User login
-
Firings, furloughs, and pay cuts in advance of COVID-19 surge
Doctors at a Boston-area hospital learned via video conferencing that they would be receiving a 20% pay cut – a slap in the face at the precise moment that those on the front lines of the COVID-19 pandemic need a pat on the back (and more N95 respirators).
But Steward Health Care System*, which runs the hospital and dozens of others around the country, did the math and decided that the pay cuts were necessary to survive what they called “a seismic shock to our system.” They also announced furloughs for a large number of their nonclinical staff.
Spirits sank after the announcement. “It was devastating,” said one Boston doctor, who works for Steward and asked not to be identified for fear of retribution. “I didn’t say much during the call because I was so panicked, and I didn’t want to be crying on the call.”
Someone else did speak up, a senior colleague who warned that such a cut would kill morale at a time when physicians were already feeling vulnerable because of other shortages, including personal protective equipment. (Requests for interviews with Steward Health Care System executives were declined.)
Furloughs, layoffs, and even firings are happening elsewhere too. Hospitals in virus hotspots have already come up short on beds and face masks. Now a shortage of cash is prompting many to fire some of their health care workers, furlough them temporarily, or – like Steward Health Care System – slash their pay checks.
Despite almost $200 billion earmarked for hospital systems in the recently passed federal stimulus package, many hospitals are still in dire financial straits. Most make the majority of their money through so-called elective procedures, such as knee replacements and cataract surgeries, almost all of which have been postponed in order to conserve personal protective equipment and minimize spread of the virus. Those cancellations translate to a significant financial hit.
On top of that, hospitals will lose an average of $1,800 on every COVID-19 case, according to projections by Strata Decision Technology, a health care financial planning and analytic company. Some, they estimate, may lose much more, between $6,000 and $8,000 per patient. And hospitals were already hurting. According to a report from Bloomberg, at least 30 hospitals entered bankruptcy in 2019.
“This pressure on institutions to control costs has been around for several years,” said Steve Lefar, executive director of the data science division of Strata Decision Technology and lead author of the study. “This is just making it incredibly acute for them.”
Many hospital executives are bracing for months of hardship, leading to wrenching decisions to furlough or lay off staff, suspend bonuses, or cut pay – even as some short-staffed hospitals in COVID-19 hotspots are issuing pleas for doctors to come out of retirement.
Forward thinking?
While most furloughs and layoffs so far have affected people who don’t work directly with patients, many on the front lines have been hit with pay cuts or withheld bonuses or retirement contributions. In Massachusetts, the state’s medical society has asked Governor Charlie Baker for financial relief for health care workers in the form of grants, no-interest or forgivable small-business loans for physician practices, and deferment of medical student loan payments.
At St. Alexius Hospital in St. Louis, Sonny Saggar, MD, was fired as CEO after he clashed with a bankruptcy trustee. Dr. Saggar had proposed offering open beds to other hospital systems during the pandemic – an idea that, he said, was turned down out of concern for the bottom line.
“This is one of those times where we need to put down our search for profit and money and just look after people’s lives. We’re supposed to have that calling in health care,” said Dr. Saggar, who has since been reinstated as chief strategy officer and director of the COVID task force and ED. He noted that he and the trustee have resolved differences over funding.
At St. Claire HealthCare in Morehead, Ky., 300 employees who were not involved in direct patient care – a quarter of the hospital’s staff – have been furloughed, something Donald Lloyd II, St. Claire HealthCare’s CEO as of May 1, described as forward thinking.
To prepare for the influx of COVID-19 patients, the hospital shut down elective procedures early. “Prudence dictates the need to be extremely proactive,” Mr. Lloyd said. “We need to devote our limited resources to frontline clinical teams.”
Other hospitals are making similar moves, although many are not doing so publicly. Mr. Lloyd decided to put out a press release because he found it offensive that the federal government was “bailing out airlines and cruise lines before our frontline men and women caring for patients.”
Massachusetts-based Atrius Health, for instance, placed many staffers on a 1-month furlough, while simultaneously withholding a percentage of working physicians’ paychecks, saying that they plan to pay them back at a later date. TriHealth, in Cincinnati, looked elsewhere for ways to save money. Instead of cutting physician salaries, 11 executives took a 20% pay cut.
There are both better and worse ways to go about such staff reductions, according to Mr. Lefar. If reductions have to be made, it would be best if CEOs keep cuts as far away as possible from the front lines of patient care.
“My bias is to start with pay reductions for high-paid executives, then furloughs, and beyond that layoffs,” he said. (Furloughs allow employees to be brought back and receive unemployment benefits while not working.) “Anyone related to patient care – these are the people who are getting the country through this, these are the heroes.”
After the pandemic
Large hospital systems that can designate separate buildings for COVID-19 care may fare best financially, Mr. Lefar said. By retaining a clean, noninfectious facility, such setups could allow for an earlier return to regular procedures – as long as rapid COVID-19 testing becomes available.
Smaller hospitals, nearly half of which run at a financial loss, according to the Chartis Center for Rural Health, face the additional burdens of both limited capacity and a limited ability to separate COVID-19 care.
Mostly, Mr. Lefar said, it’s a matter of doing whatever is necessary to get through the worst of it. “A lot of what is deemed elective or scheduled will come back,” he said. “Right now it’s crisis mode. ... I think it’s going to be a rough 6-9 months, but we will get back to it.”
*Correction, 4/7/20: An earlier version of this article misstated the name of a hospital in the Boston area run by Steward Health Care System.
A version of this article originally appeared on Medscape.com.
Doctors at a Boston-area hospital learned via video conferencing that they would be receiving a 20% pay cut – a slap in the face at the precise moment that those on the front lines of the COVID-19 pandemic need a pat on the back (and more N95 respirators).
But Steward Health Care System*, which runs the hospital and dozens of others around the country, did the math and decided that the pay cuts were necessary to survive what they called “a seismic shock to our system.” They also announced furloughs for a large number of their nonclinical staff.
Spirits sank after the announcement. “It was devastating,” said one Boston doctor, who works for Steward and asked not to be identified for fear of retribution. “I didn’t say much during the call because I was so panicked, and I didn’t want to be crying on the call.”
Someone else did speak up, a senior colleague who warned that such a cut would kill morale at a time when physicians were already feeling vulnerable because of other shortages, including personal protective equipment. (Requests for interviews with Steward Health Care System executives were declined.)
Furloughs, layoffs, and even firings are happening elsewhere too. Hospitals in virus hotspots have already come up short on beds and face masks. Now a shortage of cash is prompting many to fire some of their health care workers, furlough them temporarily, or – like Steward Health Care System – slash their pay checks.
Despite almost $200 billion earmarked for hospital systems in the recently passed federal stimulus package, many hospitals are still in dire financial straits. Most make the majority of their money through so-called elective procedures, such as knee replacements and cataract surgeries, almost all of which have been postponed in order to conserve personal protective equipment and minimize spread of the virus. Those cancellations translate to a significant financial hit.
On top of that, hospitals will lose an average of $1,800 on every COVID-19 case, according to projections by Strata Decision Technology, a health care financial planning and analytic company. Some, they estimate, may lose much more, between $6,000 and $8,000 per patient. And hospitals were already hurting. According to a report from Bloomberg, at least 30 hospitals entered bankruptcy in 2019.
“This pressure on institutions to control costs has been around for several years,” said Steve Lefar, executive director of the data science division of Strata Decision Technology and lead author of the study. “This is just making it incredibly acute for them.”
Many hospital executives are bracing for months of hardship, leading to wrenching decisions to furlough or lay off staff, suspend bonuses, or cut pay – even as some short-staffed hospitals in COVID-19 hotspots are issuing pleas for doctors to come out of retirement.
Forward thinking?
While most furloughs and layoffs so far have affected people who don’t work directly with patients, many on the front lines have been hit with pay cuts or withheld bonuses or retirement contributions. In Massachusetts, the state’s medical society has asked Governor Charlie Baker for financial relief for health care workers in the form of grants, no-interest or forgivable small-business loans for physician practices, and deferment of medical student loan payments.
At St. Alexius Hospital in St. Louis, Sonny Saggar, MD, was fired as CEO after he clashed with a bankruptcy trustee. Dr. Saggar had proposed offering open beds to other hospital systems during the pandemic – an idea that, he said, was turned down out of concern for the bottom line.
“This is one of those times where we need to put down our search for profit and money and just look after people’s lives. We’re supposed to have that calling in health care,” said Dr. Saggar, who has since been reinstated as chief strategy officer and director of the COVID task force and ED. He noted that he and the trustee have resolved differences over funding.
At St. Claire HealthCare in Morehead, Ky., 300 employees who were not involved in direct patient care – a quarter of the hospital’s staff – have been furloughed, something Donald Lloyd II, St. Claire HealthCare’s CEO as of May 1, described as forward thinking.
To prepare for the influx of COVID-19 patients, the hospital shut down elective procedures early. “Prudence dictates the need to be extremely proactive,” Mr. Lloyd said. “We need to devote our limited resources to frontline clinical teams.”
Other hospitals are making similar moves, although many are not doing so publicly. Mr. Lloyd decided to put out a press release because he found it offensive that the federal government was “bailing out airlines and cruise lines before our frontline men and women caring for patients.”
Massachusetts-based Atrius Health, for instance, placed many staffers on a 1-month furlough, while simultaneously withholding a percentage of working physicians’ paychecks, saying that they plan to pay them back at a later date. TriHealth, in Cincinnati, looked elsewhere for ways to save money. Instead of cutting physician salaries, 11 executives took a 20% pay cut.
There are both better and worse ways to go about such staff reductions, according to Mr. Lefar. If reductions have to be made, it would be best if CEOs keep cuts as far away as possible from the front lines of patient care.
“My bias is to start with pay reductions for high-paid executives, then furloughs, and beyond that layoffs,” he said. (Furloughs allow employees to be brought back and receive unemployment benefits while not working.) “Anyone related to patient care – these are the people who are getting the country through this, these are the heroes.”
After the pandemic
Large hospital systems that can designate separate buildings for COVID-19 care may fare best financially, Mr. Lefar said. By retaining a clean, noninfectious facility, such setups could allow for an earlier return to regular procedures – as long as rapid COVID-19 testing becomes available.
Smaller hospitals, nearly half of which run at a financial loss, according to the Chartis Center for Rural Health, face the additional burdens of both limited capacity and a limited ability to separate COVID-19 care.
Mostly, Mr. Lefar said, it’s a matter of doing whatever is necessary to get through the worst of it. “A lot of what is deemed elective or scheduled will come back,” he said. “Right now it’s crisis mode. ... I think it’s going to be a rough 6-9 months, but we will get back to it.”
*Correction, 4/7/20: An earlier version of this article misstated the name of a hospital in the Boston area run by Steward Health Care System.
A version of this article originally appeared on Medscape.com.
Doctors at a Boston-area hospital learned via video conferencing that they would be receiving a 20% pay cut – a slap in the face at the precise moment that those on the front lines of the COVID-19 pandemic need a pat on the back (and more N95 respirators).
But Steward Health Care System*, which runs the hospital and dozens of others around the country, did the math and decided that the pay cuts were necessary to survive what they called “a seismic shock to our system.” They also announced furloughs for a large number of their nonclinical staff.
Spirits sank after the announcement. “It was devastating,” said one Boston doctor, who works for Steward and asked not to be identified for fear of retribution. “I didn’t say much during the call because I was so panicked, and I didn’t want to be crying on the call.”
Someone else did speak up, a senior colleague who warned that such a cut would kill morale at a time when physicians were already feeling vulnerable because of other shortages, including personal protective equipment. (Requests for interviews with Steward Health Care System executives were declined.)
Furloughs, layoffs, and even firings are happening elsewhere too. Hospitals in virus hotspots have already come up short on beds and face masks. Now a shortage of cash is prompting many to fire some of their health care workers, furlough them temporarily, or – like Steward Health Care System – slash their pay checks.
Despite almost $200 billion earmarked for hospital systems in the recently passed federal stimulus package, many hospitals are still in dire financial straits. Most make the majority of their money through so-called elective procedures, such as knee replacements and cataract surgeries, almost all of which have been postponed in order to conserve personal protective equipment and minimize spread of the virus. Those cancellations translate to a significant financial hit.
On top of that, hospitals will lose an average of $1,800 on every COVID-19 case, according to projections by Strata Decision Technology, a health care financial planning and analytic company. Some, they estimate, may lose much more, between $6,000 and $8,000 per patient. And hospitals were already hurting. According to a report from Bloomberg, at least 30 hospitals entered bankruptcy in 2019.
“This pressure on institutions to control costs has been around for several years,” said Steve Lefar, executive director of the data science division of Strata Decision Technology and lead author of the study. “This is just making it incredibly acute for them.”
Many hospital executives are bracing for months of hardship, leading to wrenching decisions to furlough or lay off staff, suspend bonuses, or cut pay – even as some short-staffed hospitals in COVID-19 hotspots are issuing pleas for doctors to come out of retirement.
Forward thinking?
While most furloughs and layoffs so far have affected people who don’t work directly with patients, many on the front lines have been hit with pay cuts or withheld bonuses or retirement contributions. In Massachusetts, the state’s medical society has asked Governor Charlie Baker for financial relief for health care workers in the form of grants, no-interest or forgivable small-business loans for physician practices, and deferment of medical student loan payments.
At St. Alexius Hospital in St. Louis, Sonny Saggar, MD, was fired as CEO after he clashed with a bankruptcy trustee. Dr. Saggar had proposed offering open beds to other hospital systems during the pandemic – an idea that, he said, was turned down out of concern for the bottom line.
“This is one of those times where we need to put down our search for profit and money and just look after people’s lives. We’re supposed to have that calling in health care,” said Dr. Saggar, who has since been reinstated as chief strategy officer and director of the COVID task force and ED. He noted that he and the trustee have resolved differences over funding.
At St. Claire HealthCare in Morehead, Ky., 300 employees who were not involved in direct patient care – a quarter of the hospital’s staff – have been furloughed, something Donald Lloyd II, St. Claire HealthCare’s CEO as of May 1, described as forward thinking.
To prepare for the influx of COVID-19 patients, the hospital shut down elective procedures early. “Prudence dictates the need to be extremely proactive,” Mr. Lloyd said. “We need to devote our limited resources to frontline clinical teams.”
Other hospitals are making similar moves, although many are not doing so publicly. Mr. Lloyd decided to put out a press release because he found it offensive that the federal government was “bailing out airlines and cruise lines before our frontline men and women caring for patients.”
Massachusetts-based Atrius Health, for instance, placed many staffers on a 1-month furlough, while simultaneously withholding a percentage of working physicians’ paychecks, saying that they plan to pay them back at a later date. TriHealth, in Cincinnati, looked elsewhere for ways to save money. Instead of cutting physician salaries, 11 executives took a 20% pay cut.
There are both better and worse ways to go about such staff reductions, according to Mr. Lefar. If reductions have to be made, it would be best if CEOs keep cuts as far away as possible from the front lines of patient care.
“My bias is to start with pay reductions for high-paid executives, then furloughs, and beyond that layoffs,” he said. (Furloughs allow employees to be brought back and receive unemployment benefits while not working.) “Anyone related to patient care – these are the people who are getting the country through this, these are the heroes.”
After the pandemic
Large hospital systems that can designate separate buildings for COVID-19 care may fare best financially, Mr. Lefar said. By retaining a clean, noninfectious facility, such setups could allow for an earlier return to regular procedures – as long as rapid COVID-19 testing becomes available.
Smaller hospitals, nearly half of which run at a financial loss, according to the Chartis Center for Rural Health, face the additional burdens of both limited capacity and a limited ability to separate COVID-19 care.
Mostly, Mr. Lefar said, it’s a matter of doing whatever is necessary to get through the worst of it. “A lot of what is deemed elective or scheduled will come back,” he said. “Right now it’s crisis mode. ... I think it’s going to be a rough 6-9 months, but we will get back to it.”
*Correction, 4/7/20: An earlier version of this article misstated the name of a hospital in the Boston area run by Steward Health Care System.
A version of this article originally appeared on Medscape.com.
CMS implements temporary regulatory changes to aid COVID-19 response
The Centers for Medicare & Medicaid Services has announced a wide range of temporary regulatory moves aimed at helping hospitals and health systems handle the surge of COVID-19 patients.
“We are waiving a wide and unprecedented range of regulatory requirements to equip the American health care system with maximum flexibility to deal with an influx of cases,” CMS Administrator Seema Verma said during a March 30 conference call with reporters. “Many health care systems may not need these waivers and they shouldn’t use them if the situation doesn’t warrant it. But the flexibilities are there if it does. At a time of crisis, no regulatory barriers should stand in the way of patient care.”
Among the changes is an expansion of the venues in which health care systems and hospitals can provide services.
Federal regulations call for hospitals to provide services within their own buildings, raising concerns as to whether there will be enough capacity to handle the anticipated COVID-19 caseload.
“Under CMS’s temporary new rules, hospitals will be able to transfer patients to outside facilities, such as ambulatory surgery centers, inpatient rehabilitation hospitals, hotels, and dormitories, while still receiving hospital payments under Medicare,” CMS stated in a fact sheet highlighting the regulatory changes. “For example, a health care system can use a hotel to take care of patients needing less intensive care while using inpatient beds for COVID-19 patients.”
With these waivers, hospital systems will not have to rely on the Federal Emergency Management Agency to set up temporary hospitals and can move ahead using available community resources to help deal with the expected surge, Ms. Verma said.
These regulatory changes will be effect for the duration of the public health emergency, according to Ms. Verma.
Ambulatory surgery centers will have the option to contract with local health care systems to provide hospital services or they can enroll and bill as hospitals during the emergency, the fact sheet noted. They will be able to perform hospital services such as cancer procedures, trauma surgeries, and other essential surgeries.
CMS also is waiving the limit on the number of beds a doctor-owned hospital can have.
Additionally, for Medicare patients who may be homebound, CMS will now pay for a laboratory technician to make a home visit to collect a specimen for COVID-19 testing, and hospitals will be able to conduct testing in homes or other community-based settings under certain circumstances.
CMS also is taking actions aimed at expanding the health care workforce.
For instance, the agency is issuing a “blanket waiver” that allows hospitals to provide benefits to medical staff, including multiple daily meals, laundry service for personal clothing, or child care services while the staff is at the hospital providing patient care, according to the fact sheet.
Teaching hospitals will also receive more flexibility in using residents to provide health care services under the virtual direction of a teaching physician, who may be available through audio/video technology.
CMS also is temporarily eliminating paperwork requirements, and allowed greater use of verbal orders, to allow clinicians to spend more time on direct patient care.
On the device/equipment side, Medicare will cover respiratory-related devices and equipment “for any medical reason determined by clinicians,” according to the fact sheet, rather than only under certain circumstances.
And on the telehealth side, CMS is expanding the number of services that it will pay for via telehealth by more than 80, including emergency department visits, initial nursing facility and discharge visits, and home visits, which must be provided by a clinician that is allowed to provide telehealth. CMS will allow the use of commonly available interactive apps with audio and video, as well as audio-only phones.
The Centers for Medicare & Medicaid Services has announced a wide range of temporary regulatory moves aimed at helping hospitals and health systems handle the surge of COVID-19 patients.
“We are waiving a wide and unprecedented range of regulatory requirements to equip the American health care system with maximum flexibility to deal with an influx of cases,” CMS Administrator Seema Verma said during a March 30 conference call with reporters. “Many health care systems may not need these waivers and they shouldn’t use them if the situation doesn’t warrant it. But the flexibilities are there if it does. At a time of crisis, no regulatory barriers should stand in the way of patient care.”
Among the changes is an expansion of the venues in which health care systems and hospitals can provide services.
Federal regulations call for hospitals to provide services within their own buildings, raising concerns as to whether there will be enough capacity to handle the anticipated COVID-19 caseload.
“Under CMS’s temporary new rules, hospitals will be able to transfer patients to outside facilities, such as ambulatory surgery centers, inpatient rehabilitation hospitals, hotels, and dormitories, while still receiving hospital payments under Medicare,” CMS stated in a fact sheet highlighting the regulatory changes. “For example, a health care system can use a hotel to take care of patients needing less intensive care while using inpatient beds for COVID-19 patients.”
With these waivers, hospital systems will not have to rely on the Federal Emergency Management Agency to set up temporary hospitals and can move ahead using available community resources to help deal with the expected surge, Ms. Verma said.
These regulatory changes will be effect for the duration of the public health emergency, according to Ms. Verma.
Ambulatory surgery centers will have the option to contract with local health care systems to provide hospital services or they can enroll and bill as hospitals during the emergency, the fact sheet noted. They will be able to perform hospital services such as cancer procedures, trauma surgeries, and other essential surgeries.
CMS also is waiving the limit on the number of beds a doctor-owned hospital can have.
Additionally, for Medicare patients who may be homebound, CMS will now pay for a laboratory technician to make a home visit to collect a specimen for COVID-19 testing, and hospitals will be able to conduct testing in homes or other community-based settings under certain circumstances.
CMS also is taking actions aimed at expanding the health care workforce.
For instance, the agency is issuing a “blanket waiver” that allows hospitals to provide benefits to medical staff, including multiple daily meals, laundry service for personal clothing, or child care services while the staff is at the hospital providing patient care, according to the fact sheet.
Teaching hospitals will also receive more flexibility in using residents to provide health care services under the virtual direction of a teaching physician, who may be available through audio/video technology.
CMS also is temporarily eliminating paperwork requirements, and allowed greater use of verbal orders, to allow clinicians to spend more time on direct patient care.
On the device/equipment side, Medicare will cover respiratory-related devices and equipment “for any medical reason determined by clinicians,” according to the fact sheet, rather than only under certain circumstances.
And on the telehealth side, CMS is expanding the number of services that it will pay for via telehealth by more than 80, including emergency department visits, initial nursing facility and discharge visits, and home visits, which must be provided by a clinician that is allowed to provide telehealth. CMS will allow the use of commonly available interactive apps with audio and video, as well as audio-only phones.
The Centers for Medicare & Medicaid Services has announced a wide range of temporary regulatory moves aimed at helping hospitals and health systems handle the surge of COVID-19 patients.
“We are waiving a wide and unprecedented range of regulatory requirements to equip the American health care system with maximum flexibility to deal with an influx of cases,” CMS Administrator Seema Verma said during a March 30 conference call with reporters. “Many health care systems may not need these waivers and they shouldn’t use them if the situation doesn’t warrant it. But the flexibilities are there if it does. At a time of crisis, no regulatory barriers should stand in the way of patient care.”
Among the changes is an expansion of the venues in which health care systems and hospitals can provide services.
Federal regulations call for hospitals to provide services within their own buildings, raising concerns as to whether there will be enough capacity to handle the anticipated COVID-19 caseload.
“Under CMS’s temporary new rules, hospitals will be able to transfer patients to outside facilities, such as ambulatory surgery centers, inpatient rehabilitation hospitals, hotels, and dormitories, while still receiving hospital payments under Medicare,” CMS stated in a fact sheet highlighting the regulatory changes. “For example, a health care system can use a hotel to take care of patients needing less intensive care while using inpatient beds for COVID-19 patients.”
With these waivers, hospital systems will not have to rely on the Federal Emergency Management Agency to set up temporary hospitals and can move ahead using available community resources to help deal with the expected surge, Ms. Verma said.
These regulatory changes will be effect for the duration of the public health emergency, according to Ms. Verma.
Ambulatory surgery centers will have the option to contract with local health care systems to provide hospital services or they can enroll and bill as hospitals during the emergency, the fact sheet noted. They will be able to perform hospital services such as cancer procedures, trauma surgeries, and other essential surgeries.
CMS also is waiving the limit on the number of beds a doctor-owned hospital can have.
Additionally, for Medicare patients who may be homebound, CMS will now pay for a laboratory technician to make a home visit to collect a specimen for COVID-19 testing, and hospitals will be able to conduct testing in homes or other community-based settings under certain circumstances.
CMS also is taking actions aimed at expanding the health care workforce.
For instance, the agency is issuing a “blanket waiver” that allows hospitals to provide benefits to medical staff, including multiple daily meals, laundry service for personal clothing, or child care services while the staff is at the hospital providing patient care, according to the fact sheet.
Teaching hospitals will also receive more flexibility in using residents to provide health care services under the virtual direction of a teaching physician, who may be available through audio/video technology.
CMS also is temporarily eliminating paperwork requirements, and allowed greater use of verbal orders, to allow clinicians to spend more time on direct patient care.
On the device/equipment side, Medicare will cover respiratory-related devices and equipment “for any medical reason determined by clinicians,” according to the fact sheet, rather than only under certain circumstances.
And on the telehealth side, CMS is expanding the number of services that it will pay for via telehealth by more than 80, including emergency department visits, initial nursing facility and discharge visits, and home visits, which must be provided by a clinician that is allowed to provide telehealth. CMS will allow the use of commonly available interactive apps with audio and video, as well as audio-only phones.
Blood test might detect multiple cancer types, study suggests
Investigators led by Minetta C. Liu, MD, a medical oncologist with the Mayo Clinic, Rochester, Minn., studied 6,689 participants – 2,482 with cancers of more than 50 types and 4,207 without cancer – drawn from the Circulating Cell-free Genome Atlas Study and the STRIVE Study populations.
The investigators performed bisulfite sequencing that targeted informative methylation regions of plasma cell-free DNA (cfDNA), and developed and validated a molecular classifier using methylation patterns to detect cancer and determine its tissue of origin.
Test performance was assessed both for cancer overall and for a prespecified set of 12 cancers (anus, bladder, colon/rectum, esophagus, head and neck, liver/bile duct, lung, lymphoma, ovary, pancreas, plasma cell neoplasm, stomach) that account for about 63% of U.S. cancer deaths annually.
Results reported this week in the Annals of Oncology showed that the test had a specificity of 99.3% in the validation cohort, corresponding to a false-positive rate of just 0.7%.
Sensitivity for detecting stage I-III disease was 43.9% for cancer overall and 67.3% for the prespecified set of cancers accounting for the majority of U.S. cancer deaths.
Test sensitivity increased with stage both for cancer overall (18%, 43%, 81%, and 93% for stage I, II, III, and IV disease, respectively) and for the prespecified set of cancers (39%, 69%, 83%, and 92%, respectively).
The test was able to predict a tissue of origin in 96% of samples in which a cancerlike signal was detected, and in 93% of cases, that prediction was accurate.
Some of the patients who had cancer were symptomatic and therefore would not be considered a screening population, Dr. Liu and coinvestigators acknowledged. Also, the test’s potential for reducing mortality remains unknown, and 1-year follow-up to verify cancer-free status was not yet available for all of the individuals without cancer.
“Together, these data provide compelling evidence that targeted methylation analysis of cfDNA can detect and localize a broad range of nonmetastatic and metastatic cancer types including many common and deadly cancers that lack effective screening strategies,” they maintained. The test’s “specificity and sensitivity performance approach ... the goal for population-level screening.”
“Considering the potential value of early detection in deadly malignancies, further evaluation of this test is justified in prospective population-level studies,” the investigators conclude. “Clinical validation in intended use populations is ongoing ... and a study has been initiated that is returning results to health care providers and patients ....”
Dr. Liu disclosed that the Mayo Clinic was compensated for her advisory board activities for GRAIL Inc. The study was supported by GRAIL, and by Princess Margaret Cancer Centre’s McCain Genitourinary BioBank in the department of surgical oncology.
SOURCE: Liu MC et al. Ann Oncol. 2020 Mar 31. doi: 10.1016/j.annonc.2020.02.011.
Investigators led by Minetta C. Liu, MD, a medical oncologist with the Mayo Clinic, Rochester, Minn., studied 6,689 participants – 2,482 with cancers of more than 50 types and 4,207 without cancer – drawn from the Circulating Cell-free Genome Atlas Study and the STRIVE Study populations.
The investigators performed bisulfite sequencing that targeted informative methylation regions of plasma cell-free DNA (cfDNA), and developed and validated a molecular classifier using methylation patterns to detect cancer and determine its tissue of origin.
Test performance was assessed both for cancer overall and for a prespecified set of 12 cancers (anus, bladder, colon/rectum, esophagus, head and neck, liver/bile duct, lung, lymphoma, ovary, pancreas, plasma cell neoplasm, stomach) that account for about 63% of U.S. cancer deaths annually.
Results reported this week in the Annals of Oncology showed that the test had a specificity of 99.3% in the validation cohort, corresponding to a false-positive rate of just 0.7%.
Sensitivity for detecting stage I-III disease was 43.9% for cancer overall and 67.3% for the prespecified set of cancers accounting for the majority of U.S. cancer deaths.
Test sensitivity increased with stage both for cancer overall (18%, 43%, 81%, and 93% for stage I, II, III, and IV disease, respectively) and for the prespecified set of cancers (39%, 69%, 83%, and 92%, respectively).
The test was able to predict a tissue of origin in 96% of samples in which a cancerlike signal was detected, and in 93% of cases, that prediction was accurate.
Some of the patients who had cancer were symptomatic and therefore would not be considered a screening population, Dr. Liu and coinvestigators acknowledged. Also, the test’s potential for reducing mortality remains unknown, and 1-year follow-up to verify cancer-free status was not yet available for all of the individuals without cancer.
“Together, these data provide compelling evidence that targeted methylation analysis of cfDNA can detect and localize a broad range of nonmetastatic and metastatic cancer types including many common and deadly cancers that lack effective screening strategies,” they maintained. The test’s “specificity and sensitivity performance approach ... the goal for population-level screening.”
“Considering the potential value of early detection in deadly malignancies, further evaluation of this test is justified in prospective population-level studies,” the investigators conclude. “Clinical validation in intended use populations is ongoing ... and a study has been initiated that is returning results to health care providers and patients ....”
Dr. Liu disclosed that the Mayo Clinic was compensated for her advisory board activities for GRAIL Inc. The study was supported by GRAIL, and by Princess Margaret Cancer Centre’s McCain Genitourinary BioBank in the department of surgical oncology.
SOURCE: Liu MC et al. Ann Oncol. 2020 Mar 31. doi: 10.1016/j.annonc.2020.02.011.
Investigators led by Minetta C. Liu, MD, a medical oncologist with the Mayo Clinic, Rochester, Minn., studied 6,689 participants – 2,482 with cancers of more than 50 types and 4,207 without cancer – drawn from the Circulating Cell-free Genome Atlas Study and the STRIVE Study populations.
The investigators performed bisulfite sequencing that targeted informative methylation regions of plasma cell-free DNA (cfDNA), and developed and validated a molecular classifier using methylation patterns to detect cancer and determine its tissue of origin.
Test performance was assessed both for cancer overall and for a prespecified set of 12 cancers (anus, bladder, colon/rectum, esophagus, head and neck, liver/bile duct, lung, lymphoma, ovary, pancreas, plasma cell neoplasm, stomach) that account for about 63% of U.S. cancer deaths annually.
Results reported this week in the Annals of Oncology showed that the test had a specificity of 99.3% in the validation cohort, corresponding to a false-positive rate of just 0.7%.
Sensitivity for detecting stage I-III disease was 43.9% for cancer overall and 67.3% for the prespecified set of cancers accounting for the majority of U.S. cancer deaths.
Test sensitivity increased with stage both for cancer overall (18%, 43%, 81%, and 93% for stage I, II, III, and IV disease, respectively) and for the prespecified set of cancers (39%, 69%, 83%, and 92%, respectively).
The test was able to predict a tissue of origin in 96% of samples in which a cancerlike signal was detected, and in 93% of cases, that prediction was accurate.
Some of the patients who had cancer were symptomatic and therefore would not be considered a screening population, Dr. Liu and coinvestigators acknowledged. Also, the test’s potential for reducing mortality remains unknown, and 1-year follow-up to verify cancer-free status was not yet available for all of the individuals without cancer.
“Together, these data provide compelling evidence that targeted methylation analysis of cfDNA can detect and localize a broad range of nonmetastatic and metastatic cancer types including many common and deadly cancers that lack effective screening strategies,” they maintained. The test’s “specificity and sensitivity performance approach ... the goal for population-level screening.”
“Considering the potential value of early detection in deadly malignancies, further evaluation of this test is justified in prospective population-level studies,” the investigators conclude. “Clinical validation in intended use populations is ongoing ... and a study has been initiated that is returning results to health care providers and patients ....”
Dr. Liu disclosed that the Mayo Clinic was compensated for her advisory board activities for GRAIL Inc. The study was supported by GRAIL, and by Princess Margaret Cancer Centre’s McCain Genitourinary BioBank in the department of surgical oncology.
SOURCE: Liu MC et al. Ann Oncol. 2020 Mar 31. doi: 10.1016/j.annonc.2020.02.011.
FROM ANNALS OF ONCOLOGY
Top 10 must-dos in ICU in COVID-19 include prone ventilation
As the first international guidelines on the management of critically ill patients with COVID-19 are understandably comprehensive, one expert involved in their development highlights the essential recommendations and explains the rationale behind prone ventilation.
A panel of 39 experts from 12 countries from across the globe developed the 50 recommendations within four domains, under the auspices of the Surviving Sepsis Campaign. They are issued by the European Society of Intensive Care Medicine (ESICM), and will subsequently be published in the journal Intensive Care Medicine.
A central aspect of the guidance is what works, and what does not, in treating critically ill patients with COVID-19 in intensive care.
Ten of the recommendations cover potential pharmacotherapies, most of which have only weak or no evidence of benefit, as discussed in a recent perspective on Medscape. All 50 recommendations, along with the associated level of evidence, are detailed in table 2 in the paper.
There is also an algorithm for the management of patients with acute hypoxemic respiratory failure secondary to COVID-19 (figure 2) and a summary of clinical practice recommendations (figure 3).
In an editorial in the Journal of the American Medical Association issued just days after these new guidelines, Francois Lamontagne, MD, MSc, and Derek C. Angus, MD, MPH, say they “represent an excellent first step toward optimal, evidence-informed care for patients with COVID-19.” Lamontagne is from Universitaire de Sherbrooke, Canada, and Angus is from University of Pittsburgh School of Medicine, Pennsylvania, and is an associate editor with JAMA.
Dealing With Tide of COVID-19 Patients, Protecting Healthcare Workers
Editor in chief of Intensive Care Medicine Giuseppe Citerio, MD, from University of Milano-Bicocca, Monza, Italy, said: “COVID-19 cases are rising rapidly worldwide, and so we are increasingly seeing that intensive care units [ICUs] have difficulty in dealing with the tide of patients.”
“We need more resource in ICUs, and quickly. This means more ventilators and more trained personnel. In the meantime, this guidance aims to rationalize our approach and to avoid unproven strategies,” he explains in a press release from ESICM.
“This is the first guidance to lay out what works and what doesn’t in treating coronavirus-infected patients in intensive care. It’s based on decades of research on acute respiratory infection being applied to COVID-19 patients,” added ESICM President-Elect Maurizio Cecconi, MD, from Humanitas University, Milan, Italy.
“At the same time as caring for patients, we need to make sure that health workers are following procedures which will allow themselves to be protected against infection,” he stressed.
“We must protect them, they are in the frontline. We cannot allow our healthcare workers to be at risk. On top of that, if they get infected they could also spread the disease further.”
Top-10 Recommendations
While all 50 recommendations are key to the successful management of COVID-19 patients, busy clinicians on the frontline need to zone in on those indispensable practical recommendations that they should implement immediately.
Medscape Medical News therefore asked lead author Waleed Alhazzani, MD, MSc, from the Division of Critical Care, McMaster University, Hamilton, Canada, to give his personal top 10, the first three of which are focused on limiting the spread of infection.
1. For healthcare workers performing aerosol-generating procedures1 on patients with COVID-19 in the ICU, we recommend using fitted respirator masks (N95 respirators, FFP2, or equivalent), as compared to surgical/medical masks, in addition to other personal protective equipment (eg, gloves, gown, and eye protection such as a face shield or safety goggles.
2. We recommend performing aerosol-generating procedures on ICU patients with COVID-19 in a negative-pressure room.
3. For healthcare workers providing usual care for nonventilated COVID-19 patients, we suggest using surgical/medical masks, as compared to respirator masks in addition to other personal protective equipment.
4. For healthcare workers performing endotracheal intubation on patients with COVID-19, we suggest using video guided laryngoscopy, over direct laryngoscopy, if available.
5. We recommend endotracheal intubation in patients with COVID-19, performed by healthcare workers experienced with airway management, to minimize the number of attempts and risk of transmission.
6. For intubated and mechanically ventilated adults with suspicion of COVID-19, we suggest obtaining endotracheal aspirates, over bronchial wash or bronchoalveolar lavage samples.
7. For adults with COVID-19 and acute hypoxemic respiratory failure, we suggest using high-flow nasal cannula [HFNC] over noninvasive positive pressure ventilation [NIPPV].
8. For adults with COVID-19 receiving NIPPV or HFNC, we recommend close monitoring for worsening of respiratory status and early intubation in a controlled setting if worsening occurs.
9. For mechanically ventilated adults with COVID-19 and moderate to severe acute respiratory distress syndrome [ARDS], we suggest prone ventilation for 12 to 16 hours over no prone ventilation.
10. For mechanically ventilated adults with COVID-19 and respiratory failure (without ARDS), we don’t recommend routine use of systemic corticosteroids.
1 This includes endotracheal intubation, bronchoscopy, open suctioning, administration of nebulized treatment, manual ventilation before intubation, physical proning of the patient, disconnecting the patient from the ventilator, noninvasive positive pressure ventilation, tracheostomy, and cardiopulmonary resuscitation.
These choices are in broad agreement with those selected by Jason T. Poston, MD, University of Chicago, Illinois, and colleagues in their synopsis of these guidelines, published online March 26 in JAMA, although they also highlight another recommendation on infection control:
- For healthcare workers who are performing non-aerosol-generating procedures on mechanically ventilated (closed circuit) patients with COVID-19, we suggest using surgical/medical masks, as opposed to respirator masks, in addition to other personal protective equipment.
Importance of Prone Ventilation, Perhaps for Many Days
One recommendation singled out by both Alhazzani and coauthors, and Poston and colleagues, relates to prone ventilation for 12 to 16 hours in adults with moderate to severe ARDS receiving mechanical ventilation.
Michelle N. Gong, MD, MS, chief of critical care medicine at Montefiore Medical Center, New York City, also highlighted this practice in a live-stream interview with JAMA editor in chief Howard Bauchner, MD.
She explained that, in her institution, they have been “very aggressive about proning these patients as early as possible, but unlike some of the past ARDS patients…they tend to require many, many days of proning in order to get a response”.
Gong added that patients “may improve very rapidly when they are proned, but when we supinate them, they lose [the improvement] and then they get proned for upwards of 10 days or more, if need be.”
Alhazzani told Medscape Medical News that prone ventilation “is a simple intervention that requires training of healthcare providers but can be applied in most contexts.”
He explained that the recommendation “is driven by indirect evidence from ARDS,” not specifically those in COVID-19, with recent studies having shown that COVID-19 “can affect lung bases and may cause significant atelectasis and reduced lung compliance in the context of ARDS.”
“Prone ventilation has been shown to reduce mortality in patients with moderate to severe ARDS. Therefore, we issued a suggestion for clinicians to consider prone ventilation in this population.”
‘Impressively Thorough’ Recommendations, With Some Caveats
In their JAMA editorial, Lamontagne and Angus describe the recommendations as “impressively thorough and expansive.”
They note that they address resource scarcity, which “is likely to be a critical issue in low- and middle-income countries experiencing any reasonably large number of cases and in high-income countries experiencing a surge in the demand for critical care.”
The authors say, however, that a “weakness” of the guidelines is that they make recommendations for interventions that “lack supporting evidence.”
Consequently, “when prioritizing scarce resources, clinicians and healthcare systems will have to choose among options that have limited evidence to support them.”
“In future iterations of the guidelines, there should be more detailed recommendations for how clinicians should prioritize scarce resources, or include more recommendations against the use of unproven therapies.”
“The tasks ahead for the dissemination and uptake of optimal critical care are herculean,” Lamontagne and Angus say.
They include “a need to generate more robust evidence, consider carefully the application of that evidence across a wide variety of clinical circumstances, and generate supporting materials to ensure effective implementation of the guideline recommendations,” they conclude.
ESICM recommendations coauthor Yaseen Arabi is the principal investigator on a clinical trial for lopinavir/ritonavir and interferon in Middle East respiratory syndrome (MERS) and he was a nonpaid consultant on antiviral active for MERS- coronavirus (CoV) for Gilead Sciences and SAB Biotherapeutics. He is an investigator on REMAP-CAP trial and is a Board Members of the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC). Coauthor Eddy Fan declared receiving consultancy fees from ALung Technologies and MC3 Cardiopulmonary. Coauthor Maurizio Cecconi declared consultancy work with Edwards Lifesciences, Directed Systems, and Cheetah Medical.
JAMA Clinical Guidelines Synopsis coauthor Poston declares receiving honoraria for the CHEST Critical Care Board Review Course.
Editorialist Lamontagne reported receiving grants from the National Institute for Health Research (NIHR), Fonds de recherche du Québec-Santé, and the Lotte & John Hecht Foundation, unrelated to this work. Editorialist Angus participated in the development of Surviving Sepsis Campaign guidelines for sepsis, but had no role in the creation of the current COVID-19 guidelines, nor the decision to create these guidelines.
This article first appeared on Medscape.com.
As the first international guidelines on the management of critically ill patients with COVID-19 are understandably comprehensive, one expert involved in their development highlights the essential recommendations and explains the rationale behind prone ventilation.
A panel of 39 experts from 12 countries from across the globe developed the 50 recommendations within four domains, under the auspices of the Surviving Sepsis Campaign. They are issued by the European Society of Intensive Care Medicine (ESICM), and will subsequently be published in the journal Intensive Care Medicine.
A central aspect of the guidance is what works, and what does not, in treating critically ill patients with COVID-19 in intensive care.
Ten of the recommendations cover potential pharmacotherapies, most of which have only weak or no evidence of benefit, as discussed in a recent perspective on Medscape. All 50 recommendations, along with the associated level of evidence, are detailed in table 2 in the paper.
There is also an algorithm for the management of patients with acute hypoxemic respiratory failure secondary to COVID-19 (figure 2) and a summary of clinical practice recommendations (figure 3).
In an editorial in the Journal of the American Medical Association issued just days after these new guidelines, Francois Lamontagne, MD, MSc, and Derek C. Angus, MD, MPH, say they “represent an excellent first step toward optimal, evidence-informed care for patients with COVID-19.” Lamontagne is from Universitaire de Sherbrooke, Canada, and Angus is from University of Pittsburgh School of Medicine, Pennsylvania, and is an associate editor with JAMA.
Dealing With Tide of COVID-19 Patients, Protecting Healthcare Workers
Editor in chief of Intensive Care Medicine Giuseppe Citerio, MD, from University of Milano-Bicocca, Monza, Italy, said: “COVID-19 cases are rising rapidly worldwide, and so we are increasingly seeing that intensive care units [ICUs] have difficulty in dealing with the tide of patients.”
“We need more resource in ICUs, and quickly. This means more ventilators and more trained personnel. In the meantime, this guidance aims to rationalize our approach and to avoid unproven strategies,” he explains in a press release from ESICM.
“This is the first guidance to lay out what works and what doesn’t in treating coronavirus-infected patients in intensive care. It’s based on decades of research on acute respiratory infection being applied to COVID-19 patients,” added ESICM President-Elect Maurizio Cecconi, MD, from Humanitas University, Milan, Italy.
“At the same time as caring for patients, we need to make sure that health workers are following procedures which will allow themselves to be protected against infection,” he stressed.
“We must protect them, they are in the frontline. We cannot allow our healthcare workers to be at risk. On top of that, if they get infected they could also spread the disease further.”
Top-10 Recommendations
While all 50 recommendations are key to the successful management of COVID-19 patients, busy clinicians on the frontline need to zone in on those indispensable practical recommendations that they should implement immediately.
Medscape Medical News therefore asked lead author Waleed Alhazzani, MD, MSc, from the Division of Critical Care, McMaster University, Hamilton, Canada, to give his personal top 10, the first three of which are focused on limiting the spread of infection.
1. For healthcare workers performing aerosol-generating procedures1 on patients with COVID-19 in the ICU, we recommend using fitted respirator masks (N95 respirators, FFP2, or equivalent), as compared to surgical/medical masks, in addition to other personal protective equipment (eg, gloves, gown, and eye protection such as a face shield or safety goggles.
2. We recommend performing aerosol-generating procedures on ICU patients with COVID-19 in a negative-pressure room.
3. For healthcare workers providing usual care for nonventilated COVID-19 patients, we suggest using surgical/medical masks, as compared to respirator masks in addition to other personal protective equipment.
4. For healthcare workers performing endotracheal intubation on patients with COVID-19, we suggest using video guided laryngoscopy, over direct laryngoscopy, if available.
5. We recommend endotracheal intubation in patients with COVID-19, performed by healthcare workers experienced with airway management, to minimize the number of attempts and risk of transmission.
6. For intubated and mechanically ventilated adults with suspicion of COVID-19, we suggest obtaining endotracheal aspirates, over bronchial wash or bronchoalveolar lavage samples.
7. For adults with COVID-19 and acute hypoxemic respiratory failure, we suggest using high-flow nasal cannula [HFNC] over noninvasive positive pressure ventilation [NIPPV].
8. For adults with COVID-19 receiving NIPPV or HFNC, we recommend close monitoring for worsening of respiratory status and early intubation in a controlled setting if worsening occurs.
9. For mechanically ventilated adults with COVID-19 and moderate to severe acute respiratory distress syndrome [ARDS], we suggest prone ventilation for 12 to 16 hours over no prone ventilation.
10. For mechanically ventilated adults with COVID-19 and respiratory failure (without ARDS), we don’t recommend routine use of systemic corticosteroids.
1 This includes endotracheal intubation, bronchoscopy, open suctioning, administration of nebulized treatment, manual ventilation before intubation, physical proning of the patient, disconnecting the patient from the ventilator, noninvasive positive pressure ventilation, tracheostomy, and cardiopulmonary resuscitation.
These choices are in broad agreement with those selected by Jason T. Poston, MD, University of Chicago, Illinois, and colleagues in their synopsis of these guidelines, published online March 26 in JAMA, although they also highlight another recommendation on infection control:
- For healthcare workers who are performing non-aerosol-generating procedures on mechanically ventilated (closed circuit) patients with COVID-19, we suggest using surgical/medical masks, as opposed to respirator masks, in addition to other personal protective equipment.
Importance of Prone Ventilation, Perhaps for Many Days
One recommendation singled out by both Alhazzani and coauthors, and Poston and colleagues, relates to prone ventilation for 12 to 16 hours in adults with moderate to severe ARDS receiving mechanical ventilation.
Michelle N. Gong, MD, MS, chief of critical care medicine at Montefiore Medical Center, New York City, also highlighted this practice in a live-stream interview with JAMA editor in chief Howard Bauchner, MD.
She explained that, in her institution, they have been “very aggressive about proning these patients as early as possible, but unlike some of the past ARDS patients…they tend to require many, many days of proning in order to get a response”.
Gong added that patients “may improve very rapidly when they are proned, but when we supinate them, they lose [the improvement] and then they get proned for upwards of 10 days or more, if need be.”
Alhazzani told Medscape Medical News that prone ventilation “is a simple intervention that requires training of healthcare providers but can be applied in most contexts.”
He explained that the recommendation “is driven by indirect evidence from ARDS,” not specifically those in COVID-19, with recent studies having shown that COVID-19 “can affect lung bases and may cause significant atelectasis and reduced lung compliance in the context of ARDS.”
“Prone ventilation has been shown to reduce mortality in patients with moderate to severe ARDS. Therefore, we issued a suggestion for clinicians to consider prone ventilation in this population.”
‘Impressively Thorough’ Recommendations, With Some Caveats
In their JAMA editorial, Lamontagne and Angus describe the recommendations as “impressively thorough and expansive.”
They note that they address resource scarcity, which “is likely to be a critical issue in low- and middle-income countries experiencing any reasonably large number of cases and in high-income countries experiencing a surge in the demand for critical care.”
The authors say, however, that a “weakness” of the guidelines is that they make recommendations for interventions that “lack supporting evidence.”
Consequently, “when prioritizing scarce resources, clinicians and healthcare systems will have to choose among options that have limited evidence to support them.”
“In future iterations of the guidelines, there should be more detailed recommendations for how clinicians should prioritize scarce resources, or include more recommendations against the use of unproven therapies.”
“The tasks ahead for the dissemination and uptake of optimal critical care are herculean,” Lamontagne and Angus say.
They include “a need to generate more robust evidence, consider carefully the application of that evidence across a wide variety of clinical circumstances, and generate supporting materials to ensure effective implementation of the guideline recommendations,” they conclude.
ESICM recommendations coauthor Yaseen Arabi is the principal investigator on a clinical trial for lopinavir/ritonavir and interferon in Middle East respiratory syndrome (MERS) and he was a nonpaid consultant on antiviral active for MERS- coronavirus (CoV) for Gilead Sciences and SAB Biotherapeutics. He is an investigator on REMAP-CAP trial and is a Board Members of the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC). Coauthor Eddy Fan declared receiving consultancy fees from ALung Technologies and MC3 Cardiopulmonary. Coauthor Maurizio Cecconi declared consultancy work with Edwards Lifesciences, Directed Systems, and Cheetah Medical.
JAMA Clinical Guidelines Synopsis coauthor Poston declares receiving honoraria for the CHEST Critical Care Board Review Course.
Editorialist Lamontagne reported receiving grants from the National Institute for Health Research (NIHR), Fonds de recherche du Québec-Santé, and the Lotte & John Hecht Foundation, unrelated to this work. Editorialist Angus participated in the development of Surviving Sepsis Campaign guidelines for sepsis, but had no role in the creation of the current COVID-19 guidelines, nor the decision to create these guidelines.
This article first appeared on Medscape.com.
As the first international guidelines on the management of critically ill patients with COVID-19 are understandably comprehensive, one expert involved in their development highlights the essential recommendations and explains the rationale behind prone ventilation.
A panel of 39 experts from 12 countries from across the globe developed the 50 recommendations within four domains, under the auspices of the Surviving Sepsis Campaign. They are issued by the European Society of Intensive Care Medicine (ESICM), and will subsequently be published in the journal Intensive Care Medicine.
A central aspect of the guidance is what works, and what does not, in treating critically ill patients with COVID-19 in intensive care.
Ten of the recommendations cover potential pharmacotherapies, most of which have only weak or no evidence of benefit, as discussed in a recent perspective on Medscape. All 50 recommendations, along with the associated level of evidence, are detailed in table 2 in the paper.
There is also an algorithm for the management of patients with acute hypoxemic respiratory failure secondary to COVID-19 (figure 2) and a summary of clinical practice recommendations (figure 3).
In an editorial in the Journal of the American Medical Association issued just days after these new guidelines, Francois Lamontagne, MD, MSc, and Derek C. Angus, MD, MPH, say they “represent an excellent first step toward optimal, evidence-informed care for patients with COVID-19.” Lamontagne is from Universitaire de Sherbrooke, Canada, and Angus is from University of Pittsburgh School of Medicine, Pennsylvania, and is an associate editor with JAMA.
Dealing With Tide of COVID-19 Patients, Protecting Healthcare Workers
Editor in chief of Intensive Care Medicine Giuseppe Citerio, MD, from University of Milano-Bicocca, Monza, Italy, said: “COVID-19 cases are rising rapidly worldwide, and so we are increasingly seeing that intensive care units [ICUs] have difficulty in dealing with the tide of patients.”
“We need more resource in ICUs, and quickly. This means more ventilators and more trained personnel. In the meantime, this guidance aims to rationalize our approach and to avoid unproven strategies,” he explains in a press release from ESICM.
“This is the first guidance to lay out what works and what doesn’t in treating coronavirus-infected patients in intensive care. It’s based on decades of research on acute respiratory infection being applied to COVID-19 patients,” added ESICM President-Elect Maurizio Cecconi, MD, from Humanitas University, Milan, Italy.
“At the same time as caring for patients, we need to make sure that health workers are following procedures which will allow themselves to be protected against infection,” he stressed.
“We must protect them, they are in the frontline. We cannot allow our healthcare workers to be at risk. On top of that, if they get infected they could also spread the disease further.”
Top-10 Recommendations
While all 50 recommendations are key to the successful management of COVID-19 patients, busy clinicians on the frontline need to zone in on those indispensable practical recommendations that they should implement immediately.
Medscape Medical News therefore asked lead author Waleed Alhazzani, MD, MSc, from the Division of Critical Care, McMaster University, Hamilton, Canada, to give his personal top 10, the first three of which are focused on limiting the spread of infection.
1. For healthcare workers performing aerosol-generating procedures1 on patients with COVID-19 in the ICU, we recommend using fitted respirator masks (N95 respirators, FFP2, or equivalent), as compared to surgical/medical masks, in addition to other personal protective equipment (eg, gloves, gown, and eye protection such as a face shield or safety goggles.
2. We recommend performing aerosol-generating procedures on ICU patients with COVID-19 in a negative-pressure room.
3. For healthcare workers providing usual care for nonventilated COVID-19 patients, we suggest using surgical/medical masks, as compared to respirator masks in addition to other personal protective equipment.
4. For healthcare workers performing endotracheal intubation on patients with COVID-19, we suggest using video guided laryngoscopy, over direct laryngoscopy, if available.
5. We recommend endotracheal intubation in patients with COVID-19, performed by healthcare workers experienced with airway management, to minimize the number of attempts and risk of transmission.
6. For intubated and mechanically ventilated adults with suspicion of COVID-19, we suggest obtaining endotracheal aspirates, over bronchial wash or bronchoalveolar lavage samples.
7. For adults with COVID-19 and acute hypoxemic respiratory failure, we suggest using high-flow nasal cannula [HFNC] over noninvasive positive pressure ventilation [NIPPV].
8. For adults with COVID-19 receiving NIPPV or HFNC, we recommend close monitoring for worsening of respiratory status and early intubation in a controlled setting if worsening occurs.
9. For mechanically ventilated adults with COVID-19 and moderate to severe acute respiratory distress syndrome [ARDS], we suggest prone ventilation for 12 to 16 hours over no prone ventilation.
10. For mechanically ventilated adults with COVID-19 and respiratory failure (without ARDS), we don’t recommend routine use of systemic corticosteroids.
1 This includes endotracheal intubation, bronchoscopy, open suctioning, administration of nebulized treatment, manual ventilation before intubation, physical proning of the patient, disconnecting the patient from the ventilator, noninvasive positive pressure ventilation, tracheostomy, and cardiopulmonary resuscitation.
These choices are in broad agreement with those selected by Jason T. Poston, MD, University of Chicago, Illinois, and colleagues in their synopsis of these guidelines, published online March 26 in JAMA, although they also highlight another recommendation on infection control:
- For healthcare workers who are performing non-aerosol-generating procedures on mechanically ventilated (closed circuit) patients with COVID-19, we suggest using surgical/medical masks, as opposed to respirator masks, in addition to other personal protective equipment.
Importance of Prone Ventilation, Perhaps for Many Days
One recommendation singled out by both Alhazzani and coauthors, and Poston and colleagues, relates to prone ventilation for 12 to 16 hours in adults with moderate to severe ARDS receiving mechanical ventilation.
Michelle N. Gong, MD, MS, chief of critical care medicine at Montefiore Medical Center, New York City, also highlighted this practice in a live-stream interview with JAMA editor in chief Howard Bauchner, MD.
She explained that, in her institution, they have been “very aggressive about proning these patients as early as possible, but unlike some of the past ARDS patients…they tend to require many, many days of proning in order to get a response”.
Gong added that patients “may improve very rapidly when they are proned, but when we supinate them, they lose [the improvement] and then they get proned for upwards of 10 days or more, if need be.”
Alhazzani told Medscape Medical News that prone ventilation “is a simple intervention that requires training of healthcare providers but can be applied in most contexts.”
He explained that the recommendation “is driven by indirect evidence from ARDS,” not specifically those in COVID-19, with recent studies having shown that COVID-19 “can affect lung bases and may cause significant atelectasis and reduced lung compliance in the context of ARDS.”
“Prone ventilation has been shown to reduce mortality in patients with moderate to severe ARDS. Therefore, we issued a suggestion for clinicians to consider prone ventilation in this population.”
‘Impressively Thorough’ Recommendations, With Some Caveats
In their JAMA editorial, Lamontagne and Angus describe the recommendations as “impressively thorough and expansive.”
They note that they address resource scarcity, which “is likely to be a critical issue in low- and middle-income countries experiencing any reasonably large number of cases and in high-income countries experiencing a surge in the demand for critical care.”
The authors say, however, that a “weakness” of the guidelines is that they make recommendations for interventions that “lack supporting evidence.”
Consequently, “when prioritizing scarce resources, clinicians and healthcare systems will have to choose among options that have limited evidence to support them.”
“In future iterations of the guidelines, there should be more detailed recommendations for how clinicians should prioritize scarce resources, or include more recommendations against the use of unproven therapies.”
“The tasks ahead for the dissemination and uptake of optimal critical care are herculean,” Lamontagne and Angus say.
They include “a need to generate more robust evidence, consider carefully the application of that evidence across a wide variety of clinical circumstances, and generate supporting materials to ensure effective implementation of the guideline recommendations,” they conclude.
ESICM recommendations coauthor Yaseen Arabi is the principal investigator on a clinical trial for lopinavir/ritonavir and interferon in Middle East respiratory syndrome (MERS) and he was a nonpaid consultant on antiviral active for MERS- coronavirus (CoV) for Gilead Sciences and SAB Biotherapeutics. He is an investigator on REMAP-CAP trial and is a Board Members of the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC). Coauthor Eddy Fan declared receiving consultancy fees from ALung Technologies and MC3 Cardiopulmonary. Coauthor Maurizio Cecconi declared consultancy work with Edwards Lifesciences, Directed Systems, and Cheetah Medical.
JAMA Clinical Guidelines Synopsis coauthor Poston declares receiving honoraria for the CHEST Critical Care Board Review Course.
Editorialist Lamontagne reported receiving grants from the National Institute for Health Research (NIHR), Fonds de recherche du Québec-Santé, and the Lotte & John Hecht Foundation, unrelated to this work. Editorialist Angus participated in the development of Surviving Sepsis Campaign guidelines for sepsis, but had no role in the creation of the current COVID-19 guidelines, nor the decision to create these guidelines.
This article first appeared on Medscape.com.
‘We will get through this’: Advice for lessening your pandemic anxiety
The COVID-19 pandemic is an experience that is unprecedented in our lifetime. It is having a pervasive effect due to how mysterious, potentially dangerous, and sustained it is. We don’t know how bad it’s going to get or how long it’s going to last. We have natural disasters like hurricanes and earthquakes, but they are limited in time and scope. But this global pandemic is something we can’t put our arms around just yet, breeding uncertainty, worry, and fear. This is where mental health professionals need to come in.
The populations being affected by this pandemic can be placed into different groups on the basis of their mental health consequences and needs. First you have, for lack of a better term, “the worried well.” These are people with no preexisting mental disorder who are naturally worried by this and are trying to take appropriate actions to protect themselves and prepare. For such individuals, the equivalent of mental health first-aid should be useful (we’ll come back to that in a moment). Given the proper guidance and sources of information, most such people should be able to manage the anxiety, worry, and dysphoria associated with this critical pandemic.
Then there are those who have preexisting mental conditions related to mood, anxiety, stress, or obsessive tendencies. They are probably going to have an increase in their symptoms, and as such, a corresponding need for adjusting treatment. This may require an increase in their existing medications or the addition of an ad hoc medication, or perhaps more frequent contact with their doctor or therapist.
Because travel and direct visitation is discouraged at the moment, virtual methods of communication should be used to speak with these patients. Such methods have long existed but haven’t been adopted in large numbers; this may be the impetus to finally make it happen. Using the telephone, FaceTime, Skype, WebEx, Zoom, and other means of videoconferencing should be feasible. As billing procedures are being adapted for this moment, there’s no reason why individuals shouldn’t be able to contact their mental health provider.
Substance abuse is also a condition vulnerable to the stress effects of this pandemic. This will prompt or tempt those to use substances that they’ve abused or turned to in the past as a way of self-medicating and assuaging their anxiety and worry.
It’s possible that the pandemic could find its way into delusions or exacerbate symptoms, but somewhat paradoxically, people with serious mental illnesses often respond more calmly to crises than do individuals without them. As a result, the number of these patients requiring emergency room admission for possible exacerbation of symptoms is probably not going to be that much greater than normal.
How to Cope With an Unprecedented Situation
For the worried well and for the clinicians who have understandable fears about exposure, there are several things you can try to manage your anxiety. There are concentric circles of concern that you have to maintain. Think of it like the instructions on an airplane when, if there’s a drop in cabin pressure, you’re asked to apply your own oxygen mask first before placing one on your child. In the same way, you must first think about protecting yourself by limiting your exposure and monitoring your own physical state for any symptoms. But then you must be concerned about your family, your friends, and also society. This is a situation where the impulse and the ethos of worrying about your fellow persons—being your brother’s keeper—is imperative.
The epidemic has been successfully managed in some countries, like Singapore and China, which, once they got on top of it, were able to limit contagion in a very dramatic way. But these are authoritarian governments. The United States doesn’t work that way, which is what makes appealing to the principle of caring for others so crucial. You can protect yourself, but if other people aren’t also protected, it may not matter. You have to worry not just about yourself but about everyone else.
When it comes to stress management, I recommend not catastrophizing or watching the news media 24/7. Distract yourself with other work or recreational activities. Reach out and communicate—virtually, of course—with friends, family, and healthcare providers as needed. Staying in touch acts not just as a diversion but also as an outlet for assuaging your feelings, your sense of being in this alone, feeling isolated.
There are also cognitive reframing mechanisms you can employ. Consider that although this is bad, some countries have already gone through it. And we’ll get through it too. You’ll understandably ask yourself what it would mean if you were to be exposed. In most cases you can say, “I’m going to have the flu and symptoms that are not going to be pleasant, but I’ve had the flu or serious sickness before.”
Remember that there are already antiretroviral treatments being tested in clinical trials and showing efficacy. It’s good to know that before this pandemic ends, some of these treatments will probably be clinically applied, mostly to those who are severely affected and in intensive care.
Diagnose yourself. Monitor your state. Determine whether the stress is really having an impact on you. Is it affecting your sleep, appetite, concentration, mood? And if you do have a preexisting psychiatric condition, don’t feel afraid to reach out to your mental health provider. Understand that you’re going to be anxious, which may aggravate your symptoms and require an adjustment in your treatment. That’s okay. It’s to be expected and your provider should be available to help you.
Controlling this outbreak via the same epidemiologic infectious disease prevention guidance that works in authoritarian societies is not going to be applicable here because of the liberties that we experience in American society. What will determine our success is the belief that we’re in this together, that we’re going to help each other. We should be proud of that, as it shows how Americans and people around the world stand up in situations like this.
Let’s also note that even though everybody is affected and undergoing previously unimaginable levels of anticipated stress and dislocation, it’s the healthcare providers who are really on the frontlines. They’re under tremendous pressure to continue to perform heroically, at great risk to themselves. They deserve a real debt of gratitude.
We will get through this, but as we do, it will not end until we’ve undergone an extreme test of our character. I certainly hope and trust that we will be up to it.
Dr. Jeffrey A. Lieberman is chairman of the Department of Psychiatry at Columbia University. He is a former president of the American Psychiatric Association.
Disclosure: Jeffrey A. Lieberman, MD, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for Clintara; Intracellular Therapies. Received research grant from Alkermes; Biomarin; EnVivo/Forum; Genentech; Novartis/Novation; Sunovion. Patent: Repligen.
This article first appeared on Medscape.com.
The COVID-19 pandemic is an experience that is unprecedented in our lifetime. It is having a pervasive effect due to how mysterious, potentially dangerous, and sustained it is. We don’t know how bad it’s going to get or how long it’s going to last. We have natural disasters like hurricanes and earthquakes, but they are limited in time and scope. But this global pandemic is something we can’t put our arms around just yet, breeding uncertainty, worry, and fear. This is where mental health professionals need to come in.
The populations being affected by this pandemic can be placed into different groups on the basis of their mental health consequences and needs. First you have, for lack of a better term, “the worried well.” These are people with no preexisting mental disorder who are naturally worried by this and are trying to take appropriate actions to protect themselves and prepare. For such individuals, the equivalent of mental health first-aid should be useful (we’ll come back to that in a moment). Given the proper guidance and sources of information, most such people should be able to manage the anxiety, worry, and dysphoria associated with this critical pandemic.
Then there are those who have preexisting mental conditions related to mood, anxiety, stress, or obsessive tendencies. They are probably going to have an increase in their symptoms, and as such, a corresponding need for adjusting treatment. This may require an increase in their existing medications or the addition of an ad hoc medication, or perhaps more frequent contact with their doctor or therapist.
Because travel and direct visitation is discouraged at the moment, virtual methods of communication should be used to speak with these patients. Such methods have long existed but haven’t been adopted in large numbers; this may be the impetus to finally make it happen. Using the telephone, FaceTime, Skype, WebEx, Zoom, and other means of videoconferencing should be feasible. As billing procedures are being adapted for this moment, there’s no reason why individuals shouldn’t be able to contact their mental health provider.
Substance abuse is also a condition vulnerable to the stress effects of this pandemic. This will prompt or tempt those to use substances that they’ve abused or turned to in the past as a way of self-medicating and assuaging their anxiety and worry.
It’s possible that the pandemic could find its way into delusions or exacerbate symptoms, but somewhat paradoxically, people with serious mental illnesses often respond more calmly to crises than do individuals without them. As a result, the number of these patients requiring emergency room admission for possible exacerbation of symptoms is probably not going to be that much greater than normal.
How to Cope With an Unprecedented Situation
For the worried well and for the clinicians who have understandable fears about exposure, there are several things you can try to manage your anxiety. There are concentric circles of concern that you have to maintain. Think of it like the instructions on an airplane when, if there’s a drop in cabin pressure, you’re asked to apply your own oxygen mask first before placing one on your child. In the same way, you must first think about protecting yourself by limiting your exposure and monitoring your own physical state for any symptoms. But then you must be concerned about your family, your friends, and also society. This is a situation where the impulse and the ethos of worrying about your fellow persons—being your brother’s keeper—is imperative.
The epidemic has been successfully managed in some countries, like Singapore and China, which, once they got on top of it, were able to limit contagion in a very dramatic way. But these are authoritarian governments. The United States doesn’t work that way, which is what makes appealing to the principle of caring for others so crucial. You can protect yourself, but if other people aren’t also protected, it may not matter. You have to worry not just about yourself but about everyone else.
When it comes to stress management, I recommend not catastrophizing or watching the news media 24/7. Distract yourself with other work or recreational activities. Reach out and communicate—virtually, of course—with friends, family, and healthcare providers as needed. Staying in touch acts not just as a diversion but also as an outlet for assuaging your feelings, your sense of being in this alone, feeling isolated.
There are also cognitive reframing mechanisms you can employ. Consider that although this is bad, some countries have already gone through it. And we’ll get through it too. You’ll understandably ask yourself what it would mean if you were to be exposed. In most cases you can say, “I’m going to have the flu and symptoms that are not going to be pleasant, but I’ve had the flu or serious sickness before.”
Remember that there are already antiretroviral treatments being tested in clinical trials and showing efficacy. It’s good to know that before this pandemic ends, some of these treatments will probably be clinically applied, mostly to those who are severely affected and in intensive care.
Diagnose yourself. Monitor your state. Determine whether the stress is really having an impact on you. Is it affecting your sleep, appetite, concentration, mood? And if you do have a preexisting psychiatric condition, don’t feel afraid to reach out to your mental health provider. Understand that you’re going to be anxious, which may aggravate your symptoms and require an adjustment in your treatment. That’s okay. It’s to be expected and your provider should be available to help you.
Controlling this outbreak via the same epidemiologic infectious disease prevention guidance that works in authoritarian societies is not going to be applicable here because of the liberties that we experience in American society. What will determine our success is the belief that we’re in this together, that we’re going to help each other. We should be proud of that, as it shows how Americans and people around the world stand up in situations like this.
Let’s also note that even though everybody is affected and undergoing previously unimaginable levels of anticipated stress and dislocation, it’s the healthcare providers who are really on the frontlines. They’re under tremendous pressure to continue to perform heroically, at great risk to themselves. They deserve a real debt of gratitude.
We will get through this, but as we do, it will not end until we’ve undergone an extreme test of our character. I certainly hope and trust that we will be up to it.
Dr. Jeffrey A. Lieberman is chairman of the Department of Psychiatry at Columbia University. He is a former president of the American Psychiatric Association.
Disclosure: Jeffrey A. Lieberman, MD, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for Clintara; Intracellular Therapies. Received research grant from Alkermes; Biomarin; EnVivo/Forum; Genentech; Novartis/Novation; Sunovion. Patent: Repligen.
This article first appeared on Medscape.com.
The COVID-19 pandemic is an experience that is unprecedented in our lifetime. It is having a pervasive effect due to how mysterious, potentially dangerous, and sustained it is. We don’t know how bad it’s going to get or how long it’s going to last. We have natural disasters like hurricanes and earthquakes, but they are limited in time and scope. But this global pandemic is something we can’t put our arms around just yet, breeding uncertainty, worry, and fear. This is where mental health professionals need to come in.
The populations being affected by this pandemic can be placed into different groups on the basis of their mental health consequences and needs. First you have, for lack of a better term, “the worried well.” These are people with no preexisting mental disorder who are naturally worried by this and are trying to take appropriate actions to protect themselves and prepare. For such individuals, the equivalent of mental health first-aid should be useful (we’ll come back to that in a moment). Given the proper guidance and sources of information, most such people should be able to manage the anxiety, worry, and dysphoria associated with this critical pandemic.
Then there are those who have preexisting mental conditions related to mood, anxiety, stress, or obsessive tendencies. They are probably going to have an increase in their symptoms, and as such, a corresponding need for adjusting treatment. This may require an increase in their existing medications or the addition of an ad hoc medication, or perhaps more frequent contact with their doctor or therapist.
Because travel and direct visitation is discouraged at the moment, virtual methods of communication should be used to speak with these patients. Such methods have long existed but haven’t been adopted in large numbers; this may be the impetus to finally make it happen. Using the telephone, FaceTime, Skype, WebEx, Zoom, and other means of videoconferencing should be feasible. As billing procedures are being adapted for this moment, there’s no reason why individuals shouldn’t be able to contact their mental health provider.
Substance abuse is also a condition vulnerable to the stress effects of this pandemic. This will prompt or tempt those to use substances that they’ve abused or turned to in the past as a way of self-medicating and assuaging their anxiety and worry.
It’s possible that the pandemic could find its way into delusions or exacerbate symptoms, but somewhat paradoxically, people with serious mental illnesses often respond more calmly to crises than do individuals without them. As a result, the number of these patients requiring emergency room admission for possible exacerbation of symptoms is probably not going to be that much greater than normal.
How to Cope With an Unprecedented Situation
For the worried well and for the clinicians who have understandable fears about exposure, there are several things you can try to manage your anxiety. There are concentric circles of concern that you have to maintain. Think of it like the instructions on an airplane when, if there’s a drop in cabin pressure, you’re asked to apply your own oxygen mask first before placing one on your child. In the same way, you must first think about protecting yourself by limiting your exposure and monitoring your own physical state for any symptoms. But then you must be concerned about your family, your friends, and also society. This is a situation where the impulse and the ethos of worrying about your fellow persons—being your brother’s keeper—is imperative.
The epidemic has been successfully managed in some countries, like Singapore and China, which, once they got on top of it, were able to limit contagion in a very dramatic way. But these are authoritarian governments. The United States doesn’t work that way, which is what makes appealing to the principle of caring for others so crucial. You can protect yourself, but if other people aren’t also protected, it may not matter. You have to worry not just about yourself but about everyone else.
When it comes to stress management, I recommend not catastrophizing or watching the news media 24/7. Distract yourself with other work or recreational activities. Reach out and communicate—virtually, of course—with friends, family, and healthcare providers as needed. Staying in touch acts not just as a diversion but also as an outlet for assuaging your feelings, your sense of being in this alone, feeling isolated.
There are also cognitive reframing mechanisms you can employ. Consider that although this is bad, some countries have already gone through it. And we’ll get through it too. You’ll understandably ask yourself what it would mean if you were to be exposed. In most cases you can say, “I’m going to have the flu and symptoms that are not going to be pleasant, but I’ve had the flu or serious sickness before.”
Remember that there are already antiretroviral treatments being tested in clinical trials and showing efficacy. It’s good to know that before this pandemic ends, some of these treatments will probably be clinically applied, mostly to those who are severely affected and in intensive care.
Diagnose yourself. Monitor your state. Determine whether the stress is really having an impact on you. Is it affecting your sleep, appetite, concentration, mood? And if you do have a preexisting psychiatric condition, don’t feel afraid to reach out to your mental health provider. Understand that you’re going to be anxious, which may aggravate your symptoms and require an adjustment in your treatment. That’s okay. It’s to be expected and your provider should be available to help you.
Controlling this outbreak via the same epidemiologic infectious disease prevention guidance that works in authoritarian societies is not going to be applicable here because of the liberties that we experience in American society. What will determine our success is the belief that we’re in this together, that we’re going to help each other. We should be proud of that, as it shows how Americans and people around the world stand up in situations like this.
Let’s also note that even though everybody is affected and undergoing previously unimaginable levels of anticipated stress and dislocation, it’s the healthcare providers who are really on the frontlines. They’re under tremendous pressure to continue to perform heroically, at great risk to themselves. They deserve a real debt of gratitude.
We will get through this, but as we do, it will not end until we’ve undergone an extreme test of our character. I certainly hope and trust that we will be up to it.
Dr. Jeffrey A. Lieberman is chairman of the Department of Psychiatry at Columbia University. He is a former president of the American Psychiatric Association.
Disclosure: Jeffrey A. Lieberman, MD, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for Clintara; Intracellular Therapies. Received research grant from Alkermes; Biomarin; EnVivo/Forum; Genentech; Novartis/Novation; Sunovion. Patent: Repligen.
This article first appeared on Medscape.com.
U.S. lifts visa halt to boost COVID-19 physician workforce
New information from the US State Department indicates that it is lifting the suspension on visas for foreign-trained medical professionals, a move that has promise for boosting the US physician workforce battling COVID-19.
The move may also help physicians extend their visas.
The communication late last week follows a March 18 announcement that, because of COVID-19, the United States was suspending routine processing of immigrant and nonimmigrant visas, including the J and H visas, at embassies and consulates worldwide.
As reported by Medscape Medical News, the Educational Commission for Foreign Medical Graduates (ECFMG) appealed to the State Department to lift the suspension, noting that 4222 graduates of medical schools outside the United States who had matched into residencies in the United States and were ready to start on July 1 would not get the visas most of them need to begin training.
The State Department lifted the suspensions and issued this update:
“We encourage medical professionals with an approved US non-immigrant or immigrant visa petition (I-129, I-140, or similar) or a certificate of eligibility in an approved exchange visitor program (DS-2019), particularly those working to treat or mitigate the effects of COVID-19, to review the website of their nearest embassy or consulate for procedures to request a visa appointment.”
The State Department also issued guidance for foreign medical professionals already in the United States:
“J-1 Alien Physicians (medical residents) may consult with their program sponsor, ECFMG, to extend their programs in the United States. Generally, a J-1 program for a foreign medical resident can be extended one year at a time for up to seven years.
“Note that the expiration date on a US visa does not determine how long one can be in the United States. The way to confirm one’s required departure date is here : https://i94.cbp.dhs.gov/I94/#/home.
“Those who need to extend their stay or adjust their visa status must apply with USCIS (US Citizenship and Immigration Services).”
Complications Still Exist
ECFMG’s CEO, William W. Pinsky, MD, told Medscape Medical News that, although they welcomed the news from the State Department, there are still unanswered questions.
ECFMG explained that J-1 visas are currently granted only 30 days before the residency program begins.
However, travel to the United States may still be difficult in June, Pinsky said, and physicians may need to be quarantined for 2 weeks upon arrival.
“We’re still having some discussion with the Department of State on whether that regulation could be relaxed and they could come in earlier,” he said.
He cautioned that even after a J-1 visa application is made, the physician’s home country has to endorse the application.
Pinsky said he did not yet know whether that would be a problem.
He also said that, in response to New York’s plea for more healthcare workers, ECFMG is offering to verify education and licensing credentials for physicians educated outside the United States at no cost.
Individual hospitals and regulatory authorities can decide whether there may be roles in some capacity for physicians who have graduated from medical school, even if they have not completed residency or have not been licensed, he said.
This article first appeared on Medscape.com.
New information from the US State Department indicates that it is lifting the suspension on visas for foreign-trained medical professionals, a move that has promise for boosting the US physician workforce battling COVID-19.
The move may also help physicians extend their visas.
The communication late last week follows a March 18 announcement that, because of COVID-19, the United States was suspending routine processing of immigrant and nonimmigrant visas, including the J and H visas, at embassies and consulates worldwide.
As reported by Medscape Medical News, the Educational Commission for Foreign Medical Graduates (ECFMG) appealed to the State Department to lift the suspension, noting that 4222 graduates of medical schools outside the United States who had matched into residencies in the United States and were ready to start on July 1 would not get the visas most of them need to begin training.
The State Department lifted the suspensions and issued this update:
“We encourage medical professionals with an approved US non-immigrant or immigrant visa petition (I-129, I-140, or similar) or a certificate of eligibility in an approved exchange visitor program (DS-2019), particularly those working to treat or mitigate the effects of COVID-19, to review the website of their nearest embassy or consulate for procedures to request a visa appointment.”
The State Department also issued guidance for foreign medical professionals already in the United States:
“J-1 Alien Physicians (medical residents) may consult with their program sponsor, ECFMG, to extend their programs in the United States. Generally, a J-1 program for a foreign medical resident can be extended one year at a time for up to seven years.
“Note that the expiration date on a US visa does not determine how long one can be in the United States. The way to confirm one’s required departure date is here : https://i94.cbp.dhs.gov/I94/#/home.
“Those who need to extend their stay or adjust their visa status must apply with USCIS (US Citizenship and Immigration Services).”
Complications Still Exist
ECFMG’s CEO, William W. Pinsky, MD, told Medscape Medical News that, although they welcomed the news from the State Department, there are still unanswered questions.
ECFMG explained that J-1 visas are currently granted only 30 days before the residency program begins.
However, travel to the United States may still be difficult in June, Pinsky said, and physicians may need to be quarantined for 2 weeks upon arrival.
“We’re still having some discussion with the Department of State on whether that regulation could be relaxed and they could come in earlier,” he said.
He cautioned that even after a J-1 visa application is made, the physician’s home country has to endorse the application.
Pinsky said he did not yet know whether that would be a problem.
He also said that, in response to New York’s plea for more healthcare workers, ECFMG is offering to verify education and licensing credentials for physicians educated outside the United States at no cost.
Individual hospitals and regulatory authorities can decide whether there may be roles in some capacity for physicians who have graduated from medical school, even if they have not completed residency or have not been licensed, he said.
This article first appeared on Medscape.com.
New information from the US State Department indicates that it is lifting the suspension on visas for foreign-trained medical professionals, a move that has promise for boosting the US physician workforce battling COVID-19.
The move may also help physicians extend their visas.
The communication late last week follows a March 18 announcement that, because of COVID-19, the United States was suspending routine processing of immigrant and nonimmigrant visas, including the J and H visas, at embassies and consulates worldwide.
As reported by Medscape Medical News, the Educational Commission for Foreign Medical Graduates (ECFMG) appealed to the State Department to lift the suspension, noting that 4222 graduates of medical schools outside the United States who had matched into residencies in the United States and were ready to start on July 1 would not get the visas most of them need to begin training.
The State Department lifted the suspensions and issued this update:
“We encourage medical professionals with an approved US non-immigrant or immigrant visa petition (I-129, I-140, or similar) or a certificate of eligibility in an approved exchange visitor program (DS-2019), particularly those working to treat or mitigate the effects of COVID-19, to review the website of their nearest embassy or consulate for procedures to request a visa appointment.”
The State Department also issued guidance for foreign medical professionals already in the United States:
“J-1 Alien Physicians (medical residents) may consult with their program sponsor, ECFMG, to extend their programs in the United States. Generally, a J-1 program for a foreign medical resident can be extended one year at a time for up to seven years.
“Note that the expiration date on a US visa does not determine how long one can be in the United States. The way to confirm one’s required departure date is here : https://i94.cbp.dhs.gov/I94/#/home.
“Those who need to extend their stay or adjust their visa status must apply with USCIS (US Citizenship and Immigration Services).”
Complications Still Exist
ECFMG’s CEO, William W. Pinsky, MD, told Medscape Medical News that, although they welcomed the news from the State Department, there are still unanswered questions.
ECFMG explained that J-1 visas are currently granted only 30 days before the residency program begins.
However, travel to the United States may still be difficult in June, Pinsky said, and physicians may need to be quarantined for 2 weeks upon arrival.
“We’re still having some discussion with the Department of State on whether that regulation could be relaxed and they could come in earlier,” he said.
He cautioned that even after a J-1 visa application is made, the physician’s home country has to endorse the application.
Pinsky said he did not yet know whether that would be a problem.
He also said that, in response to New York’s plea for more healthcare workers, ECFMG is offering to verify education and licensing credentials for physicians educated outside the United States at no cost.
Individual hospitals and regulatory authorities can decide whether there may be roles in some capacity for physicians who have graduated from medical school, even if they have not completed residency or have not been licensed, he said.
This article first appeared on Medscape.com.
Sunshine on my shoulders
On March 26, 2020, it’s hard to write or think of anything beyond the COVID-19 pandemic. Those of you who are on the front lines of the battle may find it strange that I am just a bit envious. Having stepped back from clinical medicine nearly a decade ago, it is frustrating to feel that there is little I can do to help other than offering to venture into the grocery store to shop for friends and neighbors who feel more vulnerable than I do.
Here in Maine, we are blessed by geographic isolation that for the moment seems to have damped the surge from the metropolitan centers to our south. But, the virus is here and, as the state with the oldest population, we are beginning to be affected.
For nearly a century, we could count on the outhouses here in Maine would be stocked with outdated Sears Roebucks catalogs when toilet paper was in short supply. Many outhouses remain but Sears Roebucks and its catalogs have disappeared from the landscape. I take a little comfort in the learning that I’m not the only human on the planet who can envision the horror of a week or even a day without toilet paper.
So I am left to sit on the sidelines and watch how my fellow Mainers are coping with the anxiety, depression, and loneliness that come with the forced social isolation. It is pretty clear that walking outside has become the coping strategy of choice. On a usual March day the walkers comprise a skimpy mix of dog walkers and wannabe arctic explorers testing the weather-defying capabilities of their high-tech outerwear. But, to say the least, this is not a usual March and the number of walkers has surged bolstered by gym rats forced off their sweat-drenched ellipticals and treadmills.
This increase in outdoor activity is clearly perceptible even on an overcast day, but it is far less than one would expect given the magnitude of the disruption to everyone’s routines. But, when the sun comes out! The doors fly open and onto the sidewalks and quiet rural roads spill scores of people I haven’t seen for months and in some cases decades. One can almost hear John Denver singing “sunshine on my shoulders makes me happy.” Everyone is smiling and waving to each other. It feels as though the community has, at least for a few hours, been able to throw off the burden of angst that the pandemic laid on us.
There has been a good bit of research about seasonal affective disorder, and I suspect that almost everyone has heard about the value of sunshine for depression. But it is unfortunate that the psychological benefits of just being outdoors – even on an overcast day – has gone pretty much unpublicized. As part of their marketing strategy, a local company that specializes in recreational clothing and gear is encouraging its customers to become “outsiders.” It may be that the pandemic will make more people realize the psychological benefits of being active outside. As physicians we should continue to encourage our patients to be more active and remind them that they don’t need to wait for a sunny day to do so.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” He has no relevant financial disclosures. Email him at [email protected].
On March 26, 2020, it’s hard to write or think of anything beyond the COVID-19 pandemic. Those of you who are on the front lines of the battle may find it strange that I am just a bit envious. Having stepped back from clinical medicine nearly a decade ago, it is frustrating to feel that there is little I can do to help other than offering to venture into the grocery store to shop for friends and neighbors who feel more vulnerable than I do.
Here in Maine, we are blessed by geographic isolation that for the moment seems to have damped the surge from the metropolitan centers to our south. But, the virus is here and, as the state with the oldest population, we are beginning to be affected.
For nearly a century, we could count on the outhouses here in Maine would be stocked with outdated Sears Roebucks catalogs when toilet paper was in short supply. Many outhouses remain but Sears Roebucks and its catalogs have disappeared from the landscape. I take a little comfort in the learning that I’m not the only human on the planet who can envision the horror of a week or even a day without toilet paper.
So I am left to sit on the sidelines and watch how my fellow Mainers are coping with the anxiety, depression, and loneliness that come with the forced social isolation. It is pretty clear that walking outside has become the coping strategy of choice. On a usual March day the walkers comprise a skimpy mix of dog walkers and wannabe arctic explorers testing the weather-defying capabilities of their high-tech outerwear. But, to say the least, this is not a usual March and the number of walkers has surged bolstered by gym rats forced off their sweat-drenched ellipticals and treadmills.
This increase in outdoor activity is clearly perceptible even on an overcast day, but it is far less than one would expect given the magnitude of the disruption to everyone’s routines. But, when the sun comes out! The doors fly open and onto the sidewalks and quiet rural roads spill scores of people I haven’t seen for months and in some cases decades. One can almost hear John Denver singing “sunshine on my shoulders makes me happy.” Everyone is smiling and waving to each other. It feels as though the community has, at least for a few hours, been able to throw off the burden of angst that the pandemic laid on us.
There has been a good bit of research about seasonal affective disorder, and I suspect that almost everyone has heard about the value of sunshine for depression. But it is unfortunate that the psychological benefits of just being outdoors – even on an overcast day – has gone pretty much unpublicized. As part of their marketing strategy, a local company that specializes in recreational clothing and gear is encouraging its customers to become “outsiders.” It may be that the pandemic will make more people realize the psychological benefits of being active outside. As physicians we should continue to encourage our patients to be more active and remind them that they don’t need to wait for a sunny day to do so.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” He has no relevant financial disclosures. Email him at [email protected].
On March 26, 2020, it’s hard to write or think of anything beyond the COVID-19 pandemic. Those of you who are on the front lines of the battle may find it strange that I am just a bit envious. Having stepped back from clinical medicine nearly a decade ago, it is frustrating to feel that there is little I can do to help other than offering to venture into the grocery store to shop for friends and neighbors who feel more vulnerable than I do.
Here in Maine, we are blessed by geographic isolation that for the moment seems to have damped the surge from the metropolitan centers to our south. But, the virus is here and, as the state with the oldest population, we are beginning to be affected.
For nearly a century, we could count on the outhouses here in Maine would be stocked with outdated Sears Roebucks catalogs when toilet paper was in short supply. Many outhouses remain but Sears Roebucks and its catalogs have disappeared from the landscape. I take a little comfort in the learning that I’m not the only human on the planet who can envision the horror of a week or even a day without toilet paper.
So I am left to sit on the sidelines and watch how my fellow Mainers are coping with the anxiety, depression, and loneliness that come with the forced social isolation. It is pretty clear that walking outside has become the coping strategy of choice. On a usual March day the walkers comprise a skimpy mix of dog walkers and wannabe arctic explorers testing the weather-defying capabilities of their high-tech outerwear. But, to say the least, this is not a usual March and the number of walkers has surged bolstered by gym rats forced off their sweat-drenched ellipticals and treadmills.
This increase in outdoor activity is clearly perceptible even on an overcast day, but it is far less than one would expect given the magnitude of the disruption to everyone’s routines. But, when the sun comes out! The doors fly open and onto the sidewalks and quiet rural roads spill scores of people I haven’t seen for months and in some cases decades. One can almost hear John Denver singing “sunshine on my shoulders makes me happy.” Everyone is smiling and waving to each other. It feels as though the community has, at least for a few hours, been able to throw off the burden of angst that the pandemic laid on us.
There has been a good bit of research about seasonal affective disorder, and I suspect that almost everyone has heard about the value of sunshine for depression. But it is unfortunate that the psychological benefits of just being outdoors – even on an overcast day – has gone pretty much unpublicized. As part of their marketing strategy, a local company that specializes in recreational clothing and gear is encouraging its customers to become “outsiders.” It may be that the pandemic will make more people realize the psychological benefits of being active outside. As physicians we should continue to encourage our patients to be more active and remind them that they don’t need to wait for a sunny day to do so.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” He has no relevant financial disclosures. Email him at [email protected].
CARAVAGGIO expands DOAC pool in cancer-related VTE
Oral apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) was as effective as subcutaneous dalteparin (Fragmin, Pfizer) for cancer-related venous thromboembolism (VTE) without an increased risk of major bleeding, the CARAVAGGIO study suggests.
Over 6 months of follow-up, the primary efficacy outcome of recurrent thromboembolism occurred in 32 of 576 patients (5.6%) randomly assigned to apixaban and in 46 of 579 patients (7.9%) assigned dalteparin (hazard ratio, 0.63; 95% confidence interval, 0.37-1.07). The risk difference met the criteria for noninferiority (P < .001) but not for superiority (P = .09).
The risk for major bleeding was similar in the apixaban and dalteparin groups (3.8% and 4.0%; P = .60), including major gastrointestinal (GI) bleeds (11 vs 10 events).
There was a numeric excess of clinically relevant nonmajor bleeding in the apixaban group (9.0% vs 6.0%; HR, 1.42; 95% CI, 0.88-2.30).
However, the site of this bleeding “was essentially the genitourinary tract and the upper respiratory tract, so again there was no increase in gastrointestinal bleeding, even when the clinically relevant major bleeding was considered,” said lead author Giancarlo Agnelli, MD, University of Perugia, Italy.
Taken together, “We believe that the findings of CARAVAGGIO expand the proportion of patients with cancer-associated thrombosis who are eligible for treatment with oral direct anticoagulants, including patients with gastrointestinal cancer,” he concluded.
The findings were presented online March 29 at the American College of Cardiology 2020 Scientific Session (ACC.20)/World Congress of Cardiology (WCC) and published simultaneously in the New England Journal of Medicine.
Major guidelines recommend the use of low-molecular-weight heparin (LMWH) for the treatment of cancer-related VTE but also support the use of edoxaban (Savaysa, Daiichi Sankyo) and rivaroxaban (Xarelto, Janssen Pharmaceuticals) as an alternative based on data from the OKUSAI VTE and SELECT-D trials, respectively. But an increased risk for bleeding was observed among patients with GI cancer in both studies.
“The findings are of clinical relevance because we were able to confirm the efficacy of another [novel oral anticoagulant] NOAC but we have the absence of bleeding, GI bleeding in particular. This is an important point; this is what the clinical community is looking for,” Agnelli told theheart.org | Medscape Cardiology.
The recent ADAM VTE trial testing apixaban, a factor Xa inhibitor, vs dalteparin, a LMWH, reported no major bleeding among patients treated with apixaban (primary safety endpoint) and a significant reduction of VTE (secondary efficacy endpoint). But the trial included only 300 patients with cancer and a more selected population compared with the CARAVAGGIO trial, noted Chiara Melloni, MD, MHS, a cardiologist at Duke Clinical Research Institute, Durham, North Carolina, who was not involved with the trial.
“The trial presented today by Prof. Agnelli provides evidence that apixaban represents an additional valid option, next to edoxaban and rivaroxaban, for the treatment of VTE in cancer patients,” she told theheart.org | Medscape Cardiology in an email. “The subgroup analyses showed consistent results across all different subgroups, but a significant interaction was observed between age groups, with a more favorable profile among those less than 75 years old (and mostly among those <65 years old). This may require more investigation.”
The CARAVAGGIO investigators randomly assigned 576 consecutive patients with cancer who had newly diagnosed symptomatic or incidental acute proximal deep-vein thrombosis or pulmonary embolism to receive apixaban 10 mg twice daily for 7 days followed by 5 mg twice daily or subcutaneous dalteparin 200 IU per kg once daily for 1 month followed by 150 U/kg once daily, both for a total of 6 months. Dose reduction was allowed for dalteparin but not for apixaban during the study.
Various types of cancer were included in the trial, including lung, breast, genitourinary, and upper GI.
The incidence of death was similar in the apixaban and dalteparin groups (23.4% vs 26.4%), with most deaths related to cancer (85.2% vs 88.2%, respectively).
During a discussion of the findings, panelist Bonnie Ky, MD, from the Hospital of the University of Pennsylvania in Philadelphia, and editor in chief of JACC: CardioOncology, congratulated the authors on an “excellent, well-done study” in a high-need cancer population suffering from a clinically significant burden of VTE, reported to be anywhere from 8% to 19% depending on tumor type.
“I was particularly impressed by the low rate of bleeding, which has been traditionally a concern with DOACs, as well the demonstration of noninferiority of apixaban,” she said.
Ky asked why the bleeding rate was lower than observed in other published studies and in whom clinicians shouldn’t be considering apixaban now.
Agnelli said that a head-to-head study is needed to compare the various oral anticoagulant agents but that the gastrointestinal bleeding rate is well known to be reduced with apixaban in patients with atrial fibrillation.
“So whether this is related to the drug or the administration twice daily, it’s something that can be discussed, but honestly the final solution would be to have a comparative study,” he said. “It’s going to be difficult, but it’s what we need.”
As to the clinical application of the data, Agnelli said, “The apixaban data actually extend the number of our patients who could receive the oral agents, including patients with GI cancer. So I do believe this indication about using DOACs in cancer patients will change and the indication expanded. But of course, we are building on something that was already known. We did not discover this all by ourselves.”
Panelist Robert M. Carey, MD, a leader in cardiovascular endocrinology and dean emeritus, University of Virginia School of Medicine in Charlottesville, said the study “conclusively shows noninferiority” but asked for more detail on the subset of patients with GI malignancies and the bleeding rate there.
Agnelli replied that the proportion and number of these patients in CARAVAGGIO is the same as, if not slightly higher than, in other studies. “So we have a population that is representative of all the cancer population, including GI cancer,” he said, adding that subanalyses are underway correlating the site of cancer with the type of bleeding.
Agnes Y.Y. Lee, MD, University of British Columbia, Vancouver Coastal Health, and the British Cancer Agency, all in Vancouver, Canada, notes in a linked editorial that CARAVAGGIO excluded patients with primary and metastatic brain lesions and included few patients with cancers of the upper GI tract, with hematologic cancers, or receiving newer cancer therapies, such as checkpoint inhibitors.
She says clinicians will have to choose carefully which anticoagulant to use but that LMWH is “preferred in patients in whom drug-drug interaction is a concern and in those who have undergone surgery involving the upper gastrointestinal tract because absorption of all direct oral anticoagulants occurs in the stomach or proximal small bowel.”
Warfarin may also be the only option when cost is the “decision driver” in patients with cancer facing major financial healthcare burdens, Lee writes.
Duke’s Melloni also said the cost of oral anticoagulants needs to be taken into account and varies widely for patients based on their insurance and availability of other copay assistance programs. “It is therefore important to discuss with the patients upfront because if the patients are started but cannot afford long term, early discontinuation can impact their safety,” she said.
The trial was sponsored by FADOI (Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti) and was funded by an unrestricted grant from the Bristol-Myers Squibb-Pfizer Alliance. Agnelli reports personal fees from Pfizer and Bayer Healthcare, and “other” from Daiichi Sankyo outside the submitted work. Melloni reports having no relevant conflicts of interest. Lee reports personal fees and nonfinancial support from Bayer; grants, personal fees, and nonfinancial support from Bristol-Myers Squibb; and personal fees from LEO Pharma, Pfizer, and Quercegen Pharmaceuticals outside the submitted work.
This article first appeared on Medscape.com.
Oral apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) was as effective as subcutaneous dalteparin (Fragmin, Pfizer) for cancer-related venous thromboembolism (VTE) without an increased risk of major bleeding, the CARAVAGGIO study suggests.
Over 6 months of follow-up, the primary efficacy outcome of recurrent thromboembolism occurred in 32 of 576 patients (5.6%) randomly assigned to apixaban and in 46 of 579 patients (7.9%) assigned dalteparin (hazard ratio, 0.63; 95% confidence interval, 0.37-1.07). The risk difference met the criteria for noninferiority (P < .001) but not for superiority (P = .09).
The risk for major bleeding was similar in the apixaban and dalteparin groups (3.8% and 4.0%; P = .60), including major gastrointestinal (GI) bleeds (11 vs 10 events).
There was a numeric excess of clinically relevant nonmajor bleeding in the apixaban group (9.0% vs 6.0%; HR, 1.42; 95% CI, 0.88-2.30).
However, the site of this bleeding “was essentially the genitourinary tract and the upper respiratory tract, so again there was no increase in gastrointestinal bleeding, even when the clinically relevant major bleeding was considered,” said lead author Giancarlo Agnelli, MD, University of Perugia, Italy.
Taken together, “We believe that the findings of CARAVAGGIO expand the proportion of patients with cancer-associated thrombosis who are eligible for treatment with oral direct anticoagulants, including patients with gastrointestinal cancer,” he concluded.
The findings were presented online March 29 at the American College of Cardiology 2020 Scientific Session (ACC.20)/World Congress of Cardiology (WCC) and published simultaneously in the New England Journal of Medicine.
Major guidelines recommend the use of low-molecular-weight heparin (LMWH) for the treatment of cancer-related VTE but also support the use of edoxaban (Savaysa, Daiichi Sankyo) and rivaroxaban (Xarelto, Janssen Pharmaceuticals) as an alternative based on data from the OKUSAI VTE and SELECT-D trials, respectively. But an increased risk for bleeding was observed among patients with GI cancer in both studies.
“The findings are of clinical relevance because we were able to confirm the efficacy of another [novel oral anticoagulant] NOAC but we have the absence of bleeding, GI bleeding in particular. This is an important point; this is what the clinical community is looking for,” Agnelli told theheart.org | Medscape Cardiology.
The recent ADAM VTE trial testing apixaban, a factor Xa inhibitor, vs dalteparin, a LMWH, reported no major bleeding among patients treated with apixaban (primary safety endpoint) and a significant reduction of VTE (secondary efficacy endpoint). But the trial included only 300 patients with cancer and a more selected population compared with the CARAVAGGIO trial, noted Chiara Melloni, MD, MHS, a cardiologist at Duke Clinical Research Institute, Durham, North Carolina, who was not involved with the trial.
“The trial presented today by Prof. Agnelli provides evidence that apixaban represents an additional valid option, next to edoxaban and rivaroxaban, for the treatment of VTE in cancer patients,” she told theheart.org | Medscape Cardiology in an email. “The subgroup analyses showed consistent results across all different subgroups, but a significant interaction was observed between age groups, with a more favorable profile among those less than 75 years old (and mostly among those <65 years old). This may require more investigation.”
The CARAVAGGIO investigators randomly assigned 576 consecutive patients with cancer who had newly diagnosed symptomatic or incidental acute proximal deep-vein thrombosis or pulmonary embolism to receive apixaban 10 mg twice daily for 7 days followed by 5 mg twice daily or subcutaneous dalteparin 200 IU per kg once daily for 1 month followed by 150 U/kg once daily, both for a total of 6 months. Dose reduction was allowed for dalteparin but not for apixaban during the study.
Various types of cancer were included in the trial, including lung, breast, genitourinary, and upper GI.
The incidence of death was similar in the apixaban and dalteparin groups (23.4% vs 26.4%), with most deaths related to cancer (85.2% vs 88.2%, respectively).
During a discussion of the findings, panelist Bonnie Ky, MD, from the Hospital of the University of Pennsylvania in Philadelphia, and editor in chief of JACC: CardioOncology, congratulated the authors on an “excellent, well-done study” in a high-need cancer population suffering from a clinically significant burden of VTE, reported to be anywhere from 8% to 19% depending on tumor type.
“I was particularly impressed by the low rate of bleeding, which has been traditionally a concern with DOACs, as well the demonstration of noninferiority of apixaban,” she said.
Ky asked why the bleeding rate was lower than observed in other published studies and in whom clinicians shouldn’t be considering apixaban now.
Agnelli said that a head-to-head study is needed to compare the various oral anticoagulant agents but that the gastrointestinal bleeding rate is well known to be reduced with apixaban in patients with atrial fibrillation.
“So whether this is related to the drug or the administration twice daily, it’s something that can be discussed, but honestly the final solution would be to have a comparative study,” he said. “It’s going to be difficult, but it’s what we need.”
As to the clinical application of the data, Agnelli said, “The apixaban data actually extend the number of our patients who could receive the oral agents, including patients with GI cancer. So I do believe this indication about using DOACs in cancer patients will change and the indication expanded. But of course, we are building on something that was already known. We did not discover this all by ourselves.”
Panelist Robert M. Carey, MD, a leader in cardiovascular endocrinology and dean emeritus, University of Virginia School of Medicine in Charlottesville, said the study “conclusively shows noninferiority” but asked for more detail on the subset of patients with GI malignancies and the bleeding rate there.
Agnelli replied that the proportion and number of these patients in CARAVAGGIO is the same as, if not slightly higher than, in other studies. “So we have a population that is representative of all the cancer population, including GI cancer,” he said, adding that subanalyses are underway correlating the site of cancer with the type of bleeding.
Agnes Y.Y. Lee, MD, University of British Columbia, Vancouver Coastal Health, and the British Cancer Agency, all in Vancouver, Canada, notes in a linked editorial that CARAVAGGIO excluded patients with primary and metastatic brain lesions and included few patients with cancers of the upper GI tract, with hematologic cancers, or receiving newer cancer therapies, such as checkpoint inhibitors.
She says clinicians will have to choose carefully which anticoagulant to use but that LMWH is “preferred in patients in whom drug-drug interaction is a concern and in those who have undergone surgery involving the upper gastrointestinal tract because absorption of all direct oral anticoagulants occurs in the stomach or proximal small bowel.”
Warfarin may also be the only option when cost is the “decision driver” in patients with cancer facing major financial healthcare burdens, Lee writes.
Duke’s Melloni also said the cost of oral anticoagulants needs to be taken into account and varies widely for patients based on their insurance and availability of other copay assistance programs. “It is therefore important to discuss with the patients upfront because if the patients are started but cannot afford long term, early discontinuation can impact their safety,” she said.
The trial was sponsored by FADOI (Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti) and was funded by an unrestricted grant from the Bristol-Myers Squibb-Pfizer Alliance. Agnelli reports personal fees from Pfizer and Bayer Healthcare, and “other” from Daiichi Sankyo outside the submitted work. Melloni reports having no relevant conflicts of interest. Lee reports personal fees and nonfinancial support from Bayer; grants, personal fees, and nonfinancial support from Bristol-Myers Squibb; and personal fees from LEO Pharma, Pfizer, and Quercegen Pharmaceuticals outside the submitted work.
This article first appeared on Medscape.com.
Oral apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) was as effective as subcutaneous dalteparin (Fragmin, Pfizer) for cancer-related venous thromboembolism (VTE) without an increased risk of major bleeding, the CARAVAGGIO study suggests.
Over 6 months of follow-up, the primary efficacy outcome of recurrent thromboembolism occurred in 32 of 576 patients (5.6%) randomly assigned to apixaban and in 46 of 579 patients (7.9%) assigned dalteparin (hazard ratio, 0.63; 95% confidence interval, 0.37-1.07). The risk difference met the criteria for noninferiority (P < .001) but not for superiority (P = .09).
The risk for major bleeding was similar in the apixaban and dalteparin groups (3.8% and 4.0%; P = .60), including major gastrointestinal (GI) bleeds (11 vs 10 events).
There was a numeric excess of clinically relevant nonmajor bleeding in the apixaban group (9.0% vs 6.0%; HR, 1.42; 95% CI, 0.88-2.30).
However, the site of this bleeding “was essentially the genitourinary tract and the upper respiratory tract, so again there was no increase in gastrointestinal bleeding, even when the clinically relevant major bleeding was considered,” said lead author Giancarlo Agnelli, MD, University of Perugia, Italy.
Taken together, “We believe that the findings of CARAVAGGIO expand the proportion of patients with cancer-associated thrombosis who are eligible for treatment with oral direct anticoagulants, including patients with gastrointestinal cancer,” he concluded.
The findings were presented online March 29 at the American College of Cardiology 2020 Scientific Session (ACC.20)/World Congress of Cardiology (WCC) and published simultaneously in the New England Journal of Medicine.
Major guidelines recommend the use of low-molecular-weight heparin (LMWH) for the treatment of cancer-related VTE but also support the use of edoxaban (Savaysa, Daiichi Sankyo) and rivaroxaban (Xarelto, Janssen Pharmaceuticals) as an alternative based on data from the OKUSAI VTE and SELECT-D trials, respectively. But an increased risk for bleeding was observed among patients with GI cancer in both studies.
“The findings are of clinical relevance because we were able to confirm the efficacy of another [novel oral anticoagulant] NOAC but we have the absence of bleeding, GI bleeding in particular. This is an important point; this is what the clinical community is looking for,” Agnelli told theheart.org | Medscape Cardiology.
The recent ADAM VTE trial testing apixaban, a factor Xa inhibitor, vs dalteparin, a LMWH, reported no major bleeding among patients treated with apixaban (primary safety endpoint) and a significant reduction of VTE (secondary efficacy endpoint). But the trial included only 300 patients with cancer and a more selected population compared with the CARAVAGGIO trial, noted Chiara Melloni, MD, MHS, a cardiologist at Duke Clinical Research Institute, Durham, North Carolina, who was not involved with the trial.
“The trial presented today by Prof. Agnelli provides evidence that apixaban represents an additional valid option, next to edoxaban and rivaroxaban, for the treatment of VTE in cancer patients,” she told theheart.org | Medscape Cardiology in an email. “The subgroup analyses showed consistent results across all different subgroups, but a significant interaction was observed between age groups, with a more favorable profile among those less than 75 years old (and mostly among those <65 years old). This may require more investigation.”
The CARAVAGGIO investigators randomly assigned 576 consecutive patients with cancer who had newly diagnosed symptomatic or incidental acute proximal deep-vein thrombosis or pulmonary embolism to receive apixaban 10 mg twice daily for 7 days followed by 5 mg twice daily or subcutaneous dalteparin 200 IU per kg once daily for 1 month followed by 150 U/kg once daily, both for a total of 6 months. Dose reduction was allowed for dalteparin but not for apixaban during the study.
Various types of cancer were included in the trial, including lung, breast, genitourinary, and upper GI.
The incidence of death was similar in the apixaban and dalteparin groups (23.4% vs 26.4%), with most deaths related to cancer (85.2% vs 88.2%, respectively).
During a discussion of the findings, panelist Bonnie Ky, MD, from the Hospital of the University of Pennsylvania in Philadelphia, and editor in chief of JACC: CardioOncology, congratulated the authors on an “excellent, well-done study” in a high-need cancer population suffering from a clinically significant burden of VTE, reported to be anywhere from 8% to 19% depending on tumor type.
“I was particularly impressed by the low rate of bleeding, which has been traditionally a concern with DOACs, as well the demonstration of noninferiority of apixaban,” she said.
Ky asked why the bleeding rate was lower than observed in other published studies and in whom clinicians shouldn’t be considering apixaban now.
Agnelli said that a head-to-head study is needed to compare the various oral anticoagulant agents but that the gastrointestinal bleeding rate is well known to be reduced with apixaban in patients with atrial fibrillation.
“So whether this is related to the drug or the administration twice daily, it’s something that can be discussed, but honestly the final solution would be to have a comparative study,” he said. “It’s going to be difficult, but it’s what we need.”
As to the clinical application of the data, Agnelli said, “The apixaban data actually extend the number of our patients who could receive the oral agents, including patients with GI cancer. So I do believe this indication about using DOACs in cancer patients will change and the indication expanded. But of course, we are building on something that was already known. We did not discover this all by ourselves.”
Panelist Robert M. Carey, MD, a leader in cardiovascular endocrinology and dean emeritus, University of Virginia School of Medicine in Charlottesville, said the study “conclusively shows noninferiority” but asked for more detail on the subset of patients with GI malignancies and the bleeding rate there.
Agnelli replied that the proportion and number of these patients in CARAVAGGIO is the same as, if not slightly higher than, in other studies. “So we have a population that is representative of all the cancer population, including GI cancer,” he said, adding that subanalyses are underway correlating the site of cancer with the type of bleeding.
Agnes Y.Y. Lee, MD, University of British Columbia, Vancouver Coastal Health, and the British Cancer Agency, all in Vancouver, Canada, notes in a linked editorial that CARAVAGGIO excluded patients with primary and metastatic brain lesions and included few patients with cancers of the upper GI tract, with hematologic cancers, or receiving newer cancer therapies, such as checkpoint inhibitors.
She says clinicians will have to choose carefully which anticoagulant to use but that LMWH is “preferred in patients in whom drug-drug interaction is a concern and in those who have undergone surgery involving the upper gastrointestinal tract because absorption of all direct oral anticoagulants occurs in the stomach or proximal small bowel.”
Warfarin may also be the only option when cost is the “decision driver” in patients with cancer facing major financial healthcare burdens, Lee writes.
Duke’s Melloni also said the cost of oral anticoagulants needs to be taken into account and varies widely for patients based on their insurance and availability of other copay assistance programs. “It is therefore important to discuss with the patients upfront because if the patients are started but cannot afford long term, early discontinuation can impact their safety,” she said.
The trial was sponsored by FADOI (Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti) and was funded by an unrestricted grant from the Bristol-Myers Squibb-Pfizer Alliance. Agnelli reports personal fees from Pfizer and Bayer Healthcare, and “other” from Daiichi Sankyo outside the submitted work. Melloni reports having no relevant conflicts of interest. Lee reports personal fees and nonfinancial support from Bayer; grants, personal fees, and nonfinancial support from Bristol-Myers Squibb; and personal fees from LEO Pharma, Pfizer, and Quercegen Pharmaceuticals outside the submitted work.
This article first appeared on Medscape.com.
New guidance on management of acute CVD during COVID-19
The Chinese Society of Cardiology (CSC) has issued a consensus statement on the management of cardiac emergencies during the COVID-19 pandemic.
The document first appeared in the Chinese Journal of Cardiology, and a translated version was published in Circulation. The consensus statement was developed by 125 medical experts in the fields of cardiovascular disease and infectious disease. This included 23 experts currently working in Wuhan, China.
Three overarching principles guided their recommendations.
- The highest priority is prevention and control of transmission (including protecting staff).
- Patients should be assessed both for COVID-19 and for cardiovascular issues.
- At all times, all interventions and therapies provided should be in concordance with directives of infection control authorities.
“Considering that some asymptomatic patients may be a source of infection and transmission, all patients with severe emergent cardiovascular diseases should be managed as suspected cases of COVID-19 in Hubei Province,” noted writing chair and cardiologist Yaling Han, MD, of the General Hospital of Northern Theater Command in Shenyang, China.
In areas outside Hubei Province, where COVID-19 was less prevalent, this “infected until proven otherwise” approach was also recommended, although not as strictly.
Diagnosing CVD and COVID-19 simultaneously
In patients with emergent cardiovascular needs in whom COVID-19 has not been ruled out, quarantine in a single-bed room is needed, they wrote. The patient should be monitored for clinical manifestations of the disease, and undergo COVID-19 nucleic acid testing as soon as possible.
After infection control is considered, including limiting risk for infection to health care workers, risk assessment that weighs the relative advantages and disadvantages of treating the cardiovascular disease while preventing transmission can be considered, the investigators wrote.
At all times, transfers to different areas of the hospital and between hospitals should be minimized to reduce the risk for infection transmission.
The authors also recommended the use of “select laboratory tests with definitive sensitivity and specificity for disease diagnosis or assessment.”
For patients with acute aortic syndrome or acute pulmonary embolism, this means CT angiography. When acute pulmonary embolism is suspected, D-dimer testing and deep vein ultrasound can be employed, and for patients with acute coronary syndrome, ordinary electrocardiography and standard biomarkers for cardiac injury are preferred.
In addition, “all patients should undergo lung CT examination to evaluate for imaging features typical of COVID-19. ... Chest x-ray is not recommended because of a high rate of false negative diagnosis,” the authors wrote.
Intervene with caution
Medical therapy should be optimized in patients with emergent cardiovascular issues, with invasive strategies for diagnosis and therapy used “with caution,” according to the Chinese experts.
Conditions for which conservative medical treatment is recommended during COVID-19 pandemic include ST-segment elevation MI (STEMI) where thrombolytic therapy is indicated, STEMI when the optimal window for revascularization has passed, high-risk non-STEMI (NSTEMI), patients with uncomplicated Stanford type B aortic dissection, acute pulmonary embolism, acute exacerbation of heart failure, and hypertensive emergency.
“Vigilance should be paid to avoid misdiagnosing patients with pulmonary infarction as COVID-19 pneumonia,” they noted.
Diagnoses warranting invasive intervention are limited to STEMI with hemodynamic instability, life-threatening NSTEMI, Stanford type A or complex type B acute aortic dissection, bradyarrhythmia complicated by syncope or unstable hemodynamics mandating implantation of a device, and pulmonary embolism with hemodynamic instability for whom intravenous thrombolytics are too risky.
Interventions should be done in a cath lab or operating room with negative-pressure ventilation, with strict periprocedural disinfection. Personal protective equipment should also be of the strictest level.
In patients for whom COVID-19 cannot be ruled out presenting in a region with low incidence of COVID-19, interventions should only be considered for more severe cases and undertaken in a cath lab, electrophysiology lab, or operating room “with more than standard disinfection procedures that fulfill regulatory mandates for infection control.”
If negative-pressure ventilation is not available, air conditioning (for example, laminar flow and ventilation) should be stopped.
Establish plans now
“We operationalized all of these strategies at Beth Israel Deaconess Medical Center several weeks ago, since Boston had that early outbreak with the Biogen conference, but I suspect many institutions nationally are still formulating plans,” said Dhruv Kazi, MD, MSc, in an interview.
Although COVID-19 is “primarily a single-organ disease – it destroys the lungs” – transmission of infection to cardiology providers was an early problem that needed to be addressed, said Dr. Kazi. “We now know that a cardiologist seeing a patient who reports shortness of breath and then leans in to carefully auscultate the lungs and heart can get exposed if not provided adequate personal protective equipment; hence the cancellation of elective procedures, conversion of most elective visits to telemedicine, if possible, and the use of surgical/N95 masks in clinic and on rounds.”
Regarding the CSC recommendation to consider medical over invasive management, Dr. Kazi noteed that this works better in a setting where rapid testing is available. “Where that is not the case – as in the U.S. – resorting to conservative therapy for all COVID suspect cases will result in suboptimal care, particularly when nine out of every 10 COVID suspects will eventually rule out.”
One of his biggest worries now is that patients simply won’t come. Afraid of being exposed to COVID-19, patients with MIs and strokes may avoid or delay coming to the hospital.
“There is some evidence that this occurred in Wuhan, and I’m starting to see anecdotal evidence of this in Boston,” said Dr. Kazi. “We need to remind our patients that, if they experience symptoms of a heart attack or stroke, they deserve the same lifesaving treatment we offered before this pandemic set in. They should not try and sit it out.”
A version of this article originally appeared on Medscape.com.
The Chinese Society of Cardiology (CSC) has issued a consensus statement on the management of cardiac emergencies during the COVID-19 pandemic.
The document first appeared in the Chinese Journal of Cardiology, and a translated version was published in Circulation. The consensus statement was developed by 125 medical experts in the fields of cardiovascular disease and infectious disease. This included 23 experts currently working in Wuhan, China.
Three overarching principles guided their recommendations.
- The highest priority is prevention and control of transmission (including protecting staff).
- Patients should be assessed both for COVID-19 and for cardiovascular issues.
- At all times, all interventions and therapies provided should be in concordance with directives of infection control authorities.
“Considering that some asymptomatic patients may be a source of infection and transmission, all patients with severe emergent cardiovascular diseases should be managed as suspected cases of COVID-19 in Hubei Province,” noted writing chair and cardiologist Yaling Han, MD, of the General Hospital of Northern Theater Command in Shenyang, China.
In areas outside Hubei Province, where COVID-19 was less prevalent, this “infected until proven otherwise” approach was also recommended, although not as strictly.
Diagnosing CVD and COVID-19 simultaneously
In patients with emergent cardiovascular needs in whom COVID-19 has not been ruled out, quarantine in a single-bed room is needed, they wrote. The patient should be monitored for clinical manifestations of the disease, and undergo COVID-19 nucleic acid testing as soon as possible.
After infection control is considered, including limiting risk for infection to health care workers, risk assessment that weighs the relative advantages and disadvantages of treating the cardiovascular disease while preventing transmission can be considered, the investigators wrote.
At all times, transfers to different areas of the hospital and between hospitals should be minimized to reduce the risk for infection transmission.
The authors also recommended the use of “select laboratory tests with definitive sensitivity and specificity for disease diagnosis or assessment.”
For patients with acute aortic syndrome or acute pulmonary embolism, this means CT angiography. When acute pulmonary embolism is suspected, D-dimer testing and deep vein ultrasound can be employed, and for patients with acute coronary syndrome, ordinary electrocardiography and standard biomarkers for cardiac injury are preferred.
In addition, “all patients should undergo lung CT examination to evaluate for imaging features typical of COVID-19. ... Chest x-ray is not recommended because of a high rate of false negative diagnosis,” the authors wrote.
Intervene with caution
Medical therapy should be optimized in patients with emergent cardiovascular issues, with invasive strategies for diagnosis and therapy used “with caution,” according to the Chinese experts.
Conditions for which conservative medical treatment is recommended during COVID-19 pandemic include ST-segment elevation MI (STEMI) where thrombolytic therapy is indicated, STEMI when the optimal window for revascularization has passed, high-risk non-STEMI (NSTEMI), patients with uncomplicated Stanford type B aortic dissection, acute pulmonary embolism, acute exacerbation of heart failure, and hypertensive emergency.
“Vigilance should be paid to avoid misdiagnosing patients with pulmonary infarction as COVID-19 pneumonia,” they noted.
Diagnoses warranting invasive intervention are limited to STEMI with hemodynamic instability, life-threatening NSTEMI, Stanford type A or complex type B acute aortic dissection, bradyarrhythmia complicated by syncope or unstable hemodynamics mandating implantation of a device, and pulmonary embolism with hemodynamic instability for whom intravenous thrombolytics are too risky.
Interventions should be done in a cath lab or operating room with negative-pressure ventilation, with strict periprocedural disinfection. Personal protective equipment should also be of the strictest level.
In patients for whom COVID-19 cannot be ruled out presenting in a region with low incidence of COVID-19, interventions should only be considered for more severe cases and undertaken in a cath lab, electrophysiology lab, or operating room “with more than standard disinfection procedures that fulfill regulatory mandates for infection control.”
If negative-pressure ventilation is not available, air conditioning (for example, laminar flow and ventilation) should be stopped.
Establish plans now
“We operationalized all of these strategies at Beth Israel Deaconess Medical Center several weeks ago, since Boston had that early outbreak with the Biogen conference, but I suspect many institutions nationally are still formulating plans,” said Dhruv Kazi, MD, MSc, in an interview.
Although COVID-19 is “primarily a single-organ disease – it destroys the lungs” – transmission of infection to cardiology providers was an early problem that needed to be addressed, said Dr. Kazi. “We now know that a cardiologist seeing a patient who reports shortness of breath and then leans in to carefully auscultate the lungs and heart can get exposed if not provided adequate personal protective equipment; hence the cancellation of elective procedures, conversion of most elective visits to telemedicine, if possible, and the use of surgical/N95 masks in clinic and on rounds.”
Regarding the CSC recommendation to consider medical over invasive management, Dr. Kazi noteed that this works better in a setting where rapid testing is available. “Where that is not the case – as in the U.S. – resorting to conservative therapy for all COVID suspect cases will result in suboptimal care, particularly when nine out of every 10 COVID suspects will eventually rule out.”
One of his biggest worries now is that patients simply won’t come. Afraid of being exposed to COVID-19, patients with MIs and strokes may avoid or delay coming to the hospital.
“There is some evidence that this occurred in Wuhan, and I’m starting to see anecdotal evidence of this in Boston,” said Dr. Kazi. “We need to remind our patients that, if they experience symptoms of a heart attack or stroke, they deserve the same lifesaving treatment we offered before this pandemic set in. They should not try and sit it out.”
A version of this article originally appeared on Medscape.com.
The Chinese Society of Cardiology (CSC) has issued a consensus statement on the management of cardiac emergencies during the COVID-19 pandemic.
The document first appeared in the Chinese Journal of Cardiology, and a translated version was published in Circulation. The consensus statement was developed by 125 medical experts in the fields of cardiovascular disease and infectious disease. This included 23 experts currently working in Wuhan, China.
Three overarching principles guided their recommendations.
- The highest priority is prevention and control of transmission (including protecting staff).
- Patients should be assessed both for COVID-19 and for cardiovascular issues.
- At all times, all interventions and therapies provided should be in concordance with directives of infection control authorities.
“Considering that some asymptomatic patients may be a source of infection and transmission, all patients with severe emergent cardiovascular diseases should be managed as suspected cases of COVID-19 in Hubei Province,” noted writing chair and cardiologist Yaling Han, MD, of the General Hospital of Northern Theater Command in Shenyang, China.
In areas outside Hubei Province, where COVID-19 was less prevalent, this “infected until proven otherwise” approach was also recommended, although not as strictly.
Diagnosing CVD and COVID-19 simultaneously
In patients with emergent cardiovascular needs in whom COVID-19 has not been ruled out, quarantine in a single-bed room is needed, they wrote. The patient should be monitored for clinical manifestations of the disease, and undergo COVID-19 nucleic acid testing as soon as possible.
After infection control is considered, including limiting risk for infection to health care workers, risk assessment that weighs the relative advantages and disadvantages of treating the cardiovascular disease while preventing transmission can be considered, the investigators wrote.
At all times, transfers to different areas of the hospital and between hospitals should be minimized to reduce the risk for infection transmission.
The authors also recommended the use of “select laboratory tests with definitive sensitivity and specificity for disease diagnosis or assessment.”
For patients with acute aortic syndrome or acute pulmonary embolism, this means CT angiography. When acute pulmonary embolism is suspected, D-dimer testing and deep vein ultrasound can be employed, and for patients with acute coronary syndrome, ordinary electrocardiography and standard biomarkers for cardiac injury are preferred.
In addition, “all patients should undergo lung CT examination to evaluate for imaging features typical of COVID-19. ... Chest x-ray is not recommended because of a high rate of false negative diagnosis,” the authors wrote.
Intervene with caution
Medical therapy should be optimized in patients with emergent cardiovascular issues, with invasive strategies for diagnosis and therapy used “with caution,” according to the Chinese experts.
Conditions for which conservative medical treatment is recommended during COVID-19 pandemic include ST-segment elevation MI (STEMI) where thrombolytic therapy is indicated, STEMI when the optimal window for revascularization has passed, high-risk non-STEMI (NSTEMI), patients with uncomplicated Stanford type B aortic dissection, acute pulmonary embolism, acute exacerbation of heart failure, and hypertensive emergency.
“Vigilance should be paid to avoid misdiagnosing patients with pulmonary infarction as COVID-19 pneumonia,” they noted.
Diagnoses warranting invasive intervention are limited to STEMI with hemodynamic instability, life-threatening NSTEMI, Stanford type A or complex type B acute aortic dissection, bradyarrhythmia complicated by syncope or unstable hemodynamics mandating implantation of a device, and pulmonary embolism with hemodynamic instability for whom intravenous thrombolytics are too risky.
Interventions should be done in a cath lab or operating room with negative-pressure ventilation, with strict periprocedural disinfection. Personal protective equipment should also be of the strictest level.
In patients for whom COVID-19 cannot be ruled out presenting in a region with low incidence of COVID-19, interventions should only be considered for more severe cases and undertaken in a cath lab, electrophysiology lab, or operating room “with more than standard disinfection procedures that fulfill regulatory mandates for infection control.”
If negative-pressure ventilation is not available, air conditioning (for example, laminar flow and ventilation) should be stopped.
Establish plans now
“We operationalized all of these strategies at Beth Israel Deaconess Medical Center several weeks ago, since Boston had that early outbreak with the Biogen conference, but I suspect many institutions nationally are still formulating plans,” said Dhruv Kazi, MD, MSc, in an interview.
Although COVID-19 is “primarily a single-organ disease – it destroys the lungs” – transmission of infection to cardiology providers was an early problem that needed to be addressed, said Dr. Kazi. “We now know that a cardiologist seeing a patient who reports shortness of breath and then leans in to carefully auscultate the lungs and heart can get exposed if not provided adequate personal protective equipment; hence the cancellation of elective procedures, conversion of most elective visits to telemedicine, if possible, and the use of surgical/N95 masks in clinic and on rounds.”
Regarding the CSC recommendation to consider medical over invasive management, Dr. Kazi noteed that this works better in a setting where rapid testing is available. “Where that is not the case – as in the U.S. – resorting to conservative therapy for all COVID suspect cases will result in suboptimal care, particularly when nine out of every 10 COVID suspects will eventually rule out.”
One of his biggest worries now is that patients simply won’t come. Afraid of being exposed to COVID-19, patients with MIs and strokes may avoid or delay coming to the hospital.
“There is some evidence that this occurred in Wuhan, and I’m starting to see anecdotal evidence of this in Boston,” said Dr. Kazi. “We need to remind our patients that, if they experience symptoms of a heart attack or stroke, they deserve the same lifesaving treatment we offered before this pandemic set in. They should not try and sit it out.”
A version of this article originally appeared on Medscape.com.
FDA issues EUA allowing hydroxychloroquine sulfate, chloroquine phosphate treatment in COVID-19
The Food and Drug Administration issued an Emergency Use Authorization on March 28, 2020, allowing for the usage of hydroxychloroquine sulfate and chloroquine phosphate products in certain hospitalized patients with COVID-19.
The products, currently stored by the Strategic National Stockpile, will be distributed by the SNS to states so that doctors may prescribe the drugs to adolescent and adult patients hospitalized with COVID-19 in the absence of appropriate or feasible clinical trials. The SNS will work with the Federal Emergency Management Agency to ship the products to states.
According to the Emergency Use Authorization, fact sheets will be provided to health care providers and patients with important information about hydroxychloroquine sulfate and chloroquine phosphate, including the risks of using them to treat COVID-19.
The Food and Drug Administration issued an Emergency Use Authorization on March 28, 2020, allowing for the usage of hydroxychloroquine sulfate and chloroquine phosphate products in certain hospitalized patients with COVID-19.
The products, currently stored by the Strategic National Stockpile, will be distributed by the SNS to states so that doctors may prescribe the drugs to adolescent and adult patients hospitalized with COVID-19 in the absence of appropriate or feasible clinical trials. The SNS will work with the Federal Emergency Management Agency to ship the products to states.
According to the Emergency Use Authorization, fact sheets will be provided to health care providers and patients with important information about hydroxychloroquine sulfate and chloroquine phosphate, including the risks of using them to treat COVID-19.
The Food and Drug Administration issued an Emergency Use Authorization on March 28, 2020, allowing for the usage of hydroxychloroquine sulfate and chloroquine phosphate products in certain hospitalized patients with COVID-19.
The products, currently stored by the Strategic National Stockpile, will be distributed by the SNS to states so that doctors may prescribe the drugs to adolescent and adult patients hospitalized with COVID-19 in the absence of appropriate or feasible clinical trials. The SNS will work with the Federal Emergency Management Agency to ship the products to states.
According to the Emergency Use Authorization, fact sheets will be provided to health care providers and patients with important information about hydroxychloroquine sulfate and chloroquine phosphate, including the risks of using them to treat COVID-19.