CHEST Physician

An additional 5 cases of 2019 novel coronavirus (2109-nCoV) have been confirmed in the United States, bringing the total number of confirmed cases to 11, Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, said during a Centers for Disease Control and Prevention press briefing.

Four of the new cases are in California, and one in Massachusetts. Although four of the new cases have recent travel history to Wuhan, China, the epicenter of the 2019-nCoV outbreak, the fifth is a close household contact of one of the other California patients, said Dr. Messonnier. This last case is the second instance of person-to-person spread of 2019-nCoV in the United States.

“We expect to find additional cases of the novel coronavirus in the United States,” she said. “We expect to see more cases of person-to-person spread among close contacts. And we continue to expect this will happen given the explosive nature of this outbreak in China.”

As of the morning of Feb. 3, 167 persons under investigation, or PUIs, for possible 2019-nCoV have tested negative for the virus, and an additional 82 PUIs have testing pending – this latter figure includes some tests that are still in transit to the CDC, said Dr. Messonnier.

During the briefing, Dr. Messonnier emphasized both the aggressive nature of the U.S. public health response and the rationale for quick and assertive action. “The goal of our public health response is to protect and contain,” she said. “Strong measures now may blunt the impact of this virus on the United States.”

She cited the intensity of transmission in Hubei Province, the expansion of transmission to other provinces in China, the expansion of cases outside of China, and sporadic ongoing deaths from 2019-nCoV as drivers of the aggressive U.S. public health response.

A presidential proclamation is currently in place that bars U.S. entry to foreign nationals who have visited mainland China within the past 14 days; the ban does not apply to travelers from Hong Kong and Macao. Immediate family members of U.S. citizens and individuals who have U.S. permanent resident status are exempted from the entry ban and will be allowed entry into the United States.

However, explained Dr. Messonnier, those who have traveled to China recently and are permitted entry will be subject to screening. All passengers with such recent travel will be directed to one of 11 U.S. airports set up to perform additional screening.

As of Feb 3, the list of airports includes:

• San Francisco International Airport in California.
• Los Angeles International Airport in California.
• Hartsfield-Jackson Atlanta International Airport in Georgia.
• Daniel K. Inouye International Airport in Hawaii.
• O’Hare International Airport in Illinois.
• Detroit Metropolitan Airport in Michigan.
• Newark Liberty International Airport in New Jersey.
• John F. Kennedy International Airport in New York.
• Dallas/Fort Worth International Airport in Texas.
• Washington Dulles International Airport in Virginia.
• Seattle-Tacoma International Airport in Washington.

Travelers who have been to Hubei Province in the previous 14 days will have an additional health assessment at which they will be screened for fever, cough, or difficulty breathing. Any American citizens or exempt individuals who are symptomatic would then be transferred for further medical evaluation. Asymptomatic travelers in this category will be subject to a mandatory 14-day quarantine near their point of entry, rather than continuing on to their final destinations.

Dr. Messonnier emphasized that the mandatory 14-day quarantine is specifically for Americans or exempt individuals returning from Hubei Province, adding that the CDC is presently working with individual states to determine the exact venues for quarantine.

American citizens and exempt individuals returning from other parts of mainland China will be routed to one of the 11 airports and will also receive additional health screening. Symptomatic individuals in this travel category would be referred for further evaluation before being able to complete their itinerary.

Asymptomatic American citizens and exempt individuals who are returning from mainland China – but not Hubei Province – will be allowed to travel on to their final destinations, but will be asked to stay home as much as possible and to monitor their health during the 14 days after their return.

The U.S. Department of State is bringing back more Americans from Wuhan province this week, and these individuals will also be kept under federal quarantine for 14 days.

“There are likely to be confirmed infections among returning travelers,” said Dr. Messonnier. “It is important to note that this strategy is not meant to catch every single traveler returning from China with novel coronavirus; given the nature of this virus and how it’s spreading, that would be impossible, but working together we can catch the majority of them.

“The goal here is to slow the entry of this virus into the United States,” she said, adding that the nation’s health care and public health systems stand on high alert to detect the virus in community settings. In response to questioning from the press, Dr. Messonnier defended the stringent quarantine measures, noting that they are in line with those taken by some other nations, and with the aggressive action being taken by the Chinese government itself. “These actions are science based and aimed at protecting the health of all Americans,” she said.

The real-time reverse transcription polymerase chain reaction (rRT-PCR) assay that the CDC has developed detects 2019-nCoV in both respiratory and serum specimens. Dr. Messonnier reported that the CDC is today filing an emergency use authorization (EUA) application to the U.S. Food and Drug Administration to expedite access to the assay for public health laboratories across the country. “This will greatly enhance our capacity to test for this virus,” she said, noting that EUA approval may come as soon as the end of this week.

Although the CDC is poised to send an expert team to China, it’s still awaiting favorable results from the international negotiations currently underway. “This is a horrible situation in China,” said Dr. Messonnier. “Our presence on the ground in China would be a help to China. ... Science should trump everything else; that’s what we’re hoping – that the scientific expertise of the global community can be brought to bear on the incredibly complicated, difficult situation that our colleagues in China are dealing with.”

[email protected]

An additional 5 cases of 2019 novel coronavirus (2109-nCoV) have been confirmed in the United States, bringing the total number of confirmed cases to 11, Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, said during a Centers for Disease Control and Prevention press briefing.

Four of the new cases are in California, and one in Massachusetts. Although four of the new cases have recent travel history to Wuhan, China, the epicenter of the 2019-nCoV outbreak, the fifth is a close household contact of one of the other California patients, said Dr. Messonnier. This last case is the second instance of person-to-person spread of 2019-nCoV in the United States.

“We expect to find additional cases of the novel coronavirus in the United States,” she said. “We expect to see more cases of person-to-person spread among close contacts. And we continue to expect this will happen given the explosive nature of this outbreak in China.”

As of the morning of Feb. 3, 167 persons under investigation, or PUIs, for possible 2019-nCoV have tested negative for the virus, and an additional 82 PUIs have testing pending – this latter figure includes some tests that are still in transit to the CDC, said Dr. Messonnier.

During the briefing, Dr. Messonnier emphasized both the aggressive nature of the U.S. public health response and the rationale for quick and assertive action. “The goal of our public health response is to protect and contain,” she said. “Strong measures now may blunt the impact of this virus on the United States.”

She cited the intensity of transmission in Hubei Province, the expansion of transmission to other provinces in China, the expansion of cases outside of China, and sporadic ongoing deaths from 2019-nCoV as drivers of the aggressive U.S. public health response.

A presidential proclamation is currently in place that bars U.S. entry to foreign nationals who have visited mainland China within the past 14 days; the ban does not apply to travelers from Hong Kong and Macao. Immediate family members of U.S. citizens and individuals who have U.S. permanent resident status are exempted from the entry ban and will be allowed entry into the United States.

However, explained Dr. Messonnier, those who have traveled to China recently and are permitted entry will be subject to screening. All passengers with such recent travel will be directed to one of 11 U.S. airports set up to perform additional screening.

As of Feb 3, the list of airports includes:

• San Francisco International Airport in California.
• Los Angeles International Airport in California.
• Hartsfield-Jackson Atlanta International Airport in Georgia.
• Daniel K. Inouye International Airport in Hawaii.
• O’Hare International Airport in Illinois.
• Detroit Metropolitan Airport in Michigan.
• Newark Liberty International Airport in New Jersey.
• John F. Kennedy International Airport in New York.
• Dallas/Fort Worth International Airport in Texas.
• Washington Dulles International Airport in Virginia.
• Seattle-Tacoma International Airport in Washington.

Travelers who have been to Hubei Province in the previous 14 days will have an additional health assessment at which they will be screened for fever, cough, or difficulty breathing. Any American citizens or exempt individuals who are symptomatic would then be transferred for further medical evaluation. Asymptomatic travelers in this category will be subject to a mandatory 14-day quarantine near their point of entry, rather than continuing on to their final destinations.

Dr. Messonnier emphasized that the mandatory 14-day quarantine is specifically for Americans or exempt individuals returning from Hubei Province, adding that the CDC is presently working with individual states to determine the exact venues for quarantine.

American citizens and exempt individuals returning from other parts of mainland China will be routed to one of the 11 airports and will also receive additional health screening. Symptomatic individuals in this travel category would be referred for further evaluation before being able to complete their itinerary.

Asymptomatic American citizens and exempt individuals who are returning from mainland China – but not Hubei Province – will be allowed to travel on to their final destinations, but will be asked to stay home as much as possible and to monitor their health during the 14 days after their return.

The U.S. Department of State is bringing back more Americans from Wuhan province this week, and these individuals will also be kept under federal quarantine for 14 days.

“There are likely to be confirmed infections among returning travelers,” said Dr. Messonnier. “It is important to note that this strategy is not meant to catch every single traveler returning from China with novel coronavirus; given the nature of this virus and how it’s spreading, that would be impossible, but working together we can catch the majority of them.

“The goal here is to slow the entry of this virus into the United States,” she said, adding that the nation’s health care and public health systems stand on high alert to detect the virus in community settings. In response to questioning from the press, Dr. Messonnier defended the stringent quarantine measures, noting that they are in line with those taken by some other nations, and with the aggressive action being taken by the Chinese government itself. “These actions are science based and aimed at protecting the health of all Americans,” she said.

The real-time reverse transcription polymerase chain reaction (rRT-PCR) assay that the CDC has developed detects 2019-nCoV in both respiratory and serum specimens. Dr. Messonnier reported that the CDC is today filing an emergency use authorization (EUA) application to the U.S. Food and Drug Administration to expedite access to the assay for public health laboratories across the country. “This will greatly enhance our capacity to test for this virus,” she said, noting that EUA approval may come as soon as the end of this week.

Although the CDC is poised to send an expert team to China, it’s still awaiting favorable results from the international negotiations currently underway. “This is a horrible situation in China,” said Dr. Messonnier. “Our presence on the ground in China would be a help to China. ... Science should trump everything else; that’s what we’re hoping – that the scientific expertise of the global community can be brought to bear on the incredibly complicated, difficult situation that our colleagues in China are dealing with.”

[email protected]

An additional 5 cases of 2019 novel coronavirus (2109-nCoV) have been confirmed in the United States, bringing the total number of confirmed cases to 11, Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, said during a Centers for Disease Control and Prevention press briefing.

Four of the new cases are in California, and one in Massachusetts. Although four of the new cases have recent travel history to Wuhan, China, the epicenter of the 2019-nCoV outbreak, the fifth is a close household contact of one of the other California patients, said Dr. Messonnier. This last case is the second instance of person-to-person spread of 2019-nCoV in the United States.

“We expect to find additional cases of the novel coronavirus in the United States,” she said. “We expect to see more cases of person-to-person spread among close contacts. And we continue to expect this will happen given the explosive nature of this outbreak in China.”

As of the morning of Feb. 3, 167 persons under investigation, or PUIs, for possible 2019-nCoV have tested negative for the virus, and an additional 82 PUIs have testing pending – this latter figure includes some tests that are still in transit to the CDC, said Dr. Messonnier.

During the briefing, Dr. Messonnier emphasized both the aggressive nature of the U.S. public health response and the rationale for quick and assertive action. “The goal of our public health response is to protect and contain,” she said. “Strong measures now may blunt the impact of this virus on the United States.”

She cited the intensity of transmission in Hubei Province, the expansion of transmission to other provinces in China, the expansion of cases outside of China, and sporadic ongoing deaths from 2019-nCoV as drivers of the aggressive U.S. public health response.

A presidential proclamation is currently in place that bars U.S. entry to foreign nationals who have visited mainland China within the past 14 days; the ban does not apply to travelers from Hong Kong and Macao. Immediate family members of U.S. citizens and individuals who have U.S. permanent resident status are exempted from the entry ban and will be allowed entry into the United States.

However, explained Dr. Messonnier, those who have traveled to China recently and are permitted entry will be subject to screening. All passengers with such recent travel will be directed to one of 11 U.S. airports set up to perform additional screening.

As of Feb 3, the list of airports includes:

• San Francisco International Airport in California.
• Los Angeles International Airport in California.
• Hartsfield-Jackson Atlanta International Airport in Georgia.
• Daniel K. Inouye International Airport in Hawaii.
• O’Hare International Airport in Illinois.
• Detroit Metropolitan Airport in Michigan.
• Newark Liberty International Airport in New Jersey.
• John F. Kennedy International Airport in New York.
• Dallas/Fort Worth International Airport in Texas.
• Washington Dulles International Airport in Virginia.
• Seattle-Tacoma International Airport in Washington.

Travelers who have been to Hubei Province in the previous 14 days will have an additional health assessment at which they will be screened for fever, cough, or difficulty breathing. Any American citizens or exempt individuals who are symptomatic would then be transferred for further medical evaluation. Asymptomatic travelers in this category will be subject to a mandatory 14-day quarantine near their point of entry, rather than continuing on to their final destinations.

Dr. Messonnier emphasized that the mandatory 14-day quarantine is specifically for Americans or exempt individuals returning from Hubei Province, adding that the CDC is presently working with individual states to determine the exact venues for quarantine.

American citizens and exempt individuals returning from other parts of mainland China will be routed to one of the 11 airports and will also receive additional health screening. Symptomatic individuals in this travel category would be referred for further evaluation before being able to complete their itinerary.

Asymptomatic American citizens and exempt individuals who are returning from mainland China – but not Hubei Province – will be allowed to travel on to their final destinations, but will be asked to stay home as much as possible and to monitor their health during the 14 days after their return.

The U.S. Department of State is bringing back more Americans from Wuhan province this week, and these individuals will also be kept under federal quarantine for 14 days.

“There are likely to be confirmed infections among returning travelers,” said Dr. Messonnier. “It is important to note that this strategy is not meant to catch every single traveler returning from China with novel coronavirus; given the nature of this virus and how it’s spreading, that would be impossible, but working together we can catch the majority of them.

“The goal here is to slow the entry of this virus into the United States,” she said, adding that the nation’s health care and public health systems stand on high alert to detect the virus in community settings. In response to questioning from the press, Dr. Messonnier defended the stringent quarantine measures, noting that they are in line with those taken by some other nations, and with the aggressive action being taken by the Chinese government itself. “These actions are science based and aimed at protecting the health of all Americans,” she said.

The real-time reverse transcription polymerase chain reaction (rRT-PCR) assay that the CDC has developed detects 2019-nCoV in both respiratory and serum specimens. Dr. Messonnier reported that the CDC is today filing an emergency use authorization (EUA) application to the U.S. Food and Drug Administration to expedite access to the assay for public health laboratories across the country. “This will greatly enhance our capacity to test for this virus,” she said, noting that EUA approval may come as soon as the end of this week.

Although the CDC is poised to send an expert team to China, it’s still awaiting favorable results from the international negotiations currently underway. “This is a horrible situation in China,” said Dr. Messonnier. “Our presence on the ground in China would be a help to China. ... Science should trump everything else; that’s what we’re hoping – that the scientific expertise of the global community can be brought to bear on the incredibly complicated, difficult situation that our colleagues in China are dealing with.”

[email protected]

SNOWMASS, COLO. – The number of transcatheter aortic valve replacements (TAVRs) performed annually in the United States is forecast to rocket up from 75,000 in 2019 to 100,000 in 2020 in response to the procedure’s recent approval in low-surgical-risk patients with symptomatic aortic stenosis, Michael J. Mack, MD, said at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

Bruce Jancin/MDedge News

“In 2020, TAVR seems like a tsunami that’s totally overwhelming SAVR [surgical aortic valve replacement]. And the question is, after the wave hits shore, is there going to be anything left in the surgical arena?” asked Dr. Mack, who is medical director of cardiothoracic surgery and chairman of the Baylor Scott & White The Heart Hospital – Plano (Tex.) Research Center.

He answered his own question with a quote from Mark Twain: “Reports of my death are greatly exaggerated.”

The trend is clear: TAVR will take over the market for isolated aortic valve replacement in much the same way that endovascular abdominal aortic aneurysm repair (EVAR) has come to dominate open surgical repair by an 80:20 margin. And with the recent expansion of TAVR indications to include low-risk patients, the pool of potential candidates for TAVR has grown staggeringly large. By one estimate, it could include some 270,000 individuals per year in North America and the European Union (Eur Heart J. 2018 Jul 21;39[28]:2635-42).

But there’s no need to shed a tear at the prospect of SAVR surgeons standing in unemployment lines. They will continue to have their hands full performing combined SAVR plus coronary artery bypass graft (CABG) procedures, SAVR plus mitral or tricuspid valve operations, and Bentall procedures, Dr. Mack predicted.

Who should get SAVR for aortic stenosis in 2020? For starters, he said, the sorts of patients who were excluded from the major TAVR-versus-SAVR randomized trials. The low-surgical-risk trials were restricted to patients who had symptomatic aortic stenosis involving a tricuspid valve, no left ventricular outflow tract calcium, no or minimal coronary artery disease (CAD), a relatively normal left ventricular ejection fraction, and an aortic valve anatomy suitable for TAVR. And, 92% of study participants were over age 65 years.

Dr. Mack called the evidence for the safety and effectiveness of TAVR “the most robust evidence base in the history of medical devices,” backed by nine U.S. trials and 8,000 randomized patients during the last dozen years. He has played a major role in developing that evidence base, having served most recently as cochair of the landmark PARTNER 3 trial, which demonstrated superiority for TAVR over SAVR in low-surgical-risk patients. But the evidence base doesn’t apply to patients not enrolled in the trials. So for the foreseeable future, patients younger than age 65 years should probably stick with SAVR, mainly because of the still-open question of tissue valve durability and TAVR’s high rate of associated conduction system impairment and need for new pacemaker implantation. Younger patients find permanent pacemakers particularly problematic, he noted.

Others who should stick with surgery include patients with bicuspid valves, especially when aortopathy is present, individuals with low-lying coronary arteries, patients with heavy calcium deposits at the left ventricular outflow tract, those with infective endocarditis or rheumatic valve disease, and patients with structural valve deterioration after a valve-in-valve TAVR.

“Once you get beyond the first valve-in-valve, the outcomes are not going to be good. Those patients should preferentially be considered for surgery. The results for valve-in-valve have been very disappointing, with a 33% all-cause mortality at 3 years in the PARTNER Aortic Valve-in-Valve Registry,” according to the surgeon.

In patients with aortic stenosis and CAD, the clinical decision making should be based on the coronary disease. In a patient with triple-vessel disease, diabetes, and/or a high Syntax score for whom the collaborative multidisciplinary heart team would recommend surgical revascularization if aortic stenosis wasn’t present, the most appropriate option is SAVR plus CABG. On the other hand, if the CAD is amenable to percutaneous coronary intervention (PCI) and the Syntax score is low, TAVR plus PCI is a safe and solid strategy, he continued.

In addition to the unresolved issue of tissue valve durability, another unanswered question pushing against universal adoption of TAVR involves the clinical implications of bioprosthetic valve leaflet thrombosis and the optimal antithrombotic therapy, both early and late. Leaflet thrombosis post-TAVR is common – as well as post-SAVR with bioprosthetic valves, albeit less so – but the lesions often come and go. Although there is a theoretical concern that they might be a precursor to leaflet destruction, at this point, their clinical significance remains unclear. In the recent GALILEO trial, TAVR patients randomized to low-dose rivaroxaban (Xarelto) plus aspirin showed fewer leaflet motion abnormalities and less leaflet thickening than did those on dual-antiplatelet therapy, but a significantly higher all-cause mortality (N Engl J Med 2020 Jan 9;382:120-9).

“I know that nowhere else in the body is thrombus a good thing, so thrombus in the valve can’t be a good thing. The only question is, how bad is it? And right now all we know is, some of our treatments for it are worse than the disease,” the surgeon commented.

Dr. Mack indicated that, at this time, clinical decision making in aortic stenosis should begin on the basis of patient age, which influences the key decision of whether to opt for a mechanical versus tissue replacement valve. For patients aged 50-70 years, shared decision making between the heart team and patient is appropriate. The evidence suggests SAVR with a mechanical valve is the better option, but many patients in this intermediate age group loathe the ideal of lifelong oral anticoagulation and favor a tissue valve.

For patients under age 50 years, the best evidence indicates that SAVR with a mechanical valve is clearly the best option; however, most young patients are instead opting for a tissue valve, even after being cautioned about the lingering uncertainty surrounding tissue valve durability, be it SAVR or TAVR. For patients over age 70 years, a tissue valve is the best choice based on the outcomes in PARTNER 3 and other low-surgical-risk trials. If the patient is younger than 65 years and wants a tissue valve, Dr. Mack thinks the best evidence-based option is SAVR. Above age 80 years, TAVR is the clear choice. Age 65-80 years is shared–decision making territory regarding TAVR versus SAVR.

Dr. Mack reported serving as a consultant to Gore and receiving research grants from Abbott Vascular, Edwards Lifesciences, and Medtronic.

[email protected]

SNOWMASS, COLO. – The number of transcatheter aortic valve replacements (TAVRs) performed annually in the United States is forecast to rocket up from 75,000 in 2019 to 100,000 in 2020 in response to the procedure’s recent approval in low-surgical-risk patients with symptomatic aortic stenosis, Michael J. Mack, MD, said at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

Bruce Jancin/MDedge News

“In 2020, TAVR seems like a tsunami that’s totally overwhelming SAVR [surgical aortic valve replacement]. And the question is, after the wave hits shore, is there going to be anything left in the surgical arena?” asked Dr. Mack, who is medical director of cardiothoracic surgery and chairman of the Baylor Scott & White The Heart Hospital – Plano (Tex.) Research Center.

He answered his own question with a quote from Mark Twain: “Reports of my death are greatly exaggerated.”

The trend is clear: TAVR will take over the market for isolated aortic valve replacement in much the same way that endovascular abdominal aortic aneurysm repair (EVAR) has come to dominate open surgical repair by an 80:20 margin. And with the recent expansion of TAVR indications to include low-risk patients, the pool of potential candidates for TAVR has grown staggeringly large. By one estimate, it could include some 270,000 individuals per year in North America and the European Union (Eur Heart J. 2018 Jul 21;39[28]:2635-42).

But there’s no need to shed a tear at the prospect of SAVR surgeons standing in unemployment lines. They will continue to have their hands full performing combined SAVR plus coronary artery bypass graft (CABG) procedures, SAVR plus mitral or tricuspid valve operations, and Bentall procedures, Dr. Mack predicted.

Who should get SAVR for aortic stenosis in 2020? For starters, he said, the sorts of patients who were excluded from the major TAVR-versus-SAVR randomized trials. The low-surgical-risk trials were restricted to patients who had symptomatic aortic stenosis involving a tricuspid valve, no left ventricular outflow tract calcium, no or minimal coronary artery disease (CAD), a relatively normal left ventricular ejection fraction, and an aortic valve anatomy suitable for TAVR. And, 92% of study participants were over age 65 years.

Dr. Mack called the evidence for the safety and effectiveness of TAVR “the most robust evidence base in the history of medical devices,” backed by nine U.S. trials and 8,000 randomized patients during the last dozen years. He has played a major role in developing that evidence base, having served most recently as cochair of the landmark PARTNER 3 trial, which demonstrated superiority for TAVR over SAVR in low-surgical-risk patients. But the evidence base doesn’t apply to patients not enrolled in the trials. So for the foreseeable future, patients younger than age 65 years should probably stick with SAVR, mainly because of the still-open question of tissue valve durability and TAVR’s high rate of associated conduction system impairment and need for new pacemaker implantation. Younger patients find permanent pacemakers particularly problematic, he noted.

Others who should stick with surgery include patients with bicuspid valves, especially when aortopathy is present, individuals with low-lying coronary arteries, patients with heavy calcium deposits at the left ventricular outflow tract, those with infective endocarditis or rheumatic valve disease, and patients with structural valve deterioration after a valve-in-valve TAVR.

“Once you get beyond the first valve-in-valve, the outcomes are not going to be good. Those patients should preferentially be considered for surgery. The results for valve-in-valve have been very disappointing, with a 33% all-cause mortality at 3 years in the PARTNER Aortic Valve-in-Valve Registry,” according to the surgeon.

In patients with aortic stenosis and CAD, the clinical decision making should be based on the coronary disease. In a patient with triple-vessel disease, diabetes, and/or a high Syntax score for whom the collaborative multidisciplinary heart team would recommend surgical revascularization if aortic stenosis wasn’t present, the most appropriate option is SAVR plus CABG. On the other hand, if the CAD is amenable to percutaneous coronary intervention (PCI) and the Syntax score is low, TAVR plus PCI is a safe and solid strategy, he continued.

In addition to the unresolved issue of tissue valve durability, another unanswered question pushing against universal adoption of TAVR involves the clinical implications of bioprosthetic valve leaflet thrombosis and the optimal antithrombotic therapy, both early and late. Leaflet thrombosis post-TAVR is common – as well as post-SAVR with bioprosthetic valves, albeit less so – but the lesions often come and go. Although there is a theoretical concern that they might be a precursor to leaflet destruction, at this point, their clinical significance remains unclear. In the recent GALILEO trial, TAVR patients randomized to low-dose rivaroxaban (Xarelto) plus aspirin showed fewer leaflet motion abnormalities and less leaflet thickening than did those on dual-antiplatelet therapy, but a significantly higher all-cause mortality (N Engl J Med 2020 Jan 9;382:120-9).

“I know that nowhere else in the body is thrombus a good thing, so thrombus in the valve can’t be a good thing. The only question is, how bad is it? And right now all we know is, some of our treatments for it are worse than the disease,” the surgeon commented.

Dr. Mack indicated that, at this time, clinical decision making in aortic stenosis should begin on the basis of patient age, which influences the key decision of whether to opt for a mechanical versus tissue replacement valve. For patients aged 50-70 years, shared decision making between the heart team and patient is appropriate. The evidence suggests SAVR with a mechanical valve is the better option, but many patients in this intermediate age group loathe the ideal of lifelong oral anticoagulation and favor a tissue valve.

For patients under age 50 years, the best evidence indicates that SAVR with a mechanical valve is clearly the best option; however, most young patients are instead opting for a tissue valve, even after being cautioned about the lingering uncertainty surrounding tissue valve durability, be it SAVR or TAVR. For patients over age 70 years, a tissue valve is the best choice based on the outcomes in PARTNER 3 and other low-surgical-risk trials. If the patient is younger than 65 years and wants a tissue valve, Dr. Mack thinks the best evidence-based option is SAVR. Above age 80 years, TAVR is the clear choice. Age 65-80 years is shared–decision making territory regarding TAVR versus SAVR.

Dr. Mack reported serving as a consultant to Gore and receiving research grants from Abbott Vascular, Edwards Lifesciences, and Medtronic.

[email protected]

SNOWMASS, COLO. – The number of transcatheter aortic valve replacements (TAVRs) performed annually in the United States is forecast to rocket up from 75,000 in 2019 to 100,000 in 2020 in response to the procedure’s recent approval in low-surgical-risk patients with symptomatic aortic stenosis, Michael J. Mack, MD, said at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

Bruce Jancin/MDedge News

“In 2020, TAVR seems like a tsunami that’s totally overwhelming SAVR [surgical aortic valve replacement]. And the question is, after the wave hits shore, is there going to be anything left in the surgical arena?” asked Dr. Mack, who is medical director of cardiothoracic surgery and chairman of the Baylor Scott & White The Heart Hospital – Plano (Tex.) Research Center.

He answered his own question with a quote from Mark Twain: “Reports of my death are greatly exaggerated.”

The trend is clear: TAVR will take over the market for isolated aortic valve replacement in much the same way that endovascular abdominal aortic aneurysm repair (EVAR) has come to dominate open surgical repair by an 80:20 margin. And with the recent expansion of TAVR indications to include low-risk patients, the pool of potential candidates for TAVR has grown staggeringly large. By one estimate, it could include some 270,000 individuals per year in North America and the European Union (Eur Heart J. 2018 Jul 21;39[28]:2635-42).

But there’s no need to shed a tear at the prospect of SAVR surgeons standing in unemployment lines. They will continue to have their hands full performing combined SAVR plus coronary artery bypass graft (CABG) procedures, SAVR plus mitral or tricuspid valve operations, and Bentall procedures, Dr. Mack predicted.

Who should get SAVR for aortic stenosis in 2020? For starters, he said, the sorts of patients who were excluded from the major TAVR-versus-SAVR randomized trials. The low-surgical-risk trials were restricted to patients who had symptomatic aortic stenosis involving a tricuspid valve, no left ventricular outflow tract calcium, no or minimal coronary artery disease (CAD), a relatively normal left ventricular ejection fraction, and an aortic valve anatomy suitable for TAVR. And, 92% of study participants were over age 65 years.

Dr. Mack called the evidence for the safety and effectiveness of TAVR “the most robust evidence base in the history of medical devices,” backed by nine U.S. trials and 8,000 randomized patients during the last dozen years. He has played a major role in developing that evidence base, having served most recently as cochair of the landmark PARTNER 3 trial, which demonstrated superiority for TAVR over SAVR in low-surgical-risk patients. But the evidence base doesn’t apply to patients not enrolled in the trials. So for the foreseeable future, patients younger than age 65 years should probably stick with SAVR, mainly because of the still-open question of tissue valve durability and TAVR’s high rate of associated conduction system impairment and need for new pacemaker implantation. Younger patients find permanent pacemakers particularly problematic, he noted.

Others who should stick with surgery include patients with bicuspid valves, especially when aortopathy is present, individuals with low-lying coronary arteries, patients with heavy calcium deposits at the left ventricular outflow tract, those with infective endocarditis or rheumatic valve disease, and patients with structural valve deterioration after a valve-in-valve TAVR.

“Once you get beyond the first valve-in-valve, the outcomes are not going to be good. Those patients should preferentially be considered for surgery. The results for valve-in-valve have been very disappointing, with a 33% all-cause mortality at 3 years in the PARTNER Aortic Valve-in-Valve Registry,” according to the surgeon.

In patients with aortic stenosis and CAD, the clinical decision making should be based on the coronary disease. In a patient with triple-vessel disease, diabetes, and/or a high Syntax score for whom the collaborative multidisciplinary heart team would recommend surgical revascularization if aortic stenosis wasn’t present, the most appropriate option is SAVR plus CABG. On the other hand, if the CAD is amenable to percutaneous coronary intervention (PCI) and the Syntax score is low, TAVR plus PCI is a safe and solid strategy, he continued.

In addition to the unresolved issue of tissue valve durability, another unanswered question pushing against universal adoption of TAVR involves the clinical implications of bioprosthetic valve leaflet thrombosis and the optimal antithrombotic therapy, both early and late. Leaflet thrombosis post-TAVR is common – as well as post-SAVR with bioprosthetic valves, albeit less so – but the lesions often come and go. Although there is a theoretical concern that they might be a precursor to leaflet destruction, at this point, their clinical significance remains unclear. In the recent GALILEO trial, TAVR patients randomized to low-dose rivaroxaban (Xarelto) plus aspirin showed fewer leaflet motion abnormalities and less leaflet thickening than did those on dual-antiplatelet therapy, but a significantly higher all-cause mortality (N Engl J Med 2020 Jan 9;382:120-9).

“I know that nowhere else in the body is thrombus a good thing, so thrombus in the valve can’t be a good thing. The only question is, how bad is it? And right now all we know is, some of our treatments for it are worse than the disease,” the surgeon commented.

Dr. Mack indicated that, at this time, clinical decision making in aortic stenosis should begin on the basis of patient age, which influences the key decision of whether to opt for a mechanical versus tissue replacement valve. For patients aged 50-70 years, shared decision making between the heart team and patient is appropriate. The evidence suggests SAVR with a mechanical valve is the better option, but many patients in this intermediate age group loathe the ideal of lifelong oral anticoagulation and favor a tissue valve.

For patients under age 50 years, the best evidence indicates that SAVR with a mechanical valve is clearly the best option; however, most young patients are instead opting for a tissue valve, even after being cautioned about the lingering uncertainty surrounding tissue valve durability, be it SAVR or TAVR. For patients over age 70 years, a tissue valve is the best choice based on the outcomes in PARTNER 3 and other low-surgical-risk trials. If the patient is younger than 65 years and wants a tissue valve, Dr. Mack thinks the best evidence-based option is SAVR. Above age 80 years, TAVR is the clear choice. Age 65-80 years is shared–decision making territory regarding TAVR versus SAVR.

Dr. Mack reported serving as a consultant to Gore and receiving research grants from Abbott Vascular, Edwards Lifesciences, and Medtronic.

[email protected]

Endobronchial ultrasound with transbronchial needle aspiration (EBUS-TBNA) had the highest diagnostic yield of lung lesions, compared with other bronchoscopic approaches, according to a multisite study of current and former smokers with suspected lung cancer.

Bronchoscopy has long played a role in the identification of lung lesions, but the yield varies according to many factors associated with the lesion and the type of bronchoscopy, and recent studies suggest that the yield may be lower than previously thought, wrote Gerard A. Silvestri, MD, of Medical University of South Carolina, Charleston, and colleagues.

In a study published in Chest, the researchers sought to assess the yield of bronchoscopy based on procedure and characteristics, as well as the physician-calculated pretest probability of cancer.

They conducted a secondary analysis of 687 patients from the AEGIS trial, a prospective 28-site study of current and former smokers who underwent bronchoscopy for suspected lung cancer. Patients under 21, those without a history of smoking, and those with a concurrent cancer or history of lung cancer were excluded. The average age of the participants was 63 years, and two-thirds were male. Of these, 474 had diagnostic bronchoscopies and 213 had nondiagnostic bronchoscopies.

The overall diagnostic yield was 69%. However, the diagnostic yield significantly higher (80%) with the use of EBUS-TBNA, compared with 55% for standard bronchoscopy with biopsy +/– fluoroscopy, 57% for electromagnetic navigation, and 74% for combination procedures.

Patients with diagnostic bronchoscopies were significantly more likely than were those who had nondiagnostic bronchoscopies to have lesions greater than 3 cm (67% vs. 45%), to have central locations (75% vs. 50%), and to have lymphadenopathy (57% vs. 55%).

In addition, yields were significantly higher (77%) for patients whose preprocedure physician-assessed probability of cancer was at least 60%, compared with yields in those whose preprocedure physician-assessed probability of cancer was less than 10% or 10%-60% (44% and 42%, respectively).

The study findings were limited by several factors including the high prevalence of cancer in the study population, a 1-year follow-up that may have missed slow-growing cancers, and lack of data on the presence or absence of a bronchus sign, the researchers noted. However, the results were strengthened by the large size, mixture of sites, and use of multiple technologies and presentations, they said.

The study is the largest to assess diagnostic yields and various bronchoscopy techniques and supports EBUS-TBNA as the most reliable, but patient selection and improved procedural training can help improve diagnostic yields, the researchers emphasized.

“While the overall yield of bronchoscopy is reasonable, EBUS-TBNA is the only technique that reliably provides a diagnosis in those suspected of having lung cancer, likely because the biopsy is targeting a central lymph node and there is direct visualization of the needle passing into the target,” they said. However,“better bronchoscopic technology is needed and there are devices in the development pipeline that promise improved diagnostic yield, though these products will require evaluation through prospective comparative effectiveness trials prior to widespread adoption,” they noted. Clinicians should be prepared to pursue alternatives to bronchoscopy if a diagnosis is unlikely, they concluded.

Dr. Silvestri disclosed research grant awards to his university from Olympus America, Auris robotics, Veracyte, and Veran Medical, as well as consulting fees from Olympus and Auris robotics.

SOURCE: Silvestri GA et al. CHEST. 2020 Jan 21. doi: 10.1016/j.chest.2019.12.024.

Endobronchial ultrasound with transbronchial needle aspiration (EBUS-TBNA) had the highest diagnostic yield of lung lesions, compared with other bronchoscopic approaches, according to a multisite study of current and former smokers with suspected lung cancer.

Bronchoscopy has long played a role in the identification of lung lesions, but the yield varies according to many factors associated with the lesion and the type of bronchoscopy, and recent studies suggest that the yield may be lower than previously thought, wrote Gerard A. Silvestri, MD, of Medical University of South Carolina, Charleston, and colleagues.

In a study published in Chest, the researchers sought to assess the yield of bronchoscopy based on procedure and characteristics, as well as the physician-calculated pretest probability of cancer.

They conducted a secondary analysis of 687 patients from the AEGIS trial, a prospective 28-site study of current and former smokers who underwent bronchoscopy for suspected lung cancer. Patients under 21, those without a history of smoking, and those with a concurrent cancer or history of lung cancer were excluded. The average age of the participants was 63 years, and two-thirds were male. Of these, 474 had diagnostic bronchoscopies and 213 had nondiagnostic bronchoscopies.

The overall diagnostic yield was 69%. However, the diagnostic yield significantly higher (80%) with the use of EBUS-TBNA, compared with 55% for standard bronchoscopy with biopsy +/– fluoroscopy, 57% for electromagnetic navigation, and 74% for combination procedures.

Patients with diagnostic bronchoscopies were significantly more likely than were those who had nondiagnostic bronchoscopies to have lesions greater than 3 cm (67% vs. 45%), to have central locations (75% vs. 50%), and to have lymphadenopathy (57% vs. 55%).

In addition, yields were significantly higher (77%) for patients whose preprocedure physician-assessed probability of cancer was at least 60%, compared with yields in those whose preprocedure physician-assessed probability of cancer was less than 10% or 10%-60% (44% and 42%, respectively).

The study findings were limited by several factors including the high prevalence of cancer in the study population, a 1-year follow-up that may have missed slow-growing cancers, and lack of data on the presence or absence of a bronchus sign, the researchers noted. However, the results were strengthened by the large size, mixture of sites, and use of multiple technologies and presentations, they said.

The study is the largest to assess diagnostic yields and various bronchoscopy techniques and supports EBUS-TBNA as the most reliable, but patient selection and improved procedural training can help improve diagnostic yields, the researchers emphasized.

“While the overall yield of bronchoscopy is reasonable, EBUS-TBNA is the only technique that reliably provides a diagnosis in those suspected of having lung cancer, likely because the biopsy is targeting a central lymph node and there is direct visualization of the needle passing into the target,” they said. However,“better bronchoscopic technology is needed and there are devices in the development pipeline that promise improved diagnostic yield, though these products will require evaluation through prospective comparative effectiveness trials prior to widespread adoption,” they noted. Clinicians should be prepared to pursue alternatives to bronchoscopy if a diagnosis is unlikely, they concluded.

Dr. Silvestri disclosed research grant awards to his university from Olympus America, Auris robotics, Veracyte, and Veran Medical, as well as consulting fees from Olympus and Auris robotics.

SOURCE: Silvestri GA et al. CHEST. 2020 Jan 21. doi: 10.1016/j.chest.2019.12.024.

Endobronchial ultrasound with transbronchial needle aspiration (EBUS-TBNA) had the highest diagnostic yield of lung lesions, compared with other bronchoscopic approaches, according to a multisite study of current and former smokers with suspected lung cancer.

Bronchoscopy has long played a role in the identification of lung lesions, but the yield varies according to many factors associated with the lesion and the type of bronchoscopy, and recent studies suggest that the yield may be lower than previously thought, wrote Gerard A. Silvestri, MD, of Medical University of South Carolina, Charleston, and colleagues.

In a study published in Chest, the researchers sought to assess the yield of bronchoscopy based on procedure and characteristics, as well as the physician-calculated pretest probability of cancer.

They conducted a secondary analysis of 687 patients from the AEGIS trial, a prospective 28-site study of current and former smokers who underwent bronchoscopy for suspected lung cancer. Patients under 21, those without a history of smoking, and those with a concurrent cancer or history of lung cancer were excluded. The average age of the participants was 63 years, and two-thirds were male. Of these, 474 had diagnostic bronchoscopies and 213 had nondiagnostic bronchoscopies.

The overall diagnostic yield was 69%. However, the diagnostic yield significantly higher (80%) with the use of EBUS-TBNA, compared with 55% for standard bronchoscopy with biopsy +/– fluoroscopy, 57% for electromagnetic navigation, and 74% for combination procedures.

Patients with diagnostic bronchoscopies were significantly more likely than were those who had nondiagnostic bronchoscopies to have lesions greater than 3 cm (67% vs. 45%), to have central locations (75% vs. 50%), and to have lymphadenopathy (57% vs. 55%).

In addition, yields were significantly higher (77%) for patients whose preprocedure physician-assessed probability of cancer was at least 60%, compared with yields in those whose preprocedure physician-assessed probability of cancer was less than 10% or 10%-60% (44% and 42%, respectively).

The study findings were limited by several factors including the high prevalence of cancer in the study population, a 1-year follow-up that may have missed slow-growing cancers, and lack of data on the presence or absence of a bronchus sign, the researchers noted. However, the results were strengthened by the large size, mixture of sites, and use of multiple technologies and presentations, they said.

The study is the largest to assess diagnostic yields and various bronchoscopy techniques and supports EBUS-TBNA as the most reliable, but patient selection and improved procedural training can help improve diagnostic yields, the researchers emphasized.

“While the overall yield of bronchoscopy is reasonable, EBUS-TBNA is the only technique that reliably provides a diagnosis in those suspected of having lung cancer, likely because the biopsy is targeting a central lymph node and there is direct visualization of the needle passing into the target,” they said. However,“better bronchoscopic technology is needed and there are devices in the development pipeline that promise improved diagnostic yield, though these products will require evaluation through prospective comparative effectiveness trials prior to widespread adoption,” they noted. Clinicians should be prepared to pursue alternatives to bronchoscopy if a diagnosis is unlikely, they concluded.

Dr. Silvestri disclosed research grant awards to his university from Olympus America, Auris robotics, Veracyte, and Veran Medical, as well as consulting fees from Olympus and Auris robotics.

SOURCE: Silvestri GA et al. CHEST. 2020 Jan 21. doi: 10.1016/j.chest.2019.12.024.

It took less than a day for physician groups to start pushing back at the Centers for Medicare & Medicaid Services over its new Medicaid block grant plan, which was introduced on Jan. 30.

Dubbed “Healthy Adult Opportunity,” the agency is offering all states the chance to participate in a block grant program through the 1115 waiver process.

According to a fact sheet issued by the agency, the program will focus on “adults under age 65 who are not eligible for Medicaid on the basis of disability or their need for long term care services and supports, and who are not eligible under a state plan. Other very low-income parents, children, pregnant women, elderly adults, and people eligible on the basis of a disability will not be directly affected – except from the improvement that results from states reinvesting savings into strengthening their overall programs.”

States will be operating within a defined budget when participating in the program and expenditures exceeding that defined budget will not be eligible for additional federal funding. Budgets will be based on a state’s historic costs, as well as national and regional trends, and will be tied to inflation with the potential to have adjustments made for extraordinary events. States can set their baseline using the prior year’s total spending or a per-enrollee spending model.

A Jan. 30 letter to state Medicaid directors notes that states participating in the program “will be granted extensive flexibility to test alternative approaches to implementing their Medicaid programs, including the ability to make many ongoing program adjustments without the need for demonstration or state plan amendments that require prior approval.”

Among the activities states can engage in under this plan are adjusting cost-sharing requirements, adopting a closed formulary, and applying additional conditions of eligibility. Requests, if approved, will be approved for a 5-year initial period, with a renewal option of up to 10 years.

But physician groups are not seeing a benefit with this new block grant program.

“Moving to a block grant system will likely limit the ability of Medicaid patients to receive preventive and needed medical care from their family physicians, and it will only increase the health disparities that exist in these communities, worsen overall health outcomes, and ultimately increase costs,” Gary LeRoy, MD, president of the American Academy of Family Physicians, said in a statement.

The American Medical Association concurred.

“The AMA opposes caps on federal Medicaid funding, such as block grants, because they would increase the number of uninsured and undermine Medicaid’s role as an indispensable safety net,” Patrice Harris, MD, the AMA’s president, said in a statement. “The AMA supports flexibility in Medicaid and encourages CMS to work with states to develop and test new Medicaid models that best meet the needs and priorities of low-income patients. While encouraging flexibility, the AMA is mindful that expanding Medicaid has been a literal lifesaver for low-income patients. We need to find ways to build on this success. We look forward to reviewing the proposal in detail.”

Officials at the American College of Obstetricians and Gynecologists said the changes have the potential to harm women and children’s health, as well as negatively impact physician reimbursement and ultimately access to care.

“Limits on the federal contribution to the Medicaid program would negatively impact patients by forcing states to reduce the number of people who are eligible for Medicaid coverage, eliminate covered services, and increase beneficiary cost-sharing,” ACOG President Ted Anderson, MD, said in a statement. “ACOG is also concerned that this block grant opportunity could lower physician reimbursement for certain services, forcing providers out of the program and jeopardizing patients’ ability to access health care services. Given our nation’s stark rates of maternal mortality and severe maternal morbidity, we are alarmed by the Administration’s willingness to weaken physician payment in Medicaid.”

[email protected]

It took less than a day for physician groups to start pushing back at the Centers for Medicare & Medicaid Services over its new Medicaid block grant plan, which was introduced on Jan. 30.

Dubbed “Healthy Adult Opportunity,” the agency is offering all states the chance to participate in a block grant program through the 1115 waiver process.

According to a fact sheet issued by the agency, the program will focus on “adults under age 65 who are not eligible for Medicaid on the basis of disability or their need for long term care services and supports, and who are not eligible under a state plan. Other very low-income parents, children, pregnant women, elderly adults, and people eligible on the basis of a disability will not be directly affected – except from the improvement that results from states reinvesting savings into strengthening their overall programs.”

States will be operating within a defined budget when participating in the program and expenditures exceeding that defined budget will not be eligible for additional federal funding. Budgets will be based on a state’s historic costs, as well as national and regional trends, and will be tied to inflation with the potential to have adjustments made for extraordinary events. States can set their baseline using the prior year’s total spending or a per-enrollee spending model.

A Jan. 30 letter to state Medicaid directors notes that states participating in the program “will be granted extensive flexibility to test alternative approaches to implementing their Medicaid programs, including the ability to make many ongoing program adjustments without the need for demonstration or state plan amendments that require prior approval.”

Among the activities states can engage in under this plan are adjusting cost-sharing requirements, adopting a closed formulary, and applying additional conditions of eligibility. Requests, if approved, will be approved for a 5-year initial period, with a renewal option of up to 10 years.

But physician groups are not seeing a benefit with this new block grant program.

“Moving to a block grant system will likely limit the ability of Medicaid patients to receive preventive and needed medical care from their family physicians, and it will only increase the health disparities that exist in these communities, worsen overall health outcomes, and ultimately increase costs,” Gary LeRoy, MD, president of the American Academy of Family Physicians, said in a statement.

The American Medical Association concurred.

“The AMA opposes caps on federal Medicaid funding, such as block grants, because they would increase the number of uninsured and undermine Medicaid’s role as an indispensable safety net,” Patrice Harris, MD, the AMA’s president, said in a statement. “The AMA supports flexibility in Medicaid and encourages CMS to work with states to develop and test new Medicaid models that best meet the needs and priorities of low-income patients. While encouraging flexibility, the AMA is mindful that expanding Medicaid has been a literal lifesaver for low-income patients. We need to find ways to build on this success. We look forward to reviewing the proposal in detail.”

Officials at the American College of Obstetricians and Gynecologists said the changes have the potential to harm women and children’s health, as well as negatively impact physician reimbursement and ultimately access to care.

“Limits on the federal contribution to the Medicaid program would negatively impact patients by forcing states to reduce the number of people who are eligible for Medicaid coverage, eliminate covered services, and increase beneficiary cost-sharing,” ACOG President Ted Anderson, MD, said in a statement. “ACOG is also concerned that this block grant opportunity could lower physician reimbursement for certain services, forcing providers out of the program and jeopardizing patients’ ability to access health care services. Given our nation’s stark rates of maternal mortality and severe maternal morbidity, we are alarmed by the Administration’s willingness to weaken physician payment in Medicaid.”

[email protected]

It took less than a day for physician groups to start pushing back at the Centers for Medicare & Medicaid Services over its new Medicaid block grant plan, which was introduced on Jan. 30.

Dubbed “Healthy Adult Opportunity,” the agency is offering all states the chance to participate in a block grant program through the 1115 waiver process.

According to a fact sheet issued by the agency, the program will focus on “adults under age 65 who are not eligible for Medicaid on the basis of disability or their need for long term care services and supports, and who are not eligible under a state plan. Other very low-income parents, children, pregnant women, elderly adults, and people eligible on the basis of a disability will not be directly affected – except from the improvement that results from states reinvesting savings into strengthening their overall programs.”

States will be operating within a defined budget when participating in the program and expenditures exceeding that defined budget will not be eligible for additional federal funding. Budgets will be based on a state’s historic costs, as well as national and regional trends, and will be tied to inflation with the potential to have adjustments made for extraordinary events. States can set their baseline using the prior year’s total spending or a per-enrollee spending model.

A Jan. 30 letter to state Medicaid directors notes that states participating in the program “will be granted extensive flexibility to test alternative approaches to implementing their Medicaid programs, including the ability to make many ongoing program adjustments without the need for demonstration or state plan amendments that require prior approval.”

Among the activities states can engage in under this plan are adjusting cost-sharing requirements, adopting a closed formulary, and applying additional conditions of eligibility. Requests, if approved, will be approved for a 5-year initial period, with a renewal option of up to 10 years.

But physician groups are not seeing a benefit with this new block grant program.

“Moving to a block grant system will likely limit the ability of Medicaid patients to receive preventive and needed medical care from their family physicians, and it will only increase the health disparities that exist in these communities, worsen overall health outcomes, and ultimately increase costs,” Gary LeRoy, MD, president of the American Academy of Family Physicians, said in a statement.

The American Medical Association concurred.

“The AMA opposes caps on federal Medicaid funding, such as block grants, because they would increase the number of uninsured and undermine Medicaid’s role as an indispensable safety net,” Patrice Harris, MD, the AMA’s president, said in a statement. “The AMA supports flexibility in Medicaid and encourages CMS to work with states to develop and test new Medicaid models that best meet the needs and priorities of low-income patients. While encouraging flexibility, the AMA is mindful that expanding Medicaid has been a literal lifesaver for low-income patients. We need to find ways to build on this success. We look forward to reviewing the proposal in detail.”

Officials at the American College of Obstetricians and Gynecologists said the changes have the potential to harm women and children’s health, as well as negatively impact physician reimbursement and ultimately access to care.

“Limits on the federal contribution to the Medicaid program would negatively impact patients by forcing states to reduce the number of people who are eligible for Medicaid coverage, eliminate covered services, and increase beneficiary cost-sharing,” ACOG President Ted Anderson, MD, said in a statement. “ACOG is also concerned that this block grant opportunity could lower physician reimbursement for certain services, forcing providers out of the program and jeopardizing patients’ ability to access health care services. Given our nation’s stark rates of maternal mortality and severe maternal morbidity, we are alarmed by the Administration’s willingness to weaken physician payment in Medicaid.”

[email protected]

For lung cancer patients with moderately decreased lung function, the 6-minute walk test may be a useful tool to help predict postoperative cardiopulmonary complications, researchers have found.

Risk of cardiopulmonary complications increased nearly eightfold in patients with moderate lung function decreases who failed to walk 400 m or more, according to the study, which included data on 416 patients with non–small cell lung cancer (NSCLC) who underwent lobectomy.

This is believed to be the first large study evaluating the utility of the 6-minute walk test (6MWT) to predict postoperative cardiopulmonary complications in this surgical setting, according to researchers led by Hyun Lee, MD, of Hanyang University in Seoul, South Korea. 

“Our findings suggest that 6-minute walk distance would provide additional information in lung cancer patients with moderately decreased lung function who plan to undergo surgical resection,” said Dr. Lee and coauthors of the study report, which appears in CHEST.

More specifically, the option of curative resection should be considered in those lung cancer patients with moderately decreased lung function but a longer 6-minute walk distance, they added.

Exercise testing is currently recommended to further stratify risk of postoperative complications among patient with moderately decreased lung function, according to the researchers. The 6-minute walk test might be a good tool to evaluate feasibility for moderate risk patients, according to one recent review. However, studies so far have been limited by small numbers of patients, and larger studies have not specifically looked at predicted postoperative lung function status, they said.

Accordingly, the researchers evaluated data from patients expected to undergo curative lung cancer surgery who were enrolled in a prospective cohort study in Korea. They were classified as low or moderate risk based on pulmonary function tests, and further classified into short distance (less than 400 m) and long distance (400 m or more) groups based on their performance on the 6-minute walk test. 

Postoperative cardiopulmonary complications were seen in 42.9% of the moderate-risk, short-distance group, versus 14.4% of patients in the moderate-risk, long-distance group. In the low-risk patients, those complications were seen in 9.5% and 8.3% of those in the long and short distance groups.

Odds for postoperative cardiopulmonary complications were significantly increased in the moderate-risk, short-distance group, compared with the low-risk, long-distance group (adjusted odds ratio, 7.84; 95% confidence interval, 2.24-27.46).

By contrast, odds for complications were not significantly increased in the moderate-risk, long-distance group, nor in the low-risk, short-distance groups, investigators said.

Dr. Lee and coauthors said they had no conflicts of interest to disclose.

SOURCE: Lee H et al. CHEST. 2020. doi: 10.1016/j.chest.2019.12.039.

For lung cancer patients with moderately decreased lung function, the 6-minute walk test may be a useful tool to help predict postoperative cardiopulmonary complications, researchers have found.

Risk of cardiopulmonary complications increased nearly eightfold in patients with moderate lung function decreases who failed to walk 400 m or more, according to the study, which included data on 416 patients with non–small cell lung cancer (NSCLC) who underwent lobectomy.

This is believed to be the first large study evaluating the utility of the 6-minute walk test (6MWT) to predict postoperative cardiopulmonary complications in this surgical setting, according to researchers led by Hyun Lee, MD, of Hanyang University in Seoul, South Korea. 

“Our findings suggest that 6-minute walk distance would provide additional information in lung cancer patients with moderately decreased lung function who plan to undergo surgical resection,” said Dr. Lee and coauthors of the study report, which appears in CHEST.

More specifically, the option of curative resection should be considered in those lung cancer patients with moderately decreased lung function but a longer 6-minute walk distance, they added.

Exercise testing is currently recommended to further stratify risk of postoperative complications among patient with moderately decreased lung function, according to the researchers. The 6-minute walk test might be a good tool to evaluate feasibility for moderate risk patients, according to one recent review. However, studies so far have been limited by small numbers of patients, and larger studies have not specifically looked at predicted postoperative lung function status, they said.

Accordingly, the researchers evaluated data from patients expected to undergo curative lung cancer surgery who were enrolled in a prospective cohort study in Korea. They were classified as low or moderate risk based on pulmonary function tests, and further classified into short distance (less than 400 m) and long distance (400 m or more) groups based on their performance on the 6-minute walk test. 

Postoperative cardiopulmonary complications were seen in 42.9% of the moderate-risk, short-distance group, versus 14.4% of patients in the moderate-risk, long-distance group. In the low-risk patients, those complications were seen in 9.5% and 8.3% of those in the long and short distance groups.

Odds for postoperative cardiopulmonary complications were significantly increased in the moderate-risk, short-distance group, compared with the low-risk, long-distance group (adjusted odds ratio, 7.84; 95% confidence interval, 2.24-27.46).

By contrast, odds for complications were not significantly increased in the moderate-risk, long-distance group, nor in the low-risk, short-distance groups, investigators said.

Dr. Lee and coauthors said they had no conflicts of interest to disclose.

SOURCE: Lee H et al. CHEST. 2020. doi: 10.1016/j.chest.2019.12.039.

For lung cancer patients with moderately decreased lung function, the 6-minute walk test may be a useful tool to help predict postoperative cardiopulmonary complications, researchers have found.

Risk of cardiopulmonary complications increased nearly eightfold in patients with moderate lung function decreases who failed to walk 400 m or more, according to the study, which included data on 416 patients with non–small cell lung cancer (NSCLC) who underwent lobectomy.

This is believed to be the first large study evaluating the utility of the 6-minute walk test (6MWT) to predict postoperative cardiopulmonary complications in this surgical setting, according to researchers led by Hyun Lee, MD, of Hanyang University in Seoul, South Korea. 

“Our findings suggest that 6-minute walk distance would provide additional information in lung cancer patients with moderately decreased lung function who plan to undergo surgical resection,” said Dr. Lee and coauthors of the study report, which appears in CHEST.

More specifically, the option of curative resection should be considered in those lung cancer patients with moderately decreased lung function but a longer 6-minute walk distance, they added.

Exercise testing is currently recommended to further stratify risk of postoperative complications among patient with moderately decreased lung function, according to the researchers. The 6-minute walk test might be a good tool to evaluate feasibility for moderate risk patients, according to one recent review. However, studies so far have been limited by small numbers of patients, and larger studies have not specifically looked at predicted postoperative lung function status, they said.

Accordingly, the researchers evaluated data from patients expected to undergo curative lung cancer surgery who were enrolled in a prospective cohort study in Korea. They were classified as low or moderate risk based on pulmonary function tests, and further classified into short distance (less than 400 m) and long distance (400 m or more) groups based on their performance on the 6-minute walk test. 

Postoperative cardiopulmonary complications were seen in 42.9% of the moderate-risk, short-distance group, versus 14.4% of patients in the moderate-risk, long-distance group. In the low-risk patients, those complications were seen in 9.5% and 8.3% of those in the long and short distance groups.

Odds for postoperative cardiopulmonary complications were significantly increased in the moderate-risk, short-distance group, compared with the low-risk, long-distance group (adjusted odds ratio, 7.84; 95% confidence interval, 2.24-27.46).

By contrast, odds for complications were not significantly increased in the moderate-risk, long-distance group, nor in the low-risk, short-distance groups, investigators said.

Dr. Lee and coauthors said they had no conflicts of interest to disclose.

SOURCE: Lee H et al. CHEST. 2020. doi: 10.1016/j.chest.2019.12.039.

After 2 weeks of declines at the beginning of the year, flu activity has now increased for 2 consecutive weeks, according to the U.S. Centers for Disease Control and Prevention.

Nationally, an estimated 5.7% of all outpatients visiting health care providers had influenza-like illness (ILI) for the week ending Jan. 25, which was up from 5.1% the previous week but still lower than the current seasonal high of 7.1% recorded during the week of Dec. 22-28, the CDC’s influenza division reported.

Another key indicator of influenza activity, the percentage of respiratory specimens testing positive, also remains high as it rose from 25.7% the week before to 27.7% for the week ending Jan. 25, the influenza division said. That is the highest rate of the 2019-2020 season so far, surpassing the 26.8% reached during Dec. 22-28.

Another new seasonal high involves the number of states, 33 plus Puerto Rico, at the highest level of ILI activity on the CDC’s 1-10 scale for the latest reporting week, topping the 32 jurisdictions from the last full week of December. Another eight states and the District of Columbia were in the “high” range with activity levels of 8 and 9, and no state with available data was lower than level 6, the CDC data show.

Going along with the recent 2-week increase in activity is a large increase in the number of ILI-related pediatric deaths, which rose from 39 on Jan. 11 to the current count of 68, the CDC said. At the same point last year, there had been 36 pediatric deaths.

Other indicators of ILI severity, however, “are not high at this point in the season,” the influenza division noted. “Overall, hospitalization rates remain similar to what has been seen at this time during recent seasons, but rates among children and young adults are higher at this time than in recent seasons.” Overall pneumonia and influenza mortality is also low, the CDC added.

[email protected]

After 2 weeks of declines at the beginning of the year, flu activity has now increased for 2 consecutive weeks, according to the U.S. Centers for Disease Control and Prevention.

Nationally, an estimated 5.7% of all outpatients visiting health care providers had influenza-like illness (ILI) for the week ending Jan. 25, which was up from 5.1% the previous week but still lower than the current seasonal high of 7.1% recorded during the week of Dec. 22-28, the CDC’s influenza division reported.

Another key indicator of influenza activity, the percentage of respiratory specimens testing positive, also remains high as it rose from 25.7% the week before to 27.7% for the week ending Jan. 25, the influenza division said. That is the highest rate of the 2019-2020 season so far, surpassing the 26.8% reached during Dec. 22-28.

Another new seasonal high involves the number of states, 33 plus Puerto Rico, at the highest level of ILI activity on the CDC’s 1-10 scale for the latest reporting week, topping the 32 jurisdictions from the last full week of December. Another eight states and the District of Columbia were in the “high” range with activity levels of 8 and 9, and no state with available data was lower than level 6, the CDC data show.

Going along with the recent 2-week increase in activity is a large increase in the number of ILI-related pediatric deaths, which rose from 39 on Jan. 11 to the current count of 68, the CDC said. At the same point last year, there had been 36 pediatric deaths.

Other indicators of ILI severity, however, “are not high at this point in the season,” the influenza division noted. “Overall, hospitalization rates remain similar to what has been seen at this time during recent seasons, but rates among children and young adults are higher at this time than in recent seasons.” Overall pneumonia and influenza mortality is also low, the CDC added.

[email protected]

After 2 weeks of declines at the beginning of the year, flu activity has now increased for 2 consecutive weeks, according to the U.S. Centers for Disease Control and Prevention.

Nationally, an estimated 5.7% of all outpatients visiting health care providers had influenza-like illness (ILI) for the week ending Jan. 25, which was up from 5.1% the previous week but still lower than the current seasonal high of 7.1% recorded during the week of Dec. 22-28, the CDC’s influenza division reported.

Another key indicator of influenza activity, the percentage of respiratory specimens testing positive, also remains high as it rose from 25.7% the week before to 27.7% for the week ending Jan. 25, the influenza division said. That is the highest rate of the 2019-2020 season so far, surpassing the 26.8% reached during Dec. 22-28.

Another new seasonal high involves the number of states, 33 plus Puerto Rico, at the highest level of ILI activity on the CDC’s 1-10 scale for the latest reporting week, topping the 32 jurisdictions from the last full week of December. Another eight states and the District of Columbia were in the “high” range with activity levels of 8 and 9, and no state with available data was lower than level 6, the CDC data show.

Going along with the recent 2-week increase in activity is a large increase in the number of ILI-related pediatric deaths, which rose from 39 on Jan. 11 to the current count of 68, the CDC said. At the same point last year, there had been 36 pediatric deaths.

Other indicators of ILI severity, however, “are not high at this point in the season,” the influenza division noted. “Overall, hospitalization rates remain similar to what has been seen at this time during recent seasons, but rates among children and young adults are higher at this time than in recent seasons.” Overall pneumonia and influenza mortality is also low, the CDC added.

[email protected]

The U.S. Food and Drug Administration’s approval of an expanded indication for a leadless pacemaker for patients “who may benefit from maintenance of atrioventricular synchrony” will make this technology potentially available to nearly half of the Americans who need a pacemaker, roughly triple the number of patients who have been candidates for a leadless pacemaker up to now.

Mitchel L. Zoler/MDedge News

“This approval was huge. The complication rate with leadless pacemakers has been 63% less than the rate using pacemakers with transvenous leads,” said Larry A. Chinitz, MD, a cardiac electrophysiologist and a coinvestigator on some of the studies that led to the new indication. By expanding the types of patients suitable for leadless pacing “we’ll achieve AV [atrioventricular] synchrony in more patients with fewer complications,” said Dr. Chinitz, professor of medicine and director of the Cardiac Electrophysiology and Heart Rhythm Center at NYU Langone Health in New York.

Because the device is both leadless and requires no pocket owing to its small size and placement in a patient’s right ventricle, it has implications for potentially broadening the population that could benefit from the device, he said in an interview. “When we started with this pacemaker, it was limited to elderly patients with persistent atrial fibrillation who needed only ventricular pacing, a very small group,” just under 15% of the universe of patients who need pacemakers. The broadened indication, for patients with high-grade AV block who also have atrial function, makes it possible to think of using this safer and easier-to-place device in patients who need infrequent pacing, and in patients with multiple comorbidities that give them an increased complication risk, he said. The new indication means “you’re treating a much broader patient population, doing it more safely, and creating the foundation for expanding this technology.”

The Micra AV pacemaker uses the same basic design as the previously approved Micra Transcatheter Pacing System, which came onto the U.S. market in 2016 and provides single-chamber pacing. An accelerometer on the device allows it to detect atrial motion and thereby synchronize ventricular and atrial contractions, which led to the new indication. Although the Micra AV device looks similar to the original single-chamber model, it has an entirely new circuitry that prolongs battery life during dual-chamber pacing as well as new software that incorporates the accelerometer data, explained Robert Kowal, MD, a cardiac electrophysiologist, and vice president of medical affairs and chief medical officer of cardiac rhythm and heart failure at Medtronic in Minneapolis. The battery of the Micra AV is designed to last about 15 years, Dr. Chinitz noted.

Results from two studies that Dr. Chinitz helped run established the safety and efficacy of the device for dual-chamber pacing. The MARVEL (Micra Atrial Tracking Using a Ventricular Accelerometer) study included 64 patients who completed the study at 12 worldwide centers, which produced an average 80% AV synchrony in 33 patients with high-degree AV block (The other patients in the study had predominantly intrinsic AV conduction; Heart Rhythm. 2018 Sep;15[9]:1363-71). The MARVEL 2 study included 75 patients with either second- or third-degree AV block at 12 worldwide centers and showed that AV synchrony increased from an average of 27% without two-chamber pacing to 89% with the dual-chamber function turned on, and with 95% of patients achieving at least 70% AV synchrony (JACC Clin Electrophysiol. 2020 Jan;6[1]:94-106).

The 2016 indication for single-chamber pacing included patients with “high-grade” AV bloc with or without atrial fibrillation, typically patients for whom dual-chamber pacemaker was not a great option because of the risks for complication but with the downside of limited AV synchrony, a limitation now mitigated by the option of mechanical synchronization, Dr. Kowal said. The AV device remains intended for patients with high-grade AV node block, which means patients with second- or third-degree block, he added in an interview. The estimated prevalence of third-degree AV block among U.S. adults is about 0.02%, which translates into about 50,000 people; the estimated prevalence of second-degree AV block is much less, about 10% of the third-degree prevalence.

Despite the substantial cut in complications by a leadless and pocketless pacemaker, “some patients may still benefit from a traditional dual-chamber pacemaker,” specifically active patients who might sometimes get their heart rates up with exercise to levels of about 150 beats/min or higher, Dr. Kowal said. That’s because currently the programing algorithms used to synchronize the ventricle and atrium become less reliable at heart rates above 105 beats/min, he explained. However, the ability for mechanical synchronization to keep up at higher heart rates should improve as additional data are collected that can refine the algorithms. It’s also unusual for most patients who are pacemaker candidates to reach heart rates this high, he said.

The MARVEL and MARVEL 2 studies were sponsored by Medtronic, the company that markets Micra pacemakers. Dr. Chinitz has received fees and fellowship support from Medtronic, and has also received fees from Abbott, Biosense Webster, Biotronik, and Pfizer, and he has also received fellowship support from Biotronik and Boston Scientific. Dr. Kowal is a Medtronic employee.

[email protected]

The U.S. Food and Drug Administration’s approval of an expanded indication for a leadless pacemaker for patients “who may benefit from maintenance of atrioventricular synchrony” will make this technology potentially available to nearly half of the Americans who need a pacemaker, roughly triple the number of patients who have been candidates for a leadless pacemaker up to now.

Mitchel L. Zoler/MDedge News

“This approval was huge. The complication rate with leadless pacemakers has been 63% less than the rate using pacemakers with transvenous leads,” said Larry A. Chinitz, MD, a cardiac electrophysiologist and a coinvestigator on some of the studies that led to the new indication. By expanding the types of patients suitable for leadless pacing “we’ll achieve AV [atrioventricular] synchrony in more patients with fewer complications,” said Dr. Chinitz, professor of medicine and director of the Cardiac Electrophysiology and Heart Rhythm Center at NYU Langone Health in New York.

Because the device is both leadless and requires no pocket owing to its small size and placement in a patient’s right ventricle, it has implications for potentially broadening the population that could benefit from the device, he said in an interview. “When we started with this pacemaker, it was limited to elderly patients with persistent atrial fibrillation who needed only ventricular pacing, a very small group,” just under 15% of the universe of patients who need pacemakers. The broadened indication, for patients with high-grade AV block who also have atrial function, makes it possible to think of using this safer and easier-to-place device in patients who need infrequent pacing, and in patients with multiple comorbidities that give them an increased complication risk, he said. The new indication means “you’re treating a much broader patient population, doing it more safely, and creating the foundation for expanding this technology.”

The Micra AV pacemaker uses the same basic design as the previously approved Micra Transcatheter Pacing System, which came onto the U.S. market in 2016 and provides single-chamber pacing. An accelerometer on the device allows it to detect atrial motion and thereby synchronize ventricular and atrial contractions, which led to the new indication. Although the Micra AV device looks similar to the original single-chamber model, it has an entirely new circuitry that prolongs battery life during dual-chamber pacing as well as new software that incorporates the accelerometer data, explained Robert Kowal, MD, a cardiac electrophysiologist, and vice president of medical affairs and chief medical officer of cardiac rhythm and heart failure at Medtronic in Minneapolis. The battery of the Micra AV is designed to last about 15 years, Dr. Chinitz noted.

Results from two studies that Dr. Chinitz helped run established the safety and efficacy of the device for dual-chamber pacing. The MARVEL (Micra Atrial Tracking Using a Ventricular Accelerometer) study included 64 patients who completed the study at 12 worldwide centers, which produced an average 80% AV synchrony in 33 patients with high-degree AV block (The other patients in the study had predominantly intrinsic AV conduction; Heart Rhythm. 2018 Sep;15[9]:1363-71). The MARVEL 2 study included 75 patients with either second- or third-degree AV block at 12 worldwide centers and showed that AV synchrony increased from an average of 27% without two-chamber pacing to 89% with the dual-chamber function turned on, and with 95% of patients achieving at least 70% AV synchrony (JACC Clin Electrophysiol. 2020 Jan;6[1]:94-106).

The 2016 indication for single-chamber pacing included patients with “high-grade” AV bloc with or without atrial fibrillation, typically patients for whom dual-chamber pacemaker was not a great option because of the risks for complication but with the downside of limited AV synchrony, a limitation now mitigated by the option of mechanical synchronization, Dr. Kowal said. The AV device remains intended for patients with high-grade AV node block, which means patients with second- or third-degree block, he added in an interview. The estimated prevalence of third-degree AV block among U.S. adults is about 0.02%, which translates into about 50,000 people; the estimated prevalence of second-degree AV block is much less, about 10% of the third-degree prevalence.

Despite the substantial cut in complications by a leadless and pocketless pacemaker, “some patients may still benefit from a traditional dual-chamber pacemaker,” specifically active patients who might sometimes get their heart rates up with exercise to levels of about 150 beats/min or higher, Dr. Kowal said. That’s because currently the programing algorithms used to synchronize the ventricle and atrium become less reliable at heart rates above 105 beats/min, he explained. However, the ability for mechanical synchronization to keep up at higher heart rates should improve as additional data are collected that can refine the algorithms. It’s also unusual for most patients who are pacemaker candidates to reach heart rates this high, he said.

The MARVEL and MARVEL 2 studies were sponsored by Medtronic, the company that markets Micra pacemakers. Dr. Chinitz has received fees and fellowship support from Medtronic, and has also received fees from Abbott, Biosense Webster, Biotronik, and Pfizer, and he has also received fellowship support from Biotronik and Boston Scientific. Dr. Kowal is a Medtronic employee.

[email protected]

The U.S. Food and Drug Administration’s approval of an expanded indication for a leadless pacemaker for patients “who may benefit from maintenance of atrioventricular synchrony” will make this technology potentially available to nearly half of the Americans who need a pacemaker, roughly triple the number of patients who have been candidates for a leadless pacemaker up to now.

Mitchel L. Zoler/MDedge News

“This approval was huge. The complication rate with leadless pacemakers has been 63% less than the rate using pacemakers with transvenous leads,” said Larry A. Chinitz, MD, a cardiac electrophysiologist and a coinvestigator on some of the studies that led to the new indication. By expanding the types of patients suitable for leadless pacing “we’ll achieve AV [atrioventricular] synchrony in more patients with fewer complications,” said Dr. Chinitz, professor of medicine and director of the Cardiac Electrophysiology and Heart Rhythm Center at NYU Langone Health in New York.

Because the device is both leadless and requires no pocket owing to its small size and placement in a patient’s right ventricle, it has implications for potentially broadening the population that could benefit from the device, he said in an interview. “When we started with this pacemaker, it was limited to elderly patients with persistent atrial fibrillation who needed only ventricular pacing, a very small group,” just under 15% of the universe of patients who need pacemakers. The broadened indication, for patients with high-grade AV block who also have atrial function, makes it possible to think of using this safer and easier-to-place device in patients who need infrequent pacing, and in patients with multiple comorbidities that give them an increased complication risk, he said. The new indication means “you’re treating a much broader patient population, doing it more safely, and creating the foundation for expanding this technology.”

The Micra AV pacemaker uses the same basic design as the previously approved Micra Transcatheter Pacing System, which came onto the U.S. market in 2016 and provides single-chamber pacing. An accelerometer on the device allows it to detect atrial motion and thereby synchronize ventricular and atrial contractions, which led to the new indication. Although the Micra AV device looks similar to the original single-chamber model, it has an entirely new circuitry that prolongs battery life during dual-chamber pacing as well as new software that incorporates the accelerometer data, explained Robert Kowal, MD, a cardiac electrophysiologist, and vice president of medical affairs and chief medical officer of cardiac rhythm and heart failure at Medtronic in Minneapolis. The battery of the Micra AV is designed to last about 15 years, Dr. Chinitz noted.

Results from two studies that Dr. Chinitz helped run established the safety and efficacy of the device for dual-chamber pacing. The MARVEL (Micra Atrial Tracking Using a Ventricular Accelerometer) study included 64 patients who completed the study at 12 worldwide centers, which produced an average 80% AV synchrony in 33 patients with high-degree AV block (The other patients in the study had predominantly intrinsic AV conduction; Heart Rhythm. 2018 Sep;15[9]:1363-71). The MARVEL 2 study included 75 patients with either second- or third-degree AV block at 12 worldwide centers and showed that AV synchrony increased from an average of 27% without two-chamber pacing to 89% with the dual-chamber function turned on, and with 95% of patients achieving at least 70% AV synchrony (JACC Clin Electrophysiol. 2020 Jan;6[1]:94-106).

The 2016 indication for single-chamber pacing included patients with “high-grade” AV bloc with or without atrial fibrillation, typically patients for whom dual-chamber pacemaker was not a great option because of the risks for complication but with the downside of limited AV synchrony, a limitation now mitigated by the option of mechanical synchronization, Dr. Kowal said. The AV device remains intended for patients with high-grade AV node block, which means patients with second- or third-degree block, he added in an interview. The estimated prevalence of third-degree AV block among U.S. adults is about 0.02%, which translates into about 50,000 people; the estimated prevalence of second-degree AV block is much less, about 10% of the third-degree prevalence.

Despite the substantial cut in complications by a leadless and pocketless pacemaker, “some patients may still benefit from a traditional dual-chamber pacemaker,” specifically active patients who might sometimes get their heart rates up with exercise to levels of about 150 beats/min or higher, Dr. Kowal said. That’s because currently the programing algorithms used to synchronize the ventricle and atrium become less reliable at heart rates above 105 beats/min, he explained. However, the ability for mechanical synchronization to keep up at higher heart rates should improve as additional data are collected that can refine the algorithms. It’s also unusual for most patients who are pacemaker candidates to reach heart rates this high, he said.

The MARVEL and MARVEL 2 studies were sponsored by Medtronic, the company that markets Micra pacemakers. Dr. Chinitz has received fees and fellowship support from Medtronic, and has also received fees from Abbott, Biosense Webster, Biotronik, and Pfizer, and he has also received fellowship support from Biotronik and Boston Scientific. Dr. Kowal is a Medtronic employee.

[email protected]

Enrichment next-generation sequencing (NGS) provides a more cost-efficient and sensitive method for detecting and sequencing novel coronaviruses from wild bat populations, according to a study reported in mSphere, an open-access journal from the American Society for Microbiology.

Wikimedia Commons/Mickey Samuni-Blank

With the appearance of the new zoonotic Wuhan coronavirus, the importance of monitoring the likelihood of new virus risks in wildlife reservoirs has been heightened. Bats in particular have been found to be the most common reservoir of coronaviruses, including being a probable source or mixing vessel for two previous modern epidemic coronaviruses: SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome).

“We should be alert and vigilant with the knowledge that bat CoVs [coronaviruses] are likely to cause another disease outbreak, not only because of their prevalence but also because the high frequency of recombination between viruses may lead to the generation of viruses with changes in virulence,” according to Bei Li, MD, of the Wuhan (China) Institute of Virology, and colleagues.

“We previously provided serological evidence that [HKU8-related] CoV had jumped over from bats to camels and recombined with MERS-CoV, alerting other researchers that the CoV species could be dangerous. ... Genome-level comparison is needed to monitor the risk of alterations in species tropism and pathogenesis,” according to study authors. They performed a study to develop a more effective and cost efficient method for detecting and sequencing novel coronaviruses in the bat population.

The taxonomy of coronaviruses is particularly complex and may be too narrowly defined, given the high level of genetic plasticity found. There are four genera (Alpha-, Beta-, Gamma-, and Deltacoronavirus) consisting of 38 unique species in the CoV subfamily Orthocoronavirinae, and the number is increasing. Viral taxomists rely on the open reading frame 1b (ORF1b) gene for classification, but viruses in the same species may show great diversity in regions outside ORF1b, confounding the species designation. In particular, bat CoVs classed as the same species can differ significantly in terms of receptor usage or virus-host interaction, as observed in bat SARS-related CoVs, according to the researchers.

The researchers obtained RNA from previous bat CoV surveillance projects, which used bat rectal swabs. Libraries for NGS were constructed from total RNA and processed to generate RNA fragments larger than 300 nucleotides. Following first- and second-strand cDNA synthesis, double-stranded cDNA was purified and the library was amplified by polymerase chain reaction (PCR) technology.

Targeted CoV genome enrichment was achieved using 4,303 customized biotinylated 120-mer baits. These baits were designed from 90 representative CoV genomes, and in silico analysis determined that these baits should target the known CoV species tested. These baits were added and hybridized to the libraries. To capture virus-specific library fragments, streptavidin magnetic beads (which bind to biotin) were added to the hybridization reaction mixture. The beads were then washed to remove unbound DNA. The postcapture virus-specific library fragments were then amplified using a subsequent round of PCR.

The enrichment NGS were retrospectively complemented with unbiased NGS and/or additional Sanger sequencing to obtain full-length genomes. The study showed that enrichment NGS not only decreased the amount of data requiring analysis but produced full-length genome coverage in both laboratory and clinical samples.

Using this technology, the researchers “effectively reduced sequencing costs by increasing the sensitivity of detection. We discovered nine full genomes of bat CoVs in this study and revealed great genetic diversity for eight of them.” In addition, they noted that using standard targeted PCR, which is common practice for many surveillance studies, would not have discovered this diversity.

“We should be alert and vigilant with the knowledge that bat CoVs are likely to cause another disease outbreak, not only because of their prevalence but also because the high frequency of recombination between viruses may lead to the generation of viruses with changes in virulence,” according to the researchers.

“We have provided a cost-effective methodology for bat CoV surveillance. The high genetic diversity observed in our newly sequenced samples suggests further work is needed to characterize these bat CoVs prior to or in the early stages of spillover to humans,” the authors concluded.

This study was supported by the Chinese government. The authors reported that they had no conflicts.

Viral genome data for new CoVs from this study are available in GenBank under accession numbers MN611517 to MN611525.

[email protected]

SOURCE: Li B et al. mSphere 2020 Jan 29;5:e00807-19.

Enrichment next-generation sequencing (NGS) provides a more cost-efficient and sensitive method for detecting and sequencing novel coronaviruses from wild bat populations, according to a study reported in mSphere, an open-access journal from the American Society for Microbiology.

Wikimedia Commons/Mickey Samuni-Blank

With the appearance of the new zoonotic Wuhan coronavirus, the importance of monitoring the likelihood of new virus risks in wildlife reservoirs has been heightened. Bats in particular have been found to be the most common reservoir of coronaviruses, including being a probable source or mixing vessel for two previous modern epidemic coronaviruses: SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome).

“We should be alert and vigilant with the knowledge that bat CoVs [coronaviruses] are likely to cause another disease outbreak, not only because of their prevalence but also because the high frequency of recombination between viruses may lead to the generation of viruses with changes in virulence,” according to Bei Li, MD, of the Wuhan (China) Institute of Virology, and colleagues.

“We previously provided serological evidence that [HKU8-related] CoV had jumped over from bats to camels and recombined with MERS-CoV, alerting other researchers that the CoV species could be dangerous. ... Genome-level comparison is needed to monitor the risk of alterations in species tropism and pathogenesis,” according to study authors. They performed a study to develop a more effective and cost efficient method for detecting and sequencing novel coronaviruses in the bat population.

The taxonomy of coronaviruses is particularly complex and may be too narrowly defined, given the high level of genetic plasticity found. There are four genera (Alpha-, Beta-, Gamma-, and Deltacoronavirus) consisting of 38 unique species in the CoV subfamily Orthocoronavirinae, and the number is increasing. Viral taxomists rely on the open reading frame 1b (ORF1b) gene for classification, but viruses in the same species may show great diversity in regions outside ORF1b, confounding the species designation. In particular, bat CoVs classed as the same species can differ significantly in terms of receptor usage or virus-host interaction, as observed in bat SARS-related CoVs, according to the researchers.

The researchers obtained RNA from previous bat CoV surveillance projects, which used bat rectal swabs. Libraries for NGS were constructed from total RNA and processed to generate RNA fragments larger than 300 nucleotides. Following first- and second-strand cDNA synthesis, double-stranded cDNA was purified and the library was amplified by polymerase chain reaction (PCR) technology.

Targeted CoV genome enrichment was achieved using 4,303 customized biotinylated 120-mer baits. These baits were designed from 90 representative CoV genomes, and in silico analysis determined that these baits should target the known CoV species tested. These baits were added and hybridized to the libraries. To capture virus-specific library fragments, streptavidin magnetic beads (which bind to biotin) were added to the hybridization reaction mixture. The beads were then washed to remove unbound DNA. The postcapture virus-specific library fragments were then amplified using a subsequent round of PCR.

The enrichment NGS were retrospectively complemented with unbiased NGS and/or additional Sanger sequencing to obtain full-length genomes. The study showed that enrichment NGS not only decreased the amount of data requiring analysis but produced full-length genome coverage in both laboratory and clinical samples.

Using this technology, the researchers “effectively reduced sequencing costs by increasing the sensitivity of detection. We discovered nine full genomes of bat CoVs in this study and revealed great genetic diversity for eight of them.” In addition, they noted that using standard targeted PCR, which is common practice for many surveillance studies, would not have discovered this diversity.

“We should be alert and vigilant with the knowledge that bat CoVs are likely to cause another disease outbreak, not only because of their prevalence but also because the high frequency of recombination between viruses may lead to the generation of viruses with changes in virulence,” according to the researchers.

“We have provided a cost-effective methodology for bat CoV surveillance. The high genetic diversity observed in our newly sequenced samples suggests further work is needed to characterize these bat CoVs prior to or in the early stages of spillover to humans,” the authors concluded.

This study was supported by the Chinese government. The authors reported that they had no conflicts.

Viral genome data for new CoVs from this study are available in GenBank under accession numbers MN611517 to MN611525.

[email protected]

SOURCE: Li B et al. mSphere 2020 Jan 29;5:e00807-19.

Enrichment next-generation sequencing (NGS) provides a more cost-efficient and sensitive method for detecting and sequencing novel coronaviruses from wild bat populations, according to a study reported in mSphere, an open-access journal from the American Society for Microbiology.

Wikimedia Commons/Mickey Samuni-Blank

With the appearance of the new zoonotic Wuhan coronavirus, the importance of monitoring the likelihood of new virus risks in wildlife reservoirs has been heightened. Bats in particular have been found to be the most common reservoir of coronaviruses, including being a probable source or mixing vessel for two previous modern epidemic coronaviruses: SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome).

“We should be alert and vigilant with the knowledge that bat CoVs [coronaviruses] are likely to cause another disease outbreak, not only because of their prevalence but also because the high frequency of recombination between viruses may lead to the generation of viruses with changes in virulence,” according to Bei Li, MD, of the Wuhan (China) Institute of Virology, and colleagues.

“We previously provided serological evidence that [HKU8-related] CoV had jumped over from bats to camels and recombined with MERS-CoV, alerting other researchers that the CoV species could be dangerous. ... Genome-level comparison is needed to monitor the risk of alterations in species tropism and pathogenesis,” according to study authors. They performed a study to develop a more effective and cost efficient method for detecting and sequencing novel coronaviruses in the bat population.

The taxonomy of coronaviruses is particularly complex and may be too narrowly defined, given the high level of genetic plasticity found. There are four genera (Alpha-, Beta-, Gamma-, and Deltacoronavirus) consisting of 38 unique species in the CoV subfamily Orthocoronavirinae, and the number is increasing. Viral taxomists rely on the open reading frame 1b (ORF1b) gene for classification, but viruses in the same species may show great diversity in regions outside ORF1b, confounding the species designation. In particular, bat CoVs classed as the same species can differ significantly in terms of receptor usage or virus-host interaction, as observed in bat SARS-related CoVs, according to the researchers.

The researchers obtained RNA from previous bat CoV surveillance projects, which used bat rectal swabs. Libraries for NGS were constructed from total RNA and processed to generate RNA fragments larger than 300 nucleotides. Following first- and second-strand cDNA synthesis, double-stranded cDNA was purified and the library was amplified by polymerase chain reaction (PCR) technology.

Targeted CoV genome enrichment was achieved using 4,303 customized biotinylated 120-mer baits. These baits were designed from 90 representative CoV genomes, and in silico analysis determined that these baits should target the known CoV species tested. These baits were added and hybridized to the libraries. To capture virus-specific library fragments, streptavidin magnetic beads (which bind to biotin) were added to the hybridization reaction mixture. The beads were then washed to remove unbound DNA. The postcapture virus-specific library fragments were then amplified using a subsequent round of PCR.

The enrichment NGS were retrospectively complemented with unbiased NGS and/or additional Sanger sequencing to obtain full-length genomes. The study showed that enrichment NGS not only decreased the amount of data requiring analysis but produced full-length genome coverage in both laboratory and clinical samples.

Using this technology, the researchers “effectively reduced sequencing costs by increasing the sensitivity of detection. We discovered nine full genomes of bat CoVs in this study and revealed great genetic diversity for eight of them.” In addition, they noted that using standard targeted PCR, which is common practice for many surveillance studies, would not have discovered this diversity.

“We should be alert and vigilant with the knowledge that bat CoVs are likely to cause another disease outbreak, not only because of their prevalence but also because the high frequency of recombination between viruses may lead to the generation of viruses with changes in virulence,” according to the researchers.

“We have provided a cost-effective methodology for bat CoV surveillance. The high genetic diversity observed in our newly sequenced samples suggests further work is needed to characterize these bat CoVs prior to or in the early stages of spillover to humans,” the authors concluded.

This study was supported by the Chinese government. The authors reported that they had no conflicts.

Viral genome data for new CoVs from this study are available in GenBank under accession numbers MN611517 to MN611525.

[email protected]

SOURCE: Li B et al. mSphere 2020 Jan 29;5:e00807-19.

The Food and Drug Administration has approved the first drug to combat peanut allergy in children, (Palforzia, Aimmune Therapeutics), although those who take it must continue to avoid peanuts in their diets.

The peanut (Arachis hypogaea) allergen powder is also the first drug ever approved to treat a food allergy. It is not a cure, but it mitigates allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts, the FDA said in a news release.

Treatment with the oral powder, which is mixed into semisolid food – such as applesauce or yogurt – can be started in children aged 4 through 17 years who have a confirmed peanut allergy and then continued as a maintenance medication. Some 1 million American children have peanut allergy, and only a fifth will outgrow the allergy, the agency said.

“Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the statement.

An FDA advisory panel backed the medication in September 2019, but some committee members expressed concern about the large number of children in clinical trials who required epinephrine after receiving a dose of Palforzia.

The initial dose phase is given on a single day, while updosing consists of 11 increasing doses over several months. If the patient tolerates the first administration of an increased dose level, they may continue that dose daily at home. Daily maintenance begins after the completion of all updosing levels.

The drug will carry a boxed warning on the risk of anaphylaxis with the drug, and the FDA is requiring a Risk Evaluation and Mitigation Strategy (REMS).

Palforzia will be available only through specially certified health care providers, health care settings, and pharmacies to patients enrolled in the REMS program, the agency said. Also, the initial dose escalation and first dose of each updosing level can be given only in a certified setting.

The agency said that patients or parents or caregivers must be counseled on the need for constant availability of injectable epinephrine, the need for continued dietary peanut avoidance, and on how to recognize the signs and symptoms of anaphylaxis.

‘Eagerly’ awaited

Palforzia’s effectiveness was based on a randomized, double-blind, placebo-controlled study involving about 500 peanut-allergic individuals that found that 67.2% of allergic patients tolerated an oral challenge with a single 600-mg dose of peanut protein with no more than mild allergic symptoms after 6 months of maintenance treatment, compared with 4% of placebo recipients, the FDA said.

In two double-blind, placebo-controlled studies looking at safety, the most commonly reported side effects among about 700 individuals involved in the research were abdominal pain, vomiting, nausea, tingling in the mouth, itching (including in the mouth and ears), cough, runny nose, throat irritation and tightness, hives, wheezing and shortness of breath, and anaphylaxis.

Palforzia should not be given to those with uncontrolled asthma and can’t be used for emergency treatment of allergic reactions, including anaphylaxis.

“The food allergy community has been eagerly awaiting an FDA-approved treatment that can help mitigate allergic reactions to peanut and, as allergists, we want nothing more than to have a treatment option to offer our patients that has demonstrated both the safety and efficacy to truly impact the lives of patients who live with peanut allergy,” said Christina Ciaccio, MD, chief of Allergy/Immunology and Pediatric Pulmonary Medicine at the University of Chicago Medical Center and Biological Sciences, in a company statement from Aimmune. “With today’s approval of Palforzia, we can – for the first time – offer children and teens with peanut allergy a proven medicine that employs an established therapeutic approach.”

This article first appeared on Medscape.com.

The Food and Drug Administration has approved the first drug to combat peanut allergy in children, (Palforzia, Aimmune Therapeutics), although those who take it must continue to avoid peanuts in their diets.

The peanut (Arachis hypogaea) allergen powder is also the first drug ever approved to treat a food allergy. It is not a cure, but it mitigates allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts, the FDA said in a news release.

Treatment with the oral powder, which is mixed into semisolid food – such as applesauce or yogurt – can be started in children aged 4 through 17 years who have a confirmed peanut allergy and then continued as a maintenance medication. Some 1 million American children have peanut allergy, and only a fifth will outgrow the allergy, the agency said.

“Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the statement.

An FDA advisory panel backed the medication in September 2019, but some committee members expressed concern about the large number of children in clinical trials who required epinephrine after receiving a dose of Palforzia.

The initial dose phase is given on a single day, while updosing consists of 11 increasing doses over several months. If the patient tolerates the first administration of an increased dose level, they may continue that dose daily at home. Daily maintenance begins after the completion of all updosing levels.

The drug will carry a boxed warning on the risk of anaphylaxis with the drug, and the FDA is requiring a Risk Evaluation and Mitigation Strategy (REMS).

Palforzia will be available only through specially certified health care providers, health care settings, and pharmacies to patients enrolled in the REMS program, the agency said. Also, the initial dose escalation and first dose of each updosing level can be given only in a certified setting.

The agency said that patients or parents or caregivers must be counseled on the need for constant availability of injectable epinephrine, the need for continued dietary peanut avoidance, and on how to recognize the signs and symptoms of anaphylaxis.

‘Eagerly’ awaited

Palforzia’s effectiveness was based on a randomized, double-blind, placebo-controlled study involving about 500 peanut-allergic individuals that found that 67.2% of allergic patients tolerated an oral challenge with a single 600-mg dose of peanut protein with no more than mild allergic symptoms after 6 months of maintenance treatment, compared with 4% of placebo recipients, the FDA said.

In two double-blind, placebo-controlled studies looking at safety, the most commonly reported side effects among about 700 individuals involved in the research were abdominal pain, vomiting, nausea, tingling in the mouth, itching (including in the mouth and ears), cough, runny nose, throat irritation and tightness, hives, wheezing and shortness of breath, and anaphylaxis.

Palforzia should not be given to those with uncontrolled asthma and can’t be used for emergency treatment of allergic reactions, including anaphylaxis.

“The food allergy community has been eagerly awaiting an FDA-approved treatment that can help mitigate allergic reactions to peanut and, as allergists, we want nothing more than to have a treatment option to offer our patients that has demonstrated both the safety and efficacy to truly impact the lives of patients who live with peanut allergy,” said Christina Ciaccio, MD, chief of Allergy/Immunology and Pediatric Pulmonary Medicine at the University of Chicago Medical Center and Biological Sciences, in a company statement from Aimmune. “With today’s approval of Palforzia, we can – for the first time – offer children and teens with peanut allergy a proven medicine that employs an established therapeutic approach.”

This article first appeared on Medscape.com.

The Food and Drug Administration has approved the first drug to combat peanut allergy in children, (Palforzia, Aimmune Therapeutics), although those who take it must continue to avoid peanuts in their diets.

The peanut (Arachis hypogaea) allergen powder is also the first drug ever approved to treat a food allergy. It is not a cure, but it mitigates allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts, the FDA said in a news release.

Treatment with the oral powder, which is mixed into semisolid food – such as applesauce or yogurt – can be started in children aged 4 through 17 years who have a confirmed peanut allergy and then continued as a maintenance medication. Some 1 million American children have peanut allergy, and only a fifth will outgrow the allergy, the agency said.

“Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the statement.

An FDA advisory panel backed the medication in September 2019, but some committee members expressed concern about the large number of children in clinical trials who required epinephrine after receiving a dose of Palforzia.

The initial dose phase is given on a single day, while updosing consists of 11 increasing doses over several months. If the patient tolerates the first administration of an increased dose level, they may continue that dose daily at home. Daily maintenance begins after the completion of all updosing levels.

The drug will carry a boxed warning on the risk of anaphylaxis with the drug, and the FDA is requiring a Risk Evaluation and Mitigation Strategy (REMS).

Palforzia will be available only through specially certified health care providers, health care settings, and pharmacies to patients enrolled in the REMS program, the agency said. Also, the initial dose escalation and first dose of each updosing level can be given only in a certified setting.

The agency said that patients or parents or caregivers must be counseled on the need for constant availability of injectable epinephrine, the need for continued dietary peanut avoidance, and on how to recognize the signs and symptoms of anaphylaxis.

‘Eagerly’ awaited

Palforzia’s effectiveness was based on a randomized, double-blind, placebo-controlled study involving about 500 peanut-allergic individuals that found that 67.2% of allergic patients tolerated an oral challenge with a single 600-mg dose of peanut protein with no more than mild allergic symptoms after 6 months of maintenance treatment, compared with 4% of placebo recipients, the FDA said.

In two double-blind, placebo-controlled studies looking at safety, the most commonly reported side effects among about 700 individuals involved in the research were abdominal pain, vomiting, nausea, tingling in the mouth, itching (including in the mouth and ears), cough, runny nose, throat irritation and tightness, hives, wheezing and shortness of breath, and anaphylaxis.

Palforzia should not be given to those with uncontrolled asthma and can’t be used for emergency treatment of allergic reactions, including anaphylaxis.

“The food allergy community has been eagerly awaiting an FDA-approved treatment that can help mitigate allergic reactions to peanut and, as allergists, we want nothing more than to have a treatment option to offer our patients that has demonstrated both the safety and efficacy to truly impact the lives of patients who live with peanut allergy,” said Christina Ciaccio, MD, chief of Allergy/Immunology and Pediatric Pulmonary Medicine at the University of Chicago Medical Center and Biological Sciences, in a company statement from Aimmune. “With today’s approval of Palforzia, we can – for the first time – offer children and teens with peanut allergy a proven medicine that employs an established therapeutic approach.”

This article first appeared on Medscape.com.

The federal government declared a formal public health emergency on Jan. 31 to aid in the response to the 2019 Novel Coronavirus (2019-nCoV). The declaration, issued by Health and Human Services Secretary Alex. M. Azar II gives state, tribal, and local health departments additional flexibility to request assistance from the federal government in responding to the coronavirus.

"While this virus poses a serious public health threat, the risk to the American public remains low at this time, and we are working to keep this risk low."*

The government also began a quarantine of travelers. The 195 passengers who arrived at March Air Reserve Base in Ontario, Calif., from Wuhan, China on Jan. 29 are under federal quarantine amid growing concerns about the 2019-nCoV—the first such action taken by the Centers for Disease Control and Prevention in more than 50 years.

“This decision is based on the current scientific facts,” Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, said during a press briefing Jan. 31. “While we understand the action seems drastic, our goal today, tomorrow, and always continues to be the safety of the American public. We would rather be remembered for over-reacting than under-reacting.”

These actions come on the heels of the World Health Organization’s Jan. 30 declaration of 2019-nCoV as a public health emergency of international concern, and from a recent spike in cases reported by Chinese health officials. “Every day this week China has reported additional cases,” Dr. Messonnier said. “Today’s numbers are a 26% increase since yesterday. Over the course of the last week, there have been nearly 7,000 new cases reported. This tells us the virus is continuing to spread rapidly in China. The reported deaths have continued to rise as well. In addition, locations outside China have continued to report cases. There have been an increasing number of reports of person-to-person spread, and now, most recently, a report in the New England Journal of Medicine of asymptomatic spread.”

The quarantine of passengers will last 14 days from when the plane left Wuhan, China. Martin Cetron, MD, who directs the CDC’s Division of Global Migration and Quarantine, said that the quarantine order “offers the greatest level of protection for the American public in preventing introduction and spread. That is our primary concern. Prior epidemics suggest that when people are properly informed, they’re usually very compliant with this request to restrict their movement. This allows someone who would become symptomatic to be rapidly identified. Offering early, rapid diagnosis of their illness could alleviate a lot of anxiety and uncertainty. In addition, this is a protective effect on family members. No individual wants to be the source of introducing or exposing a family member or a loved one to their virus. Additionally, this is part of their civic responsibility to protect their communities.”

[email protected]

* This story was updated on 01/31/2020. 

The federal government declared a formal public health emergency on Jan. 31 to aid in the response to the 2019 Novel Coronavirus (2019-nCoV). The declaration, issued by Health and Human Services Secretary Alex. M. Azar II gives state, tribal, and local health departments additional flexibility to request assistance from the federal government in responding to the coronavirus.

"While this virus poses a serious public health threat, the risk to the American public remains low at this time, and we are working to keep this risk low."*

The government also began a quarantine of travelers. The 195 passengers who arrived at March Air Reserve Base in Ontario, Calif., from Wuhan, China on Jan. 29 are under federal quarantine amid growing concerns about the 2019-nCoV—the first such action taken by the Centers for Disease Control and Prevention in more than 50 years.

“This decision is based on the current scientific facts,” Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, said during a press briefing Jan. 31. “While we understand the action seems drastic, our goal today, tomorrow, and always continues to be the safety of the American public. We would rather be remembered for over-reacting than under-reacting.”

These actions come on the heels of the World Health Organization’s Jan. 30 declaration of 2019-nCoV as a public health emergency of international concern, and from a recent spike in cases reported by Chinese health officials. “Every day this week China has reported additional cases,” Dr. Messonnier said. “Today’s numbers are a 26% increase since yesterday. Over the course of the last week, there have been nearly 7,000 new cases reported. This tells us the virus is continuing to spread rapidly in China. The reported deaths have continued to rise as well. In addition, locations outside China have continued to report cases. There have been an increasing number of reports of person-to-person spread, and now, most recently, a report in the New England Journal of Medicine of asymptomatic spread.”

The quarantine of passengers will last 14 days from when the plane left Wuhan, China. Martin Cetron, MD, who directs the CDC’s Division of Global Migration and Quarantine, said that the quarantine order “offers the greatest level of protection for the American public in preventing introduction and spread. That is our primary concern. Prior epidemics suggest that when people are properly informed, they’re usually very compliant with this request to restrict their movement. This allows someone who would become symptomatic to be rapidly identified. Offering early, rapid diagnosis of their illness could alleviate a lot of anxiety and uncertainty. In addition, this is a protective effect on family members. No individual wants to be the source of introducing or exposing a family member or a loved one to their virus. Additionally, this is part of their civic responsibility to protect their communities.”

[email protected]

* This story was updated on 01/31/2020. 

The federal government declared a formal public health emergency on Jan. 31 to aid in the response to the 2019 Novel Coronavirus (2019-nCoV). The declaration, issued by Health and Human Services Secretary Alex. M. Azar II gives state, tribal, and local health departments additional flexibility to request assistance from the federal government in responding to the coronavirus.

"While this virus poses a serious public health threat, the risk to the American public remains low at this time, and we are working to keep this risk low."*

The government also began a quarantine of travelers. The 195 passengers who arrived at March Air Reserve Base in Ontario, Calif., from Wuhan, China on Jan. 29 are under federal quarantine amid growing concerns about the 2019-nCoV—the first such action taken by the Centers for Disease Control and Prevention in more than 50 years.

“This decision is based on the current scientific facts,” Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, said during a press briefing Jan. 31. “While we understand the action seems drastic, our goal today, tomorrow, and always continues to be the safety of the American public. We would rather be remembered for over-reacting than under-reacting.”

These actions come on the heels of the World Health Organization’s Jan. 30 declaration of 2019-nCoV as a public health emergency of international concern, and from a recent spike in cases reported by Chinese health officials. “Every day this week China has reported additional cases,” Dr. Messonnier said. “Today’s numbers are a 26% increase since yesterday. Over the course of the last week, there have been nearly 7,000 new cases reported. This tells us the virus is continuing to spread rapidly in China. The reported deaths have continued to rise as well. In addition, locations outside China have continued to report cases. There have been an increasing number of reports of person-to-person spread, and now, most recently, a report in the New England Journal of Medicine of asymptomatic spread.”

The quarantine of passengers will last 14 days from when the plane left Wuhan, China. Martin Cetron, MD, who directs the CDC’s Division of Global Migration and Quarantine, said that the quarantine order “offers the greatest level of protection for the American public in preventing introduction and spread. That is our primary concern. Prior epidemics suggest that when people are properly informed, they’re usually very compliant with this request to restrict their movement. This allows someone who would become symptomatic to be rapidly identified. Offering early, rapid diagnosis of their illness could alleviate a lot of anxiety and uncertainty. In addition, this is a protective effect on family members. No individual wants to be the source of introducing or exposing a family member or a loved one to their virus. Additionally, this is part of their civic responsibility to protect their communities.”

[email protected]

* This story was updated on 01/31/2020.