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Wuhan virus: What clinicians need to know

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As the Wuhan coronavirus story unfolds, the most important thing for clinicians in the United States to do is ask patients who appear to have the flu if they, or someone they have been in contact with, recently returned from China, according to infectious disease experts.

China News Service/CC BY 3.0
Medical staff in Wuhan railway station during the Wuhan coronavirus outbreak, Jan. 24, 2020.

“We are asking that of everyone with fever and respiratory symptoms who comes to our clinics, hospital, or emergency room. It’s a powerful screening tool,” said William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center, Nashville, Tenn.

In addition to fever, common signs of infection include cough, shortness of breath, and breathing difficulties. Some patients have had diarrhea, vomiting, and other gastrointestinal symptoms. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure, and death. The incubation period appears to be up to 2 weeks, according to the World Health Organization (WHO).

If patients exhibit symptoms and either they or a close contact has returned from China recently, take standard airborne precautions and send specimens – a serum sample, oral and nasal pharyngeal swabs, and lower respiratory tract specimens if available – to the local health department, which will forward them to the Centers for Disease Control and Prevention (CDC) for testing. Turnaround time is 24-48 hours.

Dr. William Shaffner


The 2019 Novel Coronavirus (2019-nCoV), identified as the cause of an outbreak of respiratory illness first detected in December in association with a live animal market in Wuhan, China, has been implicated in almost 2,000 cases and 56 deaths in that country. Cases have been reported in 13 countries besides China. Five cases of 2019-nCoV infection have been confirmed in the United States, all in people recently returned from Wuhan. As the virus spreads in China, however, it’s almost certain more cases will show up in the United States. Travel history is key, Dr. Schaffner and others said.
 

Plan and rehearse

The first step to prepare is to use the CDC’s Interim Guidance for Healthcare Professionals to make a written plan specific to your practice to respond to a potential case. The plan must include notifying the local health department, the CDC liaison for testing, and tracking down patient contacts.

“It’s not good enough to just download CDC’s guidance; use it to make your own local plan and know what to do 24/7,” said Daniel Lucey, MD, an infectious disease expert at Georgetown University Medical Center, Washington, D.C.

“Know who is on call at the health department on weekends and nights,” he said. Know where the patient is going to be isolated; figure out what to do if there’s more than one, and tests come back positive. Have masks on hand, and rehearse the response. “Make a coronavirus team, and absolutely have the nurses involved,” as well as other providers who may come into contact with a case, he added.

Dr. Daniel Lucey


“You want to be able to do as well as your counterparts in Washington state and Chicago,” where the first two U.S. cases emerged. “They were prepared. They knew what to do,” Dr. Lucey said.

Those first two U.S. patients – a man in Everett, Wash., and a Chicago woman – developed symptoms after returning from Wuhan, a city of 11 million just over 400 miles inland from the port city of Shanghai. On Jan. 26 three more cases were confirmed by the CDC, two in California and one in Arizona, and each had recently traveled to Wuhan.  All five patients remain hospitalized, and there’s no evidence they spread the infection further. There is also no evidence of human-to-human transmission of other cases exported from China to any other countries, according to the WHO.

WHO declined to declare a global health emergency – a Public Health Emergency of International Concern, in its parlance – on Jan. 23. The step would have triggered travel and trade restrictions in member states, including the United States. For now, at least, the group said it wasn’t warranted at this point.
 
 

 

Fatality rates

The focus right now is China. The outbreak has spread beyond Wuhan to other parts of the country, and there’s evidence of fourth-generation spread.



Transportation into and out of Wuhan and other cities has been curtailed, Lunar New Year festivals have been canceled, and the Shanghai Disneyland has been closed, among other measures taken by Chinese officials.

The government could be taking drastic measures in part to prevent the public criticism it took in the early 2000’s for the delayed response and lack of transparency during the global outbreak of another wildlife market coronavirus epidemic, severe acute respiratory syndrome (SARS). In a press conference Jan. 22, WHO officials commended the government’s containment efforts but did not say they recommended them.

According to WHO, serious cases in China have mostly been in people over 40 years old with significant comorbidities and have skewed towards men. Spread seems to be limited to family members, health care providers, and other close contacts, probably by respiratory droplets. If that pattern holds, WHO officials said, the outbreak is containable.

The fatality rate appears to be around 3%, a good deal lower than the 10% reported for SARS and much lower than the nearly 40% reported for Middle East respiratory syndrome (MERS), another recent coronavirus mutation from the animal trade.

The Wuhan virus fatality rate might drop as milder cases are detected and added to the denominator. “It definitely appears to be less severe than SARS and MERS,” said Amesh Adalja, MD, an infectious disease physician in Pittsburgh and emerging infectious disease researcher at Johns Hopkins University, Baltimore.

SARS: Lessons learned

In general, the world is much better equipped for coronavirus outbreaks than when SARS, in particular, emerged in 2003.

Dr. Amesh Adalja

WHO officials in their press conference lauded China for it openness with the current outbreak, and for isolating and sequencing the virus immediately, which gave the world a diagnostic test in the first days of the outbreak, something that wasn’t available for SARS. China and other countries also are cooperating and working closely to contain the Wuhan virus.

“What we know today might change tomorrow, so we have to keep tuned in to new information, but we learned a lot from SARS,” Dr. Shaffner said. Overall, it’s likely “the impact on the United States of this new coronavirus is going to be trivial,” he predicted.

Dr. Lucey, however, recalled that the SARS outbreak in Toronto in 2003 started with one missed case. A woman returned asymptomatic from Hong Kong and spread the infection to her family members before she died. Her cause of death wasn’t immediately recognized, nor was the reason her family members were sick, since they hadn’t been to Hong Kong recently.

The infection ultimately spread to more than 200 people, about half of them health care workers. A few people died.

If a virus is sufficiently contagious, “it just takes one. You don’t want to be the one who misses that first patient,” Dr. Lucey said.

Currently, there are no antivirals or vaccines for coronaviruses; researchers are working on both, but for now, care is supportive.

aotto@mdedge.com

This article was updated with new case numbers on 1/26/20.

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As the Wuhan coronavirus story unfolds, the most important thing for clinicians in the United States to do is ask patients who appear to have the flu if they, or someone they have been in contact with, recently returned from China, according to infectious disease experts.

China News Service/CC BY 3.0
Medical staff in Wuhan railway station during the Wuhan coronavirus outbreak, Jan. 24, 2020.

“We are asking that of everyone with fever and respiratory symptoms who comes to our clinics, hospital, or emergency room. It’s a powerful screening tool,” said William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center, Nashville, Tenn.

In addition to fever, common signs of infection include cough, shortness of breath, and breathing difficulties. Some patients have had diarrhea, vomiting, and other gastrointestinal symptoms. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure, and death. The incubation period appears to be up to 2 weeks, according to the World Health Organization (WHO).

If patients exhibit symptoms and either they or a close contact has returned from China recently, take standard airborne precautions and send specimens – a serum sample, oral and nasal pharyngeal swabs, and lower respiratory tract specimens if available – to the local health department, which will forward them to the Centers for Disease Control and Prevention (CDC) for testing. Turnaround time is 24-48 hours.

Dr. William Shaffner


The 2019 Novel Coronavirus (2019-nCoV), identified as the cause of an outbreak of respiratory illness first detected in December in association with a live animal market in Wuhan, China, has been implicated in almost 2,000 cases and 56 deaths in that country. Cases have been reported in 13 countries besides China. Five cases of 2019-nCoV infection have been confirmed in the United States, all in people recently returned from Wuhan. As the virus spreads in China, however, it’s almost certain more cases will show up in the United States. Travel history is key, Dr. Schaffner and others said.
 

Plan and rehearse

The first step to prepare is to use the CDC’s Interim Guidance for Healthcare Professionals to make a written plan specific to your practice to respond to a potential case. The plan must include notifying the local health department, the CDC liaison for testing, and tracking down patient contacts.

“It’s not good enough to just download CDC’s guidance; use it to make your own local plan and know what to do 24/7,” said Daniel Lucey, MD, an infectious disease expert at Georgetown University Medical Center, Washington, D.C.

“Know who is on call at the health department on weekends and nights,” he said. Know where the patient is going to be isolated; figure out what to do if there’s more than one, and tests come back positive. Have masks on hand, and rehearse the response. “Make a coronavirus team, and absolutely have the nurses involved,” as well as other providers who may come into contact with a case, he added.

Dr. Daniel Lucey


“You want to be able to do as well as your counterparts in Washington state and Chicago,” where the first two U.S. cases emerged. “They were prepared. They knew what to do,” Dr. Lucey said.

Those first two U.S. patients – a man in Everett, Wash., and a Chicago woman – developed symptoms after returning from Wuhan, a city of 11 million just over 400 miles inland from the port city of Shanghai. On Jan. 26 three more cases were confirmed by the CDC, two in California and one in Arizona, and each had recently traveled to Wuhan.  All five patients remain hospitalized, and there’s no evidence they spread the infection further. There is also no evidence of human-to-human transmission of other cases exported from China to any other countries, according to the WHO.

WHO declined to declare a global health emergency – a Public Health Emergency of International Concern, in its parlance – on Jan. 23. The step would have triggered travel and trade restrictions in member states, including the United States. For now, at least, the group said it wasn’t warranted at this point.
 
 

 

Fatality rates

The focus right now is China. The outbreak has spread beyond Wuhan to other parts of the country, and there’s evidence of fourth-generation spread.



Transportation into and out of Wuhan and other cities has been curtailed, Lunar New Year festivals have been canceled, and the Shanghai Disneyland has been closed, among other measures taken by Chinese officials.

The government could be taking drastic measures in part to prevent the public criticism it took in the early 2000’s for the delayed response and lack of transparency during the global outbreak of another wildlife market coronavirus epidemic, severe acute respiratory syndrome (SARS). In a press conference Jan. 22, WHO officials commended the government’s containment efforts but did not say they recommended them.

According to WHO, serious cases in China have mostly been in people over 40 years old with significant comorbidities and have skewed towards men. Spread seems to be limited to family members, health care providers, and other close contacts, probably by respiratory droplets. If that pattern holds, WHO officials said, the outbreak is containable.

The fatality rate appears to be around 3%, a good deal lower than the 10% reported for SARS and much lower than the nearly 40% reported for Middle East respiratory syndrome (MERS), another recent coronavirus mutation from the animal trade.

The Wuhan virus fatality rate might drop as milder cases are detected and added to the denominator. “It definitely appears to be less severe than SARS and MERS,” said Amesh Adalja, MD, an infectious disease physician in Pittsburgh and emerging infectious disease researcher at Johns Hopkins University, Baltimore.

SARS: Lessons learned

In general, the world is much better equipped for coronavirus outbreaks than when SARS, in particular, emerged in 2003.

Dr. Amesh Adalja

WHO officials in their press conference lauded China for it openness with the current outbreak, and for isolating and sequencing the virus immediately, which gave the world a diagnostic test in the first days of the outbreak, something that wasn’t available for SARS. China and other countries also are cooperating and working closely to contain the Wuhan virus.

“What we know today might change tomorrow, so we have to keep tuned in to new information, but we learned a lot from SARS,” Dr. Shaffner said. Overall, it’s likely “the impact on the United States of this new coronavirus is going to be trivial,” he predicted.

Dr. Lucey, however, recalled that the SARS outbreak in Toronto in 2003 started with one missed case. A woman returned asymptomatic from Hong Kong and spread the infection to her family members before she died. Her cause of death wasn’t immediately recognized, nor was the reason her family members were sick, since they hadn’t been to Hong Kong recently.

The infection ultimately spread to more than 200 people, about half of them health care workers. A few people died.

If a virus is sufficiently contagious, “it just takes one. You don’t want to be the one who misses that first patient,” Dr. Lucey said.

Currently, there are no antivirals or vaccines for coronaviruses; researchers are working on both, but for now, care is supportive.

aotto@mdedge.com

This article was updated with new case numbers on 1/26/20.

As the Wuhan coronavirus story unfolds, the most important thing for clinicians in the United States to do is ask patients who appear to have the flu if they, or someone they have been in contact with, recently returned from China, according to infectious disease experts.

China News Service/CC BY 3.0
Medical staff in Wuhan railway station during the Wuhan coronavirus outbreak, Jan. 24, 2020.

“We are asking that of everyone with fever and respiratory symptoms who comes to our clinics, hospital, or emergency room. It’s a powerful screening tool,” said William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center, Nashville, Tenn.

In addition to fever, common signs of infection include cough, shortness of breath, and breathing difficulties. Some patients have had diarrhea, vomiting, and other gastrointestinal symptoms. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure, and death. The incubation period appears to be up to 2 weeks, according to the World Health Organization (WHO).

If patients exhibit symptoms and either they or a close contact has returned from China recently, take standard airborne precautions and send specimens – a serum sample, oral and nasal pharyngeal swabs, and lower respiratory tract specimens if available – to the local health department, which will forward them to the Centers for Disease Control and Prevention (CDC) for testing. Turnaround time is 24-48 hours.

Dr. William Shaffner


The 2019 Novel Coronavirus (2019-nCoV), identified as the cause of an outbreak of respiratory illness first detected in December in association with a live animal market in Wuhan, China, has been implicated in almost 2,000 cases and 56 deaths in that country. Cases have been reported in 13 countries besides China. Five cases of 2019-nCoV infection have been confirmed in the United States, all in people recently returned from Wuhan. As the virus spreads in China, however, it’s almost certain more cases will show up in the United States. Travel history is key, Dr. Schaffner and others said.
 

Plan and rehearse

The first step to prepare is to use the CDC’s Interim Guidance for Healthcare Professionals to make a written plan specific to your practice to respond to a potential case. The plan must include notifying the local health department, the CDC liaison for testing, and tracking down patient contacts.

“It’s not good enough to just download CDC’s guidance; use it to make your own local plan and know what to do 24/7,” said Daniel Lucey, MD, an infectious disease expert at Georgetown University Medical Center, Washington, D.C.

“Know who is on call at the health department on weekends and nights,” he said. Know where the patient is going to be isolated; figure out what to do if there’s more than one, and tests come back positive. Have masks on hand, and rehearse the response. “Make a coronavirus team, and absolutely have the nurses involved,” as well as other providers who may come into contact with a case, he added.

Dr. Daniel Lucey


“You want to be able to do as well as your counterparts in Washington state and Chicago,” where the first two U.S. cases emerged. “They were prepared. They knew what to do,” Dr. Lucey said.

Those first two U.S. patients – a man in Everett, Wash., and a Chicago woman – developed symptoms after returning from Wuhan, a city of 11 million just over 400 miles inland from the port city of Shanghai. On Jan. 26 three more cases were confirmed by the CDC, two in California and one in Arizona, and each had recently traveled to Wuhan.  All five patients remain hospitalized, and there’s no evidence they spread the infection further. There is also no evidence of human-to-human transmission of other cases exported from China to any other countries, according to the WHO.

WHO declined to declare a global health emergency – a Public Health Emergency of International Concern, in its parlance – on Jan. 23. The step would have triggered travel and trade restrictions in member states, including the United States. For now, at least, the group said it wasn’t warranted at this point.
 
 

 

Fatality rates

The focus right now is China. The outbreak has spread beyond Wuhan to other parts of the country, and there’s evidence of fourth-generation spread.



Transportation into and out of Wuhan and other cities has been curtailed, Lunar New Year festivals have been canceled, and the Shanghai Disneyland has been closed, among other measures taken by Chinese officials.

The government could be taking drastic measures in part to prevent the public criticism it took in the early 2000’s for the delayed response and lack of transparency during the global outbreak of another wildlife market coronavirus epidemic, severe acute respiratory syndrome (SARS). In a press conference Jan. 22, WHO officials commended the government’s containment efforts but did not say they recommended them.

According to WHO, serious cases in China have mostly been in people over 40 years old with significant comorbidities and have skewed towards men. Spread seems to be limited to family members, health care providers, and other close contacts, probably by respiratory droplets. If that pattern holds, WHO officials said, the outbreak is containable.

The fatality rate appears to be around 3%, a good deal lower than the 10% reported for SARS and much lower than the nearly 40% reported for Middle East respiratory syndrome (MERS), another recent coronavirus mutation from the animal trade.

The Wuhan virus fatality rate might drop as milder cases are detected and added to the denominator. “It definitely appears to be less severe than SARS and MERS,” said Amesh Adalja, MD, an infectious disease physician in Pittsburgh and emerging infectious disease researcher at Johns Hopkins University, Baltimore.

SARS: Lessons learned

In general, the world is much better equipped for coronavirus outbreaks than when SARS, in particular, emerged in 2003.

Dr. Amesh Adalja

WHO officials in their press conference lauded China for it openness with the current outbreak, and for isolating and sequencing the virus immediately, which gave the world a diagnostic test in the first days of the outbreak, something that wasn’t available for SARS. China and other countries also are cooperating and working closely to contain the Wuhan virus.

“What we know today might change tomorrow, so we have to keep tuned in to new information, but we learned a lot from SARS,” Dr. Shaffner said. Overall, it’s likely “the impact on the United States of this new coronavirus is going to be trivial,” he predicted.

Dr. Lucey, however, recalled that the SARS outbreak in Toronto in 2003 started with one missed case. A woman returned asymptomatic from Hong Kong and spread the infection to her family members before she died. Her cause of death wasn’t immediately recognized, nor was the reason her family members were sick, since they hadn’t been to Hong Kong recently.

The infection ultimately spread to more than 200 people, about half of them health care workers. A few people died.

If a virus is sufficiently contagious, “it just takes one. You don’t want to be the one who misses that first patient,” Dr. Lucey said.

Currently, there are no antivirals or vaccines for coronaviruses; researchers are working on both, but for now, care is supportive.

aotto@mdedge.com

This article was updated with new case numbers on 1/26/20.

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EVALI update warns of chemicals in vaping products

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A report issued by the Centers for Disease Control and Prevention confirms that 82% of patients presenting with e-cigarette– or vaping product use–associated lung injury (EVALI) used products containing tetrahydrocannabinol (THC).

ArminStautBerlin/Thinkstock

Another report published in the CDC’s Morbidity and Mortality Weekly Report assessed cases in which the patients reported using only nicotine-containing vaping products.

“As of Jan. 14, 2020, a total of 2,668 hospitalized EVALI cases had been reported to CDC,” based on data from the National Syndromic Surveillance Program (NSSP), wrote Vikram P. Krishnasamy, MD, of the National Center for Injury Prevention and Control at the CDC, Atlanta, and colleagues. Cases have occurred in all 50 states, the District of Columbia, the U.S. Virgin Islands, and Puerto Rico. The age of the patients ranged from 13 to 85 years, with an average age of 24 years; 66% were male, and 73% were non-Hispanic white.

Of the 82% of patients who reported using a THC-containing e-cigarette or vaping product, 33% reported only THC-containing product use. In addition, 57% of the patients reported using any nicotine-containing product, and 14% of these reported use of nicotine products exclusively.

Previous studies have shown that vitamin E acetate is associated with the EVALI outbreak, which peaked during the week of Sept. 15, 2019, with 215 reported hospital admissions, Dr. Krishnasamy and associates noted. “However, evidence is not sufficient to rule out the contribution of other chemicals of concern, including chemicals in either THC- or non-THC–containing products, in some reported EVALI cases,” they said.

The study findings were limited by several factors, including incomplete data on product use, increased reporting of vaping product use at emergency department visits after increased public awareness of risk, and inconsistency in the health care facilities contributing data via the NSSP, the researchers wrote.

The decline in EVALI cases since September 2019 may be related to factors including the rapid public health response to increase awareness of the risks of vaping, and the possible removal of vitamin E acetate as a diluent in THC-containing products, but clinicians and public health professionals should remain on alert for new EVALI cases and continue to discourage the use of THC-containing e-cigarette or vaping products, Dr. Krishnasamy and associates concluded.

Nicotine-only vaping products

In a second report published in MMWR, Isaac Ghinai, MBBS, of the Illinois Department of Public Health and CDC researchers examined characteristics of EVALI patients in Illinois who reported using only nicotine-containing vaping products.

A total of 9 of 121 (7%) EVALI patients surveyed in Illinois reported no indication of THC use. These patients were more likely than those who reported any use of THC-containing products to be female (78% vs. 25%) and aged 45 years and older (33% vs. 2%); P less than .01 in both cases.

In addition, EVALI patients with no indication of THC-containing product use were less likely than THC product users to present with constitutional symptoms (56% vs. 96%) or initial leukocytosis (38% vs. 91%), or to have previously visited an outpatient provider or ED before being hospitalized (25% vs. 80%).

Other presenting characteristics including initial vital signs and lab results, as well as the frequency of severe outcomes such as death or respiratory failure, were not significantly different between users and nonusers of THC-containing vaping products.

The study findings were limited by factors including the use of self-reports, the small sample size, and lack of initial and follow-up interviews for all EVALI patients, the researchers noted. However, the results support the CDC’s recommendation that “persons should not use THC-containing e-cigarette, or vaping, products, particularly those obtained from informal sources such as friends, family members, or from in-person or online dealers,” and should not add vitamin E acetate or other substances to these products, they said.

In addition, users of nicotine-containing e-cigarette or vaping products as an alternative to cigarettes should not return to cigarettes, but should explore other options to help them quit, Dr. Ghinai, and associates said.

The studies were supported by the CDC. The researchers in both studies had no financial conflicts to disclose.

SOURCES: Krishnasamy VP et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e2; Ghinai I et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e1.

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A report issued by the Centers for Disease Control and Prevention confirms that 82% of patients presenting with e-cigarette– or vaping product use–associated lung injury (EVALI) used products containing tetrahydrocannabinol (THC).

ArminStautBerlin/Thinkstock

Another report published in the CDC’s Morbidity and Mortality Weekly Report assessed cases in which the patients reported using only nicotine-containing vaping products.

“As of Jan. 14, 2020, a total of 2,668 hospitalized EVALI cases had been reported to CDC,” based on data from the National Syndromic Surveillance Program (NSSP), wrote Vikram P. Krishnasamy, MD, of the National Center for Injury Prevention and Control at the CDC, Atlanta, and colleagues. Cases have occurred in all 50 states, the District of Columbia, the U.S. Virgin Islands, and Puerto Rico. The age of the patients ranged from 13 to 85 years, with an average age of 24 years; 66% were male, and 73% were non-Hispanic white.

Of the 82% of patients who reported using a THC-containing e-cigarette or vaping product, 33% reported only THC-containing product use. In addition, 57% of the patients reported using any nicotine-containing product, and 14% of these reported use of nicotine products exclusively.

Previous studies have shown that vitamin E acetate is associated with the EVALI outbreak, which peaked during the week of Sept. 15, 2019, with 215 reported hospital admissions, Dr. Krishnasamy and associates noted. “However, evidence is not sufficient to rule out the contribution of other chemicals of concern, including chemicals in either THC- or non-THC–containing products, in some reported EVALI cases,” they said.

The study findings were limited by several factors, including incomplete data on product use, increased reporting of vaping product use at emergency department visits after increased public awareness of risk, and inconsistency in the health care facilities contributing data via the NSSP, the researchers wrote.

The decline in EVALI cases since September 2019 may be related to factors including the rapid public health response to increase awareness of the risks of vaping, and the possible removal of vitamin E acetate as a diluent in THC-containing products, but clinicians and public health professionals should remain on alert for new EVALI cases and continue to discourage the use of THC-containing e-cigarette or vaping products, Dr. Krishnasamy and associates concluded.

Nicotine-only vaping products

In a second report published in MMWR, Isaac Ghinai, MBBS, of the Illinois Department of Public Health and CDC researchers examined characteristics of EVALI patients in Illinois who reported using only nicotine-containing vaping products.

A total of 9 of 121 (7%) EVALI patients surveyed in Illinois reported no indication of THC use. These patients were more likely than those who reported any use of THC-containing products to be female (78% vs. 25%) and aged 45 years and older (33% vs. 2%); P less than .01 in both cases.

In addition, EVALI patients with no indication of THC-containing product use were less likely than THC product users to present with constitutional symptoms (56% vs. 96%) or initial leukocytosis (38% vs. 91%), or to have previously visited an outpatient provider or ED before being hospitalized (25% vs. 80%).

Other presenting characteristics including initial vital signs and lab results, as well as the frequency of severe outcomes such as death or respiratory failure, were not significantly different between users and nonusers of THC-containing vaping products.

The study findings were limited by factors including the use of self-reports, the small sample size, and lack of initial and follow-up interviews for all EVALI patients, the researchers noted. However, the results support the CDC’s recommendation that “persons should not use THC-containing e-cigarette, or vaping, products, particularly those obtained from informal sources such as friends, family members, or from in-person or online dealers,” and should not add vitamin E acetate or other substances to these products, they said.

In addition, users of nicotine-containing e-cigarette or vaping products as an alternative to cigarettes should not return to cigarettes, but should explore other options to help them quit, Dr. Ghinai, and associates said.

The studies were supported by the CDC. The researchers in both studies had no financial conflicts to disclose.

SOURCES: Krishnasamy VP et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e2; Ghinai I et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e1.

 

A report issued by the Centers for Disease Control and Prevention confirms that 82% of patients presenting with e-cigarette– or vaping product use–associated lung injury (EVALI) used products containing tetrahydrocannabinol (THC).

ArminStautBerlin/Thinkstock

Another report published in the CDC’s Morbidity and Mortality Weekly Report assessed cases in which the patients reported using only nicotine-containing vaping products.

“As of Jan. 14, 2020, a total of 2,668 hospitalized EVALI cases had been reported to CDC,” based on data from the National Syndromic Surveillance Program (NSSP), wrote Vikram P. Krishnasamy, MD, of the National Center for Injury Prevention and Control at the CDC, Atlanta, and colleagues. Cases have occurred in all 50 states, the District of Columbia, the U.S. Virgin Islands, and Puerto Rico. The age of the patients ranged from 13 to 85 years, with an average age of 24 years; 66% were male, and 73% were non-Hispanic white.

Of the 82% of patients who reported using a THC-containing e-cigarette or vaping product, 33% reported only THC-containing product use. In addition, 57% of the patients reported using any nicotine-containing product, and 14% of these reported use of nicotine products exclusively.

Previous studies have shown that vitamin E acetate is associated with the EVALI outbreak, which peaked during the week of Sept. 15, 2019, with 215 reported hospital admissions, Dr. Krishnasamy and associates noted. “However, evidence is not sufficient to rule out the contribution of other chemicals of concern, including chemicals in either THC- or non-THC–containing products, in some reported EVALI cases,” they said.

The study findings were limited by several factors, including incomplete data on product use, increased reporting of vaping product use at emergency department visits after increased public awareness of risk, and inconsistency in the health care facilities contributing data via the NSSP, the researchers wrote.

The decline in EVALI cases since September 2019 may be related to factors including the rapid public health response to increase awareness of the risks of vaping, and the possible removal of vitamin E acetate as a diluent in THC-containing products, but clinicians and public health professionals should remain on alert for new EVALI cases and continue to discourage the use of THC-containing e-cigarette or vaping products, Dr. Krishnasamy and associates concluded.

Nicotine-only vaping products

In a second report published in MMWR, Isaac Ghinai, MBBS, of the Illinois Department of Public Health and CDC researchers examined characteristics of EVALI patients in Illinois who reported using only nicotine-containing vaping products.

A total of 9 of 121 (7%) EVALI patients surveyed in Illinois reported no indication of THC use. These patients were more likely than those who reported any use of THC-containing products to be female (78% vs. 25%) and aged 45 years and older (33% vs. 2%); P less than .01 in both cases.

In addition, EVALI patients with no indication of THC-containing product use were less likely than THC product users to present with constitutional symptoms (56% vs. 96%) or initial leukocytosis (38% vs. 91%), or to have previously visited an outpatient provider or ED before being hospitalized (25% vs. 80%).

Other presenting characteristics including initial vital signs and lab results, as well as the frequency of severe outcomes such as death or respiratory failure, were not significantly different between users and nonusers of THC-containing vaping products.

The study findings were limited by factors including the use of self-reports, the small sample size, and lack of initial and follow-up interviews for all EVALI patients, the researchers noted. However, the results support the CDC’s recommendation that “persons should not use THC-containing e-cigarette, or vaping, products, particularly those obtained from informal sources such as friends, family members, or from in-person or online dealers,” and should not add vitamin E acetate or other substances to these products, they said.

In addition, users of nicotine-containing e-cigarette or vaping products as an alternative to cigarettes should not return to cigarettes, but should explore other options to help them quit, Dr. Ghinai, and associates said.

The studies were supported by the CDC. The researchers in both studies had no financial conflicts to disclose.

SOURCES: Krishnasamy VP et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e2; Ghinai I et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e1.

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Second U.S. coronavirus patient confirmed

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The Centers for Disease Control and Prevention has confirmed a second case of the infectious coronavirus, 2019-nCoV, in the United States at a Jan. 24, 2020, press briefing.

The first U.S. case, a traveler who entered the United States at Seattle-Tacoma International Airport, was confirmed on Jan. 20.

Sercomi/Science Source
Colored transmission electron micrograph of a coronavirus.


A Chicago resident returning from Wuhan, China, on Jan. 13, 2020, developed symptoms of the disease and contacted her health care clinician and is currently being treated in isolation at an unnamed hospital, according to Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases at the CDC. The patient, a woman in her 60s, is in stable condition and remains hospitalized. She was not symptomatic on her flight to Chicago but developed symptoms in the following days after her return from Wuhan. She had limited contacts after her return, and all potential contacts are being tracked.

Dr. Messonnier said the CDC expects more cases in the United States but stressed that, although this is a serious public health threat, the risk to the American public is low. She noted that the situation is evolving rapidly and that the CDC is following the developments hour by hour.

Jennifer Layden, MD, PhD, chief medical officer and state epidemiologist with the Illinois Department of Public Health, said public health preparations made it possible to quickly identify and arrange appropriate hospitalization for this patient. Allison Arwady, MD, Chicago Department of Health commissioner, said the Illinois Department of Health partnered with the CDC to test specimens quickly, which led to the diagnosis in this patient.

So far, 63 U.S. patients have been investigated for possible infection with the 2019-nCoV; 11 so far have tested negative and 2 have tested positive. Testing of the remaining potential cases and others is ongoing.

Currently, samples from patients with suspected 2010-nCoV infections are being sent to the CDC for testing, Dr. Messonnier said. The turnaround for testing is currently 4-6 hours. Respiratory samples and some blood samples are being tested by the CDC labs.

The CDC is developing diagnostic kits for public health authorities in the United States for local testing and will work with the World Health Organization to make these kits available to the international community when possible.

Dr. Messonnier said that, at present, the incubation period for this disease appears to be about 14 days, but she suggested that further study will be required to identify the range of time for contagion. She also said it is premature to compare the 2019-nCoV with previous coronavirus outbreaks, such as severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS), in terms of contagion or fatality rates.

Meanwhile, Andrew D. Mesecar, PhD, the Walther Professor in Cancer Structural Biology and head of the department of biochemistry at Purdue University, West Lafayette, Ind., said on Jan. 24 in a news release that 2019-nCoV is genetically similar to the SARS variant. “MERS virus and the SARS virus are more different genetically,” noted Dr. Mesecar, whose team received the genome of 2019-nCoV on Jan. 17 and analyzed it the next day. “But the Wuhan virus is genetically almost identical to the SARS virus and, therefore, it is expected to look and act nearly the same. In another week or two, we’ll be able to begin to see if the virus is mutating.”

Dr. Messonnier said that nonessential travel to Wuhan is not recommended. In addition, she said, and all other visitors to China need to take appropriate precautions, such as handwashing and avoiding other individuals with respiratory illness.

Screenings at five U.S. airports will continue. So far, approximately 200 flights and 2,000 travelers have been screened as of Jan. 23. No cases were reported, but one traveler has been identified for further for evaluation. Possible contacts with those suspected of infection have been identified and alerted in 22 states.

The CDC will continue to update the public and will post information on the CDC newsroom website.

 

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The Centers for Disease Control and Prevention has confirmed a second case of the infectious coronavirus, 2019-nCoV, in the United States at a Jan. 24, 2020, press briefing.

The first U.S. case, a traveler who entered the United States at Seattle-Tacoma International Airport, was confirmed on Jan. 20.

Sercomi/Science Source
Colored transmission electron micrograph of a coronavirus.


A Chicago resident returning from Wuhan, China, on Jan. 13, 2020, developed symptoms of the disease and contacted her health care clinician and is currently being treated in isolation at an unnamed hospital, according to Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases at the CDC. The patient, a woman in her 60s, is in stable condition and remains hospitalized. She was not symptomatic on her flight to Chicago but developed symptoms in the following days after her return from Wuhan. She had limited contacts after her return, and all potential contacts are being tracked.

Dr. Messonnier said the CDC expects more cases in the United States but stressed that, although this is a serious public health threat, the risk to the American public is low. She noted that the situation is evolving rapidly and that the CDC is following the developments hour by hour.

Jennifer Layden, MD, PhD, chief medical officer and state epidemiologist with the Illinois Department of Public Health, said public health preparations made it possible to quickly identify and arrange appropriate hospitalization for this patient. Allison Arwady, MD, Chicago Department of Health commissioner, said the Illinois Department of Health partnered with the CDC to test specimens quickly, which led to the diagnosis in this patient.

So far, 63 U.S. patients have been investigated for possible infection with the 2019-nCoV; 11 so far have tested negative and 2 have tested positive. Testing of the remaining potential cases and others is ongoing.

Currently, samples from patients with suspected 2010-nCoV infections are being sent to the CDC for testing, Dr. Messonnier said. The turnaround for testing is currently 4-6 hours. Respiratory samples and some blood samples are being tested by the CDC labs.

The CDC is developing diagnostic kits for public health authorities in the United States for local testing and will work with the World Health Organization to make these kits available to the international community when possible.

Dr. Messonnier said that, at present, the incubation period for this disease appears to be about 14 days, but she suggested that further study will be required to identify the range of time for contagion. She also said it is premature to compare the 2019-nCoV with previous coronavirus outbreaks, such as severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS), in terms of contagion or fatality rates.

Meanwhile, Andrew D. Mesecar, PhD, the Walther Professor in Cancer Structural Biology and head of the department of biochemistry at Purdue University, West Lafayette, Ind., said on Jan. 24 in a news release that 2019-nCoV is genetically similar to the SARS variant. “MERS virus and the SARS virus are more different genetically,” noted Dr. Mesecar, whose team received the genome of 2019-nCoV on Jan. 17 and analyzed it the next day. “But the Wuhan virus is genetically almost identical to the SARS virus and, therefore, it is expected to look and act nearly the same. In another week or two, we’ll be able to begin to see if the virus is mutating.”

Dr. Messonnier said that nonessential travel to Wuhan is not recommended. In addition, she said, and all other visitors to China need to take appropriate precautions, such as handwashing and avoiding other individuals with respiratory illness.

Screenings at five U.S. airports will continue. So far, approximately 200 flights and 2,000 travelers have been screened as of Jan. 23. No cases were reported, but one traveler has been identified for further for evaluation. Possible contacts with those suspected of infection have been identified and alerted in 22 states.

The CDC will continue to update the public and will post information on the CDC newsroom website.

 

The Centers for Disease Control and Prevention has confirmed a second case of the infectious coronavirus, 2019-nCoV, in the United States at a Jan. 24, 2020, press briefing.

The first U.S. case, a traveler who entered the United States at Seattle-Tacoma International Airport, was confirmed on Jan. 20.

Sercomi/Science Source
Colored transmission electron micrograph of a coronavirus.


A Chicago resident returning from Wuhan, China, on Jan. 13, 2020, developed symptoms of the disease and contacted her health care clinician and is currently being treated in isolation at an unnamed hospital, according to Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases at the CDC. The patient, a woman in her 60s, is in stable condition and remains hospitalized. She was not symptomatic on her flight to Chicago but developed symptoms in the following days after her return from Wuhan. She had limited contacts after her return, and all potential contacts are being tracked.

Dr. Messonnier said the CDC expects more cases in the United States but stressed that, although this is a serious public health threat, the risk to the American public is low. She noted that the situation is evolving rapidly and that the CDC is following the developments hour by hour.

Jennifer Layden, MD, PhD, chief medical officer and state epidemiologist with the Illinois Department of Public Health, said public health preparations made it possible to quickly identify and arrange appropriate hospitalization for this patient. Allison Arwady, MD, Chicago Department of Health commissioner, said the Illinois Department of Health partnered with the CDC to test specimens quickly, which led to the diagnosis in this patient.

So far, 63 U.S. patients have been investigated for possible infection with the 2019-nCoV; 11 so far have tested negative and 2 have tested positive. Testing of the remaining potential cases and others is ongoing.

Currently, samples from patients with suspected 2010-nCoV infections are being sent to the CDC for testing, Dr. Messonnier said. The turnaround for testing is currently 4-6 hours. Respiratory samples and some blood samples are being tested by the CDC labs.

The CDC is developing diagnostic kits for public health authorities in the United States for local testing and will work with the World Health Organization to make these kits available to the international community when possible.

Dr. Messonnier said that, at present, the incubation period for this disease appears to be about 14 days, but she suggested that further study will be required to identify the range of time for contagion. She also said it is premature to compare the 2019-nCoV with previous coronavirus outbreaks, such as severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS), in terms of contagion or fatality rates.

Meanwhile, Andrew D. Mesecar, PhD, the Walther Professor in Cancer Structural Biology and head of the department of biochemistry at Purdue University, West Lafayette, Ind., said on Jan. 24 in a news release that 2019-nCoV is genetically similar to the SARS variant. “MERS virus and the SARS virus are more different genetically,” noted Dr. Mesecar, whose team received the genome of 2019-nCoV on Jan. 17 and analyzed it the next day. “But the Wuhan virus is genetically almost identical to the SARS virus and, therefore, it is expected to look and act nearly the same. In another week or two, we’ll be able to begin to see if the virus is mutating.”

Dr. Messonnier said that nonessential travel to Wuhan is not recommended. In addition, she said, and all other visitors to China need to take appropriate precautions, such as handwashing and avoiding other individuals with respiratory illness.

Screenings at five U.S. airports will continue. So far, approximately 200 flights and 2,000 travelers have been screened as of Jan. 23. No cases were reported, but one traveler has been identified for further for evaluation. Possible contacts with those suspected of infection have been identified and alerted in 22 states.

The CDC will continue to update the public and will post information on the CDC newsroom website.

 

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FDA: Cybersecurity vulnerabilities identified in GE Healthcare monitoring devices

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The Food and Drug Administration has issued a warning that certain GE Healthcare Clinical Information Central Stations and Telemetry Servers have cybersecurity vulnerabilities that may introduce risk to monitored patients.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

A security firm identified several vulnerabilities in the GE devices that allow attackers to remotely take control of the medical device, silence alarms, generate false alarms, and interfere with alarms of patient monitors connected to these devices, according to an “Urgent Medical Device Correction” letter issued by GE Healthcare in November 2019.

The affected devices are the ApexPro Telemetry Server and CARESCAPE Telemetry Server, the CARESCAPE Central Station (CSCS) version 1, and the CIC Pro Clinical Information Center Central Station version 1. These devices are used in health care facilities for displaying information, such as the patient’s physiological parameters, and for monitoring patient status from a central location in a facility.

No adverse events related to the vulnerabilities have been reported to the FDA. Health care facility staff should update their devices when GE Healthcare issues a software patch that addresses the vulnerability, separate the network connecting patient monitors using affected devices from the rest of the hospital, and use firewalls and other means to minimize the risk of remote or local network attacks.

“The FDA takes reports of cybersecurity vulnerabilities in medical devices seriously and will continue to work with GE Healthcare as the firm develops software patches to correct these vulnerabilities as soon as possible. The FDA will continue to assess new information concerning the vulnerabilities and will keep the public informed if significant new information becomes available,” the FDA said in the Safety Communication.

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The Food and Drug Administration has issued a warning that certain GE Healthcare Clinical Information Central Stations and Telemetry Servers have cybersecurity vulnerabilities that may introduce risk to monitored patients.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

A security firm identified several vulnerabilities in the GE devices that allow attackers to remotely take control of the medical device, silence alarms, generate false alarms, and interfere with alarms of patient monitors connected to these devices, according to an “Urgent Medical Device Correction” letter issued by GE Healthcare in November 2019.

The affected devices are the ApexPro Telemetry Server and CARESCAPE Telemetry Server, the CARESCAPE Central Station (CSCS) version 1, and the CIC Pro Clinical Information Center Central Station version 1. These devices are used in health care facilities for displaying information, such as the patient’s physiological parameters, and for monitoring patient status from a central location in a facility.

No adverse events related to the vulnerabilities have been reported to the FDA. Health care facility staff should update their devices when GE Healthcare issues a software patch that addresses the vulnerability, separate the network connecting patient monitors using affected devices from the rest of the hospital, and use firewalls and other means to minimize the risk of remote or local network attacks.

“The FDA takes reports of cybersecurity vulnerabilities in medical devices seriously and will continue to work with GE Healthcare as the firm develops software patches to correct these vulnerabilities as soon as possible. The FDA will continue to assess new information concerning the vulnerabilities and will keep the public informed if significant new information becomes available,” the FDA said in the Safety Communication.

 

The Food and Drug Administration has issued a warning that certain GE Healthcare Clinical Information Central Stations and Telemetry Servers have cybersecurity vulnerabilities that may introduce risk to monitored patients.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

A security firm identified several vulnerabilities in the GE devices that allow attackers to remotely take control of the medical device, silence alarms, generate false alarms, and interfere with alarms of patient monitors connected to these devices, according to an “Urgent Medical Device Correction” letter issued by GE Healthcare in November 2019.

The affected devices are the ApexPro Telemetry Server and CARESCAPE Telemetry Server, the CARESCAPE Central Station (CSCS) version 1, and the CIC Pro Clinical Information Center Central Station version 1. These devices are used in health care facilities for displaying information, such as the patient’s physiological parameters, and for monitoring patient status from a central location in a facility.

No adverse events related to the vulnerabilities have been reported to the FDA. Health care facility staff should update their devices when GE Healthcare issues a software patch that addresses the vulnerability, separate the network connecting patient monitors using affected devices from the rest of the hospital, and use firewalls and other means to minimize the risk of remote or local network attacks.

“The FDA takes reports of cybersecurity vulnerabilities in medical devices seriously and will continue to work with GE Healthcare as the firm develops software patches to correct these vulnerabilities as soon as possible. The FDA will continue to assess new information concerning the vulnerabilities and will keep the public informed if significant new information becomes available,” the FDA said in the Safety Communication.

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Suicide rate higher than average for female clinicians

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The suicide rate for women who provide health care is higher than that of all women of working age, while male health care practitioners are less likely to end their lives than working-age men as a whole, according to the Centers for Disease Control and Prevention.

In 2016, the suicide rate for women classified as “healthcare practitioners and technical” – a category that includes physicians and surgeons, as well as chiropractors, physician assistants, and nurse practitioners – was 8.5 per 100,000 population, compared with 7.7 per 100,000 for all working women aged 16-64 years. That difference, however, was not statistically significant, Cora Peterson, PhD, and associates at the CDC said in the Morbidity and Mortality Weekly Report.

For females classified as “healthcare support” – medical assistants and transcriptionists, phlebotomists, and pharmacy aides – the suicide rate of 10.6 per 100,000 was significantly higher than that of all working women, the investigators noted.

The suicide rate for males in each of the two occupation categories was 23.6 per 100,000 population in 2016, lower than the rate of 27.4 per 100,000 for males of all occupations, they said, based on data from 32 states that participated in the 2016 National Violent Death Reporting System.



For males, the highest suicide rates in occupations meeting criteria for sample size were “construction and extraction” (49.4 per 100,000); “installation, maintenance, and repair” (36.9); and “arts, design, entertainment, sports, and media” (32.0). Among females, the highest rates were seen in “construction and extraction” (25.5 per 100,000), “protective service” (14.0), and “transportation and material moving” (12.5), with healthcare support next, Dr. Peterson and associates reported.

“Although relative comparisons of suicide rates in this manner are useful for prevention purposes, these results should not overshadow the essential fact that the suicide rate in the U.S. working-age population overall has increased by 40% in less than 2 decades. Therefore, all industry sectors and occupational groups can contribute to reducing suicide incidence,” they wrote.

SOURCE: Peterson C et al. MMWR. 2020 Jan 24;69(3):57-62.

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The suicide rate for women who provide health care is higher than that of all women of working age, while male health care practitioners are less likely to end their lives than working-age men as a whole, according to the Centers for Disease Control and Prevention.

In 2016, the suicide rate for women classified as “healthcare practitioners and technical” – a category that includes physicians and surgeons, as well as chiropractors, physician assistants, and nurse practitioners – was 8.5 per 100,000 population, compared with 7.7 per 100,000 for all working women aged 16-64 years. That difference, however, was not statistically significant, Cora Peterson, PhD, and associates at the CDC said in the Morbidity and Mortality Weekly Report.

For females classified as “healthcare support” – medical assistants and transcriptionists, phlebotomists, and pharmacy aides – the suicide rate of 10.6 per 100,000 was significantly higher than that of all working women, the investigators noted.

The suicide rate for males in each of the two occupation categories was 23.6 per 100,000 population in 2016, lower than the rate of 27.4 per 100,000 for males of all occupations, they said, based on data from 32 states that participated in the 2016 National Violent Death Reporting System.



For males, the highest suicide rates in occupations meeting criteria for sample size were “construction and extraction” (49.4 per 100,000); “installation, maintenance, and repair” (36.9); and “arts, design, entertainment, sports, and media” (32.0). Among females, the highest rates were seen in “construction and extraction” (25.5 per 100,000), “protective service” (14.0), and “transportation and material moving” (12.5), with healthcare support next, Dr. Peterson and associates reported.

“Although relative comparisons of suicide rates in this manner are useful for prevention purposes, these results should not overshadow the essential fact that the suicide rate in the U.S. working-age population overall has increased by 40% in less than 2 decades. Therefore, all industry sectors and occupational groups can contribute to reducing suicide incidence,” they wrote.

SOURCE: Peterson C et al. MMWR. 2020 Jan 24;69(3):57-62.

The suicide rate for women who provide health care is higher than that of all women of working age, while male health care practitioners are less likely to end their lives than working-age men as a whole, according to the Centers for Disease Control and Prevention.

In 2016, the suicide rate for women classified as “healthcare practitioners and technical” – a category that includes physicians and surgeons, as well as chiropractors, physician assistants, and nurse practitioners – was 8.5 per 100,000 population, compared with 7.7 per 100,000 for all working women aged 16-64 years. That difference, however, was not statistically significant, Cora Peterson, PhD, and associates at the CDC said in the Morbidity and Mortality Weekly Report.

For females classified as “healthcare support” – medical assistants and transcriptionists, phlebotomists, and pharmacy aides – the suicide rate of 10.6 per 100,000 was significantly higher than that of all working women, the investigators noted.

The suicide rate for males in each of the two occupation categories was 23.6 per 100,000 population in 2016, lower than the rate of 27.4 per 100,000 for males of all occupations, they said, based on data from 32 states that participated in the 2016 National Violent Death Reporting System.



For males, the highest suicide rates in occupations meeting criteria for sample size were “construction and extraction” (49.4 per 100,000); “installation, maintenance, and repair” (36.9); and “arts, design, entertainment, sports, and media” (32.0). Among females, the highest rates were seen in “construction and extraction” (25.5 per 100,000), “protective service” (14.0), and “transportation and material moving” (12.5), with healthcare support next, Dr. Peterson and associates reported.

“Although relative comparisons of suicide rates in this manner are useful for prevention purposes, these results should not overshadow the essential fact that the suicide rate in the U.S. working-age population overall has increased by 40% in less than 2 decades. Therefore, all industry sectors and occupational groups can contribute to reducing suicide incidence,” they wrote.

SOURCE: Peterson C et al. MMWR. 2020 Jan 24;69(3):57-62.

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Race, ethnicity may influence outcomes after supratentorial intracerebral hemorrhage

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Among young adults with supratentorial intracerebral hemorrhage (ICH), black race and Hispanic ethnicity are associated with better functional outcomes, compared with white race, researchers reported Jan. 22 in Neurology.

“There has been considerable research on stroke in older people, but there is still much to be learned about stroke in younger people and how it affects people of different races and ethnicities,” study author Daniel Woo, MD, professor of neurology at the University of Cincinnati, said in a news release. “Our study found that, even when you account for factors that affect outcomes, such as how big the stroke is, race and ethnicity were still independent predictors of how well people would recover.”
 

A subset of ERICH participants

To examine predictors of functional outcome in young patients with ICH, researchers analyzed data from a subset of patients in the Ethnic/Racial Variations in Intracerebral Hemorrhage (ERICH) study. ERICH enrolled patients with nontraumatic ICHs at 42 sites in the United States. It included 1,000 non-Hispanic black patients, 1,000 non-Hispanic white patients, and 1,000 Hispanic patients. Participants self-reported race and ethnicity.

Lead author Laura C. Miyares from Yale School of Medicine in New Haven, Conn., and colleagues analyzed data from 418 patients in ERICH who were aged 18-49 years and had supratentorial ICH. The cohort had an average age of 43 years, and 69% were male. In this subset, 41% were black, 12% were white, and 47% were Hispanic.

The primary outcome was modified Rankin Scale (mRS) score 3 months after the ICH, and the investigators defined a poor outcome as a score of 4 or greater. At 3 months, 35% had a poor functional outcome. Approximately 18% were unable to walk without assistance and attend to their bodily needs (mRS 4); 8% were bedridden, incontinent, and required nursing care (mRS 5); and 10% had died (mRS 6).

The percentage of patients with a poor functional outcome was 52% among white patients, 35% among black patients, and 31% among Hispanic patients. In a univariable analysis, black patients had a 51% reduction in odds of a poor outcome, compared with white patients, and Hispanic patients had a 59% reduction.

“The association between race/ethnicity and 3-month post-ICH functional outcome remained significant after adjusting for age, sex, premorbid disability, ICH location, ICH volume, [intraventricular hemorrhage] extension, systolic blood pressure, and [Glasgow Coma Scale] score on admission,” the researchers said. “In multivariable analysis, using white patients as the reference category, black patients had a 58% reduction in the odds of poor functional outcome at 3 months and Hispanic patients had a 66% reduction in the same odds.”

Their analysis identified the importance of other risk factors as well. “The volume of the hematoma, the most powerful predictor of outcome in older patients with ICH, was also found to be the most significant predictor of poor outcome in young patients,” they said.
 

Vascular risks and oral anticoagulants

About 80% of the young adults with ICH had a history of diagnosed hypertension. In nearly half, the condition was untreated. “After hypertension, the most common stroke risk factors in the young were diabetes, high cholesterol, smoking, and alcohol abuse,” the authors said. “In combination, these results indicate that vascular risk factors, especially untreated, could explain a large proportion of cases of ICH in the young.”

 

 

“Our results also point to treatment with oral anticoagulants before hospitalization as a potential mediator of the effect of race/ethnicity on short-term functional outcomes,” they said. About 8% of the white patients used oral anticoagulants, compared with 4% of the black patients and 1% of the Hispanic patients. Oral anticoagulant treatment “is a known risk factor for ICH and an established predictor of poor outcome in this condition. However, because only a small proportion of enrolled young patients with ICH were on [oral anticoagulants] prior to presentation, these results should be further validated by future studies.”

The study’s limitations include the broad categorization of racial and ethnic groups, the fact that younger patients with supratentorial ICH were more likely to be black or Hispanic and less likely to be white, and the exclusion of a significant proportion of cases of young white patients with smaller ICH volumes because of missing data, the researchers noted. Although the cohort was large, researchers may need to study more patients to capture differences among racial and ethnic groups, the investigators said.

The association between race/ethnicity and functional outcome could relate to “distinct pathophysiologies of the initial bleed or unique mechanisms of secondary injury,” the researchers suggested. “Future studies are necessary to probe the potential biological and social mediators of these findings to elucidate the role of race/ethnicity in ICH severity and functional recovery, and to develop improved prognostication for a racially varied population.”

ERICH is supported by the National Institute of Neurological Disorders and Stroke. Authors disclosed grants from the government, professional societies, and a university.

SOURCE: Miyares LC et al. Neurology. 2020 Jan 22. doi: 10.1212/WNL.0000000000008930.

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Among young adults with supratentorial intracerebral hemorrhage (ICH), black race and Hispanic ethnicity are associated with better functional outcomes, compared with white race, researchers reported Jan. 22 in Neurology.

“There has been considerable research on stroke in older people, but there is still much to be learned about stroke in younger people and how it affects people of different races and ethnicities,” study author Daniel Woo, MD, professor of neurology at the University of Cincinnati, said in a news release. “Our study found that, even when you account for factors that affect outcomes, such as how big the stroke is, race and ethnicity were still independent predictors of how well people would recover.”
 

A subset of ERICH participants

To examine predictors of functional outcome in young patients with ICH, researchers analyzed data from a subset of patients in the Ethnic/Racial Variations in Intracerebral Hemorrhage (ERICH) study. ERICH enrolled patients with nontraumatic ICHs at 42 sites in the United States. It included 1,000 non-Hispanic black patients, 1,000 non-Hispanic white patients, and 1,000 Hispanic patients. Participants self-reported race and ethnicity.

Lead author Laura C. Miyares from Yale School of Medicine in New Haven, Conn., and colleagues analyzed data from 418 patients in ERICH who were aged 18-49 years and had supratentorial ICH. The cohort had an average age of 43 years, and 69% were male. In this subset, 41% were black, 12% were white, and 47% were Hispanic.

The primary outcome was modified Rankin Scale (mRS) score 3 months after the ICH, and the investigators defined a poor outcome as a score of 4 or greater. At 3 months, 35% had a poor functional outcome. Approximately 18% were unable to walk without assistance and attend to their bodily needs (mRS 4); 8% were bedridden, incontinent, and required nursing care (mRS 5); and 10% had died (mRS 6).

The percentage of patients with a poor functional outcome was 52% among white patients, 35% among black patients, and 31% among Hispanic patients. In a univariable analysis, black patients had a 51% reduction in odds of a poor outcome, compared with white patients, and Hispanic patients had a 59% reduction.

“The association between race/ethnicity and 3-month post-ICH functional outcome remained significant after adjusting for age, sex, premorbid disability, ICH location, ICH volume, [intraventricular hemorrhage] extension, systolic blood pressure, and [Glasgow Coma Scale] score on admission,” the researchers said. “In multivariable analysis, using white patients as the reference category, black patients had a 58% reduction in the odds of poor functional outcome at 3 months and Hispanic patients had a 66% reduction in the same odds.”

Their analysis identified the importance of other risk factors as well. “The volume of the hematoma, the most powerful predictor of outcome in older patients with ICH, was also found to be the most significant predictor of poor outcome in young patients,” they said.
 

Vascular risks and oral anticoagulants

About 80% of the young adults with ICH had a history of diagnosed hypertension. In nearly half, the condition was untreated. “After hypertension, the most common stroke risk factors in the young were diabetes, high cholesterol, smoking, and alcohol abuse,” the authors said. “In combination, these results indicate that vascular risk factors, especially untreated, could explain a large proportion of cases of ICH in the young.”

 

 

“Our results also point to treatment with oral anticoagulants before hospitalization as a potential mediator of the effect of race/ethnicity on short-term functional outcomes,” they said. About 8% of the white patients used oral anticoagulants, compared with 4% of the black patients and 1% of the Hispanic patients. Oral anticoagulant treatment “is a known risk factor for ICH and an established predictor of poor outcome in this condition. However, because only a small proportion of enrolled young patients with ICH were on [oral anticoagulants] prior to presentation, these results should be further validated by future studies.”

The study’s limitations include the broad categorization of racial and ethnic groups, the fact that younger patients with supratentorial ICH were more likely to be black or Hispanic and less likely to be white, and the exclusion of a significant proportion of cases of young white patients with smaller ICH volumes because of missing data, the researchers noted. Although the cohort was large, researchers may need to study more patients to capture differences among racial and ethnic groups, the investigators said.

The association between race/ethnicity and functional outcome could relate to “distinct pathophysiologies of the initial bleed or unique mechanisms of secondary injury,” the researchers suggested. “Future studies are necessary to probe the potential biological and social mediators of these findings to elucidate the role of race/ethnicity in ICH severity and functional recovery, and to develop improved prognostication for a racially varied population.”

ERICH is supported by the National Institute of Neurological Disorders and Stroke. Authors disclosed grants from the government, professional societies, and a university.

SOURCE: Miyares LC et al. Neurology. 2020 Jan 22. doi: 10.1212/WNL.0000000000008930.

Among young adults with supratentorial intracerebral hemorrhage (ICH), black race and Hispanic ethnicity are associated with better functional outcomes, compared with white race, researchers reported Jan. 22 in Neurology.

“There has been considerable research on stroke in older people, but there is still much to be learned about stroke in younger people and how it affects people of different races and ethnicities,” study author Daniel Woo, MD, professor of neurology at the University of Cincinnati, said in a news release. “Our study found that, even when you account for factors that affect outcomes, such as how big the stroke is, race and ethnicity were still independent predictors of how well people would recover.”
 

A subset of ERICH participants

To examine predictors of functional outcome in young patients with ICH, researchers analyzed data from a subset of patients in the Ethnic/Racial Variations in Intracerebral Hemorrhage (ERICH) study. ERICH enrolled patients with nontraumatic ICHs at 42 sites in the United States. It included 1,000 non-Hispanic black patients, 1,000 non-Hispanic white patients, and 1,000 Hispanic patients. Participants self-reported race and ethnicity.

Lead author Laura C. Miyares from Yale School of Medicine in New Haven, Conn., and colleagues analyzed data from 418 patients in ERICH who were aged 18-49 years and had supratentorial ICH. The cohort had an average age of 43 years, and 69% were male. In this subset, 41% were black, 12% were white, and 47% were Hispanic.

The primary outcome was modified Rankin Scale (mRS) score 3 months after the ICH, and the investigators defined a poor outcome as a score of 4 or greater. At 3 months, 35% had a poor functional outcome. Approximately 18% were unable to walk without assistance and attend to their bodily needs (mRS 4); 8% were bedridden, incontinent, and required nursing care (mRS 5); and 10% had died (mRS 6).

The percentage of patients with a poor functional outcome was 52% among white patients, 35% among black patients, and 31% among Hispanic patients. In a univariable analysis, black patients had a 51% reduction in odds of a poor outcome, compared with white patients, and Hispanic patients had a 59% reduction.

“The association between race/ethnicity and 3-month post-ICH functional outcome remained significant after adjusting for age, sex, premorbid disability, ICH location, ICH volume, [intraventricular hemorrhage] extension, systolic blood pressure, and [Glasgow Coma Scale] score on admission,” the researchers said. “In multivariable analysis, using white patients as the reference category, black patients had a 58% reduction in the odds of poor functional outcome at 3 months and Hispanic patients had a 66% reduction in the same odds.”

Their analysis identified the importance of other risk factors as well. “The volume of the hematoma, the most powerful predictor of outcome in older patients with ICH, was also found to be the most significant predictor of poor outcome in young patients,” they said.
 

Vascular risks and oral anticoagulants

About 80% of the young adults with ICH had a history of diagnosed hypertension. In nearly half, the condition was untreated. “After hypertension, the most common stroke risk factors in the young were diabetes, high cholesterol, smoking, and alcohol abuse,” the authors said. “In combination, these results indicate that vascular risk factors, especially untreated, could explain a large proportion of cases of ICH in the young.”

 

 

“Our results also point to treatment with oral anticoagulants before hospitalization as a potential mediator of the effect of race/ethnicity on short-term functional outcomes,” they said. About 8% of the white patients used oral anticoagulants, compared with 4% of the black patients and 1% of the Hispanic patients. Oral anticoagulant treatment “is a known risk factor for ICH and an established predictor of poor outcome in this condition. However, because only a small proportion of enrolled young patients with ICH were on [oral anticoagulants] prior to presentation, these results should be further validated by future studies.”

The study’s limitations include the broad categorization of racial and ethnic groups, the fact that younger patients with supratentorial ICH were more likely to be black or Hispanic and less likely to be white, and the exclusion of a significant proportion of cases of young white patients with smaller ICH volumes because of missing data, the researchers noted. Although the cohort was large, researchers may need to study more patients to capture differences among racial and ethnic groups, the investigators said.

The association between race/ethnicity and functional outcome could relate to “distinct pathophysiologies of the initial bleed or unique mechanisms of secondary injury,” the researchers suggested. “Future studies are necessary to probe the potential biological and social mediators of these findings to elucidate the role of race/ethnicity in ICH severity and functional recovery, and to develop improved prognostication for a racially varied population.”

ERICH is supported by the National Institute of Neurological Disorders and Stroke. Authors disclosed grants from the government, professional societies, and a university.

SOURCE: Miyares LC et al. Neurology. 2020 Jan 22. doi: 10.1212/WNL.0000000000008930.

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Key clinical point: Among young adults with supratentorial intracerebral hemorrhage (ICH), black race and Hispanic ethnicity are associated with better functional outcomes, compared with white race.

Major finding: In multivariable analysis, black patients had a 58% reduction in the odds of poor functional outcome at 3 months, compared with white patients, and Hispanic patients had a 66% reduction.

Study details: An analysis of data from a subset of 418 patients in the Ethnic/Racial Variations in Intracerebral Hemorrhage (ERICH) study.

Disclosures: ERICH is supported by the National Institute of Neurological Disorders and Stroke. Authors disclosed grants from the government, professional societies, and a university.

Source: Miyares LC et al. Neurology. 2020 Jan 22. doi: 10.1212/WNL.0000000000008930.

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Redo PCI or CABG, left main patients pay a price: EXCEL

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Repeat revascularization was more frequent after left main percutaneous coronary intervention than after coronary artery bypass surgery, but raised the mortality risk after both procedures in a secondary EXCEL analysis.
 

Dr. Gregg W. Stone

The 3-year rate of any repeat revascularization was 12.9% after PCI and 7.6% after CABG (hazard ratio, 1.73; 95% confidence interval, 1.28-2.33).

“It’s a real difference and shouldn’t be minimized. About 1 in 20 patients will need an additional repeat revascularization after PCI, compared with surgery,” study author Gregg Stone, MD, Icahn School of Medicine at Mount Sinai in New York, said in an interview. “Surgery is a more durable procedure in that regard, and patients need to be informed of that by heart team discussions.”

That said, Dr. Stone highlighted other differences between the two strategies, including more bleeding and atrial fibrillation after surgery and better early quality of life after PCI. There’s also an early myocardial infarction (MI) benefit with PCI but a late MI benefit with surgery, which “is probably a more important difference between the two, as opposed to the difference in repeat revascularization,” he added.

Although the increased need to perform repeat vascularization after PCI is not unexpected, the analysis of 346 repeat revascularizations in 185 patients provides more details on the timing and prognosis of these procedures in left main disease.

The need for repeat revascularization was independently associated with 3-year all-cause mortality (adjusted HR, 2.05; 95% CI, 1.13-3.70) and cardiovascular mortality (adjusted HR, 4.22; 95% CI, 2.10-8.48) for both PCI and CABG (P for interaction = .85 for both outcomes).

The increase in mortality risk, however, was smaller than that for MI (adjusted HR, 4.03; 95% CI, 2.43-6.67) or stroke (adjusted HR, 16.62; 95% CI, 9.97-27.69).

The risk for death peaked in the 30 days after redo revascularization and then declined during follow-up. Most of the deaths were cardiovascular (74/128).

The incidence of repeat left main PCI was only 17.5%, whereas the left main was the most common site for redo revascularization in the CABG group.

Repeat revascularization of the index target vessel and target lesion – but not of other lesions – were both strongly associated with increased all-cause and cardiovascular mortality, the authors reported January 15 in JACC: Cardiovascular Interventions.

Dr. Richard J. Shemin

“It just continues to show that, no matter what intervention we use, we haven’t achieved perfection yet and the opportunities for improvement and decision making between a PCI and a CABG is still up in the air,” Richard J. Shemin, MD, chief of cardiac surgery, UCLA Medical Center, Los Angeles, said in an interview. “And there’s some evidence to suggest coronary bypass might be better in terms of mortality and the need for repeat revascularization.”


 

Enhancing durability

“Measures to reduce the need for repeat revascularization including improved stent platforms and implantation technique, use of pan-arterial bypass grafting, and aggressive risk factor control with guideline-directed medical therapy may improve prognosis after both PCI and CABG,” the authors concluded.

In a linked editorial, David O. Williams, MD, and Pinak B. Shah, MD, both with Brigham and Women’s Hospital and Harvard Medical School, Boston, say intravascular imaging should be “mandatory for all complex PCI,” but that intravascular ultrasound was used in only 77.2% of cases in EXCEL.

Dr. David O. Williams


“There are also data suggesting careful image guidance during complex PCI is associated with a mortality benefit,” they wrote. “In a similar fashion, arterial revascularization (especially with a mammary artery graft to the [left anterior descending]) and complete revascularization during CABG needs to be achieved.”

“Surgeons need to be intellectually challenged to not take the easy way out and just do a saphenous vein graft,” Dr. Shemin agreed. “And because we are dealing with an underlying progressive disease, continued medical and preventive measures to prevent atherosclerosis are key.”

Higher body mass index, insulin-treated diabetes, and hemodynamic support during the procedure were associated with a higher risk for repeat revascularization after PCI, whereas statin use at discharge was protective.

Younger age, female sex, and peripheral vascular disease were independent predictors of repeat revascularization after CABG.

Most redo procedures were performed by PCI in both groups. However, repeat revascularization by CABG was more common during follow-up in patients randomized to initial PCI vs. CABG (3.3% vs .0.8%; P = .0002) and was significantly associated with increased all-cause mortality.

“This observation suggests that CABG should be reserved for repeat revascularization procedures that are not amenable to repeat PCI, irrespective of the initial revascularization approach,” the authors wrote.

The editorialists point out that more than half of EXCEL patients with one repeat revascularization went on to have another. Overall, 55.1% of patients underwent one repeat revascularization, 22.2% underwent two redos, and 22.7% underwent more than two redos.

Although enhancing the durability of the initial revascularization is an important goal, “one might also conclude that a safer and potentially more durable treatment specifically developed for recurrent lesions is as equally an important objective,” they opined.

5-year kerfuffle

As previously reported, the EXCEL trial’s 5-year analysis showed no significant difference between PCI and CABG for the primary endpoint of all-cause death, MI, or stroke.

However, recent allegations that key MI data were withheld have called into question the final conclusion of relative parity and led the European Association for Cardio-Thoracic Surgery (EACTS) to withdraw support for the left main portion of the 2018 EACTS-European Society of Cardiology (ESC) clinical guidelines based on 3-year EXCEL outcomes.

On January 14, the Society of Thoracic Surgeons (STS) joined EACTS and the American Association for Thoracic Surgery in calling for independent reanalysis of the EXCEL data.

“Any final conclusions drawn from the EXCEL trial will not only affect the actions of physicians, surgeons, regulatory agencies, and third-party payers but, more importantly, they will seriously impact the health and wellbeing of our patients and their families for years to come,” the statement says.

“Given such potentially profound consequences, the Society believes that the final interpretation regarding the outcomes of the EXCEL study should wait until an independent analysis of all aspects of the EXCEL study has been performed.”

EXCEL was sponsored by Abbott Vascular. Dr. Stone reported speaker honoraria from Terumo and Amaranth and serving as a consultant to Reva. Coauthor conflict of interest disclosures are listed in the paper. Dr. Shemin reported no relevant conflicts of interest.
 

This article first appeared on Medscape.com.

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Repeat revascularization was more frequent after left main percutaneous coronary intervention than after coronary artery bypass surgery, but raised the mortality risk after both procedures in a secondary EXCEL analysis.
 

Dr. Gregg W. Stone

The 3-year rate of any repeat revascularization was 12.9% after PCI and 7.6% after CABG (hazard ratio, 1.73; 95% confidence interval, 1.28-2.33).

“It’s a real difference and shouldn’t be minimized. About 1 in 20 patients will need an additional repeat revascularization after PCI, compared with surgery,” study author Gregg Stone, MD, Icahn School of Medicine at Mount Sinai in New York, said in an interview. “Surgery is a more durable procedure in that regard, and patients need to be informed of that by heart team discussions.”

That said, Dr. Stone highlighted other differences between the two strategies, including more bleeding and atrial fibrillation after surgery and better early quality of life after PCI. There’s also an early myocardial infarction (MI) benefit with PCI but a late MI benefit with surgery, which “is probably a more important difference between the two, as opposed to the difference in repeat revascularization,” he added.

Although the increased need to perform repeat vascularization after PCI is not unexpected, the analysis of 346 repeat revascularizations in 185 patients provides more details on the timing and prognosis of these procedures in left main disease.

The need for repeat revascularization was independently associated with 3-year all-cause mortality (adjusted HR, 2.05; 95% CI, 1.13-3.70) and cardiovascular mortality (adjusted HR, 4.22; 95% CI, 2.10-8.48) for both PCI and CABG (P for interaction = .85 for both outcomes).

The increase in mortality risk, however, was smaller than that for MI (adjusted HR, 4.03; 95% CI, 2.43-6.67) or stroke (adjusted HR, 16.62; 95% CI, 9.97-27.69).

The risk for death peaked in the 30 days after redo revascularization and then declined during follow-up. Most of the deaths were cardiovascular (74/128).

The incidence of repeat left main PCI was only 17.5%, whereas the left main was the most common site for redo revascularization in the CABG group.

Repeat revascularization of the index target vessel and target lesion – but not of other lesions – were both strongly associated with increased all-cause and cardiovascular mortality, the authors reported January 15 in JACC: Cardiovascular Interventions.

Dr. Richard J. Shemin

“It just continues to show that, no matter what intervention we use, we haven’t achieved perfection yet and the opportunities for improvement and decision making between a PCI and a CABG is still up in the air,” Richard J. Shemin, MD, chief of cardiac surgery, UCLA Medical Center, Los Angeles, said in an interview. “And there’s some evidence to suggest coronary bypass might be better in terms of mortality and the need for repeat revascularization.”


 

Enhancing durability

“Measures to reduce the need for repeat revascularization including improved stent platforms and implantation technique, use of pan-arterial bypass grafting, and aggressive risk factor control with guideline-directed medical therapy may improve prognosis after both PCI and CABG,” the authors concluded.

In a linked editorial, David O. Williams, MD, and Pinak B. Shah, MD, both with Brigham and Women’s Hospital and Harvard Medical School, Boston, say intravascular imaging should be “mandatory for all complex PCI,” but that intravascular ultrasound was used in only 77.2% of cases in EXCEL.

Dr. David O. Williams


“There are also data suggesting careful image guidance during complex PCI is associated with a mortality benefit,” they wrote. “In a similar fashion, arterial revascularization (especially with a mammary artery graft to the [left anterior descending]) and complete revascularization during CABG needs to be achieved.”

“Surgeons need to be intellectually challenged to not take the easy way out and just do a saphenous vein graft,” Dr. Shemin agreed. “And because we are dealing with an underlying progressive disease, continued medical and preventive measures to prevent atherosclerosis are key.”

Higher body mass index, insulin-treated diabetes, and hemodynamic support during the procedure were associated with a higher risk for repeat revascularization after PCI, whereas statin use at discharge was protective.

Younger age, female sex, and peripheral vascular disease were independent predictors of repeat revascularization after CABG.

Most redo procedures were performed by PCI in both groups. However, repeat revascularization by CABG was more common during follow-up in patients randomized to initial PCI vs. CABG (3.3% vs .0.8%; P = .0002) and was significantly associated with increased all-cause mortality.

“This observation suggests that CABG should be reserved for repeat revascularization procedures that are not amenable to repeat PCI, irrespective of the initial revascularization approach,” the authors wrote.

The editorialists point out that more than half of EXCEL patients with one repeat revascularization went on to have another. Overall, 55.1% of patients underwent one repeat revascularization, 22.2% underwent two redos, and 22.7% underwent more than two redos.

Although enhancing the durability of the initial revascularization is an important goal, “one might also conclude that a safer and potentially more durable treatment specifically developed for recurrent lesions is as equally an important objective,” they opined.

5-year kerfuffle

As previously reported, the EXCEL trial’s 5-year analysis showed no significant difference between PCI and CABG for the primary endpoint of all-cause death, MI, or stroke.

However, recent allegations that key MI data were withheld have called into question the final conclusion of relative parity and led the European Association for Cardio-Thoracic Surgery (EACTS) to withdraw support for the left main portion of the 2018 EACTS-European Society of Cardiology (ESC) clinical guidelines based on 3-year EXCEL outcomes.

On January 14, the Society of Thoracic Surgeons (STS) joined EACTS and the American Association for Thoracic Surgery in calling for independent reanalysis of the EXCEL data.

“Any final conclusions drawn from the EXCEL trial will not only affect the actions of physicians, surgeons, regulatory agencies, and third-party payers but, more importantly, they will seriously impact the health and wellbeing of our patients and their families for years to come,” the statement says.

“Given such potentially profound consequences, the Society believes that the final interpretation regarding the outcomes of the EXCEL study should wait until an independent analysis of all aspects of the EXCEL study has been performed.”

EXCEL was sponsored by Abbott Vascular. Dr. Stone reported speaker honoraria from Terumo and Amaranth and serving as a consultant to Reva. Coauthor conflict of interest disclosures are listed in the paper. Dr. Shemin reported no relevant conflicts of interest.
 

This article first appeared on Medscape.com.

Repeat revascularization was more frequent after left main percutaneous coronary intervention than after coronary artery bypass surgery, but raised the mortality risk after both procedures in a secondary EXCEL analysis.
 

Dr. Gregg W. Stone

The 3-year rate of any repeat revascularization was 12.9% after PCI and 7.6% after CABG (hazard ratio, 1.73; 95% confidence interval, 1.28-2.33).

“It’s a real difference and shouldn’t be minimized. About 1 in 20 patients will need an additional repeat revascularization after PCI, compared with surgery,” study author Gregg Stone, MD, Icahn School of Medicine at Mount Sinai in New York, said in an interview. “Surgery is a more durable procedure in that regard, and patients need to be informed of that by heart team discussions.”

That said, Dr. Stone highlighted other differences between the two strategies, including more bleeding and atrial fibrillation after surgery and better early quality of life after PCI. There’s also an early myocardial infarction (MI) benefit with PCI but a late MI benefit with surgery, which “is probably a more important difference between the two, as opposed to the difference in repeat revascularization,” he added.

Although the increased need to perform repeat vascularization after PCI is not unexpected, the analysis of 346 repeat revascularizations in 185 patients provides more details on the timing and prognosis of these procedures in left main disease.

The need for repeat revascularization was independently associated with 3-year all-cause mortality (adjusted HR, 2.05; 95% CI, 1.13-3.70) and cardiovascular mortality (adjusted HR, 4.22; 95% CI, 2.10-8.48) for both PCI and CABG (P for interaction = .85 for both outcomes).

The increase in mortality risk, however, was smaller than that for MI (adjusted HR, 4.03; 95% CI, 2.43-6.67) or stroke (adjusted HR, 16.62; 95% CI, 9.97-27.69).

The risk for death peaked in the 30 days after redo revascularization and then declined during follow-up. Most of the deaths were cardiovascular (74/128).

The incidence of repeat left main PCI was only 17.5%, whereas the left main was the most common site for redo revascularization in the CABG group.

Repeat revascularization of the index target vessel and target lesion – but not of other lesions – were both strongly associated with increased all-cause and cardiovascular mortality, the authors reported January 15 in JACC: Cardiovascular Interventions.

Dr. Richard J. Shemin

“It just continues to show that, no matter what intervention we use, we haven’t achieved perfection yet and the opportunities for improvement and decision making between a PCI and a CABG is still up in the air,” Richard J. Shemin, MD, chief of cardiac surgery, UCLA Medical Center, Los Angeles, said in an interview. “And there’s some evidence to suggest coronary bypass might be better in terms of mortality and the need for repeat revascularization.”


 

Enhancing durability

“Measures to reduce the need for repeat revascularization including improved stent platforms and implantation technique, use of pan-arterial bypass grafting, and aggressive risk factor control with guideline-directed medical therapy may improve prognosis after both PCI and CABG,” the authors concluded.

In a linked editorial, David O. Williams, MD, and Pinak B. Shah, MD, both with Brigham and Women’s Hospital and Harvard Medical School, Boston, say intravascular imaging should be “mandatory for all complex PCI,” but that intravascular ultrasound was used in only 77.2% of cases in EXCEL.

Dr. David O. Williams


“There are also data suggesting careful image guidance during complex PCI is associated with a mortality benefit,” they wrote. “In a similar fashion, arterial revascularization (especially with a mammary artery graft to the [left anterior descending]) and complete revascularization during CABG needs to be achieved.”

“Surgeons need to be intellectually challenged to not take the easy way out and just do a saphenous vein graft,” Dr. Shemin agreed. “And because we are dealing with an underlying progressive disease, continued medical and preventive measures to prevent atherosclerosis are key.”

Higher body mass index, insulin-treated diabetes, and hemodynamic support during the procedure were associated with a higher risk for repeat revascularization after PCI, whereas statin use at discharge was protective.

Younger age, female sex, and peripheral vascular disease were independent predictors of repeat revascularization after CABG.

Most redo procedures were performed by PCI in both groups. However, repeat revascularization by CABG was more common during follow-up in patients randomized to initial PCI vs. CABG (3.3% vs .0.8%; P = .0002) and was significantly associated with increased all-cause mortality.

“This observation suggests that CABG should be reserved for repeat revascularization procedures that are not amenable to repeat PCI, irrespective of the initial revascularization approach,” the authors wrote.

The editorialists point out that more than half of EXCEL patients with one repeat revascularization went on to have another. Overall, 55.1% of patients underwent one repeat revascularization, 22.2% underwent two redos, and 22.7% underwent more than two redos.

Although enhancing the durability of the initial revascularization is an important goal, “one might also conclude that a safer and potentially more durable treatment specifically developed for recurrent lesions is as equally an important objective,” they opined.

5-year kerfuffle

As previously reported, the EXCEL trial’s 5-year analysis showed no significant difference between PCI and CABG for the primary endpoint of all-cause death, MI, or stroke.

However, recent allegations that key MI data were withheld have called into question the final conclusion of relative parity and led the European Association for Cardio-Thoracic Surgery (EACTS) to withdraw support for the left main portion of the 2018 EACTS-European Society of Cardiology (ESC) clinical guidelines based on 3-year EXCEL outcomes.

On January 14, the Society of Thoracic Surgeons (STS) joined EACTS and the American Association for Thoracic Surgery in calling for independent reanalysis of the EXCEL data.

“Any final conclusions drawn from the EXCEL trial will not only affect the actions of physicians, surgeons, regulatory agencies, and third-party payers but, more importantly, they will seriously impact the health and wellbeing of our patients and their families for years to come,” the statement says.

“Given such potentially profound consequences, the Society believes that the final interpretation regarding the outcomes of the EXCEL study should wait until an independent analysis of all aspects of the EXCEL study has been performed.”

EXCEL was sponsored by Abbott Vascular. Dr. Stone reported speaker honoraria from Terumo and Amaranth and serving as a consultant to Reva. Coauthor conflict of interest disclosures are listed in the paper. Dr. Shemin reported no relevant conflicts of interest.
 

This article first appeared on Medscape.com.

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Why STEMI patients benefit from PCI of nonculprit lesions

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– Nearly half of patients with ST-elevation MI and multivessel coronary artery disease in the landmark COMPLETE trial had an obstructive coronary lesion with vulnerable plaque morphology in a segment far from the culprit lesion, Natalia Pinilla-Echeverri, MD, reported at the American Heart Association scientific sessions.

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Dr. Natalia Pinilla-Echeverri

This novel finding from an optical coherence tomography (OCT) substudy of COMPLETE provides a likely mechanistic explanation for the major clinical benefits documented in the full COMPLETE trial, noted Dr. Pinilla-Echeverri, a cardiologist at the Population Health Research Institute at McMaster University, Hamilton, Ont.

COMPLETE was a multinational trial which randomized 4,041 ST-elevation MI (STEMI) patients with multivessel disease to culprit lesion–only percutaneous coronary intervention (PCI) or additional routine angiography–guided staged PCI of nonculprit obstructive lesions with at least 70% stenosis. As previously reported, the risk of the coprimary composite endpoint comprising cardiovascular death, new MI, or ischemia-driven revascularization was reduced by 49% over 3 years of follow-up in the group with staged PCI of nonculprit lesions, with an impressive number needed to treat of just 13 (N Engl J Med. 2019 Oct 10;381[15]:1411-21).

Dr. Pinella-Echeverri reported on the 93 patients who participated in the OCT substudy, the purpose of which was to determine the prevalence of high-risk, vulnerable plaque in obstructive and nonobstructive nonculprit lesions. For this purpose, vulnerable plaque was defined as thin-cap fibroatheroma (TCFA), a coronary lesion known to pose high risk of worsening stenosis, plaque rupture, and cardiovascular events.



Of note, these 93 patients had a total of 425 diseased segments: 150 obstructive and 275 nonobstructive.

“This is reassuring that the concept of acute coronary syndrome implies a diffuse pathophysiology of affecting not only the culprit segment but the coronary vasculature as a whole,” Dr. Pinella-Echeverri observed.

The main study finding, however, was that TCFA was significantly more prevalent in obstructive, compared with nonobstructive, nonculprit lesions by a margin of 35% to 23%. The obstructive and nonobstructive TCFA lesions had a similar lipid-rich composition; however, the obstructive ones were significantly longer and had a smaller mean lumen area.

When breaking down the prevalence of TCFA per patient, 47% of patients had a nonculprit obstructive lesion with vulnerable plaque morphology. Another 20% had nonobstructive TCFA lesions. And only 32% of the STEMI patients had no TCFA in their obstructive or nonobstructive segments.

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Dr. Frans Van de Werf

Discussant Frans Van de Werf, MD, PhD, commented: “This [OCT substudy result] immediately explains the clinical benefit observed with preventive PCI in STEMI patients with obstructive multivessel disease.”

The finding that 20% of the STEMI patients had nonobstructive lesions with vulnerable plaque morphology by OCT provides powerful support for the current guideline-recommended strategy of immediately starting STEMI patients on intensive lipid-lowering therapy, added Dr. Van de Werf, professor of medicine at the Catholic University of Leuven (Belgium).

He argued that the decision to revascularize nonculprit lesions by means of PCI versus the more complete revascularization achieved via coronary artery bypass graft surgery shouldn’t be made during the initial primary PCI, citing evidence that when the decision gets made at that time, coronary artery bypass grafting (CABG) is less likely to be chosen.

“I believe that OCT and [fractional flow reserve] should not be performed during the index primary PCI, not only for the comfort of the patient, but also for the better selection of complete revascularization. Interventional cardiologists should not forget that CABG might be a better revascularization treatment in some cases, such as left main disease and diabetes mellitus,” the cardiologist cautioned.

The COMPLETE OCT Substudy was supported by Abbott Vascular, the Population Health Research Institute, Hamilton Health Sciences, and the Canadian Institutes of Health Research.

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– Nearly half of patients with ST-elevation MI and multivessel coronary artery disease in the landmark COMPLETE trial had an obstructive coronary lesion with vulnerable plaque morphology in a segment far from the culprit lesion, Natalia Pinilla-Echeverri, MD, reported at the American Heart Association scientific sessions.

Bruce Jancin/MDedge News
Dr. Natalia Pinilla-Echeverri

This novel finding from an optical coherence tomography (OCT) substudy of COMPLETE provides a likely mechanistic explanation for the major clinical benefits documented in the full COMPLETE trial, noted Dr. Pinilla-Echeverri, a cardiologist at the Population Health Research Institute at McMaster University, Hamilton, Ont.

COMPLETE was a multinational trial which randomized 4,041 ST-elevation MI (STEMI) patients with multivessel disease to culprit lesion–only percutaneous coronary intervention (PCI) or additional routine angiography–guided staged PCI of nonculprit obstructive lesions with at least 70% stenosis. As previously reported, the risk of the coprimary composite endpoint comprising cardiovascular death, new MI, or ischemia-driven revascularization was reduced by 49% over 3 years of follow-up in the group with staged PCI of nonculprit lesions, with an impressive number needed to treat of just 13 (N Engl J Med. 2019 Oct 10;381[15]:1411-21).

Dr. Pinella-Echeverri reported on the 93 patients who participated in the OCT substudy, the purpose of which was to determine the prevalence of high-risk, vulnerable plaque in obstructive and nonobstructive nonculprit lesions. For this purpose, vulnerable plaque was defined as thin-cap fibroatheroma (TCFA), a coronary lesion known to pose high risk of worsening stenosis, plaque rupture, and cardiovascular events.



Of note, these 93 patients had a total of 425 diseased segments: 150 obstructive and 275 nonobstructive.

“This is reassuring that the concept of acute coronary syndrome implies a diffuse pathophysiology of affecting not only the culprit segment but the coronary vasculature as a whole,” Dr. Pinella-Echeverri observed.

The main study finding, however, was that TCFA was significantly more prevalent in obstructive, compared with nonobstructive, nonculprit lesions by a margin of 35% to 23%. The obstructive and nonobstructive TCFA lesions had a similar lipid-rich composition; however, the obstructive ones were significantly longer and had a smaller mean lumen area.

When breaking down the prevalence of TCFA per patient, 47% of patients had a nonculprit obstructive lesion with vulnerable plaque morphology. Another 20% had nonobstructive TCFA lesions. And only 32% of the STEMI patients had no TCFA in their obstructive or nonobstructive segments.

Bruce Jancin/MDedge News
Dr. Frans Van de Werf

Discussant Frans Van de Werf, MD, PhD, commented: “This [OCT substudy result] immediately explains the clinical benefit observed with preventive PCI in STEMI patients with obstructive multivessel disease.”

The finding that 20% of the STEMI patients had nonobstructive lesions with vulnerable plaque morphology by OCT provides powerful support for the current guideline-recommended strategy of immediately starting STEMI patients on intensive lipid-lowering therapy, added Dr. Van de Werf, professor of medicine at the Catholic University of Leuven (Belgium).

He argued that the decision to revascularize nonculprit lesions by means of PCI versus the more complete revascularization achieved via coronary artery bypass graft surgery shouldn’t be made during the initial primary PCI, citing evidence that when the decision gets made at that time, coronary artery bypass grafting (CABG) is less likely to be chosen.

“I believe that OCT and [fractional flow reserve] should not be performed during the index primary PCI, not only for the comfort of the patient, but also for the better selection of complete revascularization. Interventional cardiologists should not forget that CABG might be a better revascularization treatment in some cases, such as left main disease and diabetes mellitus,” the cardiologist cautioned.

The COMPLETE OCT Substudy was supported by Abbott Vascular, the Population Health Research Institute, Hamilton Health Sciences, and the Canadian Institutes of Health Research.

– Nearly half of patients with ST-elevation MI and multivessel coronary artery disease in the landmark COMPLETE trial had an obstructive coronary lesion with vulnerable plaque morphology in a segment far from the culprit lesion, Natalia Pinilla-Echeverri, MD, reported at the American Heart Association scientific sessions.

Bruce Jancin/MDedge News
Dr. Natalia Pinilla-Echeverri

This novel finding from an optical coherence tomography (OCT) substudy of COMPLETE provides a likely mechanistic explanation for the major clinical benefits documented in the full COMPLETE trial, noted Dr. Pinilla-Echeverri, a cardiologist at the Population Health Research Institute at McMaster University, Hamilton, Ont.

COMPLETE was a multinational trial which randomized 4,041 ST-elevation MI (STEMI) patients with multivessel disease to culprit lesion–only percutaneous coronary intervention (PCI) or additional routine angiography–guided staged PCI of nonculprit obstructive lesions with at least 70% stenosis. As previously reported, the risk of the coprimary composite endpoint comprising cardiovascular death, new MI, or ischemia-driven revascularization was reduced by 49% over 3 years of follow-up in the group with staged PCI of nonculprit lesions, with an impressive number needed to treat of just 13 (N Engl J Med. 2019 Oct 10;381[15]:1411-21).

Dr. Pinella-Echeverri reported on the 93 patients who participated in the OCT substudy, the purpose of which was to determine the prevalence of high-risk, vulnerable plaque in obstructive and nonobstructive nonculprit lesions. For this purpose, vulnerable plaque was defined as thin-cap fibroatheroma (TCFA), a coronary lesion known to pose high risk of worsening stenosis, plaque rupture, and cardiovascular events.



Of note, these 93 patients had a total of 425 diseased segments: 150 obstructive and 275 nonobstructive.

“This is reassuring that the concept of acute coronary syndrome implies a diffuse pathophysiology of affecting not only the culprit segment but the coronary vasculature as a whole,” Dr. Pinella-Echeverri observed.

The main study finding, however, was that TCFA was significantly more prevalent in obstructive, compared with nonobstructive, nonculprit lesions by a margin of 35% to 23%. The obstructive and nonobstructive TCFA lesions had a similar lipid-rich composition; however, the obstructive ones were significantly longer and had a smaller mean lumen area.

When breaking down the prevalence of TCFA per patient, 47% of patients had a nonculprit obstructive lesion with vulnerable plaque morphology. Another 20% had nonobstructive TCFA lesions. And only 32% of the STEMI patients had no TCFA in their obstructive or nonobstructive segments.

Bruce Jancin/MDedge News
Dr. Frans Van de Werf

Discussant Frans Van de Werf, MD, PhD, commented: “This [OCT substudy result] immediately explains the clinical benefit observed with preventive PCI in STEMI patients with obstructive multivessel disease.”

The finding that 20% of the STEMI patients had nonobstructive lesions with vulnerable plaque morphology by OCT provides powerful support for the current guideline-recommended strategy of immediately starting STEMI patients on intensive lipid-lowering therapy, added Dr. Van de Werf, professor of medicine at the Catholic University of Leuven (Belgium).

He argued that the decision to revascularize nonculprit lesions by means of PCI versus the more complete revascularization achieved via coronary artery bypass graft surgery shouldn’t be made during the initial primary PCI, citing evidence that when the decision gets made at that time, coronary artery bypass grafting (CABG) is less likely to be chosen.

“I believe that OCT and [fractional flow reserve] should not be performed during the index primary PCI, not only for the comfort of the patient, but also for the better selection of complete revascularization. Interventional cardiologists should not forget that CABG might be a better revascularization treatment in some cases, such as left main disease and diabetes mellitus,” the cardiologist cautioned.

The COMPLETE OCT Substudy was supported by Abbott Vascular, the Population Health Research Institute, Hamilton Health Sciences, and the Canadian Institutes of Health Research.

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Cardiac biomarkers refine antihypertensive drug initiation decisions

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– Incorporation of cardiac biomarkers into current guideline-based decision-making regarding initiation of antihypertensive medication in patients with previously untreated mild or moderate high blood pressure leads to more appropriate and selective matching of intensive blood pressure control with true patient risk, Ambarish Pandey, MD, reported at the American Heart Association scientific sessions.

Bruce Jancin/MDedge News
Dr. Ambarish Pandey

That’s because the 2017 American College of Cardiology/AHA blood pressure guidelines recommend incorporating the ACC/AHA 10-Year Atherosclerotic Cardiovascular Disease (ASCVD) Risk Calculator into decision making as to whether to start antihypertensive drug therapy in patients with stage 1 hypertension (130-139/80-89 mm Hg), but the risk calculator doesn’t account for the risk of heart failure.

Yet by far the greatest benefit of intensive BP lowering is in reducing the risk of developing heart failure, as demonstrated in the landmark SPRINT trial, which showed that intensive BP lowering achieved much greater risk reduction in new-onset heart failure than in atherosclerotic cardiovascular events.

Thus, there’s a need for better strategies to guide antihypertensive therapy. And therein lies the rationale for incorporating into the risk assessment an individual’s values for N-terminal pro–brain natriuretic peptide (NT-proBNP), which reflects chronic myocardial stress, and high-sensitivity cardiac troponin T (hs-cTnT), which when elevated signals myocardial injury.

“Cardiac biomarkers are intermediate phenotypes from hypertension to future cardiovascular events. They can identify individuals at increased risk for atherosclerotic events, and at even higher risk for heart failure events,” explained Dr. Pandey, a cardiologist at the University of Texas Southwestern Medical Center, Dallas.

He presented a study of 12,987 participants in three major U.S. cohort studies: the Atherosclerosis Risk In Communities (ARIC) study, the Multi-Ethnic Study of Atherosclerosis (MESA), and the Dallas Heart Study. At baseline, none of the participants were on antihypertensive therapy or had known cardiovascular disease. During 10 years of prospective follow-up, 825 of them experienced a first cardiovascular disease event: 251 developed heart failure and 574 had an MI, stroke, or cardiovascular death. Dr. Pandey and his coworkers calculated the cardiovascular event incidence rate and number-needed-to-treat with intensive antihypertensive drug therapy to prevent a first cardiovascular disease event on the basis of whether patients in the various BP categories were positive or negative for one or more biomarkers.
 

The results

Fifty-four percent of subjects had normal BP, defined in the guidelines as less than 120/80 mm Hg. Another 3% had BP in excess of 160/100 mm Hg. No controversy exists regarding pharmacotherapy in either of these groups: It’s not warranted in the former, essential in the latter.

Another 3,000 individuals had what the ACC/AHA guidelines define as elevated BP, meaning 120-129/<80 mm Hg, or low-risk stage 1 hypertension of 130-139/80-89 mm Hg and a 10-year ASCVD risk score of less than 10%. Initiation of antihypertensive medication in these groups is not recommended in the guidelines. Yet 36% of these individuals had at least one positive cardiac biomarker. And here’s the eye-opening finding: Notably, the 10-year cardiovascular event incidence rate in this biomarker group not currently recommended for antihypertensive pharmacotherapy was 11%, more than double the 4.6% rate in the biomarker-negative group, which in turn was comparable to the 3.8% in the normal BP participants.

Antihypertensive therapy was recommended according to the guidelines in 20% of the total study population, comprising patients with stage 1 hypertension who had an ASCVD risk score of 10% or more as well as those with stage 2 hypertension, defined as BP greater than 140/90 mm Hg but less than 160/100 mm Hg. Forty-eight percent of these subjects were positive for at least one biomarker. Their cardiovascular incidence rate was 15.1%, compared to the 7.9% rate in biomarker-negative individuals.

The estimated number-needed-to-treat (NNT) with intensive blood pressure–lowering therapy to a target systolic BP of less than 120 mm Hg, as in SPRINT, to prevent one cardiovascular event in individuals not currently guideline-recommended for antihypertensive medications was 86 in those who were biomarker-negative. The NNT dropped to 36 in the biomarker-positive subgroup, a far more attractive figure that suggests a reasonable likelihood of benefit from intensive blood pressure control, in Dr. Pandey’s view.

Similarly, among individuals currently recommended for pharmacotherapy initiation, the NNTs were 49 if biomarker-negative, improving to 26 in those positive for one or both biomarkers, which was comparable to the NNT of 22 in the group with blood pressures greater than 160/100 mm Hg. The NNT of 49 in the biomarker-negative subgroup is in a borderline gray zone warranting individualized shared decision-making regarding pharmacotherapy, Dr. Pandey said.

In this study, an elevated hs-cTnT was defined as 6 ng/L or more, while an elevated NT-proBNP was considered to be at least 100 pg/mL.

“It’s noteworthy that the degree of elevation in hs-cTnT and NT-proBNP which were observed in our study were pretty subtle and much below the threshold used for diagnosis of ischemic events or heart failure. Thus, these elevations were largely representative of subtle chronic injury and not acute events,” according to the cardiologist.

One audience member asked if the elevated biomarkers could simply be a surrogate for longer duration of exposure of the heart to high BP. Sure, Dr. Pandey replied, pointing to the 6-year greater average age of the biomarker-positive participants.

“It is likely that biomarker-positive status is capturing the culmination of longstanding exposure. But the thing about hypertension is there are no symptoms that can signal to the patient or the doctor that they have this disease, so testing for the biomarkers can actually capture the high-risk group that may have had hypertension for a long duration but now needs to be treated in order to prevent the advance of downstream adverse events,” he said.

Dr. Pandey reported having no financial conflicts of interest regarding his study, conducted free of commercial support.
 

SOURCE: Pandey A. AHA 2019 Abstract EP.AOS.521.141

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– Incorporation of cardiac biomarkers into current guideline-based decision-making regarding initiation of antihypertensive medication in patients with previously untreated mild or moderate high blood pressure leads to more appropriate and selective matching of intensive blood pressure control with true patient risk, Ambarish Pandey, MD, reported at the American Heart Association scientific sessions.

Bruce Jancin/MDedge News
Dr. Ambarish Pandey

That’s because the 2017 American College of Cardiology/AHA blood pressure guidelines recommend incorporating the ACC/AHA 10-Year Atherosclerotic Cardiovascular Disease (ASCVD) Risk Calculator into decision making as to whether to start antihypertensive drug therapy in patients with stage 1 hypertension (130-139/80-89 mm Hg), but the risk calculator doesn’t account for the risk of heart failure.

Yet by far the greatest benefit of intensive BP lowering is in reducing the risk of developing heart failure, as demonstrated in the landmark SPRINT trial, which showed that intensive BP lowering achieved much greater risk reduction in new-onset heart failure than in atherosclerotic cardiovascular events.

Thus, there’s a need for better strategies to guide antihypertensive therapy. And therein lies the rationale for incorporating into the risk assessment an individual’s values for N-terminal pro–brain natriuretic peptide (NT-proBNP), which reflects chronic myocardial stress, and high-sensitivity cardiac troponin T (hs-cTnT), which when elevated signals myocardial injury.

“Cardiac biomarkers are intermediate phenotypes from hypertension to future cardiovascular events. They can identify individuals at increased risk for atherosclerotic events, and at even higher risk for heart failure events,” explained Dr. Pandey, a cardiologist at the University of Texas Southwestern Medical Center, Dallas.

He presented a study of 12,987 participants in three major U.S. cohort studies: the Atherosclerosis Risk In Communities (ARIC) study, the Multi-Ethnic Study of Atherosclerosis (MESA), and the Dallas Heart Study. At baseline, none of the participants were on antihypertensive therapy or had known cardiovascular disease. During 10 years of prospective follow-up, 825 of them experienced a first cardiovascular disease event: 251 developed heart failure and 574 had an MI, stroke, or cardiovascular death. Dr. Pandey and his coworkers calculated the cardiovascular event incidence rate and number-needed-to-treat with intensive antihypertensive drug therapy to prevent a first cardiovascular disease event on the basis of whether patients in the various BP categories were positive or negative for one or more biomarkers.
 

The results

Fifty-four percent of subjects had normal BP, defined in the guidelines as less than 120/80 mm Hg. Another 3% had BP in excess of 160/100 mm Hg. No controversy exists regarding pharmacotherapy in either of these groups: It’s not warranted in the former, essential in the latter.

Another 3,000 individuals had what the ACC/AHA guidelines define as elevated BP, meaning 120-129/<80 mm Hg, or low-risk stage 1 hypertension of 130-139/80-89 mm Hg and a 10-year ASCVD risk score of less than 10%. Initiation of antihypertensive medication in these groups is not recommended in the guidelines. Yet 36% of these individuals had at least one positive cardiac biomarker. And here’s the eye-opening finding: Notably, the 10-year cardiovascular event incidence rate in this biomarker group not currently recommended for antihypertensive pharmacotherapy was 11%, more than double the 4.6% rate in the biomarker-negative group, which in turn was comparable to the 3.8% in the normal BP participants.

Antihypertensive therapy was recommended according to the guidelines in 20% of the total study population, comprising patients with stage 1 hypertension who had an ASCVD risk score of 10% or more as well as those with stage 2 hypertension, defined as BP greater than 140/90 mm Hg but less than 160/100 mm Hg. Forty-eight percent of these subjects were positive for at least one biomarker. Their cardiovascular incidence rate was 15.1%, compared to the 7.9% rate in biomarker-negative individuals.

The estimated number-needed-to-treat (NNT) with intensive blood pressure–lowering therapy to a target systolic BP of less than 120 mm Hg, as in SPRINT, to prevent one cardiovascular event in individuals not currently guideline-recommended for antihypertensive medications was 86 in those who were biomarker-negative. The NNT dropped to 36 in the biomarker-positive subgroup, a far more attractive figure that suggests a reasonable likelihood of benefit from intensive blood pressure control, in Dr. Pandey’s view.

Similarly, among individuals currently recommended for pharmacotherapy initiation, the NNTs were 49 if biomarker-negative, improving to 26 in those positive for one or both biomarkers, which was comparable to the NNT of 22 in the group with blood pressures greater than 160/100 mm Hg. The NNT of 49 in the biomarker-negative subgroup is in a borderline gray zone warranting individualized shared decision-making regarding pharmacotherapy, Dr. Pandey said.

In this study, an elevated hs-cTnT was defined as 6 ng/L or more, while an elevated NT-proBNP was considered to be at least 100 pg/mL.

“It’s noteworthy that the degree of elevation in hs-cTnT and NT-proBNP which were observed in our study were pretty subtle and much below the threshold used for diagnosis of ischemic events or heart failure. Thus, these elevations were largely representative of subtle chronic injury and not acute events,” according to the cardiologist.

One audience member asked if the elevated biomarkers could simply be a surrogate for longer duration of exposure of the heart to high BP. Sure, Dr. Pandey replied, pointing to the 6-year greater average age of the biomarker-positive participants.

“It is likely that biomarker-positive status is capturing the culmination of longstanding exposure. But the thing about hypertension is there are no symptoms that can signal to the patient or the doctor that they have this disease, so testing for the biomarkers can actually capture the high-risk group that may have had hypertension for a long duration but now needs to be treated in order to prevent the advance of downstream adverse events,” he said.

Dr. Pandey reported having no financial conflicts of interest regarding his study, conducted free of commercial support.
 

SOURCE: Pandey A. AHA 2019 Abstract EP.AOS.521.141

– Incorporation of cardiac biomarkers into current guideline-based decision-making regarding initiation of antihypertensive medication in patients with previously untreated mild or moderate high blood pressure leads to more appropriate and selective matching of intensive blood pressure control with true patient risk, Ambarish Pandey, MD, reported at the American Heart Association scientific sessions.

Bruce Jancin/MDedge News
Dr. Ambarish Pandey

That’s because the 2017 American College of Cardiology/AHA blood pressure guidelines recommend incorporating the ACC/AHA 10-Year Atherosclerotic Cardiovascular Disease (ASCVD) Risk Calculator into decision making as to whether to start antihypertensive drug therapy in patients with stage 1 hypertension (130-139/80-89 mm Hg), but the risk calculator doesn’t account for the risk of heart failure.

Yet by far the greatest benefit of intensive BP lowering is in reducing the risk of developing heart failure, as demonstrated in the landmark SPRINT trial, which showed that intensive BP lowering achieved much greater risk reduction in new-onset heart failure than in atherosclerotic cardiovascular events.

Thus, there’s a need for better strategies to guide antihypertensive therapy. And therein lies the rationale for incorporating into the risk assessment an individual’s values for N-terminal pro–brain natriuretic peptide (NT-proBNP), which reflects chronic myocardial stress, and high-sensitivity cardiac troponin T (hs-cTnT), which when elevated signals myocardial injury.

“Cardiac biomarkers are intermediate phenotypes from hypertension to future cardiovascular events. They can identify individuals at increased risk for atherosclerotic events, and at even higher risk for heart failure events,” explained Dr. Pandey, a cardiologist at the University of Texas Southwestern Medical Center, Dallas.

He presented a study of 12,987 participants in three major U.S. cohort studies: the Atherosclerosis Risk In Communities (ARIC) study, the Multi-Ethnic Study of Atherosclerosis (MESA), and the Dallas Heart Study. At baseline, none of the participants were on antihypertensive therapy or had known cardiovascular disease. During 10 years of prospective follow-up, 825 of them experienced a first cardiovascular disease event: 251 developed heart failure and 574 had an MI, stroke, or cardiovascular death. Dr. Pandey and his coworkers calculated the cardiovascular event incidence rate and number-needed-to-treat with intensive antihypertensive drug therapy to prevent a first cardiovascular disease event on the basis of whether patients in the various BP categories were positive or negative for one or more biomarkers.
 

The results

Fifty-four percent of subjects had normal BP, defined in the guidelines as less than 120/80 mm Hg. Another 3% had BP in excess of 160/100 mm Hg. No controversy exists regarding pharmacotherapy in either of these groups: It’s not warranted in the former, essential in the latter.

Another 3,000 individuals had what the ACC/AHA guidelines define as elevated BP, meaning 120-129/<80 mm Hg, or low-risk stage 1 hypertension of 130-139/80-89 mm Hg and a 10-year ASCVD risk score of less than 10%. Initiation of antihypertensive medication in these groups is not recommended in the guidelines. Yet 36% of these individuals had at least one positive cardiac biomarker. And here’s the eye-opening finding: Notably, the 10-year cardiovascular event incidence rate in this biomarker group not currently recommended for antihypertensive pharmacotherapy was 11%, more than double the 4.6% rate in the biomarker-negative group, which in turn was comparable to the 3.8% in the normal BP participants.

Antihypertensive therapy was recommended according to the guidelines in 20% of the total study population, comprising patients with stage 1 hypertension who had an ASCVD risk score of 10% or more as well as those with stage 2 hypertension, defined as BP greater than 140/90 mm Hg but less than 160/100 mm Hg. Forty-eight percent of these subjects were positive for at least one biomarker. Their cardiovascular incidence rate was 15.1%, compared to the 7.9% rate in biomarker-negative individuals.

The estimated number-needed-to-treat (NNT) with intensive blood pressure–lowering therapy to a target systolic BP of less than 120 mm Hg, as in SPRINT, to prevent one cardiovascular event in individuals not currently guideline-recommended for antihypertensive medications was 86 in those who were biomarker-negative. The NNT dropped to 36 in the biomarker-positive subgroup, a far more attractive figure that suggests a reasonable likelihood of benefit from intensive blood pressure control, in Dr. Pandey’s view.

Similarly, among individuals currently recommended for pharmacotherapy initiation, the NNTs were 49 if biomarker-negative, improving to 26 in those positive for one or both biomarkers, which was comparable to the NNT of 22 in the group with blood pressures greater than 160/100 mm Hg. The NNT of 49 in the biomarker-negative subgroup is in a borderline gray zone warranting individualized shared decision-making regarding pharmacotherapy, Dr. Pandey said.

In this study, an elevated hs-cTnT was defined as 6 ng/L or more, while an elevated NT-proBNP was considered to be at least 100 pg/mL.

“It’s noteworthy that the degree of elevation in hs-cTnT and NT-proBNP which were observed in our study were pretty subtle and much below the threshold used for diagnosis of ischemic events or heart failure. Thus, these elevations were largely representative of subtle chronic injury and not acute events,” according to the cardiologist.

One audience member asked if the elevated biomarkers could simply be a surrogate for longer duration of exposure of the heart to high BP. Sure, Dr. Pandey replied, pointing to the 6-year greater average age of the biomarker-positive participants.

“It is likely that biomarker-positive status is capturing the culmination of longstanding exposure. But the thing about hypertension is there are no symptoms that can signal to the patient or the doctor that they have this disease, so testing for the biomarkers can actually capture the high-risk group that may have had hypertension for a long duration but now needs to be treated in order to prevent the advance of downstream adverse events,” he said.

Dr. Pandey reported having no financial conflicts of interest regarding his study, conducted free of commercial support.
 

SOURCE: Pandey A. AHA 2019 Abstract EP.AOS.521.141

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Washington state patient is first U.S. case of novel coronavirus

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The first case of the novel coronavirus, named 2019-nCoV, in the United States has been diagnosed in a traveler from China who came through Seattle-Tacoma International Airport on Jan 15, the Centers for Disease Control and Prevention announced today at a press briefing.

CDC/John Hierholzer, MD

The outbreak began at a animal and meat market in China and now has spread to at least three other countries, including Thailand, Japan and South Korea. While originally thought to be spreading from animal to person, it appears that limited person-to-person transmission is occurring, although it is currently unknown how easily this virus spreads between people.

More than 300 cases have been reported and six deaths have occurred. Fourteen health care workers have been infected.

Scott Lindquist, MD, MPH, Washington state epidemiologist, said at the briefing that the patient, a man who had been in Wuhan, arrived at Sea-Tac on Jan. 15, 2 days before airport screening had been initiated. He was symptom free at the time of his arrival and probably would not have been identified as infected with 2019-nCoV. The patient had been aware of the public health and news media coverage of 2019-nCoV and, after developing symptoms, contacted his health care provider on Jan. 19. The patient did not fly directly from Wuhan, but Dr. Lindquist said that he has been fully cooperative and has been helpful to authorities in tracing his route and contacts. The man is being treated at Providence Regional Medical Center, Everett, Wash.

The CDC obtained a specimen from the patient immediately and identified the 2019-nCoV within 24 hours.

Screening at airports is part of a multipart strategy to address this type of infection that includes public health information dissemination, patient education, as well as hospital preparation and training exercises. Currently, a strategy referred to as “funneling” is being implemented wherein travelers from China are rerouted and reticketed to one of the five airports conducting screening. At present, JFK in New York, San Francisco International, Los Angeles International, Hartsfield-Jackson Atlanta International Airport, and Chicago O’Hare International Airport are conducting inbound traveler screening.

The CDC is working in close cooperation with the Department of Homeland Security and the Federal Aviation Administration to coordinate travel screenings and reroutings. In addition, the CDC is working with the World Health Organization and the international global health community to share information about this outbreak. The CDC also has staff on site in Wuhan and is communicating with local health authorities. The CDC has activated its Emergency Operations Center to better provide ongoing support to the 2019-nCoV response. Currently, the focus is on tracing contacts and the means of transmission of this virus.

Updates on the outbreak will be posted on the CDC coronavirus website.
 

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The first case of the novel coronavirus, named 2019-nCoV, in the United States has been diagnosed in a traveler from China who came through Seattle-Tacoma International Airport on Jan 15, the Centers for Disease Control and Prevention announced today at a press briefing.

CDC/John Hierholzer, MD

The outbreak began at a animal and meat market in China and now has spread to at least three other countries, including Thailand, Japan and South Korea. While originally thought to be spreading from animal to person, it appears that limited person-to-person transmission is occurring, although it is currently unknown how easily this virus spreads between people.

More than 300 cases have been reported and six deaths have occurred. Fourteen health care workers have been infected.

Scott Lindquist, MD, MPH, Washington state epidemiologist, said at the briefing that the patient, a man who had been in Wuhan, arrived at Sea-Tac on Jan. 15, 2 days before airport screening had been initiated. He was symptom free at the time of his arrival and probably would not have been identified as infected with 2019-nCoV. The patient had been aware of the public health and news media coverage of 2019-nCoV and, after developing symptoms, contacted his health care provider on Jan. 19. The patient did not fly directly from Wuhan, but Dr. Lindquist said that he has been fully cooperative and has been helpful to authorities in tracing his route and contacts. The man is being treated at Providence Regional Medical Center, Everett, Wash.

The CDC obtained a specimen from the patient immediately and identified the 2019-nCoV within 24 hours.

Screening at airports is part of a multipart strategy to address this type of infection that includes public health information dissemination, patient education, as well as hospital preparation and training exercises. Currently, a strategy referred to as “funneling” is being implemented wherein travelers from China are rerouted and reticketed to one of the five airports conducting screening. At present, JFK in New York, San Francisco International, Los Angeles International, Hartsfield-Jackson Atlanta International Airport, and Chicago O’Hare International Airport are conducting inbound traveler screening.

The CDC is working in close cooperation with the Department of Homeland Security and the Federal Aviation Administration to coordinate travel screenings and reroutings. In addition, the CDC is working with the World Health Organization and the international global health community to share information about this outbreak. The CDC also has staff on site in Wuhan and is communicating with local health authorities. The CDC has activated its Emergency Operations Center to better provide ongoing support to the 2019-nCoV response. Currently, the focus is on tracing contacts and the means of transmission of this virus.

Updates on the outbreak will be posted on the CDC coronavirus website.
 

The first case of the novel coronavirus, named 2019-nCoV, in the United States has been diagnosed in a traveler from China who came through Seattle-Tacoma International Airport on Jan 15, the Centers for Disease Control and Prevention announced today at a press briefing.

CDC/John Hierholzer, MD

The outbreak began at a animal and meat market in China and now has spread to at least three other countries, including Thailand, Japan and South Korea. While originally thought to be spreading from animal to person, it appears that limited person-to-person transmission is occurring, although it is currently unknown how easily this virus spreads between people.

More than 300 cases have been reported and six deaths have occurred. Fourteen health care workers have been infected.

Scott Lindquist, MD, MPH, Washington state epidemiologist, said at the briefing that the patient, a man who had been in Wuhan, arrived at Sea-Tac on Jan. 15, 2 days before airport screening had been initiated. He was symptom free at the time of his arrival and probably would not have been identified as infected with 2019-nCoV. The patient had been aware of the public health and news media coverage of 2019-nCoV and, after developing symptoms, contacted his health care provider on Jan. 19. The patient did not fly directly from Wuhan, but Dr. Lindquist said that he has been fully cooperative and has been helpful to authorities in tracing his route and contacts. The man is being treated at Providence Regional Medical Center, Everett, Wash.

The CDC obtained a specimen from the patient immediately and identified the 2019-nCoV within 24 hours.

Screening at airports is part of a multipart strategy to address this type of infection that includes public health information dissemination, patient education, as well as hospital preparation and training exercises. Currently, a strategy referred to as “funneling” is being implemented wherein travelers from China are rerouted and reticketed to one of the five airports conducting screening. At present, JFK in New York, San Francisco International, Los Angeles International, Hartsfield-Jackson Atlanta International Airport, and Chicago O’Hare International Airport are conducting inbound traveler screening.

The CDC is working in close cooperation with the Department of Homeland Security and the Federal Aviation Administration to coordinate travel screenings and reroutings. In addition, the CDC is working with the World Health Organization and the international global health community to share information about this outbreak. The CDC also has staff on site in Wuhan and is communicating with local health authorities. The CDC has activated its Emergency Operations Center to better provide ongoing support to the 2019-nCoV response. Currently, the focus is on tracing contacts and the means of transmission of this virus.

Updates on the outbreak will be posted on the CDC coronavirus website.
 

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