Federal Practitioner

As the coronavirus pandemic persists, insurers and the federal government are making it easier for mental health professionals to deliver safe and effective psychiatric services to patients via Zoom, FaceTime, and other conferencing tools. Many psychiatrists, meanwhile, are embracing telepsychiatry for the first time – in some cases with urgency.

Jay H. Shore, MD, MPH, said in an interview that mental health providers at his medical center have gone entirely virtual in recent weeks.

“The genie is out of the bottle on this,” said Dr. Shore, director of telemedicine at the Helen and Arthur E. Johnson Depression Center and director of telemedicine programming for the department of psychiatry at the University of Colorado at Denver, Aurora. He thinks this is the beginning of a new era that will last beyond the pandemic. “There’s going to be a much wider and diffuse acceptance of telemedicine as we go forward,” he added.

Dr. Shore and several colleagues from across the country offered several tips about factors to consider while learning to use telepsychiatry as a treatment tool.

To start, Dr. Shore advised reviewing the American Psychiatric Association’s Telepsychiatry Practice Guidelines and its Telepsychiatry Toolkit, which include dozens of brief videos about topics such as room lighting and managing the content process.

Another resource is the joint APA–American Academy of Child and Adolescent Psychiatry Telepsychiatry Toolkit, said Shabana Khan, MD, an assistant professor and director of telemedicine for the department of child and adolescent psychiatry at New York University Langone Health.

One of the challenges is managing emergencies long distance. If a patient experiences a mental health emergency in a psychiatrist’s office, the clinician can call 911 or direct staff to seek help. “When they’re at their house,” said Dr. Shore, “it’s a little different.”

Staff members are not present at home offices, for example, and the patient might live in a different city and therefore have a different 911 system. “It’s important to know your protocol about how you plan to handle these emergencies before you start working with the patient,” Dr. Shore said.

“Initially, I assumed that those with psychotic symptoms might struggle more. But I have been surprised at how well some patients have done,” said Andrew J. McLean, MD, MPH, clinical professor and chair of the department of psychiatry and behavioral science at the University of North Dakota, Grand Forks.

However, it might help to provide additional coaching to those patients, said Dr. Bristow. He offers a warning to these patients: “If you feel like you’re getting messages over the TV, my talking to you may make you feel worse.” However, “in every case, the patient was able to say, ‘I know you’re real.’ One patient even said: ‘I’ve heard these voices from my TV for years. But I know you’re a doctor, and you’re in an office trying to help me.’ ”

Dr. Shore thinks that video meetings have the potential to help psychiatrists and patients form better personal connections than in-person meetings. Patients with anxiety or PTSD, for example, “may feel safer since they’re in their own space, and they have a greater sense of control over the session than being in somebody’s office,” he said.

Dr. Khan agreed. “Some children, such as those with a significant trauma history or with significant anxiety, may feel more comfortable with this modality and may open up more during video sessions,” she said. In addition, “the distance that telepsychiatry provides may also enhance feelings of confidentiality and reduce potential stigma that may be associated with seeking mental health care.”

When it comes to using videoconferencing to treat children, take advantage of interactive features that are available, said Katherine Nguyen Williams, PhD. Zoom’s HIPAA-compliant health care software, for example, offers a “share screen” capability. “It allows for easy interactive activities,” said Dr. Nguyen Williams, director of strategic development and clinical innovation at Rady Children’s Hospital’s department of psychiatry at the University of California, San Diego. “Clinicians can play tic-tac-toe on the screen with the young patients, and they can work on cognitive-behavioral therapy worksheets together on the digital screen. Clinicians can even show a mindfulness video to the patient while actively coaching and giving feedback to the patient as they practice diaphragmatic breathing while viewing the video.

For more details about using telepsychiatry in the time of COVID-19, listen to the April 8 Psychcast Masterclass lecture by Dr. Shore.

As the coronavirus pandemic persists, insurers and the federal government are making it easier for mental health professionals to deliver safe and effective psychiatric services to patients via Zoom, FaceTime, and other conferencing tools. Many psychiatrists, meanwhile, are embracing telepsychiatry for the first time – in some cases with urgency.

Jay H. Shore, MD, MPH, said in an interview that mental health providers at his medical center have gone entirely virtual in recent weeks.

“The genie is out of the bottle on this,” said Dr. Shore, director of telemedicine at the Helen and Arthur E. Johnson Depression Center and director of telemedicine programming for the department of psychiatry at the University of Colorado at Denver, Aurora. He thinks this is the beginning of a new era that will last beyond the pandemic. “There’s going to be a much wider and diffuse acceptance of telemedicine as we go forward,” he added.

Dr. Shore and several colleagues from across the country offered several tips about factors to consider while learning to use telepsychiatry as a treatment tool.

To start, Dr. Shore advised reviewing the American Psychiatric Association’s Telepsychiatry Practice Guidelines and its Telepsychiatry Toolkit, which include dozens of brief videos about topics such as room lighting and managing the content process.

Another resource is the joint APA–American Academy of Child and Adolescent Psychiatry Telepsychiatry Toolkit, said Shabana Khan, MD, an assistant professor and director of telemedicine for the department of child and adolescent psychiatry at New York University Langone Health.

One of the challenges is managing emergencies long distance. If a patient experiences a mental health emergency in a psychiatrist’s office, the clinician can call 911 or direct staff to seek help. “When they’re at their house,” said Dr. Shore, “it’s a little different.”

Staff members are not present at home offices, for example, and the patient might live in a different city and therefore have a different 911 system. “It’s important to know your protocol about how you plan to handle these emergencies before you start working with the patient,” Dr. Shore said.

“Initially, I assumed that those with psychotic symptoms might struggle more. But I have been surprised at how well some patients have done,” said Andrew J. McLean, MD, MPH, clinical professor and chair of the department of psychiatry and behavioral science at the University of North Dakota, Grand Forks.

However, it might help to provide additional coaching to those patients, said Dr. Bristow. He offers a warning to these patients: “If you feel like you’re getting messages over the TV, my talking to you may make you feel worse.” However, “in every case, the patient was able to say, ‘I know you’re real.’ One patient even said: ‘I’ve heard these voices from my TV for years. But I know you’re a doctor, and you’re in an office trying to help me.’ ”

Dr. Shore thinks that video meetings have the potential to help psychiatrists and patients form better personal connections than in-person meetings. Patients with anxiety or PTSD, for example, “may feel safer since they’re in their own space, and they have a greater sense of control over the session than being in somebody’s office,” he said.

Dr. Khan agreed. “Some children, such as those with a significant trauma history or with significant anxiety, may feel more comfortable with this modality and may open up more during video sessions,” she said. In addition, “the distance that telepsychiatry provides may also enhance feelings of confidentiality and reduce potential stigma that may be associated with seeking mental health care.”

When it comes to using videoconferencing to treat children, take advantage of interactive features that are available, said Katherine Nguyen Williams, PhD. Zoom’s HIPAA-compliant health care software, for example, offers a “share screen” capability. “It allows for easy interactive activities,” said Dr. Nguyen Williams, director of strategic development and clinical innovation at Rady Children’s Hospital’s department of psychiatry at the University of California, San Diego. “Clinicians can play tic-tac-toe on the screen with the young patients, and they can work on cognitive-behavioral therapy worksheets together on the digital screen. Clinicians can even show a mindfulness video to the patient while actively coaching and giving feedback to the patient as they practice diaphragmatic breathing while viewing the video.

For more details about using telepsychiatry in the time of COVID-19, listen to the April 8 Psychcast Masterclass lecture by Dr. Shore.

As the coronavirus pandemic persists, insurers and the federal government are making it easier for mental health professionals to deliver safe and effective psychiatric services to patients via Zoom, FaceTime, and other conferencing tools. Many psychiatrists, meanwhile, are embracing telepsychiatry for the first time – in some cases with urgency.

Jay H. Shore, MD, MPH, said in an interview that mental health providers at his medical center have gone entirely virtual in recent weeks.

“The genie is out of the bottle on this,” said Dr. Shore, director of telemedicine at the Helen and Arthur E. Johnson Depression Center and director of telemedicine programming for the department of psychiatry at the University of Colorado at Denver, Aurora. He thinks this is the beginning of a new era that will last beyond the pandemic. “There’s going to be a much wider and diffuse acceptance of telemedicine as we go forward,” he added.

Dr. Shore and several colleagues from across the country offered several tips about factors to consider while learning to use telepsychiatry as a treatment tool.

To start, Dr. Shore advised reviewing the American Psychiatric Association’s Telepsychiatry Practice Guidelines and its Telepsychiatry Toolkit, which include dozens of brief videos about topics such as room lighting and managing the content process.

Another resource is the joint APA–American Academy of Child and Adolescent Psychiatry Telepsychiatry Toolkit, said Shabana Khan, MD, an assistant professor and director of telemedicine for the department of child and adolescent psychiatry at New York University Langone Health.

One of the challenges is managing emergencies long distance. If a patient experiences a mental health emergency in a psychiatrist’s office, the clinician can call 911 or direct staff to seek help. “When they’re at their house,” said Dr. Shore, “it’s a little different.”

Staff members are not present at home offices, for example, and the patient might live in a different city and therefore have a different 911 system. “It’s important to know your protocol about how you plan to handle these emergencies before you start working with the patient,” Dr. Shore said.

“Initially, I assumed that those with psychotic symptoms might struggle more. But I have been surprised at how well some patients have done,” said Andrew J. McLean, MD, MPH, clinical professor and chair of the department of psychiatry and behavioral science at the University of North Dakota, Grand Forks.

However, it might help to provide additional coaching to those patients, said Dr. Bristow. He offers a warning to these patients: “If you feel like you’re getting messages over the TV, my talking to you may make you feel worse.” However, “in every case, the patient was able to say, ‘I know you’re real.’ One patient even said: ‘I’ve heard these voices from my TV for years. But I know you’re a doctor, and you’re in an office trying to help me.’ ”

Dr. Shore thinks that video meetings have the potential to help psychiatrists and patients form better personal connections than in-person meetings. Patients with anxiety or PTSD, for example, “may feel safer since they’re in their own space, and they have a greater sense of control over the session than being in somebody’s office,” he said.

Dr. Khan agreed. “Some children, such as those with a significant trauma history or with significant anxiety, may feel more comfortable with this modality and may open up more during video sessions,” she said. In addition, “the distance that telepsychiatry provides may also enhance feelings of confidentiality and reduce potential stigma that may be associated with seeking mental health care.”

When it comes to using videoconferencing to treat children, take advantage of interactive features that are available, said Katherine Nguyen Williams, PhD. Zoom’s HIPAA-compliant health care software, for example, offers a “share screen” capability. “It allows for easy interactive activities,” said Dr. Nguyen Williams, director of strategic development and clinical innovation at Rady Children’s Hospital’s department of psychiatry at the University of California, San Diego. “Clinicians can play tic-tac-toe on the screen with the young patients, and they can work on cognitive-behavioral therapy worksheets together on the digital screen. Clinicians can even show a mindfulness video to the patient while actively coaching and giving feedback to the patient as they practice diaphragmatic breathing while viewing the video.

For more details about using telepsychiatry in the time of COVID-19, listen to the April 8 Psychcast Masterclass lecture by Dr. Shore.

The nation’s leading cardiology associations urged caution with hydroxychloroquine and azithromycin for COVID-19 in patients with cardiovascular disease.

Thinkstock

“Hydroxychloroquine and azithromycin have been touted for potential prophylaxis or treatment for COVID-19; both drugs are listed as definite causes of torsade de pointes” and increase in the risk of other arrhythmias and sudden death, the American Heart Association, the American College of Cardiology, and the Heart Rhythm Society said in a joint statement April 8 in Circulation.

The statement came amid ongoing promotion by the Trump administration of hydroxychloroquine, in particular, for COVID-19 despite lack of strong data.

In addition to underlying cardiovascular disease, “seriously ill patients often have comorbidities that can increase risk of serious arrhythmias,” including hypokalemia, hypomagnesemia, fever, and systemic inflammation, the groups said.

They recommended withholding the drugs in patients with baseline QT prolongation (e.g., QTc of at least 500 msec) or with known congenital long QT syndrome; monitoring cardiac rhythm and QT interval and withdrawing hydroxychloroquine and azithromycin if QTc exceeds 500 msec; correcting hypokalemia to levels greater than 4 mEq/L and hypomagnesemia to more than 2 mg/dL; and avoiding other QTc-prolonging agents when possible.

The groups noted that, “in patients critically ill with COVID-19 infection, frequent caregiver contact may need to be minimized, so optimal electrocardiographic interval and rhythm monitoring may not be possible.” There is also a possible compounding arrhythmic effect when hydroxychloroquine and azithromycin are used together, but that has not been studied.

There’s a known risk of torsade de pointes with chloroquine and a possible risk with the antiviral HIV combination drug lopinavir-ritonavir, two other candidates for COVID-19 treatment. Hydroxychloroquine and chloroquine, both antimalarials, might help prevent or treat infection by interfering with angiotensin-converting enzyme 2 receptors, which the COVID-19 virus uses for cell entry, the groups said.

“The urgency of COVID-19 must not diminish the scientific rigor with which we approach COVID-19 treatment. While these medications may work against COVID-19 individually or in combination, we recommend caution with these medications for patients with existing cardiovascular disease,” Robert A. Harrington, MD, AHA president and chair of the department of medicine at Stanford (Calif.) University, emphasized in a press release.

[email protected]

SOURCE: Roden DM et al. Circulation. 2020 Apr 8. doi:10.1161/CIRCULATIONAHA.120.047521.

The nation’s leading cardiology associations urged caution with hydroxychloroquine and azithromycin for COVID-19 in patients with cardiovascular disease.

Thinkstock

“Hydroxychloroquine and azithromycin have been touted for potential prophylaxis or treatment for COVID-19; both drugs are listed as definite causes of torsade de pointes” and increase in the risk of other arrhythmias and sudden death, the American Heart Association, the American College of Cardiology, and the Heart Rhythm Society said in a joint statement April 8 in Circulation.

The statement came amid ongoing promotion by the Trump administration of hydroxychloroquine, in particular, for COVID-19 despite lack of strong data.

In addition to underlying cardiovascular disease, “seriously ill patients often have comorbidities that can increase risk of serious arrhythmias,” including hypokalemia, hypomagnesemia, fever, and systemic inflammation, the groups said.

They recommended withholding the drugs in patients with baseline QT prolongation (e.g., QTc of at least 500 msec) or with known congenital long QT syndrome; monitoring cardiac rhythm and QT interval and withdrawing hydroxychloroquine and azithromycin if QTc exceeds 500 msec; correcting hypokalemia to levels greater than 4 mEq/L and hypomagnesemia to more than 2 mg/dL; and avoiding other QTc-prolonging agents when possible.

The groups noted that, “in patients critically ill with COVID-19 infection, frequent caregiver contact may need to be minimized, so optimal electrocardiographic interval and rhythm monitoring may not be possible.” There is also a possible compounding arrhythmic effect when hydroxychloroquine and azithromycin are used together, but that has not been studied.

There’s a known risk of torsade de pointes with chloroquine and a possible risk with the antiviral HIV combination drug lopinavir-ritonavir, two other candidates for COVID-19 treatment. Hydroxychloroquine and chloroquine, both antimalarials, might help prevent or treat infection by interfering with angiotensin-converting enzyme 2 receptors, which the COVID-19 virus uses for cell entry, the groups said.

“The urgency of COVID-19 must not diminish the scientific rigor with which we approach COVID-19 treatment. While these medications may work against COVID-19 individually or in combination, we recommend caution with these medications for patients with existing cardiovascular disease,” Robert A. Harrington, MD, AHA president and chair of the department of medicine at Stanford (Calif.) University, emphasized in a press release.

[email protected]

SOURCE: Roden DM et al. Circulation. 2020 Apr 8. doi:10.1161/CIRCULATIONAHA.120.047521.

The nation’s leading cardiology associations urged caution with hydroxychloroquine and azithromycin for COVID-19 in patients with cardiovascular disease.

Thinkstock

“Hydroxychloroquine and azithromycin have been touted for potential prophylaxis or treatment for COVID-19; both drugs are listed as definite causes of torsade de pointes” and increase in the risk of other arrhythmias and sudden death, the American Heart Association, the American College of Cardiology, and the Heart Rhythm Society said in a joint statement April 8 in Circulation.

The statement came amid ongoing promotion by the Trump administration of hydroxychloroquine, in particular, for COVID-19 despite lack of strong data.

In addition to underlying cardiovascular disease, “seriously ill patients often have comorbidities that can increase risk of serious arrhythmias,” including hypokalemia, hypomagnesemia, fever, and systemic inflammation, the groups said.

They recommended withholding the drugs in patients with baseline QT prolongation (e.g., QTc of at least 500 msec) or with known congenital long QT syndrome; monitoring cardiac rhythm and QT interval and withdrawing hydroxychloroquine and azithromycin if QTc exceeds 500 msec; correcting hypokalemia to levels greater than 4 mEq/L and hypomagnesemia to more than 2 mg/dL; and avoiding other QTc-prolonging agents when possible.

The groups noted that, “in patients critically ill with COVID-19 infection, frequent caregiver contact may need to be minimized, so optimal electrocardiographic interval and rhythm monitoring may not be possible.” There is also a possible compounding arrhythmic effect when hydroxychloroquine and azithromycin are used together, but that has not been studied.

There’s a known risk of torsade de pointes with chloroquine and a possible risk with the antiviral HIV combination drug lopinavir-ritonavir, two other candidates for COVID-19 treatment. Hydroxychloroquine and chloroquine, both antimalarials, might help prevent or treat infection by interfering with angiotensin-converting enzyme 2 receptors, which the COVID-19 virus uses for cell entry, the groups said.

“The urgency of COVID-19 must not diminish the scientific rigor with which we approach COVID-19 treatment. While these medications may work against COVID-19 individually or in combination, we recommend caution with these medications for patients with existing cardiovascular disease,” Robert A. Harrington, MD, AHA president and chair of the department of medicine at Stanford (Calif.) University, emphasized in a press release.

[email protected]

SOURCE: Roden DM et al. Circulation. 2020 Apr 8. doi:10.1161/CIRCULATIONAHA.120.047521.

In the wake of the coronavirus pandemic, the rules and regulations governing telepsychiatry services have changed dramatically, the most radical of which is the introduction of a new waiver by the Centers for Medicare & Medicaid Services.

Under the 1135 emergency waiver, Medicare has expanded telehealth services to include patients across the country – not just in rural areas or under other limited conditions, as was previously the case. In addition, there’s now a waiver to the Ryan Haight Act that allows the prescribing of controlled substances via telemedicine.

Peter Yellowlees, MD, from University of California, Davis, reported that outpatient service at his center was converted to an almost 100% telepsychiatry service from mid- to late March.

He and John Torous, MD, director of digital psychiatry at Beth Israel Deaconess Medical Center, Boston, led a free webinar late last month sponsored by the Substance Abuse and Mental Health Services Administration (SAMHSA).

During the hour-long event, they answered questions and offered tips on changes in licensure, patient safety, new prescribing rules, and equipment needed.

“Clinicians need to be aware of these changes so they can ensure they are reaching as many people as possible and taking advantage of the reduced barriers to offering safe and effective video visits,” Dr. Torous said in an interview.
 

‘This is huge’

The new 1135 waiver “basically says CMS will pay for any patient on Medicare who is seen by video by any provider who is correctly licensed in any state in this country,” Dr. Yellowlees told webinar attendees.

“You don’t need to be licensed in the state where the patient is if the patient is on Medicare. This opens up a huge number of patients we can now see on video,” he said. “And you can bill at normal Medicare rates for whatever you normally get for your in-person patients.”

Although this temporary rule only applies to Medicare and not to private insurers, or to patients on Medicaid, “these are really big changes. This is huge,” Dr. Torous said.

Previously, the “originating site” rule stated that, for the most part, clinicians had to be licensed in the state where the patient was located and not where the physician was stationed.

Asked about college students receiving mental health care who were in school in the psychiatrist’s area but are now back home in a state where the clinician doesn’t have a license, Dr. Yellowlees said that scenario could be a bit “tricky.”

“Most of those patients probably aren’t on Medicare. Legally, you [usually] can’t see them on video if they have private insurance or Medicaid. So, hopefully you can give them a 3-month supply of medication and then recommend they see a local provider,” he said.

Still, all states have their own rules, Dr. Yellowlees said. He and Dr. Torous noted that the Federation of State Medical Boards has a “very up-to-date” listing of policies at FSMB.org, all of which are organized by state. In addition, the American Psychiatric Association provides a telepsychiatry toolkit on its website.

Ryan Haight Act and prescribing

Physicians are now permitted to prescribe medication to patients assessed via telemedicine.

For those with substance use disorders, the U.S. Drug Enforcement Administration has announced a new waiver for the Ryan Haight Online Pharmacy Consumer Protection Act.

The waiver states that “practitioners in all areas of the United States may issue prescriptions for all schedule II-V controlled substances” – as long as it’s for a legitimate medical purpose; real-time, two-way interactive communication with patients has been used; and the clinician “is acting in accordance with applicable Federal and State laws.”

“It’s now possible to prescribe all the normal psychiatric drugs but also benzodiazepines, stimulants, and potentially narcotics over telepsychiatry,” even at a first visit via video, Dr. Yellowlees said.

However, he noted at this point the waiver is current for only 60 days. “This isn’t a permanent condition. It could be extended or even shortened at any given time.”

In addition, SAMHSA has relaxed some of its own regulations regarding telehealth and opioid treatment programs. An FAQ section on the organization’s website provides guidance for providing methadone and buprenorphine treatment.

“Some of the previous regulations will probably be put back in place later on, but the new changes are helpful now,” Dr. Yellowlees said.

Simple equipment needed

Regarding equipment, Dr. Yellowlees noted that the most important component is just a laptop, tablet, or smartphone – for the clinician and for the patient.

“You don’t need fancy new technology with a separate camera or microphone,” he said. However, it might be worth investing in a little better system down the line, he added.

Simple platforms that can be used to meet virtually with patients include FaceTime, Google Hangouts, and Skype.

Although some of these (such as FaceTime) are not HIPAA compliant, “that’s okay for now” under the new rules, Dr. Yellowlees said. While the health system/commercial version of Skype is compliant, the normal consumer-downloaded version is not, he noted.

“I would still strongly suggest using HIPAA-compliant video-conferencing programs in the long run,” he added.

Either way, it’s important for various safety practices to be put into place. For example, clinicians should be careful because the consumer version of Skype can show names of patients who were previously spoken with.

A business associate agreement (BAA) is something that HIPAA-compliant video systems will offer and which should be signed. It’s an agreement that “you’ll be, essentially, looking through a tunnel at the persona at the other end, and the company cannot get inside the tunnel and watch you while you’re having your interview,” said Dr. Yellowlees.

“There are multiple videoconferencing systems around that you can use,” he added. “The three major ones are from Zoom, Vidyo, and VSee, but there are probably 40 or 50 more.”

“There are a lot out there, and we’re certainly not endorsing any one of them,” Dr. Torous added.

When evaluating potential programs, Dr. Yellowlees suggested looking at Yelp-style reviews or telemedicine review sites, or talk with colleagues.

“Basically, you want systems that offer high-definition video quality and the ability to ‘lock’ and ‘unlock’ the rooms. And you want it to have an app so mobile devices can use it,” he said.

Phone vs. video

Some patients, especially older ones, may be resistant to the idea of video chats, preferring to talk via telephone instead.

“If you can use video, it’s better to do that if you can, especially when setting up the systems are relatively simple,” Dr. Yellowlees said, adding that it might just be an issue of patients needing help to get started.

However, “for some people, this is a barrier that we have to respect,” Dr. Torous said.

Either way, clinicians should check the American Medical Association’s website for information about coding for both video and phone visits.

Asked whether a clinician needs written consent from patients for conducting telepsychiatry visits, Dr. Yellowlees said it’s important to check state-by-state rules. For example, California allows a verbal consent.

In many cases, “simply jot down a note that consent was given and how” and write down the address where the patient is located at time of visit, such as for their home, he said.

If a patient wants to conduct a telehealth session while in their car, Dr. Yellowlees suggested getting the address of the parking lot. For safety, clinicians also are advised asking for the cell phone number of the patient as well as that of a loved one.

Vital signs

When it comes to checking vital signs, Dr. Yellowlees suggested asking patients to purchase an inexpensive blood pressure (BP) monitor, thermometer, etc, prior to an appointment.

“Ask them to do a BP test on video and show you the readings. For the AIMS [Abnormal Involuntary Movement Scale] test, or to check for tardive dyskinesia, instruct patients to come close to the camera to show movement.”

In addition, most psychiatric rating scales are available online, which patients can fill out before a telehealth visit. The Serious Mental Illness (SMI) Adviser mobile app also includes several of these scales, Dr. Torous noted.

Overall, “there have been dramatic changes in the rules and regulations governing [telepsychiatry] that, for the next 60 days, make it easier to offer telehealth to patients,” Dr. Torous said.

Therefore, all psychiatrists need to “get on board,” as soon as possible, Dr. Yellowlees added.

The webinar was funded in part by a grant from SAMHSA.

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

In the wake of the coronavirus pandemic, the rules and regulations governing telepsychiatry services have changed dramatically, the most radical of which is the introduction of a new waiver by the Centers for Medicare & Medicaid Services.

Under the 1135 emergency waiver, Medicare has expanded telehealth services to include patients across the country – not just in rural areas or under other limited conditions, as was previously the case. In addition, there’s now a waiver to the Ryan Haight Act that allows the prescribing of controlled substances via telemedicine.

Peter Yellowlees, MD, from University of California, Davis, reported that outpatient service at his center was converted to an almost 100% telepsychiatry service from mid- to late March.

He and John Torous, MD, director of digital psychiatry at Beth Israel Deaconess Medical Center, Boston, led a free webinar late last month sponsored by the Substance Abuse and Mental Health Services Administration (SAMHSA).

During the hour-long event, they answered questions and offered tips on changes in licensure, patient safety, new prescribing rules, and equipment needed.

“Clinicians need to be aware of these changes so they can ensure they are reaching as many people as possible and taking advantage of the reduced barriers to offering safe and effective video visits,” Dr. Torous said in an interview.
 

‘This is huge’

The new 1135 waiver “basically says CMS will pay for any patient on Medicare who is seen by video by any provider who is correctly licensed in any state in this country,” Dr. Yellowlees told webinar attendees.

“You don’t need to be licensed in the state where the patient is if the patient is on Medicare. This opens up a huge number of patients we can now see on video,” he said. “And you can bill at normal Medicare rates for whatever you normally get for your in-person patients.”

Although this temporary rule only applies to Medicare and not to private insurers, or to patients on Medicaid, “these are really big changes. This is huge,” Dr. Torous said.

Previously, the “originating site” rule stated that, for the most part, clinicians had to be licensed in the state where the patient was located and not where the physician was stationed.

Asked about college students receiving mental health care who were in school in the psychiatrist’s area but are now back home in a state where the clinician doesn’t have a license, Dr. Yellowlees said that scenario could be a bit “tricky.”

“Most of those patients probably aren’t on Medicare. Legally, you [usually] can’t see them on video if they have private insurance or Medicaid. So, hopefully you can give them a 3-month supply of medication and then recommend they see a local provider,” he said.

Still, all states have their own rules, Dr. Yellowlees said. He and Dr. Torous noted that the Federation of State Medical Boards has a “very up-to-date” listing of policies at FSMB.org, all of which are organized by state. In addition, the American Psychiatric Association provides a telepsychiatry toolkit on its website.

Ryan Haight Act and prescribing

Physicians are now permitted to prescribe medication to patients assessed via telemedicine.

For those with substance use disorders, the U.S. Drug Enforcement Administration has announced a new waiver for the Ryan Haight Online Pharmacy Consumer Protection Act.

The waiver states that “practitioners in all areas of the United States may issue prescriptions for all schedule II-V controlled substances” – as long as it’s for a legitimate medical purpose; real-time, two-way interactive communication with patients has been used; and the clinician “is acting in accordance with applicable Federal and State laws.”

“It’s now possible to prescribe all the normal psychiatric drugs but also benzodiazepines, stimulants, and potentially narcotics over telepsychiatry,” even at a first visit via video, Dr. Yellowlees said.

However, he noted at this point the waiver is current for only 60 days. “This isn’t a permanent condition. It could be extended or even shortened at any given time.”

In addition, SAMHSA has relaxed some of its own regulations regarding telehealth and opioid treatment programs. An FAQ section on the organization’s website provides guidance for providing methadone and buprenorphine treatment.

“Some of the previous regulations will probably be put back in place later on, but the new changes are helpful now,” Dr. Yellowlees said.

Simple equipment needed

Regarding equipment, Dr. Yellowlees noted that the most important component is just a laptop, tablet, or smartphone – for the clinician and for the patient.

“You don’t need fancy new technology with a separate camera or microphone,” he said. However, it might be worth investing in a little better system down the line, he added.

Simple platforms that can be used to meet virtually with patients include FaceTime, Google Hangouts, and Skype.

Although some of these (such as FaceTime) are not HIPAA compliant, “that’s okay for now” under the new rules, Dr. Yellowlees said. While the health system/commercial version of Skype is compliant, the normal consumer-downloaded version is not, he noted.

“I would still strongly suggest using HIPAA-compliant video-conferencing programs in the long run,” he added.

Either way, it’s important for various safety practices to be put into place. For example, clinicians should be careful because the consumer version of Skype can show names of patients who were previously spoken with.

A business associate agreement (BAA) is something that HIPAA-compliant video systems will offer and which should be signed. It’s an agreement that “you’ll be, essentially, looking through a tunnel at the persona at the other end, and the company cannot get inside the tunnel and watch you while you’re having your interview,” said Dr. Yellowlees.

“There are multiple videoconferencing systems around that you can use,” he added. “The three major ones are from Zoom, Vidyo, and VSee, but there are probably 40 or 50 more.”

“There are a lot out there, and we’re certainly not endorsing any one of them,” Dr. Torous added.

When evaluating potential programs, Dr. Yellowlees suggested looking at Yelp-style reviews or telemedicine review sites, or talk with colleagues.

“Basically, you want systems that offer high-definition video quality and the ability to ‘lock’ and ‘unlock’ the rooms. And you want it to have an app so mobile devices can use it,” he said.

Phone vs. video

Some patients, especially older ones, may be resistant to the idea of video chats, preferring to talk via telephone instead.

“If you can use video, it’s better to do that if you can, especially when setting up the systems are relatively simple,” Dr. Yellowlees said, adding that it might just be an issue of patients needing help to get started.

However, “for some people, this is a barrier that we have to respect,” Dr. Torous said.

Either way, clinicians should check the American Medical Association’s website for information about coding for both video and phone visits.

Asked whether a clinician needs written consent from patients for conducting telepsychiatry visits, Dr. Yellowlees said it’s important to check state-by-state rules. For example, California allows a verbal consent.

In many cases, “simply jot down a note that consent was given and how” and write down the address where the patient is located at time of visit, such as for their home, he said.

If a patient wants to conduct a telehealth session while in their car, Dr. Yellowlees suggested getting the address of the parking lot. For safety, clinicians also are advised asking for the cell phone number of the patient as well as that of a loved one.

Vital signs

When it comes to checking vital signs, Dr. Yellowlees suggested asking patients to purchase an inexpensive blood pressure (BP) monitor, thermometer, etc, prior to an appointment.

“Ask them to do a BP test on video and show you the readings. For the AIMS [Abnormal Involuntary Movement Scale] test, or to check for tardive dyskinesia, instruct patients to come close to the camera to show movement.”

In addition, most psychiatric rating scales are available online, which patients can fill out before a telehealth visit. The Serious Mental Illness (SMI) Adviser mobile app also includes several of these scales, Dr. Torous noted.

Overall, “there have been dramatic changes in the rules and regulations governing [telepsychiatry] that, for the next 60 days, make it easier to offer telehealth to patients,” Dr. Torous said.

Therefore, all psychiatrists need to “get on board,” as soon as possible, Dr. Yellowlees added.

The webinar was funded in part by a grant from SAMHSA.

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

In the wake of the coronavirus pandemic, the rules and regulations governing telepsychiatry services have changed dramatically, the most radical of which is the introduction of a new waiver by the Centers for Medicare & Medicaid Services.

Under the 1135 emergency waiver, Medicare has expanded telehealth services to include patients across the country – not just in rural areas or under other limited conditions, as was previously the case. In addition, there’s now a waiver to the Ryan Haight Act that allows the prescribing of controlled substances via telemedicine.

Peter Yellowlees, MD, from University of California, Davis, reported that outpatient service at his center was converted to an almost 100% telepsychiatry service from mid- to late March.

He and John Torous, MD, director of digital psychiatry at Beth Israel Deaconess Medical Center, Boston, led a free webinar late last month sponsored by the Substance Abuse and Mental Health Services Administration (SAMHSA).

During the hour-long event, they answered questions and offered tips on changes in licensure, patient safety, new prescribing rules, and equipment needed.

“Clinicians need to be aware of these changes so they can ensure they are reaching as many people as possible and taking advantage of the reduced barriers to offering safe and effective video visits,” Dr. Torous said in an interview.
 

‘This is huge’

The new 1135 waiver “basically says CMS will pay for any patient on Medicare who is seen by video by any provider who is correctly licensed in any state in this country,” Dr. Yellowlees told webinar attendees.

“You don’t need to be licensed in the state where the patient is if the patient is on Medicare. This opens up a huge number of patients we can now see on video,” he said. “And you can bill at normal Medicare rates for whatever you normally get for your in-person patients.”

Although this temporary rule only applies to Medicare and not to private insurers, or to patients on Medicaid, “these are really big changes. This is huge,” Dr. Torous said.

Previously, the “originating site” rule stated that, for the most part, clinicians had to be licensed in the state where the patient was located and not where the physician was stationed.

Asked about college students receiving mental health care who were in school in the psychiatrist’s area but are now back home in a state where the clinician doesn’t have a license, Dr. Yellowlees said that scenario could be a bit “tricky.”

“Most of those patients probably aren’t on Medicare. Legally, you [usually] can’t see them on video if they have private insurance or Medicaid. So, hopefully you can give them a 3-month supply of medication and then recommend they see a local provider,” he said.

Still, all states have their own rules, Dr. Yellowlees said. He and Dr. Torous noted that the Federation of State Medical Boards has a “very up-to-date” listing of policies at FSMB.org, all of which are organized by state. In addition, the American Psychiatric Association provides a telepsychiatry toolkit on its website.

Ryan Haight Act and prescribing

Physicians are now permitted to prescribe medication to patients assessed via telemedicine.

For those with substance use disorders, the U.S. Drug Enforcement Administration has announced a new waiver for the Ryan Haight Online Pharmacy Consumer Protection Act.

The waiver states that “practitioners in all areas of the United States may issue prescriptions for all schedule II-V controlled substances” – as long as it’s for a legitimate medical purpose; real-time, two-way interactive communication with patients has been used; and the clinician “is acting in accordance with applicable Federal and State laws.”

“It’s now possible to prescribe all the normal psychiatric drugs but also benzodiazepines, stimulants, and potentially narcotics over telepsychiatry,” even at a first visit via video, Dr. Yellowlees said.

However, he noted at this point the waiver is current for only 60 days. “This isn’t a permanent condition. It could be extended or even shortened at any given time.”

In addition, SAMHSA has relaxed some of its own regulations regarding telehealth and opioid treatment programs. An FAQ section on the organization’s website provides guidance for providing methadone and buprenorphine treatment.

“Some of the previous regulations will probably be put back in place later on, but the new changes are helpful now,” Dr. Yellowlees said.

Simple equipment needed

Regarding equipment, Dr. Yellowlees noted that the most important component is just a laptop, tablet, or smartphone – for the clinician and for the patient.

“You don’t need fancy new technology with a separate camera or microphone,” he said. However, it might be worth investing in a little better system down the line, he added.

Simple platforms that can be used to meet virtually with patients include FaceTime, Google Hangouts, and Skype.

Although some of these (such as FaceTime) are not HIPAA compliant, “that’s okay for now” under the new rules, Dr. Yellowlees said. While the health system/commercial version of Skype is compliant, the normal consumer-downloaded version is not, he noted.

“I would still strongly suggest using HIPAA-compliant video-conferencing programs in the long run,” he added.

Either way, it’s important for various safety practices to be put into place. For example, clinicians should be careful because the consumer version of Skype can show names of patients who were previously spoken with.

A business associate agreement (BAA) is something that HIPAA-compliant video systems will offer and which should be signed. It’s an agreement that “you’ll be, essentially, looking through a tunnel at the persona at the other end, and the company cannot get inside the tunnel and watch you while you’re having your interview,” said Dr. Yellowlees.

“There are multiple videoconferencing systems around that you can use,” he added. “The three major ones are from Zoom, Vidyo, and VSee, but there are probably 40 or 50 more.”

“There are a lot out there, and we’re certainly not endorsing any one of them,” Dr. Torous added.

When evaluating potential programs, Dr. Yellowlees suggested looking at Yelp-style reviews or telemedicine review sites, or talk with colleagues.

“Basically, you want systems that offer high-definition video quality and the ability to ‘lock’ and ‘unlock’ the rooms. And you want it to have an app so mobile devices can use it,” he said.

Phone vs. video

Some patients, especially older ones, may be resistant to the idea of video chats, preferring to talk via telephone instead.

“If you can use video, it’s better to do that if you can, especially when setting up the systems are relatively simple,” Dr. Yellowlees said, adding that it might just be an issue of patients needing help to get started.

However, “for some people, this is a barrier that we have to respect,” Dr. Torous said.

Either way, clinicians should check the American Medical Association’s website for information about coding for both video and phone visits.

Asked whether a clinician needs written consent from patients for conducting telepsychiatry visits, Dr. Yellowlees said it’s important to check state-by-state rules. For example, California allows a verbal consent.

In many cases, “simply jot down a note that consent was given and how” and write down the address where the patient is located at time of visit, such as for their home, he said.

If a patient wants to conduct a telehealth session while in their car, Dr. Yellowlees suggested getting the address of the parking lot. For safety, clinicians also are advised asking for the cell phone number of the patient as well as that of a loved one.

Vital signs

When it comes to checking vital signs, Dr. Yellowlees suggested asking patients to purchase an inexpensive blood pressure (BP) monitor, thermometer, etc, prior to an appointment.

“Ask them to do a BP test on video and show you the readings. For the AIMS [Abnormal Involuntary Movement Scale] test, or to check for tardive dyskinesia, instruct patients to come close to the camera to show movement.”

In addition, most psychiatric rating scales are available online, which patients can fill out before a telehealth visit. The Serious Mental Illness (SMI) Adviser mobile app also includes several of these scales, Dr. Torous noted.

Overall, “there have been dramatic changes in the rules and regulations governing [telepsychiatry] that, for the next 60 days, make it easier to offer telehealth to patients,” Dr. Torous said.

Therefore, all psychiatrists need to “get on board,” as soon as possible, Dr. Yellowlees added.

The webinar was funded in part by a grant from SAMHSA.

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

In New York state, just over 86% of reported COVID-19 deaths involved at least one comorbidity, according to the state’s department of health.

As of midnight on April 6, there had been 5,489 fatalities caused by COVID-19 in the state, of which 86.2% (4,732) had at least one underlying condition, the New York State Department of Health reported April 7 on its COVID-19 tracker.

The leading comorbidity, seen in 55.4% of all deaths, was hypertension. In comparison, a recent estimate from the U.S. Department of Health & Human Services put the prevalence of high blood pressure at about 45% in the overall adult population.

In New York, the rest of the 10 most common comorbidities in COVID-19 fatalities were diabetes (37.3%), hyperlipidemia (18.5%), coronary artery disease (12.4%), renal disease (11.0%), dementia (9.1%), chronic obstructive pulmonary disease (8.3%), cancer (8.1%), atrial fibrillation (7.1%), and heart failure (7.1%), the NYSDOH said.

Other data on the tracker site show that 63% of all deaths involved a patient who was aged 70 years or older and that 61% of COVID-19 patients who have died in New York were male and 38.8% were female (sex unknown for 0.2%). Among all individuals who have tested positive, 54.8% were male and 44.6% were female (sex unknown for 0.6%).

As of the end of day on April 6, a total of 340,058 persons had been tested in the state and 40.8% (138,863) were positive for the SARS-CoV-2 virus. By county, the highest positive rates are in New York City: Queens at 57.4%, Brooklyn at 52.4%, and the Bronx at 52.3%, according to the NYSDOH.

[email protected]

In New York state, just over 86% of reported COVID-19 deaths involved at least one comorbidity, according to the state’s department of health.

As of midnight on April 6, there had been 5,489 fatalities caused by COVID-19 in the state, of which 86.2% (4,732) had at least one underlying condition, the New York State Department of Health reported April 7 on its COVID-19 tracker.

The leading comorbidity, seen in 55.4% of all deaths, was hypertension. In comparison, a recent estimate from the U.S. Department of Health & Human Services put the prevalence of high blood pressure at about 45% in the overall adult population.

In New York, the rest of the 10 most common comorbidities in COVID-19 fatalities were diabetes (37.3%), hyperlipidemia (18.5%), coronary artery disease (12.4%), renal disease (11.0%), dementia (9.1%), chronic obstructive pulmonary disease (8.3%), cancer (8.1%), atrial fibrillation (7.1%), and heart failure (7.1%), the NYSDOH said.

Other data on the tracker site show that 63% of all deaths involved a patient who was aged 70 years or older and that 61% of COVID-19 patients who have died in New York were male and 38.8% were female (sex unknown for 0.2%). Among all individuals who have tested positive, 54.8% were male and 44.6% were female (sex unknown for 0.6%).

As of the end of day on April 6, a total of 340,058 persons had been tested in the state and 40.8% (138,863) were positive for the SARS-CoV-2 virus. By county, the highest positive rates are in New York City: Queens at 57.4%, Brooklyn at 52.4%, and the Bronx at 52.3%, according to the NYSDOH.

[email protected]

In New York state, just over 86% of reported COVID-19 deaths involved at least one comorbidity, according to the state’s department of health.

As of midnight on April 6, there had been 5,489 fatalities caused by COVID-19 in the state, of which 86.2% (4,732) had at least one underlying condition, the New York State Department of Health reported April 7 on its COVID-19 tracker.

The leading comorbidity, seen in 55.4% of all deaths, was hypertension. In comparison, a recent estimate from the U.S. Department of Health & Human Services put the prevalence of high blood pressure at about 45% in the overall adult population.

In New York, the rest of the 10 most common comorbidities in COVID-19 fatalities were diabetes (37.3%), hyperlipidemia (18.5%), coronary artery disease (12.4%), renal disease (11.0%), dementia (9.1%), chronic obstructive pulmonary disease (8.3%), cancer (8.1%), atrial fibrillation (7.1%), and heart failure (7.1%), the NYSDOH said.

Other data on the tracker site show that 63% of all deaths involved a patient who was aged 70 years or older and that 61% of COVID-19 patients who have died in New York were male and 38.8% were female (sex unknown for 0.2%). Among all individuals who have tested positive, 54.8% were male and 44.6% were female (sex unknown for 0.6%).

As of the end of day on April 6, a total of 340,058 persons had been tested in the state and 40.8% (138,863) were positive for the SARS-CoV-2 virus. By county, the highest positive rates are in New York City: Queens at 57.4%, Brooklyn at 52.4%, and the Bronx at 52.3%, according to the NYSDOH.

[email protected]

Early results from the massive National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry indicate that the rollout of the Watchman device into routine clinical practice is going smoothly, with a higher implant success rate and a substantially lower in-hospital complication rate than that seen in the pivotal randomized clinical trials, James V. Freeman, MD, reported at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic.

American College of Cardiology

These real-world results are particularly impressive because the 38,158 registry participants were on average significantly older and sicker than were patients in the clinical trials. They were at higher risk of both stroke and bleeding, yet they fared better in terms of procedural safety, observed Dr. Freeman, an electrophysiologist and director of the Yale University Atrial Fibrillation Center in New Haven, Conn.

“You always worry that once you get outside of the clinical trials setting and you roll out to a large number of centers, including some that are relatively low volume, that you’re going to start to see higher rates of complications. And overall, broadly speaking, the rates of adverse events were quite reassuring,” he said.

The registry, maintained by the ACC, serves as the postmarketing surveillance tool mandated by the Food and Drug Administration and Centers for Medicare & Medicaid Services. The 38,158 participants make this registry the world’s largest patient experience with the Watchman device by many orders of magnitude. Dr. Freeman’s report included patients enrolled during 2016-2018 who were treated at 495 hospitals by 1,318 physician interventionalists. CMS reimbursement requires participation in the registry, which captures more than 95% of all Watchman procedures done in the United States. Although Dr. Freeman presented only the acute in-hospital outcomes, active follow-up for adverse events and medical therapy will be conducted at 45 days, 6 months, and 1 and 2 years.

Participants in the Left Atrial Appendage Occlusion (LAAO) Registry averaged 76.1 years of age, which is 2-4 years older than patients in the pivotal PROTECT-AF and PREVAIL trials or the 1,025-patient EWOLUTION registry. The LAAO Registry participants had a mean CHA2DS2-VASc score of 4.6, compared with 3.4 in PROTECT-AF and 3.8 in PREVAIL. Their mean HAS BLED score was 3.0. Thirty percent had a prior ischemic stroke or transient ischemic attack, 12% had a prior intracranial hemorrhage, and 69% had a history of clinically relevant bleeding. Thirty percent had heart failure, 92% were hypertensive, and 30% had diabetes.

“The take home here is that these patients were at moderate to high risk of stroke and they also carried a high risk of bleeding and therefore had some relative contraindication to anticoagulation,” according to the cardiologist. “The patient population overall is really in accordance with the CMS guidance. We’re not seeing a lot of patients who are getting this device for a lifestyle indication. Most of these patients are really stuck between a rock and a hard place.”

Most hospitals offering the Watchman did 10-40 cases per year. The median annual physician volume was 12 cases. However, there was substantial variation in both hospital and physician volumes.

The device was deployed in 93% of procedures attempted; roughly half of cancellations were cause by LAAO thrombus detected on the day of the procedure. The acute procedural success rate when the device was deployed was 98.3%, compared with 90.9% in PROTECT-AF and 95.1% in PREVAIL. The rate of device margin residual leak of 5 mm or more among registry participants with an acutely successful procedure was 0.2%.

The rate of any major in-hospital complication in the LAAO Registry was 2.16%, the most common of which was pericardial effusion requiring intervention, which occurred in 1.39% of cases. The major bleeding rate was 1.25%. The stroke/transient ischemic attack rate was 0.17%. Systemic arterial embolism was a rare event, occurring in less than 0.01% of patients, as was acute MI, with an incidence of 0.04%. Device embolization occurred in 0.07% of patients.

By comparison, the 7-day rate of pericardial effusion requiring intervention was 4.0% in PROTECT-AF and 1.9% in PREVAIL, with procedure-related stroke rates of 1.1% and 0.7%, respectively, and device embolization rates of 0.4% and 0.7%. The major bleeding rate in PROTECT-AF was 3.5%, nearly triple that in the real-world registry.

Discussant Mark A. Estes, MD, characterized the acute outcomes in the LAAO Registry as “an improvement – a considerable improvement – over some of the early data in PREVAIL and PROTECT-AF.” He credited this to the “very robust validation procedure” the Watchman closure device has undergone, which included the clinical trials, regulatory requirements for training and patient selection, and mandatory reporting of outcomes in the registry.

He noted that a lot is happening now with the Watchman device. There are a couple of dozen prospective clinical trials, including one on the Watchman versus direct oral anticoagulant (DOAC) therapy and another on left atrial ablation plus left atrial appendage closure versus a DOAC. A new-generation Watchman device, the Watchman FLX, is approved in Europe and undergoing an ongoing FDA-mandated approval trial in the United States.

“It has a lot of technical advantages,” according to Dr. Estes, an electrophysiologist and professor of medicine at the University of Pittsburgh.

Current guidelines give LAAO a class IIb rating, meaning it “could be considered” in patients with atrial fibrillation at increased risk of stroke who have a contraindication to long-term anticoagulation. Dr. Estes asked: Does the LAAO Registry data warrant a rating upgrade to a stronger recommendation?

Dr. Freeman replied that the new data should allay the guideline writers’ and government regulators’ concerns regarding acute procedural safety. But that’s only part of the picture. He and his coinvestigators are busy gathering data on intermediate-term outcomes, analyzing the impact of various strategies for periprocedural and long-term management of antiplatelet and anticoagulant medications with an eye toward identifying best practices, and investigating the relationship between procedural volume and outcomes, information, which could have an impact on the next iteration of the guidelines.

Simultaneous with his presentation at ACC 2020, the study was published online (J Am Coll Cardiol. 2020 Mar 13;75[13]1503-18).

In an accompanying editorial, Dhanunjaya Lakkireddy, MD, commented that an important contribution of the LAAO Registry is its inclusion of an enormous number of patients with contraindications to oral anticoagulation, a population excluded from the PROTECT-AF and PREVAIL randomized trials.

The short-term results of the registry suggest a relaxation of the current strict requirement for surgical backup during Watchman procedures is in order, added Dr. Lakkireddy, professor of medicine at the University of Missouri, Columbia, and medical director of the Kansas City Heart Rhythm Institute (J Am Coll Cardiol. 2020 Mar 13;75[13]:1519-22).

Dr. Freeman reported serving as a consultant to Boston Scientific, which markets the Watchman, as well as to Medtronic, Janssen, and Biosense Webster.

[email protected]

SOURCE: Freeman JF. ACC 2020, Abstract 409-10.

Early results from the massive National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry indicate that the rollout of the Watchman device into routine clinical practice is going smoothly, with a higher implant success rate and a substantially lower in-hospital complication rate than that seen in the pivotal randomized clinical trials, James V. Freeman, MD, reported at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic.

American College of Cardiology

These real-world results are particularly impressive because the 38,158 registry participants were on average significantly older and sicker than were patients in the clinical trials. They were at higher risk of both stroke and bleeding, yet they fared better in terms of procedural safety, observed Dr. Freeman, an electrophysiologist and director of the Yale University Atrial Fibrillation Center in New Haven, Conn.

“You always worry that once you get outside of the clinical trials setting and you roll out to a large number of centers, including some that are relatively low volume, that you’re going to start to see higher rates of complications. And overall, broadly speaking, the rates of adverse events were quite reassuring,” he said.

The registry, maintained by the ACC, serves as the postmarketing surveillance tool mandated by the Food and Drug Administration and Centers for Medicare & Medicaid Services. The 38,158 participants make this registry the world’s largest patient experience with the Watchman device by many orders of magnitude. Dr. Freeman’s report included patients enrolled during 2016-2018 who were treated at 495 hospitals by 1,318 physician interventionalists. CMS reimbursement requires participation in the registry, which captures more than 95% of all Watchman procedures done in the United States. Although Dr. Freeman presented only the acute in-hospital outcomes, active follow-up for adverse events and medical therapy will be conducted at 45 days, 6 months, and 1 and 2 years.

Participants in the Left Atrial Appendage Occlusion (LAAO) Registry averaged 76.1 years of age, which is 2-4 years older than patients in the pivotal PROTECT-AF and PREVAIL trials or the 1,025-patient EWOLUTION registry. The LAAO Registry participants had a mean CHA2DS2-VASc score of 4.6, compared with 3.4 in PROTECT-AF and 3.8 in PREVAIL. Their mean HAS BLED score was 3.0. Thirty percent had a prior ischemic stroke or transient ischemic attack, 12% had a prior intracranial hemorrhage, and 69% had a history of clinically relevant bleeding. Thirty percent had heart failure, 92% were hypertensive, and 30% had diabetes.

“The take home here is that these patients were at moderate to high risk of stroke and they also carried a high risk of bleeding and therefore had some relative contraindication to anticoagulation,” according to the cardiologist. “The patient population overall is really in accordance with the CMS guidance. We’re not seeing a lot of patients who are getting this device for a lifestyle indication. Most of these patients are really stuck between a rock and a hard place.”

Most hospitals offering the Watchman did 10-40 cases per year. The median annual physician volume was 12 cases. However, there was substantial variation in both hospital and physician volumes.

The device was deployed in 93% of procedures attempted; roughly half of cancellations were cause by LAAO thrombus detected on the day of the procedure. The acute procedural success rate when the device was deployed was 98.3%, compared with 90.9% in PROTECT-AF and 95.1% in PREVAIL. The rate of device margin residual leak of 5 mm or more among registry participants with an acutely successful procedure was 0.2%.

The rate of any major in-hospital complication in the LAAO Registry was 2.16%, the most common of which was pericardial effusion requiring intervention, which occurred in 1.39% of cases. The major bleeding rate was 1.25%. The stroke/transient ischemic attack rate was 0.17%. Systemic arterial embolism was a rare event, occurring in less than 0.01% of patients, as was acute MI, with an incidence of 0.04%. Device embolization occurred in 0.07% of patients.

By comparison, the 7-day rate of pericardial effusion requiring intervention was 4.0% in PROTECT-AF and 1.9% in PREVAIL, with procedure-related stroke rates of 1.1% and 0.7%, respectively, and device embolization rates of 0.4% and 0.7%. The major bleeding rate in PROTECT-AF was 3.5%, nearly triple that in the real-world registry.

Discussant Mark A. Estes, MD, characterized the acute outcomes in the LAAO Registry as “an improvement – a considerable improvement – over some of the early data in PREVAIL and PROTECT-AF.” He credited this to the “very robust validation procedure” the Watchman closure device has undergone, which included the clinical trials, regulatory requirements for training and patient selection, and mandatory reporting of outcomes in the registry.

He noted that a lot is happening now with the Watchman device. There are a couple of dozen prospective clinical trials, including one on the Watchman versus direct oral anticoagulant (DOAC) therapy and another on left atrial ablation plus left atrial appendage closure versus a DOAC. A new-generation Watchman device, the Watchman FLX, is approved in Europe and undergoing an ongoing FDA-mandated approval trial in the United States.

“It has a lot of technical advantages,” according to Dr. Estes, an electrophysiologist and professor of medicine at the University of Pittsburgh.

Current guidelines give LAAO a class IIb rating, meaning it “could be considered” in patients with atrial fibrillation at increased risk of stroke who have a contraindication to long-term anticoagulation. Dr. Estes asked: Does the LAAO Registry data warrant a rating upgrade to a stronger recommendation?

Dr. Freeman replied that the new data should allay the guideline writers’ and government regulators’ concerns regarding acute procedural safety. But that’s only part of the picture. He and his coinvestigators are busy gathering data on intermediate-term outcomes, analyzing the impact of various strategies for periprocedural and long-term management of antiplatelet and anticoagulant medications with an eye toward identifying best practices, and investigating the relationship between procedural volume and outcomes, information, which could have an impact on the next iteration of the guidelines.

Simultaneous with his presentation at ACC 2020, the study was published online (J Am Coll Cardiol. 2020 Mar 13;75[13]1503-18).

In an accompanying editorial, Dhanunjaya Lakkireddy, MD, commented that an important contribution of the LAAO Registry is its inclusion of an enormous number of patients with contraindications to oral anticoagulation, a population excluded from the PROTECT-AF and PREVAIL randomized trials.

The short-term results of the registry suggest a relaxation of the current strict requirement for surgical backup during Watchman procedures is in order, added Dr. Lakkireddy, professor of medicine at the University of Missouri, Columbia, and medical director of the Kansas City Heart Rhythm Institute (J Am Coll Cardiol. 2020 Mar 13;75[13]:1519-22).

Dr. Freeman reported serving as a consultant to Boston Scientific, which markets the Watchman, as well as to Medtronic, Janssen, and Biosense Webster.

[email protected]

SOURCE: Freeman JF. ACC 2020, Abstract 409-10.

Early results from the massive National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry indicate that the rollout of the Watchman device into routine clinical practice is going smoothly, with a higher implant success rate and a substantially lower in-hospital complication rate than that seen in the pivotal randomized clinical trials, James V. Freeman, MD, reported at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic.

American College of Cardiology

These real-world results are particularly impressive because the 38,158 registry participants were on average significantly older and sicker than were patients in the clinical trials. They were at higher risk of both stroke and bleeding, yet they fared better in terms of procedural safety, observed Dr. Freeman, an electrophysiologist and director of the Yale University Atrial Fibrillation Center in New Haven, Conn.

“You always worry that once you get outside of the clinical trials setting and you roll out to a large number of centers, including some that are relatively low volume, that you’re going to start to see higher rates of complications. And overall, broadly speaking, the rates of adverse events were quite reassuring,” he said.

The registry, maintained by the ACC, serves as the postmarketing surveillance tool mandated by the Food and Drug Administration and Centers for Medicare & Medicaid Services. The 38,158 participants make this registry the world’s largest patient experience with the Watchman device by many orders of magnitude. Dr. Freeman’s report included patients enrolled during 2016-2018 who were treated at 495 hospitals by 1,318 physician interventionalists. CMS reimbursement requires participation in the registry, which captures more than 95% of all Watchman procedures done in the United States. Although Dr. Freeman presented only the acute in-hospital outcomes, active follow-up for adverse events and medical therapy will be conducted at 45 days, 6 months, and 1 and 2 years.

Participants in the Left Atrial Appendage Occlusion (LAAO) Registry averaged 76.1 years of age, which is 2-4 years older than patients in the pivotal PROTECT-AF and PREVAIL trials or the 1,025-patient EWOLUTION registry. The LAAO Registry participants had a mean CHA2DS2-VASc score of 4.6, compared with 3.4 in PROTECT-AF and 3.8 in PREVAIL. Their mean HAS BLED score was 3.0. Thirty percent had a prior ischemic stroke or transient ischemic attack, 12% had a prior intracranial hemorrhage, and 69% had a history of clinically relevant bleeding. Thirty percent had heart failure, 92% were hypertensive, and 30% had diabetes.

“The take home here is that these patients were at moderate to high risk of stroke and they also carried a high risk of bleeding and therefore had some relative contraindication to anticoagulation,” according to the cardiologist. “The patient population overall is really in accordance with the CMS guidance. We’re not seeing a lot of patients who are getting this device for a lifestyle indication. Most of these patients are really stuck between a rock and a hard place.”

Most hospitals offering the Watchman did 10-40 cases per year. The median annual physician volume was 12 cases. However, there was substantial variation in both hospital and physician volumes.

The device was deployed in 93% of procedures attempted; roughly half of cancellations were cause by LAAO thrombus detected on the day of the procedure. The acute procedural success rate when the device was deployed was 98.3%, compared with 90.9% in PROTECT-AF and 95.1% in PREVAIL. The rate of device margin residual leak of 5 mm or more among registry participants with an acutely successful procedure was 0.2%.

The rate of any major in-hospital complication in the LAAO Registry was 2.16%, the most common of which was pericardial effusion requiring intervention, which occurred in 1.39% of cases. The major bleeding rate was 1.25%. The stroke/transient ischemic attack rate was 0.17%. Systemic arterial embolism was a rare event, occurring in less than 0.01% of patients, as was acute MI, with an incidence of 0.04%. Device embolization occurred in 0.07% of patients.

By comparison, the 7-day rate of pericardial effusion requiring intervention was 4.0% in PROTECT-AF and 1.9% in PREVAIL, with procedure-related stroke rates of 1.1% and 0.7%, respectively, and device embolization rates of 0.4% and 0.7%. The major bleeding rate in PROTECT-AF was 3.5%, nearly triple that in the real-world registry.

Discussant Mark A. Estes, MD, characterized the acute outcomes in the LAAO Registry as “an improvement – a considerable improvement – over some of the early data in PREVAIL and PROTECT-AF.” He credited this to the “very robust validation procedure” the Watchman closure device has undergone, which included the clinical trials, regulatory requirements for training and patient selection, and mandatory reporting of outcomes in the registry.

He noted that a lot is happening now with the Watchman device. There are a couple of dozen prospective clinical trials, including one on the Watchman versus direct oral anticoagulant (DOAC) therapy and another on left atrial ablation plus left atrial appendage closure versus a DOAC. A new-generation Watchman device, the Watchman FLX, is approved in Europe and undergoing an ongoing FDA-mandated approval trial in the United States.

“It has a lot of technical advantages,” according to Dr. Estes, an electrophysiologist and professor of medicine at the University of Pittsburgh.

Current guidelines give LAAO a class IIb rating, meaning it “could be considered” in patients with atrial fibrillation at increased risk of stroke who have a contraindication to long-term anticoagulation. Dr. Estes asked: Does the LAAO Registry data warrant a rating upgrade to a stronger recommendation?

Dr. Freeman replied that the new data should allay the guideline writers’ and government regulators’ concerns regarding acute procedural safety. But that’s only part of the picture. He and his coinvestigators are busy gathering data on intermediate-term outcomes, analyzing the impact of various strategies for periprocedural and long-term management of antiplatelet and anticoagulant medications with an eye toward identifying best practices, and investigating the relationship between procedural volume and outcomes, information, which could have an impact on the next iteration of the guidelines.

Simultaneous with his presentation at ACC 2020, the study was published online (J Am Coll Cardiol. 2020 Mar 13;75[13]1503-18).

In an accompanying editorial, Dhanunjaya Lakkireddy, MD, commented that an important contribution of the LAAO Registry is its inclusion of an enormous number of patients with contraindications to oral anticoagulation, a population excluded from the PROTECT-AF and PREVAIL randomized trials.

The short-term results of the registry suggest a relaxation of the current strict requirement for surgical backup during Watchman procedures is in order, added Dr. Lakkireddy, professor of medicine at the University of Missouri, Columbia, and medical director of the Kansas City Heart Rhythm Institute (J Am Coll Cardiol. 2020 Mar 13;75[13]:1519-22).

Dr. Freeman reported serving as a consultant to Boston Scientific, which markets the Watchman, as well as to Medtronic, Janssen, and Biosense Webster.

[email protected]

SOURCE: Freeman JF. ACC 2020, Abstract 409-10.

June 9, 2020 — Editor’s note: The study on which this news story is based has been retracted by the journal. The retraction notice can be found here. 

Cotton and surgical masks were not effective at filtering SARS-CoV-2 during coughs from patients infected with the virus, according to Seongman Bae, MD, of the University of Ulsan College of Medicine in Seoul, South Korea, and associates.

The report was published in Annals of Internal Medicine.

Because the COVID-19 pandemic has caused a shortage of N95 and surgical masks, cotton masks have gained interest as a substitute, as surgical masks have been shown to effectively filter influenza virus, the researchers wrote. However, the size of and concentrations of SARS-CoV-2 in aerosols generated during coughing are unknown.

To compare the effectiveness of cotton and surgical masks, a group of patients infected with SARS-CoV-2 coughed into petri dishes while wearing no mask, a surgical mask, and a cotton mask. The mask surfaces were swabbed afterward to assess viral positivity on the mask itself.

The median nasopharyngeal and saliva viral load was 5.66 log copies/mL and 4.00 log copies/mL, respectively. The median viral loads after coughing was 2.56 log copies/mL without a mask, 2.42 log copies/mL with a surgical mask, and 1.85 log copies/mL with a cotton mask. All outer surfaces of the mask were positive for SARS-CoV-2, while most inner surfaces were negative.

The investigators acknowledged that the test did not include N95 masks and does not reflect the actual infection transmission, and that they didn’t know whether cotton or surgical masks shorten the travel distance of droplets while coughing.

“Further study is needed to recommend whether face masks decrease transmission of virus from asymptomatic individuals or those with suspected COVID-19 who are not coughing,” they added.

The study was funded by a grant from the government-wide R&D Fund Project for Infectious Disease Research. The investigators reported that they had no conflicts of interest.

[email protected]

SOURCE: Bae S et al. Ann Intern Med. 2020 Apr 6. doi: 10.7326/M20-1342.

Correction, 4/9/20: The headline of an earlier version of this article misstated a finding of this study. Whether cotton and surgical masks can block transmission was not investigated.

June 9, 2020 — Editor’s note: The study on which this news story is based has been retracted by the journal. The retraction notice can be found here. 

Cotton and surgical masks were not effective at filtering SARS-CoV-2 during coughs from patients infected with the virus, according to Seongman Bae, MD, of the University of Ulsan College of Medicine in Seoul, South Korea, and associates.

The report was published in Annals of Internal Medicine.

Because the COVID-19 pandemic has caused a shortage of N95 and surgical masks, cotton masks have gained interest as a substitute, as surgical masks have been shown to effectively filter influenza virus, the researchers wrote. However, the size of and concentrations of SARS-CoV-2 in aerosols generated during coughing are unknown.

To compare the effectiveness of cotton and surgical masks, a group of patients infected with SARS-CoV-2 coughed into petri dishes while wearing no mask, a surgical mask, and a cotton mask. The mask surfaces were swabbed afterward to assess viral positivity on the mask itself.

The median nasopharyngeal and saliva viral load was 5.66 log copies/mL and 4.00 log copies/mL, respectively. The median viral loads after coughing was 2.56 log copies/mL without a mask, 2.42 log copies/mL with a surgical mask, and 1.85 log copies/mL with a cotton mask. All outer surfaces of the mask were positive for SARS-CoV-2, while most inner surfaces were negative.

The investigators acknowledged that the test did not include N95 masks and does not reflect the actual infection transmission, and that they didn’t know whether cotton or surgical masks shorten the travel distance of droplets while coughing.

“Further study is needed to recommend whether face masks decrease transmission of virus from asymptomatic individuals or those with suspected COVID-19 who are not coughing,” they added.

The study was funded by a grant from the government-wide R&D Fund Project for Infectious Disease Research. The investigators reported that they had no conflicts of interest.

[email protected]

SOURCE: Bae S et al. Ann Intern Med. 2020 Apr 6. doi: 10.7326/M20-1342.

Correction, 4/9/20: The headline of an earlier version of this article misstated a finding of this study. Whether cotton and surgical masks can block transmission was not investigated.

June 9, 2020 — Editor’s note: The study on which this news story is based has been retracted by the journal. The retraction notice can be found here. 

Cotton and surgical masks were not effective at filtering SARS-CoV-2 during coughs from patients infected with the virus, according to Seongman Bae, MD, of the University of Ulsan College of Medicine in Seoul, South Korea, and associates.

The report was published in Annals of Internal Medicine.

Because the COVID-19 pandemic has caused a shortage of N95 and surgical masks, cotton masks have gained interest as a substitute, as surgical masks have been shown to effectively filter influenza virus, the researchers wrote. However, the size of and concentrations of SARS-CoV-2 in aerosols generated during coughing are unknown.

To compare the effectiveness of cotton and surgical masks, a group of patients infected with SARS-CoV-2 coughed into petri dishes while wearing no mask, a surgical mask, and a cotton mask. The mask surfaces were swabbed afterward to assess viral positivity on the mask itself.

The median nasopharyngeal and saliva viral load was 5.66 log copies/mL and 4.00 log copies/mL, respectively. The median viral loads after coughing was 2.56 log copies/mL without a mask, 2.42 log copies/mL with a surgical mask, and 1.85 log copies/mL with a cotton mask. All outer surfaces of the mask were positive for SARS-CoV-2, while most inner surfaces were negative.

The investigators acknowledged that the test did not include N95 masks and does not reflect the actual infection transmission, and that they didn’t know whether cotton or surgical masks shorten the travel distance of droplets while coughing.

“Further study is needed to recommend whether face masks decrease transmission of virus from asymptomatic individuals or those with suspected COVID-19 who are not coughing,” they added.

The study was funded by a grant from the government-wide R&D Fund Project for Infectious Disease Research. The investigators reported that they had no conflicts of interest.

[email protected]

SOURCE: Bae S et al. Ann Intern Med. 2020 Apr 6. doi: 10.7326/M20-1342.

Correction, 4/9/20: The headline of an earlier version of this article misstated a finding of this study. Whether cotton and surgical masks can block transmission was not investigated.

►Zachary Reese, MD, Chief Medical Resident, VABHS and Beth Israel Deaconess Medical Center (BIDMC):Dr. Weller, the differential diagnosis for altered mental status is quite broad. How does the presence of clonus change or focus your approach to altered mental status?

►Jason Weller, MD, Instructor of Neurology, Boston Medical Center (BMC) and VABHS:The presence of clonus does not significantly narrow the differential. It does, however, suggest a central component to the patient’s altered mental status. Specifically, it implies that the underlying process, whether systemic or neurologic, interferes with central nervous system (CNS) control of the neuromuscular system.¹ The differential is still quite broad and includes metabolic derangements (eg, uremia, electrolyte disturbances, hypercarbia, and thyroid dysfunction), medication toxicity from olanzapine or duloxetine, and vascular processes (eg, CNS vasculitis). Infectious etiologies, both within the CNS and systemically, can cause encephalopathy, as can autoimmune processes, such as immune-mediated encephalitis. Finally, primary neurologic conditions such as myoclonic epilepsy can be considered. Given the patient’s medical history, serotonin syndrome must be considered.

►Dr. Reese: Given the concern for serotonin syndrome, the admitting medical team discontinued the patient’s duloxetine. Dr. Weller, what is the pathophysiology of serotonin syndrome, and how is it diagnosed?

►Dr. Weller: Serotonin is ubiquitous throughout the body and brain. Serotonin syndrome is caused by excess endogenous or exogenous serotonin, and this is usually caused by a variety of medications. The symptoms range from tachycardia, agitation, and diaphoresis to sustained clonus, hyperthermia, and shock.^2,3 The extent of serotonin syndrome is typically thought to reflect the degree of serotonergic activity.⁴

Serotonin syndrome is a clinical diagnosis. While there are no tests that can confirm the diagnosis, the Hunter criteria can be used to assist with making the diagnosis.⁵ Per the Hunter criteria, a patient can be diagnosed with serotonin syndrome if they have taken a serotonergic agent and have at least 1 of the following: spontaneous clonus, inducible or ocular clonus with agitation or diaphoresis, tremor and hyperreflexia, or hypertonia with fever and clonus. This patient had taken duloxetine and had inducible clonus and diaphoresis, thus suggesting a diagnosis of serotonin syndrome.

►Dr. Reese: Aside from selective serotonin reuptake inhibitors (SSRIs), are there other medications that we typically prescribe that can cause serotonin syndrome?

►Dr. Weller: In addition to SSRIs and serotonin-norepinephrine reuptake inhibitors (SNRIs), other commonly prescribed medications that can cause serotonin syndrome are 5-HT3 antagonists (eg, ondansetron), 5-HT agonists (eg, triptans), and opioids (eg, fentanyl and tramadol). There are also case reports of atypical antipsychotics (eg, olanzapine) causing serotonin syndrome because of their antagonism of the 5-HT2 and 5-HT3 receptors.² Additionally, linezolid is commonly overlooked as a cause of serotonin syndrome given its action as a monoamine oxidase inhibitor.⁴ In this patient, it would be prudent to discontinue olanzapine and duloxetine.

►Dr. Reese: Duloxetine, olanzapine, and buprenorphine/naloxone were discontinuedgiven concern for serotonin syndrome. Although there are not strong data that buprenorphine/ naloxone can cause serotonin syndrome, the team discontinued the medication in case it might be contributing to the patient’s encephalopathy, while closely monitoring the patient for withdrawal. There was a rapid improvement in the patient’s symptoms over the 24 hours after discontinuation of the 3 medications.

As part of the initial workup, the patient received a computed tomography (CT) scan of his chest to follow up pulmonary nodules identified 16 months prior. The CT scan showed interval growth of the pulmonary nodules in the right lower lobe to 2 cm with extension into the major fissure, which was concerning for malignancy. Plans were made for an outpatient positron emission tomography (PET) scan after hospital discharge.

Dr. Schlechter and Dr. Rangachari, what factors can help us determine whether or not further workup of a malignancy should occur before discharge or can be deferred to the outpatient setting?

►Benjamin Schlechter, MD, Instructor in Medicine, BIDMC; and Deepa Rangachari, MD, Assistant Professor of Medicine, BIDMC: Key considerations in this domain include rapidity of growth and any threat to critical end-organ function (ie, brain, heart, lungs, kidney, and liver). If the malignancy is bulky and/or rapidly progressing to the point that the patient has significant symptoms burden and/or end-organ dysfunction, then initiating the evaluation as an inpatient may be necessary. For suspected intrathoracic malignancies, considering whether this may be a high-grade process (ie, small cell lung cancer) is often a vital branch point. Key considerations in this regard are the following: Is it a bulky central tumor? Is there evidence of widespread metastatic disease, an obstructing mass, and/or tumor lysis? One final and critical aspect to consider is whether there are any patient- specific barriers to timely and reliable outpatient follow-up. If there is no evidence of rapid progression, bulky disease with threatened end-organ involvement, and/or issues with timely and reliable follow-up, then outpatient evaluation is often the best approach to ensure a comprehensive and well-coordinated effort on the patient’s behalf.

►Dr. Reese: Buprenorphine/naloxone was restarted without return of the symptoms. The patient was discharged home with an outpatient PET scan scheduled the following week. Unfortunately, the patient was unable to keep this appointment. Three weeks after hospital discharge, the patient presented again to the emergency department with gradually worsening altered mental status, confusion, visual hallucinations, and myoclonic jerking of the arms and legs. Medication adherence was confirmed by the patient’s wife, resulting in a low concern for serotonin syndrome. Physical examination revealed confusion, dysarthria, diffuse, arrhythmic, myoclonic jerking in all extremities, asterixis in the upper extremities, and hyperreflexia.

A CT scan of the brain did not reveal an intracranial process. A spot electroencephalograph (EEG) and magnetic resonance image (MRI) of the brain were obtained. Dr. Weller, what is the utility of spot EEG vs 24-hour EEG? When might we choose one over the other?

►Dr. Weller: If a patient is persistently altered, then a spot EEG would be sufficient to capture a seizure if that is what is causing the patient’s altered mental status. However, if the patient’s mental status is waxing and waning, then that may warrant a 24-hour EEG because the patient may need to be monitored for longer periods to capture an event that is causing intermittent alterations in mental status.6 Additionally, patients who are acutely ill may require long-term monitoring for the purpose of treatment and outcome management.

►Dr. Reese: The spot EEG showed nearly continuous generalized slowing indicative of a diffuse encephalopathy. The MRI of the brain showed scattered, nonspecific periventricular T2 hyperintense foci, suggestive of advanced chronic microvascular ischemic changes.

A PET CT was obtained and revealed mildly fluorodeoxyglucose (FDG)-avid, enlarging nodules within the right lower lobe, which was suspicious for malignancy. There were no other areas of FDG avidity on the PET scan. Valproic acid was initiated for treatment of myoclonus with transition to clonazepam when no improvement was seen. After starting clonazepam, the patient’s condition stabilized.

Dr. Weller, given the additional history, how has your differential diagnosis changed?

►Dr. Weller: Given the patient’s laboratory findings, we can be quite sure that there is not a contributing metabolic process. The findings suggestive of metastatic cancer, along with the profound neurologic changes, are most concerning for a paraneoplastic syndrome. I would suggest biopsy and consideration of a lumbar puncture. One can also send serum markers, including a paraneoplastic antibody panel.

►Dr. Reese: Biopsy of the mass in his right lower lobe revealed squamous cell lung cancer. Dr. Schlechter and Dr. Rangachari, do you have a framework for the different forms of lung cancer?

►Dr. Schlechter/Dr. Rangachari: The 2 broad categories of lung cancer are small cell and non-small cell (NSCLC). Small cell lung cancer has a tight association with tobacco exposure and is often clinically defined by rapid, bulky progression (ie, weeks to months).^7,8 NSCLCs are also commonly seen in those with tobacco exposure, though not always. The main subgroups in this category are adenocarcinoma and squamous cell carcinoma. These cancers often evolve at a slower pace (ie, months to years).⁸ While small cell lung cancers are highgrade tumors and exquisitely sensitive to chemotherapy and radiation, NSCLCs tend to be less responsive to such therapies. The staging evaluation for either entity is the same and consists of defining localized vs metastatic disease.

►Dr. Reese: Because this patient had an MRI and PET scan that were both negative for metastatic disease, can we assume that this patient had stage I NSCLC?

►Dr. Schlechter/Dr. Rangachari: Not necessarily. While PET and MRI brain are exceptionally helpful in detecting distant metastases, they may over- or underestimate intrathoracic lymph node involvement by as much as 20%.⁹ As such, dedicated lymph node staging—either via bronchoscopy (endobronchial ultrasound) or surgically (mediastinoscopy) is indicated as lymph node involvement can significantly alter the stage, prognosis, and optimal therapeutic approach.^10,11

►Dr. Reese: After this diagnosis was made, the teams caring for this patient attributed his altered mental status to a paraneoplastic syndrome. What is a paraneoplastic syndrome, and how does a paraneoplastic syndrome from malignancy present? Does its presence worsen a patient’s prognosis?

►Dr. Schlechter/Dr. Rangachari: A paraneoplastic syndrome is defined by an immunologic response to the cancer that ends up erroneously targeting self-antigens. Paraneoplastic syndromes are associated with a broad array of clinical findings—from endocrinopathy to encephalopathy—and certain neoplasms are more commonly associated with these syndromes than others (eg, small cell lung cancer and thymoma). Further, severity and onset of a paraneoplastic syndrome does not correlate with the burden of visible disease—and the syndrome may predate the cancer diagnosis by months to years.¹¹ While treatment of the cancer affords the best hope of resolving the paraneoplastic syndrome, the cancer and the paraneoplastic process may have a discordant trajectory, with the paraneoplastic syndrome persisting even after the cancer is maximally treated. Although one might assume that paraneoplastic syndromes portend worse outcomes, in some cases, a presentation with the paraneoplastic syndrome may afford sooner detection of an otherwise occult/asymptomatic malignancy.

►Dr. Reese: The following week, the serum paraneoplastic antibody panel that tested for anti-Yo antibody, anti-Ri antibody,and anti-Hu antibody came back negative. Dr. Weller, what does this mean? Since we have yet to obtain a lumbar puncture, might his symptoms still be caused by a paraneoplastic syndrome?

►Dr. Weller: The negative serum test just means that he does not have antibodies to those 3 antibodies. There are now over 30 different paraneoplastic antibodies that have been discovered, and there are always more that are being discovered. So this negative test result does not exclude a paraneoplastic syndrome in the appropriate clinical context.12 Furthermore, the sensitivity and specificity for certain antibodies are different based upon source fluid, and cerebrospinal fluid testing would provide more diagnostic clarity. A negative test for paraneoplastic syndrome, by itself, would similarly not exclude a paraneoplastic syndrome. Often, empiric treatment is the best diagnostic option for paraneoplastic and autoimmune encephalopathies.

►Dr. Reese: The following week, the patient was discharged to rehabilitation with clonazepam for his symptoms and a scheduled follow-up. Given the patient’s frailty and medical comorbidities, thoracic surgery recommended consultation with radiation oncology. Dr. Schlechter and Dr. Rangachari, when do we decide to use radiation vs chemotherapy for someone with lung cancer?

►Dr. Schlechter/Dr. Rangachari: Patients with early stage, nonmetastatic NSCLC may not always be candidates for surgical resection on the basis of pulmonary function, other medical comorbidities (as in this case), anatomic considerations, and/or patient preference. In these cases, if there is lung-limited disease without lymph node involvement (ie, stage I/II NSCLC) and the patient is not felt to be an operative candidate, then alternatives to surgery include either radiation or ablation.13,14 As we care for an aging and comorbid population, evolving evidence suggests that well-selected patients with early stage disease undergoing these nonoperative approaches have roughly equivalent outcomes to those undergoing conventional surgical resection.13 In such cases, multidisciplinary consultation with a team having dedicated expertise in these various operative and nonoperative modalities is essential.

►Dr. Reese: The patient followed up with radiation oncology for consideration of radiation treatment, but his simulation CT scan showed some ground-glass opacity that were concerning for inflammation vs infection. The patient’s case was discussed at the multidisciplinary tumor board, and it was determined to treat him with antibiotics for a possible pneumonia before proceeding with radiation therapy. After he completed antibiotic treatment, he underwent 10 fractions of radiation treatment, which he tolerated well.