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Weight-related COVID-19 severity starts in normal BMI range, especially in young
The risk of severe outcomes with COVID-19 increases with excess weight in a linear manner beginning in normal body mass index ranges, with the effect apparently independent of obesity-related diseases such as diabetes, and stronger among younger people and Black persons, new research shows.
“Even a small increase in body mass index above 23 kg/m² is a risk factor for adverse outcomes after infection with SARS-CoV-2,” the authors reported.
“Excess weight is a modifiable risk factor and investment in the treatment of overweight and obesity, and long-term preventive strategies could help reduce the severity of COVID-19 disease,” they wrote.
The findings shed important new light in the ongoing efforts to understand COVID-19 effects, Krishnan Bhaskaran, PhD, said in an interview.
“These results confirm and add detail to the established links between overweight and obesity and COVID-19, and also add new information on risks among people with low BMI levels,” said Dr. Bhaskaran, an epidemiologist at the London School of Hygiene & Tropical Medicine, who authored an accompanying editorial.
Obesity has been well established as a major risk factor for poor outcomes among people with COVID-19; however, less is known about the risk of severe outcomes over the broader spectrum of excess weight, and its relationship with other factors.
For the prospective, community-based study, Carmen Piernas, PhD, of the University of Oxford (England) and colleagues evaluated data on nearly 7 million individuals registered in the U.K. QResearch database during Jan. 24–April 30, 2020.
Overall, patients had a mean BMI of 27 kg/m². Among them, 13,503 (.20%) were admitted to the hospital during the study period, 1,601 (.02%) were admitted to an ICU and 5,479 (.08%) died after testing positive for SARS-CoV-2.
Risk rises from BMI of 23 kg/m²
In looking at the risk of hospital admission with COVID-19, the authors found a J-shaped relationship with BMI, with the risk increased with a BMI of 20 kg/m² or lower, as well as an increased risk beginning with a BMI of 23 kg/m² – considered normal weight – or higher (hazard ratio, 1.05).
The risk of death from COVID-19 was also J-shaped, however the association with increases in BMI started higher – at 28 kg/m² (adjusted HR 1.04).
In terms of the risk of ICU admission with COVID-19, the curve was not J-shaped, with just a linear association of admission with increasing BMI beginning at 23 kg/m2 (adjusted HR 1.10).
“It was surprising to see that the lowest risk of severe COVID-19 was found at a BMI of 23, and each extra BMI unit was associated with significantly higher risk, but we don’t really know yet what the reason is for this,” Dr. Piernas said in an interview.
The association between increasing BMI and risk of hospital admission for COVID-19 beginning at a BMI of 23 kg/m² was more significant among younger people aged 20-39 years than in those aged 80-100 years, with an adjusted HR for hospital admission per BMI unit above 23 kg/m² of 1.09 versus 1.01 (P < .0001).
In addition, the risk associated with BMI and hospital admission was stronger in people who were Black, compared with those who were White (1.07 vs. 1.04), as was the risk of death due to COVID-19 (1.08 vs. 1.04; P < .0001 for both).
“For the risk of death, Blacks have an 8% higher risk with each extra BMI unit, whereas Whites have a 4% increase, which is half the risk,” Dr. Piernas said.
Notably, the increased risks of hospital admission and ICU due to COVID-19 seen with increases in BMI were slightly lower among people with type 2 diabetes, hypertension, and cardiovascular disease compared with patients who did not have those comorbidities, suggesting the association with BMI is not explained by those risk factors.
Dr. Piernas speculated that the effect could reflect that people with diabetes or cardiovascular disease already have a preexisting condition which makes them more susceptible to SARS-CoV-2.
Hence, “the association with BMI in this group may not be as strong as the association found among those without those conditions, in which BMI explains a higher proportion of this increased risk, given the absence of these preexisting conditions.”
Similarly, the effect of BMI on COVID-19 outcomes in younger patients may appear stronger because their rates of other comorbidities are much lower than in older patients.
“Among older people, preexisting conditions and perhaps a weaker immune system may explain their much higher rates of severe COVID outcomes,” Dr. Piernas noted.
Furthermore, older patients may have frailty and high comorbidities that could explain their lower rates of ICU admission with COVID-19, Dr. Bhaskaran added in further comments.
The findings overall underscore that excess weight can represent a risk in COVID-19 outcomes that is, importantly, modifiable, and “suggest that supporting people to reach and maintain a healthy weight is likely to help people reduce their risk of experiencing severe outcomes from this disease, now or in any future waves,” he concluded.
Dr. Piernas and Dr. Bhaskaran had no disclosures to report. Coauthors’ disclosures are detailed in the published study.
The risk of severe outcomes with COVID-19 increases with excess weight in a linear manner beginning in normal body mass index ranges, with the effect apparently independent of obesity-related diseases such as diabetes, and stronger among younger people and Black persons, new research shows.
“Even a small increase in body mass index above 23 kg/m² is a risk factor for adverse outcomes after infection with SARS-CoV-2,” the authors reported.
“Excess weight is a modifiable risk factor and investment in the treatment of overweight and obesity, and long-term preventive strategies could help reduce the severity of COVID-19 disease,” they wrote.
The findings shed important new light in the ongoing efforts to understand COVID-19 effects, Krishnan Bhaskaran, PhD, said in an interview.
“These results confirm and add detail to the established links between overweight and obesity and COVID-19, and also add new information on risks among people with low BMI levels,” said Dr. Bhaskaran, an epidemiologist at the London School of Hygiene & Tropical Medicine, who authored an accompanying editorial.
Obesity has been well established as a major risk factor for poor outcomes among people with COVID-19; however, less is known about the risk of severe outcomes over the broader spectrum of excess weight, and its relationship with other factors.
For the prospective, community-based study, Carmen Piernas, PhD, of the University of Oxford (England) and colleagues evaluated data on nearly 7 million individuals registered in the U.K. QResearch database during Jan. 24–April 30, 2020.
Overall, patients had a mean BMI of 27 kg/m². Among them, 13,503 (.20%) were admitted to the hospital during the study period, 1,601 (.02%) were admitted to an ICU and 5,479 (.08%) died after testing positive for SARS-CoV-2.
Risk rises from BMI of 23 kg/m²
In looking at the risk of hospital admission with COVID-19, the authors found a J-shaped relationship with BMI, with the risk increased with a BMI of 20 kg/m² or lower, as well as an increased risk beginning with a BMI of 23 kg/m² – considered normal weight – or higher (hazard ratio, 1.05).
The risk of death from COVID-19 was also J-shaped, however the association with increases in BMI started higher – at 28 kg/m² (adjusted HR 1.04).
In terms of the risk of ICU admission with COVID-19, the curve was not J-shaped, with just a linear association of admission with increasing BMI beginning at 23 kg/m2 (adjusted HR 1.10).
“It was surprising to see that the lowest risk of severe COVID-19 was found at a BMI of 23, and each extra BMI unit was associated with significantly higher risk, but we don’t really know yet what the reason is for this,” Dr. Piernas said in an interview.
The association between increasing BMI and risk of hospital admission for COVID-19 beginning at a BMI of 23 kg/m² was more significant among younger people aged 20-39 years than in those aged 80-100 years, with an adjusted HR for hospital admission per BMI unit above 23 kg/m² of 1.09 versus 1.01 (P < .0001).
In addition, the risk associated with BMI and hospital admission was stronger in people who were Black, compared with those who were White (1.07 vs. 1.04), as was the risk of death due to COVID-19 (1.08 vs. 1.04; P < .0001 for both).
“For the risk of death, Blacks have an 8% higher risk with each extra BMI unit, whereas Whites have a 4% increase, which is half the risk,” Dr. Piernas said.
Notably, the increased risks of hospital admission and ICU due to COVID-19 seen with increases in BMI were slightly lower among people with type 2 diabetes, hypertension, and cardiovascular disease compared with patients who did not have those comorbidities, suggesting the association with BMI is not explained by those risk factors.
Dr. Piernas speculated that the effect could reflect that people with diabetes or cardiovascular disease already have a preexisting condition which makes them more susceptible to SARS-CoV-2.
Hence, “the association with BMI in this group may not be as strong as the association found among those without those conditions, in which BMI explains a higher proportion of this increased risk, given the absence of these preexisting conditions.”
Similarly, the effect of BMI on COVID-19 outcomes in younger patients may appear stronger because their rates of other comorbidities are much lower than in older patients.
“Among older people, preexisting conditions and perhaps a weaker immune system may explain their much higher rates of severe COVID outcomes,” Dr. Piernas noted.
Furthermore, older patients may have frailty and high comorbidities that could explain their lower rates of ICU admission with COVID-19, Dr. Bhaskaran added in further comments.
The findings overall underscore that excess weight can represent a risk in COVID-19 outcomes that is, importantly, modifiable, and “suggest that supporting people to reach and maintain a healthy weight is likely to help people reduce their risk of experiencing severe outcomes from this disease, now or in any future waves,” he concluded.
Dr. Piernas and Dr. Bhaskaran had no disclosures to report. Coauthors’ disclosures are detailed in the published study.
The risk of severe outcomes with COVID-19 increases with excess weight in a linear manner beginning in normal body mass index ranges, with the effect apparently independent of obesity-related diseases such as diabetes, and stronger among younger people and Black persons, new research shows.
“Even a small increase in body mass index above 23 kg/m² is a risk factor for adverse outcomes after infection with SARS-CoV-2,” the authors reported.
“Excess weight is a modifiable risk factor and investment in the treatment of overweight and obesity, and long-term preventive strategies could help reduce the severity of COVID-19 disease,” they wrote.
The findings shed important new light in the ongoing efforts to understand COVID-19 effects, Krishnan Bhaskaran, PhD, said in an interview.
“These results confirm and add detail to the established links between overweight and obesity and COVID-19, and also add new information on risks among people with low BMI levels,” said Dr. Bhaskaran, an epidemiologist at the London School of Hygiene & Tropical Medicine, who authored an accompanying editorial.
Obesity has been well established as a major risk factor for poor outcomes among people with COVID-19; however, less is known about the risk of severe outcomes over the broader spectrum of excess weight, and its relationship with other factors.
For the prospective, community-based study, Carmen Piernas, PhD, of the University of Oxford (England) and colleagues evaluated data on nearly 7 million individuals registered in the U.K. QResearch database during Jan. 24–April 30, 2020.
Overall, patients had a mean BMI of 27 kg/m². Among them, 13,503 (.20%) were admitted to the hospital during the study period, 1,601 (.02%) were admitted to an ICU and 5,479 (.08%) died after testing positive for SARS-CoV-2.
Risk rises from BMI of 23 kg/m²
In looking at the risk of hospital admission with COVID-19, the authors found a J-shaped relationship with BMI, with the risk increased with a BMI of 20 kg/m² or lower, as well as an increased risk beginning with a BMI of 23 kg/m² – considered normal weight – or higher (hazard ratio, 1.05).
The risk of death from COVID-19 was also J-shaped, however the association with increases in BMI started higher – at 28 kg/m² (adjusted HR 1.04).
In terms of the risk of ICU admission with COVID-19, the curve was not J-shaped, with just a linear association of admission with increasing BMI beginning at 23 kg/m2 (adjusted HR 1.10).
“It was surprising to see that the lowest risk of severe COVID-19 was found at a BMI of 23, and each extra BMI unit was associated with significantly higher risk, but we don’t really know yet what the reason is for this,” Dr. Piernas said in an interview.
The association between increasing BMI and risk of hospital admission for COVID-19 beginning at a BMI of 23 kg/m² was more significant among younger people aged 20-39 years than in those aged 80-100 years, with an adjusted HR for hospital admission per BMI unit above 23 kg/m² of 1.09 versus 1.01 (P < .0001).
In addition, the risk associated with BMI and hospital admission was stronger in people who were Black, compared with those who were White (1.07 vs. 1.04), as was the risk of death due to COVID-19 (1.08 vs. 1.04; P < .0001 for both).
“For the risk of death, Blacks have an 8% higher risk with each extra BMI unit, whereas Whites have a 4% increase, which is half the risk,” Dr. Piernas said.
Notably, the increased risks of hospital admission and ICU due to COVID-19 seen with increases in BMI were slightly lower among people with type 2 diabetes, hypertension, and cardiovascular disease compared with patients who did not have those comorbidities, suggesting the association with BMI is not explained by those risk factors.
Dr. Piernas speculated that the effect could reflect that people with diabetes or cardiovascular disease already have a preexisting condition which makes them more susceptible to SARS-CoV-2.
Hence, “the association with BMI in this group may not be as strong as the association found among those without those conditions, in which BMI explains a higher proportion of this increased risk, given the absence of these preexisting conditions.”
Similarly, the effect of BMI on COVID-19 outcomes in younger patients may appear stronger because their rates of other comorbidities are much lower than in older patients.
“Among older people, preexisting conditions and perhaps a weaker immune system may explain their much higher rates of severe COVID outcomes,” Dr. Piernas noted.
Furthermore, older patients may have frailty and high comorbidities that could explain their lower rates of ICU admission with COVID-19, Dr. Bhaskaran added in further comments.
The findings overall underscore that excess weight can represent a risk in COVID-19 outcomes that is, importantly, modifiable, and “suggest that supporting people to reach and maintain a healthy weight is likely to help people reduce their risk of experiencing severe outcomes from this disease, now or in any future waves,” he concluded.
Dr. Piernas and Dr. Bhaskaran had no disclosures to report. Coauthors’ disclosures are detailed in the published study.
FROM LANCET DIABETES & ENDOCRINOLOGY
FDA set to okay Pfizer vaccine in younger teens
The Food and Drug Administration could expand the use of the Pfizer COVID-19 vaccine to teens early next week, The New York Times and CNN reported, both citing unnamed officials familiar with the agency’s plans.
In late March, Pfizer submitted data to the FDA showing its mRNA vaccine was 100% effective at preventing COVID-19 infection in children ages 12 to 15. Their vaccine is already authorized for use teens and adults ages 16 and older.
The move would make about 17 million more Americans eligible for vaccination and would be a major step toward getting both adolescents and teens back into classrooms full time by next fall.
“Across the globe, we are longing for a normal life. This is especially true for our children. The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 U.K. variant,” Ugur Sahin, CEO and co-founder of Pfizer partner BioNTech, said in a March 31 press release.
Getting schools fully reopened for in-person learning has been a goal of both the Trump and Biden administrations, but it has been tricky to pull off, as some parents and teachers have been reluctant to return to classrooms with so much uncertainty about the risk and the role of children in spreading the virus.
A recent study of roughly 150,000 school-aged children in Israel found that while kids under age 10 were unlikely to catch or spread the virus as they reentered classrooms. Older children, though, were a different story. The study found that children ages 10-19 had risks of catching the virus that were as high as adults ages 20-60.
The risk for severe illness and death from COVID-19 rises with age.
Children and teens are at relatively low risk from severe outcomes after a COVID-19 infection compared to adults, but they can catch it and some will get really sick with it, especially if they have an underlying health condition, like obesity or asthma that makes them more vulnerable.
Beyond the initial infection, children can get a rare late complication called MIS-C, that while treatable, can be severe and requires hospitalization. Emerging reports also suggest there are some kids that become long haulers in much the same way adults do, dealing with lingering problems for months after they first get sick.
As new variants of the coronavirus circulate in the United States, some states have seen big increases in the number of children and teens with COVID. In Michigan, for example, which recently dealt with a spring surge of cases dominated by the B.1.1.7 variant, cases in children and teens quadrupled in April compared to February.
Beyond individual protection, vaccinating children and teens has been seen as important to achieving strong community protection, or herd immunity, against the new coronavirus.
If the FDA expands the authorization for the Pfizer vaccine, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will likely meet to review data on the safety and efficacy of the vaccine. The committee may then vote on new recommendations for use of the vaccine in the United States.
Not everyone agrees with the idea that American adolescents, who are at relatively low risk of bad outcomes, could get access to COVID vaccines ahead of vulnerable essential workers and seniors in other parts of the world that are still fighting the pandemic with little access to vaccines.
A version of this article first appeared on WebMD.com.
The Food and Drug Administration could expand the use of the Pfizer COVID-19 vaccine to teens early next week, The New York Times and CNN reported, both citing unnamed officials familiar with the agency’s plans.
In late March, Pfizer submitted data to the FDA showing its mRNA vaccine was 100% effective at preventing COVID-19 infection in children ages 12 to 15. Their vaccine is already authorized for use teens and adults ages 16 and older.
The move would make about 17 million more Americans eligible for vaccination and would be a major step toward getting both adolescents and teens back into classrooms full time by next fall.
“Across the globe, we are longing for a normal life. This is especially true for our children. The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 U.K. variant,” Ugur Sahin, CEO and co-founder of Pfizer partner BioNTech, said in a March 31 press release.
Getting schools fully reopened for in-person learning has been a goal of both the Trump and Biden administrations, but it has been tricky to pull off, as some parents and teachers have been reluctant to return to classrooms with so much uncertainty about the risk and the role of children in spreading the virus.
A recent study of roughly 150,000 school-aged children in Israel found that while kids under age 10 were unlikely to catch or spread the virus as they reentered classrooms. Older children, though, were a different story. The study found that children ages 10-19 had risks of catching the virus that were as high as adults ages 20-60.
The risk for severe illness and death from COVID-19 rises with age.
Children and teens are at relatively low risk from severe outcomes after a COVID-19 infection compared to adults, but they can catch it and some will get really sick with it, especially if they have an underlying health condition, like obesity or asthma that makes them more vulnerable.
Beyond the initial infection, children can get a rare late complication called MIS-C, that while treatable, can be severe and requires hospitalization. Emerging reports also suggest there are some kids that become long haulers in much the same way adults do, dealing with lingering problems for months after they first get sick.
As new variants of the coronavirus circulate in the United States, some states have seen big increases in the number of children and teens with COVID. In Michigan, for example, which recently dealt with a spring surge of cases dominated by the B.1.1.7 variant, cases in children and teens quadrupled in April compared to February.
Beyond individual protection, vaccinating children and teens has been seen as important to achieving strong community protection, or herd immunity, against the new coronavirus.
If the FDA expands the authorization for the Pfizer vaccine, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will likely meet to review data on the safety and efficacy of the vaccine. The committee may then vote on new recommendations for use of the vaccine in the United States.
Not everyone agrees with the idea that American adolescents, who are at relatively low risk of bad outcomes, could get access to COVID vaccines ahead of vulnerable essential workers and seniors in other parts of the world that are still fighting the pandemic with little access to vaccines.
A version of this article first appeared on WebMD.com.
The Food and Drug Administration could expand the use of the Pfizer COVID-19 vaccine to teens early next week, The New York Times and CNN reported, both citing unnamed officials familiar with the agency’s plans.
In late March, Pfizer submitted data to the FDA showing its mRNA vaccine was 100% effective at preventing COVID-19 infection in children ages 12 to 15. Their vaccine is already authorized for use teens and adults ages 16 and older.
The move would make about 17 million more Americans eligible for vaccination and would be a major step toward getting both adolescents and teens back into classrooms full time by next fall.
“Across the globe, we are longing for a normal life. This is especially true for our children. The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 U.K. variant,” Ugur Sahin, CEO and co-founder of Pfizer partner BioNTech, said in a March 31 press release.
Getting schools fully reopened for in-person learning has been a goal of both the Trump and Biden administrations, but it has been tricky to pull off, as some parents and teachers have been reluctant to return to classrooms with so much uncertainty about the risk and the role of children in spreading the virus.
A recent study of roughly 150,000 school-aged children in Israel found that while kids under age 10 were unlikely to catch or spread the virus as they reentered classrooms. Older children, though, were a different story. The study found that children ages 10-19 had risks of catching the virus that were as high as adults ages 20-60.
The risk for severe illness and death from COVID-19 rises with age.
Children and teens are at relatively low risk from severe outcomes after a COVID-19 infection compared to adults, but they can catch it and some will get really sick with it, especially if they have an underlying health condition, like obesity or asthma that makes them more vulnerable.
Beyond the initial infection, children can get a rare late complication called MIS-C, that while treatable, can be severe and requires hospitalization. Emerging reports also suggest there are some kids that become long haulers in much the same way adults do, dealing with lingering problems for months after they first get sick.
As new variants of the coronavirus circulate in the United States, some states have seen big increases in the number of children and teens with COVID. In Michigan, for example, which recently dealt with a spring surge of cases dominated by the B.1.1.7 variant, cases in children and teens quadrupled in April compared to February.
Beyond individual protection, vaccinating children and teens has been seen as important to achieving strong community protection, or herd immunity, against the new coronavirus.
If the FDA expands the authorization for the Pfizer vaccine, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will likely meet to review data on the safety and efficacy of the vaccine. The committee may then vote on new recommendations for use of the vaccine in the United States.
Not everyone agrees with the idea that American adolescents, who are at relatively low risk of bad outcomes, could get access to COVID vaccines ahead of vulnerable essential workers and seniors in other parts of the world that are still fighting the pandemic with little access to vaccines.
A version of this article first appeared on WebMD.com.
Patchy growth of TAVR programs leaves poorer communities behind
Inequities in the initial growth of transcatheter aortic valve replacement (TAVR) programs in American hospitals has led to less use of the transformative procedure in poorer communities, a new cross-sectional study suggests.
Using Medicare claims data, investigators identified 554 new TAVR programs created between January 2012 and December 2018.
Of these, 98% were established in metropolitan areas (>50,000 residents) and 53% were started in areas with preexisting TAVR programs, “thereby increasing the number of programs but not necessarily increasing the geographic availability of the procedure,” said study author Ashwin Nathan, MD, Hospital of the University of Pennsylvania, Philadelphia.
Only 11 programs were started in nonmetropolitan areas over the study period, he noted during the featured clinical research presentation at the Society for Cardiovascular Angiography and Interventions (SCAI) 2021 annual scientific sessions, held virtually this year.
Hospitals that established TAVR programs, compared with those that did not, cared for patients with higher median household incomes (difference, $1,305; P = .03) and from areas with better economic well-being based on the Distressed Communities Index (difference, –3.15 units; P < .01), and cared for fewer patients with dual eligibility for Medicaid (difference, –3.15%; P < .01).
When the investigators looked at rates of TAVR between the core-based statistical areas, there were fewer TAVR procedures per 100,000 Medicare beneficiaries in areas with more Medicaid dual-eligible patients (difference, –1.19% per 1% increase), lower average median household incomes (difference, –0.62% per $1,000 decrease), and more average community distress (difference, –0.35% per 1 unit increase; P < .01 for all).
“What we can conclude is that the increased number of TAVR programs that we found during the study period did not necessarily translate to increased access to TAVR ... Wealthy, more privileged patients had more access to TAVR by virtue of the hospitals that serve them,” Dr. Nathan said.
Future steps, he said, are to identify the role of race and ethnicity in inequitable access to TAVR, identify system- and patient-level barriers to access, and to develop and test solutions to address inequitable care.
Elaborating on the latter point during a discussion of the results, study coauthor Jay S. Giri, MD, MPH, also from the Hospital of the University of Pennsylvania, observed that although the data showed rural areas are left behind, not every part of an urban area acts like the area more generally.
As a result, they’re delving into the 25 largest urban areas and trying to disaggregate, based on both socioeconomic status and race within the area, whether inequities exist, he said. “Believe it or not, in some urban areas where there clearly is access – there might even be a dozen TAVR programs within a 25 mile radius – do some of those areas still act like rural areas that don’t have access? So more to come on that.”
Session comoderator Steven Yakubov, MD, MidWest Cardiology Research Foundation in Columbus, Ohio, said the results show TAVR programs tend to be developed in well-served areas but asked whether some of the responsibility falls on patients to seek medical attention. “Do we just not give enough education to patients on how to access care?”
Dr. Giri responded by highlighting the complexity of navigating from even being diagnosed with aortic stenosis to making it through a multidisciplinary TAVR evaluation.
“Individuals with increased health literacy and more means are more likely to make it through that gauntlet. But from a public health perspective, obviously, I’d argue that the onus is probably more on the medical community at large to figure out how to roll these programs out more widespread,” he said.
“It looked to us like market forces overwhelmingly seemed to drive the development of new TAVR programs over access to care considerations,” Dr. Giri added. “And just to point out, those market forces aren’t at the level of the device manufacturers, who are often maligned for cost. This is really about the market forces at the level of hospitals and health systems.”
Session comoderator Megan Coylewright, MD, MPH, Erlanger Heart and Lung Institute, Chattanooga, Tenn., said, “I think that’s really well stated,” and noted that physicians may bear some responsibility as well.
“From a physician responsibility, especially for structural heart, we tended to all aggregate together, all of us that have structural heart training or that have trained in certain institutions,” she said. “It’s certainly on us to continue to spread out and go to the communities in need to ensure access. I think, as Dr. Giri said, there are a lot of solutions and that needs to be the focus for the next couple of years.”
Dr. Nathan reported having no relevant disclosures. Dr. Giri reported serving as a principal investigator for a research study for Boston Scientific, Inari Medical, Abbott, and Recor Medical; consulting for Boston Scientific; and serving on an advisory board for Inari Medical.
A version of this article first appeared on Medscape.com.
Inequities in the initial growth of transcatheter aortic valve replacement (TAVR) programs in American hospitals has led to less use of the transformative procedure in poorer communities, a new cross-sectional study suggests.
Using Medicare claims data, investigators identified 554 new TAVR programs created between January 2012 and December 2018.
Of these, 98% were established in metropolitan areas (>50,000 residents) and 53% were started in areas with preexisting TAVR programs, “thereby increasing the number of programs but not necessarily increasing the geographic availability of the procedure,” said study author Ashwin Nathan, MD, Hospital of the University of Pennsylvania, Philadelphia.
Only 11 programs were started in nonmetropolitan areas over the study period, he noted during the featured clinical research presentation at the Society for Cardiovascular Angiography and Interventions (SCAI) 2021 annual scientific sessions, held virtually this year.
Hospitals that established TAVR programs, compared with those that did not, cared for patients with higher median household incomes (difference, $1,305; P = .03) and from areas with better economic well-being based on the Distressed Communities Index (difference, –3.15 units; P < .01), and cared for fewer patients with dual eligibility for Medicaid (difference, –3.15%; P < .01).
When the investigators looked at rates of TAVR between the core-based statistical areas, there were fewer TAVR procedures per 100,000 Medicare beneficiaries in areas with more Medicaid dual-eligible patients (difference, –1.19% per 1% increase), lower average median household incomes (difference, –0.62% per $1,000 decrease), and more average community distress (difference, –0.35% per 1 unit increase; P < .01 for all).
“What we can conclude is that the increased number of TAVR programs that we found during the study period did not necessarily translate to increased access to TAVR ... Wealthy, more privileged patients had more access to TAVR by virtue of the hospitals that serve them,” Dr. Nathan said.
Future steps, he said, are to identify the role of race and ethnicity in inequitable access to TAVR, identify system- and patient-level barriers to access, and to develop and test solutions to address inequitable care.
Elaborating on the latter point during a discussion of the results, study coauthor Jay S. Giri, MD, MPH, also from the Hospital of the University of Pennsylvania, observed that although the data showed rural areas are left behind, not every part of an urban area acts like the area more generally.
As a result, they’re delving into the 25 largest urban areas and trying to disaggregate, based on both socioeconomic status and race within the area, whether inequities exist, he said. “Believe it or not, in some urban areas where there clearly is access – there might even be a dozen TAVR programs within a 25 mile radius – do some of those areas still act like rural areas that don’t have access? So more to come on that.”
Session comoderator Steven Yakubov, MD, MidWest Cardiology Research Foundation in Columbus, Ohio, said the results show TAVR programs tend to be developed in well-served areas but asked whether some of the responsibility falls on patients to seek medical attention. “Do we just not give enough education to patients on how to access care?”
Dr. Giri responded by highlighting the complexity of navigating from even being diagnosed with aortic stenosis to making it through a multidisciplinary TAVR evaluation.
“Individuals with increased health literacy and more means are more likely to make it through that gauntlet. But from a public health perspective, obviously, I’d argue that the onus is probably more on the medical community at large to figure out how to roll these programs out more widespread,” he said.
“It looked to us like market forces overwhelmingly seemed to drive the development of new TAVR programs over access to care considerations,” Dr. Giri added. “And just to point out, those market forces aren’t at the level of the device manufacturers, who are often maligned for cost. This is really about the market forces at the level of hospitals and health systems.”
Session comoderator Megan Coylewright, MD, MPH, Erlanger Heart and Lung Institute, Chattanooga, Tenn., said, “I think that’s really well stated,” and noted that physicians may bear some responsibility as well.
“From a physician responsibility, especially for structural heart, we tended to all aggregate together, all of us that have structural heart training or that have trained in certain institutions,” she said. “It’s certainly on us to continue to spread out and go to the communities in need to ensure access. I think, as Dr. Giri said, there are a lot of solutions and that needs to be the focus for the next couple of years.”
Dr. Nathan reported having no relevant disclosures. Dr. Giri reported serving as a principal investigator for a research study for Boston Scientific, Inari Medical, Abbott, and Recor Medical; consulting for Boston Scientific; and serving on an advisory board for Inari Medical.
A version of this article first appeared on Medscape.com.
Inequities in the initial growth of transcatheter aortic valve replacement (TAVR) programs in American hospitals has led to less use of the transformative procedure in poorer communities, a new cross-sectional study suggests.
Using Medicare claims data, investigators identified 554 new TAVR programs created between January 2012 and December 2018.
Of these, 98% were established in metropolitan areas (>50,000 residents) and 53% were started in areas with preexisting TAVR programs, “thereby increasing the number of programs but not necessarily increasing the geographic availability of the procedure,” said study author Ashwin Nathan, MD, Hospital of the University of Pennsylvania, Philadelphia.
Only 11 programs were started in nonmetropolitan areas over the study period, he noted during the featured clinical research presentation at the Society for Cardiovascular Angiography and Interventions (SCAI) 2021 annual scientific sessions, held virtually this year.
Hospitals that established TAVR programs, compared with those that did not, cared for patients with higher median household incomes (difference, $1,305; P = .03) and from areas with better economic well-being based on the Distressed Communities Index (difference, –3.15 units; P < .01), and cared for fewer patients with dual eligibility for Medicaid (difference, –3.15%; P < .01).
When the investigators looked at rates of TAVR between the core-based statistical areas, there were fewer TAVR procedures per 100,000 Medicare beneficiaries in areas with more Medicaid dual-eligible patients (difference, –1.19% per 1% increase), lower average median household incomes (difference, –0.62% per $1,000 decrease), and more average community distress (difference, –0.35% per 1 unit increase; P < .01 for all).
“What we can conclude is that the increased number of TAVR programs that we found during the study period did not necessarily translate to increased access to TAVR ... Wealthy, more privileged patients had more access to TAVR by virtue of the hospitals that serve them,” Dr. Nathan said.
Future steps, he said, are to identify the role of race and ethnicity in inequitable access to TAVR, identify system- and patient-level barriers to access, and to develop and test solutions to address inequitable care.
Elaborating on the latter point during a discussion of the results, study coauthor Jay S. Giri, MD, MPH, also from the Hospital of the University of Pennsylvania, observed that although the data showed rural areas are left behind, not every part of an urban area acts like the area more generally.
As a result, they’re delving into the 25 largest urban areas and trying to disaggregate, based on both socioeconomic status and race within the area, whether inequities exist, he said. “Believe it or not, in some urban areas where there clearly is access – there might even be a dozen TAVR programs within a 25 mile radius – do some of those areas still act like rural areas that don’t have access? So more to come on that.”
Session comoderator Steven Yakubov, MD, MidWest Cardiology Research Foundation in Columbus, Ohio, said the results show TAVR programs tend to be developed in well-served areas but asked whether some of the responsibility falls on patients to seek medical attention. “Do we just not give enough education to patients on how to access care?”
Dr. Giri responded by highlighting the complexity of navigating from even being diagnosed with aortic stenosis to making it through a multidisciplinary TAVR evaluation.
“Individuals with increased health literacy and more means are more likely to make it through that gauntlet. But from a public health perspective, obviously, I’d argue that the onus is probably more on the medical community at large to figure out how to roll these programs out more widespread,” he said.
“It looked to us like market forces overwhelmingly seemed to drive the development of new TAVR programs over access to care considerations,” Dr. Giri added. “And just to point out, those market forces aren’t at the level of the device manufacturers, who are often maligned for cost. This is really about the market forces at the level of hospitals and health systems.”
Session comoderator Megan Coylewright, MD, MPH, Erlanger Heart and Lung Institute, Chattanooga, Tenn., said, “I think that’s really well stated,” and noted that physicians may bear some responsibility as well.
“From a physician responsibility, especially for structural heart, we tended to all aggregate together, all of us that have structural heart training or that have trained in certain institutions,” she said. “It’s certainly on us to continue to spread out and go to the communities in need to ensure access. I think, as Dr. Giri said, there are a lot of solutions and that needs to be the focus for the next couple of years.”
Dr. Nathan reported having no relevant disclosures. Dr. Giri reported serving as a principal investigator for a research study for Boston Scientific, Inari Medical, Abbott, and Recor Medical; consulting for Boston Scientific; and serving on an advisory board for Inari Medical.
A version of this article first appeared on Medscape.com.
FDA approves dapagliflozin (Farxiga) for chronic kidney disease
The Food and Drug Administration has approved dapagliflozin (Farxiga, AstraZeneca) to reduce the risk for kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) at risk for disease progression.
“Chronic kidney disease is an important public health issue, and there is a significant unmet need for therapies that slow disease progression and improve outcomes,” said Aliza Thompson, MD, deputy director of the division of cardiology and nephrology at the FDA’s Center for Drug Evaluation and Research. “Today’s approval of Farxiga for the treatment of chronic kidney disease is an important step forward in helping people living with kidney disease.”
Dapagliflozin was approved in 2014 to improve glycemic control in patients with diabetes mellitus, and approval was expanded in 2020 to include treatment of patients with heart failure and reduced ejection fraction, based on results of the DAPA-HF trial.
This new approval in chronic kidney disease was based on results of the DAPA-CKD trial that was stopped early in March 2020 because of efficacy of the treatment.
DAPA-CKD randomly assigned 4,304 patients with CKD but without diabetes to receive either dapagliflozin or placebo. The full study results, reported at the 2020 annual congress of the European Society of Cardiology and simultaneously published in the New England Journal of Medicine, showed that, during a median of 2.4 years, treatment with dapagliflozin led to a significant 31% relative reduction, compared with placebo in the study’s primary outcome, a composite that included at least a 50% drop in estimated glomerular filtration rate, compared with baseline, end-stage kidney disease, kidney transplant, renal death, or cardiovascular death.
Dapagliflozin treatment also cut all-cause mortality by a statistically significant relative reduction of 31%, and another secondary-endpoint analysis showed a statistically significant 29% relative reduction in the rate of cardiovascular death or heart failure hospitalization.
“Farxiga was not studied, nor is expected to be effective, in treating chronic kidney disease among patients with autosomal dominant or recessive polycystic (characterized by multiple cysts) kidney disease or among patients who require or have recently used immunosuppressive therapy to treat kidney disease,” the FDA statement noted.
Dapagliflozin should not be used by patients with a history of serious hypersensitivity reactions to this medication, or who are on dialysis, the agency added. “Serious, life-threatening cases of Fournier’s Gangrene have occurred in patients with diabetes taking Farxiga.”
Patients should consider taking a lower dose of insulin or insulin secretagogue to reduce hypoglycemic risk if they are also taking dapagliflozin. Treatment can also cause dehydration, serious urinary tract infections, genital yeast infections, and metabolic acidosis, the announcement said. “Patients should be assessed for their volume status and kidney function before starting Farxiga.”
Dapagliflozin previously received Fast Track, Breakthrough Therapy, and Priority Review designations for this new indication.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved dapagliflozin (Farxiga, AstraZeneca) to reduce the risk for kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) at risk for disease progression.
“Chronic kidney disease is an important public health issue, and there is a significant unmet need for therapies that slow disease progression and improve outcomes,” said Aliza Thompson, MD, deputy director of the division of cardiology and nephrology at the FDA’s Center for Drug Evaluation and Research. “Today’s approval of Farxiga for the treatment of chronic kidney disease is an important step forward in helping people living with kidney disease.”
Dapagliflozin was approved in 2014 to improve glycemic control in patients with diabetes mellitus, and approval was expanded in 2020 to include treatment of patients with heart failure and reduced ejection fraction, based on results of the DAPA-HF trial.
This new approval in chronic kidney disease was based on results of the DAPA-CKD trial that was stopped early in March 2020 because of efficacy of the treatment.
DAPA-CKD randomly assigned 4,304 patients with CKD but without diabetes to receive either dapagliflozin or placebo. The full study results, reported at the 2020 annual congress of the European Society of Cardiology and simultaneously published in the New England Journal of Medicine, showed that, during a median of 2.4 years, treatment with dapagliflozin led to a significant 31% relative reduction, compared with placebo in the study’s primary outcome, a composite that included at least a 50% drop in estimated glomerular filtration rate, compared with baseline, end-stage kidney disease, kidney transplant, renal death, or cardiovascular death.
Dapagliflozin treatment also cut all-cause mortality by a statistically significant relative reduction of 31%, and another secondary-endpoint analysis showed a statistically significant 29% relative reduction in the rate of cardiovascular death or heart failure hospitalization.
“Farxiga was not studied, nor is expected to be effective, in treating chronic kidney disease among patients with autosomal dominant or recessive polycystic (characterized by multiple cysts) kidney disease or among patients who require or have recently used immunosuppressive therapy to treat kidney disease,” the FDA statement noted.
Dapagliflozin should not be used by patients with a history of serious hypersensitivity reactions to this medication, or who are on dialysis, the agency added. “Serious, life-threatening cases of Fournier’s Gangrene have occurred in patients with diabetes taking Farxiga.”
Patients should consider taking a lower dose of insulin or insulin secretagogue to reduce hypoglycemic risk if they are also taking dapagliflozin. Treatment can also cause dehydration, serious urinary tract infections, genital yeast infections, and metabolic acidosis, the announcement said. “Patients should be assessed for their volume status and kidney function before starting Farxiga.”
Dapagliflozin previously received Fast Track, Breakthrough Therapy, and Priority Review designations for this new indication.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved dapagliflozin (Farxiga, AstraZeneca) to reduce the risk for kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) at risk for disease progression.
“Chronic kidney disease is an important public health issue, and there is a significant unmet need for therapies that slow disease progression and improve outcomes,” said Aliza Thompson, MD, deputy director of the division of cardiology and nephrology at the FDA’s Center for Drug Evaluation and Research. “Today’s approval of Farxiga for the treatment of chronic kidney disease is an important step forward in helping people living with kidney disease.”
Dapagliflozin was approved in 2014 to improve glycemic control in patients with diabetes mellitus, and approval was expanded in 2020 to include treatment of patients with heart failure and reduced ejection fraction, based on results of the DAPA-HF trial.
This new approval in chronic kidney disease was based on results of the DAPA-CKD trial that was stopped early in March 2020 because of efficacy of the treatment.
DAPA-CKD randomly assigned 4,304 patients with CKD but without diabetes to receive either dapagliflozin or placebo. The full study results, reported at the 2020 annual congress of the European Society of Cardiology and simultaneously published in the New England Journal of Medicine, showed that, during a median of 2.4 years, treatment with dapagliflozin led to a significant 31% relative reduction, compared with placebo in the study’s primary outcome, a composite that included at least a 50% drop in estimated glomerular filtration rate, compared with baseline, end-stage kidney disease, kidney transplant, renal death, or cardiovascular death.
Dapagliflozin treatment also cut all-cause mortality by a statistically significant relative reduction of 31%, and another secondary-endpoint analysis showed a statistically significant 29% relative reduction in the rate of cardiovascular death or heart failure hospitalization.
“Farxiga was not studied, nor is expected to be effective, in treating chronic kidney disease among patients with autosomal dominant or recessive polycystic (characterized by multiple cysts) kidney disease or among patients who require or have recently used immunosuppressive therapy to treat kidney disease,” the FDA statement noted.
Dapagliflozin should not be used by patients with a history of serious hypersensitivity reactions to this medication, or who are on dialysis, the agency added. “Serious, life-threatening cases of Fournier’s Gangrene have occurred in patients with diabetes taking Farxiga.”
Patients should consider taking a lower dose of insulin or insulin secretagogue to reduce hypoglycemic risk if they are also taking dapagliflozin. Treatment can also cause dehydration, serious urinary tract infections, genital yeast infections, and metabolic acidosis, the announcement said. “Patients should be assessed for their volume status and kidney function before starting Farxiga.”
Dapagliflozin previously received Fast Track, Breakthrough Therapy, and Priority Review designations for this new indication.
A version of this article first appeared on Medscape.com.
AHA issues new advice on managing stage 1 hypertension
Clinicians should consider the use of medication for adults with untreated stage 1 hypertension (130-139/80-89 mm Hg) whose 10-year risk for atherosclerotic cardiovascular disease is <10% and who fail to meet the blood pressure goal of <130/80 mm Hg after 6 months of guideline-based lifestyle therapy, the American Heart Association (AHA) advises in new scientific statement.
The statement was published online April 29 in Hypertension.
The recommendation complements the 2017 American College of Cardiology/American Heart Association Blood Pressure Management Guidelines, which do not fully address how to manage untreated stage 1 hypertension, the AHA says.
“There are no treatment recommendations in current guidelines for patients who are at relatively low short-term risk of heart disease when blood pressure does not drop below 130 mm Hg after six months of recommended lifestyle changes. This statement fills that gap,” Daniel W. Jones, MD, chair of the statement writing group and a past president of the AHA, said in a news release.
If after 6 months with lifestyle changes, blood pressure does not improve, lifestyle therapy should be continued and “clinicians should consider adding medications to control blood pressure,” said Dr. Jones, professor and dean emeritus, University of Mississippi, Jackson.
Healthy lifestyle changes to lower blood pressure include achieving ideal body weight, exercising (30 min of moderate to vigorous physical activity on most days, if possible), limiting dietary sodium, enhancing potassium intake, and following the Dietary Approaches to Stop Hypertension (DASH) diet, which is plentiful in fruits and vegetables with low-fat dairy products and reduced saturated fat and total fat. In addition, patients should be advised to limit alcohol intake and to not smoke.
The writing group acknowledges that these goals can be hard to achieve and maintain over time.
“It is very hard in America and most industrialized countries to limit sodium sufficiently to lower blood pressure, and it is difficult for all of us to maintain a healthy weight in what I refer to as a toxic food environment,” Dr. Jones said.
“We want clinicians to advise patients to take healthy lifestyle changes seriously and do their best. We certainly prefer to achieve blood pressure goals without adding medication; however, successfully treating high blood pressure does extend both years and quality of life,” said Dr. Jones.
The AHA statement also addresses cases in which adults were found to have hypertension during adolescence or childhood and were prescribed antihypertensive drug therapy.
In this patient population, clinicians should consider the original indications for starting antihypertensive drug treatment and the need to continue the medication and lifestyle therapy as young adults, the AHA advises.
“In young adults with stage 1 hypertension who are not controlled with lifestyle therapy, special consideration should be given to use of antihypertensive medication in individuals with a family history of premature CVD, a history of hypertension during pregnancy, or a personal history of premature birth,” the AHA states.
The scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Hypertension; the Council on the Kidney in Cardiovascular Disease; the Council on Arteriosclerosis, Thrombosis and Vascular Biology; the Council on Cardiovascular Radiology and Intervention; the Council on Lifelong Congenital Heart Disease and Heart Health in the Young; and the Stroke Council.
The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Clinicians should consider the use of medication for adults with untreated stage 1 hypertension (130-139/80-89 mm Hg) whose 10-year risk for atherosclerotic cardiovascular disease is <10% and who fail to meet the blood pressure goal of <130/80 mm Hg after 6 months of guideline-based lifestyle therapy, the American Heart Association (AHA) advises in new scientific statement.
The statement was published online April 29 in Hypertension.
The recommendation complements the 2017 American College of Cardiology/American Heart Association Blood Pressure Management Guidelines, which do not fully address how to manage untreated stage 1 hypertension, the AHA says.
“There are no treatment recommendations in current guidelines for patients who are at relatively low short-term risk of heart disease when blood pressure does not drop below 130 mm Hg after six months of recommended lifestyle changes. This statement fills that gap,” Daniel W. Jones, MD, chair of the statement writing group and a past president of the AHA, said in a news release.
If after 6 months with lifestyle changes, blood pressure does not improve, lifestyle therapy should be continued and “clinicians should consider adding medications to control blood pressure,” said Dr. Jones, professor and dean emeritus, University of Mississippi, Jackson.
Healthy lifestyle changes to lower blood pressure include achieving ideal body weight, exercising (30 min of moderate to vigorous physical activity on most days, if possible), limiting dietary sodium, enhancing potassium intake, and following the Dietary Approaches to Stop Hypertension (DASH) diet, which is plentiful in fruits and vegetables with low-fat dairy products and reduced saturated fat and total fat. In addition, patients should be advised to limit alcohol intake and to not smoke.
The writing group acknowledges that these goals can be hard to achieve and maintain over time.
“It is very hard in America and most industrialized countries to limit sodium sufficiently to lower blood pressure, and it is difficult for all of us to maintain a healthy weight in what I refer to as a toxic food environment,” Dr. Jones said.
“We want clinicians to advise patients to take healthy lifestyle changes seriously and do their best. We certainly prefer to achieve blood pressure goals without adding medication; however, successfully treating high blood pressure does extend both years and quality of life,” said Dr. Jones.
The AHA statement also addresses cases in which adults were found to have hypertension during adolescence or childhood and were prescribed antihypertensive drug therapy.
In this patient population, clinicians should consider the original indications for starting antihypertensive drug treatment and the need to continue the medication and lifestyle therapy as young adults, the AHA advises.
“In young adults with stage 1 hypertension who are not controlled with lifestyle therapy, special consideration should be given to use of antihypertensive medication in individuals with a family history of premature CVD, a history of hypertension during pregnancy, or a personal history of premature birth,” the AHA states.
The scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Hypertension; the Council on the Kidney in Cardiovascular Disease; the Council on Arteriosclerosis, Thrombosis and Vascular Biology; the Council on Cardiovascular Radiology and Intervention; the Council on Lifelong Congenital Heart Disease and Heart Health in the Young; and the Stroke Council.
The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Clinicians should consider the use of medication for adults with untreated stage 1 hypertension (130-139/80-89 mm Hg) whose 10-year risk for atherosclerotic cardiovascular disease is <10% and who fail to meet the blood pressure goal of <130/80 mm Hg after 6 months of guideline-based lifestyle therapy, the American Heart Association (AHA) advises in new scientific statement.
The statement was published online April 29 in Hypertension.
The recommendation complements the 2017 American College of Cardiology/American Heart Association Blood Pressure Management Guidelines, which do not fully address how to manage untreated stage 1 hypertension, the AHA says.
“There are no treatment recommendations in current guidelines for patients who are at relatively low short-term risk of heart disease when blood pressure does not drop below 130 mm Hg after six months of recommended lifestyle changes. This statement fills that gap,” Daniel W. Jones, MD, chair of the statement writing group and a past president of the AHA, said in a news release.
If after 6 months with lifestyle changes, blood pressure does not improve, lifestyle therapy should be continued and “clinicians should consider adding medications to control blood pressure,” said Dr. Jones, professor and dean emeritus, University of Mississippi, Jackson.
Healthy lifestyle changes to lower blood pressure include achieving ideal body weight, exercising (30 min of moderate to vigorous physical activity on most days, if possible), limiting dietary sodium, enhancing potassium intake, and following the Dietary Approaches to Stop Hypertension (DASH) diet, which is plentiful in fruits and vegetables with low-fat dairy products and reduced saturated fat and total fat. In addition, patients should be advised to limit alcohol intake and to not smoke.
The writing group acknowledges that these goals can be hard to achieve and maintain over time.
“It is very hard in America and most industrialized countries to limit sodium sufficiently to lower blood pressure, and it is difficult for all of us to maintain a healthy weight in what I refer to as a toxic food environment,” Dr. Jones said.
“We want clinicians to advise patients to take healthy lifestyle changes seriously and do their best. We certainly prefer to achieve blood pressure goals without adding medication; however, successfully treating high blood pressure does extend both years and quality of life,” said Dr. Jones.
The AHA statement also addresses cases in which adults were found to have hypertension during adolescence or childhood and were prescribed antihypertensive drug therapy.
In this patient population, clinicians should consider the original indications for starting antihypertensive drug treatment and the need to continue the medication and lifestyle therapy as young adults, the AHA advises.
“In young adults with stage 1 hypertension who are not controlled with lifestyle therapy, special consideration should be given to use of antihypertensive medication in individuals with a family history of premature CVD, a history of hypertension during pregnancy, or a personal history of premature birth,” the AHA states.
The scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Hypertension; the Council on the Kidney in Cardiovascular Disease; the Council on Arteriosclerosis, Thrombosis and Vascular Biology; the Council on Cardiovascular Radiology and Intervention; the Council on Lifelong Congenital Heart Disease and Heart Health in the Young; and the Stroke Council.
The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Doctors lose jobs after speaking out about unsafe conditions
In April 2020, hospitalist Samantha Houston, MD, lost her job at Baptist Memorial Hospital–North, in Oxford, Miss., after she publicly campaigned to get donations of N95 masks for nurses. Dr. Houston filed a lawsuit against the hospital, saying she was improperly fired for speaking out. The lawsuit has not yet gone to trial.
In January 2017, emergency physician Raymond Brovont, MD, was fired by EmCare, an emergency physician staffing company, after reporting understaffing at hospitals with which it contracted in the Kansas City, Mo., area. Dr. Brovont sued EmCare, and the company lost the case. In February 2019, it was ordered to pay him $13.1 million in damages.
These are just two of several cases in recent years in which physicians have spoken out about problems involving patient care and have been sanctioned. Other physicians who see problems choose to stay silent.
Doctors often hesitate to speak out because of the prospect of losing their jobs. A 2013 study of emergency physicians found that nearly 20% reported a possible or real threat to their employment if they expressed concerns about quality of care.
When physicians do not speak openly about important medical issues, the quality of care in their institutions suffers, said a coauthor of the study, Larry D. Weiss, MD, JD, a retired professor of emergency medicine at the University of Maryland, Baltimore.
“Physicians can’t effectively represent patients if they are always thinking they can get fired for what they say,” Dr. Weiss said. “If you don’t have protections like due process, which is often the case, you are less likely to speak out.”
In the first few weeks, health care facilities were struggling to obtain personal protective equipment (PPE) and to create policies that would keep patients and caregivers safe.
Physicians such as Dr. Houston took the initiative to make sure their institutions were taking the right steps against COVID-19 and found themselves at loggerheads with administrators who were concerned that their organizations were being portrayed as unsafe.
The case of one physician who spoke out
One of the highest-profile cases of a physician speaking out and being removed from work during the pandemic is that of Ming Lin, MD, an emergency physician who lost a job he had held for 17 years at St. Joseph Medical Center, in Bellingham, Wash. Dr. Lin lost his job after he made a series of Facebook posts that criticized the hospital’s COVID-19 preparedness efforts.
In an interview, Dr. Lin discussed the details of his situation to a degree that rarely occurs in such cases. This is one of the most extensive interviews he has granted.
Postings on Facebook
Dr. Lin said that on the basis of an intense study of the virus at the onset of the pandemic, he developed many ideas as to what could be done to mitigate its spread. While working as a locum tenens physician on his time off, he could see how others dealt with COVID-19.
Dr. Lin said from past experiences he did not feel that he could present his ideas directly to administration and be heard, so he decided to air his ideas about how his hospital could handle COVID-19 on his Facebook page, which drew a large audience.
He said he was certain that hospital administrators were reading his posts. He said receptionists at this hospital were advised not to wear masks, evidently because it would alarm patients. Dr. Lin said he posted concerns about their safety and called for them to wear masks. Soon after, the hospital directed receptionists to wear masks.
Dr. Lin’s Facebook posts also criticized the hospital for taking what he felt was too long to get results on COVID-19 tests. “It was taking them up to 10 days to get test results, because samples were being sent to a lab in California,” he said. He suggested it would be faster to send samples to the University of Washington. Soon after, the hospital started sending samples there.
In just a couple of weeks, Dr. Lin said, he voiced almost a dozen concerns. Each time the hospital made changes in line with his recommendations. Although he didn’t get any direct acknowledgment from the hospital for his help, he said he felt he was making a positive impact.
How employers react to physicians who speak out
Physicians who speak out about conditions tend to deeply disturb administrators, said William P. Sullivan, DO, JD, an emergency physician and lawyer in Frankfort, Ill., who has written about physicians being terminated by hospitals.
“These physicians go to the news media or they use social media,” Dr. Sullivan said, “but hospital administrators don’t want the public to hear bad things about their hospital.”
Then the public might not come to the hospital, which is an administrator’s worst nightmare. Even if physicians think their criticisms are reasonable, administrators may still fear a resulting drop in patients.
Dr. Houston, for example, was helping her Mississippi hospital by collecting donations of N95 masks for nurses, but to administrators, it showed that the hospital did not have enough masks.
“It is not helpful to stoke fear and anxiety, even if the intent is sincere,” a spokesperson for the hospital said.
Administrator fires back
Dr. Lin’s posts were deeply concerning to Richard DeCarlo, chief operating officer of PeaceHealth, which runs St. Joseph Hospital. Mr. DeCarlo discussed his concerns in a video interview in April with the blogger Zubin Damania, MD, known as ZDoggMD.
Comments on Dr. Lin’s Facebook posts showed that people “were fearful to go to the hospital,” he told Dr. Damania. “They were concluding that they would need to drive to another hospital.”
Mr. DeCarlo said he was also unhappy that Dr. Lin did not directly contact administrators about his concerns. “He didn’t communicate with his medical director,” Mr. DeCarlo said in the interview. “The ED staff had been meeting three times a week with the chief medical officer to make sure they had everything they needed, but he only attended one of these meetings and didn’t ask any questions.”
Dr. Lin maintains he did ask questions at the first meeting but stopped attending because he felt he wasn’t being heeded. “I found their tone not very receptive,” he said.
Doctor allegedly offered “misinformation”
At the start of the pandemic, some hospitals made it clear what would happen to doctors who brought up lack of PPE or other problems to the media. For example, NYU Langone Medical Center in New York sent an email to staff warning that speaking to the media without permission “will be subject to disciplinary action, including termination.”
PeaceHealth took a different tack. “It’s not that we have a policy that says don’t ever talk to the media,” Mr. DeCarlo said in the ZDoggMD interview, but in Dr. Lin’s case, “what was at issue was the misinformation. His leader went to him and said, ‘Look, you’re posting things that aren’t accurate.’ ”
Dr. Lin disputes that he provided any misinformation. In the interview, Mr. DeCarlo cited just one example of alleged misinformation. He said Dr. Lin called for a tent outside the emergency department (ED) to protect patients entering the department from aerosol exposure to COVID-19. Mr. DeCarlo said the tent was not needed because fewer people were using the ED.
“To put it in an extreme way,” Mr. DeCarlo said of Dr. Lin’s posts, “it was like yelling fire in a theater where there is not a fire.”
Dr. Lin said the hospital did briefly erect a tent and then removed it, and he still insisted that a tent was a good idea. He added that Mr. DeCarlo never mentioned any of the other suggestions Dr. Lin made, nor did he state that the hospital adopted them.
Doctor gets a warning
Dr. Lin said that after he started posting his concerns, he got a call from the emergency department director who worked for TeamHealth, an emergency medicine staffing firm that contracted with PeaceHealth and employed Dr. Lin, too.
Dr. Lin said his immediate supervisor at TeamHealth told him the hospital was unhappy with his posts and that he should take them down and suggested he might be fired. Dr. Lin said the supervisor also asked him to apologize to the hospital administration for these posts, but he refused to do so.
“Retracting and apologizing was not only wrong but would have left me vulnerable to being terminated with no repercussions,” he said.
“At that point, I realized I had crossed the Rubicon,” Dr. Lin said. He thought he might well be fired, no matter what he did, so he took his story to The Seattle Times, which had a much wider platform than his Facebook page had.
Dr. Lin lost his job at St. Joseph a week after The Seattle Times story about him appeared. “About 10 minutes before my shift was supposed to start, I received a text message from TeamHealth saying that someone else would be taking the shift,” he said.
In a release, TeamHealth insisted Dr. Lin was not fired and that he was scheduled to be reassigned to work at other hospitals. Dr. Lin, however, said he was not told this at the time and that he found out later that the new assignment would involve a pay cut and a significant commute. He said he has not taken any new assignments from TeamHealth since he lost his job at St. Joseph.
Dr. Lin has filed a lawsuit against PeaceHealth, TeamHealth, and Mr. DeCarlo, asking for his job back and for an apology. He said he has not asked for any financial damages at this point.
Since leaving St. Joseph, Dr. Lin has been working as an administrator for the Indian Health Service in the upper plains states. He said he can do some of the work at home in Washington State, which allows him to be with his wife and three young children.
Dr. Lin no longer sees patients. “I feel I have lost my confidence as a clinician,” he said. “I’m not sure why, but I find it hard to make quick judgments when taking care of patients.”
He said many doctors have told him about their own troubles with speaking out, but they did not want to come forward and talk about it because they feared more repercussions.
Do doctors who speak out have any rights?
Because TeamHealth, Dr. Lin’s actual employer, asserts he was never actually terminated, Dr. Lin has not been able to appeal his case internally in accordance with due process, an option that allows doctors to get a fair hearing and to appeal decisions against them.
The American Academy of Emergency Medicine pointed out this problem. “Dr. Lin, as a member of the medical staff, is entitled to full due process and a fair hearing from his peers on the medical staff,” the academy said in a statement supporting him.
The Joint Commission, the hospital accreditor, requires that hospitals provide due process to doctors before they can be terminated. However, Dr. Sullivan said employers often make physicians waive their due process rights in the employment contract. “The result is that the employer can terminate doctors for no reason,” he said.
In the 2013 survey of emergency physicians, 62% reported that their employers could terminate them without full due process.
Dr. Weiss, the Maryland MD-JD, said that when he advises doctors on their contracts, he generally tells them to cross out the waiver language. The applicant, he says, may also tell the employer that the waivers are considered unethical by many physician professional societies. In some cases, he said, the hospital will back down.
Conclusion
To maintain quality of care, it is essential that physicians feel free to speak out about issues that concern them. They can improve their chances of being heard by working directly with management and attending meetings, but in some cases, management may be unwilling to listen.
A version of this article first appeared on Medscape.com.
In April 2020, hospitalist Samantha Houston, MD, lost her job at Baptist Memorial Hospital–North, in Oxford, Miss., after she publicly campaigned to get donations of N95 masks for nurses. Dr. Houston filed a lawsuit against the hospital, saying she was improperly fired for speaking out. The lawsuit has not yet gone to trial.
In January 2017, emergency physician Raymond Brovont, MD, was fired by EmCare, an emergency physician staffing company, after reporting understaffing at hospitals with which it contracted in the Kansas City, Mo., area. Dr. Brovont sued EmCare, and the company lost the case. In February 2019, it was ordered to pay him $13.1 million in damages.
These are just two of several cases in recent years in which physicians have spoken out about problems involving patient care and have been sanctioned. Other physicians who see problems choose to stay silent.
Doctors often hesitate to speak out because of the prospect of losing their jobs. A 2013 study of emergency physicians found that nearly 20% reported a possible or real threat to their employment if they expressed concerns about quality of care.
When physicians do not speak openly about important medical issues, the quality of care in their institutions suffers, said a coauthor of the study, Larry D. Weiss, MD, JD, a retired professor of emergency medicine at the University of Maryland, Baltimore.
“Physicians can’t effectively represent patients if they are always thinking they can get fired for what they say,” Dr. Weiss said. “If you don’t have protections like due process, which is often the case, you are less likely to speak out.”
In the first few weeks, health care facilities were struggling to obtain personal protective equipment (PPE) and to create policies that would keep patients and caregivers safe.
Physicians such as Dr. Houston took the initiative to make sure their institutions were taking the right steps against COVID-19 and found themselves at loggerheads with administrators who were concerned that their organizations were being portrayed as unsafe.
The case of one physician who spoke out
One of the highest-profile cases of a physician speaking out and being removed from work during the pandemic is that of Ming Lin, MD, an emergency physician who lost a job he had held for 17 years at St. Joseph Medical Center, in Bellingham, Wash. Dr. Lin lost his job after he made a series of Facebook posts that criticized the hospital’s COVID-19 preparedness efforts.
In an interview, Dr. Lin discussed the details of his situation to a degree that rarely occurs in such cases. This is one of the most extensive interviews he has granted.
Postings on Facebook
Dr. Lin said that on the basis of an intense study of the virus at the onset of the pandemic, he developed many ideas as to what could be done to mitigate its spread. While working as a locum tenens physician on his time off, he could see how others dealt with COVID-19.
Dr. Lin said from past experiences he did not feel that he could present his ideas directly to administration and be heard, so he decided to air his ideas about how his hospital could handle COVID-19 on his Facebook page, which drew a large audience.
He said he was certain that hospital administrators were reading his posts. He said receptionists at this hospital were advised not to wear masks, evidently because it would alarm patients. Dr. Lin said he posted concerns about their safety and called for them to wear masks. Soon after, the hospital directed receptionists to wear masks.
Dr. Lin’s Facebook posts also criticized the hospital for taking what he felt was too long to get results on COVID-19 tests. “It was taking them up to 10 days to get test results, because samples were being sent to a lab in California,” he said. He suggested it would be faster to send samples to the University of Washington. Soon after, the hospital started sending samples there.
In just a couple of weeks, Dr. Lin said, he voiced almost a dozen concerns. Each time the hospital made changes in line with his recommendations. Although he didn’t get any direct acknowledgment from the hospital for his help, he said he felt he was making a positive impact.
How employers react to physicians who speak out
Physicians who speak out about conditions tend to deeply disturb administrators, said William P. Sullivan, DO, JD, an emergency physician and lawyer in Frankfort, Ill., who has written about physicians being terminated by hospitals.
“These physicians go to the news media or they use social media,” Dr. Sullivan said, “but hospital administrators don’t want the public to hear bad things about their hospital.”
Then the public might not come to the hospital, which is an administrator’s worst nightmare. Even if physicians think their criticisms are reasonable, administrators may still fear a resulting drop in patients.
Dr. Houston, for example, was helping her Mississippi hospital by collecting donations of N95 masks for nurses, but to administrators, it showed that the hospital did not have enough masks.
“It is not helpful to stoke fear and anxiety, even if the intent is sincere,” a spokesperson for the hospital said.
Administrator fires back
Dr. Lin’s posts were deeply concerning to Richard DeCarlo, chief operating officer of PeaceHealth, which runs St. Joseph Hospital. Mr. DeCarlo discussed his concerns in a video interview in April with the blogger Zubin Damania, MD, known as ZDoggMD.
Comments on Dr. Lin’s Facebook posts showed that people “were fearful to go to the hospital,” he told Dr. Damania. “They were concluding that they would need to drive to another hospital.”
Mr. DeCarlo said he was also unhappy that Dr. Lin did not directly contact administrators about his concerns. “He didn’t communicate with his medical director,” Mr. DeCarlo said in the interview. “The ED staff had been meeting three times a week with the chief medical officer to make sure they had everything they needed, but he only attended one of these meetings and didn’t ask any questions.”
Dr. Lin maintains he did ask questions at the first meeting but stopped attending because he felt he wasn’t being heeded. “I found their tone not very receptive,” he said.
Doctor allegedly offered “misinformation”
At the start of the pandemic, some hospitals made it clear what would happen to doctors who brought up lack of PPE or other problems to the media. For example, NYU Langone Medical Center in New York sent an email to staff warning that speaking to the media without permission “will be subject to disciplinary action, including termination.”
PeaceHealth took a different tack. “It’s not that we have a policy that says don’t ever talk to the media,” Mr. DeCarlo said in the ZDoggMD interview, but in Dr. Lin’s case, “what was at issue was the misinformation. His leader went to him and said, ‘Look, you’re posting things that aren’t accurate.’ ”
Dr. Lin disputes that he provided any misinformation. In the interview, Mr. DeCarlo cited just one example of alleged misinformation. He said Dr. Lin called for a tent outside the emergency department (ED) to protect patients entering the department from aerosol exposure to COVID-19. Mr. DeCarlo said the tent was not needed because fewer people were using the ED.
“To put it in an extreme way,” Mr. DeCarlo said of Dr. Lin’s posts, “it was like yelling fire in a theater where there is not a fire.”
Dr. Lin said the hospital did briefly erect a tent and then removed it, and he still insisted that a tent was a good idea. He added that Mr. DeCarlo never mentioned any of the other suggestions Dr. Lin made, nor did he state that the hospital adopted them.
Doctor gets a warning
Dr. Lin said that after he started posting his concerns, he got a call from the emergency department director who worked for TeamHealth, an emergency medicine staffing firm that contracted with PeaceHealth and employed Dr. Lin, too.
Dr. Lin said his immediate supervisor at TeamHealth told him the hospital was unhappy with his posts and that he should take them down and suggested he might be fired. Dr. Lin said the supervisor also asked him to apologize to the hospital administration for these posts, but he refused to do so.
“Retracting and apologizing was not only wrong but would have left me vulnerable to being terminated with no repercussions,” he said.
“At that point, I realized I had crossed the Rubicon,” Dr. Lin said. He thought he might well be fired, no matter what he did, so he took his story to The Seattle Times, which had a much wider platform than his Facebook page had.
Dr. Lin lost his job at St. Joseph a week after The Seattle Times story about him appeared. “About 10 minutes before my shift was supposed to start, I received a text message from TeamHealth saying that someone else would be taking the shift,” he said.
In a release, TeamHealth insisted Dr. Lin was not fired and that he was scheduled to be reassigned to work at other hospitals. Dr. Lin, however, said he was not told this at the time and that he found out later that the new assignment would involve a pay cut and a significant commute. He said he has not taken any new assignments from TeamHealth since he lost his job at St. Joseph.
Dr. Lin has filed a lawsuit against PeaceHealth, TeamHealth, and Mr. DeCarlo, asking for his job back and for an apology. He said he has not asked for any financial damages at this point.
Since leaving St. Joseph, Dr. Lin has been working as an administrator for the Indian Health Service in the upper plains states. He said he can do some of the work at home in Washington State, which allows him to be with his wife and three young children.
Dr. Lin no longer sees patients. “I feel I have lost my confidence as a clinician,” he said. “I’m not sure why, but I find it hard to make quick judgments when taking care of patients.”
He said many doctors have told him about their own troubles with speaking out, but they did not want to come forward and talk about it because they feared more repercussions.
Do doctors who speak out have any rights?
Because TeamHealth, Dr. Lin’s actual employer, asserts he was never actually terminated, Dr. Lin has not been able to appeal his case internally in accordance with due process, an option that allows doctors to get a fair hearing and to appeal decisions against them.
The American Academy of Emergency Medicine pointed out this problem. “Dr. Lin, as a member of the medical staff, is entitled to full due process and a fair hearing from his peers on the medical staff,” the academy said in a statement supporting him.
The Joint Commission, the hospital accreditor, requires that hospitals provide due process to doctors before they can be terminated. However, Dr. Sullivan said employers often make physicians waive their due process rights in the employment contract. “The result is that the employer can terminate doctors for no reason,” he said.
In the 2013 survey of emergency physicians, 62% reported that their employers could terminate them without full due process.
Dr. Weiss, the Maryland MD-JD, said that when he advises doctors on their contracts, he generally tells them to cross out the waiver language. The applicant, he says, may also tell the employer that the waivers are considered unethical by many physician professional societies. In some cases, he said, the hospital will back down.
Conclusion
To maintain quality of care, it is essential that physicians feel free to speak out about issues that concern them. They can improve their chances of being heard by working directly with management and attending meetings, but in some cases, management may be unwilling to listen.
A version of this article first appeared on Medscape.com.
In April 2020, hospitalist Samantha Houston, MD, lost her job at Baptist Memorial Hospital–North, in Oxford, Miss., after she publicly campaigned to get donations of N95 masks for nurses. Dr. Houston filed a lawsuit against the hospital, saying she was improperly fired for speaking out. The lawsuit has not yet gone to trial.
In January 2017, emergency physician Raymond Brovont, MD, was fired by EmCare, an emergency physician staffing company, after reporting understaffing at hospitals with which it contracted in the Kansas City, Mo., area. Dr. Brovont sued EmCare, and the company lost the case. In February 2019, it was ordered to pay him $13.1 million in damages.
These are just two of several cases in recent years in which physicians have spoken out about problems involving patient care and have been sanctioned. Other physicians who see problems choose to stay silent.
Doctors often hesitate to speak out because of the prospect of losing their jobs. A 2013 study of emergency physicians found that nearly 20% reported a possible or real threat to their employment if they expressed concerns about quality of care.
When physicians do not speak openly about important medical issues, the quality of care in their institutions suffers, said a coauthor of the study, Larry D. Weiss, MD, JD, a retired professor of emergency medicine at the University of Maryland, Baltimore.
“Physicians can’t effectively represent patients if they are always thinking they can get fired for what they say,” Dr. Weiss said. “If you don’t have protections like due process, which is often the case, you are less likely to speak out.”
In the first few weeks, health care facilities were struggling to obtain personal protective equipment (PPE) and to create policies that would keep patients and caregivers safe.
Physicians such as Dr. Houston took the initiative to make sure their institutions were taking the right steps against COVID-19 and found themselves at loggerheads with administrators who were concerned that their organizations were being portrayed as unsafe.
The case of one physician who spoke out
One of the highest-profile cases of a physician speaking out and being removed from work during the pandemic is that of Ming Lin, MD, an emergency physician who lost a job he had held for 17 years at St. Joseph Medical Center, in Bellingham, Wash. Dr. Lin lost his job after he made a series of Facebook posts that criticized the hospital’s COVID-19 preparedness efforts.
In an interview, Dr. Lin discussed the details of his situation to a degree that rarely occurs in such cases. This is one of the most extensive interviews he has granted.
Postings on Facebook
Dr. Lin said that on the basis of an intense study of the virus at the onset of the pandemic, he developed many ideas as to what could be done to mitigate its spread. While working as a locum tenens physician on his time off, he could see how others dealt with COVID-19.
Dr. Lin said from past experiences he did not feel that he could present his ideas directly to administration and be heard, so he decided to air his ideas about how his hospital could handle COVID-19 on his Facebook page, which drew a large audience.
He said he was certain that hospital administrators were reading his posts. He said receptionists at this hospital were advised not to wear masks, evidently because it would alarm patients. Dr. Lin said he posted concerns about their safety and called for them to wear masks. Soon after, the hospital directed receptionists to wear masks.
Dr. Lin’s Facebook posts also criticized the hospital for taking what he felt was too long to get results on COVID-19 tests. “It was taking them up to 10 days to get test results, because samples were being sent to a lab in California,” he said. He suggested it would be faster to send samples to the University of Washington. Soon after, the hospital started sending samples there.
In just a couple of weeks, Dr. Lin said, he voiced almost a dozen concerns. Each time the hospital made changes in line with his recommendations. Although he didn’t get any direct acknowledgment from the hospital for his help, he said he felt he was making a positive impact.
How employers react to physicians who speak out
Physicians who speak out about conditions tend to deeply disturb administrators, said William P. Sullivan, DO, JD, an emergency physician and lawyer in Frankfort, Ill., who has written about physicians being terminated by hospitals.
“These physicians go to the news media or they use social media,” Dr. Sullivan said, “but hospital administrators don’t want the public to hear bad things about their hospital.”
Then the public might not come to the hospital, which is an administrator’s worst nightmare. Even if physicians think their criticisms are reasonable, administrators may still fear a resulting drop in patients.
Dr. Houston, for example, was helping her Mississippi hospital by collecting donations of N95 masks for nurses, but to administrators, it showed that the hospital did not have enough masks.
“It is not helpful to stoke fear and anxiety, even if the intent is sincere,” a spokesperson for the hospital said.
Administrator fires back
Dr. Lin’s posts were deeply concerning to Richard DeCarlo, chief operating officer of PeaceHealth, which runs St. Joseph Hospital. Mr. DeCarlo discussed his concerns in a video interview in April with the blogger Zubin Damania, MD, known as ZDoggMD.
Comments on Dr. Lin’s Facebook posts showed that people “were fearful to go to the hospital,” he told Dr. Damania. “They were concluding that they would need to drive to another hospital.”
Mr. DeCarlo said he was also unhappy that Dr. Lin did not directly contact administrators about his concerns. “He didn’t communicate with his medical director,” Mr. DeCarlo said in the interview. “The ED staff had been meeting three times a week with the chief medical officer to make sure they had everything they needed, but he only attended one of these meetings and didn’t ask any questions.”
Dr. Lin maintains he did ask questions at the first meeting but stopped attending because he felt he wasn’t being heeded. “I found their tone not very receptive,” he said.
Doctor allegedly offered “misinformation”
At the start of the pandemic, some hospitals made it clear what would happen to doctors who brought up lack of PPE or other problems to the media. For example, NYU Langone Medical Center in New York sent an email to staff warning that speaking to the media without permission “will be subject to disciplinary action, including termination.”
PeaceHealth took a different tack. “It’s not that we have a policy that says don’t ever talk to the media,” Mr. DeCarlo said in the ZDoggMD interview, but in Dr. Lin’s case, “what was at issue was the misinformation. His leader went to him and said, ‘Look, you’re posting things that aren’t accurate.’ ”
Dr. Lin disputes that he provided any misinformation. In the interview, Mr. DeCarlo cited just one example of alleged misinformation. He said Dr. Lin called for a tent outside the emergency department (ED) to protect patients entering the department from aerosol exposure to COVID-19. Mr. DeCarlo said the tent was not needed because fewer people were using the ED.
“To put it in an extreme way,” Mr. DeCarlo said of Dr. Lin’s posts, “it was like yelling fire in a theater where there is not a fire.”
Dr. Lin said the hospital did briefly erect a tent and then removed it, and he still insisted that a tent was a good idea. He added that Mr. DeCarlo never mentioned any of the other suggestions Dr. Lin made, nor did he state that the hospital adopted them.
Doctor gets a warning
Dr. Lin said that after he started posting his concerns, he got a call from the emergency department director who worked for TeamHealth, an emergency medicine staffing firm that contracted with PeaceHealth and employed Dr. Lin, too.
Dr. Lin said his immediate supervisor at TeamHealth told him the hospital was unhappy with his posts and that he should take them down and suggested he might be fired. Dr. Lin said the supervisor also asked him to apologize to the hospital administration for these posts, but he refused to do so.
“Retracting and apologizing was not only wrong but would have left me vulnerable to being terminated with no repercussions,” he said.
“At that point, I realized I had crossed the Rubicon,” Dr. Lin said. He thought he might well be fired, no matter what he did, so he took his story to The Seattle Times, which had a much wider platform than his Facebook page had.
Dr. Lin lost his job at St. Joseph a week after The Seattle Times story about him appeared. “About 10 minutes before my shift was supposed to start, I received a text message from TeamHealth saying that someone else would be taking the shift,” he said.
In a release, TeamHealth insisted Dr. Lin was not fired and that he was scheduled to be reassigned to work at other hospitals. Dr. Lin, however, said he was not told this at the time and that he found out later that the new assignment would involve a pay cut and a significant commute. He said he has not taken any new assignments from TeamHealth since he lost his job at St. Joseph.
Dr. Lin has filed a lawsuit against PeaceHealth, TeamHealth, and Mr. DeCarlo, asking for his job back and for an apology. He said he has not asked for any financial damages at this point.
Since leaving St. Joseph, Dr. Lin has been working as an administrator for the Indian Health Service in the upper plains states. He said he can do some of the work at home in Washington State, which allows him to be with his wife and three young children.
Dr. Lin no longer sees patients. “I feel I have lost my confidence as a clinician,” he said. “I’m not sure why, but I find it hard to make quick judgments when taking care of patients.”
He said many doctors have told him about their own troubles with speaking out, but they did not want to come forward and talk about it because they feared more repercussions.
Do doctors who speak out have any rights?
Because TeamHealth, Dr. Lin’s actual employer, asserts he was never actually terminated, Dr. Lin has not been able to appeal his case internally in accordance with due process, an option that allows doctors to get a fair hearing and to appeal decisions against them.
The American Academy of Emergency Medicine pointed out this problem. “Dr. Lin, as a member of the medical staff, is entitled to full due process and a fair hearing from his peers on the medical staff,” the academy said in a statement supporting him.
The Joint Commission, the hospital accreditor, requires that hospitals provide due process to doctors before they can be terminated. However, Dr. Sullivan said employers often make physicians waive their due process rights in the employment contract. “The result is that the employer can terminate doctors for no reason,” he said.
In the 2013 survey of emergency physicians, 62% reported that their employers could terminate them without full due process.
Dr. Weiss, the Maryland MD-JD, said that when he advises doctors on their contracts, he generally tells them to cross out the waiver language. The applicant, he says, may also tell the employer that the waivers are considered unethical by many physician professional societies. In some cases, he said, the hospital will back down.
Conclusion
To maintain quality of care, it is essential that physicians feel free to speak out about issues that concern them. They can improve their chances of being heard by working directly with management and attending meetings, but in some cases, management may be unwilling to listen.
A version of this article first appeared on Medscape.com.
AHA guidance on blood clots linked to COVID-19 vaccine
A newly released report is offering guidance concerning rare conditions associated with COVID-19 as well as vaccines against the virus.
The report was released April 29, 2021, by the American Heart Association/American Stroke Association Stroke Council Leadership in answer to the decision April 23 by the Centers for Disease Control and Prevention and the Food and Drug Administration to lift an earlier “pause” in administration of the Johnson & Johnson (Janssen) vaccine.
That pause had been put in place after reports were received of a possible association between the J&J vaccine and cerebral venous sinus thrombosis (CVST) and thrombosis-thrombocytopenia syndrome (TTS, blood clots plus low blood platelets). CVST and TTS were also linked to patients in Europe and Canada who received the AstraZeneca COVID-19 vaccine.
However, the new report noted that these conditions are very rare.
“The risk of CVST due to infection with COVID-19 is 8-10 times higher than the risk of CVST after receiving a COVID-19 vaccine,” lead author Karen L. Furie, MD, chair of the department of neurology at Brown University, Providence, R.I., said in a press release.
“The public can be reassured by the CDC’s and FDA’s investigation and these statistics – the likelihood of developing CVST after a COVID-19 vaccine is extremely low,” said Dr. Furie, adding that the authors “urge all adults to receive any of the approved COVID-19 vaccines.”
The new guidance, which was published online April 29, 2021, in Stroke, discusses signs and symptoms of CVST and TTS, as well as vaccine-induced immune thrombotic thrombocytopenia (VITT). It also recommends best options for treating these conditions.
Assessing 81 million patients
In their analysis, the investigators assessed a database of 59 health care organizations and 81 million patients, 98% of whom were in the United States.
Of almost 514,000 patients diagnosed with COVID-19 between January 2020 and March 2021, 20 also received a diagnosis of CVST.
Among about 490,000 adults who received either the Pfizer or Moderna vaccines, there were no diagnosed cases of thrombocytopenia.
Dr. Furie reiterated that CVST blood clots “are very rare adverse events,” but recommended that any patient in the ED with a suspected clot should be screened immediately to determine if they received a COVID vaccine during the previous few weeks.
For those who have recently received the COVID-19 vaccine, a suspected clot should be treated with nonheparin anticoagulants, Dr. Furie said.
“No heparin products in any dose should be given for suspected CVST, TTS, or VITT. With the right treatment, most patients can have a full recovery,” she added. The report includes additional, detailed treatment recommendations if one of these conditions are suspected.
Rare events
The authors noted that cases of TTS/VITT occurred up to 2.5 weeks after receiving the J&J vaccine in the United States and up to 3.5 weeks after receiving the AstraZeneca vaccine in Europe.
An April 23 report from the CDC and FDA noted that, out of almost 7 million adults who received the J&J vaccine, the agencies investigated only 15 reported cases of TTS.
An April 7 report from the European Medicines Agency noted that, out of more than 25 million people who received the AstraZeneca vaccine in the European Union, it found 62 cases of CVST.
A statement put out by the American Heart Association/American Stroke Association urges “everyone to receive a COVID-19 vaccine” as soon as possible.
“We are confident the benefits of vaccination far exceed the very small, rare risks,” the organizations said. “The risks of vaccination are also far smaller than the risk of COVID-19 and its potentially fatal consequences.”
A version of this article first appeared on Medscape.com.
A newly released report is offering guidance concerning rare conditions associated with COVID-19 as well as vaccines against the virus.
The report was released April 29, 2021, by the American Heart Association/American Stroke Association Stroke Council Leadership in answer to the decision April 23 by the Centers for Disease Control and Prevention and the Food and Drug Administration to lift an earlier “pause” in administration of the Johnson & Johnson (Janssen) vaccine.
That pause had been put in place after reports were received of a possible association between the J&J vaccine and cerebral venous sinus thrombosis (CVST) and thrombosis-thrombocytopenia syndrome (TTS, blood clots plus low blood platelets). CVST and TTS were also linked to patients in Europe and Canada who received the AstraZeneca COVID-19 vaccine.
However, the new report noted that these conditions are very rare.
“The risk of CVST due to infection with COVID-19 is 8-10 times higher than the risk of CVST after receiving a COVID-19 vaccine,” lead author Karen L. Furie, MD, chair of the department of neurology at Brown University, Providence, R.I., said in a press release.
“The public can be reassured by the CDC’s and FDA’s investigation and these statistics – the likelihood of developing CVST after a COVID-19 vaccine is extremely low,” said Dr. Furie, adding that the authors “urge all adults to receive any of the approved COVID-19 vaccines.”
The new guidance, which was published online April 29, 2021, in Stroke, discusses signs and symptoms of CVST and TTS, as well as vaccine-induced immune thrombotic thrombocytopenia (VITT). It also recommends best options for treating these conditions.
Assessing 81 million patients
In their analysis, the investigators assessed a database of 59 health care organizations and 81 million patients, 98% of whom were in the United States.
Of almost 514,000 patients diagnosed with COVID-19 between January 2020 and March 2021, 20 also received a diagnosis of CVST.
Among about 490,000 adults who received either the Pfizer or Moderna vaccines, there were no diagnosed cases of thrombocytopenia.
Dr. Furie reiterated that CVST blood clots “are very rare adverse events,” but recommended that any patient in the ED with a suspected clot should be screened immediately to determine if they received a COVID vaccine during the previous few weeks.
For those who have recently received the COVID-19 vaccine, a suspected clot should be treated with nonheparin anticoagulants, Dr. Furie said.
“No heparin products in any dose should be given for suspected CVST, TTS, or VITT. With the right treatment, most patients can have a full recovery,” she added. The report includes additional, detailed treatment recommendations if one of these conditions are suspected.
Rare events
The authors noted that cases of TTS/VITT occurred up to 2.5 weeks after receiving the J&J vaccine in the United States and up to 3.5 weeks after receiving the AstraZeneca vaccine in Europe.
An April 23 report from the CDC and FDA noted that, out of almost 7 million adults who received the J&J vaccine, the agencies investigated only 15 reported cases of TTS.
An April 7 report from the European Medicines Agency noted that, out of more than 25 million people who received the AstraZeneca vaccine in the European Union, it found 62 cases of CVST.
A statement put out by the American Heart Association/American Stroke Association urges “everyone to receive a COVID-19 vaccine” as soon as possible.
“We are confident the benefits of vaccination far exceed the very small, rare risks,” the organizations said. “The risks of vaccination are also far smaller than the risk of COVID-19 and its potentially fatal consequences.”
A version of this article first appeared on Medscape.com.
A newly released report is offering guidance concerning rare conditions associated with COVID-19 as well as vaccines against the virus.
The report was released April 29, 2021, by the American Heart Association/American Stroke Association Stroke Council Leadership in answer to the decision April 23 by the Centers for Disease Control and Prevention and the Food and Drug Administration to lift an earlier “pause” in administration of the Johnson & Johnson (Janssen) vaccine.
That pause had been put in place after reports were received of a possible association between the J&J vaccine and cerebral venous sinus thrombosis (CVST) and thrombosis-thrombocytopenia syndrome (TTS, blood clots plus low blood platelets). CVST and TTS were also linked to patients in Europe and Canada who received the AstraZeneca COVID-19 vaccine.
However, the new report noted that these conditions are very rare.
“The risk of CVST due to infection with COVID-19 is 8-10 times higher than the risk of CVST after receiving a COVID-19 vaccine,” lead author Karen L. Furie, MD, chair of the department of neurology at Brown University, Providence, R.I., said in a press release.
“The public can be reassured by the CDC’s and FDA’s investigation and these statistics – the likelihood of developing CVST after a COVID-19 vaccine is extremely low,” said Dr. Furie, adding that the authors “urge all adults to receive any of the approved COVID-19 vaccines.”
The new guidance, which was published online April 29, 2021, in Stroke, discusses signs and symptoms of CVST and TTS, as well as vaccine-induced immune thrombotic thrombocytopenia (VITT). It also recommends best options for treating these conditions.
Assessing 81 million patients
In their analysis, the investigators assessed a database of 59 health care organizations and 81 million patients, 98% of whom were in the United States.
Of almost 514,000 patients diagnosed with COVID-19 between January 2020 and March 2021, 20 also received a diagnosis of CVST.
Among about 490,000 adults who received either the Pfizer or Moderna vaccines, there were no diagnosed cases of thrombocytopenia.
Dr. Furie reiterated that CVST blood clots “are very rare adverse events,” but recommended that any patient in the ED with a suspected clot should be screened immediately to determine if they received a COVID vaccine during the previous few weeks.
For those who have recently received the COVID-19 vaccine, a suspected clot should be treated with nonheparin anticoagulants, Dr. Furie said.
“No heparin products in any dose should be given for suspected CVST, TTS, or VITT. With the right treatment, most patients can have a full recovery,” she added. The report includes additional, detailed treatment recommendations if one of these conditions are suspected.
Rare events
The authors noted that cases of TTS/VITT occurred up to 2.5 weeks after receiving the J&J vaccine in the United States and up to 3.5 weeks after receiving the AstraZeneca vaccine in Europe.
An April 23 report from the CDC and FDA noted that, out of almost 7 million adults who received the J&J vaccine, the agencies investigated only 15 reported cases of TTS.
An April 7 report from the European Medicines Agency noted that, out of more than 25 million people who received the AstraZeneca vaccine in the European Union, it found 62 cases of CVST.
A statement put out by the American Heart Association/American Stroke Association urges “everyone to receive a COVID-19 vaccine” as soon as possible.
“We are confident the benefits of vaccination far exceed the very small, rare risks,” the organizations said. “The risks of vaccination are also far smaller than the risk of COVID-19 and its potentially fatal consequences.”
A version of this article first appeared on Medscape.com.
FDA class I recall for some Cordis carotid stent systems
Cordis, part of Cardinal Health, has recalled certain lots of its Precise PRO Rx carotid stent system because of a risk of separation of the distal tip of the sheathed delivery system during use.
The Food and Drug Administration has classified this recall as class I, the most serious type, because of the potential for serious injury or death.
“If the device separates during use this may cause serious adverse events such as removal of the separated tip from the carotid artery, embolization distally, or stroke,” noted the recall notice posted on the FDA website.
To date, there have been seven complaints, including five reported injuries, related to this device issue. No deaths have been reported.
The Precise PRO Rx stent system is used in patients with stenotic lesions of the carotid arteries. The system includes a metal (nitinol) self-expanding stent preloaded on a delivery catheter used to place the stent.
The recall covers 7,300 devices made between October 2019 and August 2020 and distributed between Dec. 6, 2019, to Feb. 8, 2021.
The FDA has a complete list of product and lot numbers for the recalled devices on their website.
The company sent an urgent medical device recall letter to all affected customers asking them to check inventories and providing instructions on how to return any recalled product they have on hand.
Health care providers with questions about this recall can contact the company by email at GMB-FieldCorrectiveActionp@cardinalhealth.com or by phone at 786-313-2087.
Health care providers can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.
Cordis, part of Cardinal Health, has recalled certain lots of its Precise PRO Rx carotid stent system because of a risk of separation of the distal tip of the sheathed delivery system during use.
The Food and Drug Administration has classified this recall as class I, the most serious type, because of the potential for serious injury or death.
“If the device separates during use this may cause serious adverse events such as removal of the separated tip from the carotid artery, embolization distally, or stroke,” noted the recall notice posted on the FDA website.
To date, there have been seven complaints, including five reported injuries, related to this device issue. No deaths have been reported.
The Precise PRO Rx stent system is used in patients with stenotic lesions of the carotid arteries. The system includes a metal (nitinol) self-expanding stent preloaded on a delivery catheter used to place the stent.
The recall covers 7,300 devices made between October 2019 and August 2020 and distributed between Dec. 6, 2019, to Feb. 8, 2021.
The FDA has a complete list of product and lot numbers for the recalled devices on their website.
The company sent an urgent medical device recall letter to all affected customers asking them to check inventories and providing instructions on how to return any recalled product they have on hand.
Health care providers with questions about this recall can contact the company by email at GMB-FieldCorrectiveActionp@cardinalhealth.com or by phone at 786-313-2087.
Health care providers can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.
Cordis, part of Cardinal Health, has recalled certain lots of its Precise PRO Rx carotid stent system because of a risk of separation of the distal tip of the sheathed delivery system during use.
The Food and Drug Administration has classified this recall as class I, the most serious type, because of the potential for serious injury or death.
“If the device separates during use this may cause serious adverse events such as removal of the separated tip from the carotid artery, embolization distally, or stroke,” noted the recall notice posted on the FDA website.
To date, there have been seven complaints, including five reported injuries, related to this device issue. No deaths have been reported.
The Precise PRO Rx stent system is used in patients with stenotic lesions of the carotid arteries. The system includes a metal (nitinol) self-expanding stent preloaded on a delivery catheter used to place the stent.
The recall covers 7,300 devices made between October 2019 and August 2020 and distributed between Dec. 6, 2019, to Feb. 8, 2021.
The FDA has a complete list of product and lot numbers for the recalled devices on their website.
The company sent an urgent medical device recall letter to all affected customers asking them to check inventories and providing instructions on how to return any recalled product they have on hand.
Health care providers with questions about this recall can contact the company by email at GMB-FieldCorrectiveActionp@cardinalhealth.com or by phone at 786-313-2087.
Health care providers can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.
Higher MI shock survival with NCSI protocol: Final results
What started as an attempt to standardize care for acute myocardial infarction with cardiogenic shock at a handful of Detroit-area hospitals has led to markedly better survival rates than the traditional flip of a coin, in a nationwide analysis.
Final results from the National Cardiogenic Shock Initiative (NCSI) show 71% of patients survived to discharge and 68% were alive at 30 days.
Patients presenting in stage C or D shock, who comprised the bulk of patients in previous trials, had survival rates of 79% and 77%, respectively.
Among stage E patients, who are in extremis and have typical survival rates of less than 20%, survival was 54% at discharge and 49% at 30 days, co–principal investigator Babar Basir, DO, Henry Ford Hospital, Detroit, reported at the Society for Cardiovascular Angiography and Interventions (SCAI) annual scientific sessions, held virtually.
“This is the first push to really be able to consistently get survival rates over 50%, particularly in those patients who presented in stage C and D shock,” he said. “Really, it’s important to emphasize here the hard work it’s taken to get to this point and all the research that’s been done.”
The NCSI protocol emphasizes rapid identification and support of cardiogenic shock (door to support time <90 minutes), early placement of the Impella (Abiomed) ventricular assist device prior to percutaneous coronary intervention (PCI), and right heart monitoring to reduce the use of inotropes and vasopressors.
Co–principal investigator William O’Neill, MD, also from Henry Ford, previously reported results from the pilot study showing 84% of 30 patients survived to discharge.
The present analysis was based on outcomes of 406 consecutive acute MI patients (mean age, 63.7 years; 24% female) who presented with cardiogenic shock at 32 academic and 48 community hospitals in 29 states and the District of Columbia.
Dr. Basir emphasized that this is the largest prospective North American acute MI cardiogenic shock study in 20 years and recruited “one of the sickest cohorts ever studied.” The average blood pressure among the patients was 77/50 mm Hg; 77% had a lactate of at least 2 mmol/L (mean, 4.8 mmol/L), and 25% were in stage E shock.
One-quarter of patients were transferred from other institutions, 82% presented with ST-segment elevation MI, two-thirds had multivessel disease, and 13% had a left main culprit lesion.
Right heart catheterization was used in 90% of patients, an Impella CP device in 92%, an Impella 2.5 device in 5%, femoral access PCI in 78%, and aspiration thrombectomy in a full 27%.
Despite this sick cohort, survival at 30 days was better than in any previous study of cardiogenic shock, Dr. Basir said. In comparison, 30-day survival rates were 53%, 60%, and 49% in the SHOCK, IABP SHOCK, and CULPRIT SHOCK trials, respectively.
That said, survival over the course of the first year fell to 53% in the entire cohort, 62% in patients with stage C or D shock, and 31% in those in stage E shock.
“One-year mortality continues to be a problem for these patients and emphasizes the need for goal-directed medical therapy, early advanced heart failure follow-up, and novel therapies such as what we are planning with the evaluation of [supersaturated oxygen] SSO2 to reduce infarct sizes in the ISO-SHOCK trial,” set to begin later this year, Dr. Basir said.
Given the promising results in the NCSI, the randomized controlled RECOVER IV trial is planned to begin in 2022, he noted. It will assess whether Impella pre-PCI is superior to PCI without Impella in patients with inclusion criteria similar to that of the NCSI. The DanGer Shock randomized trial is ongoing in Denmark and Germany and assessing all-cause mortality at 6 months with the Impella CP device compared with standard of care.
“We hypothesize that greater utilization of this protocol, and refinement of the escalation strategies will consistently lead to a survival rate greater than 80%,” Dr. Basir concluded.
Past SCAI president Kirk Garratt, MD, Christiana Care, Newark, Del., who moderated a press conference where the data were highlighted, noted that late complications led to a roughly 20% absolute mortality increase from discharge to 1 year, and questioned what percentage could be attributed to the mechanical support offered.
Dr. Basir said that information was not specifically tracked but that many patients presented with multiorgan failure and, irrespective of that, the majority died from ongoing heart failure.
During the formal presentation, panelist Ron Waksman, MD, MedStar Heart Institute, Washington, questioned whether results were different between academic and community centers, but also pointed to the lack of a comparator in the single-arm study.
“It’s very hard to do any comparison historically; we do need to have a control group,” he said. “If you would have opened it to any treatment at the time of the initiative, which is great, but not just limit it to use of the Impella devices, we would have better understanding if there is really a differentiation between one device versus the other devices.”
Dr. Basir replied, “I think that is a very reasonable comment and, in regard to your question, it is always difficult to differentiate between academic and community centers, but these were large community programs that have all of the technologies available in an academic center.”
NCIS is funded in part by unrestricted grants from Abiomed and Chiesi. Dr. Basir reported consulting for Abbott Vascular, Abiomed, Cardiovascular Systems, Chiesi, Procyrion, and Zoll.
A version of this article first appeared on Medscape.com.
What started as an attempt to standardize care for acute myocardial infarction with cardiogenic shock at a handful of Detroit-area hospitals has led to markedly better survival rates than the traditional flip of a coin, in a nationwide analysis.
Final results from the National Cardiogenic Shock Initiative (NCSI) show 71% of patients survived to discharge and 68% were alive at 30 days.
Patients presenting in stage C or D shock, who comprised the bulk of patients in previous trials, had survival rates of 79% and 77%, respectively.
Among stage E patients, who are in extremis and have typical survival rates of less than 20%, survival was 54% at discharge and 49% at 30 days, co–principal investigator Babar Basir, DO, Henry Ford Hospital, Detroit, reported at the Society for Cardiovascular Angiography and Interventions (SCAI) annual scientific sessions, held virtually.
“This is the first push to really be able to consistently get survival rates over 50%, particularly in those patients who presented in stage C and D shock,” he said. “Really, it’s important to emphasize here the hard work it’s taken to get to this point and all the research that’s been done.”
The NCSI protocol emphasizes rapid identification and support of cardiogenic shock (door to support time <90 minutes), early placement of the Impella (Abiomed) ventricular assist device prior to percutaneous coronary intervention (PCI), and right heart monitoring to reduce the use of inotropes and vasopressors.
Co–principal investigator William O’Neill, MD, also from Henry Ford, previously reported results from the pilot study showing 84% of 30 patients survived to discharge.
The present analysis was based on outcomes of 406 consecutive acute MI patients (mean age, 63.7 years; 24% female) who presented with cardiogenic shock at 32 academic and 48 community hospitals in 29 states and the District of Columbia.
Dr. Basir emphasized that this is the largest prospective North American acute MI cardiogenic shock study in 20 years and recruited “one of the sickest cohorts ever studied.” The average blood pressure among the patients was 77/50 mm Hg; 77% had a lactate of at least 2 mmol/L (mean, 4.8 mmol/L), and 25% were in stage E shock.
One-quarter of patients were transferred from other institutions, 82% presented with ST-segment elevation MI, two-thirds had multivessel disease, and 13% had a left main culprit lesion.
Right heart catheterization was used in 90% of patients, an Impella CP device in 92%, an Impella 2.5 device in 5%, femoral access PCI in 78%, and aspiration thrombectomy in a full 27%.
Despite this sick cohort, survival at 30 days was better than in any previous study of cardiogenic shock, Dr. Basir said. In comparison, 30-day survival rates were 53%, 60%, and 49% in the SHOCK, IABP SHOCK, and CULPRIT SHOCK trials, respectively.
That said, survival over the course of the first year fell to 53% in the entire cohort, 62% in patients with stage C or D shock, and 31% in those in stage E shock.
“One-year mortality continues to be a problem for these patients and emphasizes the need for goal-directed medical therapy, early advanced heart failure follow-up, and novel therapies such as what we are planning with the evaluation of [supersaturated oxygen] SSO2 to reduce infarct sizes in the ISO-SHOCK trial,” set to begin later this year, Dr. Basir said.
Given the promising results in the NCSI, the randomized controlled RECOVER IV trial is planned to begin in 2022, he noted. It will assess whether Impella pre-PCI is superior to PCI without Impella in patients with inclusion criteria similar to that of the NCSI. The DanGer Shock randomized trial is ongoing in Denmark and Germany and assessing all-cause mortality at 6 months with the Impella CP device compared with standard of care.
“We hypothesize that greater utilization of this protocol, and refinement of the escalation strategies will consistently lead to a survival rate greater than 80%,” Dr. Basir concluded.
Past SCAI president Kirk Garratt, MD, Christiana Care, Newark, Del., who moderated a press conference where the data were highlighted, noted that late complications led to a roughly 20% absolute mortality increase from discharge to 1 year, and questioned what percentage could be attributed to the mechanical support offered.
Dr. Basir said that information was not specifically tracked but that many patients presented with multiorgan failure and, irrespective of that, the majority died from ongoing heart failure.
During the formal presentation, panelist Ron Waksman, MD, MedStar Heart Institute, Washington, questioned whether results were different between academic and community centers, but also pointed to the lack of a comparator in the single-arm study.
“It’s very hard to do any comparison historically; we do need to have a control group,” he said. “If you would have opened it to any treatment at the time of the initiative, which is great, but not just limit it to use of the Impella devices, we would have better understanding if there is really a differentiation between one device versus the other devices.”
Dr. Basir replied, “I think that is a very reasonable comment and, in regard to your question, it is always difficult to differentiate between academic and community centers, but these were large community programs that have all of the technologies available in an academic center.”
NCIS is funded in part by unrestricted grants from Abiomed and Chiesi. Dr. Basir reported consulting for Abbott Vascular, Abiomed, Cardiovascular Systems, Chiesi, Procyrion, and Zoll.
A version of this article first appeared on Medscape.com.
What started as an attempt to standardize care for acute myocardial infarction with cardiogenic shock at a handful of Detroit-area hospitals has led to markedly better survival rates than the traditional flip of a coin, in a nationwide analysis.
Final results from the National Cardiogenic Shock Initiative (NCSI) show 71% of patients survived to discharge and 68% were alive at 30 days.
Patients presenting in stage C or D shock, who comprised the bulk of patients in previous trials, had survival rates of 79% and 77%, respectively.
Among stage E patients, who are in extremis and have typical survival rates of less than 20%, survival was 54% at discharge and 49% at 30 days, co–principal investigator Babar Basir, DO, Henry Ford Hospital, Detroit, reported at the Society for Cardiovascular Angiography and Interventions (SCAI) annual scientific sessions, held virtually.
“This is the first push to really be able to consistently get survival rates over 50%, particularly in those patients who presented in stage C and D shock,” he said. “Really, it’s important to emphasize here the hard work it’s taken to get to this point and all the research that’s been done.”
The NCSI protocol emphasizes rapid identification and support of cardiogenic shock (door to support time <90 minutes), early placement of the Impella (Abiomed) ventricular assist device prior to percutaneous coronary intervention (PCI), and right heart monitoring to reduce the use of inotropes and vasopressors.
Co–principal investigator William O’Neill, MD, also from Henry Ford, previously reported results from the pilot study showing 84% of 30 patients survived to discharge.
The present analysis was based on outcomes of 406 consecutive acute MI patients (mean age, 63.7 years; 24% female) who presented with cardiogenic shock at 32 academic and 48 community hospitals in 29 states and the District of Columbia.
Dr. Basir emphasized that this is the largest prospective North American acute MI cardiogenic shock study in 20 years and recruited “one of the sickest cohorts ever studied.” The average blood pressure among the patients was 77/50 mm Hg; 77% had a lactate of at least 2 mmol/L (mean, 4.8 mmol/L), and 25% were in stage E shock.
One-quarter of patients were transferred from other institutions, 82% presented with ST-segment elevation MI, two-thirds had multivessel disease, and 13% had a left main culprit lesion.
Right heart catheterization was used in 90% of patients, an Impella CP device in 92%, an Impella 2.5 device in 5%, femoral access PCI in 78%, and aspiration thrombectomy in a full 27%.
Despite this sick cohort, survival at 30 days was better than in any previous study of cardiogenic shock, Dr. Basir said. In comparison, 30-day survival rates were 53%, 60%, and 49% in the SHOCK, IABP SHOCK, and CULPRIT SHOCK trials, respectively.
That said, survival over the course of the first year fell to 53% in the entire cohort, 62% in patients with stage C or D shock, and 31% in those in stage E shock.
“One-year mortality continues to be a problem for these patients and emphasizes the need for goal-directed medical therapy, early advanced heart failure follow-up, and novel therapies such as what we are planning with the evaluation of [supersaturated oxygen] SSO2 to reduce infarct sizes in the ISO-SHOCK trial,” set to begin later this year, Dr. Basir said.
Given the promising results in the NCSI, the randomized controlled RECOVER IV trial is planned to begin in 2022, he noted. It will assess whether Impella pre-PCI is superior to PCI without Impella in patients with inclusion criteria similar to that of the NCSI. The DanGer Shock randomized trial is ongoing in Denmark and Germany and assessing all-cause mortality at 6 months with the Impella CP device compared with standard of care.
“We hypothesize that greater utilization of this protocol, and refinement of the escalation strategies will consistently lead to a survival rate greater than 80%,” Dr. Basir concluded.
Past SCAI president Kirk Garratt, MD, Christiana Care, Newark, Del., who moderated a press conference where the data were highlighted, noted that late complications led to a roughly 20% absolute mortality increase from discharge to 1 year, and questioned what percentage could be attributed to the mechanical support offered.
Dr. Basir said that information was not specifically tracked but that many patients presented with multiorgan failure and, irrespective of that, the majority died from ongoing heart failure.
During the formal presentation, panelist Ron Waksman, MD, MedStar Heart Institute, Washington, questioned whether results were different between academic and community centers, but also pointed to the lack of a comparator in the single-arm study.
“It’s very hard to do any comparison historically; we do need to have a control group,” he said. “If you would have opened it to any treatment at the time of the initiative, which is great, but not just limit it to use of the Impella devices, we would have better understanding if there is really a differentiation between one device versus the other devices.”
Dr. Basir replied, “I think that is a very reasonable comment and, in regard to your question, it is always difficult to differentiate between academic and community centers, but these were large community programs that have all of the technologies available in an academic center.”
NCIS is funded in part by unrestricted grants from Abiomed and Chiesi. Dr. Basir reported consulting for Abbott Vascular, Abiomed, Cardiovascular Systems, Chiesi, Procyrion, and Zoll.
A version of this article first appeared on Medscape.com.
Modest clinical gain for AF screening of asymptomatic elderly: STROKESTOP
Some, perhaps many, previously unrecognized cases of atrial fibrillation (AF) will come to light in a screening program aimed at older asymptomatic adults. The key question is whether the challenges of such systematic but age-restricted AF screening in the community, with oral anticoagulation (OAC) offered to those found to have the arrhythmia, is worthwhile in preventing events such as death or stroke.
Now there is evidence supporting such a clinical benefit from a large, prospective, randomized trial. A screening program restricted to people 75 or 76 years of age in two Swedish communities, which called on them to use a handheld single-lead ECG system at home intermittently for 2 weeks, was followed by a slight drop in clinical events over about 7 years.
The 4% decline in risk (P = .045) in the STROKESTOP trial’s “intention-to-treat” (ITT) analysis yielded a number needed to treat of 91; that is, that many people had to be targeted by the screening program to prevent one primary-endpoint clinical event.
Those included ischemic stroke, systemic thromboembolism, hospitalization for severe bleeding, and death from any cause, investigators reported April 23 during the virtual European Heart Rhythm Association (EHRA) 2021 Congress.
If that benefit and its significance seem marginal, some secondary findings might be reassuring. Half the population of the target age in the two communities – 13,979 randomly selected people – were invited to join the trial and follow the screening protocol, comprising the ITT cohort. The other half, numbering 13,996, was not invited and served as control subjects.
However, only 51% of the ITT cohort accepted the invitation and participated in the trial; they represented the “as-treated” cohort, observed Emma Svennberg, MD, PhD, Karolinska Institute, Danderyd Hospital, Stockholm, who presented the analysis at the EHRA sessions.
The screening protocol identified untreated AF, whether previously known or unknown, in about 5% of the 7,165 as-treated screening participants; OAC was initiated in about three-fourths of those cases.
The as-treated group, on their own, benefited with a 24% drop in the prospectively defined secondary endpoint of ischemic stroke, compared with the entire control group.
The clinical benefit in the ITT population was “small but significant,” but over the same period in the as-treated cohort, there was a highly significant drop in risk for ischemic stroke, Dr. Svennberg said in an interview.
The trial’s lead message, she said, is that “screening for atrial fibrillation in an elderly population reduces the risk of death and ischemic stroke without increasing the risk of bleeding.”
Caveats: As-treated vs. ITT
But there are caveats that complicate interpretation of the trial and, Dr. Svennberg proposed, point to the importance of that interpretation of both the ITT and as-treated analyses.
“We detected significantly more atrial fibrillation in the group that was randomized to screening. A major strength of our study was that we referred all of those individuals for a structured follow-up within the study,” she said. “Although the focus of the follow-up was oral anticoagulant therapy, other risk factors were also assessed and managed, such as hypertension and diabetes.”
It’s possible that increased detection of AF followed by such structured management contributed to the observed benefit, Dr. Svennberg proposed.
However, the exclusion of those in the prespecified ITT population who declined to be screened or otherwise didn’t participate left an as-treated cohort that was healthier than the ITT population or the control group.
Indeed, the nonparticipating invitees were sicker, with significantly more diabetes, vascular disease, hypertension, and heart failure, and higher CHA2DS2VASc stroke risk scores than those who agreed to participate.
“We took a more difficult route in setting up this study, in that we identified all individuals aged 75 to 76 residing in our two regions and excluded no one,” Dr. Svennberg said in an interview. “That means even individuals with end-stage disease, severe dementia, bedridden in nursing homes, et cetera, were also randomized but perhaps not likely or eligible to participate.”
Therefore, some invitees were unable to join the study even as others might have declined “out of low interest” or other personal reasons, she said. “We believe that this mimics how a population-based screening program would be performed if done in our country.”
In the ITT analysis, screening successfully identified previously unknown or untreated cases of AF, which led to expanded OAC use and intensified risk-factor management, “which was key to a successful outcome.”
In the as-treated analysis, Dr. Svennberg said, “I think a combination of the intervention and the population being overall more healthy was driving the secondary endpoint.”
Systematic vs. opportunistic screening
Although “opportunistic screening in individuals aged 65 and older” is recommended by current European Society of Cardiology guidelines, systematic screening, such as that used in STROKESTOP, has a much weaker evidence base, observed Renate B. Schnabel, MD, PhD, University Heart & Vascular Center, Hamburg, Germany, as the invited discussant after the STROKESTOP presentation.
STROKESTOP “is one of the first studies, if not the first study,” to show a clinical benefit from screening for AF, Dr. Schnabel said.
Fewer-than-projected primary outcome events were seen during the trial, and event curves for screened and control participants didn’t start to separate until about 4 years into the study, she said. It therefore might take a long time for the screened elderly to realize the clinical benefits of screening.
Studies such as the recent SCREEN-AF and mSTOPS have amply shown that AF screening in the asymptomatic elderly can reveal previously unrecognized AF far more often than would be detected in routine practice, allowing them the opportunity to go on OAC. But the trials weren’t able to show whether the benefits of such management outweigh the risks or costs.
Indeed, on April 20, the U.S. Preventive Services Task Force (USPSTF) released a draft recommendation statement concluding that “the current evidence is insufficient to assess the balance of benefits and harms” associated with AF screening in asymptomatic people at least 50 years of age.
In STROKESTOP, however, benefit for the primary outcome reached significance in the prespecified ITT analysis and “appeared to be driven by the reduction in ischemic stroke incidence,” Dr. Schnabel said.
“The future guidelines have gained strong evidence to judge on systematic atrial fibrillation screening” as it was performed in the trial, she said. “How to implement atrial fibrillation screening, including systematic screening in health care systems across Europe and beyond, remains an open question.”
A randomized population
STROKESTOP considered all 75- and 76-year-olds living in Sweden’s Stockholm County (n = 23,888) and the Halland region (n = 4,880) and randomly assigned them to the ITT group or a control group, with stratification by sex, birth year, and geographic region. In both groups, 54.6% were female and the mean CHA2DS2VASc score was 3.5.
People assigned to the ITT cohort were invited to be screened and followed. Those who agreed to participate underwent a baseline ECG assessment to detect or rule out permanent AF. Guideline-based OAC and follow-up was offered to those found with the arrhythmia. Those in sinus rhythm with no history of AF used a handheld single-lead ECG recorder (Zenicor) for 30 seconds twice daily for 14 days.
Structured management, including OAC, was offered to anyone demonstrating sufficient AF, that is, at least one bout without p waves in one 30-second recording or at least two such episodes lasting 10-29 seconds during the 2-week screening period.
In the ITT analysis, the hazard ratio (HR) for the composite clinical primary endpoint was 0.96 (95% confidence interval, 0.920-0.999; P = .045), but in the as-treated analysis, the HR for ischemic stroke was 0.76 (95% CI, 0.68-0.87; P < .001).
“I believe that this will likely be generalizable to most countries’ elderly residents,” Dr. Svennberg said. “I think if we can find a significant difference in our elderly population in Sweden, most countries will be able to do so, or find even more significant results.”
That’s because “baseline detection of AF in Sweden is high,” she said, “so new detection is likely more difficult.” Also, in Sweden, “care can be sought without monetary concern, and prescriptions are provided at low costs to the patients.” Therefore, patients newly identified with AF, whether in studies or not, “would likely be started on therapy.”
It will be important to know whether the screening strategy is cost-effective, Dr. Schnabel said, because “the overall effect, with a hazard ratio of 0.96, is not too big, and costs incurred by systematic screening are comparatively high.”
STROKESTOP “now provides sound information for cost-effectiveness analyses, which to date have largely relied on assumptions.”
STROKESTOP was partially supported by Carl Bennet AB, Boehringer-Ingelheim, Bayer, Bristol-Meyers Squibb, and Pfizer. Dr. Svennberg disclosed receiving fees for lectures or consulting from Bayer, Bristol-Meyers Squibb, Pfizer, Boehringer-Ingelheim, Merck Sharp & Dohme, and Sanofi; and institutional grants from Roche Diagnostics and Carl Bennett Ltd.
A version of this article first appeared on Medscape.com.
Some, perhaps many, previously unrecognized cases of atrial fibrillation (AF) will come to light in a screening program aimed at older asymptomatic adults. The key question is whether the challenges of such systematic but age-restricted AF screening in the community, with oral anticoagulation (OAC) offered to those found to have the arrhythmia, is worthwhile in preventing events such as death or stroke.
Now there is evidence supporting such a clinical benefit from a large, prospective, randomized trial. A screening program restricted to people 75 or 76 years of age in two Swedish communities, which called on them to use a handheld single-lead ECG system at home intermittently for 2 weeks, was followed by a slight drop in clinical events over about 7 years.
The 4% decline in risk (P = .045) in the STROKESTOP trial’s “intention-to-treat” (ITT) analysis yielded a number needed to treat of 91; that is, that many people had to be targeted by the screening program to prevent one primary-endpoint clinical event.
Those included ischemic stroke, systemic thromboembolism, hospitalization for severe bleeding, and death from any cause, investigators reported April 23 during the virtual European Heart Rhythm Association (EHRA) 2021 Congress.
If that benefit and its significance seem marginal, some secondary findings might be reassuring. Half the population of the target age in the two communities – 13,979 randomly selected people – were invited to join the trial and follow the screening protocol, comprising the ITT cohort. The other half, numbering 13,996, was not invited and served as control subjects.
However, only 51% of the ITT cohort accepted the invitation and participated in the trial; they represented the “as-treated” cohort, observed Emma Svennberg, MD, PhD, Karolinska Institute, Danderyd Hospital, Stockholm, who presented the analysis at the EHRA sessions.
The screening protocol identified untreated AF, whether previously known or unknown, in about 5% of the 7,165 as-treated screening participants; OAC was initiated in about three-fourths of those cases.
The as-treated group, on their own, benefited with a 24% drop in the prospectively defined secondary endpoint of ischemic stroke, compared with the entire control group.
The clinical benefit in the ITT population was “small but significant,” but over the same period in the as-treated cohort, there was a highly significant drop in risk for ischemic stroke, Dr. Svennberg said in an interview.
The trial’s lead message, she said, is that “screening for atrial fibrillation in an elderly population reduces the risk of death and ischemic stroke without increasing the risk of bleeding.”
Caveats: As-treated vs. ITT
But there are caveats that complicate interpretation of the trial and, Dr. Svennberg proposed, point to the importance of that interpretation of both the ITT and as-treated analyses.
“We detected significantly more atrial fibrillation in the group that was randomized to screening. A major strength of our study was that we referred all of those individuals for a structured follow-up within the study,” she said. “Although the focus of the follow-up was oral anticoagulant therapy, other risk factors were also assessed and managed, such as hypertension and diabetes.”
It’s possible that increased detection of AF followed by such structured management contributed to the observed benefit, Dr. Svennberg proposed.
However, the exclusion of those in the prespecified ITT population who declined to be screened or otherwise didn’t participate left an as-treated cohort that was healthier than the ITT population or the control group.
Indeed, the nonparticipating invitees were sicker, with significantly more diabetes, vascular disease, hypertension, and heart failure, and higher CHA2DS2VASc stroke risk scores than those who agreed to participate.
“We took a more difficult route in setting up this study, in that we identified all individuals aged 75 to 76 residing in our two regions and excluded no one,” Dr. Svennberg said in an interview. “That means even individuals with end-stage disease, severe dementia, bedridden in nursing homes, et cetera, were also randomized but perhaps not likely or eligible to participate.”
Therefore, some invitees were unable to join the study even as others might have declined “out of low interest” or other personal reasons, she said. “We believe that this mimics how a population-based screening program would be performed if done in our country.”
In the ITT analysis, screening successfully identified previously unknown or untreated cases of AF, which led to expanded OAC use and intensified risk-factor management, “which was key to a successful outcome.”
In the as-treated analysis, Dr. Svennberg said, “I think a combination of the intervention and the population being overall more healthy was driving the secondary endpoint.”
Systematic vs. opportunistic screening
Although “opportunistic screening in individuals aged 65 and older” is recommended by current European Society of Cardiology guidelines, systematic screening, such as that used in STROKESTOP, has a much weaker evidence base, observed Renate B. Schnabel, MD, PhD, University Heart & Vascular Center, Hamburg, Germany, as the invited discussant after the STROKESTOP presentation.
STROKESTOP “is one of the first studies, if not the first study,” to show a clinical benefit from screening for AF, Dr. Schnabel said.
Fewer-than-projected primary outcome events were seen during the trial, and event curves for screened and control participants didn’t start to separate until about 4 years into the study, she said. It therefore might take a long time for the screened elderly to realize the clinical benefits of screening.
Studies such as the recent SCREEN-AF and mSTOPS have amply shown that AF screening in the asymptomatic elderly can reveal previously unrecognized AF far more often than would be detected in routine practice, allowing them the opportunity to go on OAC. But the trials weren’t able to show whether the benefits of such management outweigh the risks or costs.
Indeed, on April 20, the U.S. Preventive Services Task Force (USPSTF) released a draft recommendation statement concluding that “the current evidence is insufficient to assess the balance of benefits and harms” associated with AF screening in asymptomatic people at least 50 years of age.
In STROKESTOP, however, benefit for the primary outcome reached significance in the prespecified ITT analysis and “appeared to be driven by the reduction in ischemic stroke incidence,” Dr. Schnabel said.
“The future guidelines have gained strong evidence to judge on systematic atrial fibrillation screening” as it was performed in the trial, she said. “How to implement atrial fibrillation screening, including systematic screening in health care systems across Europe and beyond, remains an open question.”
A randomized population
STROKESTOP considered all 75- and 76-year-olds living in Sweden’s Stockholm County (n = 23,888) and the Halland region (n = 4,880) and randomly assigned them to the ITT group or a control group, with stratification by sex, birth year, and geographic region. In both groups, 54.6% were female and the mean CHA2DS2VASc score was 3.5.
People assigned to the ITT cohort were invited to be screened and followed. Those who agreed to participate underwent a baseline ECG assessment to detect or rule out permanent AF. Guideline-based OAC and follow-up was offered to those found with the arrhythmia. Those in sinus rhythm with no history of AF used a handheld single-lead ECG recorder (Zenicor) for 30 seconds twice daily for 14 days.
Structured management, including OAC, was offered to anyone demonstrating sufficient AF, that is, at least one bout without p waves in one 30-second recording or at least two such episodes lasting 10-29 seconds during the 2-week screening period.
In the ITT analysis, the hazard ratio (HR) for the composite clinical primary endpoint was 0.96 (95% confidence interval, 0.920-0.999; P = .045), but in the as-treated analysis, the HR for ischemic stroke was 0.76 (95% CI, 0.68-0.87; P < .001).
“I believe that this will likely be generalizable to most countries’ elderly residents,” Dr. Svennberg said. “I think if we can find a significant difference in our elderly population in Sweden, most countries will be able to do so, or find even more significant results.”
That’s because “baseline detection of AF in Sweden is high,” she said, “so new detection is likely more difficult.” Also, in Sweden, “care can be sought without monetary concern, and prescriptions are provided at low costs to the patients.” Therefore, patients newly identified with AF, whether in studies or not, “would likely be started on therapy.”
It will be important to know whether the screening strategy is cost-effective, Dr. Schnabel said, because “the overall effect, with a hazard ratio of 0.96, is not too big, and costs incurred by systematic screening are comparatively high.”
STROKESTOP “now provides sound information for cost-effectiveness analyses, which to date have largely relied on assumptions.”
STROKESTOP was partially supported by Carl Bennet AB, Boehringer-Ingelheim, Bayer, Bristol-Meyers Squibb, and Pfizer. Dr. Svennberg disclosed receiving fees for lectures or consulting from Bayer, Bristol-Meyers Squibb, Pfizer, Boehringer-Ingelheim, Merck Sharp & Dohme, and Sanofi; and institutional grants from Roche Diagnostics and Carl Bennett Ltd.
A version of this article first appeared on Medscape.com.
Some, perhaps many, previously unrecognized cases of atrial fibrillation (AF) will come to light in a screening program aimed at older asymptomatic adults. The key question is whether the challenges of such systematic but age-restricted AF screening in the community, with oral anticoagulation (OAC) offered to those found to have the arrhythmia, is worthwhile in preventing events such as death or stroke.
Now there is evidence supporting such a clinical benefit from a large, prospective, randomized trial. A screening program restricted to people 75 or 76 years of age in two Swedish communities, which called on them to use a handheld single-lead ECG system at home intermittently for 2 weeks, was followed by a slight drop in clinical events over about 7 years.
The 4% decline in risk (P = .045) in the STROKESTOP trial’s “intention-to-treat” (ITT) analysis yielded a number needed to treat of 91; that is, that many people had to be targeted by the screening program to prevent one primary-endpoint clinical event.
Those included ischemic stroke, systemic thromboembolism, hospitalization for severe bleeding, and death from any cause, investigators reported April 23 during the virtual European Heart Rhythm Association (EHRA) 2021 Congress.
If that benefit and its significance seem marginal, some secondary findings might be reassuring. Half the population of the target age in the two communities – 13,979 randomly selected people – were invited to join the trial and follow the screening protocol, comprising the ITT cohort. The other half, numbering 13,996, was not invited and served as control subjects.
However, only 51% of the ITT cohort accepted the invitation and participated in the trial; they represented the “as-treated” cohort, observed Emma Svennberg, MD, PhD, Karolinska Institute, Danderyd Hospital, Stockholm, who presented the analysis at the EHRA sessions.
The screening protocol identified untreated AF, whether previously known or unknown, in about 5% of the 7,165 as-treated screening participants; OAC was initiated in about three-fourths of those cases.
The as-treated group, on their own, benefited with a 24% drop in the prospectively defined secondary endpoint of ischemic stroke, compared with the entire control group.
The clinical benefit in the ITT population was “small but significant,” but over the same period in the as-treated cohort, there was a highly significant drop in risk for ischemic stroke, Dr. Svennberg said in an interview.
The trial’s lead message, she said, is that “screening for atrial fibrillation in an elderly population reduces the risk of death and ischemic stroke without increasing the risk of bleeding.”
Caveats: As-treated vs. ITT
But there are caveats that complicate interpretation of the trial and, Dr. Svennberg proposed, point to the importance of that interpretation of both the ITT and as-treated analyses.
“We detected significantly more atrial fibrillation in the group that was randomized to screening. A major strength of our study was that we referred all of those individuals for a structured follow-up within the study,” she said. “Although the focus of the follow-up was oral anticoagulant therapy, other risk factors were also assessed and managed, such as hypertension and diabetes.”
It’s possible that increased detection of AF followed by such structured management contributed to the observed benefit, Dr. Svennberg proposed.
However, the exclusion of those in the prespecified ITT population who declined to be screened or otherwise didn’t participate left an as-treated cohort that was healthier than the ITT population or the control group.
Indeed, the nonparticipating invitees were sicker, with significantly more diabetes, vascular disease, hypertension, and heart failure, and higher CHA2DS2VASc stroke risk scores than those who agreed to participate.
“We took a more difficult route in setting up this study, in that we identified all individuals aged 75 to 76 residing in our two regions and excluded no one,” Dr. Svennberg said in an interview. “That means even individuals with end-stage disease, severe dementia, bedridden in nursing homes, et cetera, were also randomized but perhaps not likely or eligible to participate.”
Therefore, some invitees were unable to join the study even as others might have declined “out of low interest” or other personal reasons, she said. “We believe that this mimics how a population-based screening program would be performed if done in our country.”
In the ITT analysis, screening successfully identified previously unknown or untreated cases of AF, which led to expanded OAC use and intensified risk-factor management, “which was key to a successful outcome.”
In the as-treated analysis, Dr. Svennberg said, “I think a combination of the intervention and the population being overall more healthy was driving the secondary endpoint.”
Systematic vs. opportunistic screening
Although “opportunistic screening in individuals aged 65 and older” is recommended by current European Society of Cardiology guidelines, systematic screening, such as that used in STROKESTOP, has a much weaker evidence base, observed Renate B. Schnabel, MD, PhD, University Heart & Vascular Center, Hamburg, Germany, as the invited discussant after the STROKESTOP presentation.
STROKESTOP “is one of the first studies, if not the first study,” to show a clinical benefit from screening for AF, Dr. Schnabel said.
Fewer-than-projected primary outcome events were seen during the trial, and event curves for screened and control participants didn’t start to separate until about 4 years into the study, she said. It therefore might take a long time for the screened elderly to realize the clinical benefits of screening.
Studies such as the recent SCREEN-AF and mSTOPS have amply shown that AF screening in the asymptomatic elderly can reveal previously unrecognized AF far more often than would be detected in routine practice, allowing them the opportunity to go on OAC. But the trials weren’t able to show whether the benefits of such management outweigh the risks or costs.
Indeed, on April 20, the U.S. Preventive Services Task Force (USPSTF) released a draft recommendation statement concluding that “the current evidence is insufficient to assess the balance of benefits and harms” associated with AF screening in asymptomatic people at least 50 years of age.
In STROKESTOP, however, benefit for the primary outcome reached significance in the prespecified ITT analysis and “appeared to be driven by the reduction in ischemic stroke incidence,” Dr. Schnabel said.
“The future guidelines have gained strong evidence to judge on systematic atrial fibrillation screening” as it was performed in the trial, she said. “How to implement atrial fibrillation screening, including systematic screening in health care systems across Europe and beyond, remains an open question.”
A randomized population
STROKESTOP considered all 75- and 76-year-olds living in Sweden’s Stockholm County (n = 23,888) and the Halland region (n = 4,880) and randomly assigned them to the ITT group or a control group, with stratification by sex, birth year, and geographic region. In both groups, 54.6% were female and the mean CHA2DS2VASc score was 3.5.
People assigned to the ITT cohort were invited to be screened and followed. Those who agreed to participate underwent a baseline ECG assessment to detect or rule out permanent AF. Guideline-based OAC and follow-up was offered to those found with the arrhythmia. Those in sinus rhythm with no history of AF used a handheld single-lead ECG recorder (Zenicor) for 30 seconds twice daily for 14 days.
Structured management, including OAC, was offered to anyone demonstrating sufficient AF, that is, at least one bout without p waves in one 30-second recording or at least two such episodes lasting 10-29 seconds during the 2-week screening period.
In the ITT analysis, the hazard ratio (HR) for the composite clinical primary endpoint was 0.96 (95% confidence interval, 0.920-0.999; P = .045), but in the as-treated analysis, the HR for ischemic stroke was 0.76 (95% CI, 0.68-0.87; P < .001).
“I believe that this will likely be generalizable to most countries’ elderly residents,” Dr. Svennberg said. “I think if we can find a significant difference in our elderly population in Sweden, most countries will be able to do so, or find even more significant results.”
That’s because “baseline detection of AF in Sweden is high,” she said, “so new detection is likely more difficult.” Also, in Sweden, “care can be sought without monetary concern, and prescriptions are provided at low costs to the patients.” Therefore, patients newly identified with AF, whether in studies or not, “would likely be started on therapy.”
It will be important to know whether the screening strategy is cost-effective, Dr. Schnabel said, because “the overall effect, with a hazard ratio of 0.96, is not too big, and costs incurred by systematic screening are comparatively high.”
STROKESTOP “now provides sound information for cost-effectiveness analyses, which to date have largely relied on assumptions.”
STROKESTOP was partially supported by Carl Bennet AB, Boehringer-Ingelheim, Bayer, Bristol-Meyers Squibb, and Pfizer. Dr. Svennberg disclosed receiving fees for lectures or consulting from Bayer, Bristol-Meyers Squibb, Pfizer, Boehringer-Ingelheim, Merck Sharp & Dohme, and Sanofi; and institutional grants from Roche Diagnostics and Carl Bennett Ltd.
A version of this article first appeared on Medscape.com.