

The Medical Research Council helped to fund the trial. Executive Chair Professor Fiona Watt commented: “It is truly remarkable how fast this vaccine has progressed, with our support, through early clinical trials, and it is very encouraging that it shows no safety concerns and evokes strong immune responses.

“There is a lot that we don’t yet know about immunity to the virus that causes COVID-19. However, it seems that both antibody and T cell immunity are important, and this vaccine triggers both responses. The much anticipated next milestone will be the results of the larger trials that are happening now to find out if the vaccine will protect people from the virus.”

Jonathan Ball, professor of molecular virology at the University of Nottingham, told the SMC: “The results of the Oxford chimp adenovirus vaccine candidate show that the vaccine is able to generate antibodies and T cells in humans and these persisted for several weeks. Whilst encouraging there is still a long way to go before we can herald the arrival of a successful coronavirus vaccine.

“It is unclear whether the levels of immunity can protect against infection – that’s what the larger ongoing phase III trials are designed to test. Nor do we know if this vaccine can protect those most vulnerable to severe COVID-19 disease.”

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, commented: “For the vaccine to be really useful, we not only need the larger studies conducted where COVID-19 is still occurring at a high rate, but we need to be reasonably sure that the protection lasts for a considerable time.”

He said it was also vital that people older than 55 were included in later trials.

Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, said: “Developing a vaccine is an incredibly difficult challenge; the fact that there are multiple candidates in development is hopefully a sign that the hard work will ultimately pay off.

“But we must be patient. Proving that a vaccine is safe and effective is a long process and we could still be many months away.”

This article first appeared on Medscape.com.

Every person who received Moderna’s COVID-19 vaccine, mRNA-1273, developed an immune response to the virus that causes it, the company says in a news release.

Researchers also reported some side effects in the 45 people in the phase I study, but no significant safety issues, the news release says.

The vaccine is among hundreds being tested worldwide in an effort to halt the pandemic that has killed nearly 600,000 worldwide.

A researcher testing the vaccine called the results encouraging but cautioned more study is needed. “Importantly, the vaccine resulted in a robust immune response,” Evan Anderson, MD, principal investigator for the trial at Emory University, says in a news release. Emory and Kaiser Permanente Washington Health Research Institute were the two sites for the study.

The company is already testing the vaccine in a larger group of people, known as a phase II trial. It plans to begin phase III trials in late July. Phase III trials involve testing the vaccine on an even larger group and are the final step before FDA approval.

The study results are published in The New England Journal of Medicine. The study was led by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

Moderna’s vaccine uses messenger RNA, also called mRNA. It carries the instruction for making the spike protein, a key protein on the surface of the virus that allows it to enter cells when a person is infected. After it’s injected, it goes to the immune cells and instructs them to make copies of the spike protein, acting as if the cells have been infected with the actual coronavirus. This allows other immune cells to develop immunity.

In the study, participants were divided into three groups of 15 people each. All groups received two vaccinations 28 days apart. Each group received a different strength of the vaccine – either 25, 100, or 250 micrograms.

Every person in the study developed antibodies that can block the infection. Most commonly reported side effects after the second vaccination in the 100-microgram group were fatigue, chills, headache, and muscle pains, ranging from mild to moderately severe.

The phase II study has 300 heathy adults ages 18-55, along with another 300 ages 55 and older

Moderna says it hopes to include about 30,000 participants at the 100-microgram dose level in the U.S. for the phase III trial. The estimated start date is July 27.

This article first appeared on WebMD.com.

Every person who received Moderna’s COVID-19 vaccine, mRNA-1273, developed an immune response to the virus that causes it, the company says in a news release.

Researchers also reported some side effects in the 45 people in the phase I study, but no significant safety issues, the news release says.

The vaccine is among hundreds being tested worldwide in an effort to halt the pandemic that has killed nearly 600,000 worldwide.

A researcher testing the vaccine called the results encouraging but cautioned more study is needed. “Importantly, the vaccine resulted in a robust immune response,” Evan Anderson, MD, principal investigator for the trial at Emory University, says in a news release. Emory and Kaiser Permanente Washington Health Research Institute were the two sites for the study.

The company is already testing the vaccine in a larger group of people, known as a phase II trial. It plans to begin phase III trials in late July. Phase III trials involve testing the vaccine on an even larger group and are the final step before FDA approval.

The study results are published in The New England Journal of Medicine. The study was led by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

Moderna’s vaccine uses messenger RNA, also called mRNA. It carries the instruction for making the spike protein, a key protein on the surface of the virus that allows it to enter cells when a person is infected. After it’s injected, it goes to the immune cells and instructs them to make copies of the spike protein, acting as if the cells have been infected with the actual coronavirus. This allows other immune cells to develop immunity.

In the study, participants were divided into three groups of 15 people each. All groups received two vaccinations 28 days apart. Each group received a different strength of the vaccine – either 25, 100, or 250 micrograms.

Every person in the study developed antibodies that can block the infection. Most commonly reported side effects after the second vaccination in the 100-microgram group were fatigue, chills, headache, and muscle pains, ranging from mild to moderately severe.

The phase II study has 300 heathy adults ages 18-55, along with another 300 ages 55 and older

Moderna says it hopes to include about 30,000 participants at the 100-microgram dose level in the U.S. for the phase III trial. The estimated start date is July 27.

This article first appeared on WebMD.com.

Every person who received Moderna’s COVID-19 vaccine, mRNA-1273, developed an immune response to the virus that causes it, the company says in a news release.

Researchers also reported some side effects in the 45 people in the phase I study, but no significant safety issues, the news release says.

The vaccine is among hundreds being tested worldwide in an effort to halt the pandemic that has killed nearly 600,000 worldwide.

A researcher testing the vaccine called the results encouraging but cautioned more study is needed. “Importantly, the vaccine resulted in a robust immune response,” Evan Anderson, MD, principal investigator for the trial at Emory University, says in a news release. Emory and Kaiser Permanente Washington Health Research Institute were the two sites for the study.

The company is already testing the vaccine in a larger group of people, known as a phase II trial. It plans to begin phase III trials in late July. Phase III trials involve testing the vaccine on an even larger group and are the final step before FDA approval.

The study results are published in The New England Journal of Medicine. The study was led by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

Moderna’s vaccine uses messenger RNA, also called mRNA. It carries the instruction for making the spike protein, a key protein on the surface of the virus that allows it to enter cells when a person is infected. After it’s injected, it goes to the immune cells and instructs them to make copies of the spike protein, acting as if the cells have been infected with the actual coronavirus. This allows other immune cells to develop immunity.

In the study, participants were divided into three groups of 15 people each. All groups received two vaccinations 28 days apart. Each group received a different strength of the vaccine – either 25, 100, or 250 micrograms.

Every person in the study developed antibodies that can block the infection. Most commonly reported side effects after the second vaccination in the 100-microgram group were fatigue, chills, headache, and muscle pains, ranging from mild to moderately severe.

The phase II study has 300 heathy adults ages 18-55, along with another 300 ages 55 and older

Moderna says it hopes to include about 30,000 participants at the 100-microgram dose level in the U.S. for the phase III trial. The estimated start date is July 27.

This article first appeared on WebMD.com.