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SCAI releases first definition of cardiogenic shock
LAS VEGAS – The Society for Cardiovascular Angiography & Interventions released on May 19 the first-ever classification scheme for cardiogenic shock, dividing the condition into five severity levels.
The expert consensus panel that devised the new definition and classification model hopes it will spearhead a reset of research into the management of cardiogenic shock so that clinicians can assess interventions and introduce them into practice in a more precise, reproducible, and systematic way, Srihari S. Naidu, MD, said while presenting the proposal at the society’s annual scientific sessions.
The writing panel’s hope is that the new definition will “drive earlier recognition of shock and at a more precise stage to guide appropriate and timely escalation of care” and to “better define prospectively the value of mechanical circulatory support, extracorporeal membrane oxygenation, and other therapies,” said Dr. Naidu, chair of the writing group, as well as professor of medicine at New York Medical College and director of the cardiac catheterization laboratory at Westchester Medical Center, both in Valhalla, N.Y.
At the core of the classification scheme are the definitions for five strata of disease, which start at stage A, the “at-risk” patients before shock onset, and progress through stage B, “beginning”; stage C, “classic”; stage D, “deteriorating”; and stage E, “extremis,” which defines a patient with circulatory collapse (Catheter Cardiovasc Interv. 2019 May 19; doi: 10.1002/ccd.28329). Another key element of the classification model is the cardiac arrest “modifier,” designated by a subscripted letter A, which identifies patients who have had a cardiac arrest, regardless of duration. So a patient could be a stage BA, which identifies a patient with clinical evidence of relative hypotension or tachycardia without hypoperfusion and with a history of cardiac arrest.
The statement also itemizes several biomarkers and hemodynamic measurements that need regular, serial monitoring, such as blood lactate and right arterial pressure. Although the document leaves specific, defining values for some of these measures vaguely defined – the intent is that future research will fill in these gaps – the overall message is that clinicians caring for cardiogenic shock patients “need to be aggressive and look for these things,” Dr. Naidu said in a video interview.
“Until we agree on a definition of cardiogenic shock, we can’t go anywhere,” commented Larry S. Dean, MD, professor of medicine at and director of the Regional Heart Center of the University of Washington in Seattle. “There are a lot of conflicting data out there, and until we have a shared definition, we can’t advance our practice. We need to start looking at shock patients in a more precise way.”
“Without a clear definition of cardiogenic shock we will never improve patient outcomes. Every shock trial must define shock. If investigators just say ‘patients were in shock,’ I don’t know what that means,” noted Navin K. Kapur, MD, director of the Interventional Research Laboratories at Tufts Medical Center in Boston and a member of the writing panel.
Dr. Naidu and others on the panel highlighted the need to now validate the classification scheme’s ability to consistently categorize patients and predict their disease trajectories. They have begun the validation process with a 10,000-patient database of “all-comers” with cardiogenic shock maintained by the Mayo Clinic. Full results from this analysis will be out soon, but Dr. Naidu revealed in passing that it successfully provided validation of the proposed scheme.
The new definition received endorsements from the American College of Cardiology, the American Heart Association, the Society of Critical Care Medicine, and the Society of Thoracic Surgeons.
Dr. Naidu had no disclosures.
LAS VEGAS – The Society for Cardiovascular Angiography & Interventions released on May 19 the first-ever classification scheme for cardiogenic shock, dividing the condition into five severity levels.
The expert consensus panel that devised the new definition and classification model hopes it will spearhead a reset of research into the management of cardiogenic shock so that clinicians can assess interventions and introduce them into practice in a more precise, reproducible, and systematic way, Srihari S. Naidu, MD, said while presenting the proposal at the society’s annual scientific sessions.
The writing panel’s hope is that the new definition will “drive earlier recognition of shock and at a more precise stage to guide appropriate and timely escalation of care” and to “better define prospectively the value of mechanical circulatory support, extracorporeal membrane oxygenation, and other therapies,” said Dr. Naidu, chair of the writing group, as well as professor of medicine at New York Medical College and director of the cardiac catheterization laboratory at Westchester Medical Center, both in Valhalla, N.Y.
At the core of the classification scheme are the definitions for five strata of disease, which start at stage A, the “at-risk” patients before shock onset, and progress through stage B, “beginning”; stage C, “classic”; stage D, “deteriorating”; and stage E, “extremis,” which defines a patient with circulatory collapse (Catheter Cardiovasc Interv. 2019 May 19; doi: 10.1002/ccd.28329). Another key element of the classification model is the cardiac arrest “modifier,” designated by a subscripted letter A, which identifies patients who have had a cardiac arrest, regardless of duration. So a patient could be a stage BA, which identifies a patient with clinical evidence of relative hypotension or tachycardia without hypoperfusion and with a history of cardiac arrest.
The statement also itemizes several biomarkers and hemodynamic measurements that need regular, serial monitoring, such as blood lactate and right arterial pressure. Although the document leaves specific, defining values for some of these measures vaguely defined – the intent is that future research will fill in these gaps – the overall message is that clinicians caring for cardiogenic shock patients “need to be aggressive and look for these things,” Dr. Naidu said in a video interview.
“Until we agree on a definition of cardiogenic shock, we can’t go anywhere,” commented Larry S. Dean, MD, professor of medicine at and director of the Regional Heart Center of the University of Washington in Seattle. “There are a lot of conflicting data out there, and until we have a shared definition, we can’t advance our practice. We need to start looking at shock patients in a more precise way.”
“Without a clear definition of cardiogenic shock we will never improve patient outcomes. Every shock trial must define shock. If investigators just say ‘patients were in shock,’ I don’t know what that means,” noted Navin K. Kapur, MD, director of the Interventional Research Laboratories at Tufts Medical Center in Boston and a member of the writing panel.
Dr. Naidu and others on the panel highlighted the need to now validate the classification scheme’s ability to consistently categorize patients and predict their disease trajectories. They have begun the validation process with a 10,000-patient database of “all-comers” with cardiogenic shock maintained by the Mayo Clinic. Full results from this analysis will be out soon, but Dr. Naidu revealed in passing that it successfully provided validation of the proposed scheme.
The new definition received endorsements from the American College of Cardiology, the American Heart Association, the Society of Critical Care Medicine, and the Society of Thoracic Surgeons.
Dr. Naidu had no disclosures.
LAS VEGAS – The Society for Cardiovascular Angiography & Interventions released on May 19 the first-ever classification scheme for cardiogenic shock, dividing the condition into five severity levels.
The expert consensus panel that devised the new definition and classification model hopes it will spearhead a reset of research into the management of cardiogenic shock so that clinicians can assess interventions and introduce them into practice in a more precise, reproducible, and systematic way, Srihari S. Naidu, MD, said while presenting the proposal at the society’s annual scientific sessions.
The writing panel’s hope is that the new definition will “drive earlier recognition of shock and at a more precise stage to guide appropriate and timely escalation of care” and to “better define prospectively the value of mechanical circulatory support, extracorporeal membrane oxygenation, and other therapies,” said Dr. Naidu, chair of the writing group, as well as professor of medicine at New York Medical College and director of the cardiac catheterization laboratory at Westchester Medical Center, both in Valhalla, N.Y.
At the core of the classification scheme are the definitions for five strata of disease, which start at stage A, the “at-risk” patients before shock onset, and progress through stage B, “beginning”; stage C, “classic”; stage D, “deteriorating”; and stage E, “extremis,” which defines a patient with circulatory collapse (Catheter Cardiovasc Interv. 2019 May 19; doi: 10.1002/ccd.28329). Another key element of the classification model is the cardiac arrest “modifier,” designated by a subscripted letter A, which identifies patients who have had a cardiac arrest, regardless of duration. So a patient could be a stage BA, which identifies a patient with clinical evidence of relative hypotension or tachycardia without hypoperfusion and with a history of cardiac arrest.
The statement also itemizes several biomarkers and hemodynamic measurements that need regular, serial monitoring, such as blood lactate and right arterial pressure. Although the document leaves specific, defining values for some of these measures vaguely defined – the intent is that future research will fill in these gaps – the overall message is that clinicians caring for cardiogenic shock patients “need to be aggressive and look for these things,” Dr. Naidu said in a video interview.
“Until we agree on a definition of cardiogenic shock, we can’t go anywhere,” commented Larry S. Dean, MD, professor of medicine at and director of the Regional Heart Center of the University of Washington in Seattle. “There are a lot of conflicting data out there, and until we have a shared definition, we can’t advance our practice. We need to start looking at shock patients in a more precise way.”
“Without a clear definition of cardiogenic shock we will never improve patient outcomes. Every shock trial must define shock. If investigators just say ‘patients were in shock,’ I don’t know what that means,” noted Navin K. Kapur, MD, director of the Interventional Research Laboratories at Tufts Medical Center in Boston and a member of the writing panel.
Dr. Naidu and others on the panel highlighted the need to now validate the classification scheme’s ability to consistently categorize patients and predict their disease trajectories. They have begun the validation process with a 10,000-patient database of “all-comers” with cardiogenic shock maintained by the Mayo Clinic. Full results from this analysis will be out soon, but Dr. Naidu revealed in passing that it successfully provided validation of the proposed scheme.
The new definition received endorsements from the American College of Cardiology, the American Heart Association, the Society of Critical Care Medicine, and the Society of Thoracic Surgeons.
Dr. Naidu had no disclosures.
REPORTING FROM SCAI 2019
FDA issues warning about use of unauthorized diabetes devices
This safety communication applies to continuous glucose monitors, insulin pumps, and automated insulin-dosing systems and is intended for both patients who manage their diabetes with any of various devices and the health care providers who treat and manage those patients.
The agency’s concerns were underscored by a recent report it received about a patient who used a combination of unauthorized devices and who needed medical intervention as a result.
“Because of the complexity of these devices and the life-saving care they provide, it’s important that patients are aware of the risks that arise when they’re not used as intended, or when [patients] use devices not authorized for sale in the [United States],” Jeff Shuren, MD, director of the agency’s Center for Devices and Radiological Health, said in a news release. “[This] warning is part of our ongoing public health commitment to protect patients and communicate with the public when we become aware of issues stemming from the use, or misuse, of medical devices.”
The release noted that the agency reviews some of the diabetes management devices as an entity, or system, or as being compatible with other approved components, such as integrated continuous glucose-monitoring systems. “This is known as interoperability, which allows patients to safely tailor their diabetes management to their individual preferences by choosing devices that are authorized by the FDA to work together,” it said.
However, the agency said it is aware that some manufacturers are illegally marketing devices that it hasn’t reviewed for safety and effectiveness and that some patients combine devices or components that are not intended for use with each other in an effort to cut costs or because of personal preferences. When patients do that, it introduces new risks that “could result in inaccurate glucose level readings or unsafe insulin dosing, which can lead to risks requiring medical intervention, such as severe low blood sugar, coma, diabetic ketoacidosis, and death,” it warned.
The agency said it realized that patients with chronic conditions such as diabetes preferred having a range of options so that they could tailor their treatment and management to their specific needs, but that it was important that they were fully aware of the risks of doing so.
It recommended that patients speak to their doctor about their device and component needs and use only those that the FDA has reviewed for safety and effectiveness. In addition, any concerns about the cost or availability of approved systems should be taken up with the treating doctor and insurance provider, who can advise on coverage and acceptable, alternative options.
Any adverse events should be reported to the agency through its MedWatch reporting system.
More information about safety in diabetes management devices and components is available at safety communication and the agency’s news release.
This safety communication applies to continuous glucose monitors, insulin pumps, and automated insulin-dosing systems and is intended for both patients who manage their diabetes with any of various devices and the health care providers who treat and manage those patients.
The agency’s concerns were underscored by a recent report it received about a patient who used a combination of unauthorized devices and who needed medical intervention as a result.
“Because of the complexity of these devices and the life-saving care they provide, it’s important that patients are aware of the risks that arise when they’re not used as intended, or when [patients] use devices not authorized for sale in the [United States],” Jeff Shuren, MD, director of the agency’s Center for Devices and Radiological Health, said in a news release. “[This] warning is part of our ongoing public health commitment to protect patients and communicate with the public when we become aware of issues stemming from the use, or misuse, of medical devices.”
The release noted that the agency reviews some of the diabetes management devices as an entity, or system, or as being compatible with other approved components, such as integrated continuous glucose-monitoring systems. “This is known as interoperability, which allows patients to safely tailor their diabetes management to their individual preferences by choosing devices that are authorized by the FDA to work together,” it said.
However, the agency said it is aware that some manufacturers are illegally marketing devices that it hasn’t reviewed for safety and effectiveness and that some patients combine devices or components that are not intended for use with each other in an effort to cut costs or because of personal preferences. When patients do that, it introduces new risks that “could result in inaccurate glucose level readings or unsafe insulin dosing, which can lead to risks requiring medical intervention, such as severe low blood sugar, coma, diabetic ketoacidosis, and death,” it warned.
The agency said it realized that patients with chronic conditions such as diabetes preferred having a range of options so that they could tailor their treatment and management to their specific needs, but that it was important that they were fully aware of the risks of doing so.
It recommended that patients speak to their doctor about their device and component needs and use only those that the FDA has reviewed for safety and effectiveness. In addition, any concerns about the cost or availability of approved systems should be taken up with the treating doctor and insurance provider, who can advise on coverage and acceptable, alternative options.
Any adverse events should be reported to the agency through its MedWatch reporting system.
More information about safety in diabetes management devices and components is available at safety communication and the agency’s news release.
This safety communication applies to continuous glucose monitors, insulin pumps, and automated insulin-dosing systems and is intended for both patients who manage their diabetes with any of various devices and the health care providers who treat and manage those patients.
The agency’s concerns were underscored by a recent report it received about a patient who used a combination of unauthorized devices and who needed medical intervention as a result.
“Because of the complexity of these devices and the life-saving care they provide, it’s important that patients are aware of the risks that arise when they’re not used as intended, or when [patients] use devices not authorized for sale in the [United States],” Jeff Shuren, MD, director of the agency’s Center for Devices and Radiological Health, said in a news release. “[This] warning is part of our ongoing public health commitment to protect patients and communicate with the public when we become aware of issues stemming from the use, or misuse, of medical devices.”
The release noted that the agency reviews some of the diabetes management devices as an entity, or system, or as being compatible with other approved components, such as integrated continuous glucose-monitoring systems. “This is known as interoperability, which allows patients to safely tailor their diabetes management to their individual preferences by choosing devices that are authorized by the FDA to work together,” it said.
However, the agency said it is aware that some manufacturers are illegally marketing devices that it hasn’t reviewed for safety and effectiveness and that some patients combine devices or components that are not intended for use with each other in an effort to cut costs or because of personal preferences. When patients do that, it introduces new risks that “could result in inaccurate glucose level readings or unsafe insulin dosing, which can lead to risks requiring medical intervention, such as severe low blood sugar, coma, diabetic ketoacidosis, and death,” it warned.
The agency said it realized that patients with chronic conditions such as diabetes preferred having a range of options so that they could tailor their treatment and management to their specific needs, but that it was important that they were fully aware of the risks of doing so.
It recommended that patients speak to their doctor about their device and component needs and use only those that the FDA has reviewed for safety and effectiveness. In addition, any concerns about the cost or availability of approved systems should be taken up with the treating doctor and insurance provider, who can advise on coverage and acceptable, alternative options.
Any adverse events should be reported to the agency through its MedWatch reporting system.
More information about safety in diabetes management devices and components is available at safety communication and the agency’s news release.
HM19: Pediatric sepsis
Improving recognition and treatment
Presenters
Elise van der Jagt, MD, MPH
Workshop title
What you need to know about pediatric sepsis
Session summary
Dr. Elise van der Jagt of the University of Rochester (N.Y.) Medical Center, introduced the topic of pediatric sepsis and its epidemiology with the story of 12-year-old Rory Staunton, who died in 2012 of sepsis. In pediatrics, sepsis is the 10th leading cause of death, with severe sepsis having a mortality rate of 4%-10%. As a response to Rory Staunton’s death from sepsis, New York Governor Andrew Cuomo mandated all hospitals to implement ways to improve recognition and treatment of septic shock, especially in children.
The definition and management of sepsis in pediatrics is complex, and forms a spectrum of disease from sepsis to severe sepsis, and septic shock. Dr. van der Jagt advised not to use the adult sepsis definition in children. Sepsis, stated Dr. van der Jagt, is systemic inflammatory response syndrome in association with suspected or proven infection. Severe sepsis is sepsis with cardiovascular dysfunction, respiratory dysfunction, or dysfunction of two other systems. Septic shock is sepsis with cardiovascular dysfunction that persists despite 40 mL/kg of fluid bolus in 1 hour.
Early recognition and management of sepsis decreases mortality. Early recognition can be improved by initiating a recognition bundle. Multiple trigger tools are available such as pSOFA (Pediatric Sequential Organ Failure Assessment). Any trigger tool, however, must be combined with physician evaluation. This clinician assessment should be initiated within 15 minutes for any patient who screens positive with a trigger tool.
Resuscitation bundles also decrease mortality. A good goal is establishing intravenous or intraosseous access within 5 minutes, fluid administration within 30 minutes, and antibiotics and inotrope administration (if needed) in 60 minutes. Resuscitation bundles could include a sepsis clock, rapid response team, check list, protocol, and order set. Additional studies are needed to determine which of the components of a sepsis bundle is most important. Studies show that mortality increases with delays in initiating fluids and less fluids given. However, giving too much fluid also increases morbidity. It is imperative, stated Dr. van der Jagt, to reassess after fluid boluses. Use of lactate measurement can be problematic in pediatrics, as normal lactate can be seen with florid sepsis.
Stabilization bundles are more common in the ICU setting. They include an arterial line, central venous pressure, cardiopulmonary monitor, urinary catheter, and pulse oximeter. A performance bundle is important to assess adherence to the other bundles. This could include providing debriefing, data review, feedback, and formal quality improvement projects. Assigning a sepsis champion in each area helps to overcome barriers and continue performance bundles.
Key takeaways for HM
- Patients with severe sepsis/septic shock should be rapidly identified with the 2014/2017 American College of Critical Care Medicine consensus criteria.
- Efficient, time-based care should be provided during the first hour after recognizing pediatric severe sepsis/septic shock.
- Overcoming systems barriers to rapid sepsis recognition and treatment requires sepsis champions in each area, continuous data collection and feedback, persistence, and patience.
Dr. Eboh is a pediatric hospitalist at Covenant Children’s Hospital in Lubbock, Texas, and assistant professor of pediatrics at Texas Tech University Health Sciences Center. Dr. Wright is a pediatric hospitalist at Texas Tech University Health Sciences Center.
Improving recognition and treatment
Improving recognition and treatment
Presenters
Elise van der Jagt, MD, MPH
Workshop title
What you need to know about pediatric sepsis
Session summary
Dr. Elise van der Jagt of the University of Rochester (N.Y.) Medical Center, introduced the topic of pediatric sepsis and its epidemiology with the story of 12-year-old Rory Staunton, who died in 2012 of sepsis. In pediatrics, sepsis is the 10th leading cause of death, with severe sepsis having a mortality rate of 4%-10%. As a response to Rory Staunton’s death from sepsis, New York Governor Andrew Cuomo mandated all hospitals to implement ways to improve recognition and treatment of septic shock, especially in children.
The definition and management of sepsis in pediatrics is complex, and forms a spectrum of disease from sepsis to severe sepsis, and septic shock. Dr. van der Jagt advised not to use the adult sepsis definition in children. Sepsis, stated Dr. van der Jagt, is systemic inflammatory response syndrome in association with suspected or proven infection. Severe sepsis is sepsis with cardiovascular dysfunction, respiratory dysfunction, or dysfunction of two other systems. Septic shock is sepsis with cardiovascular dysfunction that persists despite 40 mL/kg of fluid bolus in 1 hour.
Early recognition and management of sepsis decreases mortality. Early recognition can be improved by initiating a recognition bundle. Multiple trigger tools are available such as pSOFA (Pediatric Sequential Organ Failure Assessment). Any trigger tool, however, must be combined with physician evaluation. This clinician assessment should be initiated within 15 minutes for any patient who screens positive with a trigger tool.
Resuscitation bundles also decrease mortality. A good goal is establishing intravenous or intraosseous access within 5 minutes, fluid administration within 30 minutes, and antibiotics and inotrope administration (if needed) in 60 minutes. Resuscitation bundles could include a sepsis clock, rapid response team, check list, protocol, and order set. Additional studies are needed to determine which of the components of a sepsis bundle is most important. Studies show that mortality increases with delays in initiating fluids and less fluids given. However, giving too much fluid also increases morbidity. It is imperative, stated Dr. van der Jagt, to reassess after fluid boluses. Use of lactate measurement can be problematic in pediatrics, as normal lactate can be seen with florid sepsis.
Stabilization bundles are more common in the ICU setting. They include an arterial line, central venous pressure, cardiopulmonary monitor, urinary catheter, and pulse oximeter. A performance bundle is important to assess adherence to the other bundles. This could include providing debriefing, data review, feedback, and formal quality improvement projects. Assigning a sepsis champion in each area helps to overcome barriers and continue performance bundles.
Key takeaways for HM
- Patients with severe sepsis/septic shock should be rapidly identified with the 2014/2017 American College of Critical Care Medicine consensus criteria.
- Efficient, time-based care should be provided during the first hour after recognizing pediatric severe sepsis/septic shock.
- Overcoming systems barriers to rapid sepsis recognition and treatment requires sepsis champions in each area, continuous data collection and feedback, persistence, and patience.
Dr. Eboh is a pediatric hospitalist at Covenant Children’s Hospital in Lubbock, Texas, and assistant professor of pediatrics at Texas Tech University Health Sciences Center. Dr. Wright is a pediatric hospitalist at Texas Tech University Health Sciences Center.
Presenters
Elise van der Jagt, MD, MPH
Workshop title
What you need to know about pediatric sepsis
Session summary
Dr. Elise van der Jagt of the University of Rochester (N.Y.) Medical Center, introduced the topic of pediatric sepsis and its epidemiology with the story of 12-year-old Rory Staunton, who died in 2012 of sepsis. In pediatrics, sepsis is the 10th leading cause of death, with severe sepsis having a mortality rate of 4%-10%. As a response to Rory Staunton’s death from sepsis, New York Governor Andrew Cuomo mandated all hospitals to implement ways to improve recognition and treatment of septic shock, especially in children.
The definition and management of sepsis in pediatrics is complex, and forms a spectrum of disease from sepsis to severe sepsis, and septic shock. Dr. van der Jagt advised not to use the adult sepsis definition in children. Sepsis, stated Dr. van der Jagt, is systemic inflammatory response syndrome in association with suspected or proven infection. Severe sepsis is sepsis with cardiovascular dysfunction, respiratory dysfunction, or dysfunction of two other systems. Septic shock is sepsis with cardiovascular dysfunction that persists despite 40 mL/kg of fluid bolus in 1 hour.
Early recognition and management of sepsis decreases mortality. Early recognition can be improved by initiating a recognition bundle. Multiple trigger tools are available such as pSOFA (Pediatric Sequential Organ Failure Assessment). Any trigger tool, however, must be combined with physician evaluation. This clinician assessment should be initiated within 15 minutes for any patient who screens positive with a trigger tool.
Resuscitation bundles also decrease mortality. A good goal is establishing intravenous or intraosseous access within 5 minutes, fluid administration within 30 minutes, and antibiotics and inotrope administration (if needed) in 60 minutes. Resuscitation bundles could include a sepsis clock, rapid response team, check list, protocol, and order set. Additional studies are needed to determine which of the components of a sepsis bundle is most important. Studies show that mortality increases with delays in initiating fluids and less fluids given. However, giving too much fluid also increases morbidity. It is imperative, stated Dr. van der Jagt, to reassess after fluid boluses. Use of lactate measurement can be problematic in pediatrics, as normal lactate can be seen with florid sepsis.
Stabilization bundles are more common in the ICU setting. They include an arterial line, central venous pressure, cardiopulmonary monitor, urinary catheter, and pulse oximeter. A performance bundle is important to assess adherence to the other bundles. This could include providing debriefing, data review, feedback, and formal quality improvement projects. Assigning a sepsis champion in each area helps to overcome barriers and continue performance bundles.
Key takeaways for HM
- Patients with severe sepsis/septic shock should be rapidly identified with the 2014/2017 American College of Critical Care Medicine consensus criteria.
- Efficient, time-based care should be provided during the first hour after recognizing pediatric severe sepsis/septic shock.
- Overcoming systems barriers to rapid sepsis recognition and treatment requires sepsis champions in each area, continuous data collection and feedback, persistence, and patience.
Dr. Eboh is a pediatric hospitalist at Covenant Children’s Hospital in Lubbock, Texas, and assistant professor of pediatrics at Texas Tech University Health Sciences Center. Dr. Wright is a pediatric hospitalist at Texas Tech University Health Sciences Center.
Call for 2019 AVAHO Abstracts
The AVAHO Program Planning Committee is pleased to announce the call for abstracts for our meeting in Minneapolis, Minnesota, September 20-22, 2019. Abstracts should be submitted online here: https://www.avaho.org/call-for-abstracts.
Abstracts should not exceed 350 words, excluding title and titles should not exceed 300 characters. Illustrations, tables or bullet points are not permitted.
The following categories of abstracts are suitable for submission:
- Research (eg, clinical trials, laboratory studies, translational studies, descriptive studies, qualitative studies)
- Evidence-Based Projects
- Quality Improvement Projects and initiatives
- Clinical Practice (eg, best clinical practice exemplar, case study, disease management, palliative care (non-research), survivorship (nonresearch), symptom management (non-research)
- Program Initiatives (eg, workforce, infrastructure, workflow)
- Projects in Progress
The first author is considered the primary author, is responsible for the content and integrity of the project, and will serve as the contact person by the AVAHO administrator and Planning Committee. Authors may submit more than one abstract; however, they may be first author on only one abstract. At least one author must be a member of AVAHO. One author must present the abstract at the meeting. Accepted abstracts will be published in a special edition of Federal Practitioner.
The electronic poster session was viewed very favorably by attendees last year and will be used again this year. This requires more logistic hurdles and thus, the June 1 submission deadline is firm.
Each poster will be assigned to one of two time slots for presentation. One author must be present to give a brief presentation of the poster. Authors are encouraged to record their poster presentation to provide attendees another option for viewing your poster. This recording does NOT replace the obligation to be present IN PERSON during the assigned poster session. Details regarding this recording will be forthcoming.
All abstracts must be submitted by June 1, 2019. This is a firm deadline. No extensions.
The AVAHO Program Planning Committee is pleased to announce the call for abstracts for our meeting in Minneapolis, Minnesota, September 20-22, 2019. Abstracts should be submitted online here: https://www.avaho.org/call-for-abstracts.
Abstracts should not exceed 350 words, excluding title and titles should not exceed 300 characters. Illustrations, tables or bullet points are not permitted.
The following categories of abstracts are suitable for submission:
- Research (eg, clinical trials, laboratory studies, translational studies, descriptive studies, qualitative studies)
- Evidence-Based Projects
- Quality Improvement Projects and initiatives
- Clinical Practice (eg, best clinical practice exemplar, case study, disease management, palliative care (non-research), survivorship (nonresearch), symptom management (non-research)
- Program Initiatives (eg, workforce, infrastructure, workflow)
- Projects in Progress
The first author is considered the primary author, is responsible for the content and integrity of the project, and will serve as the contact person by the AVAHO administrator and Planning Committee. Authors may submit more than one abstract; however, they may be first author on only one abstract. At least one author must be a member of AVAHO. One author must present the abstract at the meeting. Accepted abstracts will be published in a special edition of Federal Practitioner.
The electronic poster session was viewed very favorably by attendees last year and will be used again this year. This requires more logistic hurdles and thus, the June 1 submission deadline is firm.
Each poster will be assigned to one of two time slots for presentation. One author must be present to give a brief presentation of the poster. Authors are encouraged to record their poster presentation to provide attendees another option for viewing your poster. This recording does NOT replace the obligation to be present IN PERSON during the assigned poster session. Details regarding this recording will be forthcoming.
All abstracts must be submitted by June 1, 2019. This is a firm deadline. No extensions.
The AVAHO Program Planning Committee is pleased to announce the call for abstracts for our meeting in Minneapolis, Minnesota, September 20-22, 2019. Abstracts should be submitted online here: https://www.avaho.org/call-for-abstracts.
Abstracts should not exceed 350 words, excluding title and titles should not exceed 300 characters. Illustrations, tables or bullet points are not permitted.
The following categories of abstracts are suitable for submission:
- Research (eg, clinical trials, laboratory studies, translational studies, descriptive studies, qualitative studies)
- Evidence-Based Projects
- Quality Improvement Projects and initiatives
- Clinical Practice (eg, best clinical practice exemplar, case study, disease management, palliative care (non-research), survivorship (nonresearch), symptom management (non-research)
- Program Initiatives (eg, workforce, infrastructure, workflow)
- Projects in Progress
The first author is considered the primary author, is responsible for the content and integrity of the project, and will serve as the contact person by the AVAHO administrator and Planning Committee. Authors may submit more than one abstract; however, they may be first author on only one abstract. At least one author must be a member of AVAHO. One author must present the abstract at the meeting. Accepted abstracts will be published in a special edition of Federal Practitioner.
The electronic poster session was viewed very favorably by attendees last year and will be used again this year. This requires more logistic hurdles and thus, the June 1 submission deadline is firm.
Each poster will be assigned to one of two time slots for presentation. One author must be present to give a brief presentation of the poster. Authors are encouraged to record their poster presentation to provide attendees another option for viewing your poster. This recording does NOT replace the obligation to be present IN PERSON during the assigned poster session. Details regarding this recording will be forthcoming.
All abstracts must be submitted by June 1, 2019. This is a firm deadline. No extensions.
CABANA: Heart failure patients got biggest bang from AFib ablation
SAN FRANCISCO – Catheter ablation of atrial fibrillation (AFib) in the roughly one-third of patients with heart failure enrolled in the CABANA multicenter, randomized trial produced striking, statistically significant improvements both in the study’s primary, combined endpoint and in all-cause mortality in intention-to-treat analyses.
These findings, from prespecified secondary analyses, contrasted with the study’s overall result, which showed no benefit in the primary endpoint analysis in the total study population of 2,204 patients with AFib (JAMA. 2019 Apr 2;321[13]:1261-74). They are also at odds with the primary endpoint result in the two-thirds of enrolled patients without heart failure, which showed no significant between-group differences in these two outcome measures among the patients assigned to the catheter ablation arm and the study’s control, which was medical management arm.
Among the 778 AFib patients enrolled in CABANA with any form of heart failure (35% of the total study enrollment), the incidence of the study’s primary endpoint – the combined rate of death, disabling stroke, serious bleeding, or cardiac arrest during a median follow-up of slightly more than 4 years – was 36% lower among the catheter-ablated heart failure patients than in the heart failure patients assigned to medical treatment, according to an intention-to-treat analysis, which was a statistically significant difference. The incidence of all-cause mortality during follow-up was 43% lower in the ablated heart failure patients, compared with the controls, Douglas L. Packer, MD, said at the annual scientific sessions of the Heart Rhythm Society.
In contrast, among enrolled patients without heart failure, the intention-to-treat primary endpoint was 6% higher in the ablated patients, and all-cause mortality was a relative 27% higher, although neither difference was statistically significant.
It’s a “little surprising” that the results showed this much benefit in the patients with heart failure, said Dr. Packer, professor of medicine at the Mayo Clinic in Rochester, Minn., and lead investigator of the CABANA (Catheter Ablation vs Anti-Arrhythmic Drug Therapy for Atrial Fibrillation) trial. “I think these data confirm the results of the CASTLE-AF trial, but without some of the glitches some people have cited” about that study, such as concerns about a high level of patient selection in CASTLE-AF and its relatively modest number of enrolled patients, he said in an interview.
The CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) study, run entirely in patients with heart failure with reduced ejection fraction and AFib, showed a statistically significant improvement in patient survival and heart failure hospitalization after catheter ablation compared with medical management (N Engl J Med. 2018 Feb 1;378[5]:417-27). Prior to the CASTLE-AF report, results from several other small studies (J Interv Card Electrophysiol. 2018 Oct;53[1]:19-29), as well as those from the AATAC trial (Circulation. 2016 Apr 26;133[17]:1637-44), also showed consistent evidence for benefit from catheter ablation in patients with heart failure and AFib, noted CABANA coinvestigator Jonathan P. Piccini, MD, during a separate talk at the meeting.
“The improvement of cardiovascular outcomes with ablation in patients with heart failure and AFib is consistent across multiple trials, at least with respect to heart failure with reduced ejection fraction” concluded Dr. Piccini, a cardiac electrophysiologist at Duke University in Durham, N.C.
As a result of the new heart failure analysis, “I think the guidelines will change,” predicted Dr. Packer, with catheter ablation receiving a firmer endorsement for patients with heart failure the next time U.S. guidelines for heart failure and AFib management are updated. The findings say “there is substantial benefit of catheter ablation in heart failure patients, but I don’t think our findings lessen the utility of ablation in patients without heart failure,” he stressed. Even patients without heart failure showed reduction in AFib burden and improvement in quality of life that were similar to what was seen in the heart failure patients.
The new report from CABANA of benefit from AFib catheter ablation in patients with heart failure “absolutely advances the evidence,” commented Clyde W. Yancy, MD, professor of medicine and chief of cardiology at Northwestern University in Chicago. “A number of us were quite circumspect about this based on the CASTLE-AF data, but the new CABANA analyses have addressed our anxiety that the CASTLE-AF results were just by chance.” The new CABANA analyses “may not confirm CASTLE-AF, but it enriches the conversation and makes it possible that we are seeing benefit in some patients with heart failure who get ablated.”
Dr. Yancy, who chaired the most recent update to the U.S. heart failure management guideline (J Am Coll Cardiol. 2017 Aug 8;70[6]:776-803) stopped short of saying that the cumulative evidence now supports a guideline change, but he acknowledged in an interview that the evidence could legitimately influence practice. Catheter ablation should now be “strongly considered” in patients with heart failure and AFib, he said, although he also had three qualifications for opting for this approach: Patients must already be on guideline-directed medical therapy for their heart failure, the catheter ablation needs to be performed by an experienced and skilled operator, and follow-up surveillance must focus on both the patient’s AFib and heart failure. “It’s absolutely appropriate to consider catheter ablation” for heart failure patients, but the evidence is not yet there for guideline change, Dr. Yancy concluded.
It remains uncertain why catheter ablation of AFib should be more effective in patients with heart failure than in those without. Dr. Packer speculated that one reason may be the heart rate reduction that AFib ablation produces may especially benefit heart failure patients. An additional helpful effect of ablation in heart failure patients may be reducing heart rate variability. Another notable finding of the new analysis was that 79% of patients with heart failure in CABANA had heart failure with preserved ejection fraction, with a left ventricular ejection fraction of at least 50%. “Getting rid of AFib in patients with heart failure with preserved ejection fraction will be more important than we have thought,” Dr. Packer said.
Other new CABANA analyses presented for the first time in separate talks at the meeting also showed that, while catheter ablation had no meaningful difference in effect on outcomes based on the sex of patients, both age and minority ethnic and racial status appeared to make a substantial difference. For CABANA’s primary endpoint, catheter ablation was especially effective for improving outcomes in patients 64 years old or younger, and the analysis showed a signal of possibly worse outcomes in patients who were at least 75 years old. The “substantially” better outcomes in minority-group patients represented the largest between-group difference among subgroups seen in CABANA and is a “big deal,” said Dr. Packer, who predicted that future catheter ablation use will likely rise in patients with heart failure, in younger patients, and in minority patients.
Dr. Piccini noted that, “it’s possible that CABANA identified some patient subgroups that do really well after ablation, but the problem is that, in the United States, we now often don’t treat” minority patients or those with reduced left ventricular ejection fractions with ablation, according to recent registry findings.
CABANA received partial funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Packer has been a consultant to and/or received research funding from these four companies, as well as numerous drug and device companies, and has a financial interest in a licensed AFib mapping technology. Dr. Piccini has ties Boston Scientific, Medtronic, and numerous other drug and device companies, and disclosed an unspecified relationship with GlaxoSmithKline. Dr. Yancy disclosed an unspecified relationship with Abbott Laboratories.
SOURCE: Packer DL. Heart Rhythm 2019, Abstract S-AB14-06.
SAN FRANCISCO – Catheter ablation of atrial fibrillation (AFib) in the roughly one-third of patients with heart failure enrolled in the CABANA multicenter, randomized trial produced striking, statistically significant improvements both in the study’s primary, combined endpoint and in all-cause mortality in intention-to-treat analyses.
These findings, from prespecified secondary analyses, contrasted with the study’s overall result, which showed no benefit in the primary endpoint analysis in the total study population of 2,204 patients with AFib (JAMA. 2019 Apr 2;321[13]:1261-74). They are also at odds with the primary endpoint result in the two-thirds of enrolled patients without heart failure, which showed no significant between-group differences in these two outcome measures among the patients assigned to the catheter ablation arm and the study’s control, which was medical management arm.
Among the 778 AFib patients enrolled in CABANA with any form of heart failure (35% of the total study enrollment), the incidence of the study’s primary endpoint – the combined rate of death, disabling stroke, serious bleeding, or cardiac arrest during a median follow-up of slightly more than 4 years – was 36% lower among the catheter-ablated heart failure patients than in the heart failure patients assigned to medical treatment, according to an intention-to-treat analysis, which was a statistically significant difference. The incidence of all-cause mortality during follow-up was 43% lower in the ablated heart failure patients, compared with the controls, Douglas L. Packer, MD, said at the annual scientific sessions of the Heart Rhythm Society.
In contrast, among enrolled patients without heart failure, the intention-to-treat primary endpoint was 6% higher in the ablated patients, and all-cause mortality was a relative 27% higher, although neither difference was statistically significant.
It’s a “little surprising” that the results showed this much benefit in the patients with heart failure, said Dr. Packer, professor of medicine at the Mayo Clinic in Rochester, Minn., and lead investigator of the CABANA (Catheter Ablation vs Anti-Arrhythmic Drug Therapy for Atrial Fibrillation) trial. “I think these data confirm the results of the CASTLE-AF trial, but without some of the glitches some people have cited” about that study, such as concerns about a high level of patient selection in CASTLE-AF and its relatively modest number of enrolled patients, he said in an interview.
The CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) study, run entirely in patients with heart failure with reduced ejection fraction and AFib, showed a statistically significant improvement in patient survival and heart failure hospitalization after catheter ablation compared with medical management (N Engl J Med. 2018 Feb 1;378[5]:417-27). Prior to the CASTLE-AF report, results from several other small studies (J Interv Card Electrophysiol. 2018 Oct;53[1]:19-29), as well as those from the AATAC trial (Circulation. 2016 Apr 26;133[17]:1637-44), also showed consistent evidence for benefit from catheter ablation in patients with heart failure and AFib, noted CABANA coinvestigator Jonathan P. Piccini, MD, during a separate talk at the meeting.
“The improvement of cardiovascular outcomes with ablation in patients with heart failure and AFib is consistent across multiple trials, at least with respect to heart failure with reduced ejection fraction” concluded Dr. Piccini, a cardiac electrophysiologist at Duke University in Durham, N.C.
As a result of the new heart failure analysis, “I think the guidelines will change,” predicted Dr. Packer, with catheter ablation receiving a firmer endorsement for patients with heart failure the next time U.S. guidelines for heart failure and AFib management are updated. The findings say “there is substantial benefit of catheter ablation in heart failure patients, but I don’t think our findings lessen the utility of ablation in patients without heart failure,” he stressed. Even patients without heart failure showed reduction in AFib burden and improvement in quality of life that were similar to what was seen in the heart failure patients.
The new report from CABANA of benefit from AFib catheter ablation in patients with heart failure “absolutely advances the evidence,” commented Clyde W. Yancy, MD, professor of medicine and chief of cardiology at Northwestern University in Chicago. “A number of us were quite circumspect about this based on the CASTLE-AF data, but the new CABANA analyses have addressed our anxiety that the CASTLE-AF results were just by chance.” The new CABANA analyses “may not confirm CASTLE-AF, but it enriches the conversation and makes it possible that we are seeing benefit in some patients with heart failure who get ablated.”
Dr. Yancy, who chaired the most recent update to the U.S. heart failure management guideline (J Am Coll Cardiol. 2017 Aug 8;70[6]:776-803) stopped short of saying that the cumulative evidence now supports a guideline change, but he acknowledged in an interview that the evidence could legitimately influence practice. Catheter ablation should now be “strongly considered” in patients with heart failure and AFib, he said, although he also had three qualifications for opting for this approach: Patients must already be on guideline-directed medical therapy for their heart failure, the catheter ablation needs to be performed by an experienced and skilled operator, and follow-up surveillance must focus on both the patient’s AFib and heart failure. “It’s absolutely appropriate to consider catheter ablation” for heart failure patients, but the evidence is not yet there for guideline change, Dr. Yancy concluded.
It remains uncertain why catheter ablation of AFib should be more effective in patients with heart failure than in those without. Dr. Packer speculated that one reason may be the heart rate reduction that AFib ablation produces may especially benefit heart failure patients. An additional helpful effect of ablation in heart failure patients may be reducing heart rate variability. Another notable finding of the new analysis was that 79% of patients with heart failure in CABANA had heart failure with preserved ejection fraction, with a left ventricular ejection fraction of at least 50%. “Getting rid of AFib in patients with heart failure with preserved ejection fraction will be more important than we have thought,” Dr. Packer said.
Other new CABANA analyses presented for the first time in separate talks at the meeting also showed that, while catheter ablation had no meaningful difference in effect on outcomes based on the sex of patients, both age and minority ethnic and racial status appeared to make a substantial difference. For CABANA’s primary endpoint, catheter ablation was especially effective for improving outcomes in patients 64 years old or younger, and the analysis showed a signal of possibly worse outcomes in patients who were at least 75 years old. The “substantially” better outcomes in minority-group patients represented the largest between-group difference among subgroups seen in CABANA and is a “big deal,” said Dr. Packer, who predicted that future catheter ablation use will likely rise in patients with heart failure, in younger patients, and in minority patients.
Dr. Piccini noted that, “it’s possible that CABANA identified some patient subgroups that do really well after ablation, but the problem is that, in the United States, we now often don’t treat” minority patients or those with reduced left ventricular ejection fractions with ablation, according to recent registry findings.
CABANA received partial funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Packer has been a consultant to and/or received research funding from these four companies, as well as numerous drug and device companies, and has a financial interest in a licensed AFib mapping technology. Dr. Piccini has ties Boston Scientific, Medtronic, and numerous other drug and device companies, and disclosed an unspecified relationship with GlaxoSmithKline. Dr. Yancy disclosed an unspecified relationship with Abbott Laboratories.
SOURCE: Packer DL. Heart Rhythm 2019, Abstract S-AB14-06.
SAN FRANCISCO – Catheter ablation of atrial fibrillation (AFib) in the roughly one-third of patients with heart failure enrolled in the CABANA multicenter, randomized trial produced striking, statistically significant improvements both in the study’s primary, combined endpoint and in all-cause mortality in intention-to-treat analyses.
These findings, from prespecified secondary analyses, contrasted with the study’s overall result, which showed no benefit in the primary endpoint analysis in the total study population of 2,204 patients with AFib (JAMA. 2019 Apr 2;321[13]:1261-74). They are also at odds with the primary endpoint result in the two-thirds of enrolled patients without heart failure, which showed no significant between-group differences in these two outcome measures among the patients assigned to the catheter ablation arm and the study’s control, which was medical management arm.
Among the 778 AFib patients enrolled in CABANA with any form of heart failure (35% of the total study enrollment), the incidence of the study’s primary endpoint – the combined rate of death, disabling stroke, serious bleeding, or cardiac arrest during a median follow-up of slightly more than 4 years – was 36% lower among the catheter-ablated heart failure patients than in the heart failure patients assigned to medical treatment, according to an intention-to-treat analysis, which was a statistically significant difference. The incidence of all-cause mortality during follow-up was 43% lower in the ablated heart failure patients, compared with the controls, Douglas L. Packer, MD, said at the annual scientific sessions of the Heart Rhythm Society.
In contrast, among enrolled patients without heart failure, the intention-to-treat primary endpoint was 6% higher in the ablated patients, and all-cause mortality was a relative 27% higher, although neither difference was statistically significant.
It’s a “little surprising” that the results showed this much benefit in the patients with heart failure, said Dr. Packer, professor of medicine at the Mayo Clinic in Rochester, Minn., and lead investigator of the CABANA (Catheter Ablation vs Anti-Arrhythmic Drug Therapy for Atrial Fibrillation) trial. “I think these data confirm the results of the CASTLE-AF trial, but without some of the glitches some people have cited” about that study, such as concerns about a high level of patient selection in CASTLE-AF and its relatively modest number of enrolled patients, he said in an interview.
The CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) study, run entirely in patients with heart failure with reduced ejection fraction and AFib, showed a statistically significant improvement in patient survival and heart failure hospitalization after catheter ablation compared with medical management (N Engl J Med. 2018 Feb 1;378[5]:417-27). Prior to the CASTLE-AF report, results from several other small studies (J Interv Card Electrophysiol. 2018 Oct;53[1]:19-29), as well as those from the AATAC trial (Circulation. 2016 Apr 26;133[17]:1637-44), also showed consistent evidence for benefit from catheter ablation in patients with heart failure and AFib, noted CABANA coinvestigator Jonathan P. Piccini, MD, during a separate talk at the meeting.
“The improvement of cardiovascular outcomes with ablation in patients with heart failure and AFib is consistent across multiple trials, at least with respect to heart failure with reduced ejection fraction” concluded Dr. Piccini, a cardiac electrophysiologist at Duke University in Durham, N.C.
As a result of the new heart failure analysis, “I think the guidelines will change,” predicted Dr. Packer, with catheter ablation receiving a firmer endorsement for patients with heart failure the next time U.S. guidelines for heart failure and AFib management are updated. The findings say “there is substantial benefit of catheter ablation in heart failure patients, but I don’t think our findings lessen the utility of ablation in patients without heart failure,” he stressed. Even patients without heart failure showed reduction in AFib burden and improvement in quality of life that were similar to what was seen in the heart failure patients.
The new report from CABANA of benefit from AFib catheter ablation in patients with heart failure “absolutely advances the evidence,” commented Clyde W. Yancy, MD, professor of medicine and chief of cardiology at Northwestern University in Chicago. “A number of us were quite circumspect about this based on the CASTLE-AF data, but the new CABANA analyses have addressed our anxiety that the CASTLE-AF results were just by chance.” The new CABANA analyses “may not confirm CASTLE-AF, but it enriches the conversation and makes it possible that we are seeing benefit in some patients with heart failure who get ablated.”
Dr. Yancy, who chaired the most recent update to the U.S. heart failure management guideline (J Am Coll Cardiol. 2017 Aug 8;70[6]:776-803) stopped short of saying that the cumulative evidence now supports a guideline change, but he acknowledged in an interview that the evidence could legitimately influence practice. Catheter ablation should now be “strongly considered” in patients with heart failure and AFib, he said, although he also had three qualifications for opting for this approach: Patients must already be on guideline-directed medical therapy for their heart failure, the catheter ablation needs to be performed by an experienced and skilled operator, and follow-up surveillance must focus on both the patient’s AFib and heart failure. “It’s absolutely appropriate to consider catheter ablation” for heart failure patients, but the evidence is not yet there for guideline change, Dr. Yancy concluded.
It remains uncertain why catheter ablation of AFib should be more effective in patients with heart failure than in those without. Dr. Packer speculated that one reason may be the heart rate reduction that AFib ablation produces may especially benefit heart failure patients. An additional helpful effect of ablation in heart failure patients may be reducing heart rate variability. Another notable finding of the new analysis was that 79% of patients with heart failure in CABANA had heart failure with preserved ejection fraction, with a left ventricular ejection fraction of at least 50%. “Getting rid of AFib in patients with heart failure with preserved ejection fraction will be more important than we have thought,” Dr. Packer said.
Other new CABANA analyses presented for the first time in separate talks at the meeting also showed that, while catheter ablation had no meaningful difference in effect on outcomes based on the sex of patients, both age and minority ethnic and racial status appeared to make a substantial difference. For CABANA’s primary endpoint, catheter ablation was especially effective for improving outcomes in patients 64 years old or younger, and the analysis showed a signal of possibly worse outcomes in patients who were at least 75 years old. The “substantially” better outcomes in minority-group patients represented the largest between-group difference among subgroups seen in CABANA and is a “big deal,” said Dr. Packer, who predicted that future catheter ablation use will likely rise in patients with heart failure, in younger patients, and in minority patients.
Dr. Piccini noted that, “it’s possible that CABANA identified some patient subgroups that do really well after ablation, but the problem is that, in the United States, we now often don’t treat” minority patients or those with reduced left ventricular ejection fractions with ablation, according to recent registry findings.
CABANA received partial funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Packer has been a consultant to and/or received research funding from these four companies, as well as numerous drug and device companies, and has a financial interest in a licensed AFib mapping technology. Dr. Piccini has ties Boston Scientific, Medtronic, and numerous other drug and device companies, and disclosed an unspecified relationship with GlaxoSmithKline. Dr. Yancy disclosed an unspecified relationship with Abbott Laboratories.
SOURCE: Packer DL. Heart Rhythm 2019, Abstract S-AB14-06.
REPORTING FROM HEART RHYTHM 2019
Key clinical point: Catheter ablation for atrial fibrillation is especially effective in patients with heart failure.
Major finding: Heart failure patients treated with catheter ablation had a 36% relative cut in the primary endpoint, compared with control patients.
Study details: CABANA, a multicenter, randomized trial with 2,204 patients, including 778 patients with heart failure.
Disclosures: CABANA received partial funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Packer has been a consultant to and/or received research funding from these four companies, as well as numerous drug and device companies, and has a financial interest in a licensed AFib mapping technology. Source: Packer DL. Heart Rhythm 2019, Abstract S-AB14-06.
Intranasal esketamine combo tied to symptom improvement
Concern raised about drug’s abuse potential
SAN FRANCISCO – In treatment-resistant depression, a switch to a new antidepressant combined with inhaled esketamine (Spravato) led to better symptom improvement than did a switch to a new antidepressant plus placebo, results from a new trial show. The treatment effect of esketamine was modest but had a number needed to treat for remission of just five.
About 30% of patients with major depressive disorder are treatment resistant. They are at risk of suicidal behavior and self-harm during the interval between starting a new medication and onset of efficacy. Esketamine, with its rapid onset of efficacy associated with its stimulation of synaptogenesis through inhibition of the N-methyl-D-aspartate receptor, gained Food and Drug Administration approval in March for the treatment of treatment-resistant depression in adults.
The findings were part of a phase 3 study presented at a press conference at the annual meeting of the American Psychiatric Association and simultaneously published in the American Journal of Psychiatry (2019. doi: 10.1176/appi.ajp.2019.19020172).
Adding esketamine to the start of a new antidepressant was associated with a small improvement in symptoms (effect size, 0.30), and this benefit did not continue to accrue further advantage past the original separation, which led to some skepticism from the author of an accompanying editorial (Am J Psychiatry. 2019 May. doi: 10.1176/appi.ajp.2019.19040423). “The question is, do you need to keep a patient on the drug past 48 hours? There is no statistically significant difference (in patient response) past the first 48 hours. That to me is a concern,” said Alan F. Schatzberg, MD, at the press conference.
Dr. Schatzberg, who is a professor of psychiatry at the Stanford (Calif.) University, also expressed concern about the potential for abuse with esketamine, as well as withdrawal after discontinuation. “I think the drug ought to be used, but it needs to be recommended with considerable caution. We have not answered the many questions that are needed in a drug of potential abuse,” Dr. Schatzberg added.
Study coauthor Michael E. Thase, MD, who also presented at the press conference, discussed the possibility of alterations to the treatment regimen. “I have a hunch you can see this (positive response) within first week or 2, and you can at least concentrate the resource on patients that gain the largest benefit. We can be smarter about it,” said Dr. Thase, who is a professor of psychiatry at the University of Pennsylvania, Philadelphia. He predicted that protocols eventually will be put in place to streamline intranasal ketamine treatment.
Regardless of the effect size, the study produced high remission and response rates in this difficult to treat population, which is welcome news to Gerard Sanacora, MD, PhD, a professor of psychiatry at Yale University, New Haven, Conn., and director of the Yale Depression Research Program. he said in an interview.
In the phase 3 study, researchers randomized 223 patients from five countries to receive esketamine or placebo, along with either an SSRI (escitalopram or sertraline) or a selective norepinephrine reuptake inhibitor (duloxetine or venlafaxine extended release), based on investigator choice.
To be eligible, participants had to have failed two previous trials of antidepressants. After a 4-week observation period, patients began a 4-week regimen of a new antidepressant combined with twice-weekly nasal esketamine or a placebo.
Subjects in the treatment arm received esketamine on day 1 of the treatment phase with a 56-mg dose. On day 4, 45.8% were increased to a dose of 84 mg, and 66.7% were at the 84-mg dose at the end of the treatment phase.
From baseline to day 28, the esketamine group had a greater decrease in Montgomery-Åsberg Depression Rating Scale (MADRS) score (difference of least square means, –4.0; P = .020; effect size, 0.30). A scatter plot of individual MADRS data during that period revealed rapid onset and increasing rapid response during repeated dosing 24 hours after dosing (least square mean between-group difference, –3.3), day 8 (–2.9), day 15 (–2.0), and day 22 (–4.0; P = .020).
Researchers also examined subjects who achieved at least a 50% reduction MADRS score at day 2 and maintained the improvement at day 28, and the difference was not significant between the two groups. At day 2, 16.5% of esketamine patients achieved a 50% or greater reduction in MADRS, compared with 10.8% in the placebo arm, though the significance of this difference could not be determined.
A post hoc analysis showed that 69.3% of participants in the esketamine group had responded by day 28, compared with 52.0% (odds ratio, 2.4; 95% confidence interval, 1.30-4.54; number needed to treat, 6). More subjects in the treatment group were in remission at day 28 (52.5% vs. 31.0%; NNT, 5).
The most common treatment-emergent adverse events in the esketamine group were dizziness (20.9%), dissociation (26.1%), dysgeusia (24.3%), vertigo (26.1%), and nausea (26.1%).
The study was funded by Janssen Research and Development. Dr. Sanacora was an investigator on previous Janssen-funded studies and has consulted for Janssen. Dr. Schatzberg has received research support from and consulted for Janssen, and has consulted for numerous other companies. Dr. Thase has received research support from Janssen and consulted for a wide range of pharmaceutical companies.
SOURCE: Popova V et al. APA 2019, Am J Psychiatry 2019 May. doi: 10.1176/appi.ajp.2019.19020172.
Concern raised about drug’s abuse potential
Concern raised about drug’s abuse potential
SAN FRANCISCO – In treatment-resistant depression, a switch to a new antidepressant combined with inhaled esketamine (Spravato) led to better symptom improvement than did a switch to a new antidepressant plus placebo, results from a new trial show. The treatment effect of esketamine was modest but had a number needed to treat for remission of just five.
About 30% of patients with major depressive disorder are treatment resistant. They are at risk of suicidal behavior and self-harm during the interval between starting a new medication and onset of efficacy. Esketamine, with its rapid onset of efficacy associated with its stimulation of synaptogenesis through inhibition of the N-methyl-D-aspartate receptor, gained Food and Drug Administration approval in March for the treatment of treatment-resistant depression in adults.
The findings were part of a phase 3 study presented at a press conference at the annual meeting of the American Psychiatric Association and simultaneously published in the American Journal of Psychiatry (2019. doi: 10.1176/appi.ajp.2019.19020172).
Adding esketamine to the start of a new antidepressant was associated with a small improvement in symptoms (effect size, 0.30), and this benefit did not continue to accrue further advantage past the original separation, which led to some skepticism from the author of an accompanying editorial (Am J Psychiatry. 2019 May. doi: 10.1176/appi.ajp.2019.19040423). “The question is, do you need to keep a patient on the drug past 48 hours? There is no statistically significant difference (in patient response) past the first 48 hours. That to me is a concern,” said Alan F. Schatzberg, MD, at the press conference.
Dr. Schatzberg, who is a professor of psychiatry at the Stanford (Calif.) University, also expressed concern about the potential for abuse with esketamine, as well as withdrawal after discontinuation. “I think the drug ought to be used, but it needs to be recommended with considerable caution. We have not answered the many questions that are needed in a drug of potential abuse,” Dr. Schatzberg added.
Study coauthor Michael E. Thase, MD, who also presented at the press conference, discussed the possibility of alterations to the treatment regimen. “I have a hunch you can see this (positive response) within first week or 2, and you can at least concentrate the resource on patients that gain the largest benefit. We can be smarter about it,” said Dr. Thase, who is a professor of psychiatry at the University of Pennsylvania, Philadelphia. He predicted that protocols eventually will be put in place to streamline intranasal ketamine treatment.
Regardless of the effect size, the study produced high remission and response rates in this difficult to treat population, which is welcome news to Gerard Sanacora, MD, PhD, a professor of psychiatry at Yale University, New Haven, Conn., and director of the Yale Depression Research Program. he said in an interview.
In the phase 3 study, researchers randomized 223 patients from five countries to receive esketamine or placebo, along with either an SSRI (escitalopram or sertraline) or a selective norepinephrine reuptake inhibitor (duloxetine or venlafaxine extended release), based on investigator choice.
To be eligible, participants had to have failed two previous trials of antidepressants. After a 4-week observation period, patients began a 4-week regimen of a new antidepressant combined with twice-weekly nasal esketamine or a placebo.
Subjects in the treatment arm received esketamine on day 1 of the treatment phase with a 56-mg dose. On day 4, 45.8% were increased to a dose of 84 mg, and 66.7% were at the 84-mg dose at the end of the treatment phase.
From baseline to day 28, the esketamine group had a greater decrease in Montgomery-Åsberg Depression Rating Scale (MADRS) score (difference of least square means, –4.0; P = .020; effect size, 0.30). A scatter plot of individual MADRS data during that period revealed rapid onset and increasing rapid response during repeated dosing 24 hours after dosing (least square mean between-group difference, –3.3), day 8 (–2.9), day 15 (–2.0), and day 22 (–4.0; P = .020).
Researchers also examined subjects who achieved at least a 50% reduction MADRS score at day 2 and maintained the improvement at day 28, and the difference was not significant between the two groups. At day 2, 16.5% of esketamine patients achieved a 50% or greater reduction in MADRS, compared with 10.8% in the placebo arm, though the significance of this difference could not be determined.
A post hoc analysis showed that 69.3% of participants in the esketamine group had responded by day 28, compared with 52.0% (odds ratio, 2.4; 95% confidence interval, 1.30-4.54; number needed to treat, 6). More subjects in the treatment group were in remission at day 28 (52.5% vs. 31.0%; NNT, 5).
The most common treatment-emergent adverse events in the esketamine group were dizziness (20.9%), dissociation (26.1%), dysgeusia (24.3%), vertigo (26.1%), and nausea (26.1%).
The study was funded by Janssen Research and Development. Dr. Sanacora was an investigator on previous Janssen-funded studies and has consulted for Janssen. Dr. Schatzberg has received research support from and consulted for Janssen, and has consulted for numerous other companies. Dr. Thase has received research support from Janssen and consulted for a wide range of pharmaceutical companies.
SOURCE: Popova V et al. APA 2019, Am J Psychiatry 2019 May. doi: 10.1176/appi.ajp.2019.19020172.
SAN FRANCISCO – In treatment-resistant depression, a switch to a new antidepressant combined with inhaled esketamine (Spravato) led to better symptom improvement than did a switch to a new antidepressant plus placebo, results from a new trial show. The treatment effect of esketamine was modest but had a number needed to treat for remission of just five.
About 30% of patients with major depressive disorder are treatment resistant. They are at risk of suicidal behavior and self-harm during the interval between starting a new medication and onset of efficacy. Esketamine, with its rapid onset of efficacy associated with its stimulation of synaptogenesis through inhibition of the N-methyl-D-aspartate receptor, gained Food and Drug Administration approval in March for the treatment of treatment-resistant depression in adults.
The findings were part of a phase 3 study presented at a press conference at the annual meeting of the American Psychiatric Association and simultaneously published in the American Journal of Psychiatry (2019. doi: 10.1176/appi.ajp.2019.19020172).
Adding esketamine to the start of a new antidepressant was associated with a small improvement in symptoms (effect size, 0.30), and this benefit did not continue to accrue further advantage past the original separation, which led to some skepticism from the author of an accompanying editorial (Am J Psychiatry. 2019 May. doi: 10.1176/appi.ajp.2019.19040423). “The question is, do you need to keep a patient on the drug past 48 hours? There is no statistically significant difference (in patient response) past the first 48 hours. That to me is a concern,” said Alan F. Schatzberg, MD, at the press conference.
Dr. Schatzberg, who is a professor of psychiatry at the Stanford (Calif.) University, also expressed concern about the potential for abuse with esketamine, as well as withdrawal after discontinuation. “I think the drug ought to be used, but it needs to be recommended with considerable caution. We have not answered the many questions that are needed in a drug of potential abuse,” Dr. Schatzberg added.
Study coauthor Michael E. Thase, MD, who also presented at the press conference, discussed the possibility of alterations to the treatment regimen. “I have a hunch you can see this (positive response) within first week or 2, and you can at least concentrate the resource on patients that gain the largest benefit. We can be smarter about it,” said Dr. Thase, who is a professor of psychiatry at the University of Pennsylvania, Philadelphia. He predicted that protocols eventually will be put in place to streamline intranasal ketamine treatment.
Regardless of the effect size, the study produced high remission and response rates in this difficult to treat population, which is welcome news to Gerard Sanacora, MD, PhD, a professor of psychiatry at Yale University, New Haven, Conn., and director of the Yale Depression Research Program. he said in an interview.
In the phase 3 study, researchers randomized 223 patients from five countries to receive esketamine or placebo, along with either an SSRI (escitalopram or sertraline) or a selective norepinephrine reuptake inhibitor (duloxetine or venlafaxine extended release), based on investigator choice.
To be eligible, participants had to have failed two previous trials of antidepressants. After a 4-week observation period, patients began a 4-week regimen of a new antidepressant combined with twice-weekly nasal esketamine or a placebo.
Subjects in the treatment arm received esketamine on day 1 of the treatment phase with a 56-mg dose. On day 4, 45.8% were increased to a dose of 84 mg, and 66.7% were at the 84-mg dose at the end of the treatment phase.
From baseline to day 28, the esketamine group had a greater decrease in Montgomery-Åsberg Depression Rating Scale (MADRS) score (difference of least square means, –4.0; P = .020; effect size, 0.30). A scatter plot of individual MADRS data during that period revealed rapid onset and increasing rapid response during repeated dosing 24 hours after dosing (least square mean between-group difference, –3.3), day 8 (–2.9), day 15 (–2.0), and day 22 (–4.0; P = .020).
Researchers also examined subjects who achieved at least a 50% reduction MADRS score at day 2 and maintained the improvement at day 28, and the difference was not significant between the two groups. At day 2, 16.5% of esketamine patients achieved a 50% or greater reduction in MADRS, compared with 10.8% in the placebo arm, though the significance of this difference could not be determined.
A post hoc analysis showed that 69.3% of participants in the esketamine group had responded by day 28, compared with 52.0% (odds ratio, 2.4; 95% confidence interval, 1.30-4.54; number needed to treat, 6). More subjects in the treatment group were in remission at day 28 (52.5% vs. 31.0%; NNT, 5).
The most common treatment-emergent adverse events in the esketamine group were dizziness (20.9%), dissociation (26.1%), dysgeusia (24.3%), vertigo (26.1%), and nausea (26.1%).
The study was funded by Janssen Research and Development. Dr. Sanacora was an investigator on previous Janssen-funded studies and has consulted for Janssen. Dr. Schatzberg has received research support from and consulted for Janssen, and has consulted for numerous other companies. Dr. Thase has received research support from Janssen and consulted for a wide range of pharmaceutical companies.
SOURCE: Popova V et al. APA 2019, Am J Psychiatry 2019 May. doi: 10.1176/appi.ajp.2019.19020172.
REPORTING FROM APA 2019
Key clinical point: Pivotal study reports a modest benefit to symptoms when inhaled esketamine is combined with a new antidepressant in treatment-resistant depression.
Major finding: Combining esketamine with a new antidepressant led to a small improvement in symptoms, compared with the antidepressant alone (effect size, 0.30).
Study details: Results of a randomized, controlled trial (n = 223).
Disclosures: The study was funded by Janssen Research and Development. Dr. Sanacora was an investigator on previous Janssen-funded studies and has consulted for Janssen. Dr. Schatzberg has received research support from and consulted for Janssen, and has consulted for numerous other companies. Dr. Thase has received research support from Janssen and consulted for a wide range of pharmaceutical companies.
Source: Popova V et al. APA 2019, Am J Psychiatry. 2019 May. doi: 10.1176/appi.ajp.2019.19020172.
California kindergarten nonvaccination rate on rise again
from immunizations, according to Paul L. Delamater, PhD, of the University of North Carolina at Chapel Hill, and associates.
The investigators focused on vaccination data collected from 2015 – the last year before the passage of SB 277 – to 2017. They also analyzed county-level data collected from 2000 to 2014 to assess demographic behavior. In 2015, the rate of nonvaccination was 7.15%, decreasing to 4.42% in 2016. This decrease was almost entirely caused by a reduction in the rate of conditional entrants, which fell from 4.43% to 1.91%, and in personal belief exceptions, which fell from 2.37% to 0.56%.
While the rates of conditional entrants and personal belief exceptions continued to fall in 2017, other mechanisms allowed the overall rate of kindergarteners not fully up to date on their vaccines to jump to 4.87%. This was fueled by a slight increase in medical exceptions (from 0.51% in 2016 to 0.73% in 2017), and a significant increase in children who were overdue or exempt, which both increased from 0 in 2014 to over 1% by 2017.
“Although the law was successful in reducing the number of students with personal belief exemptions, our analysis reveals that a replacement effect may have stifled a larger increase in students entering kindergarten who are up to date on vaccination. ... Given these findings, policymakers should consider the various options available to increase vaccination coverage or strategies to minimize potential unintended consequences of eliminating nonmedical exemptions such as the replacement effect observed in California,” the investigators reported in Pediatrics (2019, May 21 doi: 10.1542/peds.2018-3301.
One coauthor reported receiving research and consulting support from Pfizer, Merck, and Walgreens; another reported receiving research support from Pfizer, Merck, GlaxoSmithKline, Sanofi Pasteur, Protein Science (now Sanofi Pasteur), Dynavax, and MedImmune.
from immunizations, according to Paul L. Delamater, PhD, of the University of North Carolina at Chapel Hill, and associates.
The investigators focused on vaccination data collected from 2015 – the last year before the passage of SB 277 – to 2017. They also analyzed county-level data collected from 2000 to 2014 to assess demographic behavior. In 2015, the rate of nonvaccination was 7.15%, decreasing to 4.42% in 2016. This decrease was almost entirely caused by a reduction in the rate of conditional entrants, which fell from 4.43% to 1.91%, and in personal belief exceptions, which fell from 2.37% to 0.56%.
While the rates of conditional entrants and personal belief exceptions continued to fall in 2017, other mechanisms allowed the overall rate of kindergarteners not fully up to date on their vaccines to jump to 4.87%. This was fueled by a slight increase in medical exceptions (from 0.51% in 2016 to 0.73% in 2017), and a significant increase in children who were overdue or exempt, which both increased from 0 in 2014 to over 1% by 2017.
“Although the law was successful in reducing the number of students with personal belief exemptions, our analysis reveals that a replacement effect may have stifled a larger increase in students entering kindergarten who are up to date on vaccination. ... Given these findings, policymakers should consider the various options available to increase vaccination coverage or strategies to minimize potential unintended consequences of eliminating nonmedical exemptions such as the replacement effect observed in California,” the investigators reported in Pediatrics (2019, May 21 doi: 10.1542/peds.2018-3301.
One coauthor reported receiving research and consulting support from Pfizer, Merck, and Walgreens; another reported receiving research support from Pfizer, Merck, GlaxoSmithKline, Sanofi Pasteur, Protein Science (now Sanofi Pasteur), Dynavax, and MedImmune.
from immunizations, according to Paul L. Delamater, PhD, of the University of North Carolina at Chapel Hill, and associates.
The investigators focused on vaccination data collected from 2015 – the last year before the passage of SB 277 – to 2017. They also analyzed county-level data collected from 2000 to 2014 to assess demographic behavior. In 2015, the rate of nonvaccination was 7.15%, decreasing to 4.42% in 2016. This decrease was almost entirely caused by a reduction in the rate of conditional entrants, which fell from 4.43% to 1.91%, and in personal belief exceptions, which fell from 2.37% to 0.56%.
While the rates of conditional entrants and personal belief exceptions continued to fall in 2017, other mechanisms allowed the overall rate of kindergarteners not fully up to date on their vaccines to jump to 4.87%. This was fueled by a slight increase in medical exceptions (from 0.51% in 2016 to 0.73% in 2017), and a significant increase in children who were overdue or exempt, which both increased from 0 in 2014 to over 1% by 2017.
“Although the law was successful in reducing the number of students with personal belief exemptions, our analysis reveals that a replacement effect may have stifled a larger increase in students entering kindergarten who are up to date on vaccination. ... Given these findings, policymakers should consider the various options available to increase vaccination coverage or strategies to minimize potential unintended consequences of eliminating nonmedical exemptions such as the replacement effect observed in California,” the investigators reported in Pediatrics (2019, May 21 doi: 10.1542/peds.2018-3301.
One coauthor reported receiving research and consulting support from Pfizer, Merck, and Walgreens; another reported receiving research support from Pfizer, Merck, GlaxoSmithKline, Sanofi Pasteur, Protein Science (now Sanofi Pasteur), Dynavax, and MedImmune.
FROM PEDIATRICS
Nintedanib cut lung function decline in interstitial lung disease with systemic sclerosis
DALLAS – Nintedanib, a tyrosine kinase inhibitor, decreased by 44% the annual rate of lung function decline among patients with interstitial lung disease associated with systemic sclerosis, a year-long study has found.
In a placebo-controlled 52-week trial, forced vital capacity (FVC) in patients who took nintedanib (Ofev) declined by a mean of 52 mL – significantly less than the mean 93 mL decline seen among those who were given placebo, Oliver Distler, MD, said at the annual meeting of the American Thoracic Society.
“These are people in their mid-40s and -50s,” said Dr. Distler of the University of Zürich. “They have a long time to go. If there is an annual preservation of lung function by 40%, if you have that every year, it becomes very surely clinically significant. A decline in FVC is also a good surrogate marker of mortality in interstitial lung disease associated with systemic sclerosis. Assuming the effects are ongoing above the 1 year we looked at, then indeed these results are clinically important.”
The study was simultaneously published in the New England Journal of Medicine. Nintedanib is already approved for idiopathic pulmonary fibrosis. But some data suggest that it also exerts antifibrotic and anti-inflammatory effects in animal models of systemic sclerosis and inflammatory lung disease (ILD). SENSCIS (the Safety and Efficacy of Nintedanib in Systemic Sclerosis trial) investigated the molecule’s use in patients with ILD associated with systemic sclerosis.
Conducted in 32 countries, SENSCIS comprised 576 patients with the disorder, whose sclerosis affected at least 10% of their lungs. They were assigned to 52 weeks of either placebo or 150 mg nintedanib twice weekly. However, patients stayed on their blinded treatment until the last patient enrolled had finished the year of treatment; some patients took the drug for 100 weeks, Dr. Distler said. The primary endpoint was annual rate of decline in the forced vital capacity (FEV). Secondary endpoints included changes of the modified Rodnan skin score and in the total score on the St. George’s Respiratory Questionnaire.
Patients were a mean of 54 years old, with a mean disease duration of about 3 years. About half had diffuse cutaneous systemic sclerosis; the sclerosis was limited in the remainder. The mean extent of lung fibrosis was about 36%. Half were taking mycophenolate at baseline, which was allowed as background treatment, along with up to 10 mg/day of prednisone. Any patient who experienced clinically significant lung function deterioration could receive additional therapy at the investigator’s discretion.
The mean baseline FEV for these patients was 72.5% of predicted value. The mean diffusing capacity of the lungs for carbon monoxide was 53% of expected capacity.
Most patients completed the study (80% of the active group and 89% of the placebo group). The mean drug exposure duration was 10 months in the active group and 11 in the placebo group.
Improvement began early in treatment, with the efficacy curves separating by week 12 and continuing to diverge. After 52 weeks of therapy, the annual rate of change was 41 mL less in the active group than in the placebo group (–54.4 mL vs. –93.3 mL). The mean adjusted absolute change from baseline was –54.6 mL in the active group and –101 mL in the placebo at week 52. Significantly fewer patients taking nintedanib also lost more than 10% of FVC by week 52 (16.7% vs. 18%).
The St. George’s Respiratory Questionnaire score improved about one point in the active group and declined about one point in the placebo group.
Nintedanib was equally effective across a number of subgroups, including those divided by sex, age, and race. Antitopoisomerase antibodies and so-called antitopoisomerase I antibody status did not affect nintedanib’s action. Nintedanib also significantly improved scores on the Health Assessment Questionnaire without Disability Index and dyspnea.
More patients in the active group than in on placebo discontinued treatment because of a serious adverse event (16% vs. 8.7%). The most common of these were diarrhea (75.7% vs. 31%), nausea (31.6% vs. 13.5%), and vomiting (24.7% vs.10.4%). Skin ulcers occurred in about 18% of each group. Patients in the active group were significantly more likely to develop elevated alanine and aspartate aminotransferase of up to three times normal levels (4.9% vs. 0.7%).
Treatment did not significantly affect mortality rates, however. Over the treatment period, 10 patients in the nintedanib group and 9 in the placebo group died (3.5% vs. 3.1%).
The study was sponsored by Boehringer Ingelheim. Dr. Distler was the primary investigator on the trial.
SOURCE: Distler O et al. ATS 2019, Abstract A7360.
DALLAS – Nintedanib, a tyrosine kinase inhibitor, decreased by 44% the annual rate of lung function decline among patients with interstitial lung disease associated with systemic sclerosis, a year-long study has found.
In a placebo-controlled 52-week trial, forced vital capacity (FVC) in patients who took nintedanib (Ofev) declined by a mean of 52 mL – significantly less than the mean 93 mL decline seen among those who were given placebo, Oliver Distler, MD, said at the annual meeting of the American Thoracic Society.
“These are people in their mid-40s and -50s,” said Dr. Distler of the University of Zürich. “They have a long time to go. If there is an annual preservation of lung function by 40%, if you have that every year, it becomes very surely clinically significant. A decline in FVC is also a good surrogate marker of mortality in interstitial lung disease associated with systemic sclerosis. Assuming the effects are ongoing above the 1 year we looked at, then indeed these results are clinically important.”
The study was simultaneously published in the New England Journal of Medicine. Nintedanib is already approved for idiopathic pulmonary fibrosis. But some data suggest that it also exerts antifibrotic and anti-inflammatory effects in animal models of systemic sclerosis and inflammatory lung disease (ILD). SENSCIS (the Safety and Efficacy of Nintedanib in Systemic Sclerosis trial) investigated the molecule’s use in patients with ILD associated with systemic sclerosis.
Conducted in 32 countries, SENSCIS comprised 576 patients with the disorder, whose sclerosis affected at least 10% of their lungs. They were assigned to 52 weeks of either placebo or 150 mg nintedanib twice weekly. However, patients stayed on their blinded treatment until the last patient enrolled had finished the year of treatment; some patients took the drug for 100 weeks, Dr. Distler said. The primary endpoint was annual rate of decline in the forced vital capacity (FEV). Secondary endpoints included changes of the modified Rodnan skin score and in the total score on the St. George’s Respiratory Questionnaire.
Patients were a mean of 54 years old, with a mean disease duration of about 3 years. About half had diffuse cutaneous systemic sclerosis; the sclerosis was limited in the remainder. The mean extent of lung fibrosis was about 36%. Half were taking mycophenolate at baseline, which was allowed as background treatment, along with up to 10 mg/day of prednisone. Any patient who experienced clinically significant lung function deterioration could receive additional therapy at the investigator’s discretion.
The mean baseline FEV for these patients was 72.5% of predicted value. The mean diffusing capacity of the lungs for carbon monoxide was 53% of expected capacity.
Most patients completed the study (80% of the active group and 89% of the placebo group). The mean drug exposure duration was 10 months in the active group and 11 in the placebo group.
Improvement began early in treatment, with the efficacy curves separating by week 12 and continuing to diverge. After 52 weeks of therapy, the annual rate of change was 41 mL less in the active group than in the placebo group (–54.4 mL vs. –93.3 mL). The mean adjusted absolute change from baseline was –54.6 mL in the active group and –101 mL in the placebo at week 52. Significantly fewer patients taking nintedanib also lost more than 10% of FVC by week 52 (16.7% vs. 18%).
The St. George’s Respiratory Questionnaire score improved about one point in the active group and declined about one point in the placebo group.
Nintedanib was equally effective across a number of subgroups, including those divided by sex, age, and race. Antitopoisomerase antibodies and so-called antitopoisomerase I antibody status did not affect nintedanib’s action. Nintedanib also significantly improved scores on the Health Assessment Questionnaire without Disability Index and dyspnea.
More patients in the active group than in on placebo discontinued treatment because of a serious adverse event (16% vs. 8.7%). The most common of these were diarrhea (75.7% vs. 31%), nausea (31.6% vs. 13.5%), and vomiting (24.7% vs.10.4%). Skin ulcers occurred in about 18% of each group. Patients in the active group were significantly more likely to develop elevated alanine and aspartate aminotransferase of up to three times normal levels (4.9% vs. 0.7%).
Treatment did not significantly affect mortality rates, however. Over the treatment period, 10 patients in the nintedanib group and 9 in the placebo group died (3.5% vs. 3.1%).
The study was sponsored by Boehringer Ingelheim. Dr. Distler was the primary investigator on the trial.
SOURCE: Distler O et al. ATS 2019, Abstract A7360.
DALLAS – Nintedanib, a tyrosine kinase inhibitor, decreased by 44% the annual rate of lung function decline among patients with interstitial lung disease associated with systemic sclerosis, a year-long study has found.
In a placebo-controlled 52-week trial, forced vital capacity (FVC) in patients who took nintedanib (Ofev) declined by a mean of 52 mL – significantly less than the mean 93 mL decline seen among those who were given placebo, Oliver Distler, MD, said at the annual meeting of the American Thoracic Society.
“These are people in their mid-40s and -50s,” said Dr. Distler of the University of Zürich. “They have a long time to go. If there is an annual preservation of lung function by 40%, if you have that every year, it becomes very surely clinically significant. A decline in FVC is also a good surrogate marker of mortality in interstitial lung disease associated with systemic sclerosis. Assuming the effects are ongoing above the 1 year we looked at, then indeed these results are clinically important.”
The study was simultaneously published in the New England Journal of Medicine. Nintedanib is already approved for idiopathic pulmonary fibrosis. But some data suggest that it also exerts antifibrotic and anti-inflammatory effects in animal models of systemic sclerosis and inflammatory lung disease (ILD). SENSCIS (the Safety and Efficacy of Nintedanib in Systemic Sclerosis trial) investigated the molecule’s use in patients with ILD associated with systemic sclerosis.
Conducted in 32 countries, SENSCIS comprised 576 patients with the disorder, whose sclerosis affected at least 10% of their lungs. They were assigned to 52 weeks of either placebo or 150 mg nintedanib twice weekly. However, patients stayed on their blinded treatment until the last patient enrolled had finished the year of treatment; some patients took the drug for 100 weeks, Dr. Distler said. The primary endpoint was annual rate of decline in the forced vital capacity (FEV). Secondary endpoints included changes of the modified Rodnan skin score and in the total score on the St. George’s Respiratory Questionnaire.
Patients were a mean of 54 years old, with a mean disease duration of about 3 years. About half had diffuse cutaneous systemic sclerosis; the sclerosis was limited in the remainder. The mean extent of lung fibrosis was about 36%. Half were taking mycophenolate at baseline, which was allowed as background treatment, along with up to 10 mg/day of prednisone. Any patient who experienced clinically significant lung function deterioration could receive additional therapy at the investigator’s discretion.
The mean baseline FEV for these patients was 72.5% of predicted value. The mean diffusing capacity of the lungs for carbon monoxide was 53% of expected capacity.
Most patients completed the study (80% of the active group and 89% of the placebo group). The mean drug exposure duration was 10 months in the active group and 11 in the placebo group.
Improvement began early in treatment, with the efficacy curves separating by week 12 and continuing to diverge. After 52 weeks of therapy, the annual rate of change was 41 mL less in the active group than in the placebo group (–54.4 mL vs. –93.3 mL). The mean adjusted absolute change from baseline was –54.6 mL in the active group and –101 mL in the placebo at week 52. Significantly fewer patients taking nintedanib also lost more than 10% of FVC by week 52 (16.7% vs. 18%).
The St. George’s Respiratory Questionnaire score improved about one point in the active group and declined about one point in the placebo group.
Nintedanib was equally effective across a number of subgroups, including those divided by sex, age, and race. Antitopoisomerase antibodies and so-called antitopoisomerase I antibody status did not affect nintedanib’s action. Nintedanib also significantly improved scores on the Health Assessment Questionnaire without Disability Index and dyspnea.
More patients in the active group than in on placebo discontinued treatment because of a serious adverse event (16% vs. 8.7%). The most common of these were diarrhea (75.7% vs. 31%), nausea (31.6% vs. 13.5%), and vomiting (24.7% vs.10.4%). Skin ulcers occurred in about 18% of each group. Patients in the active group were significantly more likely to develop elevated alanine and aspartate aminotransferase of up to three times normal levels (4.9% vs. 0.7%).
Treatment did not significantly affect mortality rates, however. Over the treatment period, 10 patients in the nintedanib group and 9 in the placebo group died (3.5% vs. 3.1%).
The study was sponsored by Boehringer Ingelheim. Dr. Distler was the primary investigator on the trial.
SOURCE: Distler O et al. ATS 2019, Abstract A7360.
AT ATS 2019
Key clinical point: The tyrosine kinase inhibitor nintedanib may be a useful treatment for interstitial lung disease associated with systemic sclerosis (SS-ILD).
Major finding: Nintedanib decreased the annual rate of lung function decline by 44% among patients with SS-ILD.
Study details: The randomized, placebo-controlled study comprised 576 patients.
Disclosures: The trial was sponsored by Boehringer Ingelheim. Dr. Distler is the primary investigator.
Source: Distler O et al. ATS 2019, Abstract A7360.
Keep sports fun, keep kids playing
according to a clinical report from the American Academy of Pediatrics’ Council on Sports Medicine and Fitness.
In the report, “Organized Sports for Children, Preadolescents, and Adolescents,” published online in Pediatrics, the authors addressed the risks and benefits of organized sports for children and teens and offered guidance for how clinicians, schools, and communities can involve more children in sports programs.
The authors emphasized the role of free play and the development of skills for children younger than 6 years. However, they wrote that you and parents should encourage organized sports – with emphasis on physical activity enjoyment – for children older than 6 years at a range of skill levels.
“Aspects of readiness to consider are motor skill acquisition, ability to combine those skills, and attention span,” according to the authors, who noted that most children younger than 6 years may not yet have the skills and attention for organized sports.
You also can remind parents to step back from pushing children into particular sports. Allowing children to choose which activities to try helps keep the focus on fun, even if the child’s idea of fun may differ from parental ideas. “Forcing children to participate in organized sports (or any physical activity) is likely to decrease fun in the activity and discourage future participation,” according to the authors.
They recognize barriers to organized sports for children from low socioeconomic backgrounds and advise communities to try to reduce them; other recommendations include having more options for organized sports at a range of skill levels to encourage participation and long-term involvement, and promoting physical activity.
“If we offer children a variety of sports for all skill levels, they are more likely to try new activities and stick with the ones they enjoy,” Kelsey Logan, MD, a coauthor of the report, said in a statement. “The interest should start with the child, not the parent.”
“Families can help by encouraging children to ‘sample’ sports, so they can figure out what they find enjoyable,” he said. “Ideally, there is an activity for everyone, with the focus on having fun.”
“Given the epidemic of obesity and all of its accompanying medical conditions, it is important to find ways to keep kids physically active. Organized sports participation is one tactic to accomplish this,” the authors said.
They acknowledge the potential risks involved in organized sports such as sports injuries, bullying, and burnout, but also advise empowering parents to support a positive coaching environment with playing time for all participants so they can enjoy the physical and mental benefits of being on a team.
“Young athletes typically learn skills and values that they can use in everyday life,” Steven Cuff, MD, coauthor of the report, said in a statement. “The camaraderie and teamwork needed on a playing field offers lasting lessons on personal responsibility, sportsmanship, goal-setting, and emotional control.”
Children with developmental and neurologic disabilities also can benefit from organized sports participation in programs such as Special Olympics, the authors said.
The report authors had no financial conflicts to disclose.
SOURCE: Logan K et al. Pediatrics. 2019 May 20. doi: 10.1542/peds.2019-0997.
“I think it is quite timely with the obesity epidemic and lack of PE in schools to highlight how important physical activity is for children, and organized sports is one of the ways to accomplish that,” Andrew Gregory, MD, said in an interview.
“I think the summary of both benefits and risks is well informed and complete,” he said.
However, “I think most pediatricians and parents are aware of the physical benefits of exercise, but many may be unaware of the psychological and social benefits,” Dr. Gregory noted. “It is also important that parents and coaches understand that bullying and hazing have no place in organized sports and should not be tolerated.”
“I think the most important thing for clinicians to pass on is that the benefits of organized sports far outweigh the risks,” he said. The challenge is, “How do we better incorporate organized sports into schools and community organizations so that more children have access?”
Dr. Gregory is an associate professor of orthopaedics, neurosurgery & pediatrics at Vanderbilt University in Nashville, Tenn., and serves as codirector of the Vanderbilt Sports Concussion Center. He had no financial conflicts to disclose.
“I think it is quite timely with the obesity epidemic and lack of PE in schools to highlight how important physical activity is for children, and organized sports is one of the ways to accomplish that,” Andrew Gregory, MD, said in an interview.
“I think the summary of both benefits and risks is well informed and complete,” he said.
However, “I think most pediatricians and parents are aware of the physical benefits of exercise, but many may be unaware of the psychological and social benefits,” Dr. Gregory noted. “It is also important that parents and coaches understand that bullying and hazing have no place in organized sports and should not be tolerated.”
“I think the most important thing for clinicians to pass on is that the benefits of organized sports far outweigh the risks,” he said. The challenge is, “How do we better incorporate organized sports into schools and community organizations so that more children have access?”
Dr. Gregory is an associate professor of orthopaedics, neurosurgery & pediatrics at Vanderbilt University in Nashville, Tenn., and serves as codirector of the Vanderbilt Sports Concussion Center. He had no financial conflicts to disclose.
“I think it is quite timely with the obesity epidemic and lack of PE in schools to highlight how important physical activity is for children, and organized sports is one of the ways to accomplish that,” Andrew Gregory, MD, said in an interview.
“I think the summary of both benefits and risks is well informed and complete,” he said.
However, “I think most pediatricians and parents are aware of the physical benefits of exercise, but many may be unaware of the psychological and social benefits,” Dr. Gregory noted. “It is also important that parents and coaches understand that bullying and hazing have no place in organized sports and should not be tolerated.”
“I think the most important thing for clinicians to pass on is that the benefits of organized sports far outweigh the risks,” he said. The challenge is, “How do we better incorporate organized sports into schools and community organizations so that more children have access?”
Dr. Gregory is an associate professor of orthopaedics, neurosurgery & pediatrics at Vanderbilt University in Nashville, Tenn., and serves as codirector of the Vanderbilt Sports Concussion Center. He had no financial conflicts to disclose.
according to a clinical report from the American Academy of Pediatrics’ Council on Sports Medicine and Fitness.
In the report, “Organized Sports for Children, Preadolescents, and Adolescents,” published online in Pediatrics, the authors addressed the risks and benefits of organized sports for children and teens and offered guidance for how clinicians, schools, and communities can involve more children in sports programs.
The authors emphasized the role of free play and the development of skills for children younger than 6 years. However, they wrote that you and parents should encourage organized sports – with emphasis on physical activity enjoyment – for children older than 6 years at a range of skill levels.
“Aspects of readiness to consider are motor skill acquisition, ability to combine those skills, and attention span,” according to the authors, who noted that most children younger than 6 years may not yet have the skills and attention for organized sports.
You also can remind parents to step back from pushing children into particular sports. Allowing children to choose which activities to try helps keep the focus on fun, even if the child’s idea of fun may differ from parental ideas. “Forcing children to participate in organized sports (or any physical activity) is likely to decrease fun in the activity and discourage future participation,” according to the authors.
They recognize barriers to organized sports for children from low socioeconomic backgrounds and advise communities to try to reduce them; other recommendations include having more options for organized sports at a range of skill levels to encourage participation and long-term involvement, and promoting physical activity.
“If we offer children a variety of sports for all skill levels, they are more likely to try new activities and stick with the ones they enjoy,” Kelsey Logan, MD, a coauthor of the report, said in a statement. “The interest should start with the child, not the parent.”
“Families can help by encouraging children to ‘sample’ sports, so they can figure out what they find enjoyable,” he said. “Ideally, there is an activity for everyone, with the focus on having fun.”
“Given the epidemic of obesity and all of its accompanying medical conditions, it is important to find ways to keep kids physically active. Organized sports participation is one tactic to accomplish this,” the authors said.
They acknowledge the potential risks involved in organized sports such as sports injuries, bullying, and burnout, but also advise empowering parents to support a positive coaching environment with playing time for all participants so they can enjoy the physical and mental benefits of being on a team.
“Young athletes typically learn skills and values that they can use in everyday life,” Steven Cuff, MD, coauthor of the report, said in a statement. “The camaraderie and teamwork needed on a playing field offers lasting lessons on personal responsibility, sportsmanship, goal-setting, and emotional control.”
Children with developmental and neurologic disabilities also can benefit from organized sports participation in programs such as Special Olympics, the authors said.
The report authors had no financial conflicts to disclose.
SOURCE: Logan K et al. Pediatrics. 2019 May 20. doi: 10.1542/peds.2019-0997.
according to a clinical report from the American Academy of Pediatrics’ Council on Sports Medicine and Fitness.
In the report, “Organized Sports for Children, Preadolescents, and Adolescents,” published online in Pediatrics, the authors addressed the risks and benefits of organized sports for children and teens and offered guidance for how clinicians, schools, and communities can involve more children in sports programs.
The authors emphasized the role of free play and the development of skills for children younger than 6 years. However, they wrote that you and parents should encourage organized sports – with emphasis on physical activity enjoyment – for children older than 6 years at a range of skill levels.
“Aspects of readiness to consider are motor skill acquisition, ability to combine those skills, and attention span,” according to the authors, who noted that most children younger than 6 years may not yet have the skills and attention for organized sports.
You also can remind parents to step back from pushing children into particular sports. Allowing children to choose which activities to try helps keep the focus on fun, even if the child’s idea of fun may differ from parental ideas. “Forcing children to participate in organized sports (or any physical activity) is likely to decrease fun in the activity and discourage future participation,” according to the authors.
They recognize barriers to organized sports for children from low socioeconomic backgrounds and advise communities to try to reduce them; other recommendations include having more options for organized sports at a range of skill levels to encourage participation and long-term involvement, and promoting physical activity.
“If we offer children a variety of sports for all skill levels, they are more likely to try new activities and stick with the ones they enjoy,” Kelsey Logan, MD, a coauthor of the report, said in a statement. “The interest should start with the child, not the parent.”
“Families can help by encouraging children to ‘sample’ sports, so they can figure out what they find enjoyable,” he said. “Ideally, there is an activity for everyone, with the focus on having fun.”
“Given the epidemic of obesity and all of its accompanying medical conditions, it is important to find ways to keep kids physically active. Organized sports participation is one tactic to accomplish this,” the authors said.
They acknowledge the potential risks involved in organized sports such as sports injuries, bullying, and burnout, but also advise empowering parents to support a positive coaching environment with playing time for all participants so they can enjoy the physical and mental benefits of being on a team.
“Young athletes typically learn skills and values that they can use in everyday life,” Steven Cuff, MD, coauthor of the report, said in a statement. “The camaraderie and teamwork needed on a playing field offers lasting lessons on personal responsibility, sportsmanship, goal-setting, and emotional control.”
Children with developmental and neurologic disabilities also can benefit from organized sports participation in programs such as Special Olympics, the authors said.
The report authors had no financial conflicts to disclose.
SOURCE: Logan K et al. Pediatrics. 2019 May 20. doi: 10.1542/peds.2019-0997.
FROM PEDIATRICS
The effects persist for children who witnessed 9/11
SAN FRANCISCO – according to a case-control study presented at the American Psychiatric Association annual meeting.
The investigation included 942 people who, as children under 18 years old, were in school below Canal Street in lower Manhattan when the World Trade Center was attacked. They saw the towers collapse and were evacuated from the area, but did not lose a parent. Now 18-36 years old, they were interviewed in their homes and asked to filled out questionnaires about psychiatric and physical problems. The outcomes were compared with 563 age- and gender-matched controls who were in school in Queens at the time.
In turns out that “it made a huge difference whether you were there or not. Being there had much more impact than hearing about it or watching it on TV,” said lead investigator Lawrence Amsel, MD, an assistant professor of clinical psychiatry at Columbia University in New York.
Adults who witnessed the attacks as children were more than twice as likely to have panic disorder, marijuana use disorder, and separation anxiety, which is uncommon in adults; anxiety disorders were more prevalent, as well.
They also were almost half as likely to be living with a spouse or partner, and half as likely to be living independently. “That kind of goes along with the separation anxiety; these kids were more likely to be afraid of moving away from their family and breaking out into their own lives,” Dr. Amsel said.
Overall, 36% had a psychiatric disorder, and 27% had a physical problem, such as diabetes, asthma, or eczema; 14% had both. Among adults who were in Queens during the attacks, 28% had a psychiatric disorder, and 11% a physical problem; 4% were comorbid.
The increased odds of physical-psychiatric comorbidity among witnesses (adjusted odds ratio, 4.60; 95% confidence interval, 2.75- 7.71; P less than .0001) “was not due simply to an increase in physical conditions,” according to the study team.
“This was a single event,” Dr. Amsel said, but for children who witnessed it, “it’s had effects for decades. There were huge amounts of money sent in, and lots of health care for kids who were down there, but despite that, we have this. We think the PTSD morphed into” long-term issues, Dr. Amsel said.
“We know that one of the reasons people get psychiatric disorders” after trauma “is that they generalize the fear; the message to your brain is that everything is dangerous. You’ve got to intervene there and break the association between the fear system and everything else, so that life is still safe,” he said.
There’s an added element with human violence. “Life may be unsafe” after a natural disaster, “but you know that human beings are good and helpful. With a terrorist attack, you stop trusting people,” he said.
Cognitive behavioral therapy could help, among other approaches. It also might be helpful to teach resilience to schoolchildren, just like biology and algebra, he said.
Cases and controls were evenly split between the sexes. Just over 40% of subjects in both groups were white, followed by Hispanics, Asians, and blacks. The majority of households were middle income.
The next step is to break the results down by age, ethnicity, socioeconomic factors, and support systems. The team will run blood work and heart and lung tests on the subjects to nail down the physical problems reported by witnesses. There are concerns about the lingering effects of the dust plume.
The work is funded by the federal government. Dr. Amsel didn’t have any relevant financial disclosures.
SAN FRANCISCO – according to a case-control study presented at the American Psychiatric Association annual meeting.
The investigation included 942 people who, as children under 18 years old, were in school below Canal Street in lower Manhattan when the World Trade Center was attacked. They saw the towers collapse and were evacuated from the area, but did not lose a parent. Now 18-36 years old, they were interviewed in their homes and asked to filled out questionnaires about psychiatric and physical problems. The outcomes were compared with 563 age- and gender-matched controls who were in school in Queens at the time.
In turns out that “it made a huge difference whether you were there or not. Being there had much more impact than hearing about it or watching it on TV,” said lead investigator Lawrence Amsel, MD, an assistant professor of clinical psychiatry at Columbia University in New York.
Adults who witnessed the attacks as children were more than twice as likely to have panic disorder, marijuana use disorder, and separation anxiety, which is uncommon in adults; anxiety disorders were more prevalent, as well.
They also were almost half as likely to be living with a spouse or partner, and half as likely to be living independently. “That kind of goes along with the separation anxiety; these kids were more likely to be afraid of moving away from their family and breaking out into their own lives,” Dr. Amsel said.
Overall, 36% had a psychiatric disorder, and 27% had a physical problem, such as diabetes, asthma, or eczema; 14% had both. Among adults who were in Queens during the attacks, 28% had a psychiatric disorder, and 11% a physical problem; 4% were comorbid.
The increased odds of physical-psychiatric comorbidity among witnesses (adjusted odds ratio, 4.60; 95% confidence interval, 2.75- 7.71; P less than .0001) “was not due simply to an increase in physical conditions,” according to the study team.
“This was a single event,” Dr. Amsel said, but for children who witnessed it, “it’s had effects for decades. There were huge amounts of money sent in, and lots of health care for kids who were down there, but despite that, we have this. We think the PTSD morphed into” long-term issues, Dr. Amsel said.
“We know that one of the reasons people get psychiatric disorders” after trauma “is that they generalize the fear; the message to your brain is that everything is dangerous. You’ve got to intervene there and break the association between the fear system and everything else, so that life is still safe,” he said.
There’s an added element with human violence. “Life may be unsafe” after a natural disaster, “but you know that human beings are good and helpful. With a terrorist attack, you stop trusting people,” he said.
Cognitive behavioral therapy could help, among other approaches. It also might be helpful to teach resilience to schoolchildren, just like biology and algebra, he said.
Cases and controls were evenly split between the sexes. Just over 40% of subjects in both groups were white, followed by Hispanics, Asians, and blacks. The majority of households were middle income.
The next step is to break the results down by age, ethnicity, socioeconomic factors, and support systems. The team will run blood work and heart and lung tests on the subjects to nail down the physical problems reported by witnesses. There are concerns about the lingering effects of the dust plume.
The work is funded by the federal government. Dr. Amsel didn’t have any relevant financial disclosures.
SAN FRANCISCO – according to a case-control study presented at the American Psychiatric Association annual meeting.
The investigation included 942 people who, as children under 18 years old, were in school below Canal Street in lower Manhattan when the World Trade Center was attacked. They saw the towers collapse and were evacuated from the area, but did not lose a parent. Now 18-36 years old, they were interviewed in their homes and asked to filled out questionnaires about psychiatric and physical problems. The outcomes were compared with 563 age- and gender-matched controls who were in school in Queens at the time.
In turns out that “it made a huge difference whether you were there or not. Being there had much more impact than hearing about it or watching it on TV,” said lead investigator Lawrence Amsel, MD, an assistant professor of clinical psychiatry at Columbia University in New York.
Adults who witnessed the attacks as children were more than twice as likely to have panic disorder, marijuana use disorder, and separation anxiety, which is uncommon in adults; anxiety disorders were more prevalent, as well.
They also were almost half as likely to be living with a spouse or partner, and half as likely to be living independently. “That kind of goes along with the separation anxiety; these kids were more likely to be afraid of moving away from their family and breaking out into their own lives,” Dr. Amsel said.
Overall, 36% had a psychiatric disorder, and 27% had a physical problem, such as diabetes, asthma, or eczema; 14% had both. Among adults who were in Queens during the attacks, 28% had a psychiatric disorder, and 11% a physical problem; 4% were comorbid.
The increased odds of physical-psychiatric comorbidity among witnesses (adjusted odds ratio, 4.60; 95% confidence interval, 2.75- 7.71; P less than .0001) “was not due simply to an increase in physical conditions,” according to the study team.
“This was a single event,” Dr. Amsel said, but for children who witnessed it, “it’s had effects for decades. There were huge amounts of money sent in, and lots of health care for kids who were down there, but despite that, we have this. We think the PTSD morphed into” long-term issues, Dr. Amsel said.
“We know that one of the reasons people get psychiatric disorders” after trauma “is that they generalize the fear; the message to your brain is that everything is dangerous. You’ve got to intervene there and break the association between the fear system and everything else, so that life is still safe,” he said.
There’s an added element with human violence. “Life may be unsafe” after a natural disaster, “but you know that human beings are good and helpful. With a terrorist attack, you stop trusting people,” he said.
Cognitive behavioral therapy could help, among other approaches. It also might be helpful to teach resilience to schoolchildren, just like biology and algebra, he said.
Cases and controls were evenly split between the sexes. Just over 40% of subjects in both groups were white, followed by Hispanics, Asians, and blacks. The majority of households were middle income.
The next step is to break the results down by age, ethnicity, socioeconomic factors, and support systems. The team will run blood work and heart and lung tests on the subjects to nail down the physical problems reported by witnesses. There are concerns about the lingering effects of the dust plume.
The work is funded by the federal government. Dr. Amsel didn’t have any relevant financial disclosures.
REPORTING FROM APA 2019