Federal Practitioner

In response to COVID-19, we have seen a rapid transformation to virtually delivered mental health care, essential for the prevention and treatment of various mental health conditions during an isolating and stress-inducing pandemic. Yet teletherapy and virtual medication management alone may not adequately address the needs of some of the populations we serve.

Take Jackson, whose name and details have been changed for privacy. A year ago, Jackson, in his last year of high school, began hearing voices that others could not hear. After becoming increasingly withdrawn, his father sought out treatment for him and learned that Jackson was experiencing his first episode of psychosis.

Psychosis involves disruptions in the way one processes thoughts and feelings or behaves, and includes delusions – or unusual beliefs – and hallucinations, meaning seeing and hearing things that others cannot. “First-episode psychosis” (FEP) simply refers to the first time an individual experiences this. It typically occurs between one’s teenage years and their 20s. Whereas some individuals recover from their first episode and may not experience another, others go on to experience recurrence, and sometimes a waxing and waning illness course.

Jackson enrolled in a comprehensive mental health program that not only includes a psychiatrist, but also therapists who provide case management services, as well as a peer specialist; this is someone with lived experience navigating mental illness. The program also includes an employment and education specialist and family and group therapy sessions. His team helped him identify and work toward his personal recovery goals: graduating from high school, obtaining a job, and maintaining a strong relationship with his father.

One hundred thousand adolescents and young adults like Jackson experience FEP each year, and now, in the wake of COVID-19, they probably have more limited access to the kind of support that can be vital to recovery.

Studies have shown that untreated psychosis can detrimentally affect quality of life in several ways, including by negatively affecting interpersonal relationships, interfering with obtaining or maintaining employment, and increasing the risk for problematic substance use. The psychosocial effects of COVID-19 could compound problems that individuals navigating psychosis already face, such as stigmatization, social isolation, and unemployment. On top of this, individuals who experience additional marginalization and downstream effects of systematic discriminatory practices by virtue of their race or ethnicity, immigration status, or language bear the brunt of some of this pandemic’s worst health inequities.

Early and efficacious treatment is critically important for individuals experiencing psychosis. Evidence shows that engagement in coordinated specialty care (CSC) specifically can improve outcomes, including the likelihood of being engaged in school or work and lower rates of hospitalization. CSC is a team-based approach that utilizes the unique skills of every team member to support an individual in reaching their recovery goals, whether it’s starting or finishing college or building a new relationship.

Unlike traditional treatment goals, which often focus on “symptom reduction,” recovery-oriented care is about supporting an individual in obtaining a sense of satisfaction, meaning, and purpose in life. CSC involves not only individual sessions with one’s psychiatrist or therapist, but collaboration with a patient’s peers, groups, family, and work. It also supports navigating such experiences as a job interview or a date. These key, multifaceted components must be made accessible and adapted during these times.

For individuals like Jackson, it is crucial to be able to continue accessing quality CSC, even during our current pandemic. Lisa Dixon, MD, a professor of psychiatry at Columbia University, leads ONTrackNY, a statewide FEP program. She states that “effective, recovery-oriented treatment can make such a huge difference in the lives of these young people who are at a potential inflection point in their lives. Creative, collaborative clinicians can maintain connection and support.”

So how can we adapt CSC during this time? In addition to virtualized medication management and individual therapy, other components of CSC can be creatively adapted for online platforms. Group sessions can be completed virtually, from family to peer-led. Though the unemployment rate continues to rise, we can still help participants with a desire to work find employers that are offering remote work or navigate the risks of potential COVID-19 work exposures if remote options aren’t available. We can also support their developing skills to be used once other employers that pose less risk reopen.

For those in school, virtual education support can provide study skills, ways to cope with transition to an online classroom, or help with obtaining tutoring. Nutritionists can work remotely to provide support and creatively use online platforms for real-time feedback in a participant’s kitchen. Virtual case management is even more essential in the wake of COVID-19, from assistance with applying for unemployment insurance and financial aid to obtaining health insurance or determining eligibility.

For those without access to virtual platforms, individual and group telephone sessions and text check-ins can provide meaningful opportunities for continued engagement. For those who are unstably housed or have limited privacy in housing, teams must generate ideas of where to have remote sessions, such as a nearby park.

In a world now dominated by virtual care, it is critically important that individuals needing to see a clinician in person still be able to do so. Whether it is due to an acute crisis or to administer a long-acting injection medication, it is our responsibility to thoughtfully and judiciously remain available to patients, using appropriate personal protective equipment and precautions.

Jackson is one of many young people in recovery from psychosis. He is not defined by or limited by his experiences, but rather is navigating the possibilities that lie ahead of him, defining for himself who he wants to be in this world as it evolves. In the midst of COVID-19, as we seek to innovate – from how we exercise to how we throw birthday parties – let’s also be innovative in how we provide care and support for individuals experiencing psychosis.

This article first appeared on Medscape.com.

In response to COVID-19, we have seen a rapid transformation to virtually delivered mental health care, essential for the prevention and treatment of various mental health conditions during an isolating and stress-inducing pandemic. Yet teletherapy and virtual medication management alone may not adequately address the needs of some of the populations we serve.

Take Jackson, whose name and details have been changed for privacy. A year ago, Jackson, in his last year of high school, began hearing voices that others could not hear. After becoming increasingly withdrawn, his father sought out treatment for him and learned that Jackson was experiencing his first episode of psychosis.

Psychosis involves disruptions in the way one processes thoughts and feelings or behaves, and includes delusions – or unusual beliefs – and hallucinations, meaning seeing and hearing things that others cannot. “First-episode psychosis” (FEP) simply refers to the first time an individual experiences this. It typically occurs between one’s teenage years and their 20s. Whereas some individuals recover from their first episode and may not experience another, others go on to experience recurrence, and sometimes a waxing and waning illness course.

Jackson enrolled in a comprehensive mental health program that not only includes a psychiatrist, but also therapists who provide case management services, as well as a peer specialist; this is someone with lived experience navigating mental illness. The program also includes an employment and education specialist and family and group therapy sessions. His team helped him identify and work toward his personal recovery goals: graduating from high school, obtaining a job, and maintaining a strong relationship with his father.

One hundred thousand adolescents and young adults like Jackson experience FEP each year, and now, in the wake of COVID-19, they probably have more limited access to the kind of support that can be vital to recovery.

Studies have shown that untreated psychosis can detrimentally affect quality of life in several ways, including by negatively affecting interpersonal relationships, interfering with obtaining or maintaining employment, and increasing the risk for problematic substance use. The psychosocial effects of COVID-19 could compound problems that individuals navigating psychosis already face, such as stigmatization, social isolation, and unemployment. On top of this, individuals who experience additional marginalization and downstream effects of systematic discriminatory practices by virtue of their race or ethnicity, immigration status, or language bear the brunt of some of this pandemic’s worst health inequities.

Early and efficacious treatment is critically important for individuals experiencing psychosis. Evidence shows that engagement in coordinated specialty care (CSC) specifically can improve outcomes, including the likelihood of being engaged in school or work and lower rates of hospitalization. CSC is a team-based approach that utilizes the unique skills of every team member to support an individual in reaching their recovery goals, whether it’s starting or finishing college or building a new relationship.

Unlike traditional treatment goals, which often focus on “symptom reduction,” recovery-oriented care is about supporting an individual in obtaining a sense of satisfaction, meaning, and purpose in life. CSC involves not only individual sessions with one’s psychiatrist or therapist, but collaboration with a patient’s peers, groups, family, and work. It also supports navigating such experiences as a job interview or a date. These key, multifaceted components must be made accessible and adapted during these times.

For individuals like Jackson, it is crucial to be able to continue accessing quality CSC, even during our current pandemic. Lisa Dixon, MD, a professor of psychiatry at Columbia University, leads ONTrackNY, a statewide FEP program. She states that “effective, recovery-oriented treatment can make such a huge difference in the lives of these young people who are at a potential inflection point in their lives. Creative, collaborative clinicians can maintain connection and support.”

So how can we adapt CSC during this time? In addition to virtualized medication management and individual therapy, other components of CSC can be creatively adapted for online platforms. Group sessions can be completed virtually, from family to peer-led. Though the unemployment rate continues to rise, we can still help participants with a desire to work find employers that are offering remote work or navigate the risks of potential COVID-19 work exposures if remote options aren’t available. We can also support their developing skills to be used once other employers that pose less risk reopen.

For those in school, virtual education support can provide study skills, ways to cope with transition to an online classroom, or help with obtaining tutoring. Nutritionists can work remotely to provide support and creatively use online platforms for real-time feedback in a participant’s kitchen. Virtual case management is even more essential in the wake of COVID-19, from assistance with applying for unemployment insurance and financial aid to obtaining health insurance or determining eligibility.

For those without access to virtual platforms, individual and group telephone sessions and text check-ins can provide meaningful opportunities for continued engagement. For those who are unstably housed or have limited privacy in housing, teams must generate ideas of where to have remote sessions, such as a nearby park.

In a world now dominated by virtual care, it is critically important that individuals needing to see a clinician in person still be able to do so. Whether it is due to an acute crisis or to administer a long-acting injection medication, it is our responsibility to thoughtfully and judiciously remain available to patients, using appropriate personal protective equipment and precautions.

Jackson is one of many young people in recovery from psychosis. He is not defined by or limited by his experiences, but rather is navigating the possibilities that lie ahead of him, defining for himself who he wants to be in this world as it evolves. In the midst of COVID-19, as we seek to innovate – from how we exercise to how we throw birthday parties – let’s also be innovative in how we provide care and support for individuals experiencing psychosis.

This article first appeared on Medscape.com.

In response to COVID-19, we have seen a rapid transformation to virtually delivered mental health care, essential for the prevention and treatment of various mental health conditions during an isolating and stress-inducing pandemic. Yet teletherapy and virtual medication management alone may not adequately address the needs of some of the populations we serve.

Take Jackson, whose name and details have been changed for privacy. A year ago, Jackson, in his last year of high school, began hearing voices that others could not hear. After becoming increasingly withdrawn, his father sought out treatment for him and learned that Jackson was experiencing his first episode of psychosis.

Psychosis involves disruptions in the way one processes thoughts and feelings or behaves, and includes delusions – or unusual beliefs – and hallucinations, meaning seeing and hearing things that others cannot. “First-episode psychosis” (FEP) simply refers to the first time an individual experiences this. It typically occurs between one’s teenage years and their 20s. Whereas some individuals recover from their first episode and may not experience another, others go on to experience recurrence, and sometimes a waxing and waning illness course.

Jackson enrolled in a comprehensive mental health program that not only includes a psychiatrist, but also therapists who provide case management services, as well as a peer specialist; this is someone with lived experience navigating mental illness. The program also includes an employment and education specialist and family and group therapy sessions. His team helped him identify and work toward his personal recovery goals: graduating from high school, obtaining a job, and maintaining a strong relationship with his father.

One hundred thousand adolescents and young adults like Jackson experience FEP each year, and now, in the wake of COVID-19, they probably have more limited access to the kind of support that can be vital to recovery.

Studies have shown that untreated psychosis can detrimentally affect quality of life in several ways, including by negatively affecting interpersonal relationships, interfering with obtaining or maintaining employment, and increasing the risk for problematic substance use. The psychosocial effects of COVID-19 could compound problems that individuals navigating psychosis already face, such as stigmatization, social isolation, and unemployment. On top of this, individuals who experience additional marginalization and downstream effects of systematic discriminatory practices by virtue of their race or ethnicity, immigration status, or language bear the brunt of some of this pandemic’s worst health inequities.

Early and efficacious treatment is critically important for individuals experiencing psychosis. Evidence shows that engagement in coordinated specialty care (CSC) specifically can improve outcomes, including the likelihood of being engaged in school or work and lower rates of hospitalization. CSC is a team-based approach that utilizes the unique skills of every team member to support an individual in reaching their recovery goals, whether it’s starting or finishing college or building a new relationship.

Unlike traditional treatment goals, which often focus on “symptom reduction,” recovery-oriented care is about supporting an individual in obtaining a sense of satisfaction, meaning, and purpose in life. CSC involves not only individual sessions with one’s psychiatrist or therapist, but collaboration with a patient’s peers, groups, family, and work. It also supports navigating such experiences as a job interview or a date. These key, multifaceted components must be made accessible and adapted during these times.

For individuals like Jackson, it is crucial to be able to continue accessing quality CSC, even during our current pandemic. Lisa Dixon, MD, a professor of psychiatry at Columbia University, leads ONTrackNY, a statewide FEP program. She states that “effective, recovery-oriented treatment can make such a huge difference in the lives of these young people who are at a potential inflection point in their lives. Creative, collaborative clinicians can maintain connection and support.”

So how can we adapt CSC during this time? In addition to virtualized medication management and individual therapy, other components of CSC can be creatively adapted for online platforms. Group sessions can be completed virtually, from family to peer-led. Though the unemployment rate continues to rise, we can still help participants with a desire to work find employers that are offering remote work or navigate the risks of potential COVID-19 work exposures if remote options aren’t available. We can also support their developing skills to be used once other employers that pose less risk reopen.

For those in school, virtual education support can provide study skills, ways to cope with transition to an online classroom, or help with obtaining tutoring. Nutritionists can work remotely to provide support and creatively use online platforms for real-time feedback in a participant’s kitchen. Virtual case management is even more essential in the wake of COVID-19, from assistance with applying for unemployment insurance and financial aid to obtaining health insurance or determining eligibility.

For those without access to virtual platforms, individual and group telephone sessions and text check-ins can provide meaningful opportunities for continued engagement. For those who are unstably housed or have limited privacy in housing, teams must generate ideas of where to have remote sessions, such as a nearby park.

In a world now dominated by virtual care, it is critically important that individuals needing to see a clinician in person still be able to do so. Whether it is due to an acute crisis or to administer a long-acting injection medication, it is our responsibility to thoughtfully and judiciously remain available to patients, using appropriate personal protective equipment and precautions.

Jackson is one of many young people in recovery from psychosis. He is not defined by or limited by his experiences, but rather is navigating the possibilities that lie ahead of him, defining for himself who he wants to be in this world as it evolves. In the midst of COVID-19, as we seek to innovate – from how we exercise to how we throw birthday parties – let’s also be innovative in how we provide care and support for individuals experiencing psychosis.

This article first appeared on Medscape.com.

Over the last few weeks, several conflicting reports about the efficacy of SARS-CoV-2 treatments have emerged, including high-profile papers that were placed in the limelight and groundbreaking retractions that were issued by the Lancet and New England Journal of Medicine, involving the potential dangers of COVID therapy with findings derived from the Surgisphere database. Hydroxychloroquine has garnered considerable media attention and was touted earlier by President Trump for its therapeutic effects.¹ Naturally, there are political connotations associated with the agent, and it is unlikely that hydroxychloroquine will be supplanted in the near future as ongoing clinical trials have demonstrated mixed results amid the controversy.

As clinicians navigating unchartered territory within the hospital setting, we have to come to terms with these new challenges, tailoring treatment protocols accordingly with the best clinical practices in mind. Patients with preexisting mental health conditions and who are being treated for COVID-19 are particularly susceptible to clinical deterioration. Recent studies have indicated that psychiatric patients are more prone to feelings of isolation and/or estrangement as well as exacerbation of symptoms such as paranoia.² Even more concerning is the medication regimen, namely, the novel combination therapies that arise when agents such as hydroxychloroquine are used in tandem with certain antipsychotics or antidepressants. As clinicians, we must reassess the psychotropic medication regimen for people who are currently being treated for or recovering from COVID-19.
 

What’s at stake for COVID-19–positive mental health care patients?

Although the efficacy of hydroxychloroquine is currently being investigated,³ the antimalarial is usually prescribed in tandem with azithromycin for people with COVID-19. The National Institute of Allergy and Infectious Diseases has advised against that particular combination therapy because of ongoing concerns about toxicities.^3,4

In another study, azithromycin was effectively substituted with doxycycline to help minimize systemic effects for patients with cardiac and/or pulmonary issues^.5 Azithromycin is notorious in the literature for influencing the electrical activity of the heart with the potential for fatal arrhythmia and sudden cardiac death in individuals at risk for cardiovascular disease.^5,6,7 It should be noted that both of these commonly prescribed COVID-19 medications (for example, hydroxychloroquine and azithromycin) could lead to QT interval prolongation especially within the context of combination therapy. This is largely concerning for psychiatrists and various other mental health practitioners for the following reasons: (1) higher rates of metabolic syndrome and cardiovascular diseases among psychiatric patients⁸ and/or (2) effects of certain antipsychotics (for example, IV haloperidol, thioridazine, and ziprasidone) and antidepressants (for example, citalopram and escitalopram) on the QT interval.⁹

SARS-CoV-2 and clinical judgment: Evaluating patients at higher risk

Although COVID-19 medication guidelines are still being actively developed, hydroxychloroquine appears to be commonly prescribed by physicians. The medication is known myriad untoward effects, including potential behavioral dysfunction (for example, irritability, agitation, suicidal ideation)10 as well as the aforementioned issues concerning arrhythmia (for example, torsades de pointes). Health care professionals might not have much control over the choice of COVID-19 agents because of a lack of available resources or limited options, but they can exercise clinical judgment with respect to selecting the appropriate psychotropic medications.

Treatment recommendations

1. Establish a baseline EKG

A baseline 12-lead EKG is the standard of care for patients currently being screened for COVID-19. It is necessary to rule out the presence of an underlying cardiovascular disease or a rhythm irregularity. A prolonged QTc interval is generally regarded as being around greater than 450-470 msecs with variations attributable to gender;¹¹ numerous studies have affirmed that the risk of acquiring torsades de pointes is substantial when the QTc interval exceeds 500 msecs.¹²

2. Medical management and risk assessment

Commonly prescribed antipsychotics such as IV haloperidol and ziprasidone are known for exerting a negative effect on the interval and should readily be substituted with other agents in patients who are being treated for COVID-19; the combination of these antipsychotics alongside some COVID-19 medication regimens (for example, hydroxychloroquine/azithromycin) might prove to be fatal. The same logic applies to COVID-19 patients previously on antidepressant therapeutics such as citalopram and escitalopram.

3. Embrace an individually tailored approach to therapeutics

While American Psychiatric Association guidelines historically supported a cessation or reduction in the offending agent under normal circumstances,¹² our team is recommending that the psychotropics associated with QTc interval prolongation are discontinued altogether (or substituted with a low-risk agent) in the event that a patient presents with suspected COVID-19. However, after the patients tests negative with COVID-19, they may resume therapy as indicated under the discretion of the mental health practitioner.
 

References

1. Offard C. “Lancet, NEJM Retract Surgisphere Studies on COVID-19 Patients.” The Scientist Magazine. 2020 Jun 4.

2. Shigemura J et al. Psychiatry Clin Neurosci. 2020 Apr;74(4):281-2.

3. Keshtkar-Jahromi M and Bavari S. Am J Trop Med Hyg. 2020 May;102(5):932-3.

4. Palca J. “NIH panel recommends against drug combination promoted by Trump for COVID-19.” NPR. 2020 Apr 21.

5. Mongelli L. “Long Island doctor tries new twist on hydroxychloroquine for elderly COVID-19 patients.” New York Post. 2020 Apr 4.

6. Hancox JC et al. Ther Adv Infect Dis. 2013 Oct;(5):155-65.

7. Giudicessi JR and Ackerman MJ. Cleve Clin J Med. 2013 Sep;80(9):539-44.

8. Casey DE. Am J Med. 2005 Apr 1;118(Suppl 2):15S-22S.

9. Beach SR et al. Psychosomatics. 2013 Jan 1;54(1):1-3.

10. Bogaczewicz A and Sobów T. Psychiatria i Psychologia Kliniczna. 2017;17(2):111-4.

11. Chohan PS et al. Pak J Med Sci. 2015 Sep-Oct;31(5):1269-71.

12. Lieberman JA et al. APA guidance on the use of antipsychotic drugs and cardiac sudden death. NYS Office of Mental Health. 2012.
 

Dr. Faisal A. Islam is medical adviser for the International Maternal and Child Health Foundation, Montreal, and is based in New York. He also is a postdoctoral fellow, psychopharmacologist, and a board-certified medical affairs specialist. Dr. Faisal Islam disclosed no relevant financial relationships.

Dr. Mohammed Islam is affiliated with the department of psychiatry at the Interfaith Medical Center, New York. He disclosed no relevant financial relationships.

Dr. Choudhry is the chief scientific officer and head of the department of mental health and clinical research at the International Maternal and Child Health Foundation. He disclosed no relevant financial relationships.

Over the last few weeks, several conflicting reports about the efficacy of SARS-CoV-2 treatments have emerged, including high-profile papers that were placed in the limelight and groundbreaking retractions that were issued by the Lancet and New England Journal of Medicine, involving the potential dangers of COVID therapy with findings derived from the Surgisphere database. Hydroxychloroquine has garnered considerable media attention and was touted earlier by President Trump for its therapeutic effects.¹ Naturally, there are political connotations associated with the agent, and it is unlikely that hydroxychloroquine will be supplanted in the near future as ongoing clinical trials have demonstrated mixed results amid the controversy.

As clinicians navigating unchartered territory within the hospital setting, we have to come to terms with these new challenges, tailoring treatment protocols accordingly with the best clinical practices in mind. Patients with preexisting mental health conditions and who are being treated for COVID-19 are particularly susceptible to clinical deterioration. Recent studies have indicated that psychiatric patients are more prone to feelings of isolation and/or estrangement as well as exacerbation of symptoms such as paranoia.² Even more concerning is the medication regimen, namely, the novel combination therapies that arise when agents such as hydroxychloroquine are used in tandem with certain antipsychotics or antidepressants. As clinicians, we must reassess the psychotropic medication regimen for people who are currently being treated for or recovering from COVID-19.
 

What’s at stake for COVID-19–positive mental health care patients?

Although the efficacy of hydroxychloroquine is currently being investigated,³ the antimalarial is usually prescribed in tandem with azithromycin for people with COVID-19. The National Institute of Allergy and Infectious Diseases has advised against that particular combination therapy because of ongoing concerns about toxicities.^3,4

In another study, azithromycin was effectively substituted with doxycycline to help minimize systemic effects for patients with cardiac and/or pulmonary issues^.5 Azithromycin is notorious in the literature for influencing the electrical activity of the heart with the potential for fatal arrhythmia and sudden cardiac death in individuals at risk for cardiovascular disease.^5,6,7 It should be noted that both of these commonly prescribed COVID-19 medications (for example, hydroxychloroquine and azithromycin) could lead to QT interval prolongation especially within the context of combination therapy. This is largely concerning for psychiatrists and various other mental health practitioners for the following reasons: (1) higher rates of metabolic syndrome and cardiovascular diseases among psychiatric patients⁸ and/or (2) effects of certain antipsychotics (for example, IV haloperidol, thioridazine, and ziprasidone) and antidepressants (for example, citalopram and escitalopram) on the QT interval.⁹

SARS-CoV-2 and clinical judgment: Evaluating patients at higher risk

Although COVID-19 medication guidelines are still being actively developed, hydroxychloroquine appears to be commonly prescribed by physicians. The medication is known myriad untoward effects, including potential behavioral dysfunction (for example, irritability, agitation, suicidal ideation)10 as well as the aforementioned issues concerning arrhythmia (for example, torsades de pointes). Health care professionals might not have much control over the choice of COVID-19 agents because of a lack of available resources or limited options, but they can exercise clinical judgment with respect to selecting the appropriate psychotropic medications.

Treatment recommendations

1. Establish a baseline EKG

A baseline 12-lead EKG is the standard of care for patients currently being screened for COVID-19. It is necessary to rule out the presence of an underlying cardiovascular disease or a rhythm irregularity. A prolonged QTc interval is generally regarded as being around greater than 450-470 msecs with variations attributable to gender;¹¹ numerous studies have affirmed that the risk of acquiring torsades de pointes is substantial when the QTc interval exceeds 500 msecs.¹²

2. Medical management and risk assessment

Commonly prescribed antipsychotics such as IV haloperidol and ziprasidone are known for exerting a negative effect on the interval and should readily be substituted with other agents in patients who are being treated for COVID-19; the combination of these antipsychotics alongside some COVID-19 medication regimens (for example, hydroxychloroquine/azithromycin) might prove to be fatal. The same logic applies to COVID-19 patients previously on antidepressant therapeutics such as citalopram and escitalopram.

3. Embrace an individually tailored approach to therapeutics

While American Psychiatric Association guidelines historically supported a cessation or reduction in the offending agent under normal circumstances,¹² our team is recommending that the psychotropics associated with QTc interval prolongation are discontinued altogether (or substituted with a low-risk agent) in the event that a patient presents with suspected COVID-19. However, after the patients tests negative with COVID-19, they may resume therapy as indicated under the discretion of the mental health practitioner.
 

References

1. Offard C. “Lancet, NEJM Retract Surgisphere Studies on COVID-19 Patients.” The Scientist Magazine. 2020 Jun 4.

2. Shigemura J et al. Psychiatry Clin Neurosci. 2020 Apr;74(4):281-2.

3. Keshtkar-Jahromi M and Bavari S. Am J Trop Med Hyg. 2020 May;102(5):932-3.

4. Palca J. “NIH panel recommends against drug combination promoted by Trump for COVID-19.” NPR. 2020 Apr 21.

5. Mongelli L. “Long Island doctor tries new twist on hydroxychloroquine for elderly COVID-19 patients.” New York Post. 2020 Apr 4.

6. Hancox JC et al. Ther Adv Infect Dis. 2013 Oct;(5):155-65.

7. Giudicessi JR and Ackerman MJ. Cleve Clin J Med. 2013 Sep;80(9):539-44.

8. Casey DE. Am J Med. 2005 Apr 1;118(Suppl 2):15S-22S.

9. Beach SR et al. Psychosomatics. 2013 Jan 1;54(1):1-3.

10. Bogaczewicz A and Sobów T. Psychiatria i Psychologia Kliniczna. 2017;17(2):111-4.

11. Chohan PS et al. Pak J Med Sci. 2015 Sep-Oct;31(5):1269-71.

12. Lieberman JA et al. APA guidance on the use of antipsychotic drugs and cardiac sudden death. NYS Office of Mental Health. 2012.
 

Dr. Faisal A. Islam is medical adviser for the International Maternal and Child Health Foundation, Montreal, and is based in New York. He also is a postdoctoral fellow, psychopharmacologist, and a board-certified medical affairs specialist. Dr. Faisal Islam disclosed no relevant financial relationships.

Dr. Mohammed Islam is affiliated with the department of psychiatry at the Interfaith Medical Center, New York. He disclosed no relevant financial relationships.

Dr. Choudhry is the chief scientific officer and head of the department of mental health and clinical research at the International Maternal and Child Health Foundation. He disclosed no relevant financial relationships.

Over the last few weeks, several conflicting reports about the efficacy of SARS-CoV-2 treatments have emerged, including high-profile papers that were placed in the limelight and groundbreaking retractions that were issued by the Lancet and New England Journal of Medicine, involving the potential dangers of COVID therapy with findings derived from the Surgisphere database. Hydroxychloroquine has garnered considerable media attention and was touted earlier by President Trump for its therapeutic effects.¹ Naturally, there are political connotations associated with the agent, and it is unlikely that hydroxychloroquine will be supplanted in the near future as ongoing clinical trials have demonstrated mixed results amid the controversy.

As clinicians navigating unchartered territory within the hospital setting, we have to come to terms with these new challenges, tailoring treatment protocols accordingly with the best clinical practices in mind. Patients with preexisting mental health conditions and who are being treated for COVID-19 are particularly susceptible to clinical deterioration. Recent studies have indicated that psychiatric patients are more prone to feelings of isolation and/or estrangement as well as exacerbation of symptoms such as paranoia.² Even more concerning is the medication regimen, namely, the novel combination therapies that arise when agents such as hydroxychloroquine are used in tandem with certain antipsychotics or antidepressants. As clinicians, we must reassess the psychotropic medication regimen for people who are currently being treated for or recovering from COVID-19.
 

What’s at stake for COVID-19–positive mental health care patients?

Although the efficacy of hydroxychloroquine is currently being investigated,³ the antimalarial is usually prescribed in tandem with azithromycin for people with COVID-19. The National Institute of Allergy and Infectious Diseases has advised against that particular combination therapy because of ongoing concerns about toxicities.^3,4

In another study, azithromycin was effectively substituted with doxycycline to help minimize systemic effects for patients with cardiac and/or pulmonary issues^.5 Azithromycin is notorious in the literature for influencing the electrical activity of the heart with the potential for fatal arrhythmia and sudden cardiac death in individuals at risk for cardiovascular disease.^5,6,7 It should be noted that both of these commonly prescribed COVID-19 medications (for example, hydroxychloroquine and azithromycin) could lead to QT interval prolongation especially within the context of combination therapy. This is largely concerning for psychiatrists and various other mental health practitioners for the following reasons: (1) higher rates of metabolic syndrome and cardiovascular diseases among psychiatric patients⁸ and/or (2) effects of certain antipsychotics (for example, IV haloperidol, thioridazine, and ziprasidone) and antidepressants (for example, citalopram and escitalopram) on the QT interval.⁹

SARS-CoV-2 and clinical judgment: Evaluating patients at higher risk

Although COVID-19 medication guidelines are still being actively developed, hydroxychloroquine appears to be commonly prescribed by physicians. The medication is known myriad untoward effects, including potential behavioral dysfunction (for example, irritability, agitation, suicidal ideation)10 as well as the aforementioned issues concerning arrhythmia (for example, torsades de pointes). Health care professionals might not have much control over the choice of COVID-19 agents because of a lack of available resources or limited options, but they can exercise clinical judgment with respect to selecting the appropriate psychotropic medications.

Treatment recommendations

1. Establish a baseline EKG

A baseline 12-lead EKG is the standard of care for patients currently being screened for COVID-19. It is necessary to rule out the presence of an underlying cardiovascular disease or a rhythm irregularity. A prolonged QTc interval is generally regarded as being around greater than 450-470 msecs with variations attributable to gender;¹¹ numerous studies have affirmed that the risk of acquiring torsades de pointes is substantial when the QTc interval exceeds 500 msecs.¹²

2. Medical management and risk assessment

Commonly prescribed antipsychotics such as IV haloperidol and ziprasidone are known for exerting a negative effect on the interval and should readily be substituted with other agents in patients who are being treated for COVID-19; the combination of these antipsychotics alongside some COVID-19 medication regimens (for example, hydroxychloroquine/azithromycin) might prove to be fatal. The same logic applies to COVID-19 patients previously on antidepressant therapeutics such as citalopram and escitalopram.

3. Embrace an individually tailored approach to therapeutics

While American Psychiatric Association guidelines historically supported a cessation or reduction in the offending agent under normal circumstances,¹² our team is recommending that the psychotropics associated with QTc interval prolongation are discontinued altogether (or substituted with a low-risk agent) in the event that a patient presents with suspected COVID-19. However, after the patients tests negative with COVID-19, they may resume therapy as indicated under the discretion of the mental health practitioner.
 

References

1. Offard C. “Lancet, NEJM Retract Surgisphere Studies on COVID-19 Patients.” The Scientist Magazine. 2020 Jun 4.

2. Shigemura J et al. Psychiatry Clin Neurosci. 2020 Apr;74(4):281-2.

3. Keshtkar-Jahromi M and Bavari S. Am J Trop Med Hyg. 2020 May;102(5):932-3.

4. Palca J. “NIH panel recommends against drug combination promoted by Trump for COVID-19.” NPR. 2020 Apr 21.

5. Mongelli L. “Long Island doctor tries new twist on hydroxychloroquine for elderly COVID-19 patients.” New York Post. 2020 Apr 4.

6. Hancox JC et al. Ther Adv Infect Dis. 2013 Oct;(5):155-65.

7. Giudicessi JR and Ackerman MJ. Cleve Clin J Med. 2013 Sep;80(9):539-44.

8. Casey DE. Am J Med. 2005 Apr 1;118(Suppl 2):15S-22S.

9. Beach SR et al. Psychosomatics. 2013 Jan 1;54(1):1-3.

10. Bogaczewicz A and Sobów T. Psychiatria i Psychologia Kliniczna. 2017;17(2):111-4.

11. Chohan PS et al. Pak J Med Sci. 2015 Sep-Oct;31(5):1269-71.

12. Lieberman JA et al. APA guidance on the use of antipsychotic drugs and cardiac sudden death. NYS Office of Mental Health. 2012.
 

Dr. Faisal A. Islam is medical adviser for the International Maternal and Child Health Foundation, Montreal, and is based in New York. He also is a postdoctoral fellow, psychopharmacologist, and a board-certified medical affairs specialist. Dr. Faisal Islam disclosed no relevant financial relationships.

Dr. Mohammed Islam is affiliated with the department of psychiatry at the Interfaith Medical Center, New York. He disclosed no relevant financial relationships.

Dr. Choudhry is the chief scientific officer and head of the department of mental health and clinical research at the International Maternal and Child Health Foundation. He disclosed no relevant financial relationships.

When sterilizing face masks, the type of face mask and the method of sterilization have a bearing on subsequent filtration efficiency, according to researchers. The greatest reduction in filtration efficiency after sterilization occurred with surgical face masks.

With plasma vapor hydrogen peroxide (H₂O₂) sterilization, filtration efficiency of N95 and KN95 masks was maintained at more than 95%, but for surgical face masks, filtration efficiency was reduced to less than 95%. With chlorine dioxide (ClO₂) sterilization, on the other hand, filtration efficiency was maintained at above 95% for N95 masks, but for KN95 and surgical face masks, filtration efficiency was reduced to less than 80%.

In a research letter published online June 15 in JAMA Network Open, researchers from the University of Oklahoma Health Sciences Center, Oklahoma City, report the results of a study of the two sterilization techniques on the pressure drop and filtration efficiency of N95, KN95, and surgical face masks.

“The H₂O₂ treatment showed a small effect on the overall filtration efficiency of the tested masks, but the ClO₂ treatment showed marked reduction in the overall filtration efficiency of the KN95s and surgical face masks. All pressure drop changes were within the acceptable range,” the researchers write.

The study did not evaluate the effect of repeated sterilizations on face masks.

Five masks of each type were sterilized with either H₂O₂ or ClO₂. Masks were then placed in a test chamber, and a salt aerosol was nebulized to assess both upstream and downstream filtration as well as pressure drop. The researchers used a mobility particle sizer to measure particle number concentration from 16.8 nm to 514 nm. An acceptable pressure drop was defined as a drop of less than 1.38 inches of water (35 mm) for inhalation.

Although pressure drop changes were within the acceptable range for all three mask types following sterilization with either method, H₂O₂ sterilization yielded the least reduction in filtration efficacy in all cases. After sterilization with H₂O₂, filtration efficiencies were 96.6%, 97.1%, and 91.6% for the N95s, KN95s, and the surgical face masks, respectively. In contrast, filtration efficiencies after ClO₂ sterilization were 95.1%, 76.2%, and 77.9%, respectively.

The researchers note that, although overall filtration efficiency was maintained with ClO₂ sterilization, there was a significant drop in efficiency with respect to particles of approximately 300 nm (0.3 microns) in size. For particles of that size, mean filtration efficiency decreased to 86.2% for N95s, 40.8% for KN95s, and 47.1% for surgical face masks.

The testing described in the report is “quite affordable at $350 per mask type, so it is hard to imagine any health care provider cannot set aside a small budget to conduct such an important test,” author Evan Floyd, PhD, told Medscape Medical News.

Given the high demand for effective face masks and the current risk for counterfeit products, Floyd suggested that individual facilities test all masks intended for use by healthcare workers before and after sterilization procedures.

“However, if for some reason testing is not an option, we would recommend sticking to established brands and suppliers, perhaps reach out to your state health department or a local representative of the strategic stockpile of PPE,” he noted.

The authors acknowledge that further studies using a larger sample size and a greater variety of masks, as well as studies to evaluate different sterilization techniques, are required. Further, “measuring the respirator’s filtration efficiency by aerosol size instead of only measuring the overall filtration efficiency” should also be considered. Such an approach would enable researchers to evaluate the degree to which masks protect against specific infectious agents.

This article first appeared on Medscape.com.

When sterilizing face masks, the type of face mask and the method of sterilization have a bearing on subsequent filtration efficiency, according to researchers. The greatest reduction in filtration efficiency after sterilization occurred with surgical face masks.

With plasma vapor hydrogen peroxide (H₂O₂) sterilization, filtration efficiency of N95 and KN95 masks was maintained at more than 95%, but for surgical face masks, filtration efficiency was reduced to less than 95%. With chlorine dioxide (ClO₂) sterilization, on the other hand, filtration efficiency was maintained at above 95% for N95 masks, but for KN95 and surgical face masks, filtration efficiency was reduced to less than 80%.

In a research letter published online June 15 in JAMA Network Open, researchers from the University of Oklahoma Health Sciences Center, Oklahoma City, report the results of a study of the two sterilization techniques on the pressure drop and filtration efficiency of N95, KN95, and surgical face masks.

“The H₂O₂ treatment showed a small effect on the overall filtration efficiency of the tested masks, but the ClO₂ treatment showed marked reduction in the overall filtration efficiency of the KN95s and surgical face masks. All pressure drop changes were within the acceptable range,” the researchers write.

The study did not evaluate the effect of repeated sterilizations on face masks.

Five masks of each type were sterilized with either H₂O₂ or ClO₂. Masks were then placed in a test chamber, and a salt aerosol was nebulized to assess both upstream and downstream filtration as well as pressure drop. The researchers used a mobility particle sizer to measure particle number concentration from 16.8 nm to 514 nm. An acceptable pressure drop was defined as a drop of less than 1.38 inches of water (35 mm) for inhalation.

Although pressure drop changes were within the acceptable range for all three mask types following sterilization with either method, H₂O₂ sterilization yielded the least reduction in filtration efficacy in all cases. After sterilization with H₂O₂, filtration efficiencies were 96.6%, 97.1%, and 91.6% for the N95s, KN95s, and the surgical face masks, respectively. In contrast, filtration efficiencies after ClO₂ sterilization were 95.1%, 76.2%, and 77.9%, respectively.

The researchers note that, although overall filtration efficiency was maintained with ClO₂ sterilization, there was a significant drop in efficiency with respect to particles of approximately 300 nm (0.3 microns) in size. For particles of that size, mean filtration efficiency decreased to 86.2% for N95s, 40.8% for KN95s, and 47.1% for surgical face masks.

The testing described in the report is “quite affordable at $350 per mask type, so it is hard to imagine any health care provider cannot set aside a small budget to conduct such an important test,” author Evan Floyd, PhD, told Medscape Medical News.

Given the high demand for effective face masks and the current risk for counterfeit products, Floyd suggested that individual facilities test all masks intended for use by healthcare workers before and after sterilization procedures.

“However, if for some reason testing is not an option, we would recommend sticking to established brands and suppliers, perhaps reach out to your state health department or a local representative of the strategic stockpile of PPE,” he noted.

The authors acknowledge that further studies using a larger sample size and a greater variety of masks, as well as studies to evaluate different sterilization techniques, are required. Further, “measuring the respirator’s filtration efficiency by aerosol size instead of only measuring the overall filtration efficiency” should also be considered. Such an approach would enable researchers to evaluate the degree to which masks protect against specific infectious agents.

This article first appeared on Medscape.com.

When sterilizing face masks, the type of face mask and the method of sterilization have a bearing on subsequent filtration efficiency, according to researchers. The greatest reduction in filtration efficiency after sterilization occurred with surgical face masks.

With plasma vapor hydrogen peroxide (H₂O₂) sterilization, filtration efficiency of N95 and KN95 masks was maintained at more than 95%, but for surgical face masks, filtration efficiency was reduced to less than 95%. With chlorine dioxide (ClO₂) sterilization, on the other hand, filtration efficiency was maintained at above 95% for N95 masks, but for KN95 and surgical face masks, filtration efficiency was reduced to less than 80%.

In a research letter published online June 15 in JAMA Network Open, researchers from the University of Oklahoma Health Sciences Center, Oklahoma City, report the results of a study of the two sterilization techniques on the pressure drop and filtration efficiency of N95, KN95, and surgical face masks.

“The H₂O₂ treatment showed a small effect on the overall filtration efficiency of the tested masks, but the ClO₂ treatment showed marked reduction in the overall filtration efficiency of the KN95s and surgical face masks. All pressure drop changes were within the acceptable range,” the researchers write.

The study did not evaluate the effect of repeated sterilizations on face masks.

Five masks of each type were sterilized with either H₂O₂ or ClO₂. Masks were then placed in a test chamber, and a salt aerosol was nebulized to assess both upstream and downstream filtration as well as pressure drop. The researchers used a mobility particle sizer to measure particle number concentration from 16.8 nm to 514 nm. An acceptable pressure drop was defined as a drop of less than 1.38 inches of water (35 mm) for inhalation.

Although pressure drop changes were within the acceptable range for all three mask types following sterilization with either method, H₂O₂ sterilization yielded the least reduction in filtration efficacy in all cases. After sterilization with H₂O₂, filtration efficiencies were 96.6%, 97.1%, and 91.6% for the N95s, KN95s, and the surgical face masks, respectively. In contrast, filtration efficiencies after ClO₂ sterilization were 95.1%, 76.2%, and 77.9%, respectively.

The researchers note that, although overall filtration efficiency was maintained with ClO₂ sterilization, there was a significant drop in efficiency with respect to particles of approximately 300 nm (0.3 microns) in size. For particles of that size, mean filtration efficiency decreased to 86.2% for N95s, 40.8% for KN95s, and 47.1% for surgical face masks.

The testing described in the report is “quite affordable at $350 per mask type, so it is hard to imagine any health care provider cannot set aside a small budget to conduct such an important test,” author Evan Floyd, PhD, told Medscape Medical News.

Given the high demand for effective face masks and the current risk for counterfeit products, Floyd suggested that individual facilities test all masks intended for use by healthcare workers before and after sterilization procedures.

“However, if for some reason testing is not an option, we would recommend sticking to established brands and suppliers, perhaps reach out to your state health department or a local representative of the strategic stockpile of PPE,” he noted.

The authors acknowledge that further studies using a larger sample size and a greater variety of masks, as well as studies to evaluate different sterilization techniques, are required. Further, “measuring the respirator’s filtration efficiency by aerosol size instead of only measuring the overall filtration efficiency” should also be considered. Such an approach would enable researchers to evaluate the degree to which masks protect against specific infectious agents.

This article first appeared on Medscape.com.

Frequent hypoglycemic episodes were linked to a raised incidence of cardiovascular events in adults with type 2 diabetes in a recent retrospective study, suggesting certain hypoglycemia-associated diabetes drugs should be avoided, an investigator said.

Patients who had more than five hypoglycemic episodes per year had a 61% greater risk of cardiovascular (CV) events, compared with patients with less frequent episodes, according to results of the study.

Although there were fewer strokes among younger patients, the overall increase in cardiovascular event risk held up regardless of age group, according to investigator Aman Rajpal, MD, of Louis Stokes Veterans Affairs Medical Center and Case Western Reserve University, both in Cleveland.

On the basis of these and earlier studies tying hypoglycemia to CV risk, health care providers need to “pay close attention” to low blood sugar and personalize glycemic control targets for each patient based on risk of hypoglycemia, Dr. Rajpal said in a presentation of the study at the virtual annual scientific sessions of the American Diabetes Association.

“Also, this suggests that avoidance of drugs associated with increased risk of hypoglycemia – namely insulin, sulfonylureas, or others – is essential to avoid and minimize the risk of cardiovascular events in this patient population with type 2 diabetes,” said Dr. Rajpal. “Let us remember part of our Hippocratic oath: ‘Above all, do no harm.’ ”
 

Tailoring treatment to mitigate risk

Mark Schutta, MD, medical director of Penn Rodebaugh Diabetes Center in Philadelphia, said that results of this study suggest a need to carefully select medical therapy for each individual patient with diabetes in order to mitigate CV risk.

“It’s really about tailoring their drugs to their personal situation,” Dr. Schutta said in an interview.

Although newer diabetes drug classes are associated with low to no risk of hypoglycemia, Dr. Schutta said that there is still a place for drugs such as sulfonylureas in certain situations.

Among sulfonylureas, glyburide comes with a much higher incidence of hypoglycemia, compared with glipizide and glimepiride, according to Dr. Schutta. “I think there’s a role for both drugs, but you have to be very careful, and you have to get the data from your patients.”
 

Hypoglycemia frequency and outcomes

Speculation that hypoglycemia could be linked to adverse CV outcomes was sparked years ago by trials such as ADVANCE. Severe hypoglycemia in that study was associated with a 168% increased risk of death from a CV cause (N Engl J Med. 2010 Oct 7;363:1410-8).

At the time, ADVANCE investigators said they were unable to find evidence that multiple severe hypoglycemia episodes conferred a greater risk of CV events versus a single hypoglycemia episode, though they added that few patients had recurrent events.

“In other words, the association between the number of hypoglycemia events, and adverse CV outcomes is still unclear,” said Dr. Rajpal in his virtual ADA presentation.
 

Potential elevated risks with more than five episodes

To evaluate the association between frequent hypoglycemic episodes (i.e., more than five per year, compared with one to five episodes) and CV events, Dr. Rajpal and colleagues evaluated outcomes data for 4.9 million adults with type 2 diabetes found in a large commercial database including information on patients in 27 U.S. health care networks.

Database records indicated that about 182,000 patients, or nearly 4%, had episodes of hyperglycemia, which Dr. Rajpal said was presumed to mean a plasma glucose level of less than 70 mg/dL.

Characteristics of the patients with more than five hypoglycemic episodes were similar to those with one to five episodes, although they were more likely to be 65 years or older, and were “slightly more likely” to be on insulin, which could possibly precipitate more hypoglycemic episodes in that group, Dr. Rajpal said.
 

Key findings

In the main analysis, Dr. Rajpal said, risk of CV events was significantly increased in those with more than five hypoglycemic episodes, compared with those with one to five episodes, with an odds ratio of 1.61 (95% confidence interval, 1.56-1.66). The incidence of cardiovascular events was 33.1% in those with more than five episodes and 23.5% in those with one to five episodes, according to the data presented.

Risks were also significantly increased specifically for cardiac arrhythmias, cerebrovascular accidents, and MI, Dr. Rajpal said, with ORs of 1.65 (95% CI, 1.9-1.71), 1.38 (95% CI, 1.22-1.56), and 1.43 (95% CI, 1.36-1.50), respectively.

Because individuals in the group with more than five hypoglycemic episodes were more likely to be elderly, Dr. Rajpal said that he and coinvestigators decided to perform an age-specific stratified analysis.

Although cerebral vascular incidence was low in younger patients, risk of CV events overall was nevertheless significantly elevated for those aged 65 years or older, 45-64 years, and 18-44 years, with ORs of 1.69 (95% CI, 1.61-1.7), 1.58 (95% CI, 1.48-1.69), and 1.62 (95% CI, 1.33-1.97).

“The results were still valid in stratified analysis based on different age groups,” Dr. Rajpal said.

Dr. Rajpal and coauthors reported that he had no conflicts of interest related to the research.

SOURCE: Rajpal A et al. ADA 2020, Abstract 161-OR.

Frequent hypoglycemic episodes were linked to a raised incidence of cardiovascular events in adults with type 2 diabetes in a recent retrospective study, suggesting certain hypoglycemia-associated diabetes drugs should be avoided, an investigator said.

Patients who had more than five hypoglycemic episodes per year had a 61% greater risk of cardiovascular (CV) events, compared with patients with less frequent episodes, according to results of the study.

Although there were fewer strokes among younger patients, the overall increase in cardiovascular event risk held up regardless of age group, according to investigator Aman Rajpal, MD, of Louis Stokes Veterans Affairs Medical Center and Case Western Reserve University, both in Cleveland.

On the basis of these and earlier studies tying hypoglycemia to CV risk, health care providers need to “pay close attention” to low blood sugar and personalize glycemic control targets for each patient based on risk of hypoglycemia, Dr. Rajpal said in a presentation of the study at the virtual annual scientific sessions of the American Diabetes Association.

“Also, this suggests that avoidance of drugs associated with increased risk of hypoglycemia – namely insulin, sulfonylureas, or others – is essential to avoid and minimize the risk of cardiovascular events in this patient population with type 2 diabetes,” said Dr. Rajpal. “Let us remember part of our Hippocratic oath: ‘Above all, do no harm.’ ”
 

Tailoring treatment to mitigate risk

Mark Schutta, MD, medical director of Penn Rodebaugh Diabetes Center in Philadelphia, said that results of this study suggest a need to carefully select medical therapy for each individual patient with diabetes in order to mitigate CV risk.

“It’s really about tailoring their drugs to their personal situation,” Dr. Schutta said in an interview.

Although newer diabetes drug classes are associated with low to no risk of hypoglycemia, Dr. Schutta said that there is still a place for drugs such as sulfonylureas in certain situations.

Among sulfonylureas, glyburide comes with a much higher incidence of hypoglycemia, compared with glipizide and glimepiride, according to Dr. Schutta. “I think there’s a role for both drugs, but you have to be very careful, and you have to get the data from your patients.”
 

Hypoglycemia frequency and outcomes

Speculation that hypoglycemia could be linked to adverse CV outcomes was sparked years ago by trials such as ADVANCE. Severe hypoglycemia in that study was associated with a 168% increased risk of death from a CV cause (N Engl J Med. 2010 Oct 7;363:1410-8).

At the time, ADVANCE investigators said they were unable to find evidence that multiple severe hypoglycemia episodes conferred a greater risk of CV events versus a single hypoglycemia episode, though they added that few patients had recurrent events.

“In other words, the association between the number of hypoglycemia events, and adverse CV outcomes is still unclear,” said Dr. Rajpal in his virtual ADA presentation.
 

Potential elevated risks with more than five episodes

To evaluate the association between frequent hypoglycemic episodes (i.e., more than five per year, compared with one to five episodes) and CV events, Dr. Rajpal and colleagues evaluated outcomes data for 4.9 million adults with type 2 diabetes found in a large commercial database including information on patients in 27 U.S. health care networks.

Database records indicated that about 182,000 patients, or nearly 4%, had episodes of hyperglycemia, which Dr. Rajpal said was presumed to mean a plasma glucose level of less than 70 mg/dL.

Characteristics of the patients with more than five hypoglycemic episodes were similar to those with one to five episodes, although they were more likely to be 65 years or older, and were “slightly more likely” to be on insulin, which could possibly precipitate more hypoglycemic episodes in that group, Dr. Rajpal said.
 

Key findings

In the main analysis, Dr. Rajpal said, risk of CV events was significantly increased in those with more than five hypoglycemic episodes, compared with those with one to five episodes, with an odds ratio of 1.61 (95% confidence interval, 1.56-1.66). The incidence of cardiovascular events was 33.1% in those with more than five episodes and 23.5% in those with one to five episodes, according to the data presented.

Risks were also significantly increased specifically for cardiac arrhythmias, cerebrovascular accidents, and MI, Dr. Rajpal said, with ORs of 1.65 (95% CI, 1.9-1.71), 1.38 (95% CI, 1.22-1.56), and 1.43 (95% CI, 1.36-1.50), respectively.

Because individuals in the group with more than five hypoglycemic episodes were more likely to be elderly, Dr. Rajpal said that he and coinvestigators decided to perform an age-specific stratified analysis.

Although cerebral vascular incidence was low in younger patients, risk of CV events overall was nevertheless significantly elevated for those aged 65 years or older, 45-64 years, and 18-44 years, with ORs of 1.69 (95% CI, 1.61-1.7), 1.58 (95% CI, 1.48-1.69), and 1.62 (95% CI, 1.33-1.97).

“The results were still valid in stratified analysis based on different age groups,” Dr. Rajpal said.

Dr. Rajpal and coauthors reported that he had no conflicts of interest related to the research.

SOURCE: Rajpal A et al. ADA 2020, Abstract 161-OR.

Frequent hypoglycemic episodes were linked to a raised incidence of cardiovascular events in adults with type 2 diabetes in a recent retrospective study, suggesting certain hypoglycemia-associated diabetes drugs should be avoided, an investigator said.

Patients who had more than five hypoglycemic episodes per year had a 61% greater risk of cardiovascular (CV) events, compared with patients with less frequent episodes, according to results of the study.

Although there were fewer strokes among younger patients, the overall increase in cardiovascular event risk held up regardless of age group, according to investigator Aman Rajpal, MD, of Louis Stokes Veterans Affairs Medical Center and Case Western Reserve University, both in Cleveland.

On the basis of these and earlier studies tying hypoglycemia to CV risk, health care providers need to “pay close attention” to low blood sugar and personalize glycemic control targets for each patient based on risk of hypoglycemia, Dr. Rajpal said in a presentation of the study at the virtual annual scientific sessions of the American Diabetes Association.

“Also, this suggests that avoidance of drugs associated with increased risk of hypoglycemia – namely insulin, sulfonylureas, or others – is essential to avoid and minimize the risk of cardiovascular events in this patient population with type 2 diabetes,” said Dr. Rajpal. “Let us remember part of our Hippocratic oath: ‘Above all, do no harm.’ ”
 

Tailoring treatment to mitigate risk

Mark Schutta, MD, medical director of Penn Rodebaugh Diabetes Center in Philadelphia, said that results of this study suggest a need to carefully select medical therapy for each individual patient with diabetes in order to mitigate CV risk.

“It’s really about tailoring their drugs to their personal situation,” Dr. Schutta said in an interview.

Although newer diabetes drug classes are associated with low to no risk of hypoglycemia, Dr. Schutta said that there is still a place for drugs such as sulfonylureas in certain situations.

Among sulfonylureas, glyburide comes with a much higher incidence of hypoglycemia, compared with glipizide and glimepiride, according to Dr. Schutta. “I think there’s a role for both drugs, but you have to be very careful, and you have to get the data from your patients.”
 

Hypoglycemia frequency and outcomes

Speculation that hypoglycemia could be linked to adverse CV outcomes was sparked years ago by trials such as ADVANCE. Severe hypoglycemia in that study was associated with a 168% increased risk of death from a CV cause (N Engl J Med. 2010 Oct 7;363:1410-8).

At the time, ADVANCE investigators said they were unable to find evidence that multiple severe hypoglycemia episodes conferred a greater risk of CV events versus a single hypoglycemia episode, though they added that few patients had recurrent events.

“In other words, the association between the number of hypoglycemia events, and adverse CV outcomes is still unclear,” said Dr. Rajpal in his virtual ADA presentation.
 

Potential elevated risks with more than five episodes

To evaluate the association between frequent hypoglycemic episodes (i.e., more than five per year, compared with one to five episodes) and CV events, Dr. Rajpal and colleagues evaluated outcomes data for 4.9 million adults with type 2 diabetes found in a large commercial database including information on patients in 27 U.S. health care networks.

Database records indicated that about 182,000 patients, or nearly 4%, had episodes of hyperglycemia, which Dr. Rajpal said was presumed to mean a plasma glucose level of less than 70 mg/dL.

Characteristics of the patients with more than five hypoglycemic episodes were similar to those with one to five episodes, although they were more likely to be 65 years or older, and were “slightly more likely” to be on insulin, which could possibly precipitate more hypoglycemic episodes in that group, Dr. Rajpal said.
 

Key findings

In the main analysis, Dr. Rajpal said, risk of CV events was significantly increased in those with more than five hypoglycemic episodes, compared with those with one to five episodes, with an odds ratio of 1.61 (95% confidence interval, 1.56-1.66). The incidence of cardiovascular events was 33.1% in those with more than five episodes and 23.5% in those with one to five episodes, according to the data presented.

Risks were also significantly increased specifically for cardiac arrhythmias, cerebrovascular accidents, and MI, Dr. Rajpal said, with ORs of 1.65 (95% CI, 1.9-1.71), 1.38 (95% CI, 1.22-1.56), and 1.43 (95% CI, 1.36-1.50), respectively.

Because individuals in the group with more than five hypoglycemic episodes were more likely to be elderly, Dr. Rajpal said that he and coinvestigators decided to perform an age-specific stratified analysis.

Although cerebral vascular incidence was low in younger patients, risk of CV events overall was nevertheless significantly elevated for those aged 65 years or older, 45-64 years, and 18-44 years, with ORs of 1.69 (95% CI, 1.61-1.7), 1.58 (95% CI, 1.48-1.69), and 1.62 (95% CI, 1.33-1.97).

“The results were still valid in stratified analysis based on different age groups,” Dr. Rajpal said.

Dr. Rajpal and coauthors reported that he had no conflicts of interest related to the research.

SOURCE: Rajpal A et al. ADA 2020, Abstract 161-OR.

The national incidence of vulvar melanoma is on the rise in women aged over 60 years, climbing by an average of 2.2% per year during 2000-2016, Maia K. Erickson reported in a poster at the virtual annual meeting of the American Academy of Dermatology.

These are often aggressive malignancies. The 5-year survival following diagnosis of vulvar melanoma in women aged 60 years or older was 39.7%, compared with 61.9% in younger women, according to Ms. Erickson, a visiting research fellow in the department of dermatology at Northwestern University, Chicago.

She presented a population-based study of epidemiologic trends in vulvar melanoma based upon analysis of the National Cancer Institute’s Surveillance, Epidemiology and End Results database. Vulvar melanoma was rare during the study years 2000-2016, with an overall incidence rate of 0.1 cases per 100,000 women. That worked out to 746 analyzable cases. Of note, the incidence rate ratio was 680% higher in older women (age 60 and older).

One reason for the markedly worse 5-year survival in older women was that the predominant histologic subtype of vulvar melanoma in that population was nodular melanoma, accounting for 48% of the cases where a histologic subtype was specified. In contrast, the less-aggressive superficial spreading melanoma subtype prevailed in patients aged under 60 years, accounting for 63% of cases.

About 93% of vulvar melanomas occurred in whites; 63% were local and 8.7% were metastatic.

Ms. Erickson noted that the vulva is the most common site for gynecologic tract melanomas, accounting for 70% of them. And while the female genitalia make up only 1%-2% of body surface area, that’s the anatomic site of up to 7% of all melanomas in women.

She reported having no financial conflicts regarding her study.

[email protected]

The national incidence of vulvar melanoma is on the rise in women aged over 60 years, climbing by an average of 2.2% per year during 2000-2016, Maia K. Erickson reported in a poster at the virtual annual meeting of the American Academy of Dermatology.

These are often aggressive malignancies. The 5-year survival following diagnosis of vulvar melanoma in women aged 60 years or older was 39.7%, compared with 61.9% in younger women, according to Ms. Erickson, a visiting research fellow in the department of dermatology at Northwestern University, Chicago.

She presented a population-based study of epidemiologic trends in vulvar melanoma based upon analysis of the National Cancer Institute’s Surveillance, Epidemiology and End Results database. Vulvar melanoma was rare during the study years 2000-2016, with an overall incidence rate of 0.1 cases per 100,000 women. That worked out to 746 analyzable cases. Of note, the incidence rate ratio was 680% higher in older women (age 60 and older).

One reason for the markedly worse 5-year survival in older women was that the predominant histologic subtype of vulvar melanoma in that population was nodular melanoma, accounting for 48% of the cases where a histologic subtype was specified. In contrast, the less-aggressive superficial spreading melanoma subtype prevailed in patients aged under 60 years, accounting for 63% of cases.

About 93% of vulvar melanomas occurred in whites; 63% were local and 8.7% were metastatic.

Ms. Erickson noted that the vulva is the most common site for gynecologic tract melanomas, accounting for 70% of them. And while the female genitalia make up only 1%-2% of body surface area, that’s the anatomic site of up to 7% of all melanomas in women.

She reported having no financial conflicts regarding her study.

[email protected]

The national incidence of vulvar melanoma is on the rise in women aged over 60 years, climbing by an average of 2.2% per year during 2000-2016, Maia K. Erickson reported in a poster at the virtual annual meeting of the American Academy of Dermatology.

These are often aggressive malignancies. The 5-year survival following diagnosis of vulvar melanoma in women aged 60 years or older was 39.7%, compared with 61.9% in younger women, according to Ms. Erickson, a visiting research fellow in the department of dermatology at Northwestern University, Chicago.

She presented a population-based study of epidemiologic trends in vulvar melanoma based upon analysis of the National Cancer Institute’s Surveillance, Epidemiology and End Results database. Vulvar melanoma was rare during the study years 2000-2016, with an overall incidence rate of 0.1 cases per 100,000 women. That worked out to 746 analyzable cases. Of note, the incidence rate ratio was 680% higher in older women (age 60 and older).

One reason for the markedly worse 5-year survival in older women was that the predominant histologic subtype of vulvar melanoma in that population was nodular melanoma, accounting for 48% of the cases where a histologic subtype was specified. In contrast, the less-aggressive superficial spreading melanoma subtype prevailed in patients aged under 60 years, accounting for 63% of cases.

About 93% of vulvar melanomas occurred in whites; 63% were local and 8.7% were metastatic.

Ms. Erickson noted that the vulva is the most common site for gynecologic tract melanomas, accounting for 70% of them. And while the female genitalia make up only 1%-2% of body surface area, that’s the anatomic site of up to 7% of all melanomas in women.

She reported having no financial conflicts regarding her study.

[email protected]

COVID-19 patients with an underlying condition are 6 times as likely to be hospitalized and 12 times as likely to die, compared with those who have no such condition, according to the Centers for Disease Control and Prevention.

Among those with underlying conditions such as cardiovascular disease or diabetes, 45.4% of patients with COVID-19 were hospitalized, versus 7.6% of patients without an underlying condition, said Erin K. Stokes, MPH, and associates of the CDC COVID-19 Emergency Response team.

The difference in deaths was even greater over the study period of Jan. 22–May 30, 2020: 19.5% of COVID-19 patients with underlying conditions died, compared with 1.6% of those with no underlying condition. The gap narrowed, however, for ICU admissions, with corresponding rates of 8.5% and 1.5%, the investigators reported June 15 in the Morbidity and Mortality Weekly Report.

“The COVID-19 pandemic continues to be severe, particularly in certain population groups,” they said.

The cumulative incidence of laboratory-confirmed cases up to May 30, for instance, was nearly twice as high for those aged 80 years and over (902 per 100,000 population) than for those aged 70-79 years (464.2 per 100,000). Those aged 50-59 years had the second-highest incidence, 550.5 per 100,000, Ms. Stokes and associates said.

“Among cases with known race and ethnicity, 33% of persons were Hispanic, 22% were black, and 1.3% were [American Indian/Alaska Native]. These findings suggest that persons in these groups, who account for 18%, 13%, and 0.7% of the U.S. population, respectively, are disproportionately affected by the COVID-19 pandemic,” they wrote.

Another source of disparity: “Incidence among males and females was similar overall, [but] severe outcomes were more commonly reported among males,” the investigators noted. Cumulative incidence was 401.1 per 100,000 for males and 406.0 for females, but 6.0% of male patients died, compared with 4.8% of females.

As of May 30, a total of 1,761,503 cases and 103,700 deaths had been reported to the CDC. Of those cases, approximately 1.3 million were included in the analysis, with data on individual underlying health conditions available for 287,320 (22%). The split on those cases was 198,879 with health conditions and 88,411 without, the CDC data show.

The most frequently reported underlying conditions were cardiovascular disease (32%), diabetes (30%), chronic lung disease (18%), and renal disease (7.6%), and there were no significant differences between males and females, Ms. Stokes and associates said.

The pandemic “is an ongoing public health crisis in the United States that continues to affect all populations and result in severe outcomes including death,” they said, emphasizing “the continued need for community mitigation strategies, especially for vulnerable populations, to slow COVID-19 transmission.”

[email protected]

SOURCE: Stokes EK et al. MMWR. 2020 Jun 15;69(early release):1-7.

COVID-19 patients with an underlying condition are 6 times as likely to be hospitalized and 12 times as likely to die, compared with those who have no such condition, according to the Centers for Disease Control and Prevention.

Among those with underlying conditions such as cardiovascular disease or diabetes, 45.4% of patients with COVID-19 were hospitalized, versus 7.6% of patients without an underlying condition, said Erin K. Stokes, MPH, and associates of the CDC COVID-19 Emergency Response team.

The difference in deaths was even greater over the study period of Jan. 22–May 30, 2020: 19.5% of COVID-19 patients with underlying conditions died, compared with 1.6% of those with no underlying condition. The gap narrowed, however, for ICU admissions, with corresponding rates of 8.5% and 1.5%, the investigators reported June 15 in the Morbidity and Mortality Weekly Report.

“The COVID-19 pandemic continues to be severe, particularly in certain population groups,” they said.

The cumulative incidence of laboratory-confirmed cases up to May 30, for instance, was nearly twice as high for those aged 80 years and over (902 per 100,000 population) than for those aged 70-79 years (464.2 per 100,000). Those aged 50-59 years had the second-highest incidence, 550.5 per 100,000, Ms. Stokes and associates said.

“Among cases with known race and ethnicity, 33% of persons were Hispanic, 22% were black, and 1.3% were [American Indian/Alaska Native]. These findings suggest that persons in these groups, who account for 18%, 13%, and 0.7% of the U.S. population, respectively, are disproportionately affected by the COVID-19 pandemic,” they wrote.

Another source of disparity: “Incidence among males and females was similar overall, [but] severe outcomes were more commonly reported among males,” the investigators noted. Cumulative incidence was 401.1 per 100,000 for males and 406.0 for females, but 6.0% of male patients died, compared with 4.8% of females.

As of May 30, a total of 1,761,503 cases and 103,700 deaths had been reported to the CDC. Of those cases, approximately 1.3 million were included in the analysis, with data on individual underlying health conditions available for 287,320 (22%). The split on those cases was 198,879 with health conditions and 88,411 without, the CDC data show.

The most frequently reported underlying conditions were cardiovascular disease (32%), diabetes (30%), chronic lung disease (18%), and renal disease (7.6%), and there were no significant differences between males and females, Ms. Stokes and associates said.

The pandemic “is an ongoing public health crisis in the United States that continues to affect all populations and result in severe outcomes including death,” they said, emphasizing “the continued need for community mitigation strategies, especially for vulnerable populations, to slow COVID-19 transmission.”

[email protected]

SOURCE: Stokes EK et al. MMWR. 2020 Jun 15;69(early release):1-7.

COVID-19 patients with an underlying condition are 6 times as likely to be hospitalized and 12 times as likely to die, compared with those who have no such condition, according to the Centers for Disease Control and Prevention.

Among those with underlying conditions such as cardiovascular disease or diabetes, 45.4% of patients with COVID-19 were hospitalized, versus 7.6% of patients without an underlying condition, said Erin K. Stokes, MPH, and associates of the CDC COVID-19 Emergency Response team.

The difference in deaths was even greater over the study period of Jan. 22–May 30, 2020: 19.5% of COVID-19 patients with underlying conditions died, compared with 1.6% of those with no underlying condition. The gap narrowed, however, for ICU admissions, with corresponding rates of 8.5% and 1.5%, the investigators reported June 15 in the Morbidity and Mortality Weekly Report.

“The COVID-19 pandemic continues to be severe, particularly in certain population groups,” they said.

The cumulative incidence of laboratory-confirmed cases up to May 30, for instance, was nearly twice as high for those aged 80 years and over (902 per 100,000 population) than for those aged 70-79 years (464.2 per 100,000). Those aged 50-59 years had the second-highest incidence, 550.5 per 100,000, Ms. Stokes and associates said.

“Among cases with known race and ethnicity, 33% of persons were Hispanic, 22% were black, and 1.3% were [American Indian/Alaska Native]. These findings suggest that persons in these groups, who account for 18%, 13%, and 0.7% of the U.S. population, respectively, are disproportionately affected by the COVID-19 pandemic,” they wrote.

Another source of disparity: “Incidence among males and females was similar overall, [but] severe outcomes were more commonly reported among males,” the investigators noted. Cumulative incidence was 401.1 per 100,000 for males and 406.0 for females, but 6.0% of male patients died, compared with 4.8% of females.

As of May 30, a total of 1,761,503 cases and 103,700 deaths had been reported to the CDC. Of those cases, approximately 1.3 million were included in the analysis, with data on individual underlying health conditions available for 287,320 (22%). The split on those cases was 198,879 with health conditions and 88,411 without, the CDC data show.

The most frequently reported underlying conditions were cardiovascular disease (32%), diabetes (30%), chronic lung disease (18%), and renal disease (7.6%), and there were no significant differences between males and females, Ms. Stokes and associates said.

The pandemic “is an ongoing public health crisis in the United States that continues to affect all populations and result in severe outcomes including death,” they said, emphasizing “the continued need for community mitigation strategies, especially for vulnerable populations, to slow COVID-19 transmission.”

[email protected]

SOURCE: Stokes EK et al. MMWR. 2020 Jun 15;69(early release):1-7.

Patients who underwent conversion to a laparoscopic sleeve gastrectomy after a previous laparoscopic adjustable gastric banding procedure experienced similar weight loss with either a one- or two-step procedure, a study of 78 patients showed.

“Laparoscopic adjustable gastric banding (LAGB) has largely fallen out of favor, likely related to variable efficacy in weight reduction coupled with poor effectiveness in reducing obesity related comorbidities like type 2 diabetes and hypercholesterolemia,” Vasu Chirumamilla, MD, of Westchester Medical Center, Valhalla, N.Y., and colleagues wrote in a poster presented at the virtual Annual Minimally Invasive Surgery Symposium sponsored by Global Academy for Medical Education.

LAGB also can cause complications including, slippage, erosion, and gastric pouch dilation; subsequently many patients undergo conversion to laparoscopic sleeve gastrectomy (LSG). However, the impact of a one-step vs. two-step conversion procedure on patient weight loss remains unclear, the researchers said.

To compare weight loss after the two types of procedures, the researchers reviewed data from 78 patients (71 women) aged 15-74 years treated between 2013 and 2018 at a multi-surgeon, private practice bariatric surgery center. All patients had a history of LAGB; 31 underwent conversion to LSG in one stage, and 47 underwent conversion in two stages. Weight loss, defined as the percentage excess weight loss, was the primary endpoint.

The average excess weight loss was 44% for patients in both the one-stage and two-stage groups, and body mass index decreased by 8.9 points and 8.8 points, respectively, in the two groups, the researchers wrote.

Patients in the two-stage group experienced a significant increase in body mass index (P = .008) during the time between band removal to sleeve gastrectomy, which was an average of 207 days, they said.

The findings were limited in part by the small sample size and retrospective design, and more data are needed to compare complication rates in one-stage and two-stage procedures, the researchers noted. However, the results showed “no difference in excess weight loss in patients converted from laparoscopic adjustable gastric band to sleeve gastrectomy in one-stage versus a two-stage procedure,” they concluded.

“LAGB used to be a very popular weight loss procedure – bands were placed in a great deal of patients,” Dr. Chirumamilla said in an interview. “Now those patients are presenting with increasing frequency to bariatric surgeons with band complications or weight regain. The volume for LSG is increasing and results in percentage excess weight loss of approximately 65% versus approximately 42% for LAGB,” he said. A goal of the study was to provide patients and the surgeons with a more informed approach to performing and consenting to the particular operation, he added.

“The results have not surprised us, because as long as done by experienced surgeons on compliant patients the weight loss outcomes from the day of surgery onward should be equivalent,” Dr. Chirumamilla explained. “We were also not surprised to find that patients undergoing a two-stage conversion gained weight before their second-stage sleeve gastrectomy.”

The bottom line for clinicians is that “patients getting a conversion from band to sleeve in one-stage versus two-stages experience the same percentage excess body weight loss from time of surgery,” although two-stage patients do gain weight while awaiting their second-stage sleeve gastrectomy, Dr. Chirumamilla said.

“More research is needed to compare short- and long-term complications rates between one-stage and two-stage conversions. The ideal research situation would be a randomized, multicenter, large volume study to reduce bias,” he noted.

Dr. Chirumamilla’s collaborators included Akia Caine MD, Zachary Ballinger, Rebecca Castro, Thomas Cerabona MD, and Ashutosh Kaul MD, of the surgical group Advanced Surgeons at nygetfit.com.

Global Academy for Medical Education and this news organization are owned by the same parent company. The study received no outside funding. The researchers had no financial conflicts to disclose.
 

SOURCE: Chirumamilla V et al. MISS 2020. Poster PA-14.

Patients who underwent conversion to a laparoscopic sleeve gastrectomy after a previous laparoscopic adjustable gastric banding procedure experienced similar weight loss with either a one- or two-step procedure, a study of 78 patients showed.

“Laparoscopic adjustable gastric banding (LAGB) has largely fallen out of favor, likely related to variable efficacy in weight reduction coupled with poor effectiveness in reducing obesity related comorbidities like type 2 diabetes and hypercholesterolemia,” Vasu Chirumamilla, MD, of Westchester Medical Center, Valhalla, N.Y., and colleagues wrote in a poster presented at the virtual Annual Minimally Invasive Surgery Symposium sponsored by Global Academy for Medical Education.

LAGB also can cause complications including, slippage, erosion, and gastric pouch dilation; subsequently many patients undergo conversion to laparoscopic sleeve gastrectomy (LSG). However, the impact of a one-step vs. two-step conversion procedure on patient weight loss remains unclear, the researchers said.

To compare weight loss after the two types of procedures, the researchers reviewed data from 78 patients (71 women) aged 15-74 years treated between 2013 and 2018 at a multi-surgeon, private practice bariatric surgery center. All patients had a history of LAGB; 31 underwent conversion to LSG in one stage, and 47 underwent conversion in two stages. Weight loss, defined as the percentage excess weight loss, was the primary endpoint.

The average excess weight loss was 44% for patients in both the one-stage and two-stage groups, and body mass index decreased by 8.9 points and 8.8 points, respectively, in the two groups, the researchers wrote.

Patients in the two-stage group experienced a significant increase in body mass index (P = .008) during the time between band removal to sleeve gastrectomy, which was an average of 207 days, they said.

The findings were limited in part by the small sample size and retrospective design, and more data are needed to compare complication rates in one-stage and two-stage procedures, the researchers noted. However, the results showed “no difference in excess weight loss in patients converted from laparoscopic adjustable gastric band to sleeve gastrectomy in one-stage versus a two-stage procedure,” they concluded.

“LAGB used to be a very popular weight loss procedure – bands were placed in a great deal of patients,” Dr. Chirumamilla said in an interview. “Now those patients are presenting with increasing frequency to bariatric surgeons with band complications or weight regain. The volume for LSG is increasing and results in percentage excess weight loss of approximately 65% versus approximately 42% for LAGB,” he said. A goal of the study was to provide patients and the surgeons with a more informed approach to performing and consenting to the particular operation, he added.

“The results have not surprised us, because as long as done by experienced surgeons on compliant patients the weight loss outcomes from the day of surgery onward should be equivalent,” Dr. Chirumamilla explained. “We were also not surprised to find that patients undergoing a two-stage conversion gained weight before their second-stage sleeve gastrectomy.”

The bottom line for clinicians is that “patients getting a conversion from band to sleeve in one-stage versus two-stages experience the same percentage excess body weight loss from time of surgery,” although two-stage patients do gain weight while awaiting their second-stage sleeve gastrectomy, Dr. Chirumamilla said.

“More research is needed to compare short- and long-term complications rates between one-stage and two-stage conversions. The ideal research situation would be a randomized, multicenter, large volume study to reduce bias,” he noted.

Dr. Chirumamilla’s collaborators included Akia Caine MD, Zachary Ballinger, Rebecca Castro, Thomas Cerabona MD, and Ashutosh Kaul MD, of the surgical group Advanced Surgeons at nygetfit.com.

Global Academy for Medical Education and this news organization are owned by the same parent company. The study received no outside funding. The researchers had no financial conflicts to disclose.
 

SOURCE: Chirumamilla V et al. MISS 2020. Poster PA-14.

Patients who underwent conversion to a laparoscopic sleeve gastrectomy after a previous laparoscopic adjustable gastric banding procedure experienced similar weight loss with either a one- or two-step procedure, a study of 78 patients showed.

“Laparoscopic adjustable gastric banding (LAGB) has largely fallen out of favor, likely related to variable efficacy in weight reduction coupled with poor effectiveness in reducing obesity related comorbidities like type 2 diabetes and hypercholesterolemia,” Vasu Chirumamilla, MD, of Westchester Medical Center, Valhalla, N.Y., and colleagues wrote in a poster presented at the virtual Annual Minimally Invasive Surgery Symposium sponsored by Global Academy for Medical Education.

LAGB also can cause complications including, slippage, erosion, and gastric pouch dilation; subsequently many patients undergo conversion to laparoscopic sleeve gastrectomy (LSG). However, the impact of a one-step vs. two-step conversion procedure on patient weight loss remains unclear, the researchers said.

To compare weight loss after the two types of procedures, the researchers reviewed data from 78 patients (71 women) aged 15-74 years treated between 2013 and 2018 at a multi-surgeon, private practice bariatric surgery center. All patients had a history of LAGB; 31 underwent conversion to LSG in one stage, and 47 underwent conversion in two stages. Weight loss, defined as the percentage excess weight loss, was the primary endpoint.

The average excess weight loss was 44% for patients in both the one-stage and two-stage groups, and body mass index decreased by 8.9 points and 8.8 points, respectively, in the two groups, the researchers wrote.

Patients in the two-stage group experienced a significant increase in body mass index (P = .008) during the time between band removal to sleeve gastrectomy, which was an average of 207 days, they said.

The findings were limited in part by the small sample size and retrospective design, and more data are needed to compare complication rates in one-stage and two-stage procedures, the researchers noted. However, the results showed “no difference in excess weight loss in patients converted from laparoscopic adjustable gastric band to sleeve gastrectomy in one-stage versus a two-stage procedure,” they concluded.

“LAGB used to be a very popular weight loss procedure – bands were placed in a great deal of patients,” Dr. Chirumamilla said in an interview. “Now those patients are presenting with increasing frequency to bariatric surgeons with band complications or weight regain. The volume for LSG is increasing and results in percentage excess weight loss of approximately 65% versus approximately 42% for LAGB,” he said. A goal of the study was to provide patients and the surgeons with a more informed approach to performing and consenting to the particular operation, he added.

“The results have not surprised us, because as long as done by experienced surgeons on compliant patients the weight loss outcomes from the day of surgery onward should be equivalent,” Dr. Chirumamilla explained. “We were also not surprised to find that patients undergoing a two-stage conversion gained weight before their second-stage sleeve gastrectomy.”

The bottom line for clinicians is that “patients getting a conversion from band to sleeve in one-stage versus two-stages experience the same percentage excess body weight loss from time of surgery,” although two-stage patients do gain weight while awaiting their second-stage sleeve gastrectomy, Dr. Chirumamilla said.

“More research is needed to compare short- and long-term complications rates between one-stage and two-stage conversions. The ideal research situation would be a randomized, multicenter, large volume study to reduce bias,” he noted.

Dr. Chirumamilla’s collaborators included Akia Caine MD, Zachary Ballinger, Rebecca Castro, Thomas Cerabona MD, and Ashutosh Kaul MD, of the surgical group Advanced Surgeons at nygetfit.com.

Global Academy for Medical Education and this news organization are owned by the same parent company. The study received no outside funding. The researchers had no financial conflicts to disclose.
 

SOURCE: Chirumamilla V et al. MISS 2020. Poster PA-14.

With new daily coronavirus cases rising in at least two dozen states, an explosion of new infections in Arizona is stretching some hospitals and alarming public health experts who link the surge in cases to the state’s lifting of a stay-at-home order a month ago.

Arizona has emerged as one of the country’s newest coronavirus hot spots, with the weekly average of daily cases more than doubling from 2 weeks ago. The total number of people hospitalized is climbing, too.

Over the past week, Arizona has seen an average of more than 1,300 new COVID-19 cases each day.

After the state’s largest hospital system warned about a shortage of ICU beds, Arizona Gov. Doug Ducey, a Republican, pushed back on claims that the health care system could soon be overwhelmed.

“The entire time we’ve been focused on a possible worst-case scenario with surge capacity for hospital beds, ICU beds and ventilators,” Ducey told reporters on Thursday. “Those are not needed or necessary right now.”

While he acknowledged a spike in positive cases, Ducey said a second stay-at-home order was “not under discussion.”

“We put the stay-at-home order there so we could prepare for what we are going through,” he said.

Some states have reopened more slowly with a set of specific benchmarks for different regions, but Arizona took a more aggressive approach.

The state began easing restrictions on businesses in early May and lifted its statewide lockdown order after May 15. Under Arizona’s reopening plan, businesses are advised to follow federal guidance on social distancing.

There is also no requirement for everyone to wear masks in public.

Public health experts agree: The timing of this spike reflects the state’s reopening.

“Perhaps, Arizona will be a warning sign to other areas,” said Katherine Ellingson, an epidemiologist at the University of Arizona. “We never had that consistent downward trend that would signal it’s time to reopen and we have everything in place to do it safely.”

Before Arizona lifted its stay-at-home order, only about 5% of COVID-19 tests registered as positive. On Monday, that number was around 16%.

A slower reopening gives public health agencies time to identify whether cases are rising and then respond with contact tracing and isolating those who are infected.

“With a fast, rapid reopening, we don’t have the time to mobilize those resources,” said Ellingson.

Maricopa County, home to about 60% of the state’s population, has ramped up contact tracing in recent weeks, but it may not have enough capacity if the surge in cases continues.

Dr. Peter Hotez said the spike in Arizona, as well as in parts of Texas such as Houston, Dallas and Austin, is the consequence of removing restrictions too quickly and without a public health system that can keep pace.

“It was just ‘open it up’ and then more or less business as usual, with a little bit of window dressing,” said Hotez, the dean for the National School of Tropical Medicine at Baylor College of Medicine in Houston. “This is not an abstract number of cases. We’re seeing people pile into intensive care units.”

Arizona’s governor has also faced criticism from the mayors of Arizona’s two biggest cities for not putting in place more stringent requirements.

“There is a pandemic and it’s spreading uncontrollably,” said Tucson Mayor Regina Romero, a Democrat. Ducey, she said, “is just putting up his hands and saying ‘the spread is happening and we just have to go about our business.’”

And the governor’s executive order forbids local governments from implementing their own extra measures, which adds to Romero’s frustration. Texas has a similar measure.

“What he did was pretty much tie the hands of mayors and public health officials,” Romero said.

Arizona’s hospital industry has tried to tamp down fears that it’s on the verge of a crisis. Hospitals are still performing elective surgeries.

“It’s very unfortunate because hospitals right now in Arizona are quite busy with elective procedures,” said Saskia Popescu, a Phoenix-based epidemiologist with George Mason University. “You throw in increasing cases of COVID, and that’s going to very much stress your hospital systems.”

Phoenix’s triple-digit summer temperatures actually may fuel the spread of the virus. People forgo outdoor activities and retreat to air-conditioned indoor spaces, where the risk of transmitting the virus goes up significantly.

“My concern is we’re going to see a lot more people in close quarters for prolonged periods of time,” Popescu said.

Since the stay-at-home order was lifted, Popescu and others say they’ve seen people returning to a pre-pandemic mindset, neglecting to wear masks or maintain social distance. Videos of crowded bars have only propelled these fears.

On Thursday, however, Arizona’s top doctor stressed there were also dangers to keeping the state on lockdown, including the mental health effects of loneliness and isolation.

“We know that it’s in the community. We are not going to be able to stop the spread. And so we can’t stop living as well,” said Dr. Cara Christ, health director for the Arizona Department of Health Services.

But Dr. Quinn Snyder, an emergency medicine physician in Mesa, Arizona, said there needs to be more consistent messaging on public health measures like wearing masks.

“Frankly, I just think a wholesale reevaluation of where we’re at is critical right now, but I can tell you that we’re not doing nearly enough,” said Snyder, who has seen the uptick in seriously ill COVID-19 patients firsthand.

“If we continue to head down this path, the virus will press our health care facilities beyond capacity, where we’re going to have to be making tough decisions like who gets a ventilator and who doesn’t.”

A version of this article originally appeared on Kaiser Health News, which is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

With new daily coronavirus cases rising in at least two dozen states, an explosion of new infections in Arizona is stretching some hospitals and alarming public health experts who link the surge in cases to the state’s lifting of a stay-at-home order a month ago.

Arizona has emerged as one of the country’s newest coronavirus hot spots, with the weekly average of daily cases more than doubling from 2 weeks ago. The total number of people hospitalized is climbing, too.

Over the past week, Arizona has seen an average of more than 1,300 new COVID-19 cases each day.

After the state’s largest hospital system warned about a shortage of ICU beds, Arizona Gov. Doug Ducey, a Republican, pushed back on claims that the health care system could soon be overwhelmed.

“The entire time we’ve been focused on a possible worst-case scenario with surge capacity for hospital beds, ICU beds and ventilators,” Ducey told reporters on Thursday. “Those are not needed or necessary right now.”

While he acknowledged a spike in positive cases, Ducey said a second stay-at-home order was “not under discussion.”

“We put the stay-at-home order there so we could prepare for what we are going through,” he said.

Some states have reopened more slowly with a set of specific benchmarks for different regions, but Arizona took a more aggressive approach.

The state began easing restrictions on businesses in early May and lifted its statewide lockdown order after May 15. Under Arizona’s reopening plan, businesses are advised to follow federal guidance on social distancing.

There is also no requirement for everyone to wear masks in public.

Public health experts agree: The timing of this spike reflects the state’s reopening.

“Perhaps, Arizona will be a warning sign to other areas,” said Katherine Ellingson, an epidemiologist at the University of Arizona. “We never had that consistent downward trend that would signal it’s time to reopen and we have everything in place to do it safely.”

Before Arizona lifted its stay-at-home order, only about 5% of COVID-19 tests registered as positive. On Monday, that number was around 16%.

A slower reopening gives public health agencies time to identify whether cases are rising and then respond with contact tracing and isolating those who are infected.

“With a fast, rapid reopening, we don’t have the time to mobilize those resources,” said Ellingson.

Maricopa County, home to about 60% of the state’s population, has ramped up contact tracing in recent weeks, but it may not have enough capacity if the surge in cases continues.

Dr. Peter Hotez said the spike in Arizona, as well as in parts of Texas such as Houston, Dallas and Austin, is the consequence of removing restrictions too quickly and without a public health system that can keep pace.

“It was just ‘open it up’ and then more or less business as usual, with a little bit of window dressing,” said Hotez, the dean for the National School of Tropical Medicine at Baylor College of Medicine in Houston. “This is not an abstract number of cases. We’re seeing people pile into intensive care units.”

Arizona’s governor has also faced criticism from the mayors of Arizona’s two biggest cities for not putting in place more stringent requirements.

“There is a pandemic and it’s spreading uncontrollably,” said Tucson Mayor Regina Romero, a Democrat. Ducey, she said, “is just putting up his hands and saying ‘the spread is happening and we just have to go about our business.’”

And the governor’s executive order forbids local governments from implementing their own extra measures, which adds to Romero’s frustration. Texas has a similar measure.

“What he did was pretty much tie the hands of mayors and public health officials,” Romero said.

Arizona’s hospital industry has tried to tamp down fears that it’s on the verge of a crisis. Hospitals are still performing elective surgeries.

“It’s very unfortunate because hospitals right now in Arizona are quite busy with elective procedures,” said Saskia Popescu, a Phoenix-based epidemiologist with George Mason University. “You throw in increasing cases of COVID, and that’s going to very much stress your hospital systems.”

Phoenix’s triple-digit summer temperatures actually may fuel the spread of the virus. People forgo outdoor activities and retreat to air-conditioned indoor spaces, where the risk of transmitting the virus goes up significantly.

“My concern is we’re going to see a lot more people in close quarters for prolonged periods of time,” Popescu said.

Since the stay-at-home order was lifted, Popescu and others say they’ve seen people returning to a pre-pandemic mindset, neglecting to wear masks or maintain social distance. Videos of crowded bars have only propelled these fears.

On Thursday, however, Arizona’s top doctor stressed there were also dangers to keeping the state on lockdown, including the mental health effects of loneliness and isolation.

“We know that it’s in the community. We are not going to be able to stop the spread. And so we can’t stop living as well,” said Dr. Cara Christ, health director for the Arizona Department of Health Services.

But Dr. Quinn Snyder, an emergency medicine physician in Mesa, Arizona, said there needs to be more consistent messaging on public health measures like wearing masks.

“Frankly, I just think a wholesale reevaluation of where we’re at is critical right now, but I can tell you that we’re not doing nearly enough,” said Snyder, who has seen the uptick in seriously ill COVID-19 patients firsthand.

“If we continue to head down this path, the virus will press our health care facilities beyond capacity, where we’re going to have to be making tough decisions like who gets a ventilator and who doesn’t.”

A version of this article originally appeared on Kaiser Health News, which is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

With new daily coronavirus cases rising in at least two dozen states, an explosion of new infections in Arizona is stretching some hospitals and alarming public health experts who link the surge in cases to the state’s lifting of a stay-at-home order a month ago.

Arizona has emerged as one of the country’s newest coronavirus hot spots, with the weekly average of daily cases more than doubling from 2 weeks ago. The total number of people hospitalized is climbing, too.

Over the past week, Arizona has seen an average of more than 1,300 new COVID-19 cases each day.

After the state’s largest hospital system warned about a shortage of ICU beds, Arizona Gov. Doug Ducey, a Republican, pushed back on claims that the health care system could soon be overwhelmed.

“The entire time we’ve been focused on a possible worst-case scenario with surge capacity for hospital beds, ICU beds and ventilators,” Ducey told reporters on Thursday. “Those are not needed or necessary right now.”

While he acknowledged a spike in positive cases, Ducey said a second stay-at-home order was “not under discussion.”

“We put the stay-at-home order there so we could prepare for what we are going through,” he said.

Some states have reopened more slowly with a set of specific benchmarks for different regions, but Arizona took a more aggressive approach.

The state began easing restrictions on businesses in early May and lifted its statewide lockdown order after May 15. Under Arizona’s reopening plan, businesses are advised to follow federal guidance on social distancing.

There is also no requirement for everyone to wear masks in public.

Public health experts agree: The timing of this spike reflects the state’s reopening.

“Perhaps, Arizona will be a warning sign to other areas,” said Katherine Ellingson, an epidemiologist at the University of Arizona. “We never had that consistent downward trend that would signal it’s time to reopen and we have everything in place to do it safely.”

Before Arizona lifted its stay-at-home order, only about 5% of COVID-19 tests registered as positive. On Monday, that number was around 16%.

A slower reopening gives public health agencies time to identify whether cases are rising and then respond with contact tracing and isolating those who are infected.

“With a fast, rapid reopening, we don’t have the time to mobilize those resources,” said Ellingson.

Maricopa County, home to about 60% of the state’s population, has ramped up contact tracing in recent weeks, but it may not have enough capacity if the surge in cases continues.

Dr. Peter Hotez said the spike in Arizona, as well as in parts of Texas such as Houston, Dallas and Austin, is the consequence of removing restrictions too quickly and without a public health system that can keep pace.

“It was just ‘open it up’ and then more or less business as usual, with a little bit of window dressing,” said Hotez, the dean for the National School of Tropical Medicine at Baylor College of Medicine in Houston. “This is not an abstract number of cases. We’re seeing people pile into intensive care units.”

Arizona’s governor has also faced criticism from the mayors of Arizona’s two biggest cities for not putting in place more stringent requirements.

“There is a pandemic and it’s spreading uncontrollably,” said Tucson Mayor Regina Romero, a Democrat. Ducey, she said, “is just putting up his hands and saying ‘the spread is happening and we just have to go about our business.’”

And the governor’s executive order forbids local governments from implementing their own extra measures, which adds to Romero’s frustration. Texas has a similar measure.

“What he did was pretty much tie the hands of mayors and public health officials,” Romero said.

Arizona’s hospital industry has tried to tamp down fears that it’s on the verge of a crisis. Hospitals are still performing elective surgeries.

“It’s very unfortunate because hospitals right now in Arizona are quite busy with elective procedures,” said Saskia Popescu, a Phoenix-based epidemiologist with George Mason University. “You throw in increasing cases of COVID, and that’s going to very much stress your hospital systems.”

Phoenix’s triple-digit summer temperatures actually may fuel the spread of the virus. People forgo outdoor activities and retreat to air-conditioned indoor spaces, where the risk of transmitting the virus goes up significantly.

“My concern is we’re going to see a lot more people in close quarters for prolonged periods of time,” Popescu said.

Since the stay-at-home order was lifted, Popescu and others say they’ve seen people returning to a pre-pandemic mindset, neglecting to wear masks or maintain social distance. Videos of crowded bars have only propelled these fears.

On Thursday, however, Arizona’s top doctor stressed there were also dangers to keeping the state on lockdown, including the mental health effects of loneliness and isolation.

“We know that it’s in the community. We are not going to be able to stop the spread. And so we can’t stop living as well,” said Dr. Cara Christ, health director for the Arizona Department of Health Services.

But Dr. Quinn Snyder, an emergency medicine physician in Mesa, Arizona, said there needs to be more consistent messaging on public health measures like wearing masks.

“Frankly, I just think a wholesale reevaluation of where we’re at is critical right now, but I can tell you that we’re not doing nearly enough,” said Snyder, who has seen the uptick in seriously ill COVID-19 patients firsthand.

“If we continue to head down this path, the virus will press our health care facilities beyond capacity, where we’re going to have to be making tough decisions like who gets a ventilator and who doesn’t.”

A version of this article originally appeared on Kaiser Health News, which is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.