The Hospitalist

Even as the number of new COVID-19 cases continues to drop, the United States reached the 4-million mark for infected children, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The total number of children with COVID-19 was 4,008,572 as of June 10 after just under 14,500 new cases were reported over the preceding week. That weekly total, the lowest since June of 2020, comes from 49 states (excluding N.Y.), the District of Columbia, New York City, Puerto Rico, and Guam, the AAP and CHA said in their weekly COVID-19 report.

Children represent 14.1% of all COVID-19 cases since the beginning of the pandemic, while the corresponding figure for the week ending June 10 was 19.0%. That weekly proportion of cases among children had been rising pretty steadily through the winter and early spring, but the situation has become much more volatile over the last month, the AAP/CHA data show.

Use of the Pfizer-BioNTech vaccine in children aged 16-17 years, of course, didn’t begin until April, and the vaccine wasn’t authorized for children aged 12-15 years until mid-May. The Moderna and Johnson & Johnson vaccines have not received such authorization yet, but Moderna is in the process of seeking an emergency-use recommendation from the Food and Drug Administration.

In the younger group of children who are currently eligible, completion of the vaccine regimen took a big jump in the week ending June 14, according to the Centers for Disease Control and Prevention. The cumulative share of those aged 12-15 years who had received a second dose jumped from 4.1% on June 7 to 11.4% on June 14, with comparable numbers for 16- and 17-year-olds coming in at 26.4% and 29.1%.

Activity over just the last 14 days, however, shows a slight decrease in children aged 12-15 getting a first dose: For just the 2 weeks ending June 7, 17.9% of all children in the age group initiated a first dose, but for the 14 days ending June 14, only 17.1% of the age group did so, the CDC said on its COVID Data Tracker site.

For children aged 16-17 years – of whom less than 30% have reached full vaccination – activity seems to have stagnated: 4.8% of all 16- to 17-year-olds initiated a first vaccination during the 14 days ending June 7, compared with 4.7% who did so during the 14 days ending June 14, the CDC reported.

Older age groups with higher completion rates are still producing greater vaccine initiation. As of June 14, those aged 25-39 years had a completion rate of 41.9% and 24.0% of the age group had received a first dose in the previous 2 weeks, while 61.4% of those aged 50-64 were fully vaccinated, and 18.0% had gotten their first dose, the CDC data indicate.

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Even as the number of new COVID-19 cases continues to drop, the United States reached the 4-million mark for infected children, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The total number of children with COVID-19 was 4,008,572 as of June 10 after just under 14,500 new cases were reported over the preceding week. That weekly total, the lowest since June of 2020, comes from 49 states (excluding N.Y.), the District of Columbia, New York City, Puerto Rico, and Guam, the AAP and CHA said in their weekly COVID-19 report.

Children represent 14.1% of all COVID-19 cases since the beginning of the pandemic, while the corresponding figure for the week ending June 10 was 19.0%. That weekly proportion of cases among children had been rising pretty steadily through the winter and early spring, but the situation has become much more volatile over the last month, the AAP/CHA data show.

Use of the Pfizer-BioNTech vaccine in children aged 16-17 years, of course, didn’t begin until April, and the vaccine wasn’t authorized for children aged 12-15 years until mid-May. The Moderna and Johnson & Johnson vaccines have not received such authorization yet, but Moderna is in the process of seeking an emergency-use recommendation from the Food and Drug Administration.

In the younger group of children who are currently eligible, completion of the vaccine regimen took a big jump in the week ending June 14, according to the Centers for Disease Control and Prevention. The cumulative share of those aged 12-15 years who had received a second dose jumped from 4.1% on June 7 to 11.4% on June 14, with comparable numbers for 16- and 17-year-olds coming in at 26.4% and 29.1%.

Activity over just the last 14 days, however, shows a slight decrease in children aged 12-15 getting a first dose: For just the 2 weeks ending June 7, 17.9% of all children in the age group initiated a first dose, but for the 14 days ending June 14, only 17.1% of the age group did so, the CDC said on its COVID Data Tracker site.

For children aged 16-17 years – of whom less than 30% have reached full vaccination – activity seems to have stagnated: 4.8% of all 16- to 17-year-olds initiated a first vaccination during the 14 days ending June 7, compared with 4.7% who did so during the 14 days ending June 14, the CDC reported.

Older age groups with higher completion rates are still producing greater vaccine initiation. As of June 14, those aged 25-39 years had a completion rate of 41.9% and 24.0% of the age group had received a first dose in the previous 2 weeks, while 61.4% of those aged 50-64 were fully vaccinated, and 18.0% had gotten their first dose, the CDC data indicate.

[email protected]

Even as the number of new COVID-19 cases continues to drop, the United States reached the 4-million mark for infected children, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The total number of children with COVID-19 was 4,008,572 as of June 10 after just under 14,500 new cases were reported over the preceding week. That weekly total, the lowest since June of 2020, comes from 49 states (excluding N.Y.), the District of Columbia, New York City, Puerto Rico, and Guam, the AAP and CHA said in their weekly COVID-19 report.

Children represent 14.1% of all COVID-19 cases since the beginning of the pandemic, while the corresponding figure for the week ending June 10 was 19.0%. That weekly proportion of cases among children had been rising pretty steadily through the winter and early spring, but the situation has become much more volatile over the last month, the AAP/CHA data show.

Use of the Pfizer-BioNTech vaccine in children aged 16-17 years, of course, didn’t begin until April, and the vaccine wasn’t authorized for children aged 12-15 years until mid-May. The Moderna and Johnson & Johnson vaccines have not received such authorization yet, but Moderna is in the process of seeking an emergency-use recommendation from the Food and Drug Administration.

In the younger group of children who are currently eligible, completion of the vaccine regimen took a big jump in the week ending June 14, according to the Centers for Disease Control and Prevention. The cumulative share of those aged 12-15 years who had received a second dose jumped from 4.1% on June 7 to 11.4% on June 14, with comparable numbers for 16- and 17-year-olds coming in at 26.4% and 29.1%.

Activity over just the last 14 days, however, shows a slight decrease in children aged 12-15 getting a first dose: For just the 2 weeks ending June 7, 17.9% of all children in the age group initiated a first dose, but for the 14 days ending June 14, only 17.1% of the age group did so, the CDC said on its COVID Data Tracker site.

For children aged 16-17 years – of whom less than 30% have reached full vaccination – activity seems to have stagnated: 4.8% of all 16- to 17-year-olds initiated a first vaccination during the 14 days ending June 7, compared with 4.7% who did so during the 14 days ending June 14, the CDC reported.

Older age groups with higher completion rates are still producing greater vaccine initiation. As of June 14, those aged 25-39 years had a completion rate of 41.9% and 24.0% of the age group had received a first dose in the previous 2 weeks, while 61.4% of those aged 50-64 were fully vaccinated, and 18.0% had gotten their first dose, the CDC data indicate.

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For the eighth consecutive year, Boston Children’s Hospital has captured the no. 1 spot in the national honor roll of U.S. News & World Report’s Best Children’s Hospitals.

Released June 15, the 2021-2022 rankings, which acknowledge 50 U.S. centers for delivering exceptional care in several specialties, also give the Massachusetts hospital the top spot in 4 of 10 pediatric specialties assessed: nephrology, neurology and neurosurgery, pulmonology and lung surgery, and urology.

Children’s Hospital of Philadelphia retains second spot in the annually updated list, and Texas Children’s Hospital, in Houston, moves up a rung to third place, bumping Cincinnati Children’s Hospital Medical Center from third to fourth place. Children’s Hospital Los Angeles comes in at no. 5.

The remaining top 10 placements, in descending order, are as follows:

Children’s Hospital Colorado in Aurora; Children’s National Hospital in Washington; Nationwide Children’s Hospital in Columbus, Ohio; UPMS Children’s Hospital of Pittsburgh; and Lucile Packard Children’s Hospital Stanford (Calif.).
 

New regional rankings

This year’s edition offers something new, adding rankings within states and multiple-state rankings within seven regions to facilitate choice. “The Best Children’s Hospitals rankings have always highlighted hospitals that excel in specialized care,” said Ben Harder, chief of health analysis and managing editor at U.S. News, in a press release. “Now, this year’s new state and regional rankings can help families identify conveniently located hospitals capable of meeting their child’s needs. As the pandemic continues to affect travel, finding high-quality care close to home has never been more important.”

Across the seven regions, the top-ranked institutions are as follows:

• Mid-Atlantic – Children’s Hospital of Philadelphia.
• Midwest – Cincinnati Children’s Hospital Medical Center.
• New England – Boston Children’s Hospital.
• Pacific – Children’s Hospital Los Angeles.
• Rocky Mountains – Children’s Hospital Colorado.
• Southeast – Children’s Healthcare of Atlanta and Monroe Carell Jr. Children’s Hospital of Vanderbilt, in Nashville, Tenn.
• Southwest – Texas Children’s Hospital.

Specialties

Boston Children’s not only topped the overall list but also led in four specialties. For the other six specialties that were ranked, the top hospitals on the honor roll are as follows:

• Cancer – Children’s Hospital of Philadelphia.
• Cardiology and heart surgery – Texas Children’s Hospital.
• Diabetes and endocrinology – Children’s Hospital of Philadelphia.
• Gastroenterology and gastrointestinal surgery – Children’s Hospital Colorado.
• Neonatology – Children’s National Hospital.
• Orthopedics – Children’s Hospital of Philadelphia.

For the past 15 years, the objective of the rankings has been to offer a starting point for parents in making decisions about the best place to take very sick children for high-quality care. The editors of the rankings acknowledge that considerations of travel costs and insurance coverage are other factors to consider.
 

Helpful for families

The rankings are helpful for families, according to Joe W. St. Geme, III, MD, Children’s Hospital of Philadelphia’s physician-in-chief and chair of its department of pediatrics. “Some parents, especially those coming from outside an area, find them useful when deciding on care away from home,” he told this news organization. “Most types of pediatric care are available in the community, but sometimes a child has an unusual disease or complex disease for which local care is not available.”

Dr. St. Geme said the new regional rankings may be useful in helping parents decide where to bring a child for care that is closer to where they live.

A top ranking from U.S. News is just one indication of a hospital›s overall performance, according to Angela Lorts, MD, MBA, director of the Ventricular Assist Device Program, at Cincinnati Children’s Hospital Medical Center.

“Parents seeking care for their child should use the data to ask questions and understand the limitations,” she told this news organization. “Rankings are only based on a small subset of the children we care for. Many of the metrics may not pertain to their child and may not reflect the care they will receive.”

In her view, ranking will not give parents all the information they need about medical care and outcomes for specific conditions.
 

Hospital reaction

Hospitals can use the rankings to target improvements, says Dr. St. Geme. “These rankings can provide an opportunity for some benchmarking, to see what other institutions are doing and how they’re able to deliver care. They can serve as a source of ideas and can influence planning,” he said.

He cautioned that the data are not as complete as they could be. “A number of services are not included, and we try to keep that in mind,” he said.

Rankings may also affect recruitment, Dr. St. Geme added, because higher-ranked institutions may find it easier to attract sought-after clinicians and investigators in needed areas.

Another sphere of influence is philanthropy and fund raising. “People are much more likely to consider making both small and large donations to a high-ranked institution,” said J. Howard Smart, MD, chair of pediatrics at Sharp Rees-Stealy Medical Group and chair-elect of the physician leadership council at Sharp Mary Birch Hospital for Women and Newborns in San Diego.

Dr. St. Geme agrees. “Philanthropists are interested in making investments where they feel they’re a sure bet, and rankings may indicate a sure bet. But their impact on government funding and grant support is probably less.”

Ultimately, however, some families may not have lot of choice in where to go when their children are sick, Dr. Smart said. “And people probably don’t choose a location to live in based on nearby children’s hospitals the way they do for schools,” he said.

What about hospitals that continue to rank much lower on the 50-institution list – excellent though they must be to make it onto the honor roll. “To be on the list but not to have risen in rank in recent years might be a disappointment,” said Dr. St. Geme. “But it might also motivate a hospital to think about making internal investments in order to strengthen a particular service. And it may motivate nonranked hospitals to improve care in order to break into the list.”

Dr. Lorts points out that the annual survey process requires hospitals to track the clinical outcomes of a subset of patients, which may lead to improvement in these areas. It also requires data collection on structure and process, which drives needs assessments of select hospital areas. “But ideally, all hospitals would be tracking important outcomes, benchmarking to peer hospitals, and improving where needed without the U.S. News incentive,” she said.

This year’s data, compiled by research and consulting firm RTI International, derive from feedback on more than 1,200 questions provided by 118 responding institutions. Details on each hospital on the list and the methodology used in the analysis are available on U.S. News & World Report’s website.

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

For the eighth consecutive year, Boston Children’s Hospital has captured the no. 1 spot in the national honor roll of U.S. News & World Report’s Best Children’s Hospitals.

Released June 15, the 2021-2022 rankings, which acknowledge 50 U.S. centers for delivering exceptional care in several specialties, also give the Massachusetts hospital the top spot in 4 of 10 pediatric specialties assessed: nephrology, neurology and neurosurgery, pulmonology and lung surgery, and urology.

Children’s Hospital of Philadelphia retains second spot in the annually updated list, and Texas Children’s Hospital, in Houston, moves up a rung to third place, bumping Cincinnati Children’s Hospital Medical Center from third to fourth place. Children’s Hospital Los Angeles comes in at no. 5.

The remaining top 10 placements, in descending order, are as follows:

Children’s Hospital Colorado in Aurora; Children’s National Hospital in Washington; Nationwide Children’s Hospital in Columbus, Ohio; UPMS Children’s Hospital of Pittsburgh; and Lucile Packard Children’s Hospital Stanford (Calif.).
 

New regional rankings

This year’s edition offers something new, adding rankings within states and multiple-state rankings within seven regions to facilitate choice. “The Best Children’s Hospitals rankings have always highlighted hospitals that excel in specialized care,” said Ben Harder, chief of health analysis and managing editor at U.S. News, in a press release. “Now, this year’s new state and regional rankings can help families identify conveniently located hospitals capable of meeting their child’s needs. As the pandemic continues to affect travel, finding high-quality care close to home has never been more important.”

Across the seven regions, the top-ranked institutions are as follows:

• Mid-Atlantic – Children’s Hospital of Philadelphia.
• Midwest – Cincinnati Children’s Hospital Medical Center.
• New England – Boston Children’s Hospital.
• Pacific – Children’s Hospital Los Angeles.
• Rocky Mountains – Children’s Hospital Colorado.
• Southeast – Children’s Healthcare of Atlanta and Monroe Carell Jr. Children’s Hospital of Vanderbilt, in Nashville, Tenn.
• Southwest – Texas Children’s Hospital.

Specialties

Boston Children’s not only topped the overall list but also led in four specialties. For the other six specialties that were ranked, the top hospitals on the honor roll are as follows:

• Cancer – Children’s Hospital of Philadelphia.
• Cardiology and heart surgery – Texas Children’s Hospital.
• Diabetes and endocrinology – Children’s Hospital of Philadelphia.
• Gastroenterology and gastrointestinal surgery – Children’s Hospital Colorado.
• Neonatology – Children’s National Hospital.
• Orthopedics – Children’s Hospital of Philadelphia.

For the past 15 years, the objective of the rankings has been to offer a starting point for parents in making decisions about the best place to take very sick children for high-quality care. The editors of the rankings acknowledge that considerations of travel costs and insurance coverage are other factors to consider.
 

Helpful for families

The rankings are helpful for families, according to Joe W. St. Geme, III, MD, Children’s Hospital of Philadelphia’s physician-in-chief and chair of its department of pediatrics. “Some parents, especially those coming from outside an area, find them useful when deciding on care away from home,” he told this news organization. “Most types of pediatric care are available in the community, but sometimes a child has an unusual disease or complex disease for which local care is not available.”

Dr. St. Geme said the new regional rankings may be useful in helping parents decide where to bring a child for care that is closer to where they live.

A top ranking from U.S. News is just one indication of a hospital›s overall performance, according to Angela Lorts, MD, MBA, director of the Ventricular Assist Device Program, at Cincinnati Children’s Hospital Medical Center.

“Parents seeking care for their child should use the data to ask questions and understand the limitations,” she told this news organization. “Rankings are only based on a small subset of the children we care for. Many of the metrics may not pertain to their child and may not reflect the care they will receive.”

In her view, ranking will not give parents all the information they need about medical care and outcomes for specific conditions.
 

Hospital reaction

Hospitals can use the rankings to target improvements, says Dr. St. Geme. “These rankings can provide an opportunity for some benchmarking, to see what other institutions are doing and how they’re able to deliver care. They can serve as a source of ideas and can influence planning,” he said.

He cautioned that the data are not as complete as they could be. “A number of services are not included, and we try to keep that in mind,” he said.

Rankings may also affect recruitment, Dr. St. Geme added, because higher-ranked institutions may find it easier to attract sought-after clinicians and investigators in needed areas.

Another sphere of influence is philanthropy and fund raising. “People are much more likely to consider making both small and large donations to a high-ranked institution,” said J. Howard Smart, MD, chair of pediatrics at Sharp Rees-Stealy Medical Group and chair-elect of the physician leadership council at Sharp Mary Birch Hospital for Women and Newborns in San Diego.

Dr. St. Geme agrees. “Philanthropists are interested in making investments where they feel they’re a sure bet, and rankings may indicate a sure bet. But their impact on government funding and grant support is probably less.”

Ultimately, however, some families may not have lot of choice in where to go when their children are sick, Dr. Smart said. “And people probably don’t choose a location to live in based on nearby children’s hospitals the way they do for schools,” he said.

What about hospitals that continue to rank much lower on the 50-institution list – excellent though they must be to make it onto the honor roll. “To be on the list but not to have risen in rank in recent years might be a disappointment,” said Dr. St. Geme. “But it might also motivate a hospital to think about making internal investments in order to strengthen a particular service. And it may motivate nonranked hospitals to improve care in order to break into the list.”

Dr. Lorts points out that the annual survey process requires hospitals to track the clinical outcomes of a subset of patients, which may lead to improvement in these areas. It also requires data collection on structure and process, which drives needs assessments of select hospital areas. “But ideally, all hospitals would be tracking important outcomes, benchmarking to peer hospitals, and improving where needed without the U.S. News incentive,” she said.

This year’s data, compiled by research and consulting firm RTI International, derive from feedback on more than 1,200 questions provided by 118 responding institutions. Details on each hospital on the list and the methodology used in the analysis are available on U.S. News & World Report’s website.

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

For the eighth consecutive year, Boston Children’s Hospital has captured the no. 1 spot in the national honor roll of U.S. News & World Report’s Best Children’s Hospitals.

Released June 15, the 2021-2022 rankings, which acknowledge 50 U.S. centers for delivering exceptional care in several specialties, also give the Massachusetts hospital the top spot in 4 of 10 pediatric specialties assessed: nephrology, neurology and neurosurgery, pulmonology and lung surgery, and urology.

Children’s Hospital of Philadelphia retains second spot in the annually updated list, and Texas Children’s Hospital, in Houston, moves up a rung to third place, bumping Cincinnati Children’s Hospital Medical Center from third to fourth place. Children’s Hospital Los Angeles comes in at no. 5.

The remaining top 10 placements, in descending order, are as follows:

Children’s Hospital Colorado in Aurora; Children’s National Hospital in Washington; Nationwide Children’s Hospital in Columbus, Ohio; UPMS Children’s Hospital of Pittsburgh; and Lucile Packard Children’s Hospital Stanford (Calif.).
 

New regional rankings

This year’s edition offers something new, adding rankings within states and multiple-state rankings within seven regions to facilitate choice. “The Best Children’s Hospitals rankings have always highlighted hospitals that excel in specialized care,” said Ben Harder, chief of health analysis and managing editor at U.S. News, in a press release. “Now, this year’s new state and regional rankings can help families identify conveniently located hospitals capable of meeting their child’s needs. As the pandemic continues to affect travel, finding high-quality care close to home has never been more important.”

Across the seven regions, the top-ranked institutions are as follows:

• Mid-Atlantic – Children’s Hospital of Philadelphia.
• Midwest – Cincinnati Children’s Hospital Medical Center.
• New England – Boston Children’s Hospital.
• Pacific – Children’s Hospital Los Angeles.
• Rocky Mountains – Children’s Hospital Colorado.
• Southeast – Children’s Healthcare of Atlanta and Monroe Carell Jr. Children’s Hospital of Vanderbilt, in Nashville, Tenn.
• Southwest – Texas Children’s Hospital.

Specialties

Boston Children’s not only topped the overall list but also led in four specialties. For the other six specialties that were ranked, the top hospitals on the honor roll are as follows:

• Cancer – Children’s Hospital of Philadelphia.
• Cardiology and heart surgery – Texas Children’s Hospital.
• Diabetes and endocrinology – Children’s Hospital of Philadelphia.
• Gastroenterology and gastrointestinal surgery – Children’s Hospital Colorado.
• Neonatology – Children’s National Hospital.
• Orthopedics – Children’s Hospital of Philadelphia.

For the past 15 years, the objective of the rankings has been to offer a starting point for parents in making decisions about the best place to take very sick children for high-quality care. The editors of the rankings acknowledge that considerations of travel costs and insurance coverage are other factors to consider.
 

Helpful for families

The rankings are helpful for families, according to Joe W. St. Geme, III, MD, Children’s Hospital of Philadelphia’s physician-in-chief and chair of its department of pediatrics. “Some parents, especially those coming from outside an area, find them useful when deciding on care away from home,” he told this news organization. “Most types of pediatric care are available in the community, but sometimes a child has an unusual disease or complex disease for which local care is not available.”

Dr. St. Geme said the new regional rankings may be useful in helping parents decide where to bring a child for care that is closer to where they live.

A top ranking from U.S. News is just one indication of a hospital›s overall performance, according to Angela Lorts, MD, MBA, director of the Ventricular Assist Device Program, at Cincinnati Children’s Hospital Medical Center.

“Parents seeking care for their child should use the data to ask questions and understand the limitations,” she told this news organization. “Rankings are only based on a small subset of the children we care for. Many of the metrics may not pertain to their child and may not reflect the care they will receive.”

In her view, ranking will not give parents all the information they need about medical care and outcomes for specific conditions.
 

Hospital reaction

Hospitals can use the rankings to target improvements, says Dr. St. Geme. “These rankings can provide an opportunity for some benchmarking, to see what other institutions are doing and how they’re able to deliver care. They can serve as a source of ideas and can influence planning,” he said.

He cautioned that the data are not as complete as they could be. “A number of services are not included, and we try to keep that in mind,” he said.

Rankings may also affect recruitment, Dr. St. Geme added, because higher-ranked institutions may find it easier to attract sought-after clinicians and investigators in needed areas.

Another sphere of influence is philanthropy and fund raising. “People are much more likely to consider making both small and large donations to a high-ranked institution,” said J. Howard Smart, MD, chair of pediatrics at Sharp Rees-Stealy Medical Group and chair-elect of the physician leadership council at Sharp Mary Birch Hospital for Women and Newborns in San Diego.

Dr. St. Geme agrees. “Philanthropists are interested in making investments where they feel they’re a sure bet, and rankings may indicate a sure bet. But their impact on government funding and grant support is probably less.”

Ultimately, however, some families may not have lot of choice in where to go when their children are sick, Dr. Smart said. “And people probably don’t choose a location to live in based on nearby children’s hospitals the way they do for schools,” he said.

What about hospitals that continue to rank much lower on the 50-institution list – excellent though they must be to make it onto the honor roll. “To be on the list but not to have risen in rank in recent years might be a disappointment,” said Dr. St. Geme. “But it might also motivate a hospital to think about making internal investments in order to strengthen a particular service. And it may motivate nonranked hospitals to improve care in order to break into the list.”

Dr. Lorts points out that the annual survey process requires hospitals to track the clinical outcomes of a subset of patients, which may lead to improvement in these areas. It also requires data collection on structure and process, which drives needs assessments of select hospital areas. “But ideally, all hospitals would be tracking important outcomes, benchmarking to peer hospitals, and improving where needed without the U.S. News incentive,” she said.

This year’s data, compiled by research and consulting firm RTI International, derive from feedback on more than 1,200 questions provided by 118 responding institutions. Details on each hospital on the list and the methodology used in the analysis are available on U.S. News & World Report’s website.

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

A patient’s risk for ischemic events, but not bleeding, after percutaneous coronary intervention (PCI) can be predicted simply based on whether they have one or more guideline-based standardized risk criteria, a large-scale real-world analysis suggests.

Haoyu Wang, MD, and colleagues showed that having at least one high-risk feature, as outlined in the 2018 European Society of Cardiology and European Association for Cardiothoracic Surgery (ESC/EACTS) Guidelines on Myocardial Revascularization, was associated with an increased risk for target vessel failure by 48% and for a patient-oriented composite outcome by 44%.

Moreover, they showed that implantation of at least three stents and the presence of diabetes and diffuse multivessel disease were the only high-risk features from the guidelines that were independent predictors of the two outcomes.

The study of more than 10,000 PCI patients also showed that determining whether patients were at high bleeding risk (HBR) did not modify their ischemic risk.

This, said Dr. Wang, from the National Center for Cardiovascular Diseases, Fuwai Hospital, Beijing, underscores the importance of applying the high ischemic risk (HIR) criteria from the ESC/EACTS guidelines when tailoring dual antiplatelet therapy (DAPT).

The research was presented at the European Atherosclerosis Society 2021 Virtual Congress on June 2, and published online in the Journal of Atherosclerosis and Thrombosis.

Dr. Wang told theheart.org | Medscape Cardiology that they conducted the study to determine which – HIR or HBR – is “most important to balance when treating patients undergoing PCI and then having dual antiplatelet therapy.”

The results showed that when patients have both a HIR and HBR, it is the ESC/EACTS guideline HIR criteria that have “a higher impact” than the bleeding risk, and that this can be “used to guide our choice of the duration of dual anti-platelet therapy.”

“Maybe we can extend, or use more potent, P2Y12 inhibitors” in those situations, he said.

S. Lale Tokgözoglu, MD, PhD, professor of cardiology, Hacettepe University, Ankara, Turkey, who was not involved in the study, said the HIR assessment “performed well,” adding that the HBR score might have been expected to attenuate its “prognostic advantage.”

She told this news organization that the results “are interesting since previous observations have suggested that Asian patients may be more prone to medication side effects and bleeding.”

These findings emphasize the importance of assessing HIR in daily PCI practice and confirm that it “performs well in different populations in real life,” added Dr. Tokgözoglu, a former president of the EAS.

The ESC/EACTS guidelines aimed to standardize the definition of HIR, Dr. Wang said during the presentation.

They set out 10 high-risk features for ischemic events for patients undergoing revascularization, which included patient medical history, comorbid conditions, and the characteristics of the PCI procedure.

Although the goals of the criteria are to inform decision-making and stimulate research, Dr. Wang said that their “prevalence and prognostic association with clinical outcomes are yet to be established in real-world PCI practice.”

Alongside, the Predicting Bleeding Complication in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) score was developed to predict out-of-hospital bleeding in patients receiving DAPT after stent implantation.

Although a PRECISE-DAPT score of at least 25 constitutes a patient at high bleeding risk, Dr. Wang pointed out that such patients are typically also at risk for ischemic events after PCI, and it is “unclear” whether being at HBR modifies this risk.

To investigate further, they used the prospective, real-world Fuwai PCI registry to collate an all-comer patient population with unselected use of drug-eluting stents at the National Center for Cardiovascular Diseases at Fuwai Hospital.

They excluded individuals who were treated with balloon angioplasty alone, bioresorbable scaffolds, or bare metal stents, leaving a total population of 10,167 patients who were treated in 2013.

In that cohort, 5,149 patients (50.6%) met at least one risk criterion from the ESC/EACTS guidelines (HIR patients) and 5,018 (49.4%) met none of the risk criteria (non-HIR patients).

The most common criteria were implantation of at least three stents (23.5%); total stent length greater than 60 mm (20.2%); diffuse multivessel disease, especially in diabetic patients (18.5%); and a history of ST-segment elevation myocardial infarction (13.9%).

HIR patients were significantly older than non-HIR patients (average age, 58.86 vs. 57.77 years; P < .001), were more likely to have diabetes mellitus (42.6% vs. 16.9%; P < .001); and were more likely to have already had a myocardial infarction (32.2% vs. 5.2%; P < .001).

HIR patients also had higher average PRECISE-ADAPT scores than those without HIR (11.22 vs. 9.94; P < .001), and were conversely less likely to have the left anterior descending artery as the target vessel than non-HIR patients (86.0% vs. 94.6%; P < .001).

Cox regression analysis taking into account a range of patient and clinical factors revealed that HIR patients were significantly more likely than their non-HIR counterparts to experience target vessel failure (hazard ratio, 1.48; 95% confidence interval, 1.25-1.74; P < .001).

They were also significantly more likely to have a patient-oriented composite outcome, defined as all-cause death, any myocardial infarction, or any revascularization (HR, 1.44; 95% CI, 1.28-1.63; P < .001).

There was also a significantly higher risk for cardiac death in HIR than in non-HIR patients (HR, 1.95; 95% CI, 1.16-3.29; P = .012).

However, there was no significant association between HIR status and clinically relevant bleeding (HR, 0.84; 95% CI, 0.66-1.06; P = .143).

When the researchers looked at individual ischemic risk features, they found that, on fully adjusted analyses, only two were independent predictors of target vessel failure and the patient-oriented composite outcome.

Having at least three stents implanted was significantly associated with target vessel failure (HR, 1.36; 95% CI, 1.02-1.80; P = .038), and borderline significantly associated with the patient oriented composite outcome (HR, 1.23; 95% CI, 1.00-1.53; P = .056).

Diffuse multivessel disease, especially in diabetic patients, was significantly associated with both target vessel failure (HR, 1.24; 95% CI, 1.02-1.51; P = .035) and with the patient-oriented composite outcome (HR, 1.20; 95% CI, 1.04-1.39; P = .012).

Neither risk feature was significantly associated with clinically relevant bleeding, Dr. Wang noted.

Stratifying the patients by HBR status, the team found that rates of target vessel failure, the patient-oriented composite outcome, cardiac death, myocardial infarction, and definite/probable stent thrombosis were higher in patients with both HIR and HBR than those with neither HIR nor HBR (P < .001).

Further stratifying patients by PRECISE-ADAPT scores – 10 or less indicating very low risk, 11-17 indicating low risk, 18-24 indicating moderate risk, and at least 25 indicating high risk – showed that HIR features had a consistent effect on ischemic and bleeding outcomes, regardless of bleeding risk.

No funding declared. No relevant financial relationships declared.

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

A patient’s risk for ischemic events, but not bleeding, after percutaneous coronary intervention (PCI) can be predicted simply based on whether they have one or more guideline-based standardized risk criteria, a large-scale real-world analysis suggests.

Haoyu Wang, MD, and colleagues showed that having at least one high-risk feature, as outlined in the 2018 European Society of Cardiology and European Association for Cardiothoracic Surgery (ESC/EACTS) Guidelines on Myocardial Revascularization, was associated with an increased risk for target vessel failure by 48% and for a patient-oriented composite outcome by 44%.

Moreover, they showed that implantation of at least three stents and the presence of diabetes and diffuse multivessel disease were the only high-risk features from the guidelines that were independent predictors of the two outcomes.

The study of more than 10,000 PCI patients also showed that determining whether patients were at high bleeding risk (HBR) did not modify their ischemic risk.

This, said Dr. Wang, from the National Center for Cardiovascular Diseases, Fuwai Hospital, Beijing, underscores the importance of applying the high ischemic risk (HIR) criteria from the ESC/EACTS guidelines when tailoring dual antiplatelet therapy (DAPT).

The research was presented at the European Atherosclerosis Society 2021 Virtual Congress on June 2, and published online in the Journal of Atherosclerosis and Thrombosis.

Dr. Wang told theheart.org | Medscape Cardiology that they conducted the study to determine which – HIR or HBR – is “most important to balance when treating patients undergoing PCI and then having dual antiplatelet therapy.”

The results showed that when patients have both a HIR and HBR, it is the ESC/EACTS guideline HIR criteria that have “a higher impact” than the bleeding risk, and that this can be “used to guide our choice of the duration of dual anti-platelet therapy.”

“Maybe we can extend, or use more potent, P2Y12 inhibitors” in those situations, he said.

S. Lale Tokgözoglu, MD, PhD, professor of cardiology, Hacettepe University, Ankara, Turkey, who was not involved in the study, said the HIR assessment “performed well,” adding that the HBR score might have been expected to attenuate its “prognostic advantage.”

She told this news organization that the results “are interesting since previous observations have suggested that Asian patients may be more prone to medication side effects and bleeding.”

These findings emphasize the importance of assessing HIR in daily PCI practice and confirm that it “performs well in different populations in real life,” added Dr. Tokgözoglu, a former president of the EAS.

The ESC/EACTS guidelines aimed to standardize the definition of HIR, Dr. Wang said during the presentation.

They set out 10 high-risk features for ischemic events for patients undergoing revascularization, which included patient medical history, comorbid conditions, and the characteristics of the PCI procedure.

Although the goals of the criteria are to inform decision-making and stimulate research, Dr. Wang said that their “prevalence and prognostic association with clinical outcomes are yet to be established in real-world PCI practice.”

Alongside, the Predicting Bleeding Complication in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) score was developed to predict out-of-hospital bleeding in patients receiving DAPT after stent implantation.

Although a PRECISE-DAPT score of at least 25 constitutes a patient at high bleeding risk, Dr. Wang pointed out that such patients are typically also at risk for ischemic events after PCI, and it is “unclear” whether being at HBR modifies this risk.

To investigate further, they used the prospective, real-world Fuwai PCI registry to collate an all-comer patient population with unselected use of drug-eluting stents at the National Center for Cardiovascular Diseases at Fuwai Hospital.

They excluded individuals who were treated with balloon angioplasty alone, bioresorbable scaffolds, or bare metal stents, leaving a total population of 10,167 patients who were treated in 2013.

In that cohort, 5,149 patients (50.6%) met at least one risk criterion from the ESC/EACTS guidelines (HIR patients) and 5,018 (49.4%) met none of the risk criteria (non-HIR patients).

The most common criteria were implantation of at least three stents (23.5%); total stent length greater than 60 mm (20.2%); diffuse multivessel disease, especially in diabetic patients (18.5%); and a history of ST-segment elevation myocardial infarction (13.9%).

HIR patients were significantly older than non-HIR patients (average age, 58.86 vs. 57.77 years; P < .001), were more likely to have diabetes mellitus (42.6% vs. 16.9%; P < .001); and were more likely to have already had a myocardial infarction (32.2% vs. 5.2%; P < .001).

HIR patients also had higher average PRECISE-ADAPT scores than those without HIR (11.22 vs. 9.94; P < .001), and were conversely less likely to have the left anterior descending artery as the target vessel than non-HIR patients (86.0% vs. 94.6%; P < .001).

Cox regression analysis taking into account a range of patient and clinical factors revealed that HIR patients were significantly more likely than their non-HIR counterparts to experience target vessel failure (hazard ratio, 1.48; 95% confidence interval, 1.25-1.74; P < .001).

They were also significantly more likely to have a patient-oriented composite outcome, defined as all-cause death, any myocardial infarction, or any revascularization (HR, 1.44; 95% CI, 1.28-1.63; P < .001).

There was also a significantly higher risk for cardiac death in HIR than in non-HIR patients (HR, 1.95; 95% CI, 1.16-3.29; P = .012).

However, there was no significant association between HIR status and clinically relevant bleeding (HR, 0.84; 95% CI, 0.66-1.06; P = .143).

When the researchers looked at individual ischemic risk features, they found that, on fully adjusted analyses, only two were independent predictors of target vessel failure and the patient-oriented composite outcome.

Having at least three stents implanted was significantly associated with target vessel failure (HR, 1.36; 95% CI, 1.02-1.80; P = .038), and borderline significantly associated with the patient oriented composite outcome (HR, 1.23; 95% CI, 1.00-1.53; P = .056).

Diffuse multivessel disease, especially in diabetic patients, was significantly associated with both target vessel failure (HR, 1.24; 95% CI, 1.02-1.51; P = .035) and with the patient-oriented composite outcome (HR, 1.20; 95% CI, 1.04-1.39; P = .012).

Neither risk feature was significantly associated with clinically relevant bleeding, Dr. Wang noted.

Stratifying the patients by HBR status, the team found that rates of target vessel failure, the patient-oriented composite outcome, cardiac death, myocardial infarction, and definite/probable stent thrombosis were higher in patients with both HIR and HBR than those with neither HIR nor HBR (P < .001).

Further stratifying patients by PRECISE-ADAPT scores – 10 or less indicating very low risk, 11-17 indicating low risk, 18-24 indicating moderate risk, and at least 25 indicating high risk – showed that HIR features had a consistent effect on ischemic and bleeding outcomes, regardless of bleeding risk.

No funding declared. No relevant financial relationships declared.

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

A patient’s risk for ischemic events, but not bleeding, after percutaneous coronary intervention (PCI) can be predicted simply based on whether they have one or more guideline-based standardized risk criteria, a large-scale real-world analysis suggests.

Haoyu Wang, MD, and colleagues showed that having at least one high-risk feature, as outlined in the 2018 European Society of Cardiology and European Association for Cardiothoracic Surgery (ESC/EACTS) Guidelines on Myocardial Revascularization, was associated with an increased risk for target vessel failure by 48% and for a patient-oriented composite outcome by 44%.

Moreover, they showed that implantation of at least three stents and the presence of diabetes and diffuse multivessel disease were the only high-risk features from the guidelines that were independent predictors of the two outcomes.

The study of more than 10,000 PCI patients also showed that determining whether patients were at high bleeding risk (HBR) did not modify their ischemic risk.

This, said Dr. Wang, from the National Center for Cardiovascular Diseases, Fuwai Hospital, Beijing, underscores the importance of applying the high ischemic risk (HIR) criteria from the ESC/EACTS guidelines when tailoring dual antiplatelet therapy (DAPT).

The research was presented at the European Atherosclerosis Society 2021 Virtual Congress on June 2, and published online in the Journal of Atherosclerosis and Thrombosis.

Dr. Wang told theheart.org | Medscape Cardiology that they conducted the study to determine which – HIR or HBR – is “most important to balance when treating patients undergoing PCI and then having dual antiplatelet therapy.”

The results showed that when patients have both a HIR and HBR, it is the ESC/EACTS guideline HIR criteria that have “a higher impact” than the bleeding risk, and that this can be “used to guide our choice of the duration of dual anti-platelet therapy.”

“Maybe we can extend, or use more potent, P2Y12 inhibitors” in those situations, he said.

S. Lale Tokgözoglu, MD, PhD, professor of cardiology, Hacettepe University, Ankara, Turkey, who was not involved in the study, said the HIR assessment “performed well,” adding that the HBR score might have been expected to attenuate its “prognostic advantage.”

She told this news organization that the results “are interesting since previous observations have suggested that Asian patients may be more prone to medication side effects and bleeding.”

These findings emphasize the importance of assessing HIR in daily PCI practice and confirm that it “performs well in different populations in real life,” added Dr. Tokgözoglu, a former president of the EAS.

The ESC/EACTS guidelines aimed to standardize the definition of HIR, Dr. Wang said during the presentation.

They set out 10 high-risk features for ischemic events for patients undergoing revascularization, which included patient medical history, comorbid conditions, and the characteristics of the PCI procedure.

Although the goals of the criteria are to inform decision-making and stimulate research, Dr. Wang said that their “prevalence and prognostic association with clinical outcomes are yet to be established in real-world PCI practice.”

Alongside, the Predicting Bleeding Complication in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) score was developed to predict out-of-hospital bleeding in patients receiving DAPT after stent implantation.

Although a PRECISE-DAPT score of at least 25 constitutes a patient at high bleeding risk, Dr. Wang pointed out that such patients are typically also at risk for ischemic events after PCI, and it is “unclear” whether being at HBR modifies this risk.

To investigate further, they used the prospective, real-world Fuwai PCI registry to collate an all-comer patient population with unselected use of drug-eluting stents at the National Center for Cardiovascular Diseases at Fuwai Hospital.

They excluded individuals who were treated with balloon angioplasty alone, bioresorbable scaffolds, or bare metal stents, leaving a total population of 10,167 patients who were treated in 2013.

In that cohort, 5,149 patients (50.6%) met at least one risk criterion from the ESC/EACTS guidelines (HIR patients) and 5,018 (49.4%) met none of the risk criteria (non-HIR patients).

The most common criteria were implantation of at least three stents (23.5%); total stent length greater than 60 mm (20.2%); diffuse multivessel disease, especially in diabetic patients (18.5%); and a history of ST-segment elevation myocardial infarction (13.9%).

HIR patients were significantly older than non-HIR patients (average age, 58.86 vs. 57.77 years; P < .001), were more likely to have diabetes mellitus (42.6% vs. 16.9%; P < .001); and were more likely to have already had a myocardial infarction (32.2% vs. 5.2%; P < .001).

HIR patients also had higher average PRECISE-ADAPT scores than those without HIR (11.22 vs. 9.94; P < .001), and were conversely less likely to have the left anterior descending artery as the target vessel than non-HIR patients (86.0% vs. 94.6%; P < .001).

Cox regression analysis taking into account a range of patient and clinical factors revealed that HIR patients were significantly more likely than their non-HIR counterparts to experience target vessel failure (hazard ratio, 1.48; 95% confidence interval, 1.25-1.74; P < .001).

They were also significantly more likely to have a patient-oriented composite outcome, defined as all-cause death, any myocardial infarction, or any revascularization (HR, 1.44; 95% CI, 1.28-1.63; P < .001).

There was also a significantly higher risk for cardiac death in HIR than in non-HIR patients (HR, 1.95; 95% CI, 1.16-3.29; P = .012).

However, there was no significant association between HIR status and clinically relevant bleeding (HR, 0.84; 95% CI, 0.66-1.06; P = .143).

When the researchers looked at individual ischemic risk features, they found that, on fully adjusted analyses, only two were independent predictors of target vessel failure and the patient-oriented composite outcome.

Having at least three stents implanted was significantly associated with target vessel failure (HR, 1.36; 95% CI, 1.02-1.80; P = .038), and borderline significantly associated with the patient oriented composite outcome (HR, 1.23; 95% CI, 1.00-1.53; P = .056).

Diffuse multivessel disease, especially in diabetic patients, was significantly associated with both target vessel failure (HR, 1.24; 95% CI, 1.02-1.51; P = .035) and with the patient-oriented composite outcome (HR, 1.20; 95% CI, 1.04-1.39; P = .012).

Neither risk feature was significantly associated with clinically relevant bleeding, Dr. Wang noted.

Stratifying the patients by HBR status, the team found that rates of target vessel failure, the patient-oriented composite outcome, cardiac death, myocardial infarction, and definite/probable stent thrombosis were higher in patients with both HIR and HBR than those with neither HIR nor HBR (P < .001).

Further stratifying patients by PRECISE-ADAPT scores – 10 or less indicating very low risk, 11-17 indicating low risk, 18-24 indicating moderate risk, and at least 25 indicating high risk – showed that HIR features had a consistent effect on ischemic and bleeding outcomes, regardless of bleeding risk.

No funding declared. No relevant financial relationships declared.

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

Coding and billing for the professional services of physicians and other practitioners in the hospital and for the hospital’s facility costs are separate and distinct processes. But both reflect the totality of care given to patients in the complex, costly, heavily regulated setting of an acute care hospital. And both are essential to the financial well-being of the hospital and its providers, and to their mutual ability to survive current financial uncertainties imposed by the COVID pandemic.

“What hospitalists don’t realize is that your professional billing is a completely separate entity [from the facility’s billing],” said Aziz Ansari, DO, SFHM, hospitalist, professor of medicine, and associate chief medical officer for clinical optimization and revenue integrity at Loyola University Medical Center in Maywood, Ill. “Your E/M [Evaluation and Management] coding has a separate set of rules, which are not married at all to facility billing.”

Dr. Ansari presented a session at Converge – the annual conference of SHM – in May 2021, on the hospitalist’s role in “Piloting the Twin Engines of the Mid-Revenue Cycle Ship,” with a focus on how physician documentation can optimize both facility billing and quality of care. Hospitalists generally don’t realize how much impact they actually have on their hospital’s revenue cycle and quality, he said. Thorough documentation, accurately and specifically describing the patient’s severity of illness and complexity, affects both.

“When a utilization management nurse calls you about a case, you need to realize they are your partner in getting it right.” A simple documentation lapse that would change a case from observation to inpatient could cost the hospital $3,000 or more per case, and that can add up quickly, Dr. Ansari said. “We’ve seen what happened with COVID. We realized how fragile the system is, and how razor-thin hospital margins are.”
 

Distinction between professional and facility billing

Professional billing by hospitalist physicians and advanced practice providers is done for their individual encounters with patients and charged per visit for every day the patient is in the hospital based on the treatments, examinations, and medical decision-making required to care for that patient.

These are spelled out using E/M codes derived from Current Procedural Terminology, which is maintained by the American Medical Association for specifying what the provider did during the encounter. Other parameters of professional billing include complexity of decision-making versus amount of time spent, and a variety of modifiers.

By contrast, facility billing by hospitals is based on the complexity of the patient’s condition and is generally done whether the hospitalization is considered an inpatient hospitalization or an outpatient hospitalization such as an observation stay. Inpatient hospital stays are often paid using diagnosis-related groupings (DRGs), Medicare’s patient classification system for standardizing prospective payment to hospitals and encouraging cost-containment strategies.

DRGs, which represent about half of total hospital reimbursement, are a separate payment mechanism covering all facility charges associated with the inpatient stay from admission to discharge, incorporating the costs of providing hospital care, including but not limited to space, equipment, supplies, tests, and medications. Outpatient hospital stays, by contrast, are paid based on Ambulatory Payment Classifications.

A facility bill is submitted to the payer at the end of the hospital stay, describing the patient’s condition using ICD-10 diagnostic codes. All of the patient’s diagnoses and comorbidities contribute to the assignment of a DRG that best captures the total hospital stay. But to make the issue more complicated, the system is evolving toward models of bundled payment that will eventually phase out traditional DRGs in favor of new systems combining inpatient and outpatient reimbursement into a single bundled episode of care.

Professional and facility bills for a single hospitalization may be prepared by different personnel on separate teams following different rules, although they may both be housed in the hospital’s billing department. The differing rules for coding professional services versus facility services can be hard for hospitalists to appreciate, said Wendy Arafiles, MD, a pediatric hospitalist at Phoenix Children’s Hospital and medical director for its clinical documentation integrity (CDI) team. An example is for uncertain diagnoses. There may be a clinical suspicion of a diagnosis, and language such as “likely bacterial pneumonia” might be sufficient for facility coding but not for professional services coding.

Hospitalists, depending on their group’s size, structure, and relationship to the hospital, may be responsible for selecting the CPT codes or other parameters for the insurance claim and bill. Or these may be left to billing specialists. And those specialists could be employed by the hospital or by the hospitalist group or multispecialty medical group, or they could be contracted outside agencies that handle the billing for a fee.


 

The revenue cycle

The hospital revenue cycle has a lot of cogs in the machine, Dr. Arafiles said. “This is just one of the many nuances of our crazy system. I will go out on a limb and say it is not our job as clinicians to know all of those nuances.” The DRG assignment is dependent on how providers can describe the complexity of the patient and severity of the illness, even if it doesn’t impact professional billing, Dr. Arafiles added.

Hospitalists don’t want to think about money when providing patient care. “Our job is to provide the best care to our patients. We often utilize resources without thinking about how much they are going to cost, so that we can do what we think is necessary for our patients,” she explained. But accurate diagnosis codes can capture the complexity of the care. “Maybe we don’t take that part seriously enough. As long as I, as the provider, can accurately describe the complexity of my patient, I can justify why I spent all those resources and so many days caring for him or her.”

Charles Locke, MD, executive medical director of care management for LifeBridge Health and assistant professor of medicine at Johns Hopkins University, Baltimore, said hospitalists typically are paid set salaries directly by the hospital, in some cases with productivity bonuses based in part on their billing and posted RVUs (relative value units). RVUs are the cornerstone of Medicare’s reimbursement formula for physician services.

“Another thing to keep in mind, one might think in 2021 that the computer systems would be sophisticated enough to link up professional and facility billing to ensure that bills for each are concordant for services provided on a given day. But it turns out they are not yet well connected,” Dr. Locke said.

“These are issues that everybody struggles with. Hospitalists need to know and order the appropriate status, inpatient versus outpatient, and whether and when to order observation services, as this will affect hospital reimbursement and, potentially, patient liability,” he explained.¹ If the hospital is denied its facility claim because of improper status, that denial doesn’t necessary extend to a denial for the doctor’s professional fee. “Hospitalists need to know these are often separated. Even though their professional fee is honored, the hospital’s service charges may not be.”

Dr. Locke said knowing the history of Medicare might help hospitalists to better appreciate the distinctions. When this federal entitlement was first proposed in the 1960s as a way to help older Americans in poverty obtain needed health care, organized medicine sought to be excluded from the program. “Nonhospital services and doctors’ service fees were not included in the original Medicare proposal,” he said. Medicare Part B was created to provide insurance for doctors’ professional fees, which are still handled separately under Medicare.

Many institutions use clinical documentation for multiple purposes. “There are so many masters for this one document,” Dr. Arafiles said. The information is also used for various quality and patient safety metrics and data gathering. “Every code we choose is used in many different ways by the institution. We don’t know where all it goes. But we need to know how to describe how complex the case was, and how much work it entailed. The more we know about how to describe that, the better for the institution.”

Dr. Arafiles views the clinical note, first and foremost, as clinical communication, so that one provider can seamlessly pick up where the previous left off. “If I use language in my note that is accurate and specific, it will be useful to all who later need it.” Building on metrics such as expected versus actual 30-day readmission rates, risk-adjusted mortality, and all the ways government agencies report hospital quality, she said, “what we document has lasting impact. That’s where the facility side of billing and coding is ever more important. You can’t just think about your professional billing and RVUs.”
 

Support from the hospital

Some hospitalists may think facility billing is not their concern. But consider this: The average support or subsidy paid by U.S. hospitals for a full-time equivalent hospitalist is estimated at $198,750, according to SHM’s 2020 State of Hospital Medicine.² That support reflects the difference between the cost of employing a hospitalist in a competitive labor environment and what that provider is actually able to generate in billing income, said Hardik Vora, MD, MPH, SFHM, chair of SHM’s practice management committee.

With a lot of medical specialties, the physician’s salary is only or largely supported by professional billing, said Dr. Vora, who is medical director for Hospital Medicine and physician advisor for utilization management and CDI at Riverside Health System, Yorktown, Va.

“Hospital medicine is different in that aspect, regardless of employment model. And that’s where the concept of value comes in – how else do you bring value to the hospital that supports you,” said Dr. Vora.

Hospitalists often emphasize their contributions to quality improvement, patient safety, and hospital governance committees – all the ways they contribute to the health of the institution – as justification for their support from the hospital. But beneath all of that is the income the hospital generates from facility billing and from the hospitalist’s contributions to complete, accurate, and timely documentation that can support the hospital’s bills.

Typically, this hospital support to supplement hospitalist billing income is not directly tied to the income generated by facility billing or to the hospitalist’s contribution to its completeness. But between growing technological sophistication and greater belt-tightening, that link may get closer over time.
 

Other players

Because of the importance of complete and accurate billing to the hospital’s financial well-being, specialized supportive services have evolved, from traditional utilization review or utilization management to CDI services and the role of physician advisors – experienced doctors who know well how these processes work and are able to teach providers about regulatory compliance and medical necessity.

“One of my jobs as the medical director for our hospital’s CDI program is to educate residents, fellows, and newly onboarded providers to be descriptive enough in their charting to capture the complexity of the patient’s condition,” Dr. Arafiles said. Physician advisors and CDI programs can involve clinical providers in bringing value to the institution through their documentation. They serve as the intermediaries between the coders and the clinicians.

The CDI specialist’s job description focuses on diagnosis capture and associated reimbursement. But integrity broadly defined goes to the integrity of the medical record and its contribution to quality and patient safety as well as providing a medical record that is defensible to audits, physician revenue cycle expert Glenn Krauss noted in a recent post at ICD10 Monitor.³

Dr. Vora sees his role as physician advisor to be the link between the hospital’s executive team and the hospital’s medical providers. “Providers need help in understanding a complex set of ever-changing rules of facility billing and the frequently competing priorities between facility and professional billing. I tell my providers: The longer the patient stays in the hospital, you may be generating more RVUs, but our facility may be losing money.”

Hospital administrators are acutely aware of facility billing, but they don’t necessarily understand the nuances of professional billing, said Jay Weatherly, MS, the cofounder of Hospitalist Billing, a company that specializes in comprehensive billing and collection solutions for hospitalist groups that are employed directly by their hospitals. But he sees an essential symbiotic relationship between hospital administrators and clinicians.

“We rely on hospitalists’ record keeping to do our job. We rely on them to get it right,” he said. “We want to encourage doctors to cooperate with the process. Billing should never be a physician’s top priority, but it is important, nonetheless.”

HBI is relentless in pursuit of the information needed for its coding and billing, but does so gently, in a way not to put off doctors, Mr. Weatherly said. “There is an art and a science associated with securing the needed information. We have great respect for the doctors we work with, yet we’re all spokes in a bigger wheel, and we need to bill effectively in order to keep the wheel moving.”
 

What can hospitalists do?

Sources for this article say one of the best places for hospitalists to start improving their understanding of these distinctions is to ask the coders in their institution for advice on how to make the process run more smoothly.

“If you have a CDI team, they are there to help. Reach out to them,” Dr. Arafiles said. Generally, medical schools and residency programs fail to convey the complexities of contemporary hospital economics to future doctors.

Hospitalists have become indispensable, Dr. Vora said. But salaries for hospitalists are going up while hospital reimbursement is going down, and hospitalists are not seeing more patients. “At some point we will no longer be able to say financial support for hospital medicine groups is just a cost of doing business for the hospital. COVID tested us – and demonstrated how much hospital executives value us as part of the team. Our organization absolutely stood behind its physicians despite financially challenging times. Now we need to do what we can to support the organization,” he added.

Hospitalists can also continue to educate themselves on good documentation and coding practices, by finding programs like SHM’s Utilization Management and Clinical Documentation for Hospitalists.

“As we see a significant shift to value-based payment, with its focus on value, efficiency, quality – the best care at the lowest possible price – hospital medicine as a specialty will be best positioned to help with that. If the hospital does well, we do well. We should be building relationships with the hospital’s leadership team,” Dr. Vora said. “You always want to contribute to that partnership to the highest level possible. When they look at us, they should see their most reliable partner.”
 

References

1. Locke C, Hu E. Medicare’s two-midnight rule: What hospitalists must know. The Hospitalist. 2019 Feb 22.

2. Beresford L. Hospital medicine in a worldwide pandemic: ^{State of Hospital Medicine} 2020. The Hospitalist. 2020 Sep 20.

3. Krauss G. Clinical documentation integrity: rebranding and repurposing. ICD10 Monitor. March 16, 2020 Mar 16. https://www.icd10monitor.com/clinical-documentation-integrity-rebranding-and-repurposing.
 

Coding and billing for the professional services of physicians and other practitioners in the hospital and for the hospital’s facility costs are separate and distinct processes. But both reflect the totality of care given to patients in the complex, costly, heavily regulated setting of an acute care hospital. And both are essential to the financial well-being of the hospital and its providers, and to their mutual ability to survive current financial uncertainties imposed by the COVID pandemic.

“What hospitalists don’t realize is that your professional billing is a completely separate entity [from the facility’s billing],” said Aziz Ansari, DO, SFHM, hospitalist, professor of medicine, and associate chief medical officer for clinical optimization and revenue integrity at Loyola University Medical Center in Maywood, Ill. “Your E/M [Evaluation and Management] coding has a separate set of rules, which are not married at all to facility billing.”

Dr. Ansari presented a session at Converge – the annual conference of SHM – in May 2021, on the hospitalist’s role in “Piloting the Twin Engines of the Mid-Revenue Cycle Ship,” with a focus on how physician documentation can optimize both facility billing and quality of care. Hospitalists generally don’t realize how much impact they actually have on their hospital’s revenue cycle and quality, he said. Thorough documentation, accurately and specifically describing the patient’s severity of illness and complexity, affects both.

“When a utilization management nurse calls you about a case, you need to realize they are your partner in getting it right.” A simple documentation lapse that would change a case from observation to inpatient could cost the hospital $3,000 or more per case, and that can add up quickly, Dr. Ansari said. “We’ve seen what happened with COVID. We realized how fragile the system is, and how razor-thin hospital margins are.”
 

Distinction between professional and facility billing

Professional billing by hospitalist physicians and advanced practice providers is done for their individual encounters with patients and charged per visit for every day the patient is in the hospital based on the treatments, examinations, and medical decision-making required to care for that patient.

These are spelled out using E/M codes derived from Current Procedural Terminology, which is maintained by the American Medical Association for specifying what the provider did during the encounter. Other parameters of professional billing include complexity of decision-making versus amount of time spent, and a variety of modifiers.

By contrast, facility billing by hospitals is based on the complexity of the patient’s condition and is generally done whether the hospitalization is considered an inpatient hospitalization or an outpatient hospitalization such as an observation stay. Inpatient hospital stays are often paid using diagnosis-related groupings (DRGs), Medicare’s patient classification system for standardizing prospective payment to hospitals and encouraging cost-containment strategies.

DRGs, which represent about half of total hospital reimbursement, are a separate payment mechanism covering all facility charges associated with the inpatient stay from admission to discharge, incorporating the costs of providing hospital care, including but not limited to space, equipment, supplies, tests, and medications. Outpatient hospital stays, by contrast, are paid based on Ambulatory Payment Classifications.

A facility bill is submitted to the payer at the end of the hospital stay, describing the patient’s condition using ICD-10 diagnostic codes. All of the patient’s diagnoses and comorbidities contribute to the assignment of a DRG that best captures the total hospital stay. But to make the issue more complicated, the system is evolving toward models of bundled payment that will eventually phase out traditional DRGs in favor of new systems combining inpatient and outpatient reimbursement into a single bundled episode of care.

Professional and facility bills for a single hospitalization may be prepared by different personnel on separate teams following different rules, although they may both be housed in the hospital’s billing department. The differing rules for coding professional services versus facility services can be hard for hospitalists to appreciate, said Wendy Arafiles, MD, a pediatric hospitalist at Phoenix Children’s Hospital and medical director for its clinical documentation integrity (CDI) team. An example is for uncertain diagnoses. There may be a clinical suspicion of a diagnosis, and language such as “likely bacterial pneumonia” might be sufficient for facility coding but not for professional services coding.

Hospitalists, depending on their group’s size, structure, and relationship to the hospital, may be responsible for selecting the CPT codes or other parameters for the insurance claim and bill. Or these may be left to billing specialists. And those specialists could be employed by the hospital or by the hospitalist group or multispecialty medical group, or they could be contracted outside agencies that handle the billing for a fee.


 

The revenue cycle

The hospital revenue cycle has a lot of cogs in the machine, Dr. Arafiles said. “This is just one of the many nuances of our crazy system. I will go out on a limb and say it is not our job as clinicians to know all of those nuances.” The DRG assignment is dependent on how providers can describe the complexity of the patient and severity of the illness, even if it doesn’t impact professional billing, Dr. Arafiles added.

Hospitalists don’t want to think about money when providing patient care. “Our job is to provide the best care to our patients. We often utilize resources without thinking about how much they are going to cost, so that we can do what we think is necessary for our patients,” she explained. But accurate diagnosis codes can capture the complexity of the care. “Maybe we don’t take that part seriously enough. As long as I, as the provider, can accurately describe the complexity of my patient, I can justify why I spent all those resources and so many days caring for him or her.”

Charles Locke, MD, executive medical director of care management for LifeBridge Health and assistant professor of medicine at Johns Hopkins University, Baltimore, said hospitalists typically are paid set salaries directly by the hospital, in some cases with productivity bonuses based in part on their billing and posted RVUs (relative value units). RVUs are the cornerstone of Medicare’s reimbursement formula for physician services.

“Another thing to keep in mind, one might think in 2021 that the computer systems would be sophisticated enough to link up professional and facility billing to ensure that bills for each are concordant for services provided on a given day. But it turns out they are not yet well connected,” Dr. Locke said.

“These are issues that everybody struggles with. Hospitalists need to know and order the appropriate status, inpatient versus outpatient, and whether and when to order observation services, as this will affect hospital reimbursement and, potentially, patient liability,” he explained.¹ If the hospital is denied its facility claim because of improper status, that denial doesn’t necessary extend to a denial for the doctor’s professional fee. “Hospitalists need to know these are often separated. Even though their professional fee is honored, the hospital’s service charges may not be.”

Dr. Locke said knowing the history of Medicare might help hospitalists to better appreciate the distinctions. When this federal entitlement was first proposed in the 1960s as a way to help older Americans in poverty obtain needed health care, organized medicine sought to be excluded from the program. “Nonhospital services and doctors’ service fees were not included in the original Medicare proposal,” he said. Medicare Part B was created to provide insurance for doctors’ professional fees, which are still handled separately under Medicare.

Many institutions use clinical documentation for multiple purposes. “There are so many masters for this one document,” Dr. Arafiles said. The information is also used for various quality and patient safety metrics and data gathering. “Every code we choose is used in many different ways by the institution. We don’t know where all it goes. But we need to know how to describe how complex the case was, and how much work it entailed. The more we know about how to describe that, the better for the institution.”

Dr. Arafiles views the clinical note, first and foremost, as clinical communication, so that one provider can seamlessly pick up where the previous left off. “If I use language in my note that is accurate and specific, it will be useful to all who later need it.” Building on metrics such as expected versus actual 30-day readmission rates, risk-adjusted mortality, and all the ways government agencies report hospital quality, she said, “what we document has lasting impact. That’s where the facility side of billing and coding is ever more important. You can’t just think about your professional billing and RVUs.”
 

Support from the hospital

Some hospitalists may think facility billing is not their concern. But consider this: The average support or subsidy paid by U.S. hospitals for a full-time equivalent hospitalist is estimated at $198,750, according to SHM’s 2020 State of Hospital Medicine.² That support reflects the difference between the cost of employing a hospitalist in a competitive labor environment and what that provider is actually able to generate in billing income, said Hardik Vora, MD, MPH, SFHM, chair of SHM’s practice management committee.

With a lot of medical specialties, the physician’s salary is only or largely supported by professional billing, said Dr. Vora, who is medical director for Hospital Medicine and physician advisor for utilization management and CDI at Riverside Health System, Yorktown, Va.

“Hospital medicine is different in that aspect, regardless of employment model. And that’s where the concept of value comes in – how else do you bring value to the hospital that supports you,” said Dr. Vora.

Hospitalists often emphasize their contributions to quality improvement, patient safety, and hospital governance committees – all the ways they contribute to the health of the institution – as justification for their support from the hospital. But beneath all of that is the income the hospital generates from facility billing and from the hospitalist’s contributions to complete, accurate, and timely documentation that can support the hospital’s bills.

Typically, this hospital support to supplement hospitalist billing income is not directly tied to the income generated by facility billing or to the hospitalist’s contribution to its completeness. But between growing technological sophistication and greater belt-tightening, that link may get closer over time.
 

Other players

Because of the importance of complete and accurate billing to the hospital’s financial well-being, specialized supportive services have evolved, from traditional utilization review or utilization management to CDI services and the role of physician advisors – experienced doctors who know well how these processes work and are able to teach providers about regulatory compliance and medical necessity.

“One of my jobs as the medical director for our hospital’s CDI program is to educate residents, fellows, and newly onboarded providers to be descriptive enough in their charting to capture the complexity of the patient’s condition,” Dr. Arafiles said. Physician advisors and CDI programs can involve clinical providers in bringing value to the institution through their documentation. They serve as the intermediaries between the coders and the clinicians.

The CDI specialist’s job description focuses on diagnosis capture and associated reimbursement. But integrity broadly defined goes to the integrity of the medical record and its contribution to quality and patient safety as well as providing a medical record that is defensible to audits, physician revenue cycle expert Glenn Krauss noted in a recent post at ICD10 Monitor.³

Dr. Vora sees his role as physician advisor to be the link between the hospital’s executive team and the hospital’s medical providers. “Providers need help in understanding a complex set of ever-changing rules of facility billing and the frequently competing priorities between facility and professional billing. I tell my providers: The longer the patient stays in the hospital, you may be generating more RVUs, but our facility may be losing money.”

Hospital administrators are acutely aware of facility billing, but they don’t necessarily understand the nuances of professional billing, said Jay Weatherly, MS, the cofounder of Hospitalist Billing, a company that specializes in comprehensive billing and collection solutions for hospitalist groups that are employed directly by their hospitals. But he sees an essential symbiotic relationship between hospital administrators and clinicians.

“We rely on hospitalists’ record keeping to do our job. We rely on them to get it right,” he said. “We want to encourage doctors to cooperate with the process. Billing should never be a physician’s top priority, but it is important, nonetheless.”

HBI is relentless in pursuit of the information needed for its coding and billing, but does so gently, in a way not to put off doctors, Mr. Weatherly said. “There is an art and a science associated with securing the needed information. We have great respect for the doctors we work with, yet we’re all spokes in a bigger wheel, and we need to bill effectively in order to keep the wheel moving.”
 

What can hospitalists do?

Sources for this article say one of the best places for hospitalists to start improving their understanding of these distinctions is to ask the coders in their institution for advice on how to make the process run more smoothly.

“If you have a CDI team, they are there to help. Reach out to them,” Dr. Arafiles said. Generally, medical schools and residency programs fail to convey the complexities of contemporary hospital economics to future doctors.

Hospitalists have become indispensable, Dr. Vora said. But salaries for hospitalists are going up while hospital reimbursement is going down, and hospitalists are not seeing more patients. “At some point we will no longer be able to say financial support for hospital medicine groups is just a cost of doing business for the hospital. COVID tested us – and demonstrated how much hospital executives value us as part of the team. Our organization absolutely stood behind its physicians despite financially challenging times. Now we need to do what we can to support the organization,” he added.

Hospitalists can also continue to educate themselves on good documentation and coding practices, by finding programs like SHM’s Utilization Management and Clinical Documentation for Hospitalists.

“As we see a significant shift to value-based payment, with its focus on value, efficiency, quality – the best care at the lowest possible price – hospital medicine as a specialty will be best positioned to help with that. If the hospital does well, we do well. We should be building relationships with the hospital’s leadership team,” Dr. Vora said. “You always want to contribute to that partnership to the highest level possible. When they look at us, they should see their most reliable partner.”
 

References

1. Locke C, Hu E. Medicare’s two-midnight rule: What hospitalists must know. The Hospitalist. 2019 Feb 22.

2. Beresford L. Hospital medicine in a worldwide pandemic: ^{State of Hospital Medicine} 2020. The Hospitalist. 2020 Sep 20.

3. Krauss G. Clinical documentation integrity: rebranding and repurposing. ICD10 Monitor. March 16, 2020 Mar 16. https://www.icd10monitor.com/clinical-documentation-integrity-rebranding-and-repurposing.
 

Coding and billing for the professional services of physicians and other practitioners in the hospital and for the hospital’s facility costs are separate and distinct processes. But both reflect the totality of care given to patients in the complex, costly, heavily regulated setting of an acute care hospital. And both are essential to the financial well-being of the hospital and its providers, and to their mutual ability to survive current financial uncertainties imposed by the COVID pandemic.

“What hospitalists don’t realize is that your professional billing is a completely separate entity [from the facility’s billing],” said Aziz Ansari, DO, SFHM, hospitalist, professor of medicine, and associate chief medical officer for clinical optimization and revenue integrity at Loyola University Medical Center in Maywood, Ill. “Your E/M [Evaluation and Management] coding has a separate set of rules, which are not married at all to facility billing.”

Dr. Ansari presented a session at Converge – the annual conference of SHM – in May 2021, on the hospitalist’s role in “Piloting the Twin Engines of the Mid-Revenue Cycle Ship,” with a focus on how physician documentation can optimize both facility billing and quality of care. Hospitalists generally don’t realize how much impact they actually have on their hospital’s revenue cycle and quality, he said. Thorough documentation, accurately and specifically describing the patient’s severity of illness and complexity, affects both.

“When a utilization management nurse calls you about a case, you need to realize they are your partner in getting it right.” A simple documentation lapse that would change a case from observation to inpatient could cost the hospital $3,000 or more per case, and that can add up quickly, Dr. Ansari said. “We’ve seen what happened with COVID. We realized how fragile the system is, and how razor-thin hospital margins are.”
 

Distinction between professional and facility billing

Professional billing by hospitalist physicians and advanced practice providers is done for their individual encounters with patients and charged per visit for every day the patient is in the hospital based on the treatments, examinations, and medical decision-making required to care for that patient.

These are spelled out using E/M codes derived from Current Procedural Terminology, which is maintained by the American Medical Association for specifying what the provider did during the encounter. Other parameters of professional billing include complexity of decision-making versus amount of time spent, and a variety of modifiers.

By contrast, facility billing by hospitals is based on the complexity of the patient’s condition and is generally done whether the hospitalization is considered an inpatient hospitalization or an outpatient hospitalization such as an observation stay. Inpatient hospital stays are often paid using diagnosis-related groupings (DRGs), Medicare’s patient classification system for standardizing prospective payment to hospitals and encouraging cost-containment strategies.

DRGs, which represent about half of total hospital reimbursement, are a separate payment mechanism covering all facility charges associated with the inpatient stay from admission to discharge, incorporating the costs of providing hospital care, including but not limited to space, equipment, supplies, tests, and medications. Outpatient hospital stays, by contrast, are paid based on Ambulatory Payment Classifications.

A facility bill is submitted to the payer at the end of the hospital stay, describing the patient’s condition using ICD-10 diagnostic codes. All of the patient’s diagnoses and comorbidities contribute to the assignment of a DRG that best captures the total hospital stay. But to make the issue more complicated, the system is evolving toward models of bundled payment that will eventually phase out traditional DRGs in favor of new systems combining inpatient and outpatient reimbursement into a single bundled episode of care.

Professional and facility bills for a single hospitalization may be prepared by different personnel on separate teams following different rules, although they may both be housed in the hospital’s billing department. The differing rules for coding professional services versus facility services can be hard for hospitalists to appreciate, said Wendy Arafiles, MD, a pediatric hospitalist at Phoenix Children’s Hospital and medical director for its clinical documentation integrity (CDI) team. An example is for uncertain diagnoses. There may be a clinical suspicion of a diagnosis, and language such as “likely bacterial pneumonia” might be sufficient for facility coding but not for professional services coding.

Hospitalists, depending on their group’s size, structure, and relationship to the hospital, may be responsible for selecting the CPT codes or other parameters for the insurance claim and bill. Or these may be left to billing specialists. And those specialists could be employed by the hospital or by the hospitalist group or multispecialty medical group, or they could be contracted outside agencies that handle the billing for a fee.


 

The revenue cycle

The hospital revenue cycle has a lot of cogs in the machine, Dr. Arafiles said. “This is just one of the many nuances of our crazy system. I will go out on a limb and say it is not our job as clinicians to know all of those nuances.” The DRG assignment is dependent on how providers can describe the complexity of the patient and severity of the illness, even if it doesn’t impact professional billing, Dr. Arafiles added.

Hospitalists don’t want to think about money when providing patient care. “Our job is to provide the best care to our patients. We often utilize resources without thinking about how much they are going to cost, so that we can do what we think is necessary for our patients,” she explained. But accurate diagnosis codes can capture the complexity of the care. “Maybe we don’t take that part seriously enough. As long as I, as the provider, can accurately describe the complexity of my patient, I can justify why I spent all those resources and so many days caring for him or her.”

Charles Locke, MD, executive medical director of care management for LifeBridge Health and assistant professor of medicine at Johns Hopkins University, Baltimore, said hospitalists typically are paid set salaries directly by the hospital, in some cases with productivity bonuses based in part on their billing and posted RVUs (relative value units). RVUs are the cornerstone of Medicare’s reimbursement formula for physician services.

“Another thing to keep in mind, one might think in 2021 that the computer systems would be sophisticated enough to link up professional and facility billing to ensure that bills for each are concordant for services provided on a given day. But it turns out they are not yet well connected,” Dr. Locke said.

“These are issues that everybody struggles with. Hospitalists need to know and order the appropriate status, inpatient versus outpatient, and whether and when to order observation services, as this will affect hospital reimbursement and, potentially, patient liability,” he explained.¹ If the hospital is denied its facility claim because of improper status, that denial doesn’t necessary extend to a denial for the doctor’s professional fee. “Hospitalists need to know these are often separated. Even though their professional fee is honored, the hospital’s service charges may not be.”

Dr. Locke said knowing the history of Medicare might help hospitalists to better appreciate the distinctions. When this federal entitlement was first proposed in the 1960s as a way to help older Americans in poverty obtain needed health care, organized medicine sought to be excluded from the program. “Nonhospital services and doctors’ service fees were not included in the original Medicare proposal,” he said. Medicare Part B was created to provide insurance for doctors’ professional fees, which are still handled separately under Medicare.

Many institutions use clinical documentation for multiple purposes. “There are so many masters for this one document,” Dr. Arafiles said. The information is also used for various quality and patient safety metrics and data gathering. “Every code we choose is used in many different ways by the institution. We don’t know where all it goes. But we need to know how to describe how complex the case was, and how much work it entailed. The more we know about how to describe that, the better for the institution.”

Dr. Arafiles views the clinical note, first and foremost, as clinical communication, so that one provider can seamlessly pick up where the previous left off. “If I use language in my note that is accurate and specific, it will be useful to all who later need it.” Building on metrics such as expected versus actual 30-day readmission rates, risk-adjusted mortality, and all the ways government agencies report hospital quality, she said, “what we document has lasting impact. That’s where the facility side of billing and coding is ever more important. You can’t just think about your professional billing and RVUs.”
 

Support from the hospital

Some hospitalists may think facility billing is not their concern. But consider this: The average support or subsidy paid by U.S. hospitals for a full-time equivalent hospitalist is estimated at $198,750, according to SHM’s 2020 State of Hospital Medicine.² That support reflects the difference between the cost of employing a hospitalist in a competitive labor environment and what that provider is actually able to generate in billing income, said Hardik Vora, MD, MPH, SFHM, chair of SHM’s practice management committee.

With a lot of medical specialties, the physician’s salary is only or largely supported by professional billing, said Dr. Vora, who is medical director for Hospital Medicine and physician advisor for utilization management and CDI at Riverside Health System, Yorktown, Va.

“Hospital medicine is different in that aspect, regardless of employment model. And that’s where the concept of value comes in – how else do you bring value to the hospital that supports you,” said Dr. Vora.

Hospitalists often emphasize their contributions to quality improvement, patient safety, and hospital governance committees – all the ways they contribute to the health of the institution – as justification for their support from the hospital. But beneath all of that is the income the hospital generates from facility billing and from the hospitalist’s contributions to complete, accurate, and timely documentation that can support the hospital’s bills.

Typically, this hospital support to supplement hospitalist billing income is not directly tied to the income generated by facility billing or to the hospitalist’s contribution to its completeness. But between growing technological sophistication and greater belt-tightening, that link may get closer over time.
 

Other players

Because of the importance of complete and accurate billing to the hospital’s financial well-being, specialized supportive services have evolved, from traditional utilization review or utilization management to CDI services and the role of physician advisors – experienced doctors who know well how these processes work and are able to teach providers about regulatory compliance and medical necessity.

“One of my jobs as the medical director for our hospital’s CDI program is to educate residents, fellows, and newly onboarded providers to be descriptive enough in their charting to capture the complexity of the patient’s condition,” Dr. Arafiles said. Physician advisors and CDI programs can involve clinical providers in bringing value to the institution through their documentation. They serve as the intermediaries between the coders and the clinicians.

The CDI specialist’s job description focuses on diagnosis capture and associated reimbursement. But integrity broadly defined goes to the integrity of the medical record and its contribution to quality and patient safety as well as providing a medical record that is defensible to audits, physician revenue cycle expert Glenn Krauss noted in a recent post at ICD10 Monitor.³

Dr. Vora sees his role as physician advisor to be the link between the hospital’s executive team and the hospital’s medical providers. “Providers need help in understanding a complex set of ever-changing rules of facility billing and the frequently competing priorities between facility and professional billing. I tell my providers: The longer the patient stays in the hospital, you may be generating more RVUs, but our facility may be losing money.”

Hospital administrators are acutely aware of facility billing, but they don’t necessarily understand the nuances of professional billing, said Jay Weatherly, MS, the cofounder of Hospitalist Billing, a company that specializes in comprehensive billing and collection solutions for hospitalist groups that are employed directly by their hospitals. But he sees an essential symbiotic relationship between hospital administrators and clinicians.

“We rely on hospitalists’ record keeping to do our job. We rely on them to get it right,” he said. “We want to encourage doctors to cooperate with the process. Billing should never be a physician’s top priority, but it is important, nonetheless.”

HBI is relentless in pursuit of the information needed for its coding and billing, but does so gently, in a way not to put off doctors, Mr. Weatherly said. “There is an art and a science associated with securing the needed information. We have great respect for the doctors we work with, yet we’re all spokes in a bigger wheel, and we need to bill effectively in order to keep the wheel moving.”
 

What can hospitalists do?

Sources for this article say one of the best places for hospitalists to start improving their understanding of these distinctions is to ask the coders in their institution for advice on how to make the process run more smoothly.

“If you have a CDI team, they are there to help. Reach out to them,” Dr. Arafiles said. Generally, medical schools and residency programs fail to convey the complexities of contemporary hospital economics to future doctors.

Hospitalists have become indispensable, Dr. Vora said. But salaries for hospitalists are going up while hospital reimbursement is going down, and hospitalists are not seeing more patients. “At some point we will no longer be able to say financial support for hospital medicine groups is just a cost of doing business for the hospital. COVID tested us – and demonstrated how much hospital executives value us as part of the team. Our organization absolutely stood behind its physicians despite financially challenging times. Now we need to do what we can to support the organization,” he added.

Hospitalists can also continue to educate themselves on good documentation and coding practices, by finding programs like SHM’s Utilization Management and Clinical Documentation for Hospitalists.

“As we see a significant shift to value-based payment, with its focus on value, efficiency, quality – the best care at the lowest possible price – hospital medicine as a specialty will be best positioned to help with that. If the hospital does well, we do well. We should be building relationships with the hospital’s leadership team,” Dr. Vora said. “You always want to contribute to that partnership to the highest level possible. When they look at us, they should see their most reliable partner.”
 

References

1. Locke C, Hu E. Medicare’s two-midnight rule: What hospitalists must know. The Hospitalist. 2019 Feb 22.

2. Beresford L. Hospital medicine in a worldwide pandemic: ^{State of Hospital Medicine} 2020. The Hospitalist. 2020 Sep 20.

3. Krauss G. Clinical documentation integrity: rebranding and repurposing. ICD10 Monitor. March 16, 2020 Mar 16. https://www.icd10monitor.com/clinical-documentation-integrity-rebranding-and-repurposing.
 

A federal judge in Texas has dismissed a lawsuit from 117 Houston Methodist Hospital workers who refused to get a COVID-19 vaccine and said it was illegal to require them to do so.

In the ruling issued June 12, U.S. District Judge Lynn Hughes upheld the hospital’s policy and said the vaccination requirement didn’t break any federal laws.

“This is not coercion,” Judge Hughes wrote in the ruling.

“Methodist is trying to do their business of saving lives without giving them the COVID-19 virus,” he wrote. “It is a choice made to keep staff, patients, and their families safer.”

In April, the Houston Methodist Hospital system announced a policy that required employees to be vaccinated by June 7 or request an exemption. After the deadline, 178 of 26,000 employees refused to get inoculated and were placed on suspension without pay. The employees said the vaccine was unsafe and “experimental.” In his ruling, Judge Hughes said their claim was false and irrelevant.

“Texas law only protects employees from being terminated for refusing to commit an act carrying criminal penalties to the worker,” he wrote. “Receiving a COVID-19 vaccination is not an illegal act, and it carries no criminal penalties.”

He denounced the “press-release style of the complaint” and the comparison of the hospital’s vaccine policy to forced experimentation by the Nazis against Jewish people during the Holocaust.

“Equating the injection requirement to medical experimentation in concentration camps is reprehensible,” he wrote. “Nazi doctors conducted medical experiments on victims that caused pain, mutilation, permanent disability, and in many cases, death.”

Judge Hughes also said that employees can “freely choose” to accept or refuse a COVID-19 vaccine. If they refuse, they “simply need to work somewhere else,” he wrote.

“If a worker refuses an assignment, changed office, earlier start time, or other directive, he may be properly fired,” Judge Hughes said. “Every employment includes limits on the worker’s behavior in exchange for his remuneration. This is all part of the bargain.”

The ruling could set a precedent for similar COVID-19 vaccine lawsuits across the country, NPR reported. Houston Methodist was one of the first hospitals to require staff to be vaccinated. After the ruling on June 12, the hospital system wrote in a statement that it was “pleased and reassured” that Judge Hughes dismissed a “frivolous lawsuit.”

The hospital system will begin to terminate the 178 employees who were suspended if they don’t get a vaccine by June 21.

Jennifer Bridges, a nurse who has led the campaign against the vaccine policy, said she and the other plaintiffs will appeal the decision, according to KHOU.

“We’re OK with this decision. We are appealing. This will be taken all the way to the Supreme Court,” she told the news station. “This is far from over. This is literally only the beginning.”

A version of this article first appeared on WebMD.com.

A federal judge in Texas has dismissed a lawsuit from 117 Houston Methodist Hospital workers who refused to get a COVID-19 vaccine and said it was illegal to require them to do so.

In the ruling issued June 12, U.S. District Judge Lynn Hughes upheld the hospital’s policy and said the vaccination requirement didn’t break any federal laws.

“This is not coercion,” Judge Hughes wrote in the ruling.

“Methodist is trying to do their business of saving lives without giving them the COVID-19 virus,” he wrote. “It is a choice made to keep staff, patients, and their families safer.”

In April, the Houston Methodist Hospital system announced a policy that required employees to be vaccinated by June 7 or request an exemption. After the deadline, 178 of 26,000 employees refused to get inoculated and were placed on suspension without pay. The employees said the vaccine was unsafe and “experimental.” In his ruling, Judge Hughes said their claim was false and irrelevant.

“Texas law only protects employees from being terminated for refusing to commit an act carrying criminal penalties to the worker,” he wrote. “Receiving a COVID-19 vaccination is not an illegal act, and it carries no criminal penalties.”

He denounced the “press-release style of the complaint” and the comparison of the hospital’s vaccine policy to forced experimentation by the Nazis against Jewish people during the Holocaust.

“Equating the injection requirement to medical experimentation in concentration camps is reprehensible,” he wrote. “Nazi doctors conducted medical experiments on victims that caused pain, mutilation, permanent disability, and in many cases, death.”

Judge Hughes also said that employees can “freely choose” to accept or refuse a COVID-19 vaccine. If they refuse, they “simply need to work somewhere else,” he wrote.

“If a worker refuses an assignment, changed office, earlier start time, or other directive, he may be properly fired,” Judge Hughes said. “Every employment includes limits on the worker’s behavior in exchange for his remuneration. This is all part of the bargain.”

The ruling could set a precedent for similar COVID-19 vaccine lawsuits across the country, NPR reported. Houston Methodist was one of the first hospitals to require staff to be vaccinated. After the ruling on June 12, the hospital system wrote in a statement that it was “pleased and reassured” that Judge Hughes dismissed a “frivolous lawsuit.”

The hospital system will begin to terminate the 178 employees who were suspended if they don’t get a vaccine by June 21.

Jennifer Bridges, a nurse who has led the campaign against the vaccine policy, said she and the other plaintiffs will appeal the decision, according to KHOU.

“We’re OK with this decision. We are appealing. This will be taken all the way to the Supreme Court,” she told the news station. “This is far from over. This is literally only the beginning.”

A version of this article first appeared on WebMD.com.

A federal judge in Texas has dismissed a lawsuit from 117 Houston Methodist Hospital workers who refused to get a COVID-19 vaccine and said it was illegal to require them to do so.

In the ruling issued June 12, U.S. District Judge Lynn Hughes upheld the hospital’s policy and said the vaccination requirement didn’t break any federal laws.

“This is not coercion,” Judge Hughes wrote in the ruling.

“Methodist is trying to do their business of saving lives without giving them the COVID-19 virus,” he wrote. “It is a choice made to keep staff, patients, and their families safer.”

In April, the Houston Methodist Hospital system announced a policy that required employees to be vaccinated by June 7 or request an exemption. After the deadline, 178 of 26,000 employees refused to get inoculated and were placed on suspension without pay. The employees said the vaccine was unsafe and “experimental.” In his ruling, Judge Hughes said their claim was false and irrelevant.

“Texas law only protects employees from being terminated for refusing to commit an act carrying criminal penalties to the worker,” he wrote. “Receiving a COVID-19 vaccination is not an illegal act, and it carries no criminal penalties.”

He denounced the “press-release style of the complaint” and the comparison of the hospital’s vaccine policy to forced experimentation by the Nazis against Jewish people during the Holocaust.

“Equating the injection requirement to medical experimentation in concentration camps is reprehensible,” he wrote. “Nazi doctors conducted medical experiments on victims that caused pain, mutilation, permanent disability, and in many cases, death.”

Judge Hughes also said that employees can “freely choose” to accept or refuse a COVID-19 vaccine. If they refuse, they “simply need to work somewhere else,” he wrote.

“If a worker refuses an assignment, changed office, earlier start time, or other directive, he may be properly fired,” Judge Hughes said. “Every employment includes limits on the worker’s behavior in exchange for his remuneration. This is all part of the bargain.”

The ruling could set a precedent for similar COVID-19 vaccine lawsuits across the country, NPR reported. Houston Methodist was one of the first hospitals to require staff to be vaccinated. After the ruling on June 12, the hospital system wrote in a statement that it was “pleased and reassured” that Judge Hughes dismissed a “frivolous lawsuit.”

The hospital system will begin to terminate the 178 employees who were suspended if they don’t get a vaccine by June 21.

Jennifer Bridges, a nurse who has led the campaign against the vaccine policy, said she and the other plaintiffs will appeal the decision, according to KHOU.

“We’re OK with this decision. We are appealing. This will be taken all the way to the Supreme Court,” she told the news station. “This is far from over. This is literally only the beginning.”

A version of this article first appeared on WebMD.com.

The U.S. Occupational Safety and Health Administration issued its long-awaited Emergency Temporary Standard (ETS) for COVID-19 June 10, surprising many by including only health care workers in the new emergency workplace safety rules.

“The ETS is an overdue step toward protecting health care workers, especially those working in long-term care facilities and home health care who are at greatly increased risk of infection,” said George Washington University, Washington, professor and former Obama administration Assistant Secretary of Labor David Michaels, PhD, MPH. “OSHA’s failure to issue a COVID-specific standard in other high-risk industries, like meat and poultry processing, corrections, homeless shelters, and retail establishments is disappointing. If exposure is not controlled in these workplaces, they will continue to be important drivers of infections.”

With the new regulations in place, about 10.3 million health care workers at hospitals, nursing homes, and assisted living facilities, as well as emergency responders and home health care workers, should be guaranteed protection standards that replace former guidance.

The new protections include supplying personal protective equipment and ensuring proper usage (for example, mandatory seal checks on respirators); screening everyone who enters the facility for COVID-19; ensuring proper ventilation; and establishing physical distancing requirements (6 feet) for unvaccinated workers. It also requires employers to give workers time off for vaccination. An antiretaliation clause could shield workers who complain about unsafe conditions.

“The science tells us that health care workers, particularly those who come into regular contact with the virus, are most at risk at this point in the pandemic,” Labor Secretary Marty Walsh said on a press call. “So following an extensive review of the science and data, OSHA determined that a health care–specific safety requirement will make the biggest impact.”

But questions remain, said James Brudney, JD, a professor at Fordham Law School in New York and former chief counsel of the U.S. Senate Subcommittee on Labor. The standard doesn’t amplify or address existing rules regarding a right to refuse unsafe work, for example, so employees may still feel they are risking their jobs to complain, despite the antiretaliation clause.

And although vaccinated employees don’t have to adhere to the same distancing and masking standards in many instances, the standard doesn’t spell out how employers should determine their workers’ vaccination status – instead leaving that determination to employers through their own policies and procedures. (California’s state OSHA office rules specify the mechanism for documentation of vaccination.)

The Trump administration did not issue an ETS, saying OSHA’s general duty clause sufficed. President Joe Biden took the opposite approach, calling for an investigation into an ETS on his first day in office. But the process took months longer than promised.

“I know it’s been a long time coming,” Mr. Walsh acknowledged. “Our health care workers from the very beginning have been put at risk.

While health care unions had asked for mandated safety standards sooner, National Nurses United, the country’s largest labor union for registered nurses, still welcomed the rules.

“An ETS is a major step toward requiring accountability for hospitals who consistently put their budget goals and profits over our health and safety,” Zenei Triunfo-Cortez, RN, one of NNU’s three presidents, said in a statement June 9 anticipating the publication of the rules.

The rules do not apply to retail pharmacies, ambulatory care settings that screen nonemployees for COVID-19, or certain other settings in which all employees are vaccinated and people with suspected or confirmed COVID-19 cannot enter.

The agency said it will work with states that have already issued local regulations, including two states that issued temporary standards of their own, Virginia and California.

Employers will have 2 weeks to comply with most of the regulations after they’re published in the Federal Register. The standards will expire in 6 months but could then become permanent, as Virginia’s did in January.

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

The U.S. Occupational Safety and Health Administration issued its long-awaited Emergency Temporary Standard (ETS) for COVID-19 June 10, surprising many by including only health care workers in the new emergency workplace safety rules.

“The ETS is an overdue step toward protecting health care workers, especially those working in long-term care facilities and home health care who are at greatly increased risk of infection,” said George Washington University, Washington, professor and former Obama administration Assistant Secretary of Labor David Michaels, PhD, MPH. “OSHA’s failure to issue a COVID-specific standard in other high-risk industries, like meat and poultry processing, corrections, homeless shelters, and retail establishments is disappointing. If exposure is not controlled in these workplaces, they will continue to be important drivers of infections.”

With the new regulations in place, about 10.3 million health care workers at hospitals, nursing homes, and assisted living facilities, as well as emergency responders and home health care workers, should be guaranteed protection standards that replace former guidance.

The new protections include supplying personal protective equipment and ensuring proper usage (for example, mandatory seal checks on respirators); screening everyone who enters the facility for COVID-19; ensuring proper ventilation; and establishing physical distancing requirements (6 feet) for unvaccinated workers. It also requires employers to give workers time off for vaccination. An antiretaliation clause could shield workers who complain about unsafe conditions.

“The science tells us that health care workers, particularly those who come into regular contact with the virus, are most at risk at this point in the pandemic,” Labor Secretary Marty Walsh said on a press call. “So following an extensive review of the science and data, OSHA determined that a health care–specific safety requirement will make the biggest impact.”

But questions remain, said James Brudney, JD, a professor at Fordham Law School in New York and former chief counsel of the U.S. Senate Subcommittee on Labor. The standard doesn’t amplify or address existing rules regarding a right to refuse unsafe work, for example, so employees may still feel they are risking their jobs to complain, despite the antiretaliation clause.

And although vaccinated employees don’t have to adhere to the same distancing and masking standards in many instances, the standard doesn’t spell out how employers should determine their workers’ vaccination status – instead leaving that determination to employers through their own policies and procedures. (California’s state OSHA office rules specify the mechanism for documentation of vaccination.)

The Trump administration did not issue an ETS, saying OSHA’s general duty clause sufficed. President Joe Biden took the opposite approach, calling for an investigation into an ETS on his first day in office. But the process took months longer than promised.

“I know it’s been a long time coming,” Mr. Walsh acknowledged. “Our health care workers from the very beginning have been put at risk.

While health care unions had asked for mandated safety standards sooner, National Nurses United, the country’s largest labor union for registered nurses, still welcomed the rules.

“An ETS is a major step toward requiring accountability for hospitals who consistently put their budget goals and profits over our health and safety,” Zenei Triunfo-Cortez, RN, one of NNU’s three presidents, said in a statement June 9 anticipating the publication of the rules.

The rules do not apply to retail pharmacies, ambulatory care settings that screen nonemployees for COVID-19, or certain other settings in which all employees are vaccinated and people with suspected or confirmed COVID-19 cannot enter.

The agency said it will work with states that have already issued local regulations, including two states that issued temporary standards of their own, Virginia and California.

Employers will have 2 weeks to comply with most of the regulations after they’re published in the Federal Register. The standards will expire in 6 months but could then become permanent, as Virginia’s did in January.

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

The U.S. Occupational Safety and Health Administration issued its long-awaited Emergency Temporary Standard (ETS) for COVID-19 June 10, surprising many by including only health care workers in the new emergency workplace safety rules.

“The ETS is an overdue step toward protecting health care workers, especially those working in long-term care facilities and home health care who are at greatly increased risk of infection,” said George Washington University, Washington, professor and former Obama administration Assistant Secretary of Labor David Michaels, PhD, MPH. “OSHA’s failure to issue a COVID-specific standard in other high-risk industries, like meat and poultry processing, corrections, homeless shelters, and retail establishments is disappointing. If exposure is not controlled in these workplaces, they will continue to be important drivers of infections.”

With the new regulations in place, about 10.3 million health care workers at hospitals, nursing homes, and assisted living facilities, as well as emergency responders and home health care workers, should be guaranteed protection standards that replace former guidance.

The new protections include supplying personal protective equipment and ensuring proper usage (for example, mandatory seal checks on respirators); screening everyone who enters the facility for COVID-19; ensuring proper ventilation; and establishing physical distancing requirements (6 feet) for unvaccinated workers. It also requires employers to give workers time off for vaccination. An antiretaliation clause could shield workers who complain about unsafe conditions.

“The science tells us that health care workers, particularly those who come into regular contact with the virus, are most at risk at this point in the pandemic,” Labor Secretary Marty Walsh said on a press call. “So following an extensive review of the science and data, OSHA determined that a health care–specific safety requirement will make the biggest impact.”

But questions remain, said James Brudney, JD, a professor at Fordham Law School in New York and former chief counsel of the U.S. Senate Subcommittee on Labor. The standard doesn’t amplify or address existing rules regarding a right to refuse unsafe work, for example, so employees may still feel they are risking their jobs to complain, despite the antiretaliation clause.

And although vaccinated employees don’t have to adhere to the same distancing and masking standards in many instances, the standard doesn’t spell out how employers should determine their workers’ vaccination status – instead leaving that determination to employers through their own policies and procedures. (California’s state OSHA office rules specify the mechanism for documentation of vaccination.)

The Trump administration did not issue an ETS, saying OSHA’s general duty clause sufficed. President Joe Biden took the opposite approach, calling for an investigation into an ETS on his first day in office. But the process took months longer than promised.

“I know it’s been a long time coming,” Mr. Walsh acknowledged. “Our health care workers from the very beginning have been put at risk.

While health care unions had asked for mandated safety standards sooner, National Nurses United, the country’s largest labor union for registered nurses, still welcomed the rules.

“An ETS is a major step toward requiring accountability for hospitals who consistently put their budget goals and profits over our health and safety,” Zenei Triunfo-Cortez, RN, one of NNU’s three presidents, said in a statement June 9 anticipating the publication of the rules.

The rules do not apply to retail pharmacies, ambulatory care settings that screen nonemployees for COVID-19, or certain other settings in which all employees are vaccinated and people with suspected or confirmed COVID-19 cannot enter.

The agency said it will work with states that have already issued local regulations, including two states that issued temporary standards of their own, Virginia and California.

Employers will have 2 weeks to comply with most of the regulations after they’re published in the Federal Register. The standards will expire in 6 months but could then become permanent, as Virginia’s did in January.

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

Converge 2021 session

Febrile Infant Update

Presenter

Russell J. McCulloh, MD

Session summary

Infections in infants aged younger than 90 days have been the subject of intense study in pediatric hospital medicine for many years. With the guidance of our talented presenter Dr. Russell McCulloh of Children’s Hospital & Medical Center in Omaha, Neb., the audience explored the historical perspective and evolution of this scientific question, including successes, special situations, newer screening tests, and description of cutting-edge scoring tools and platforms.

The challenge – Tens of thousands of infants present for care in the setting of fever each year. We know that our physical exam and history-taking skills are unlikely to be helpful in risk stratification. We have been guided by the desire to separate serious bacterial infection (SBI: bone infection, meningitis, pneumonia, urinary tract infection, bacteremia, enteritis) from invasive bacterial infection (IBI: meningitis and bacteremia). Data has shown that no test is 100% sensitive or specific, therefore we have to balance risk of disease to cost and invasiveness of tests. Important questions include whether to test and how to stratify by age, who to admit, and who to provide antibiotics.

The wins and exceptions – Fortunately, the early Boston, Philadelphia, and Rochester criteria set the stage for safely reducing testing. The current American College of Emergency Physicians guidelines for infants aged 29-90 days allows for lumbar puncture to be optional knowing that a look back using prior criteria identified no cases of meningitis in the low risk group. Similarly, in low-risk infants aged less that 29 days in nearly 4,000 cases there were just 2 infants with meningitis. Universal screening of moms for Group B Streptococcus with delivery of antibiotics in appropriate cases has dramatically decreased incidence of SBI. The Hib and pneumovax vaccines have likewise decreased incidence of SBI. Exceptions persist, including knowledge that infants with herpes simplex virus disease will not have fever in 50% of cases and that risk of HSV transmission is highest (25%-60% transmission) in mothers with primary disease. Given risk of HSV CNS disease after 1 week of age, in any high-risk infant less than 21 days, the mantra remains to test and treat.

The cutting edge – Thanks to ongoing research, we now have the PECARN and REVISE study groups to further aid decision-making. With PECARN we know that SBI in infants is extremely unlikely (negative predictive value, 99.7%) with a negative urinalysis , absolute neutrophil count less than 4,090, and procalcitonin less than 1.71. REVISE has revealed that infants with positive viral testing are unlikely to have SBI (7%-12%), particularly with influenza and RSV disease. Procalcitonin has also recently been shown to be an effective tool to rule out disease with the highest negative predictive value among available inflammatory markers. The just-published Aronson rule identifies a scoring system for IBI (using age less than 21 days/1pt; temp 38-38.4° C/2pt; >38.5° C/4pt; abnormal urinalysis/3pt; and absolute neutrophil count >5185/2pt) where any score greater than2 provides a sensitivity of 98.8% and NPV in validation studies of 99.4%. Likewise, multiplex polymerase chain reaction testing of spinal fluid has allowed for additional insight in pretreated cases and has helped us to remove antibiotic treatment from cases where parechovirus and enterovirus are positive because of the low risk for concomitant bacterial meningitis. As we await the release of revised national American Academy of Pediatrics guidelines, it is safe to say great progress has been made in the care of young febrile infants with shorter length of stay and fewer tests for all.

Key takeaways

• Numerous screening tests, rules, and scoring tools have been created to improve identification of infants with IBI, a low-frequency, high-morbidity event. The most recent with negative predictive values of 99.7% and 99.4% are the PECARN and Aronson scoring tools.
• Recent studies of the febrile infant population indicate that the odds of UTI or bacteremia in infants with respiratory symptoms is low, particularly for RSV and influenza.
• Among newer tests developed, a negative procalcitonin has the highest negative predictive value.
• Viral pathogens identified on cerebrospinal fluid molecular testing can be helpful in pretreated cases and indicative of low likelihood of bacterial meningitis allowing for observation off of antibiotics.

Dr. King is a hospitalist, associate director for medical education and associate program director for the pediatrics residency program at Children’s Minnesota in Minneapolis. She has shared some of her resident teaching, presentation skills, and peer-coaching work on a national level.

Converge 2021 session

Febrile Infant Update

Presenter

Russell J. McCulloh, MD

Session summary

Infections in infants aged younger than 90 days have been the subject of intense study in pediatric hospital medicine for many years. With the guidance of our talented presenter Dr. Russell McCulloh of Children’s Hospital & Medical Center in Omaha, Neb., the audience explored the historical perspective and evolution of this scientific question, including successes, special situations, newer screening tests, and description of cutting-edge scoring tools and platforms.

The challenge – Tens of thousands of infants present for care in the setting of fever each year. We know that our physical exam and history-taking skills are unlikely to be helpful in risk stratification. We have been guided by the desire to separate serious bacterial infection (SBI: bone infection, meningitis, pneumonia, urinary tract infection, bacteremia, enteritis) from invasive bacterial infection (IBI: meningitis and bacteremia). Data has shown that no test is 100% sensitive or specific, therefore we have to balance risk of disease to cost and invasiveness of tests. Important questions include whether to test and how to stratify by age, who to admit, and who to provide antibiotics.

The wins and exceptions – Fortunately, the early Boston, Philadelphia, and Rochester criteria set the stage for safely reducing testing. The current American College of Emergency Physicians guidelines for infants aged 29-90 days allows for lumbar puncture to be optional knowing that a look back using prior criteria identified no cases of meningitis in the low risk group. Similarly, in low-risk infants aged less that 29 days in nearly 4,000 cases there were just 2 infants with meningitis. Universal screening of moms for Group B Streptococcus with delivery of antibiotics in appropriate cases has dramatically decreased incidence of SBI. The Hib and pneumovax vaccines have likewise decreased incidence of SBI. Exceptions persist, including knowledge that infants with herpes simplex virus disease will not have fever in 50% of cases and that risk of HSV transmission is highest (25%-60% transmission) in mothers with primary disease. Given risk of HSV CNS disease after 1 week of age, in any high-risk infant less than 21 days, the mantra remains to test and treat.

The cutting edge – Thanks to ongoing research, we now have the PECARN and REVISE study groups to further aid decision-making. With PECARN we know that SBI in infants is extremely unlikely (negative predictive value, 99.7%) with a negative urinalysis , absolute neutrophil count less than 4,090, and procalcitonin less than 1.71. REVISE has revealed that infants with positive viral testing are unlikely to have SBI (7%-12%), particularly with influenza and RSV disease. Procalcitonin has also recently been shown to be an effective tool to rule out disease with the highest negative predictive value among available inflammatory markers. The just-published Aronson rule identifies a scoring system for IBI (using age less than 21 days/1pt; temp 38-38.4° C/2pt; >38.5° C/4pt; abnormal urinalysis/3pt; and absolute neutrophil count >5185/2pt) where any score greater than2 provides a sensitivity of 98.8% and NPV in validation studies of 99.4%. Likewise, multiplex polymerase chain reaction testing of spinal fluid has allowed for additional insight in pretreated cases and has helped us to remove antibiotic treatment from cases where parechovirus and enterovirus are positive because of the low risk for concomitant bacterial meningitis. As we await the release of revised national American Academy of Pediatrics guidelines, it is safe to say great progress has been made in the care of young febrile infants with shorter length of stay and fewer tests for all.

Key takeaways

• Numerous screening tests, rules, and scoring tools have been created to improve identification of infants with IBI, a low-frequency, high-morbidity event. The most recent with negative predictive values of 99.7% and 99.4% are the PECARN and Aronson scoring tools.
• Recent studies of the febrile infant population indicate that the odds of UTI or bacteremia in infants with respiratory symptoms is low, particularly for RSV and influenza.
• Among newer tests developed, a negative procalcitonin has the highest negative predictive value.
• Viral pathogens identified on cerebrospinal fluid molecular testing can be helpful in pretreated cases and indicative of low likelihood of bacterial meningitis allowing for observation off of antibiotics.

Dr. King is a hospitalist, associate director for medical education and associate program director for the pediatrics residency program at Children’s Minnesota in Minneapolis. She has shared some of her resident teaching, presentation skills, and peer-coaching work on a national level.

Converge 2021 session

Febrile Infant Update

Presenter

Russell J. McCulloh, MD

Session summary

Infections in infants aged younger than 90 days have been the subject of intense study in pediatric hospital medicine for many years. With the guidance of our talented presenter Dr. Russell McCulloh of Children’s Hospital & Medical Center in Omaha, Neb., the audience explored the historical perspective and evolution of this scientific question, including successes, special situations, newer screening tests, and description of cutting-edge scoring tools and platforms.

The challenge – Tens of thousands of infants present for care in the setting of fever each year. We know that our physical exam and history-taking skills are unlikely to be helpful in risk stratification. We have been guided by the desire to separate serious bacterial infection (SBI: bone infection, meningitis, pneumonia, urinary tract infection, bacteremia, enteritis) from invasive bacterial infection (IBI: meningitis and bacteremia). Data has shown that no test is 100% sensitive or specific, therefore we have to balance risk of disease to cost and invasiveness of tests. Important questions include whether to test and how to stratify by age, who to admit, and who to provide antibiotics.

The wins and exceptions – Fortunately, the early Boston, Philadelphia, and Rochester criteria set the stage for safely reducing testing. The current American College of Emergency Physicians guidelines for infants aged 29-90 days allows for lumbar puncture to be optional knowing that a look back using prior criteria identified no cases of meningitis in the low risk group. Similarly, in low-risk infants aged less that 29 days in nearly 4,000 cases there were just 2 infants with meningitis. Universal screening of moms for Group B Streptococcus with delivery of antibiotics in appropriate cases has dramatically decreased incidence of SBI. The Hib and pneumovax vaccines have likewise decreased incidence of SBI. Exceptions persist, including knowledge that infants with herpes simplex virus disease will not have fever in 50% of cases and that risk of HSV transmission is highest (25%-60% transmission) in mothers with primary disease. Given risk of HSV CNS disease after 1 week of age, in any high-risk infant less than 21 days, the mantra remains to test and treat.

The cutting edge – Thanks to ongoing research, we now have the PECARN and REVISE study groups to further aid decision-making. With PECARN we know that SBI in infants is extremely unlikely (negative predictive value, 99.7%) with a negative urinalysis , absolute neutrophil count less than 4,090, and procalcitonin less than 1.71. REVISE has revealed that infants with positive viral testing are unlikely to have SBI (7%-12%), particularly with influenza and RSV disease. Procalcitonin has also recently been shown to be an effective tool to rule out disease with the highest negative predictive value among available inflammatory markers. The just-published Aronson rule identifies a scoring system for IBI (using age less than 21 days/1pt; temp 38-38.4° C/2pt; >38.5° C/4pt; abnormal urinalysis/3pt; and absolute neutrophil count >5185/2pt) where any score greater than2 provides a sensitivity of 98.8% and NPV in validation studies of 99.4%. Likewise, multiplex polymerase chain reaction testing of spinal fluid has allowed for additional insight in pretreated cases and has helped us to remove antibiotic treatment from cases where parechovirus and enterovirus are positive because of the low risk for concomitant bacterial meningitis. As we await the release of revised national American Academy of Pediatrics guidelines, it is safe to say great progress has been made in the care of young febrile infants with shorter length of stay and fewer tests for all.

Key takeaways

• Numerous screening tests, rules, and scoring tools have been created to improve identification of infants with IBI, a low-frequency, high-morbidity event. The most recent with negative predictive values of 99.7% and 99.4% are the PECARN and Aronson scoring tools.
• Recent studies of the febrile infant population indicate that the odds of UTI or bacteremia in infants with respiratory symptoms is low, particularly for RSV and influenza.
• Among newer tests developed, a negative procalcitonin has the highest negative predictive value.
• Viral pathogens identified on cerebrospinal fluid molecular testing can be helpful in pretreated cases and indicative of low likelihood of bacterial meningitis allowing for observation off of antibiotics.

Dr. King is a hospitalist, associate director for medical education and associate program director for the pediatrics residency program at Children’s Minnesota in Minneapolis. She has shared some of her resident teaching, presentation skills, and peer-coaching work on a national level.

Three or more weeks of oral anticoagulation (OAC) sometimes isn’t up to the job of clearing any potentially embolic left atrial (LA) thrombi before procedures like cardioversion or catheter ablation in patients with atrial fibrillation (AF). Such OAC-defiant LA thrombi aren’t common, nor are they rare enough to ignore, suggests a new meta-analysis that might also have identified features that predispose to them.

Such predictors of LA clots that persist despite OAC could potentially guide selective use of transesophageal echocardiography (TEE) instead of more routine policies to either use or not use TEE for thrombus rule-out before rhythm-control procedures, researchers propose.

Their prevalence was about 2.7% among the study’s more than 14,000 patients who received at least 3 weeks of OAC with either vitamin K antagonists (VKA) or direct oral anticoagulants (DOAC) before undergoing TEE.

But OAC-resistant LA thrombi were two- to four-times as common in patients with than without certain features, including AF other than paroxysmal and higher CHADS2 and CHA2DS2-VASc stroke risk-stratification scores.

“TEE imaging in select patients at an elevated risk of LA thrombus, despite anticoagulation status, may be a reasonable approach to minimize the risk of thromboembolic complications following cardioversion or catheter ablation,” propose the study’s authors, led by Antony Lurie, BMSC, Population Health Research Institute, Hamilton, Ont. Their report was published in the June 15 issue of the Journal of the American College of Cardiology.

Guidelines don’t encourage TEE before cardioversion in patients who have been on OAC for at least 3 weeks, the group notes, and policies on TEE use before AF ablation vary widely regardless of anticoagulation status.

The current study suggests that 3 weeks of OAC isn’t enough for a substantial number of patients, who might be put at thromboembolic risk if TEE were to be skipped before rhythm-control procedures.

Conversely, many patients unlikely to have LA thrombi get preprocedure TEE anyway. That can happen “irrespective of how long they’ve been anticoagulated, their pattern of atrial fibrillation, or their stroke risk,” senior author Jorge A. Wong, MD, MPH, Population Health Research Institute and McMaster University, Hamilton, Ont., told this news organization.

But “TEE is an invasive imaging modality, so it is associated with small element of risk.” The current study, Dr. Wong said, points to potential risk-stratification tools clinicians might use to guide more selective TEE screening.

“At sites where TEEs are done all the time for patients undergoing ablation, one could use several of these risk markers to perhaps tailor use of TEE in individuals,” Dr. Wong said. “For example, in people with paroxysmal atrial fibrillation, we found that the risk of left atrial appendage clot was approximately 1% or less.” Screening by TEE might reasonably be avoided in such patients.

“Fortunately, continued oral anticoagulation already yields low peri-procedural stroke rates,” observes an accompanying editorial from Paulus Kirchhof, MD, and Christoph Sinning, MD, from the University Heart & Vascular Center and German Centre of Cardiovascular Research, Hamburg.

“Based on this new analysis of existing data, a risk-based use of TEE imaging in anticoagulated patients could enable further improvement in the safe delivery of rhythm control interventions in patients with AF,” the editorialists agree.

The meta-analysis covered 10 prospective and 25 retrospective studies with a total of 14,653 patients that reported whether LA thrombus was present in patients with AF or atrial flutter (AFL) who underwent TEE after at least 3 weeks of VKA or DOAC therapy. Reports for 30 of the studies identified patients by rhythm-control procedure, and the remaining five didn’t specify TEE indications.

The weighted mean prevalence of LA thrombus at TEE was 2.73% (95% confidence interval, 1.95%-3.80%). The finding was not significantly changed in separate sensitivity analyses, the report says, including one limited to studies with low risk of bias and others excluding patients with valvular AF, interrupted OAC, heparin bridging, or subtherapeutic anticoagulation, respectively.

Patients treated with VKA and DOACs showed similar prevalences of LA thrombi, with means of 2.80% and 3.12%, respectively (P = .674). The prevalence was significantly higher in patients:

• with nonparoxysmal than with paroxysmal AF/AFL (4.81% vs. 1.03%; P < .001)
• undergoing cardioversion than ablation (5.55% vs. 1.65; P < .001)
• with CHA2DS2-VASc scores of at least 3 than with scores of 2 or less (6.31% vs. 1.06%; P < .001).

A limitation of the study, observe Dr. Kirchhof and Dr. Sinning, “is that all patients had a clinical indication for a TEE, which might be a selection bias. When a thrombus was found on TEE, clinical judgment led to postponing of the procedure,” thereby avoiding potential thromboembolism.

“Thus, the paper cannot demonstrate that presence of a thrombus on TEE is related to peri-procedural ischemic stroke,” they write.

The literature puts the risk for stroke or systemic embolism at well under 1% for patients anticoagulated with either VKA or DOACs for at least 3 weeks prior to cardioversion, in contrast to the nearly 3% prevalence of LA appendage thrombus by TEE in the current analysis, Dr. Wong observed.

“So we’re seeing a lot more left atrial appendage thrombus than we would see stroke,” but there wasn’t a way to determine whether that increases the stroke risk, he agreed.Dr. Wong, Dr. Lurie, and the other authors report no relevant conflicts. Dr. Kirchhof discloses receiving partial support “from several drug and device companies active in atrial fibrillation” and to being listed as inventor on two AF-related patents held by the University of Birmingham. Dr. Sinning reports no relevant relationships. 

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

Three or more weeks of oral anticoagulation (OAC) sometimes isn’t up to the job of clearing any potentially embolic left atrial (LA) thrombi before procedures like cardioversion or catheter ablation in patients with atrial fibrillation (AF). Such OAC-defiant LA thrombi aren’t common, nor are they rare enough to ignore, suggests a new meta-analysis that might also have identified features that predispose to them.

Such predictors of LA clots that persist despite OAC could potentially guide selective use of transesophageal echocardiography (TEE) instead of more routine policies to either use or not use TEE for thrombus rule-out before rhythm-control procedures, researchers propose.

Their prevalence was about 2.7% among the study’s more than 14,000 patients who received at least 3 weeks of OAC with either vitamin K antagonists (VKA) or direct oral anticoagulants (DOAC) before undergoing TEE.

But OAC-resistant LA thrombi were two- to four-times as common in patients with than without certain features, including AF other than paroxysmal and higher CHADS2 and CHA2DS2-VASc stroke risk-stratification scores.

“TEE imaging in select patients at an elevated risk of LA thrombus, despite anticoagulation status, may be a reasonable approach to minimize the risk of thromboembolic complications following cardioversion or catheter ablation,” propose the study’s authors, led by Antony Lurie, BMSC, Population Health Research Institute, Hamilton, Ont. Their report was published in the June 15 issue of the Journal of the American College of Cardiology.

Guidelines don’t encourage TEE before cardioversion in patients who have been on OAC for at least 3 weeks, the group notes, and policies on TEE use before AF ablation vary widely regardless of anticoagulation status.

The current study suggests that 3 weeks of OAC isn’t enough for a substantial number of patients, who might be put at thromboembolic risk if TEE were to be skipped before rhythm-control procedures.

Conversely, many patients unlikely to have LA thrombi get preprocedure TEE anyway. That can happen “irrespective of how long they’ve been anticoagulated, their pattern of atrial fibrillation, or their stroke risk,” senior author Jorge A. Wong, MD, MPH, Population Health Research Institute and McMaster University, Hamilton, Ont., told this news organization.

But “TEE is an invasive imaging modality, so it is associated with small element of risk.” The current study, Dr. Wong said, points to potential risk-stratification tools clinicians might use to guide more selective TEE screening.

“At sites where TEEs are done all the time for patients undergoing ablation, one could use several of these risk markers to perhaps tailor use of TEE in individuals,” Dr. Wong said. “For example, in people with paroxysmal atrial fibrillation, we found that the risk of left atrial appendage clot was approximately 1% or less.” Screening by TEE might reasonably be avoided in such patients.

“Fortunately, continued oral anticoagulation already yields low peri-procedural stroke rates,” observes an accompanying editorial from Paulus Kirchhof, MD, and Christoph Sinning, MD, from the University Heart & Vascular Center and German Centre of Cardiovascular Research, Hamburg.

“Based on this new analysis of existing data, a risk-based use of TEE imaging in anticoagulated patients could enable further improvement in the safe delivery of rhythm control interventions in patients with AF,” the editorialists agree.

The meta-analysis covered 10 prospective and 25 retrospective studies with a total of 14,653 patients that reported whether LA thrombus was present in patients with AF or atrial flutter (AFL) who underwent TEE after at least 3 weeks of VKA or DOAC therapy. Reports for 30 of the studies identified patients by rhythm-control procedure, and the remaining five didn’t specify TEE indications.

The weighted mean prevalence of LA thrombus at TEE was 2.73% (95% confidence interval, 1.95%-3.80%). The finding was not significantly changed in separate sensitivity analyses, the report says, including one limited to studies with low risk of bias and others excluding patients with valvular AF, interrupted OAC, heparin bridging, or subtherapeutic anticoagulation, respectively.

Patients treated with VKA and DOACs showed similar prevalences of LA thrombi, with means of 2.80% and 3.12%, respectively (P = .674). The prevalence was significantly higher in patients:

• with nonparoxysmal than with paroxysmal AF/AFL (4.81% vs. 1.03%; P < .001)
• undergoing cardioversion than ablation (5.55% vs. 1.65; P < .001)
• with CHA2DS2-VASc scores of at least 3 than with scores of 2 or less (6.31% vs. 1.06%; P < .001).

A limitation of the study, observe Dr. Kirchhof and Dr. Sinning, “is that all patients had a clinical indication for a TEE, which might be a selection bias. When a thrombus was found on TEE, clinical judgment led to postponing of the procedure,” thereby avoiding potential thromboembolism.

“Thus, the paper cannot demonstrate that presence of a thrombus on TEE is related to peri-procedural ischemic stroke,” they write.

The literature puts the risk for stroke or systemic embolism at well under 1% for patients anticoagulated with either VKA or DOACs for at least 3 weeks prior to cardioversion, in contrast to the nearly 3% prevalence of LA appendage thrombus by TEE in the current analysis, Dr. Wong observed.

“So we’re seeing a lot more left atrial appendage thrombus than we would see stroke,” but there wasn’t a way to determine whether that increases the stroke risk, he agreed.Dr. Wong, Dr. Lurie, and the other authors report no relevant conflicts. Dr. Kirchhof discloses receiving partial support “from several drug and device companies active in atrial fibrillation” and to being listed as inventor on two AF-related patents held by the University of Birmingham. Dr. Sinning reports no relevant relationships. 

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

Three or more weeks of oral anticoagulation (OAC) sometimes isn’t up to the job of clearing any potentially embolic left atrial (LA) thrombi before procedures like cardioversion or catheter ablation in patients with atrial fibrillation (AF). Such OAC-defiant LA thrombi aren’t common, nor are they rare enough to ignore, suggests a new meta-analysis that might also have identified features that predispose to them.

Such predictors of LA clots that persist despite OAC could potentially guide selective use of transesophageal echocardiography (TEE) instead of more routine policies to either use or not use TEE for thrombus rule-out before rhythm-control procedures, researchers propose.

Their prevalence was about 2.7% among the study’s more than 14,000 patients who received at least 3 weeks of OAC with either vitamin K antagonists (VKA) or direct oral anticoagulants (DOAC) before undergoing TEE.

But OAC-resistant LA thrombi were two- to four-times as common in patients with than without certain features, including AF other than paroxysmal and higher CHADS2 and CHA2DS2-VASc stroke risk-stratification scores.

“TEE imaging in select patients at an elevated risk of LA thrombus, despite anticoagulation status, may be a reasonable approach to minimize the risk of thromboembolic complications following cardioversion or catheter ablation,” propose the study’s authors, led by Antony Lurie, BMSC, Population Health Research Institute, Hamilton, Ont. Their report was published in the June 15 issue of the Journal of the American College of Cardiology.

Guidelines don’t encourage TEE before cardioversion in patients who have been on OAC for at least 3 weeks, the group notes, and policies on TEE use before AF ablation vary widely regardless of anticoagulation status.

The current study suggests that 3 weeks of OAC isn’t enough for a substantial number of patients, who might be put at thromboembolic risk if TEE were to be skipped before rhythm-control procedures.

Conversely, many patients unlikely to have LA thrombi get preprocedure TEE anyway. That can happen “irrespective of how long they’ve been anticoagulated, their pattern of atrial fibrillation, or their stroke risk,” senior author Jorge A. Wong, MD, MPH, Population Health Research Institute and McMaster University, Hamilton, Ont., told this news organization.

But “TEE is an invasive imaging modality, so it is associated with small element of risk.” The current study, Dr. Wong said, points to potential risk-stratification tools clinicians might use to guide more selective TEE screening.

“At sites where TEEs are done all the time for patients undergoing ablation, one could use several of these risk markers to perhaps tailor use of TEE in individuals,” Dr. Wong said. “For example, in people with paroxysmal atrial fibrillation, we found that the risk of left atrial appendage clot was approximately 1% or less.” Screening by TEE might reasonably be avoided in such patients.

“Fortunately, continued oral anticoagulation already yields low peri-procedural stroke rates,” observes an accompanying editorial from Paulus Kirchhof, MD, and Christoph Sinning, MD, from the University Heart & Vascular Center and German Centre of Cardiovascular Research, Hamburg.

“Based on this new analysis of existing data, a risk-based use of TEE imaging in anticoagulated patients could enable further improvement in the safe delivery of rhythm control interventions in patients with AF,” the editorialists agree.

The meta-analysis covered 10 prospective and 25 retrospective studies with a total of 14,653 patients that reported whether LA thrombus was present in patients with AF or atrial flutter (AFL) who underwent TEE after at least 3 weeks of VKA or DOAC therapy. Reports for 30 of the studies identified patients by rhythm-control procedure, and the remaining five didn’t specify TEE indications.

The weighted mean prevalence of LA thrombus at TEE was 2.73% (95% confidence interval, 1.95%-3.80%). The finding was not significantly changed in separate sensitivity analyses, the report says, including one limited to studies with low risk of bias and others excluding patients with valvular AF, interrupted OAC, heparin bridging, or subtherapeutic anticoagulation, respectively.

Patients treated with VKA and DOACs showed similar prevalences of LA thrombi, with means of 2.80% and 3.12%, respectively (P = .674). The prevalence was significantly higher in patients:

• with nonparoxysmal than with paroxysmal AF/AFL (4.81% vs. 1.03%; P < .001)
• undergoing cardioversion than ablation (5.55% vs. 1.65; P < .001)
• with CHA2DS2-VASc scores of at least 3 than with scores of 2 or less (6.31% vs. 1.06%; P < .001).

A limitation of the study, observe Dr. Kirchhof and Dr. Sinning, “is that all patients had a clinical indication for a TEE, which might be a selection bias. When a thrombus was found on TEE, clinical judgment led to postponing of the procedure,” thereby avoiding potential thromboembolism.

“Thus, the paper cannot demonstrate that presence of a thrombus on TEE is related to peri-procedural ischemic stroke,” they write.

The literature puts the risk for stroke or systemic embolism at well under 1% for patients anticoagulated with either VKA or DOACs for at least 3 weeks prior to cardioversion, in contrast to the nearly 3% prevalence of LA appendage thrombus by TEE in the current analysis, Dr. Wong observed.

“So we’re seeing a lot more left atrial appendage thrombus than we would see stroke,” but there wasn’t a way to determine whether that increases the stroke risk, he agreed.Dr. Wong, Dr. Lurie, and the other authors report no relevant conflicts. Dr. Kirchhof discloses receiving partial support “from several drug and device companies active in atrial fibrillation” and to being listed as inventor on two AF-related patents held by the University of Birmingham. Dr. Sinning reports no relevant relationships. 

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

Graduates of international medical schools died from COVID-19 in disproportionate numbers in the United States in 2020, researchers report.

“I’ve always felt that international medical graduates [IMGs] in America are largely invisible,” said senior author Abraham Verghese, MD, MFA, an infectious disease specialist at Stanford (Calif.) University. “Everyone is aware that there are foreign doctors, but very few are aware of how many there are and also how vital they are to providing health care in America.”

IMGs made up 25% of all U.S. physicians in 2020 but accounted for 45% of those whose deaths had been attributed to COVID-19 through Nov. 23, 2020, Deendayal Dinakarpandian, MD, PhD, clinical associate professor of medicine at Stanford (Calif.) University, and colleagues report in JAMA Network Open.

IMGs are more likely to work in places where the incidence of COVID-19 is high and in facilities with fewer resources, Dr. Verghese said in an interview. “So, it’s not surprising that they were on the front lines when this thing came along,” he said.

To see whether their vulnerability affected their risk for death, Dr. Dinakarpandian and colleagues collected data from Nov. 23, 2020, from three sources of information regarding deaths among physicians: MedPage Today, which used investigative and voluntary reporting; Medscape, which used voluntary reporting of verifiable information; and a collaboration of The Guardian and Kaiser Health News, which used investigative reporting.

The Medscape project was launched on April 1, 2020. The MedPage Today and The Guardian/Kaiser Health News projects were launched on April 8, 2020.

Dr. Verghese and colleagues researched obituaries and news articles referenced by the three projects to verify their data. They used DocInfo to ascertain the deceased physicians’ medical schools.

After eliminating duplications from the lists, the researchers counted 132 physician deaths in 28 states. Of these, 59 physicians had graduated from medical schools outside the United States, a death toll 1.8 times higher than the proportion of IMGs among U.S. physicians (95% confidence interval, 1.52-2.21; P < .001).

New York, New Jersey, and Florida accounted for 66% of the deaths among IMGs but for only 45% of the deaths among U.S. medical school graduates.

Within each state, the proportion of IMGs among deceased physicians was not statistically different from their proportion among physicians in those states, with the exception of New York.

Two-thirds of the physicians’ deaths occurred in states where IMGs make up a larger proportion of physicians than in the nation as a whole. In these states, the incidence of COVID-19 was high at the start of the pandemic.

In New York, IMGs accounted for 60% of physician deaths, which was 1.62 times higher (95% CI, 1.26-2.09; P = .005) than the 37% among New York physicians overall.

Physicians who were trained abroad frequently can’t get into the most prestigious residency programs or into the highest paid specialties and are more likely to serve in primary care, Dr. Verghese said. Overall, 60% of the physicians who died of COVID-19 worked in primary care.

IMGs often staff hospitals serving low-income communities and communities of color, which were hardest hit by the pandemic and where personal protective equipment was hard to obtain, said Dr. Verghese.

In addition to these risks, IMGs sometimes endure racism, said Dr. Verghese, who obtained his medical degree at Madras Medical College, Chennai, India. “We’ve actually seen in the COVID era, in keeping with the sort of political tone that was set in Washington, that there’s been a lot more abuses of both foreign physicians and foreign looking physicians – even if they’re not foreign trained – and nurses by patients who have been given license. And I want to acknowledge the heroism of all these physicians.”

The study was partially funded by the Presence Center at Stanford. Dr. Verghese is a regular contributor to Medscape. He served on the advisory board for Gilead Sciences, serves as a speaker or a member of a speakers bureau for Leigh Bureau, and receives royalties from Penguin Random House and Simon & Schuster.

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

Graduates of international medical schools died from COVID-19 in disproportionate numbers in the United States in 2020, researchers report.

“I’ve always felt that international medical graduates [IMGs] in America are largely invisible,” said senior author Abraham Verghese, MD, MFA, an infectious disease specialist at Stanford (Calif.) University. “Everyone is aware that there are foreign doctors, but very few are aware of how many there are and also how vital they are to providing health care in America.”

IMGs made up 25% of all U.S. physicians in 2020 but accounted for 45% of those whose deaths had been attributed to COVID-19 through Nov. 23, 2020, Deendayal Dinakarpandian, MD, PhD, clinical associate professor of medicine at Stanford (Calif.) University, and colleagues report in JAMA Network Open.

IMGs are more likely to work in places where the incidence of COVID-19 is high and in facilities with fewer resources, Dr. Verghese said in an interview. “So, it’s not surprising that they were on the front lines when this thing came along,” he said.

To see whether their vulnerability affected their risk for death, Dr. Dinakarpandian and colleagues collected data from Nov. 23, 2020, from three sources of information regarding deaths among physicians: MedPage Today, which used investigative and voluntary reporting; Medscape, which used voluntary reporting of verifiable information; and a collaboration of The Guardian and Kaiser Health News, which used investigative reporting.

The Medscape project was launched on April 1, 2020. The MedPage Today and The Guardian/Kaiser Health News projects were launched on April 8, 2020.

Dr. Verghese and colleagues researched obituaries and news articles referenced by the three projects to verify their data. They used DocInfo to ascertain the deceased physicians’ medical schools.

After eliminating duplications from the lists, the researchers counted 132 physician deaths in 28 states. Of these, 59 physicians had graduated from medical schools outside the United States, a death toll 1.8 times higher than the proportion of IMGs among U.S. physicians (95% confidence interval, 1.52-2.21; P < .001).

New York, New Jersey, and Florida accounted for 66% of the deaths among IMGs but for only 45% of the deaths among U.S. medical school graduates.

Within each state, the proportion of IMGs among deceased physicians was not statistically different from their proportion among physicians in those states, with the exception of New York.

Two-thirds of the physicians’ deaths occurred in states where IMGs make up a larger proportion of physicians than in the nation as a whole. In these states, the incidence of COVID-19 was high at the start of the pandemic.

In New York, IMGs accounted for 60% of physician deaths, which was 1.62 times higher (95% CI, 1.26-2.09; P = .005) than the 37% among New York physicians overall.

Physicians who were trained abroad frequently can’t get into the most prestigious residency programs or into the highest paid specialties and are more likely to serve in primary care, Dr. Verghese said. Overall, 60% of the physicians who died of COVID-19 worked in primary care.

IMGs often staff hospitals serving low-income communities and communities of color, which were hardest hit by the pandemic and where personal protective equipment was hard to obtain, said Dr. Verghese.

In addition to these risks, IMGs sometimes endure racism, said Dr. Verghese, who obtained his medical degree at Madras Medical College, Chennai, India. “We’ve actually seen in the COVID era, in keeping with the sort of political tone that was set in Washington, that there’s been a lot more abuses of both foreign physicians and foreign looking physicians – even if they’re not foreign trained – and nurses by patients who have been given license. And I want to acknowledge the heroism of all these physicians.”

The study was partially funded by the Presence Center at Stanford. Dr. Verghese is a regular contributor to Medscape. He served on the advisory board for Gilead Sciences, serves as a speaker or a member of a speakers bureau for Leigh Bureau, and receives royalties from Penguin Random House and Simon & Schuster.

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

Graduates of international medical schools died from COVID-19 in disproportionate numbers in the United States in 2020, researchers report.

“I’ve always felt that international medical graduates [IMGs] in America are largely invisible,” said senior author Abraham Verghese, MD, MFA, an infectious disease specialist at Stanford (Calif.) University. “Everyone is aware that there are foreign doctors, but very few are aware of how many there are and also how vital they are to providing health care in America.”

IMGs made up 25% of all U.S. physicians in 2020 but accounted for 45% of those whose deaths had been attributed to COVID-19 through Nov. 23, 2020, Deendayal Dinakarpandian, MD, PhD, clinical associate professor of medicine at Stanford (Calif.) University, and colleagues report in JAMA Network Open.

IMGs are more likely to work in places where the incidence of COVID-19 is high and in facilities with fewer resources, Dr. Verghese said in an interview. “So, it’s not surprising that they were on the front lines when this thing came along,” he said.

To see whether their vulnerability affected their risk for death, Dr. Dinakarpandian and colleagues collected data from Nov. 23, 2020, from three sources of information regarding deaths among physicians: MedPage Today, which used investigative and voluntary reporting; Medscape, which used voluntary reporting of verifiable information; and a collaboration of The Guardian and Kaiser Health News, which used investigative reporting.

The Medscape project was launched on April 1, 2020. The MedPage Today and The Guardian/Kaiser Health News projects were launched on April 8, 2020.

Dr. Verghese and colleagues researched obituaries and news articles referenced by the three projects to verify their data. They used DocInfo to ascertain the deceased physicians’ medical schools.

After eliminating duplications from the lists, the researchers counted 132 physician deaths in 28 states. Of these, 59 physicians had graduated from medical schools outside the United States, a death toll 1.8 times higher than the proportion of IMGs among U.S. physicians (95% confidence interval, 1.52-2.21; P < .001).

New York, New Jersey, and Florida accounted for 66% of the deaths among IMGs but for only 45% of the deaths among U.S. medical school graduates.

Within each state, the proportion of IMGs among deceased physicians was not statistically different from their proportion among physicians in those states, with the exception of New York.

Two-thirds of the physicians’ deaths occurred in states where IMGs make up a larger proportion of physicians than in the nation as a whole. In these states, the incidence of COVID-19 was high at the start of the pandemic.

In New York, IMGs accounted for 60% of physician deaths, which was 1.62 times higher (95% CI, 1.26-2.09; P = .005) than the 37% among New York physicians overall.

Physicians who were trained abroad frequently can’t get into the most prestigious residency programs or into the highest paid specialties and are more likely to serve in primary care, Dr. Verghese said. Overall, 60% of the physicians who died of COVID-19 worked in primary care.

IMGs often staff hospitals serving low-income communities and communities of color, which were hardest hit by the pandemic and where personal protective equipment was hard to obtain, said Dr. Verghese.

In addition to these risks, IMGs sometimes endure racism, said Dr. Verghese, who obtained his medical degree at Madras Medical College, Chennai, India. “We’ve actually seen in the COVID era, in keeping with the sort of political tone that was set in Washington, that there’s been a lot more abuses of both foreign physicians and foreign looking physicians – even if they’re not foreign trained – and nurses by patients who have been given license. And I want to acknowledge the heroism of all these physicians.”

The study was partially funded by the Presence Center at Stanford. Dr. Verghese is a regular contributor to Medscape. He served on the advisory board for Gilead Sciences, serves as a speaker or a member of a speakers bureau for Leigh Bureau, and receives royalties from Penguin Random House and Simon & Schuster.

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

A new clinical score has been developed, and externally validated, to identify patients at risk of bleeding after transcatheter aortic valve replacement (TAVR).

“Despite the TAVR iterations, we recognize that bleeding remains a very important and perhaps also neglected issue. Indeed, no specifically developed standard algorithm existed before this to assess bleeding risk post-TAVR,” lead author Eliano Pio Navarese, MD, PhD, said in an interview.

Although bleeding rates can be as high as 9% at 30 days and between 3% and 11% in the first year, only a few studies have applied existing scores to TAVR patients, he noted.

The PREDICT-TAVR score includes six common variables and can be calculated by hand using a simple nomogram or a web-based calculator, with a dedicated website in the works, said Dr. Navarese, Nicolaus Copernicus University and SIRO MEDICINE Network, Bydgoszcz, Poland, and the University of Alberta, Edmonton.

A strength of the score is that machine-learning methods were used and the choice of variables optimized through recursive feature elimination and cross validation to remove the weakest variables, he said. Artificial intelligence, including use of random forest, naïve Bayes, and logistic regression classifiers, was also applied to the algorithms and the results cross-checked with standard multivariate analysis.

“It was a tremendous effort in terms of the analytics conducted,” Dr. Navarese said. “This is not a simple score but the integration of the most sophisticated machine learning methods and algorithms.”

Details are published in the June 14 issue of JACC: Cardiovascular Interventions.

The six variables used to calculate 30-day bleeding risk after TAVR and the points assigned to each are:

• blood hemoglobin (0-10 points)
• serum iron concentration (0-5 points)
• common femoral artery diameter (0-3 points)
•  (0-3 points)
• dual antiplatelet therapy (DAPT; 0-2 points)
• oral anticoagulation therapy (0-2 points)

The six items were selected among 104 baseline variables from 5,185 consecutive patients undergoing transfemoral TAVR in the prospective RISPEVA (Registro Italiano GISE sull’Impianto di Valvola Aortica Percutanea) registry between March 2012 and December 2019, then validated in 5,043 patients in the prospective POL-TAVI (Polish Registry of Transcatheter Aortic Valve Implantation) between January 2013 and December 2019.

In the derivation cohort, 216 patients (4.2%) experienced bleeding events at 1 year, with 169 events (78%) occurring during the first 30 days.

PREDICT-TAVR exhibited high discriminatory power for bleeding events at 30 days, as reflected by an area under the curve (AUC) of 0.80 (95% confidence interval, 0.75-0.83). Internal validation by optimism bootstrap-corrected AUC was consistent at 0.79 (95% CI, 0.75-0.83).

PREDICT-TAVR also outperformed scores not developed for TAVR, such as the PARIS score for patients undergoing percutaneous coronary intervention (AUC, 0.69) and the well-validated HAS-BLED for patients receiving anticoagulation (AUC, 0.58; P < .001 for both).

In the validation cohort, the AUC for bleeding complications at 30 days was 0.78 (95% CI, 0.72-0.82) versus an AUC of 0.68 for PARIS and 0.66 for HAS-BLED.

A HAS-BLED score of 4 predicted a higher rate of severe bleeding and mortality in the year after transfemoral TAVR in the 2018 Japanese OCEAN-TAVI study.
 

Bleeding events by risk categories

Risk score quartiles identified as low risk were 8 points or less, as moderate risk were 8 to less than 10 points, as high risk were 10 to less than 12 points, and as very-high-risk score were above 12 points.

In the derivation cohort, 30-day bleeding events across quartiles were 0.8%, 1.1%, 2.5%, and 8.5%, respectively (overall P < .001).

Compared with the lowest quartile, bleeding risk was numerically higher for the second quartile (odds ratio, 1.75) and significantly higher in the third (OR, 2.0) and fourth (OR, 2.49) quartiles (P < .001 for both).

A landmark cumulative-event analysis showed a significantly greater risk of bleeding for the two highest quartiles up to 30 days; however, these differences were no longer significant from 30 days to 1 year, likely because of a limited number of events, the authors suggest. Similar results were seen in the validation cohort.

The number of patients in the high- and very-high-risk groups isn’t trivial, and bleeding rates reached as high as 12.6% in the highest quartile, Dr. Navarese observed. Guidelines recommend DAPT for 3 to 6 months after TAVR; however, emerging data, including a recent meta-analysis, suggest monotherapy may be a very good option.

“So, if you had a high bleeding risk and are considering postprocedural DAPT or anticoagulation, I would think twice rather than administering dual antiplatelet therapy or anticoagulation for a long time, or at least, I would consider the impact of this score on this choice,” he said.

Subgroup analyses showed AUCs ranging from 0.77 to 0.81 for subgroups such as age older than 80 years, diabetes, obesity, female sex, previous PCI, and New York Heart Association class III or IV.

Serum iron showed the highest AUC in the primary PREDICT-TAVR model; however, should iron levels be unavailable, a simplified score modeled without iron levels retained predictive power, yielding AUCs for 30-day bleeding of 0.78 in the derivation cohort and 0.75 in the validation cohort.

“PREDICT-TAVR score can impact clinical practice, not only selecting the optimal thrombotic regimen in certain high bleeding-risk populations but also to treat pre-TAVR anemia and iron deficiencies, which may affect outcomes,” Dr. Navarese said. “Of course, future prospective biological and clinical investigations are needed to elucidate the score and the role of the score’s treatable risk traits in reducing post-TAVR bleeding complications.”

Commenting for this news organization, Sunil Rao, MD, Duke University, Durham, N.C., said anemia is a covariant in many risk models for bleeding and vascular complications in PCI and acute coronary syndrome, but hemoglobin and iron levels are collinear.

“The problem I think is when you throw hemoglobin and iron in the same model, just by play of chance, one variable can knock out the other one,” he said. “So I don’t know necessarily if we need to start measuring iron on everyone. We certainly should be measuring hemoglobin, which I think most people will have, and if a patient has pre-existing anemia, that should be a red flag for us.”

Age and Society of Thoracic Surgeons (STS) risk score did not reach statistical significance in the model – likely reflecting the high-/extremely-high-risk patient population with an average STS score of 7.7 and average age of 82 years – but may become more important as TAVR is applied more widely, Dr. Rao and Zachary Wegermann, MD, Duke Clinical Research Institute, write in an accompanying editorial.

They also point out that the study was limited by a low rate of bleeding events, and, importantly, the score can’t distinguish between minor or major bleeding.

“It’s worth trying to repeat the analyses in lower-risk patients because we may find other covariates that are important,” Dr. Rao said in an interview. “The other thing we need to get to is probably being a little bit more sophisticated. The variables included in these models are the ones that are measured; they’re also the ones that are clinically apparent.”

“But there’s a whole area of genomic medicine, proteomic medicine, metabolomic medicine that, as it starts developing and becomes more and more sophisticated, my suspicion is that we’re going to get even more precise and accurate about patients’ risk, and it’s going to become more individualized, rather than just measuring variables like age and lab values,” he said.

In the meantime, having variables documented in the electronic health record, with hard stops deployed if variables aren’t measured, is “a step in the right direction,” he added.

Dr. Navarese has received research grants from Abbott, Amgen, and Medtronic and received lecture fees and honoraria from Amgen, AstraZeneca, Bayer, Pfizer, and Sanofi-Regeneron, outside the submitted work. Dr. Rao and Dr. Wegermann report no relevant financial disclosures.

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

A new clinical score has been developed, and externally validated, to identify patients at risk of bleeding after transcatheter aortic valve replacement (TAVR).

“Despite the TAVR iterations, we recognize that bleeding remains a very important and perhaps also neglected issue. Indeed, no specifically developed standard algorithm existed before this to assess bleeding risk post-TAVR,” lead author Eliano Pio Navarese, MD, PhD, said in an interview.

Although bleeding rates can be as high as 9% at 30 days and between 3% and 11% in the first year, only a few studies have applied existing scores to TAVR patients, he noted.

The PREDICT-TAVR score includes six common variables and can be calculated by hand using a simple nomogram or a web-based calculator, with a dedicated website in the works, said Dr. Navarese, Nicolaus Copernicus University and SIRO MEDICINE Network, Bydgoszcz, Poland, and the University of Alberta, Edmonton.

A strength of the score is that machine-learning methods were used and the choice of variables optimized through recursive feature elimination and cross validation to remove the weakest variables, he said. Artificial intelligence, including use of random forest, naïve Bayes, and logistic regression classifiers, was also applied to the algorithms and the results cross-checked with standard multivariate analysis.

“It was a tremendous effort in terms of the analytics conducted,” Dr. Navarese said. “This is not a simple score but the integration of the most sophisticated machine learning methods and algorithms.”

Details are published in the June 14 issue of JACC: Cardiovascular Interventions.

The six variables used to calculate 30-day bleeding risk after TAVR and the points assigned to each are:

• blood hemoglobin (0-10 points)
• serum iron concentration (0-5 points)
• common femoral artery diameter (0-3 points)
•  (0-3 points)
• dual antiplatelet therapy (DAPT; 0-2 points)
• oral anticoagulation therapy (0-2 points)

The six items were selected among 104 baseline variables from 5,185 consecutive patients undergoing transfemoral TAVR in the prospective RISPEVA (Registro Italiano GISE sull’Impianto di Valvola Aortica Percutanea) registry between March 2012 and December 2019, then validated in 5,043 patients in the prospective POL-TAVI (Polish Registry of Transcatheter Aortic Valve Implantation) between January 2013 and December 2019.

In the derivation cohort, 216 patients (4.2%) experienced bleeding events at 1 year, with 169 events (78%) occurring during the first 30 days.

PREDICT-TAVR exhibited high discriminatory power for bleeding events at 30 days, as reflected by an area under the curve (AUC) of 0.80 (95% confidence interval, 0.75-0.83). Internal validation by optimism bootstrap-corrected AUC was consistent at 0.79 (95% CI, 0.75-0.83).

PREDICT-TAVR also outperformed scores not developed for TAVR, such as the PARIS score for patients undergoing percutaneous coronary intervention (AUC, 0.69) and the well-validated HAS-BLED for patients receiving anticoagulation (AUC, 0.58; P < .001 for both).

In the validation cohort, the AUC for bleeding complications at 30 days was 0.78 (95% CI, 0.72-0.82) versus an AUC of 0.68 for PARIS and 0.66 for HAS-BLED.

A HAS-BLED score of 4 predicted a higher rate of severe bleeding and mortality in the year after transfemoral TAVR in the 2018 Japanese OCEAN-TAVI study.
 

Bleeding events by risk categories

Risk score quartiles identified as low risk were 8 points or less, as moderate risk were 8 to less than 10 points, as high risk were 10 to less than 12 points, and as very-high-risk score were above 12 points.

In the derivation cohort, 30-day bleeding events across quartiles were 0.8%, 1.1%, 2.5%, and 8.5%, respectively (overall P < .001).

Compared with the lowest quartile, bleeding risk was numerically higher for the second quartile (odds ratio, 1.75) and significantly higher in the third (OR, 2.0) and fourth (OR, 2.49) quartiles (P < .001 for both).

A landmark cumulative-event analysis showed a significantly greater risk of bleeding for the two highest quartiles up to 30 days; however, these differences were no longer significant from 30 days to 1 year, likely because of a limited number of events, the authors suggest. Similar results were seen in the validation cohort.

The number of patients in the high- and very-high-risk groups isn’t trivial, and bleeding rates reached as high as 12.6% in the highest quartile, Dr. Navarese observed. Guidelines recommend DAPT for 3 to 6 months after TAVR; however, emerging data, including a recent meta-analysis, suggest monotherapy may be a very good option.

“So, if you had a high bleeding risk and are considering postprocedural DAPT or anticoagulation, I would think twice rather than administering dual antiplatelet therapy or anticoagulation for a long time, or at least, I would consider the impact of this score on this choice,” he said.

Subgroup analyses showed AUCs ranging from 0.77 to 0.81 for subgroups such as age older than 80 years, diabetes, obesity, female sex, previous PCI, and New York Heart Association class III or IV.

Serum iron showed the highest AUC in the primary PREDICT-TAVR model; however, should iron levels be unavailable, a simplified score modeled without iron levels retained predictive power, yielding AUCs for 30-day bleeding of 0.78 in the derivation cohort and 0.75 in the validation cohort.

“PREDICT-TAVR score can impact clinical practice, not only selecting the optimal thrombotic regimen in certain high bleeding-risk populations but also to treat pre-TAVR anemia and iron deficiencies, which may affect outcomes,” Dr. Navarese said. “Of course, future prospective biological and clinical investigations are needed to elucidate the score and the role of the score’s treatable risk traits in reducing post-TAVR bleeding complications.”

Commenting for this news organization, Sunil Rao, MD, Duke University, Durham, N.C., said anemia is a covariant in many risk models for bleeding and vascular complications in PCI and acute coronary syndrome, but hemoglobin and iron levels are collinear.

“The problem I think is when you throw hemoglobin and iron in the same model, just by play of chance, one variable can knock out the other one,” he said. “So I don’t know necessarily if we need to start measuring iron on everyone. We certainly should be measuring hemoglobin, which I think most people will have, and if a patient has pre-existing anemia, that should be a red flag for us.”

Age and Society of Thoracic Surgeons (STS) risk score did not reach statistical significance in the model – likely reflecting the high-/extremely-high-risk patient population with an average STS score of 7.7 and average age of 82 years – but may become more important as TAVR is applied more widely, Dr. Rao and Zachary Wegermann, MD, Duke Clinical Research Institute, write in an accompanying editorial.

They also point out that the study was limited by a low rate of bleeding events, and, importantly, the score can’t distinguish between minor or major bleeding.

“It’s worth trying to repeat the analyses in lower-risk patients because we may find other covariates that are important,” Dr. Rao said in an interview. “The other thing we need to get to is probably being a little bit more sophisticated. The variables included in these models are the ones that are measured; they’re also the ones that are clinically apparent.”

“But there’s a whole area of genomic medicine, proteomic medicine, metabolomic medicine that, as it starts developing and becomes more and more sophisticated, my suspicion is that we’re going to get even more precise and accurate about patients’ risk, and it’s going to become more individualized, rather than just measuring variables like age and lab values,” he said.

In the meantime, having variables documented in the electronic health record, with hard stops deployed if variables aren’t measured, is “a step in the right direction,” he added.

Dr. Navarese has received research grants from Abbott, Amgen, and Medtronic and received lecture fees and honoraria from Amgen, AstraZeneca, Bayer, Pfizer, and Sanofi-Regeneron, outside the submitted work. Dr. Rao and Dr. Wegermann report no relevant financial disclosures.

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

A new clinical score has been developed, and externally validated, to identify patients at risk of bleeding after transcatheter aortic valve replacement (TAVR).

“Despite the TAVR iterations, we recognize that bleeding remains a very important and perhaps also neglected issue. Indeed, no specifically developed standard algorithm existed before this to assess bleeding risk post-TAVR,” lead author Eliano Pio Navarese, MD, PhD, said in an interview.

Although bleeding rates can be as high as 9% at 30 days and between 3% and 11% in the first year, only a few studies have applied existing scores to TAVR patients, he noted.

The PREDICT-TAVR score includes six common variables and can be calculated by hand using a simple nomogram or a web-based calculator, with a dedicated website in the works, said Dr. Navarese, Nicolaus Copernicus University and SIRO MEDICINE Network, Bydgoszcz, Poland, and the University of Alberta, Edmonton.

A strength of the score is that machine-learning methods were used and the choice of variables optimized through recursive feature elimination and cross validation to remove the weakest variables, he said. Artificial intelligence, including use of random forest, naïve Bayes, and logistic regression classifiers, was also applied to the algorithms and the results cross-checked with standard multivariate analysis.

“It was a tremendous effort in terms of the analytics conducted,” Dr. Navarese said. “This is not a simple score but the integration of the most sophisticated machine learning methods and algorithms.”

Details are published in the June 14 issue of JACC: Cardiovascular Interventions.

The six variables used to calculate 30-day bleeding risk after TAVR and the points assigned to each are:

• blood hemoglobin (0-10 points)
• serum iron concentration (0-5 points)
• common femoral artery diameter (0-3 points)
•  (0-3 points)
• dual antiplatelet therapy (DAPT; 0-2 points)
• oral anticoagulation therapy (0-2 points)

The six items were selected among 104 baseline variables from 5,185 consecutive patients undergoing transfemoral TAVR in the prospective RISPEVA (Registro Italiano GISE sull’Impianto di Valvola Aortica Percutanea) registry between March 2012 and December 2019, then validated in 5,043 patients in the prospective POL-TAVI (Polish Registry of Transcatheter Aortic Valve Implantation) between January 2013 and December 2019.

In the derivation cohort, 216 patients (4.2%) experienced bleeding events at 1 year, with 169 events (78%) occurring during the first 30 days.

PREDICT-TAVR exhibited high discriminatory power for bleeding events at 30 days, as reflected by an area under the curve (AUC) of 0.80 (95% confidence interval, 0.75-0.83). Internal validation by optimism bootstrap-corrected AUC was consistent at 0.79 (95% CI, 0.75-0.83).

PREDICT-TAVR also outperformed scores not developed for TAVR, such as the PARIS score for patients undergoing percutaneous coronary intervention (AUC, 0.69) and the well-validated HAS-BLED for patients receiving anticoagulation (AUC, 0.58; P < .001 for both).

In the validation cohort, the AUC for bleeding complications at 30 days was 0.78 (95% CI, 0.72-0.82) versus an AUC of 0.68 for PARIS and 0.66 for HAS-BLED.

A HAS-BLED score of 4 predicted a higher rate of severe bleeding and mortality in the year after transfemoral TAVR in the 2018 Japanese OCEAN-TAVI study.
 

Bleeding events by risk categories

Risk score quartiles identified as low risk were 8 points or less, as moderate risk were 8 to less than 10 points, as high risk were 10 to less than 12 points, and as very-high-risk score were above 12 points.

In the derivation cohort, 30-day bleeding events across quartiles were 0.8%, 1.1%, 2.5%, and 8.5%, respectively (overall P < .001).

Compared with the lowest quartile, bleeding risk was numerically higher for the second quartile (odds ratio, 1.75) and significantly higher in the third (OR, 2.0) and fourth (OR, 2.49) quartiles (P < .001 for both).

A landmark cumulative-event analysis showed a significantly greater risk of bleeding for the two highest quartiles up to 30 days; however, these differences were no longer significant from 30 days to 1 year, likely because of a limited number of events, the authors suggest. Similar results were seen in the validation cohort.

The number of patients in the high- and very-high-risk groups isn’t trivial, and bleeding rates reached as high as 12.6% in the highest quartile, Dr. Navarese observed. Guidelines recommend DAPT for 3 to 6 months after TAVR; however, emerging data, including a recent meta-analysis, suggest monotherapy may be a very good option.

“So, if you had a high bleeding risk and are considering postprocedural DAPT or anticoagulation, I would think twice rather than administering dual antiplatelet therapy or anticoagulation for a long time, or at least, I would consider the impact of this score on this choice,” he said.

Subgroup analyses showed AUCs ranging from 0.77 to 0.81 for subgroups such as age older than 80 years, diabetes, obesity, female sex, previous PCI, and New York Heart Association class III or IV.

Serum iron showed the highest AUC in the primary PREDICT-TAVR model; however, should iron levels be unavailable, a simplified score modeled without iron levels retained predictive power, yielding AUCs for 30-day bleeding of 0.78 in the derivation cohort and 0.75 in the validation cohort.

“PREDICT-TAVR score can impact clinical practice, not only selecting the optimal thrombotic regimen in certain high bleeding-risk populations but also to treat pre-TAVR anemia and iron deficiencies, which may affect outcomes,” Dr. Navarese said. “Of course, future prospective biological and clinical investigations are needed to elucidate the score and the role of the score’s treatable risk traits in reducing post-TAVR bleeding complications.”

Commenting for this news organization, Sunil Rao, MD, Duke University, Durham, N.C., said anemia is a covariant in many risk models for bleeding and vascular complications in PCI and acute coronary syndrome, but hemoglobin and iron levels are collinear.

“The problem I think is when you throw hemoglobin and iron in the same model, just by play of chance, one variable can knock out the other one,” he said. “So I don’t know necessarily if we need to start measuring iron on everyone. We certainly should be measuring hemoglobin, which I think most people will have, and if a patient has pre-existing anemia, that should be a red flag for us.”

Age and Society of Thoracic Surgeons (STS) risk score did not reach statistical significance in the model – likely reflecting the high-/extremely-high-risk patient population with an average STS score of 7.7 and average age of 82 years – but may become more important as TAVR is applied more widely, Dr. Rao and Zachary Wegermann, MD, Duke Clinical Research Institute, write in an accompanying editorial.

They also point out that the study was limited by a low rate of bleeding events, and, importantly, the score can’t distinguish between minor or major bleeding.

“It’s worth trying to repeat the analyses in lower-risk patients because we may find other covariates that are important,” Dr. Rao said in an interview. “The other thing we need to get to is probably being a little bit more sophisticated. The variables included in these models are the ones that are measured; they’re also the ones that are clinically apparent.”

“But there’s a whole area of genomic medicine, proteomic medicine, metabolomic medicine that, as it starts developing and becomes more and more sophisticated, my suspicion is that we’re going to get even more precise and accurate about patients’ risk, and it’s going to become more individualized, rather than just measuring variables like age and lab values,” he said.

In the meantime, having variables documented in the electronic health record, with hard stops deployed if variables aren’t measured, is “a step in the right direction,” he added.

Dr. Navarese has received research grants from Abbott, Amgen, and Medtronic and received lecture fees and honoraria from Amgen, AstraZeneca, Bayer, Pfizer, and Sanofi-Regeneron, outside the submitted work. Dr. Rao and Dr. Wegermann report no relevant financial disclosures.

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